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Government and independent contraints details
Summary
In this page we discuss constraints introduced by
government.
Federal, State and independent organizations are reviewed.
Introduction
The government has a significant impact on health care
providers.
Independent agencies
The AIDS Institute is a nonprofit is a tax strategy selected by many hospitals in the US. These hospitals, which include: Cleveland Clinic, Johns Hopkins, Massachusetts General, Mayo Clinic; are exempt from federal and local taxes because they provide a level of community benefit. They are considered charitable institutions and benefit from tax-free contributions from donors and tax-free bonds for capital projects, explains Bellevue Hospital's Dr. Danielle Ofri. Prior to 1969, community benefit had to include charity medical care, but then the tax code was altered to allow many expenses to qualify as community benefits including: Accepting Medicaid insurance at a hospital estimated loss; and charitable care became optional. The ACA encouraged hospital networks to consolidate and with this additional pricing power, revenue at the top seven nonprofits has increased 15%, while charitable care decreased 35%.
public policy and advocacy organization.
- Trump administration proposes new policies in Federal
Register, saving $900 million annually in subsidies in 2020,
2021 and $1billion in 2022, 2023, and pushing 100,000 from the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
insurance
exchanges, increasing uncompensated care costs but
reducing ACA based tax requirements. They are proposing:
- For high cost drugs with generic alternatives, reducing
copayment discounts and reducing insurer's cost sharing is the requirement for patients to pay a portion of the cost of their health care services. Such out-of-pocket payments include: copayments, deductibles and coinsurance.
contributions to the cost of the generic, ignoring
coupons. Patient groups dislike the proposed changes
seeing patients not filling their prescriptions for: HIV is human immunodeficiency virus, an RNA retrovirus which causes AIDS. It infects T-lymphocytes helper cells slowly destroying the host's immune system. The main pandemic form of HIV is HIV-1 M which has been traced back to a spillover to Cameroon/Congolese forest Chimpanzees of SIVs that weakly infected proximate humans and then was amplified by social conditions in expanding towns: Ouesso, Brazzaville, Leopoldville; down river from these forests during the 1900 - 1920s. Additional amplification occurred through public health programs: Trypanosomiasis, STDs; which cross-infected subpopulations of Leopoldville/Kinshasa around the same time. UNESCO organized Haitian support for the DRC in the 1960s vectored HIV-1 M back to Haiti where the blood plasma trade provided an evolved amplifier for HIV-1 M infected plasma to flow into the US healthcare supply chain through Miami. Some HIV's enter the lymphocytes by leveraging the T cells CCR5 protein. The HIV X4 variant leverages CXCR4. - likely
increasing costs by $3500 a year, MS is multiple sclerosis. where generic Copaxone is
$60,000 to $65,000 a year, Diabetes includes type 1 and type 2. Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections.
patients use coupons to get prescribed drugs with astronomical
deductibles
- Reduced qualifications for federal insurance subsidies and a
requirement to spend more income on insurance premiums
- Requiring insurers to provide policies that do not cover
abortions to assist religious objectors, except in states
which require coverage: California, New York, Oregon; (Jan
2019)
- Alzheimer's is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows:
- Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
plaque inhibition trial by Eli Lilly with Solanezumab
fails (Nov
2016)
Provides information on Alzheimer's
disease is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
and dementia is a classification of memory impairment, constrained feelings and enfeebled or extinct intellect. The most common form for people under 60 is FTD. Dementia has multiple causes including: vascular disease (inducing VCI) including strokes, head trauma, syphilis and mercury poisoning for treating syphilis, alcoholism, B12 deficiency (Sep 2016), privation, Androgen deprivation therapy (Oct 2016), stress, Parkinson's disease, Alzheimer's disease, and prion infections such as CJD and kuru. The condition is typically chronic and treatment long term (Laguna Honda ward) and is predicted by Stanley Prusiner to become a major burden on the health system. It may be possible to constrain the development some forms of dementia by: physical activity, hypertension management, and ongoing cognitive training. Dementia appears to develop faster in women than men.
symptoms, diagnosis, stages, treatment, care and support
resources.
Alzheimer's
association chief science officer
Alzheimer's
association 2016 chief science officer Maria Carrillo
Maria Carrillo argues that the New England Journal of Medicine
Report (Feb
2016) that the Alzheimer's association funded, shows it is
worth pushing for healthier lifestyles to accompany efforts to find
treatments for Alzheimer's
disease is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
.
Alzheimer's association director of scientific programs and
outreach
Alzheimer's
assocation Director Keith Fargo
Keith Fargo was very excited at the results of the:
Alzheimer's
Association's Keith
Fargo said "here
is a nationally representative study. It's wonderful
news."
Alzheimer's
association sponsors DIAN-TU
DIAN-TU trial (Dominantly Inherited Alzheimer Network Trials Unit)
combines solanezumab
with Roche's gantenerumab.
The trial involves people who have not yet shown signs of Alzheimer's
disease is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
but inherited an aggressive early onset gene.
The BCBS Association is a federation of 36 separate United States Blue Cross
Blue Shield health insurance organizations.
CEO Scott Serota
In more than 30 states nonprofit is a tax strategy selected by many hospitals in the US. These hospitals, which include: Cleveland Clinic, Johns Hopkins, Massachusetts General, Mayo Clinic; are exempt from federal and local taxes because they provide a level of community benefit. They are considered charitable institutions and benefit from tax-free contributions from donors and tax-free bonds for capital projects, explains Bellevue Hospital's Dr. Danielle Ofri. Prior to 1969, community benefit had to include charity medical care, but then the tax code was altered to allow many expenses to qualify as community benefits including: Accepting Medicaid insurance at a hospital estimated loss; and charitable care became optional. The ACA encouraged hospital networks to consolidate and with this additional pricing power, revenue at the top seven nonprofits has increased 15%, while charitable care decreased 35%.
Blue Cross initially developed in the early 1930s to provide health insurance for hospital treatments. Blue Cross introduced the mechanism of individuals paying premiums into a collective pool that a third party can then use to pay for medical expenditures. The subscriber base was limited until World War 2 when wages were frozen and employers offered a benefit of health insurance tied to employment. Being associated with employment made the facility regressive since those working part-time or in small businesses had to pay for services out of pocket and could induce bankruptcy. sells
the most policies to large employers, with almost a dozen capturing
three-quarters of the market according to Kaiser
family foundation data. It is the key presence in
Massachusetts, Minnesota, Oregon and Washington. Anthem Blue Cross
is the for profit BCBS.
During the great depression the AHA is the American_hospital association. encouraged the
development of Blue Cross, and other medical societies
supported the development of Blue Shield to help catalyze use of medical services.
Both payers include four types:
- From the 1930s the insurers Blue
Cross and Blue Shield catalyzed health care activity
by paying a daily per diem to hospitals for the diagnoses
and treatments the hospital's dispensed. At their
inception in 1966 Medicare and
Medicaid followed this reimbursement model.
- From 1983 Medicare and Medicaid switched to the PPS reimbursement mechanism.
This forced alignment of the
supplier, diagnosis, treatment, billing and reimbursement
processes. The health care network is still
structurally aligned around PPS. Under scrutiny of
ProPAC and its successor MedPAC,
as well as pressure of the BBA
after 1997, the payments per DRG
have been steadily reduced until it was below the cost of
care, forcing hospitals to seek margin from their other
payers. Medicare outlier
payments benefited hospitals that inflated charges and
thus became eligible.
- Employers as they experienced cost shifting from the
hospital's increased product charges moved their employees
over to managed care based
payment.
- Private payers pay hospitals directly for their
diagnosis and treatment. Typically this group has
little power. There are default rates for private
payers - typically 40% of billed charges that are not
covered by a fixed payment or a fee schedule. For
the uninsured poor until 2004 they obtained little
discount on the hospital's chargemaster
list price, because insurers and CMS
required to be charged the lowest value offered to any
patients. Medicare has now relaxed this
constraint.
reimbursed is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include: - Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
the
hospitals with a per patient daily per diem and some additional
margin.
They must offer a competitive alternative to a combined Aetna-Humana or Anthem-Cigna. They are
faced with decreasing revenues and more competition from new
entrants, such as co-op plans enabled by the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes: - Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
and Ascension, Catholic
system and North
Shore-LIJ in New York which can leverage their local
standing.
- Trump administration proposes new policies in Federal
Register, saving $900 million annually in subsidies in 2020,
2021 and $1billion in 2022, 2023, and pushing 100,000 from the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
insurance
exchanges, increasing uncompensated care costs but
reducing ACA based tax requirements. They are proposing:
- For high cost drugs with generic alternatives, reducing
copayment discounts and reducing insurer's cost sharing is the requirement for patients to pay a portion of the cost of their health care services. Such out-of-pocket payments include: copayments, deductibles and coinsurance.
contributions to the cost of the generic, ignoring
coupons. Patient groups dislike the proposed changes
seeing patients not filling their prescriptions for: HIV is human immunodeficiency virus, an RNA retrovirus which causes AIDS. It infects T-lymphocytes helper cells slowly destroying the host's immune system. The main pandemic form of HIV is HIV-1 M which has been traced back to a spillover to Cameroon/Congolese forest Chimpanzees of SIVs that weakly infected proximate humans and then was amplified by social conditions in expanding towns: Ouesso, Brazzaville, Leopoldville; down river from these forests during the 1900 - 1920s. Additional amplification occurred through public health programs: Trypanosomiasis, STDs; which cross-infected subpopulations of Leopoldville/Kinshasa around the same time. UNESCO organized Haitian support for the DRC in the 1960s vectored HIV-1 M back to Haiti where the blood plasma trade provided an evolved amplifier for HIV-1 M infected plasma to flow into the US healthcare supply chain through Miami. Some HIV's enter the lymphocytes by leveraging the T cells CCR5 protein. The HIV X4 variant leverages CXCR4. - likely
increasing costs by $3500 a year, MS is multiple sclerosis. where generic Copaxone is
$60,000 to $65,000 a year, Diabetes includes type 1 and type 2. Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections.
patients use coupons to get prescribed drugs with astronomical
deductibles
- Reduced qualifications for federal insurance subsidies and a
requirement to spend more income on insurance premiums
- Requiring insurers to provide policies that do not cover
abortions to assist religious objectors, except in states
which require coverage: California, New York, Oregon; (Jan
2019)
The Joint
Commission, JC or JCAHO is a nonprofit that accredits more than 19,000 health care organizations and programs in the United States. - Home health care: The JC is one of three groups (JC, CHAP, ACHC) recognized by the federal government as accreditors of HHAs. The JC requires its accredited HHAs receive payment from Medicare. To become accredited an HHA must undergo detailed reviews and onsite visits, including direct observation of patient caregiving, every three years.
- Hospitals: In 1965 the federal government decided that a hospital that met joint commission accreditation met the Medicare conditions of participation. MIPPA removed the joint commission's accreditation authority requiring it to submit accreditations to CMS which subsequently determines the granting of accreditation.
- Rehabilitation: Joint Commission accreditation is an alternative to CARF certification for rehabilitation.
develops standards for health care, and accredites
providers on their conformance. Its accrediation was initially
part of the congressional Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
framework but
after MIPPA is the Medicare Improvements for Patients and Providers Act of 2008. Section 125 removed the joint commission's hospital accreditation statutory-guarantee. Subsequently these accreditations had to be submitted to CMS for acceptance. is now an
agent of CMS is the centers for Medicare and Medicaid services. .
American College of Radiology (ACR is the American College of Radiology. It is HHS's PAMA applicable imaging services appropriate use criteria standards body. )
and National Electrical Manufacturers Association (NEMA) specified a
digital imaging and communications standard that evolved into the DICOM is digital imaging and communications in Medicine a ACR-NEMA standard for for distributing and viewing any kind of medical image regardless of origin. As a communications protocol it overlaps with HL7. It is difficult to distinguish on what equipment type (echocardiogram or coronary ultrasound for example) a particular image was generated because of a lack of metadata included in the standard. standard.
IDSA is working with Express Scripts
to replace Turing's
Daraprim
prescriptions with lower cost alternative generics from Imprimis
(Dec
2015).
IHA is a California organization focused on the evolution of managed care contracts together its subscribing patients with particular groups of doctors and hospitals who agree to provide contracted care for a particular price which the managed care organization reimburses. It was based on the group practice organizations: Kaiser, Mayo Clinic; operations. The initial HMOs, supported by the HMO act and PPOs has subsequently been joined by other forms of managed care. Original capitation based implementations were problematic with only Kaiser succeeding. Managed care is now enhanced by inclusion of upside measures as in alternative quality contracts. .
It is a leadership group of health plans, physician groups and
health care systems, plus large academic, consumer and
pharmaceutical industry representatives commited to policy
development, public dialogue, and special projects associated with
the continued evolution of managed health care.
National
Comprehensive Cancer Network (NCCN)
The NCCN is an alliance of the nation's leading cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). centers.
- Global cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016).
VDS is value delivery system. : ACS,
CHAI,
NCCN,
IBM (Watson), Pfizer, Cipla; will build low
cost supply chain and delivery network to combat a W.H.O. is World Health Organization a United Nations organization. estimated
increasing number of cancer sufferers in Africa (Oct
2017)
The NCCN is an important publisher of cancer treatment
guidelines. They rate treatment efficacy, toxicity and the
quality of the underlying research. They have announced they
will be publishing treatment costs as well allowing the development
of pricing
by indication is where the price of a drug is linked to the value it provides for each disease it is being used to treat. Currently Medicare pricing of specialty pharmaceuticals is not value based. Pharmaceutical companies can gather data on the value of their drugs on different tumor types for example allowing the less valuable treatments to cost less. The American Society of Clinical Oncology and the NCCN are developing scoring methods. of cancer drugs.
Members include:
The NCCN recommends mammograms is an X-ray record of the breast used for screening and diagnosis of breast cancer. Mammograms have become progressively more sensitive allowing detection of smaller tumors. This has allowed aggressive treatment practices which may be counterproductive (Aug 2015). Mammography policies are defined by: ACOG, ACS, NCCN, USPSTF;
every year starting at age 40.
NICHE is nurses improving care for healthsystem elders is a nurse driven program designed to help health care organizations improve the care of older adults. aims to improve
care of older adults. It is a nursing driven program.
Primary Health
Care Performance Initiative (PHCPI)
PHCPI is a partnership focused on the monitoring, tracking and
sharing of performance measurements by poor and middle-income PCP is a Primary Care Physician. PCPs are viewed by legislators and regulators as central to the effective management of care. When coordinated care had worked the PCP is a key participant. In most successful cases they are central. In certain Medicare ACO models (Pioneer) PCPs are committed to achieve meaningful use requirements. Working against this is the: replacement of diagnostic skills by technological solutions, low FFS leverage of the PCP compared to specialists, demotivation of battling prior authorization for expensive treatments. . It was
announced with fanfare during the UN's development meeting in New
York City Sep 2015. The PHCPI announcement event was hosted by
Germany, Ghana and Norway. The leaders now aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group. Pinker notes the evolved pressure of social rivalry associating power with leadership. Different evolved personality types reinforced during development provided hunter-gatherer bands with alternate adult capabilities for coping with the various challenges of the African savanna. As the situation changed different personalities would prove most helpful in leading the band. Big men, chiefs and leaders of early states leveraged their power over the flow of resources to capture and redistribute wealth to their supporters. As the environmental state changed and began threatening the polity's fitness, one leader would be abandoned, replaced by another who the group hoped might improve the situation for all. Sapolsky observes the disconnect that occurs between power hierarchies and wisdom in apes. In modern Anglo-American style corporations, which typically follow Malthus, and are disconnected from the superOrganism nest site, the goal of leadership has become detached from the needs of this broader polity, instead: seeking market and revenue growth, hiring and firing workers, and leveraging power to reduce these commitments further. Dorner notes that corporate executives show an appreciation of how to control a CAS. Robert Iger with personality types: Reformer, Achiever, Investigator; describes his time as Disney CEO, where he experienced a highly aligned environment, working to nurture the good and manage the bad. He notes something is always coming up. Leadership requires the ability to adapt to challenges while compartmentalizing. John Boyd: Achiever, Investigator, Challenger; could not align with the military hierarchy but developed an innovative systematic perspective which his supporters championed and politicians leveraged. John Adair developed a modern leadership methodology based on the three-circles model. of the
countries and Bill Gates attended.
The goal is to strengthen the world-wide primary care system by
first building in sensors into its infrastructure and then measuring
and modeling its operations.
In part the poor PCP response to Ebola is a viral disease discovered in 1976. It is an ancient virus branching 20 million years ago from other filoviruses. It mainly infects rodents and other mammals. It appears highly lethal when infecting Gorillas, and is also acute in humans, so we are not a reservoir for Ebola but a dead-end host. The death toll is very small compaired to influenza or Covid-19. A West African epidemic was probably reservoir hosted by forest dwelling bats and transferred to a boy. The 1976 northern Zaire (Yambuku) strain was able to spillover to humans with a case fatality rate of 88%. Sudan, Reston (Philippines), Bundibugyo (Uganda), and Tai Forest, Ebola like viruses have lower case fatality rates. The 1995 Zaire (Kikwit) outbreak was in a forest clearing close by a city of 200,000. A man who felled trees fell ill and died of hemorrhagic fever a week later. He had fatally infected three members of his family and ten of his friends. When it reached a local maternity hospital it infected a lab technician who was transferred to the general hospital where doctors, nurses and nuns were infected and the nuns and technician died. The CDC identified the pathogen as Ebola, which had killed 245 including 60 hospital staff members. The 2014 epidemic is seen as the result of a single infection. Evolutionary biologists consider it unlikely that natural selection will give the virus the ability to spread more easily. The size of the 2014 epidemic gives more potential for mutations but the current transmission mechanism is working for the virus so there is little obvious pressure for out-competition by a new transmission path. There are likely to be lots more viruses with similar infection model to Ebola. Typically an individual is not sick for three to five day after the onset of symptoms which can fool care givers. Then around day 5 to 7 they really crash. Their blood pressure goes down, they become stuporous to unresponsive, and they start to have renal and liver failure. This correlates with the enormous viral load (making it very contagious which is a significant risk to care givers), which is just attacking every organ in the body. Ebola patients lose enormous amounts of fluid from diarrhea and vomiting, as much as five to ten quarts a day during the worst phases of the illness which lasts about a week. Doctors struggle to rehydrate them, replace electrolytes and treat bleeding problems. Thomas Eric Duncan brought Ebola to Texas Health Presbyterian hospital, where the ED failed to identify his symptoms. in West Africa
stimulated the partnership.
Presently is is often not known how often health workers are present
at clinics and how accurate their diagnoses are.
Collaborators include: The Gates
Foundation, the World
Bank was setup as part of the Bretton Woods agreements, as the International Bank for Reconstruction and Development, to repair and reconstruct Europe after the Second World War and as the World Bank continues to provide reconstruction and development resources for projects in developing economies. It includes: - International Finance Corporation
and the WHO is World Health Organization a United Nations organization. .
Dr. Margaret Chan, director general of WHO argued "We need good
information. You cannot manage what you cannot measure."
The PHITC primary focus is on:
- Effective medication use
- Pharmacist's role in IT.
They have been developing a roadmap for pharmacy health information
technology integration including pp-EHR is Pharmacist/Pharmacy EHR. It is a EHR functional profile promoted by the PHITC to promote meaningful use of standardized EHR and jointly developed with HL7. .
Regulators
American
Nurses Credentialing Center (ANCC)
The ANCC is part of the ANA.
It administers the Pathway and Magnet is an American Nurses Credentialing Center award for excellence in nursing. It requires the demonstration of platforms that ensure nursing empowerment through: - Written documentation verifying the implementation of key nursing procedures.
- Site visits
- Ongoing monitoring
- The Magnet model has five elements:
- Tranformational leadership
- Structural empowerment
- Exemplary professional practice
- New knowledge, innovation & improvements
- Empirical quality outcomes
Recognition
Programs.
Assistant
secretary for preparedness and response (ASPR)
The PAHPA is pandemic and all hazards preparedness act of 2006, which resulted in the creation of the office of the ASPR. required the
setting up of ASPR is assistant secretary for preparedness and response .
2016 ASPR is Dr. Nicole Lurie
CMS is the centers for Medicare and Medicaid services. has finalized
2006 PAHPA is pandemic and all hazards preparedness act of 2006, which resulted in the creation of the office of the ASPR. / 2013 PAHPRA is the 2013 reauthorization act for PAHPA. disaster
preparedness rules for ASPR is assistant secretary for preparedness and response . The final
version of these rules is less burdensome on
providers.
ASPR includes:
- BARDA is the biomedical advanced research and development authority, an HHS ASPR office responsible for procurement and development of vaccines, drugs, therapies and diagnostic tools for public health emergencies.
:(www.phe.gov) which is
responsible for federal response to public health is the proactive planning, coordination and execution of strategies to improve and safeguard the wellbeing of the public. Its global situation is discussed in The Great Escape by Deaton. Public health in the US is coordinated by the PHS federally but is mainly executed at the state and local levels. Public health includes: - Awareness campaigns about health threatening activities including: Smoking, Over-eating, Alcohol consumption, Contamination with poisons: lead; Joint damage from over-exercise;
- Research, monitoring and control of: disease agents, reservoir and amplifier hosts, spillover and other processes, and vectors; by agencies including the CDC.
- Monitoring of the public's health by institutes including the NIH. This includes screening for cancer & heart disease.
- Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.
- Development, deployment and maintenance of vaccination strategies.
- Development, deployment and maintenance of fluoridation.
- Development, deployment and maintenance of family planning services.
- Regulation and constraint of foods, drugs and devices by agencies including the FDA.
emergencies.
ASPR's Dr. Nicole Lurie commented "The need for patient care doesn't
stop because streets are flooded or trees are down. In fact
disasters often increase the need for health care services."
Health care coalitions have formed around the US, Dr. Lurie noted to
"bring together diverse and often competitive health care
organizations to prepare for and respond to disasters. The
entire rule stresses a community approach -- we can't approach this
one facility at a time."
CMS is shaping publically funded health care through regulation:
- As CMS is the centers for Medicare and Medicaid services. turns 50
private health plan use proliferates (Jul
2015)
- Driving FFV is fee-for-value payment. It may be a bundled payment for a set of services provided by a group of doctors and facilities, or full capitation. In each case the risk has shifted from the payer to the providers of care.
transition forward for physicians with assistance from MACRA is Medicare Access and CHIP Reauthorization Act of 2015 is designed to encourage physicians to move to FFV and to link Medicare payment to quality & value. It alters the way Medicare pays for part B physician services encouraging physicians and other ECs to conform to one of two value based payment schemes: Advanced APMs (where the EC can become a QP) or MIPS. MACRA does not apply to hospitals which have their own meaningful use. MACRA is designed to promote transformation and includes: Data reporting by ECs, New practice models, Changing clinical standards, and Physician evaluations; with hundreds of millions of dollars in penalties and bonuses. It authorizes CMS to develop and deploy new rules. It provides for PCPs in PCMHs to qualify as advanced APMs via a special lower risk pathway. It replaced the problematic physician SGR formula. . The
added expense of EHR refers to electronic health records which are a synonym of EMR. EHR analysis suggests strengths and weaknesses: - The EHR provides an integrated record of the health systems notes on a patient including: Diagnosis and Treatment plans and protocols followed, Prescribed drugs with doses, Adverse drug reactions;
- The EHR does not necessarily reflect the patient's situation accurately.
- The EHR often acts as a catch-all. There is often little time for a doctor, newly attending the patient, to review and validate the historic details.
- The meaningful use requirements of HITECH and Medicare/Medicaid specify compliance of an EHR system or EHR module for specific environments such as an ambulatory or hospital in-patient setting.
- As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient. Doctors are allocated 12 minutes to interact with a patient of which less than five minutes was used for recording hand written notes. With the EHR 12 minutes may be required to update the record!
requirements may drive independent physicians out of
business.
- CMS is the centers for Medicare and Medicaid services. responds to the
increasing percentage of elderly in the population by
stimulating PACE is either:
- Protecting Affordable Coverage for Employees Act of 2015, which amends ACA title 1 to alter the definition of a small business, or
- Program of All-Inclusive Care for the Elderly, a Medicare program which pays for facilities and services to keep older and disabled Americans in their own homes instead of their having to enter nursing homes. It was intended to consequently save Medicare and Medicaid money. All states are required to pay less than the cost of a nursing home stay. It leverages the success of Britain's Day Hospitals. PACE started as On Lok, which provided capitation funded day care, to San Francisco's Asian & Italian immigrant families trying to avoid use of nursing homes. This payment model should encourage providers to keep their patients healthy. The services include dentistry, which constrains a problematic cascade of issues and rehabilitation which protects against falls. Medicare sanctioned the model in 1990. Its implementation was restricted to non-profit organizations but in 2016 CMS allowed for-profit organizations to participate (Aug 2016).
based home care for seniors (Aug
2016).
- Long-term home health care issue: Poor pay, little allocated Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
budget at
the federal or state level which resisted Obama administration FLSA is the fair labor standards act of 1938 which introduced the 40 hour work week. Franklin Roosevelt considered it the most important legislation of the New Deal after the SSA. changes,
immigrant female staff, demeaning cultural is how we do and think about things, transmitted by non-genetic means as defined by Frans de Waal. CAS theory views cultures as operating via memetic schemata evolved by memetic operators to support a cultural superorganism. Evolutionary psychology asserts that human culture reflects adaptations generated while hunting and gathering. Dehaene views culture as essentially human, shaped by exaptations and reading, transmitted with support of the neuronal workspace and stabilized by neuronal recycling. Damasio notes prokaryotes and social insects have developed cultural social behaviors. Sapolsky argues that parents must show children how to transform their genetically derived capabilities into a culturally effective toolset. He is interested in the broad differences across cultures of: Life expectancy, GDP, Death in childbirth, Violence, Chronic bullying, Gender equality, Happiness, Response to cheating, Individualist or collectivist, Enforcing honor, Approach to hierarchy; illustrating how different a person's life will be depending on the culture where they are raised. Culture: - Is deployed during pregnancy & childhood, with parental mediation. Nutrients, immune messages and hormones all affect the prenatal brain. Hormones: Testosterone with anti-Mullerian hormone masculinizes the brain by entering target cells and after conversion to estrogen binding to intracellular estrogen receptors; have organizational effects producing lifelong changes. Parenting style typically produces adults who adopt the same approach. And mothering style can alter gene regulation in the fetus in ways that transfer epigenetically to future generations! PMS symptoms vary by culture.
- Is also significantly transmitted to children by their peers during play. So parents try to control their children's peer group.
- Is transmitted to children by their neighborhoods, tribes, nations etc.
- Influences the parenting style that is considered appropriate.
- Can transform dominance into honor. There are ecological correlates of adopting honor cultures. Parents in honor cultures are typically authoritarian.
- Is strongly adapted across a meta-ethnic frontier according to Turchin.
- Across Europe was shaped by the Carolingian empire.
- Can provide varying levels of support for innovation. Damasio suggests culture is influenced by feelings:
- As motives for intellectual creation: prompting
detection and diagnosis of homeostatic
deficiencies, identifying
desirable states worthy of creative effort.
- As monitors of the success and failure of cultural
instruments and practices
- As participants in the negotiation of adjustments
required by the cultural process over time
- Produces consciousness according to Dennet.
view of
the role; are ensuring a huge shortage of home health care aides
who will be needed to support the growing elderly
population. MIT is Massachusetts Institute of Technology.
Sloan's Osterman hopes reducing system errors will justify
investment in incentivizing the role (Aug
2017)
- Fewer people are going to SNF is skilled nursing facility.
s. Many
facilities, even with Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
5 star ratings Star ratings are CMS quality ratings of health care domains. They reflect measures of outcomes including intermediate outcomes, patient experience, access and process. Care coordination (assessed by CAHPS survey) and quality improvement measures have been added. Data is sourced from health and drug plans, from CMS contractors, from surveys of enrollees, and from CMS administrative data. They reflect HEDIS data. The ACA established Star Ratings as the basis of QBPs. 5-star health plans benefit from being able to market all year round, and beneficiaries can join at any time via a SEP. Health plans with less than 3-star ratings can be terminated by CMS starting in 2015. Star ratings cover 9 domains: - Ratings of health plans (part C)
- Staying healthy: screening, tests, vaccines
- Managing chronic (long-term) conditions
- Member experience with the health plan
- Member complaints, problems getting services, and improvements in the health plans performance
- Health plan customer service
- Ratings of drug plans (part D)
- Drug plan customer service
- Member complaints, problems getting services, and improvements in the drug plan's performance
- Member experience with the drug plan
- Patient safety and accuracy of drug pricing
are closing. At 70% occupancy, revenue from assisted living is an alternative to parents joining their children's nuclear family or entering a SNF, or Greenhouse Nursinghome. Atul Gawande's Being Mortal describes the situation. Federal Medicaid does not directly cover assisted living. State Medicaid adds coverage through a federal waiver. Congressional legislation covering assisted living is limited. Assisted living providers are represented by the National Center for Assisted Living.
and independent residents, did not compensate for SNF losses,
because of costly regulatory requirements: ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes: - Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
hospital readmission have become a source of increased revenue for hospitals. But with government interested in reducing the US health care cost curve ACA's HRRP (pay-for-performance), BPCI and CTI and Interact discharge initiative have all increased the focus on unnecessary readmissions. Now the end-to-end process is under scrutiny with hospitals reengineering discharge (RED) and PAC providers using RAI and TCN.
penalties have driven many patients to be admitted to hospital
as observation
stays observation stays are inpatient like stays in hospital, except Medicare does not count the stay towards the qualification for SNF reimbursements and the copay for the observation may be considerable. The volume of outpatient observation stays has been rising. , where Medicare won't cover rehabilitation after
discharge, More outpatient surgery is being performed, Medicare
Advantage (MA) is a private provider administered health insurance plan providing access to Medicare benefits. It was originally enacted as part of BBA Medicare + Choice or Part C plans. The government funded the plan with an annual fee, based on age and severity of the subscriber's medical conditions, rather than FFS. When a Medicare eligible person enrolls in a MA plan the government pays the private provider a set amount each month. The participant pays the Medicare part B premium and if required a part C premium each month. The MA plans offer a PCP who coordinates care. And the plans have an annual limit on out-of-pocket expenses unlike traditional Medicare. When they obtain treatment they will have to pay a copayment which may be quite high for some specialists. It is the health plan's responsibility to contract the physician network that will provide the care, leaving the risk with the insurer. About 36% of Medicare beneficiaries are enrolled with Medicare Advantage by 2019. The ACA introduced quality outcome and patient satisfaction based differential payments into MA. To measure the performance it added a five-star quality rating scheme. MA plans report their quality and patient satisfaction data to CMS annually and based on the results are awarded one to five stars. The highest rated plans are provided with large additional payments. It was assumed that subscribers would shift to the highest rated plans and the other plans would improve or drop out of MA. And the ACA eliminated subsidies which the federal government used to establish Medicare Advantage. However, the Obama administration has used a $8.5 Billion demonstration project to maintain this funding. It is intended that it will eventually taper off so that the cost of Medicare Advantage coverage will be equivalent to standard Medicare. plans seek lower cost alternatives, Patients
seek other options when they can: assisted living, home
care. The 2005 DRA is the deficit reduction act of 2005. It includes a critical imperative to CMS to develop a Medicare payment reform demonstration, using standardized patient information to examine consistency of payment incentives for various Medicare populations, treated in various settings. As the 2006 budget reconciliation bill (S 1932) it included provisions expected to reduce Medicaid spending by $10 billion over 10 years. Among the rules are: - Tighter restrictions on asset transfers. Aims to reduce seniors transferring substantial amounts of their money and other assetts to relatives to be eligible for Medicaid funded long term care services. Those with $500,000 or more in home equity would be automatically disqualified from applying for Medicaid.
- Greater flexibility to impose premiums and cost-sharing and to change benefit design for certain Medicaid beneficiaries.
- Gives all states long-term care partnership programs
- Authorizes states to include home and community-based services as an optional Medicaid benefit.
allowed Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
to fund assisted living and home care alternatives to SNF
care. Most SNF businesses are at 82% occupancy.
These businesses will cut staffing to protect margins. It
is expected that as the baby boomers reach 80 the demand for SNF
will rise again (Oct
2018)
- ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
regulated health
plans ignored by doctors. CMS is the centers for Medicare and Medicaid services. pushes to tighten
requirements of networks (May
2016)
- Research by Yale's
Zack
Cooper finds out-of-network ED is emergency department. Pain is the main reason (75%) patients go to an E.D. It has traditionally been part of an acute care hospital but recently is being deployed standalone as a catchment funnel to the owning hospital. The EMTALA legislation requires E.D. treatment to stabilize every person seeking treatment by most hospitals. Unreimbursed care is supported from federal government funds. E. D. profitability has been helped by hospitals contracting with 3rd party companies who are able to improve margins through surprise billing. The standalone E.D. competes with the positioning and brand power of lower cost urgent care clinics. Commercial nature of care requires walk-ins to register to gain access to care. With the focus on treatment of pain, E.D.s are a major distributor of opioids (5% of opioid prescriptions) and a major starting point of addiction in patients but are cutting back (Jun 2016).
doctors drive surprise
billing is where a contracted service is used by a patient and the bill contains huge out-of-network charges from doctors who were consulting to the health care provider. The opportunity to catalyze profits for: hospitals, physician staffing companies; while coping with rural E.D. staff shortages is encouraging this situation. Examples include: E.D. billing (Nov 2016, Jul 2017) (Nov
2016)
- ED is emergency department. Pain is the main reason (75%) patients go to an E.D. It has traditionally been part of an acute care hospital but recently is being deployed standalone as a catchment funnel to the owning hospital. The EMTALA legislation requires E.D. treatment to stabilize every person seeking treatment by most hospitals. Unreimbursed care is supported from federal government funds. E. D. profitability has been helped by hospitals contracting with 3rd party companies who are able to improve margins through surprise billing. The standalone E.D. competes with the positioning and brand power of lower cost urgent care clinics. Commercial nature of care requires walk-ins to register to gain access to care. With the focus on treatment of pain, E.D.s are a major distributor of opioids (5% of opioid prescriptions) and a major starting point of addiction in patients but are cutting back (Jun 2016).
pricing and surprise
billing is where a contracted service is used by a patient and the bill contains huge out-of-network charges from doctors who were consulting to the health care provider. The opportunity to catalyze profits for: hospitals, physician staffing companies; while coping with rural E.D. staff shortages is encouraging this situation. Examples include: E.D. billing (Nov 2016, Jul 2017) issues associated with outsourced
servicing provided by Envision's
EmCare finds Yale's Zack
Cooper. (Jul
2017)
- Health
Management Associates investigated by government for
alleged invalid increases in admissions via ED is emergency department. Pain is the main reason (75%) patients go to an E.D. It has traditionally been part of an acute care hospital but recently is being deployed standalone as a catchment funnel to the owning hospital. The EMTALA legislation requires E.D. treatment to stabilize every person seeking treatment by most hospitals. Unreimbursed care is supported from federal government funds. E. D. profitability has been helped by hospitals contracting with 3rd party companies who are able to improve margins through surprise billing. The standalone E.D. competes with the positioning and brand power of lower cost urgent care clinics. Commercial nature of care requires walk-ins to register to gain access to care. With the focus on treatment of pain, E.D.s are a major distributor of opioids (5% of opioid prescriptions) and a major starting point of addiction in patients but are cutting back (Jun 2016).
relationships (2013)
- CMS is the centers for Medicare and Medicaid services. faces class
action court case by: CMA,
JIA, WSGR;
on admissions policies for Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
and Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
; Vidant's
Greenville
medical center observation means outpatient observation stay.
stay - not admission
- restricts patients' access to Medicare reimbursed is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include: - Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
SNF is skilled nursing facility. (Sep
2017)
- Maryland sets up All-Payer is an annual, global hospital budget that includes inpatient and outpatient hospital services. It operates under an agreement between Maryland and CMS that exempts Maryland hospitals from IPPS and OPPS. The agreement requires Maryland:
- Limit all-payer per capita inpatient and outpatient hospital cost growth to the previous 10-year growth in gross state product.
- Generate $330 million in savings to Medicare over 5 years comparing Maryland to the US overall.
- Reduce 30-day readmission rate to the unadjusted national Medicare average.
- Reduce the rate of admissions for potentially preventable conditions by nearly 30% over 5 years.
- Submit an annual report (Oct 2016) demonstrating performance over various population health measures.
model agreement with CMS is the centers for Medicare and Medicaid services.
(Oct
2016)
- Nursing homes, many without the skills to perform required
rehabilitation, are keen to admit Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
short-stay patients discharged from hospitals but not low-profit
Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. patients
(Apr
2015)
- Impacts of hospital stays on the elderly: disrupted sleep facilitates salient memory formation and removal of non-salient memories. The five different stages of the nightly sleep cycles support different aspects of memory formation. The sleep stages follow Pre-sleep and include: Stage one characterized by light sleep and lasting 10 minutes, Stage two where theta waves and sleep spindles occur, Stage three and Stage four together represent deep slow-wave sleep (SWS) with delta waves, Stage five is REM sleep; sleep cycles last between 90-110 minutes each and as the night progresses SWS times reduce and REM times increase. Sleep includes the operation of synapse synthesis and maintenance through DNA based activity including membrane trafficking, synaptic vesicle recycling, myelin structural protein formation and cholesterol and protein synthesis. Sleep also controls inflammation (Jan 2019) Sleep deprivation undermines the thalamus & nucleus accumbens management of pain.
, unappetizing
meal impacts, reduced muscle mass, poor balance, additional
medicine complications, delirium, pain emerged as a mental experience, Damasio asserts, constructed by the mind using mapping structures and events provided by nervous systems. But feeling pain is supported by older biological functions that support homeostasis. These capabilities reflect the organism's underlying emotive processes that respond to wounds: antibacterial and analgesic chemical deployment, flinching and evading actions; that occur in organisms without nervous systems. Later in evolution, after organisms with nervous systems were able to map non-neural events, the components of this complex response were 'imageable'. Today, a wound induced by an internal disease is reported by old, unmyelinated C nerve fibers. A wound created by an external cut is signalled by evolutionarily recent myelinated fibers that result in a sharp well-localized report, that initially flows to the dorsal root ganglia, then to the spinal cord, where the signals are mixed within the dorsal and ventral horns, and then are transmitted to the brain stem nuclei, thalamus and cerebral cortex. The pain of a cut is located, but it is also felt through an emotive response that stops us in our tracks. Pain amplifies the aggression response of people by interoceptive signalling of brain regions providing social emotions including the PAG projecting to the amygdala; making aggressive people more so and less aggressive people less so. Fear of pain is a significant contributor to female anxiety. Pain is the main reason people visit the ED in the US. Pain is mediated by the thalamus and nucleus accumbens, unless undermined by sleep deprivation. , internal
bleeding, anemia is a decrease in the number of red blood cells or the amount of hemoglobin in the blood. There are various types: Fanconia anemia, Iron-deficiency anemia, Pernicious anemia, Sickle-cell anemia; ,
ED is emergency department. Pain is the main reason (75%) patients go to an E.D. It has traditionally been part of an acute care hospital but recently is being deployed standalone as a catchment funnel to the owning hospital. The EMTALA legislation requires E.D. treatment to stabilize every person seeking treatment by most hospitals. Unreimbursed care is supported from federal government funds. E. D. profitability has been helped by hospitals contracting with 3rd party companies who are able to improve margins through surprise billing. The standalone E.D. competes with the positioning and brand power of lower cost urgent care clinics. Commercial nature of care requires walk-ins to register to gain access to care. With the focus on treatment of pain, E.D.s are a major distributor of opioids (5% of opioid prescriptions) and a major starting point of addiction in patients but are cutting back (Jun 2016). crowding/chaos
induced PTSD is post-traumatic stress disorder, an induced level of stress that is so troubling to the brain that it avoids processing it, change that is necessary if the stress is to be dissipated by the normal brain processes. The hippocampus loses volume. The damage to the hippocampus results in: flashbacks, becoming emotionally numb and withdrawn from other people, irritability, jumpiness, being more aggressive, having trouble sleeping and avoidance of the sensory experiences associated with the initial event. The amygdala responds to overwhelming trauma by repeatedly grabbing attention to encourage response to the emergency, increases in volume and is hyperactive and anxious. As a result it remains in a heightened state, resulting in fear of recall and further stress. PTSD is often accompanied by depression and substance abuse. It is now being realized that PTSD can be introduced into patients by traumatic treatment regimens such as ICU procedures. Traumatic head injuries, seen in athletes and soldiers can be reflected in PTSD and can subsequently become associated with prion based dementia. Some people are genetically predisposed to PTSD, with identical twins responding similarly. Another risk factor for PTSD is childhood trauma which can induce epi-genetic changes to stress processing. PTSD can be managed with CBT, and it also responds to propranolol while recalling the traumatic event, where the drug undermines the memory reconsolidation process. , forced
to walk in hospital gowns; results in post-hospital syndrome,
after discharge - have costly handoff problems reviewed by project BOOST. When discharge takes too long it ties up acute bed space which can result in adding up to 30% more (unnecessary) capacity when improved discharge would translate into additional revenue. Various interventions aim to improve the execution of the process including: CTI, TCN and RED for discharge to outpatient; InterAct for discharge to SNFs and BPIP to HHAs. Discharge information can include: - Patient info
- Behavioral summary
- Treatment history
- Medical history
- Treatment objectives
- Insurance policy
- Discharge plans
,
Yale's
Harlam Krumholz concluded, based on readmission have become a source of increased revenue for hospitals. But with government interested in reducing the US health care cost curve ACA's HRRP (pay-for-performance), BPCI and CTI and Interact discharge initiative have all increased the focus on unnecessary readmissions. Now the end-to-end process is under scrutiny with hospitals reengineering discharge (RED) and PAC providers using RAI and TCN.
being for unrelated problems to the initial cause of
hospitalization (Aug
2018)
- CMS is the centers for Medicare and Medicaid services. fraud
organization
- Obama administration details status of fraud committed against
CMS is the centers for Medicare and Medicaid services. (Apr
2014)
- CMS CMO
Patrick
Conway still practices as he shapes policy (Mar
2016)
- Trump administration leverages DOJ - U.S. Department of Justice. to remove teeth
from federal regulatory rules. Guidance
document's provide the federal government's interpretation of laws. They are typically written by federal agencies: CMS, F.D.A.; to describe how legislation should be used. The D.O.J. prosecutors watch for violation of the guidance documents as breaking the rules developed and enforced by agencies and regulators to implement congressional legislation.
conversion to rules by DOJ enforcement
authority is abandoned, leaving prosecutors and agencies: CMS is the centers for Medicare and Medicaid services. , F.D.A. Food and Drug Administration. ; who use them
with guidance that will not be enforced (Feb
2018)
- CMS is the centers for Medicare and Medicaid services. administrator
Verma enforces ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
legislation, blocking Idaho's plan to allow the sale of
stripped-down health insurance (Mar
2018).
- Austin
Frakt explains the network
that generates high spending on drugs in the US is the United States of America. : History shows just
two bumps relative to rest of world: 1997 - 2007, 2013 - 2018;
More drugs developed (1970
- 80s genomics combines recombinant DNA editing with tools: CRISPR; DNA next generation sequencing and bioinformatics to sequence, assemble and analyse genomes.
based disease treatment explosion) and approved (increased fees
from manufactures to F.D.A. Food and Drug Administration.
increased approvals rate, but by 2007 F.D.A. approval rate was
very low, and now approval standards have lowered) in these
periods: TV promotion in 1990s with reduced regulatory
constraints on advertising, New payment mechanisms: CHIP is:
- The Children's Health Insurance Program started in 1997 as part of the BBA as SCHIP. It provides health insurance coverage for children in families with income below 200 percent of the poverty line. The coverage is focused on care specialized for children including: developmental delays, chronic conditions including asthma and obesity. CHIP's funding must be iteratively re-authorized by Congress. CHIP is financed federally, but states must enroll eligible children. In many states one agency administers CHIP and Medicaid. CHIP is leveraged by families that have employer based insurance with costly premiums, so the families only cover the adults.
- Clonal Hematopoiesis of Indeterminate Potential, where stem cells develop a somatic mutation cluster pair often found in leukemia, which is expressed in white blood cells they produce. The mutation clusters give these stem cells a competitive advantage and they accumulate over time. The white blood cells form inflammatory plaques. CHIP increases with age, increasing the risk of dying, of clot fragment induced heart attacks and stroke, over the subsequent 10 years by 54%
/Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansions, MMA is: - The Medicare Modernization Act of 2003. It includes Medicare part D, the Medicare prescription drug benefit, which constrains Medicare from negotiation of its drug prices and created MAC and RAC. It was sponsored by Senator Bill Tauzin and implemented by Tom Scully.
- Mammalian meat allergy which is induced by a month prior tick bite that introduced the allergen alpha-gal. About 1% of bitten humans develop the allergy & prevalence is increasing. Humans & old world primates & monkeys don't make alpha-gal (Jul 2018). Symptoms can include: hives, anaphylactic shock, low blood pressure.
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
universal
prescription drug benefit in 2006 is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes: - E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
; supported flows/use;
MMA mandated no Medicare constraints on brand name drug prices
in US - while UK is the United Kingdom of Great Britain and Northern Ireland. and
Germany apply price/value constraints on prescribing, which
other countries, except the US, use as models
for their prescription constraints, between 2000 and 2014 30% of
the rise in drug spending attributed to price increases &
use of higher priced drugs. In 2007 patents on cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies
started to expire shifting US to generic flows. In 2013 MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. s and other precision
medicines is the integration of molecular research: genomics, proteomics, transcriptomics, metabolomics, cell signalling; and clinical data through a taxonomy based on CAS modeling overlaid on an information commons. It aims to support treatment of disease and remove the organ and symptom based methodological flaws in the ICD. Supporters of the D.S.M. note the aggressive shift to precision medicine at the NIMH under Dr. Insel, constrained useful clinical research (Nov 2015). , which are likely to provide focused value,
started to be approved, which suggests US drug spending will
escalate again in the future (Nov
2018)
- 2006 Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
demonstration program promoting cost reductions related to the
most chronically expensive patients. Example participant
is Massachusetts
General.
- CMS is the centers for Medicare and Medicaid services. administrator
Verma warns of Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
trust fund is the social securities act of 1935 was part of the second New Deal. It attempted to limit risks of old age, poverty and unemployment. It is funded through payroll taxes via FICA and SECA into the social security trust funds. Title IV of the original SSA created what became the AFDC. The Social Security Administration controls the OASI and DI trust funds. The funds are administered by the trustees. The SSA was amended in 1965 to include: - Title V is Maternal and child health services.
- Title XVIII is Medicare.
crisis. Asks CMMI is the center for Medicare and Medicaid Innovation. It is a test bed for new ways of financing and delivering care. It allowed Congress to institutionalize innovation sending a signal to providers that they would be participating in CMS driven programs that could become mainstream. It funds evaluations of innovative health care models. Under the ACA if the HHS secretary finds any of its projects would reduce Medicare spending without harming the quality of care the projects may be expanded nationwide. The CBO estimates the CMMI will save $34 billion between 2016 and 2026. CMMI projects include: - Medicare will make a bundled payment for hip and knee replacement surgery (CJR) and 90 days of follow-up care forcing hospitals to work closely with doctors, nursing homes and home health agencies.
- New ways to pay for prescription drugs, medical devices, cancer care (OCM).
- HHS secretary has invoked his 3021 authority to institute DPP.
to investigate incentives to extend the funds life time.
Democrats fear she is calling for premium support is a Republican strategy for limiting government commitments for Medicare costs. It includes two key aspects: - Subsidy set to a level established by the market rather than the government following legislative formulas. This could use the mechanism used by both Medicare part D to set its drug premium subsidy and the ACA (Title I) to set its market place plan subsidies: BCBS MN 2016 premium submission.
- Capping the growth in subsidies. The current Medicare subsidy grows at the rate of health care inflation but premium support may allow the subsidy to grow at a lower rate. If traditional Medicare becomes less attractive and loses subscribers to other types of plan it may lose its influence to set premium pricing policy.
(Oct
2017)
- CMS is the centers for Medicare and Medicaid services. has finalized
2012 Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
Shared Savings is the Medicare Shared Savings Program. The program began in 2012 with 3 year term contracts. ACO Physician groups and hospitals are eligible to participate but there must be primary care physicians in the ACO. Participating ACOs must serve > 5000 Medicare beneficiaries. The potential for a bonus payment is based on Medicare cost savings and quality metrics. Two payment models are available. Only one has downside risk involved. CMS included 'robust' quality measures to monitor the quality of care provided and beneficiary satisfaction (see fact sheet 'Improving Quality of Care for Medicare Patients: Accountable Care Organizations').
Program rules for ACO is an Accountable Care Organization. These are accredited bundles of companies which together try to offer Dartmouth-Hitchcock like business models (Dec 2015, Sep 2016) focused on wellness, improving the provision of primary care to a large group of Medicare patients, and rewarding doctors for preventing problems. Advocate health illustrates the idea. Robert Pearl notes that the transition is difficult: hospitals that find their efficiency improving should reduce the number of doctors they utilize. But any doctors that are pushed out of the ACO will likely take their patients with them, undermining the revenues that support the FFV business. The ACA regulates qualification to be a Medicare ACO. Individual organizations within a Medicare shared savings ACO continue to submit their own claims and are paid by Medicare for FFS. But the ACO is eligible for shared savings. Within the shared savings program the CMS innovation center has setup advanced payment ACOs. As an alternative to shared savings, in a Pioneer ACO, over time 50% of the FFS payments flow directly to the ACO as a bundled payment. CMS has established quality measures for ACOs for Medicare. The CMS program's purpose is to reward providers for reducing total cost of care for patients through prevention, disease management, and coordination. - CMS initiated its Physician Group Practice Demonstration in 2005. By 2008 the congressional budget office reported on Bonus-eligible organizations.
- CMS defines ACOs as organizations that "create incentives for health care providers to work together to treat an individual patient across care settings - including doctors' offices, hospitals and long-term care facilities."
- CMS has developed APMs which include ACOs, and advanced APMs where the ACOs must be risk bearing.
- CMMI accepts providers' proposals to test various payment systems including shared savings and partial capitation.
- Private market ACOs have formed including: Providence Health & Services, Blue Shield California, Anthem Blue Cross, United Health Care, BCBS Minnesota, BCBS Illinois, Humana, CIGNA, Main Health Management Coalition, BCBS Massachusetts, Aetna.
s. The final
version of these rules is less burdensome on providers.
The finalized rules weight Meaningful Use is the set of standards defined by CMS Incentive Programs that governs the use of electronic health records and allows eligible providers and hospitals to earn incentive payments by meeting specific criteria. It aims to ensure that ARRA subsidies for HIS are used to generate health improvements. It is staged: - 2011-2012 Data capture and sharing - Criteria focus on electronically capturing health information in a standardized format. Using that information to track key clinical conditions. Communicating that information for care coordination processes. Initiating the reporting of clinical quality measures and public health information. Using information to engage patients and their families in their care. Achieving meaningful use stage 1 requires meeting all core and selected menu objectives.
- 2014 Advance clinical processes - More rigorous health information exchange requirements. Increased requirements for e-prescribing and incorporating lab results. Electronic transmission of patient care summaries across multiple settings. More patient-controlled data. A patient portal is required. CMS hospital core measures, CMS hospital menu set measures, NPRMs of stage 2 meaningful use and certification criteria have been announced (2013).
- MU2 requires EHR systems to support direct messaging to send PHI to registered users.
- 2016 Improved outcomes - Improving quality, safety, and efficiency, leading to improved health outcomes. Decision support for national high-priority conditions. Patient access to self-managed tools. Access to comprehensive patient data through patient-centered HIE. Improving population health.
more highly than any other measure for quality-scoring
purposes.
- CMS is the centers for Medicare and Medicaid services. issue rule,
effective from November, constraining nursing homes reimbursed is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include:
- Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
by
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
from
using arbitration clauses in their contracts (Sep
2016)
- Doctors overcharging Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
patients
face fines and expulsion (Jan
2014)
- Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
, under
CMS is the centers for Medicare and Medicaid services. administrator
Verma, adopts bundled
payment is where the purchaser disburses a single predefined payment to cover certain combinations of hospital, physician, post-acute, or other services performed during an episode of care relating to a particular condition (unlike capitation). This bundling is assumed (Sep 2018) to allow the value delivery system to optimize around low cost high quality long term health care. With one bundled payment physicians & hospitals must coordinate care and reduce the unit costs to remain profitable. And to avoid taking on risk of expensive complications physicians & hospitals are incented to standardize and focus on quality. This optimization is dependent on quantifying the value of the outcome of the episode of care. Previously FFS payments induced excessive treatment activity. Bundled payment is included in CMS ACE demonstrations and BPCI initiatives. There are significant impacts on IT. - It is argued that effective pricing of the bundle requires marketing data which must be extracted from the historic transaction base.
- Billing and payment systems must be updated to handle the receipt and distribution of the bundled payments.
- Care delivery must be re-architected to reduce costs and improve quality.
- Monitoring sensors can be used to feed reports to ensure re-architected operations conform.
FFV is fee-for-value payment. It may be a bundled payment for a set of services provided by a group of doctors and facilities, or full capitation. In each case the risk has shifted from the payer to the providers of care. (Jan
2018)
- Austin
Frakt explains that the Trump CMS is the centers for Medicare and Medicaid services. has undermined the
CJR is CMS's comprehensive care for joint replacement bundled payment model (formerly CCJR). It is limited to performing surgeries at hospitals rather than ambulatory surgery centers, and paying only hospitals. It is novel:
- CJR is mandatory at 800 hospitals. It randomly assigned 75 markets to be subject to bundled payments for knee and hip replacements and 121 markets to use FFS payments. In 2017 the Trump CMS allowed hospitals in half the bundled payments markets to opt out and three quarters of the hospitals did so, obscuring the impact of bundled payments in the experiment (Sep 2018).
- The episode payment covers inpatient hospital services, physician fees, & 90 days of care after discharge.
- The bundle encourages post-acute care reform to reduce variation in quality & risk.
randomized trial
of Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
bundled
payments is where the purchaser disburses a single predefined payment to cover certain combinations of hospital, physician, post-acute, or other services performed during an episode of care relating to a particular condition (unlike capitation). This bundling is assumed (Sep 2018) to allow the value delivery system to optimize around low cost high quality long term health care. With one bundled payment physicians & hospitals must coordinate care and reduce the unit costs to remain profitable. And to avoid taking on risk of expensive complications physicians & hospitals are incented to standardize and focus on quality. This optimization is dependent on quantifying the value of the outcome of the episode of care. Previously FFS payments induced excessive treatment activity. Bundled payment is included in CMS ACE demonstrations and BPCI initiatives. There are significant impacts on IT. - It is argued that effective pricing of the bundle requires marketing data which must be extracted from the historic transaction base.
- Billing and payment systems must be updated to handle the receipt and distribution of the bundled payments.
- Care delivery must be re-architected to reduce costs and improve quality.
- Monitoring sensors can be used to feed reports to ensure re-architected operations conform.
(Sep
2018)
- Medicare
Advantage (MA) is a private provider administered health insurance plan providing access to Medicare benefits. It was originally enacted as part of BBA Medicare + Choice or Part C plans. The government funded the plan with an annual fee, based on age and severity of the subscriber's medical conditions, rather than FFS. When a Medicare eligible person enrolls in a MA plan the government pays the private provider a set amount each month. The participant pays the Medicare part B premium and if required a part C premium each month. The MA plans offer a PCP who coordinates care. And the plans have an annual limit on out-of-pocket expenses unlike traditional Medicare. When they obtain treatment they will have to pay a copayment which may be quite high for some specialists. It is the health plan's responsibility to contract the physician network that will provide the care, leaving the risk with the insurer. About 36% of Medicare beneficiaries are enrolled with Medicare Advantage by 2019. The ACA introduced quality outcome and patient satisfaction based differential payments into MA. To measure the performance it added a five-star quality rating scheme. MA plans report their quality and patient satisfaction data to CMS annually and based on the results are awarded one to five stars. The highest rated plans are provided with large additional payments. It was assumed that subscribers would shift to the highest rated plans and the other plans would improve or drop out of MA. And the ACA eliminated subsidies which the federal government used to establish Medicare Advantage. However, the Obama administration has used a $8.5 Billion demonstration project to maintain this funding. It is intended that it will eventually taper off so that the cost of Medicare Advantage coverage will be equivalent to standard Medicare.
plans are being provided with more funds by
Congress, but even 5 star Star ratings are CMS quality ratings of health care domains. They reflect measures of outcomes including intermediate outcomes, patient experience, access and process. Care coordination (assessed by CAHPS survey) and quality improvement measures have been added. Data is sourced from health and drug plans, from CMS contractors, from surveys of enrollees, and from CMS administrative data. They reflect HEDIS data. The ACA established Star Ratings as the basis of QBPs. 5-star health plans benefit from being able to market all year round, and beneficiaries can join at any time via a SEP. Health plans with less than 3-star ratings can be terminated by CMS starting in 2015. Star ratings cover 9 domains: - Ratings of health plans (part C)
- Staying healthy: screening, tests, vaccines
- Managing chronic (long-term) conditions
- Member experience with the health plan
- Member complaints, problems getting services, and improvements in the health plans performance
- Health plan customer service
- Ratings of drug plans (part D)
- Drug plan customer service
- Member complaints, problems getting services, and improvements in the drug plan's performance
- Member experience with the drug plan
- Patient safety and accuracy of drug pricing
plans
are denying valid care, via prior
authorization is a constraint imposed by some insurance companies prior to their agreeing to cover some prescribed medications or medical procedures. The constraint may be due to: age, medical necessity, availability of a generic alternative, or to check drug interactions. After a healthcare provider orders a service for a patient, the provider's staff will contact the patient's insurer to determine if they require prior authorization. This should result in an exception process which may involve the provider's staff manual faxing a prior authorization form to the insurer. If the service is rejected, the healthcare provider may file an appeal based on the provider's medical review process. It may take 30 days for the insurer to approve the request. , and claims by providers and patients, to
improve FFV is fee-for-value payment. It may be a bundled payment for a set of services provided by a group of doctors and facilities, or full capitation. In each case the risk has shifted from the payer to the providers of care. profits,
the HHS is the U.S. Department of Health and Human Services. inspector
general reports. The abuse is widespread and
persistent. AHIP's
Matt Eyles defended the process. Few people appeal but 75%
of those who do succeed (Oct
2018)
- Demographic bulge helps increase spend on health care by 2025
(Jul
2016).
- Lobbyists: PhRMA,
AAM,
NCPA is the national community pharmacists associations, a lobby for pharmacists.
; move to
constrain drug price concerns (Sep
2015) in Congress by: Fundraising for friendly
Congressmen: John Skimkus; Excluding Turing
from PhRMA, Shifting blame to PBM is pharmacy benefit manager. These companies, such as Caremark, were often originally PPMs. PBMs are used by payers, such as insurance plans, to manage drug provision from pharmacies to the payer's plans subscribers. PBMs can constrain drug flow to the pharmacies: CVS, Rite-Aid, Walgreens; through the PBM's formularies. s whose lobbyists,
the PCMA,
are active in courting the Trump administration, Killing CMS is the centers for Medicare and Medicaid services. Slavitt's
Innovation
center is the CMS Innovation Center. It was created by the ACA to test new models of health care delivery and payment including the Pioneer ACO and the Advance Payment ACO. It also offers technical support to providers to improve the coordination of care and share lessons learned and best practices. In 2016 Andy Slavitt proposed testing a new Medicare part B drug pricing rule, which was furiously resisted by PhRMA and blocked by Representative Skimkus collection of 242 Representative's signatures. Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
Part B
drug pricing There is a monthy premium for Part B. It may be paid directly from Social Security. Higher earners may have to pay IRMAA. Medicare payments to doctors and hospitals for Part B drugs have been based on the average sale price of the drug plus 6%. MedPac advised Congress that this may encourage prescribers to select the highest priced alternative to maximize the 6% payment. Increasingly prescribed high priced biologics increase the impact of the nudge. rule test (May
2017)
- President Trump promises to significantly reduce drug prices:
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
direct
negotiation on prices, consumer access to Canadian drug
inventories; which are popular with American voters.
Pharmaceutical companies: Amgen,
AstraZeneca, Celgene,
Eli Lilly, Genentech, Gilead, J&J, Merck, Novartis, Pfizer; spend $171.5
million, their trade associations: Biotechnology
Industry Organization, PhRMA
$10 million in first quarter; & lobbyists: BGR Government
Affairs, More than other industries; Administration: Azar,
Gottlieb;
and Congressional supporters: Kyl, Paxon, Whitfield, Andres,
Long, and staff to Dingell and Harkin; prepare to resist after
loss on Medicare
discounts (May
2018)
- Implications of Abbvie's
top selling drug Humira biologics are drugs made in living cells. Typically they are proteins developed using genetic engineering to develop the cellular host, and to customize animal source, DNA to produce human target proteins. Such biologics partially solve the problem of previous protein sources, extracted from animals or human sources, of contamination and immune responses. The strategy is very effective for blood transported proteins such as antibodies (MABs), hormones and blood factors. But intra-cellular proteins still demand delivery and accurate cell targeting. This creates analogous problems to those of gene therapy.
global
pricing, lobbying & patent strategy and treatment benefits
reviewed (Jan
2018)
- Trump administration: HHS is the U.S. Department of Health and Human Services.
secretary
Azar; considers reducing Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
drug plan
out-of-pocket costs: Pharmaceutical rebates kept by PBM is pharmacy benefit manager. These companies, such as Caremark, were often originally PPMs. PBMs are used by payers, such as insurance plans, to manage drug provision from pharmacies to the payer's plans subscribers. PBMs can constrain drug flow to the pharmacies: CVS, Rite-Aid, Walgreens; through the PBM's formularies. s & Insurers:
Humana; would be
driven to patients; reducing political pressure on drug
companies, pleasing Medicare drug end users, increasing
insurance premiums and escalating federal Medicare costs.
PhRMA:
Amgen; defended the
proposal. PBMs: PCMA,
CVS; Part D is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes: - E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
Insurers: AHIP;
disappointed (Feb
2018)
- Judges agree with hospitals that Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
locked in
errors in discharge - have costly handoff problems reviewed by project BOOST. When discharge takes too long it ties up acute bed space which can result in adding up to 30% more (unnecessary) capacity when improved discharge would translate into additional revenue. Various interventions aim to improve the execution of the process including: CTI, TCN and RED for discharge to outpatient; InterAct for discharge to SNFs and BPIP to HHAs. Discharge information can include: - Patient info
- Behavioral summary
- Treatment history
- Medical history
- Treatment objectives
- Insurance policy
- Discharge plans
levels, reducing reimbursements is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include: - Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
for hospitals: Saint
Francis Medical Center, joined by 276 others; due to
associated models for the average
cost per discharge assessment (Jul
2018)
- Yale's Zack
Cooper finds hospitals have responded to the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
and reduced Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
funding
by increasing their local power and then increasing prices
charged to private buyers (Dec
2015).
- Study by Stanford's
Liran Einav, MIT is Massachusetts Institute of Technology. 's
Amy Finkelstein & University
of Chicago's Neale Mahoney, reports LTCH is a long-term care hospital. The formal designation began as a congressional strategy to protect the 40 chronic disease hospitals from the impact of the original PPS being deployed to constrain costs in acute care hospitals in the 1980s. A historic example San Francisco's Laguna Honda Hospital is discussed in Victoria Sweet's God's Hotel. LTCH PPS reimburses at far higher rates than the PPSs for other PAC providers. Most of the more than 400 LTCHs are now operated by large for-profit health care networks: Select Medical. LTCH's trade group is the NALTH.
market has
expanded in response to high reimbursement is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include: - Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
funds
relative to other PAC providers is a Post-Acute Care provider. A three-day hospital admission and discharge are prerequisite requirements to receiving Medicare PAC services. Acute care hospitals become portals to the PAC business. Referrals are key. PAC includes different types of facility focused on different severity of illness (high to low): - Long term care Hospital (LTCH),
- Inpatient rehabilitation facility (IRF),
- Skilled nursing facility (SNF),
- Home health agency (HHA) - most acute care hospitals and EMR providers have strategies for integration with home based care,
- Outpatient rehabilitation. SNF and HHA represent 80% of discharges and expenditures. Assisted living is not part of federal Medicaid, but states often include it through a waiver.
,
but with no indication of improvements for patients over SNF is skilled nursing facility. s. Researchers
conclude $5 billion could be saved yearly by using SNF
reimbursement rates, agreeing with MedPAC is the Medicare Payment Advisory Commission. It was established by the BBA. The mandate is to advise the U.S. Congress on payments to private health plans participating in Medicare and health providers with Medicare beneficiaries. It produces two major reports each year for Congress. 's prior
recommendations, but at odds with NALTH
and Select
Medical (Aug
2018)
- Trump administration, like Obama administration before it
& MedPac is the Medicare Payment Advisory Commission. It was established by the BBA. The mandate is to advise the U.S. Congress on payments to private health plans participating in Medicare and health providers with Medicare beneficiaries. It produces two major reports each year for Congress. ,
propose removing the Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
reimbursement is the payment process for much of US health care. Reimbursement is the centralizing mechanism in the US Health care network. It associates reward flows with central planning requirements such as HITECH. Different payment methods apportion risk differently between the payer and the provider. The payment methods include: - Fee-for-service,
- Per Diem,
- Episode of Care Payment,
- Multi-provider bundled EPC,
- Condition-specific capitation,
- Full capitation.
uplift for hospital based physicians (Mar
2019)
- Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
340B requires pharmaceutical manufacturers to provide outpatient drugs at significant price discounts to eligible health care providers and other covered entities. 340B was legislated by Congress as a section of the PHSA, as a strategy to drive federal resources to more eligible patients and to provide more comprehensive services. The eligible set of hospitals was expanded by the ACA. It is not clear that all eligible hospitals have used the discounts to extend and improve services to the poor (Aug 2018).
payments to hospitals to be reduced significantly, notes VA
Boston Health Care's Austin
Frakt. Seems clear that after the program expanded,
hospitals are misusing the discount drug margin, which was ment
to fund more services for the poor. Hospital lobbyists are
fighting the reduction in court, while pharmaceutical companies
are pushing for the reductions (Aug
2018)
- President Trump signs two laws designed to block: gaging of
best price advice by pharmacists to customers (Collins act of 2018 blocks gag contracts that limit pharmacy staff advising purchasers of the cheapest option to obtain their prescription drugs. The act was sponsored by Senator Susan Collins of Maine and signed into law by President Trump.
),
Outpatient Medicare drug coverage gaging (Stabenow act of 2018 bans gag clauses from outpatient Medicare drug coverage: both Medicare Advantage and traditional FFS plans. It was sponsored by Senator Stabenow and signed into law by President Trump. );
and in an op. ed. he attacked Democrats, signalling, is an emergent capability which is used by cooperating agents to support coordination & rival agents to support control and dominance. In eukaryotic cells signalling is used extensively. A signal interacts with the exposed region of a receptor molecule inducing it to change shape to an activated form. Chains of enzymes interact with the activated receptor relaying, amplifying and responding to the signal to change the state of the cell. Many of the signalling pathways pass through the nuclear membrane and interact with the DNA to change its state. Enzymes sensitive to the changes induced in the DNA then start to operate generating actions including sending further signals. Cell signalling is reviewed by Helmreich. Signalling is a fundamental aspect of CAS theory and is discussed from the abstract CAS perspective in signals and sensors. In AWF the eukaryotic signalling architecture has been abstracted in a codelet based implementation. To be credible signals must be hard to fake. To be effective they must be easily detected by the target recipient. To be efficient they are low cost to produce and destroy. Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
for all
will be bad for retirees. The Senate resisted Democrat's
attempts to block Trump's short term, low cost, skimpy coverage,
insurance plans (Oct
2018)
- RWJ
funded RAND study, of 1,598 hospital treatment's insurance
claims, shows Parkwiew
Health, in Indiana, charges private
insurers 4 * its Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
prices. States paying the most are: Indiana, Wyoming,
Maine, Wisconsin, Montana, Colorado, Texas, Georgia, Ohio,
Washington; on average hospitals charge 2.4 * Medicare prices to
private health insurance patients. Outpatient care was 3 *
Medicare pricing; angering employers. Employers
say they must exert discipline on health care costs: will gather
data on prices and quality to decide on the best strategy: single-payer is a healthcare architecture in which there is a single financing organization. Significant aspects of single-payer include: - Strengths of single-payer:
- Removes the extensive replication of payer organizations and their different interfaces to the other healthcare entities and subscribers.
- One payment organization, removing the need to allow subscribers the yearly choice to change payer, encouraging payers to help subscribers remain healthy
- Single-payer instantiates a political monopoly on health insurance.
- Problematic implementation of single-payer in the US
- Undermines the alignment of the healthcare network, threatening profits, power structures and financial rewards. This limits the possibility of single-payer in the US: Lobbying juggernaut: Politicians, Providers, Doctors, Insurers; leveraging dislike of tax increases, The 9 out of 10 Americans who are employed or retired are satisfied with their situation, Current insurance costs are hidden from the insured: in lowered pay packages, spread over all tax payers reducing government revenues; Current private insurers would be forced to reduce costs;
- Alters one sixth of the US economy: Commercial health insurance replaced, investors impacted by transformation of business models; a huge change of high uncertainty, something evolution works to avoid by including mechanisms to force small incremental changes.
- A state: Vermont (Jan 2014); can use public funds for all health care financing while the delivery of care is provided by non-state organizations. Analogously Intermountain Healthcare's SelectHealth Share requires organizations to use Intermountain for health care finance (Feb 2016).
,
focus on best value hospitals; Insurers are not incented
to keep prices down when working for self-insured companies -
where insurers are spending the companies money and make more
revenue when the company spends more. Anthem
claims narrow
networks - When all health insurance plans are comparable on line people are expected to choose narrower less costly plans. This has the effect of encouraging providers and PCP to compete to be part of the narrow plan by reducing their charges and driving down the prices of the plans. By limiting the number of providers/doctors offered in the plans the few that are included should get more business. Across the US in 2015 39% of health plans offered in public exchanges are narrow (30 - 70% of areas providers) or ultra-narrow (30% or less of providers). In large cities narrow networks are even more common. Typically if consumers go outside of the choices offered in their narrow network they will be responsible for the high bills. There are problems induced by narrow network constraints: - Queuing issues - while a surgeon and a hospital may be in-network other agents in an operation, such as anesthesiologists or anesthetists, may not have the same set of insurance contracts. Even if a subset do, once these are allocated to a task the hospital must then manage a complex set of resource constraints to keep its ORs running. If it does this by ignoring the 'out of network' status of these necessary resources the patient will be impacted by a high bill.
- Success is more likely when the plan maintains a broad list of PCPs but a narrow list of specialists and hospitals (Oct 2016).
of hospitals is its direction to drive down
prices. One-third of all healthcare spending goes to
hospital care. Hospitals are buying physician practices is physician practice management. This consolidation of PCP practices was partly a response to Wall Street's capitalization of HMOs and hospitals in early 1990s. As Wall Street switched to financing PPMs, enabling Medpartners's purchase of Mullikin Inc., hospitals responded by buying up the PPMs. Most PPMs struggled to control costs in the capitated care framework of the 1990s. Some of these PPMs shifted to become PBMs. and
spending on new facilities. Hospitals (AHA is the American_hospital association. ) argue they lose
money on Medicare and Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. , so the
comparison is biased (May
2019)
- ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
expansion of Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. brings
surge in signups with improves: Mental health; (Jan
2014)
- Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
access
restrictions have proved fatal: Tennessee; while
expansion has reduced mortality Chicago's
Baicker & Harvard's
Sommers & Epstein found (Jan
2018)
- Rise in ED is emergency department. Pain is the main reason (75%) patients go to an E.D. It has traditionally been part of an acute care hospital but recently is being deployed standalone as a catchment funnel to the owning hospital. The EMTALA legislation requires E.D. treatment to stabilize every person seeking treatment by most hospitals. Unreimbursed care is supported from federal government funds. E. D. profitability has been helped by hospitals contracting with 3rd party companies who are able to improve margins through surprise billing. The standalone E.D. competes with the positioning and brand power of lower cost urgent care clinics. Commercial nature of care requires walk-ins to register to gain access to care. With the focus on treatment of pain, E.D.s are a major distributor of opioids (5% of opioid prescriptions) and a major starting point of addiction in patients but are cutting back (Jun 2016).
use after
Oregon expands Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
mandate (Jan
2014)
- Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
and Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. turn 50
CBO looks at future (Jul
2015)
- Demographic bulge helps increase spend on health care by 2025
(Jul
2016).
- Dementia is a classification of memory impairment, constrained feelings and enfeebled or extinct intellect. The most common form for people under 60 is FTD. Dementia has multiple causes including: vascular disease (inducing VCI) including strokes, head trauma, syphilis and mercury poisoning for treating syphilis, alcoholism, B12 deficiency (Sep 2016), privation, Androgen deprivation therapy (Oct 2016), stress, Parkinson's disease, Alzheimer's disease, and prion infections such as CJD and kuru. The condition is typically chronic and treatment long term (Laguna Honda ward) and is predicted by Stanley Prusiner to become a major burden on the health system. It may be possible to constrain the development some forms of dementia by: physical activity, hypertension management, and ongoing cognitive training. Dementia appears to develop faster in women than men. very
costly (Oct
2015)
- The ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
individual mandate is ACA quality affordable care for all Americans. It mandates community rating & essential health benefits. It includes: - Subtitle A: Immediate improvements in health care for all Americans.
- Subtitle B: Immediate actions to preserve and expand coverage.
- Subtitle C: Quality health insurance coverage for all Americans. Which reforms the health insurance markets and prohibits preexisting condition exclusions and forms of health status discrimination.
- Subtitle D: Available coverage choices for all Americans.
- Subtitle E: Affordable coverage choices for all Americans.
- Subtitle F: Shared responsibility for health care which mandates individuals and employers to pay for insurance.
- The employer mandate requires employers with more than 50 full-time workers to offer most of their employees insurance or face penalties.
builds resentment in the Democratic voting base pushing Kentucky
to a Republican governor (Nov
2015).
- Kentucky Democratic governor issues parting plea (Nov
2015).
- The problem is structural and complex (Aug
2016)
- ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
funding
adjustments and state's: Georgia's; SCOTUS refusal of Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. expansion
threatening the hospital
safety net are hospitals which care for a financially challenged patient population. There are about 300 safety-net hospitals including: Grady memorial, Harris Health, Mcleod; in the US providing longer term care to the poor and indigent than regular for-profit and non-profit acute care hospitals. This arrangement allows the other hospitals to focus on the needs of their insured customers. Once acute treatment of a life-threatening illness, which will be funded by Emergency Medicaid, has completed, longer term treatment depends on the support of a safety net hospital. This dependency is being undermined by HRRP (Dec 2018). : Grady
Memorial (Aug
2016)
- Tenessee use of private long-term care ramps Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
costs (Mar
2014)
- Republican state governors are pushing to accept Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansion
for their citizens (Dec
2015).
- Expansion of Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
partly pays for itself (Sep
2016)
- The ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
impacts on
Indiana
University Health system through HHS is the U.S. Department of Health and Human Services. : CMS is the centers for Medicare and Medicaid services. (Jan
2017)
- Maine voters approve Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansion
- 32 states now expanded (Nov
2017)
- Virginia expands Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
(Jun
2018)
- 2018 Mid-term election ballot initiatives move Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansion
forward in Idaho, Nebraska, and Utah. Term limits replace
LePage & new Maine Democratic governor agrees to implement
its ballot. North Carolina democratic governor gained
power to start developing expansion (Nov
2018)
- Aaron
Carroll reviews Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansion
studies that indicate rural access/coverage, through community
health centers, and quality of health care has risen while
urban access/coverage has also improved (Jul
2018)
- Trump CMS is the centers for Medicare and Medicaid services. administrator
Verma, Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
director Neale, leverages work as a health improvement benefit
to justify Medicaid funding of States: Arizona, Arkansas,
Indiana, Kansas, Kentucky,
Maine, New Hampshire, North Carolina, Utah, Wisconsin; waivered
eliigibility work requirements; angering Medicaid beneficiary
advocates: CBPP;
(Jan
2018)
- Kentucky applies work requirements Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
Waiver,
but advocates for the poor: NHLP;
said they would oppose it with legal action (Jan
2018)
- CMS is the centers for Medicare and Medicaid services. administrator
Verma agrees Arkansas can implement Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
work
requirements, but delays allowing the state to roll back
Medicaid expansion (Mar
2018)
- Drug prices continue to rise significantly. Trump CMS is the centers for Medicare and Medicaid services. helps by blocking
states from constraining which drugs are provided by Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
, while Pfizer is the only
manufacturer that holds down prices for six months. Novartis influences
Trump plan (Jul
2018)
- Insurers: Cigna (Express Scripts),
Harvard
Pilgrim, Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
;
worried at the high price and lifelong commitment of Amgen's Repatha
& Regeneron/Sanofi's Praluent, PCSK9 is proprotein convertase subtilisin/kexin type 9 an enzyme activator. It is encoded as zymogen and autocatalysed in the ER. It plays a major role in cholesterol homeostasis. It binds EGF-A domain of LDLR inducing LDLR degradation. Academic researchers Dr. Helen Hobbs and Jonathan Cohen, studying large populations found reduced LDLR results in reduced metabolism of LDL which can lead to hypercholesterolemia. Drugs that can inhibit PCSK9 can lower cholesterol much more than first generation cholesterol inhibitors. inhibitors, are
limiting their use by prior-authorization is a constraint imposed by some insurance companies prior to their agreeing to cover some prescribed medications or medical procedures. The constraint may be due to: age, medical necessity, availability of a generic alternative, or to check drug interactions. After a healthcare provider orders a service for a patient, the provider's staff will contact the patient's insurer to determine if they require prior authorization. This should result in an exception process which may involve the provider's staff manual faxing a prior authorization form to the insurer. If the service is rejected, the healthcare provider may file an appeal based on the provider's medical review process. It may take 30 days for the insurer to approve the request.
constraints, even to the one million heterozygous F.H. is Familial Hypercholesterolemia, which causes heart attacks at a young age with symptoms of very high cholesterol levels. A mutation in chromosome 19 inhibits removal of low density lipoprotein. sufferers in the US is the United States of America. where the F.D.A. Food and Drug Administration. has allowed
their use, causing problems for the patients and their
providers: Cleveland
Clinic; (Oct
2018)
2017 CMS
administrator Seema Verma
- Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
, under
CMS is the centers for Medicare and Medicaid services. administrator
Verma, adopts bundled
payment is where the purchaser disburses a single predefined payment to cover certain combinations of hospital, physician, post-acute, or other services performed during an episode of care relating to a particular condition (unlike capitation). This bundling is assumed (Sep 2018) to allow the value delivery system to optimize around low cost high quality long term health care. With one bundled payment physicians & hospitals must coordinate care and reduce the unit costs to remain profitable. And to avoid taking on risk of expensive complications physicians & hospitals are incented to standardize and focus on quality. This optimization is dependent on quantifying the value of the outcome of the episode of care. Previously FFS payments induced excessive treatment activity. Bundled payment is included in CMS ACE demonstrations and BPCI initiatives. There are significant impacts on IT. - It is argued that effective pricing of the bundle requires marketing data which must be extracted from the historic transaction base.
- Billing and payment systems must be updated to handle the receipt and distribution of the bundled payments.
- Care delivery must be re-architected to reduce costs and improve quality.
- Monitoring sensors can be used to feed reports to ensure re-architected operations conform.
FFV is fee-for-value payment. It may be a bundled payment for a set of services provided by a group of doctors and facilities, or full capitation. In each case the risk has shifted from the payer to the providers of care. (Jan
2018)
- Austin
Frakt explains that the Trump CMS is the centers for Medicare and Medicaid services. has undermined the
CJR is CMS's comprehensive care for joint replacement bundled payment model (formerly CCJR). It is limited to performing surgeries at hospitals rather than ambulatory surgery centers, and paying only hospitals. It is novel:
- CJR is mandatory at 800 hospitals. It randomly assigned 75 markets to be subject to bundled payments for knee and hip replacements and 121 markets to use FFS payments. In 2017 the Trump CMS allowed hospitals in half the bundled payments markets to opt out and three quarters of the hospitals did so, obscuring the impact of bundled payments in the experiment (Sep 2018).
- The episode payment covers inpatient hospital services, physician fees, & 90 days of care after discharge.
- The bundle encourages post-acute care reform to reduce variation in quality & risk.
randomized trial
of Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
bundled
payments is where the purchaser disburses a single predefined payment to cover certain combinations of hospital, physician, post-acute, or other services performed during an episode of care relating to a particular condition (unlike capitation). This bundling is assumed (Sep 2018) to allow the value delivery system to optimize around low cost high quality long term health care. With one bundled payment physicians & hospitals must coordinate care and reduce the unit costs to remain profitable. And to avoid taking on risk of expensive complications physicians & hospitals are incented to standardize and focus on quality. This optimization is dependent on quantifying the value of the outcome of the episode of care. Previously FFS payments induced excessive treatment activity. Bundled payment is included in CMS ACE demonstrations and BPCI initiatives. There are significant impacts on IT. - It is argued that effective pricing of the bundle requires marketing data which must be extracted from the historic transaction base.
- Billing and payment systems must be updated to handle the receipt and distribution of the bundled payments.
- Care delivery must be re-architected to reduce costs and improve quality.
- Monitoring sensors can be used to feed reports to ensure re-architected operations conform.
(Sep
2018)
- CMS is the centers for Medicare and Medicaid services. administrator
Verma enforces ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
legislation, blocking Idaho's plan to allow the sale of
stripped-down health insurance (Mar
2018).
- HHS is the U.S. Department of Health and Human Services. secretary
Azar, CMS is the centers for Medicare and Medicaid services. administrator
Verma, F.D.A. Food and Drug Administration. commissioner
Gottlieb,
say Trump policy, from the CEA is either the:
- Commodity exchange act of 1936, which supported interstate commerce in grains and other commodities and regulates transactions on commodity futures exchanges to limit short selling and manipulation.
- White House Council of Economic Advisers, an agency established in 1946, to advise the President on economics in the formulation of domestic and foreign economic policy
, will stop: High
list prices for, Rising out of pocket costs for, Freeloader
countries from getting low cost access to; US is the United States of America. drugs (May
2018)
- President Trump's drug pricing plan: Increase competition in
drug markets, Allow Medicare Part D is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes:
- E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
private drug plans to negotiate discounts for Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
beneficiaries, provide incentives for drug manufacturers to
reduce list prices, Cut consumers' out-of-pocket costs;
abandoning campaign promises to allow: Medicare to negoatiate on
prices, Drugs imported from lower cost markets; Instead Trump
asks trade representative to force price increases on foreign
markets (May
2018)
- Trump administration's Medicare Part D is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes:
- E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
drug price reduction proposal for 2020, promoted by secretary
Azar & administrator
Verma, requires Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
drug
plans to notify doctors of the price and out-of-pocket costs to
the patient of prescribed drugs and removes Bush era
requirements that insurers fill prescriptions in 6 MMA is: - The Medicare Modernization Act of 2003. It includes Medicare part D, the Medicare prescription drug benefit, which constrains Medicare from negotiation of its drug prices and created MAC and RAC. It was sponsored by Senator Bill Tauzin and implemented by Tom Scully.
- Mammalian meat allergy which is induced by a month prior tick bite that introduced the allergen alpha-gal. About 1% of bitten humans develop the allergy & prevalence is increasing. Humans & old world primates & monkeys don't make alpha-gal (Jul 2018). Symptoms can include: hives, anaphylactic shock, low blood pressure.
'protected
classes' including: immunosuppressants, anti-epilepsy, cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). , AIDS is acquired auto-immune deficiency syndrome, a pandemic disease caused by the HIV. It also amplifies the threat of tuberculosis. Initially deadly, infecting and destroying the T-lymphocytes of the immune system, it can now be treated with HAART to become a chronic disease. And with an understanding of HIV's mode of entry into the T-cells, through its binding to CCR5 and CD4 encoded transmembrane proteins, AIDS may be susceptible to treatment with recombinant DNA to alter the CCR5 binding site, or with drugs that bind to the CCR5 cell surface protein preventing binding by the virus. Future optimization of drug delivery may leverage nanoscale research (May 2016). , depression is a debilitating episodic state of extreme sadness, typically beginning in late teens or early twenties. This is accompanied by a lack of energy and emotion, which is facilitated by genetic predisposition - for example genes coding for relatively low serotonin levels, estrogen sensitive CREB-1 gene which increases women's incidence of depression at puberty; and an accumulation of traumatic events. There is a significant risk of suicide: depression is involved in 50% of the 43,000 suicides in the US, and 15% of people with depression commit suicide. Depression is the primary cause of disability with about 20 million Americans impacted by depression at any time. There is evidence of shifts in the sleep/wake cycle in affected individuals (Dec 2015). The affected person will experience a pathological sense of loss of control, prolonged sadness with feelings of hopelessness, helplessness & worthlessness, irritability, sleep disturbances, loss of appetite, and inability to experience pleasure. Michael Pollan concludes depression is fear of the past. It affects 12% of men and 20% of women. It appears to be associated with androgen deprivation therapy treatment for prostate cancer (Apr 2016). Chronic stress depletes the nucleus accumbens of dopamine, biasing humans towards depression. Depression easily leads to following unhealthy pathways: drinking, overeating; which increase the risk of heart disease. It has been associated with an aging related B12 deficiency (Sep 2016). During depression, stress mediates inhibition of dopamine signalling. Both depression and stress activate the adrenal glands' release of cortisol, which will, over the long term, impact the PFC. There is an association between depression and additional brain regions: Enlarged & more active amygdala, Hippocampal dendrite and spine number reductions & in longer bouts hippocampal volume reductions and memory problems, Dorsal raphe nucleus linked to loneliness, Defective functioning of the hypothalamus undermining appetite and sex drive, Abnormalities of the ACC. Mayberg notes ACC area 25: serotonin transporters are particularly active in depressed people and lower the serotonin in area 25 impacting the emotion circuit it hubs, inducing bodily sensations that patients can't place or consciously do anything about; and right anterior insula: which normally generates emotions from internal feelings instead feel dead inside; are critical in depression. Childhood adversity can increase depression risk by linking recollections of uncontrollable situations to overgeneralizations that life will always be terrible and uncontrollable. Sufferers of mild autism often develop depression. Treatments include: CBT which works well for cases with below average activity of the right anterior insula (mild and moderate depression), UMHS depression management, deep-brain stimulation of the anterior insula to slow firing of area 25. Drug treatments are required for cases with above average activity of the right anterior insula. As of 2010 drug treatments: SSRIs (Prozac), MAO, monoamine reuptake inhibitors; take weeks to facilitate a response & many patients do not respond to the first drug applied, often prolonging the agony. By 2018, Kandel notes, Ketamine is being tested as a short term treatment, as it acts much faster, reversing the effect of cortisol in stimulating glutamate signalling, and because it reverses the atrophy induced by chronic stress. Genomic predictions of which treatment will be effective have not been possible because: Not all clinical depressions are the same, a standard definition of drug response is difficult;, schizophrenia is a chronic, psychotic, brain disorder impacting thinking and decision making that affects 1.1 percent of the adult U.S. population. It is characterized by hallucinations, delusions: paranoid, feel they are being sent special messages, feel have special powers; disorganized and unusual thinking, social withdrawal, lack of motivation and cognitive decline: executive functions & working memory; that begins with the first episode and continues throughout life. Children who eventually struggle with schizophrenia have normal working memory at age seven but are found with impairments by age 13. MRIs show that people with schizophrenia have lateral ventricles that are enlarged, a thinner cerebral cortex and smaller hippocampus. The default mode network is disrupted. It seems to be caused by over pruning of prefrontal cortex pyramidal neurons (Jan 2016), hippocampal pyramidal cells and sometimes thalamus neuron dendrites. A dopaminergic network is impacted: mesolimbic; suggesting too much dopamine signalling. Columbia University psychiatrist Franz Kallman found that a person with schizophrenia is much more likely, than non sufferers, to have a parent or sibling with the disorder. And identical twins are even more likely to share the disorder. Swedish researchers studying thousands of families in 2009 showed a strong hereditary link between bipolar disorder and schizophrenia, which was corroborated in 2012. Many of the genes associated with schizophrenia act on the developing fetal brain. MHC C4 gene supports immunity and synaptic pruning where it tags the synapses to be pruned. Variant C4-A is associated with schizophrenia where too many synapses are tagged. DISC1 translocation mutations have greatly increased the risk of schizophrenia. DISC1 supports the migration of neurons during development. There is evidence that some cases occur because of particular CNVs in the DNA of the sufferers: ZNF804A. Autism and schizophrenia risk increases with one particular chromosome 7 CNV. And de Novo mutations increase the risk. Treatments include: psychotherapy, chlorpromazine which blocks dopamine receptors of the mesolimbic pathway removing 'positive' characteristics of schizophrenia but it also impacts the nigrostriatal pathway target receptors inducing Parkinson's disease like symptoms; ;
allowing Insurer/PBM is pharmacy benefit manager. These companies, such as Caremark, were often originally PPMs. PBMs are used by payers, such as insurance plans, to manage drug provision from pharmacies to the payer's plans subscribers. PBMs can constrain drug flow to the pharmacies: CVS, Rite-Aid, Walgreens; through the PBM's formularies. /drug
manufacturer negotiations about value of particular drugs and
constraints via PBM formulary are lists of drugs that a health plan will cover. The health plans control where and if the drug is listed in the plan. A less expensive drug can be assigned a lower copayment to encourage patients to use it. To counter this attack on their profits drug companies responded with coupons to help patients pay copayments removing the incentive to select the lower-priced drugs. Health plans reacted to the copayment cards by dropping some drugs from the formulary altogether. That encourages drug companies to bid for their drug to be the only one listed resulting in some downward price pressure. .
Insurers can require prior
authorization is a constraint imposed by some insurance companies prior to their agreeing to cover some prescribed medications or medical procedures. The constraint may be due to: age, medical necessity, availability of a generic alternative, or to check drug interactions. After a healthcare provider orders a service for a patient, the provider's staff will contact the patient's insurer to determine if they require prior authorization. This should result in an exception process which may involve the provider's staff manual faxing a prior authorization form to the insurer. If the service is rejected, the healthcare provider may file an appeal based on the provider's medical review process. It may take 30 days for the insurer to approve the request. , and tests of lower cost alternative
drugs. AIDS Institute, Biotechnology
Innovation Organization, PhRMA
all deplored the proposal. Similar Obama administration
strategies were forced back by patient advocate protests (Nov
2018)
- Paul Krugman notes the value delivery system constraints
that undermine the Trump administration's drug pricing
arguments. He highlights the constraint point, with Novartis's payment
to Michael Cohen, and Representative Bill Tauzin's MMA is:
- The Medicare Modernization Act of 2003. It includes Medicare part D, the Medicare prescription drug benefit, which constrains Medicare from negotiation of its drug prices and created MAC and RAC. It was sponsored by Senator Bill Tauzin and implemented by Tom Scully.
- Mammalian meat allergy which is induced by a month prior tick bite that introduced the allergen alpha-gal. About 1% of bitten humans develop the allergy & prevalence is increasing. Humans & old world primates & monkeys don't make alpha-gal (Jul 2018). Symptoms can include: hives, anaphylactic shock, low blood pressure.
legislation and
subsequent shift to PhRMA
president (May
2018)
- HHS is the U.S. Department of Health and Human Services. secretary
Azar explains how he can: Shift prescription drugs from
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes:
- Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
part
B provides coverage for the elderly including: clinical research, ambulance services, DME, Mental health, second opinions before surgery, and limited outpatient prescription drugs to treat: cancer, rheumatoid arthritis, AMD and other conditions. Part B covers two types of services: - Medically necessary services and supplies that are accepted standards of medical practice and are needed to diagnose or treat a medical condition. Hospital based services are outpatient based. These do not include the 20 days of SNF costs for hospital inpatient rehabilitation.
- Preventative services that use treatment to help in early detection or prevention of a disease such as flu.
to Part
D is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes: - E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
so that negotiations on price can occur, Call out
prescription drug manufacturers refusing to hand over samples;
(May
2018)
- Trump administration proposes new policies in Federal
Register, saving $900 million annually in subsidies in 2020,
2021 and $1billion in 2022, 2023, and pushing 100,000 from the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
insurance
exchanges, increasing uncompensated care costs but
reducing ACA based tax requirements. They are proposing:
- For high cost drugs with generic alternatives, reducing
copayment discounts and reducing insurer's cost sharing is the requirement for patients to pay a portion of the cost of their health care services. Such out-of-pocket payments include: copayments, deductibles and coinsurance.
contributions to the cost of the generic, ignoring
coupons. Patient groups dislike the proposed changes
seeing patients not filling their prescriptions for: HIV is human immunodeficiency virus, an RNA retrovirus which causes AIDS. It infects T-lymphocytes helper cells slowly destroying the host's immune system. The main pandemic form of HIV is HIV-1 M which has been traced back to a spillover to Cameroon/Congolese forest Chimpanzees of SIVs that weakly infected proximate humans and then was amplified by social conditions in expanding towns: Ouesso, Brazzaville, Leopoldville; down river from these forests during the 1900 - 1920s. Additional amplification occurred through public health programs: Trypanosomiasis, STDs; which cross-infected subpopulations of Leopoldville/Kinshasa around the same time. UNESCO organized Haitian support for the DRC in the 1960s vectored HIV-1 M back to Haiti where the blood plasma trade provided an evolved amplifier for HIV-1 M infected plasma to flow into the US healthcare supply chain through Miami. Some HIV's enter the lymphocytes by leveraging the T cells CCR5 protein. The HIV X4 variant leverages CXCR4. - likely
increasing costs by $3500 a year, MS is multiple sclerosis. where generic Copaxone is
$60,000 to $65,000 a year, Diabetes includes type 1 and type 2. Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections.
patients use coupons to get prescribed drugs with astronomical
deductibles
- Reduced qualifications for federal insurance subsidies and a
requirement to spend more income on insurance premiums
- Requiring insurers to provide policies that do not cover
abortions to assist religious objectors, except in states
which require coverage: California, New York, Oregon; (Jan
2019)
- F.D.A. Food and Drug Administration. commissioner
Gottlieb
champions easier
drug approval. But the approach exposes
methodological issues: false positives are correlations between a random variable and markers of some event of interest. Over a statistically significant period the correlation of a false positive will fail but in small sample sizes it may hold. Identifying a statistically significant period is non-trivial. As more data becomes available via the web and it is applied in BI the problem of false positives will become more significant. ,
reduced pressure to innovate is the economic realization of invention and combinatorial exaptation. Keynes noted it provided the unquantifiable beneficial possibility that limits fear of uncertainty. Innovation operates across all CAS, being supported by genetic and cultural means. Creativity provides the mutation and recombination genetic operators for the cultural process. While highly innovative, monopolies: AT&T, IBM; usually have limited economic reach, constraining productivity. This explains the use of regulation, or even its threat, that can check their power and drive the creations across the economy.
,
limited impact on value based drug pricing strategy, reduced
feedback from smaller trials, targeted is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes: - NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies 2%
success rate. Faster approval does not affect the
patient's price experience (Jun
2018)
- Drug prices continue to rise significantly. Trump CMS is the centers for Medicare and Medicaid services. helps by blocking
states from constraining which drugs are provided by Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
, while Pfizer is the only
manufacturer that holds down prices for six months. Novartis influences
Trump plan (Jul
2018)
- CMS is the centers for Medicare and Medicaid services. implements CHRONIC care
act of 2017 is Ron Wyden & Orrin Hatch's Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act signed into law by President Trump as title III of the BBA of 2018.
through Medicare
Advantage (MA) is a private provider administered health insurance plan providing access to Medicare benefits. It was originally enacted as part of BBA Medicare + Choice or Part C plans. The government funded the plan with an annual fee, based on age and severity of the subscriber's medical conditions, rather than FFS. When a Medicare eligible person enrolls in a MA plan the government pays the private provider a set amount each month. The participant pays the Medicare part B premium and if required a part C premium each month. The MA plans offer a PCP who coordinates care. And the plans have an annual limit on out-of-pocket expenses unlike traditional Medicare. When they obtain treatment they will have to pay a copayment which may be quite high for some specialists. It is the health plan's responsibility to contract the physician network that will provide the care, leaving the risk with the insurer. About 36% of Medicare beneficiaries are enrolled with Medicare Advantage by 2019. The ACA introduced quality outcome and patient satisfaction based differential payments into MA. To measure the performance it added a five-star quality rating scheme. MA plans report their quality and patient satisfaction data to CMS annually and based on the results are awarded one to five stars. The highest rated plans are provided with large additional payments. It was assumed that subscribers would shift to the highest rated plans and the other plans would improve or drop out of MA. And the ACA eliminated subsidies which the federal government used to establish Medicare Advantage. However, the Obama administration has used a $8.5 Billion demonstration project to maintain this funding. It is intended that it will eventually taper off so that the cost of Medicare Advantage coverage will be equivalent to standard Medicare. changes, affecting the costly half of Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
's
patients with multiple chronic conditions. The act offers
additional benefits for people suffering from chronic diseases
including: diabetes includes type 1 and type 2. Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections. ,
Alzheimer's is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
,
Parkinson's corresponds to the breakdown of certain interneurons in the brain. It is not fully understood why this occurs. Dopamine system neuron breakdown generates the classical symptoms of tremors and rigidity. In some instances an uncommon LRRK2 gene mutation confers a high risk of Parkinson's disease. In rare cases Italian and Greek families are impacted in their early forties and fifties resulting from a single letter mutation in alpha-synuclein which alters the alpha-synuclein protein causing degeneration in the substantia nigra, after a build up of Lewy bodies in the neurons. But poisoning from MPTP has also been shown to destroy dopamine system neurons. DeLong showed that MPTP poisoning results in overactivity in the subthalamic nucleus. People who have an appendectomy in their 20s are at lower risk of developing Parkinson's disease. The Alpha-synuclein protein is known to build up in the appendix in association with changes in the gut microbiome. This buildup may support the 'flow' of alpha-synuclein from the gut along neurons that route to the brain. Paraquat has also been linked to Parkinson's disease. Parkinson's disease does not directly kill many sufferers. But it impacts swallowing which encourages development of pneumonia through inhaling or aspirating food. And it undermines balance which can increase the possibility of falls. Dememtia can also develop. Treatment with deep-brain stimulation, after surgical implantation of electrodes in the subthalamic nucleus removes the symptoms of Parkinson's disease in some patients. ,
CHF is congestive heart failure which occurs when the heart is unable to generate enough blood flow to meet the body's demands. There are two main types: failure due to left ventricular dysfunction and abnormal diastolic function increasing the stiffness of the left ventricle and decreasing its relaxation. Heart expansion in CHF distorts the mitral valve which exacerbates the problems. MitraClip surgery trials found effective in correcting the mitral valve damage (Sep 2018). Treatments include: digoxin; , rheumatoid
Arthritis is an autoimmune disorder where the immune system attacks the joints and can generate inflammation around the lungs and heart. It can be treated with: Enbrel, Humira, Ilaris, Xeljanz; , and some cancers is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). .
Combinations of social and medical services are funded.
The act will encourage high tech remote capabilities to be
deployed (Jun
2018)
- HHS is the U.S. Department of Health and Human Services. report concludes
1 million consumers, without eligibility for ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
subsidies, drop out
of individual
exchanges. CMS is the centers for Medicare and Medicaid services.
administrator
Verma stresses high-prices are an issue, as the Trump
administration increases pressure on the markets (Jul
2018)
- Insurance
co-op New Mexico
Health Connections wins case invalidating federal
government's risk
adjustment aims to lessen the: Influence of risk selection on the premiums that health insurance plans charge, Incentive for plans to avoid sicker enrollees. ACA legislated risk adjustment also has three additional issues: New populations, Cost & rating factors, Balanced transfers within a state/market. CMS developed a methodology that includes a risk adjustment model and a risk transfer formula to ensure premiums reflect the insurance plans scope of coverage rather than health status. Companies with healthier client pools have to transfer money to insurers with sicker populations.
formula. Judge Browning sees no
explanation of federal model justifications - which appear to
erroneously force $0 revenue loss for the government. CMS is the centers for Medicare and Medicaid services. Administrator
Verma uses the result to justify halting adjustment
payments to insurers, blaming Obama model for the error (Jul
2018)
- Insurance premiums, for ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
individual market, popular plans, will be lower in 2019 says CMS is the centers for Medicare and Medicaid services. administrator
Verma, with profits pulling insurers: Anthem,
Wellmark,
Molina, Cigna; back into the
markets (Oct
2018)
- CMS is the centers for Medicare and Medicaid services. administrator
Verma to resume paying ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
individual
market risk
adjustment aims to lessen the: Influence of risk selection on the premiums that health insurance plans charge, Incentive for plans to avoid sicker enrollees. ACA legislated risk adjustment also has three additional issues: New populations, Cost & rating factors, Balanced transfers within a state/market. CMS developed a methodology that includes a risk adjustment model and a risk transfer formula to ensure premiums reflect the insurance plans scope of coverage rather than health status. Companies with healthier client pools have to transfer money to insurers with sicker populations. payments (Jul
2018)
- CMS is the centers for Medicare and Medicaid services. administator
Verma releases rule allowing states to offer short-term
health insurance, and proposes regulations to allow companies to
provide health reimbursements for employees to use on personal
health plans (Oct
2018)
- Hospitals required to display chargemaster is a hospital specific mapping of chargeable ICD procedure codes to the description and list price set by the hospital.
and DRG is a diagnosis-related group. It transformed the health care operating model, when 467 DRGs with standard payments were introduced by Medicare in the 1980s, enabling for-profit business strategies to seek ways to cut expenses and hence increase profits. The DRG is a classification, designed by Yale's Robert Fetter and John Thompson, intended to define the products that a hospital provides. It assumes patients within a grouping are clinically similar. Grouping is based on ICDs adjusted for age, sex, discharge status and comorbidities. For Medicare hospital inpatient claims the DRG is used to select the fee that will be reimbursed. charges for
common procedures by CMS is the centers for Medicare and Medicaid services. .
Listings: Highland
Hospital, Kaiser, Santa
Clara Valley Medical Center, Seton,
Stanford,
UCSF MC;
provide little insight into patient bills (Jan
2019)
2016 CMS
Acting administrator Andrew Slavitt
Andy Slavitt talked at the April 2016 PACE
association conference explaining Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
's goal in
allowing for-profits to leverage PACE is either: - Protecting Affordable Coverage for Employees Act of 2015, which amends ACA title 1 to alter the definition of a small business, or
- Program of All-Inclusive Care for the Elderly, a Medicare program which pays for facilities and services to keep older and disabled Americans in their own homes instead of their having to enter nursing homes. It was intended to consequently save Medicare and Medicaid money. All states are required to pay less than the cost of a nursing home stay. It leverages the success of Britain's Day Hospitals. PACE started as On Lok, which provided capitation funded day care, to San Francisco's Asian & Italian immigrant families trying to avoid use of nursing homes. This payment model should encourage providers to keep their patients healthy. The services include dentistry, which constrains a problematic cascade of issues and rehabilitation which protects against falls. Medicare sanctioned the model in 1990. Its implementation was restricted to non-profit organizations but in 2016 CMS allowed for-profit organizations to participate (Aug 2016).
funds (Aug
2016).
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
acting administrator
Andy Slavitt, argued at the PACE
association meeting in Apr 2016 that "PACE is either: - Protecting Affordable Coverage for Employees Act of 2015, which amends ACA title 1 to alter the definition of a small business, or
- Program of All-Inclusive Care for the Elderly, a Medicare program which pays for facilities and services to keep older and disabled Americans in their own homes instead of their having to enter nursing homes. It was intended to consequently save Medicare and Medicaid money. All states are required to pay less than the cost of a nursing home stay. It leverages the success of Britain's Day Hospitals. PACE started as On Lok, which provided capitation funded day care, to San Francisco's Asian & Italian immigrant families trying to avoid use of nursing homes. This payment model should encourage providers to keep their patients healthy. The services include dentistry, which constrains a problematic cascade of issues and rehabilitation which protects against falls. Medicare sanctioned the model in 1990. Its implementation was restricted to non-profit organizations but in 2016 CMS allowed for-profit organizations to participate (Aug 2016).
is still a secret in
the minds of the public." The challenge is to make PACE "a
clear part of the solution."
Andy Slavitt argued that constraining surprise billing is where a contracted service is used by a patient and the bill contains huge out-of-network charges from doctors who were consulting to the health care provider. The opportunity to catalyze profits for: hospitals, physician staffing companies; while coping with rural E.D. staff shortages is encouraging this situation. Examples include: E.D. billing (Nov 2016, Jul 2017)
should be a CMS policy priority (Nov
2016).
Slavitt responds to Trump administration moves to undermine ACA:
2015 C.O.O Dr. Mandy
Cohen
Dr. Cohen reported on the state of co-operative
health insurers at a House Ways and Means Subcommittee on
Health (Nov
2015).
Food and Drug
Administration (FDA)
The F.D.A.'s Mission is to protect public
health. It is authorized by the FFDCA is the federal food, drug and cosmetic act. In 1938 it gave authority to the F.D.A. to oversee the safety of food, drugs and cosmetics. It provided physicians with power over pharmaceutical sale, which had previously been uncontrolled and operated by pharmacists. It replaced the pure food and drug act of 1906. It includes interstate constraints on medical devices and prescription drugs. As of 2016 the act does not enforce testing of cosmetic's components. While the EU has banned or restricted over 1,300 chemicals & chemical groups from use in cosmetics the F.D.A. has prohibited 11 cosmetic ingredients. .
- F.D.A. Food and Drug Administration. asks Endo to
withdraw Opana
ER. Commissioner
Gottlieb
notes its a high priority to take regulatory steps against
products fueling the epidemic is the rapid spread of infectious disease: AIDS (Oct 2016), Cholera (2010), Clostridium difficile (May 2015), Ebola, Influenza, Polio, SARS, Tuberculosis, Typhoid (Apr 2018), Malaria, Yellow fever, Zika; to large numbers of people in a population within a short period of time -- two weeks or less. Epidemics are studied and monitored by: NIAID, CDC, WHO; but are managed by states in the US. Infection control escalation is supported by biocontainment units: Emory, Nebraska. Once memes are included in the set of infectious schematic materials, human addictions can present as epidemics concludes Dr. Nora Volkow of the NIDA. CEPI aims to ensure public health networks are effectively prepared for epidemics. PHCPI aims to strengthen PCPs globally to improve responsiveness to epidemics. GAVI helps catalyze the development and deployment of vaccines. Sporadic investment in public health enables development of conditions for vector development: Mosquitos. The increasing demands of the global population are altering the planet: Climate change is shifting mosquito bases, Forests are being invaded bringing wildlife and their diseases in contact with human networks. Globalized travel acts as an infection amplifier: Ebola to Texas. Health clinics have also acted as amplifiers: AIDS in Haiti, C. diff & MRSA infections enabled & amplified by hospitals. Haiti earthquake support from the UN similarly introduced Cholera.
(Jun
2017)
- Purdue, and
its owning Sackler family, knew OxyContin
was being abused, but concealed this and promoted the drug as
less addictive results from changes in the operation of the brain's reward network's regulatory regions, altering the anticipation of rewards. Addictive drugs mediate the receptors of the reward network, increasing dopamine in the pleasure centers of the cortex. The learned association of the situation with the reward makes addiction highly prone to relapse, when the situation is subsequently experienced. This makes addiction a chronic disease, where the sufferer must remain vigilant to avoid relapse inducing situations. Repeated exposure to the addictive drug alters the reward network. The neurons that produce dopamine are impaired, no longer sending dopamine to the reward target areas, reducing the feeling of pleasure. But the situational association remains strong driving the addict to repeat the addictive activity. Destroying the memory of the pleasure inducer may provide a treatment for addiction in the future. Addiction has a genetic component, which supports inheritance. Some other compulsive disorders: eating, gambling, sexual behavior; are similar to drug addiction.
and less abused. Prosecutors discovered these issues but
the George W. Bush White House soft peddled the DOJ - U.S. Department of Justice. actions and the FDA Food and Drug Administration. allowed Purdue to
claim the formulation was 'believed to reduce' the drugs appeal
to abusers, sending a signal to the industry that amplified their actions. During
the DOJ action Rudy Giuliani was advising the defense team (May
2018)
- J&J
& Bayer will pay
$775 million to settle 25,000 lawsuits about blood thinner Xarelto
causing fatal bleeding episodes the companies did not warn
patients about. Neither company admitted any liability and
they aim to sell Xarelto to the 45 million patients it is
prescribed to. Until recently there was no antidote to the
bleeding that Xarelto, Eliquis and
Pradaxa can cause in some people. Boehringer Ingelheim has
already paid $650 million for bleeding deaths and injuries
caused by Pradaxa. This year the F.D.A. Food and Drug Administration. approved
bleeding antidote Andexxa (Mar
2019)
- Puerto Rico hurricane damage disrupts producers: AdvaMed,
Baxter,
J&J/Janssen, Mylan; medical supply
chain for 40 drugs: Humira, Xarelto,
methotrexate is a chemotherapy drug developed in 1947 and used to treat cancer: breast, leukemia, lung, lymphoma, osteosarcoma; suppress the immune system, and as a treatment for ectopic pregnancy. It is a W.H.O. essential medicine.
,
Tylenol, Prezista,
Baxter
small saline, including 13 sole-source; and AdvaMed
medical devices, produced by 10 companies, concerning F.D.A. Food and Drug Administration. 's Gottlieb
(Oct
2017)
- F.D.A. Food and Drug Administration. CDRH is the F.D.A.'s center for device and radiological health.
's Jeffrey
Shuren is struggling to regulate: with too few resources,
approval processes that allow 'updated' devices to be marketed
untested, under resourced screening, skimpy post-market
monitoring, patient issues generating a tepid response from
regulators; in the medical device market: Morcellators, a tool to shred tissue via spinning blades, used for example in the removal of uterine fibroids, so that the tissue can be easily removed using MIS techniques. It has been found to spread cancerous cells around the surgery site reducing long-time survival rates and worsening the disease (Feb 2017). (Feb
17), Essure
(Oct
16), Pelvic
Mesh are medical devices, surgically deployed to support organs that are prolapsing because of weakened pelvic muscles. They are built from fiber that is designed to bond with the proximate tissue. (Apr
18), textured silicon
implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019) (Mar
19, May
19); placing patients at risk: 80,000 deaths & 2
million injuries. F.D.A. under pressure from press
suggested it could do better - but its proposed changes are
meager or counter productive: speedup approvals; because of
Congress pushing quality responsibility and funding to device
companies which benefit from lax regulation and light
punishments (May
2019)
- F.D.A. Food and Drug Administration. reviews
safety concerns hidden by ineffective long term studies of
health impacts of breast implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019)
,
studies required after 1960s debacle where implants were banned,
even as 4 manufacturers were allowed to then deploy them.
There are now 10 million implants world wide, 400,000 women get
implants a year in the US with 1/4 after mastectomies is removal of the whole breast. Surgeons perform total, modified radical, radical, partial and subcutaneous variants. Typically performed as part of breast cancer treatment. ;
and the F.D.A. is sending warning letters to J&J's Mentor, and
Sientra, seeing
tissue changes, anaplastic large cell lymphoma is when lymphocytes continue reproducing, and do not die - a blood cancer.
associated with textured implants, and inflammatory responses to
silicone. Doctors have ignored womens complaints: meta
analysis by National
Center for Health Research's Dr. Zuckerman indicated that
long term studies had not tracked long term outcomes and lost
too many participants to be meaningful. Allergan consultant
and Mass.
Gen. plastic surgeon Dr. Amy Colwell criticized the study,
but social media has allowed the patients to find one another
and pressure the F.D.A. and a study by M.D.
Anderson plastic surgeon Mark Clemens, reported in the
Annals of Surgery that the long term outcomes of 99,993 women
with silicone implants were associated with six to eight times
the normal rates of rheumatoid
arthritis is an autoimmune disorder where the immune system attacks the joints and can generate inflammation around the lungs and heart. It can be treated with: Enbrel, Humira, Ilaris, Xeljanz; , scleroderma is an autoimmune disease, with symptoms: thickened skin, stiffness, tiredness, poor blood flow; caused by growth of connective tissues. It appears to be induced by exposure to silica.
and sjogren
syndrome is a chronic autoimmune disease affecting moisture-producing glands. Typical symptoms: dry eyes, dry mouth, problems swallowing; (Mar
2019)
- F.D.A. Food and Drug Administration. says not
enough evidence to block sale of textured implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019)
in
the US is the United States of America. .
Principal deputy commissioner Abernathy & CDRH is the F.D.A.'s center for device and radiological health. director
Shuren now require a warning of the risks, that the
patient will see. F.D.A.'s new Voluntary Malfunction
Summary Report Program may still allow manufacturers to hide the
failures from the public (May
2019)
- F.D.A. Food and Drug Administration. regulatory
review of regenerative
medicine aims to:
- Replace or regenerate human cells, tissues or organs which have been damaged.
- Grow tissues and organs in the laboratory for implanting when the body can't heal itself. This has already been done with bladder cells formed into bladders in the laboratory of Wake Forest Institute for Regenerative Medicine, and a Trachea grown in the laboratory from a patients own cells.
- Leverage stem cells created for example by researchers at the Spanish National Cancer Research Center inside of a living mouse. Cord blood stem cells are not regected by the donor's immune system introducing the potential for treating type 1 diabetes, myocardial infarction, and Parkinson's disease.
, including gene therapy is the deployment of genes into patient's cells to treat or prevent diseases. It can be performed outside the body (ex vivo) or in place (in vivo). It requires a vector such as a: Virus, Ligandal style nanoparticle, electric field (Jul 2018); to perform the deployment. But viruses are: Difficult to sanitize (bringing in oncogenes etc.) and hard to target as needed, Unable to target where the DNA is deployed into the target cell chromosomes, Key targets of the immune system. The process is disease specific: - Blood cancers: NHL; can be treated with ex vivo CAR-T (Jul 2017, Oct 2017)
- Cystic fibrosis requires a virus that infects the airways and then deploys a non-cystic fibrosis allele into the nucleus of the patient's cells. The obstacles to this process have been challenging:
- The virus must not have any problematic effects. In the case of cystic fibrosis one virus activated a cancer gene leaving several trial subjects with leukemia.
- Efficiency of delivery has to be very high and this has not proved possible as of 2015.
- The newly delivered DNA must remain intact and be replicated and transcribed. This has not proved to be the case.
- The process has not been able to avoid an immune response. Gene therapy has consequently been of limited value for cystic fibrosis.
- Hemophilia A and B; virus delivered in vivo therapies enter final stage trials (Aug 2018)
- ADA based SCID was the first human treatment with gene therapy. A normal ADA gene was inserted ex vivo into immune system cells. Initially the updated cells did not live as long as needed.
- Sickle-cell anemia requires a non-sickle-cell trait allele of the hemoglobin gene to be vectored into the bone marrow of the affected person.
- T-lymphocyte DNA updates for: mutation induced autoimmune diseases, melanoma treatment; using gene editing delivered with an electric field.
,
accelerated by Commissioner
Scott
Gottlieb, but biologics
center director
Peter Marks argues rogue clinics to be targeted (Nov
2017)
- F.D.A. Food and Drug Administration. criticised,
by HHS is the U.S. Department of Health and Human Services. inspector
general, for leaving food on shelves for too long, even
after the FSMA is the Food Safety Modernization Act of 2011 which provides the F.D.A. with additional powers to police food companies.
provided it with mandatory powers (Dec
2017)
- F.D.A. Food and Drug Administration. drives
lettuce producers to agree to packaging and labels of
origin. F.D.A. & C.D.C. is the HHS's center for disease control and prevention based in Atlanta Georgia.
trace E. coli
O157:H7 Shiga infection to Central/Northern California.
There will also be a task force to look at standards to support
supply chain traceability (Nov
2018)
- Office of Cosmetics and Colors:
- Trump administration leverages DOJ - U.S. Department of Justice. to remove teeth
from federal regulatory rules. Guidance
document's provide the federal government's interpretation of laws. They are typically written by federal agencies: CMS, F.D.A.; to describe how legislation should be used. The D.O.J. prosecutors watch for violation of the guidance documents as breaking the rules developed and enforced by agencies and regulators to implement congressional legislation.
conversion to rules by DOJ enforcement
authority is abandoned, leaving prosecutors and agencies: CMS is the centers for Medicare and Medicaid services. , F.D.A. Food and Drug Administration. ; who use them
with guidance that will not be enforced (Feb
2018)
- Banyan
Biomarkers' Banyan
Brain Trauma Indicator is a blood test for mTBI that measures the levels of UCH-L1 and GFAP that are released into the blood stream when brain tissue is damaged. It is approved for marketing by the F.D.A. and should reduce the need for CT scans of those with suspected brain injuries by a third. (Feb 2018)
blood test for mTBI is mild traumatic brain injury (TBI) , trialed by DOD - U.S. Department of Defense. , approved by F.D.A. Food and Drug Administration. reducing need
for CT is computerized tomography in which a series of X-ray views taken from many angles are combined by computer processing to create 3-D images. It is very useful for examining people who have been subject to trauma such as car accidents. The high dose of radiation is a cause for concern with over use of CT scanning (Jan 2014). The Banyan Brain Trauma Indicator blood test should help here. scans of
suspected brain injuries by third (Feb
2018)
- Electronic cigarettes (Sep
2015).
- Tobacco lobby moves to shield e-cigarettes (Sep
2016)
- F.D.A. Food and Drug Administration. 's Gottlieb
delays rule that would regulate sale of e-cigarettes (Jul
2017)
- F.D.A. Food and Drug Administration. institutes
voluntary constraint by: Juul, Altria,
Philip Morris, Imperial; of e-cigarette sales to minors.
Retailers including Walgreens
are being sent warnings. Given nicotine's addictive results from changes in the operation of the brain's reward network's regulatory regions, altering the anticipation of rewards. Addictive drugs mediate the receptors of the reward network, increasing dopamine in the pleasure centers of the cortex. The learned association of the situation with the reward makes addiction highly prone to relapse, when the situation is subsequently experienced. This makes addiction a chronic disease, where the sufferer must remain vigilant to avoid relapse inducing situations. Repeated exposure to the addictive drug alters the reward network. The neurons that produce dopamine are impaired, no longer sending dopamine to the reward target areas, reducing the feeling of pleasure. But the situational association remains strong driving the addict to repeat the addictive activity. Destroying the memory of the pleasure inducer may provide a treatment for addiction in the future. Addiction has a genetic component, which supports inheritance. Some other compulsive disorders: eating, gambling, sexual behavior; are similar to drug addiction.
quality
it seems a weak strategy compared to the regulations Gottlieb
delayed, concluded the NCHR
(Sep
2018)
- F.D.A. Food and Drug Administration. moves to ban
menthol cigarettes
& flavored cigars and limit teen access to vaping products
but does not stop sales of e-cigarettes.
Juul moves to
control its channels. Altria, R.J. Reynolds and Imperial
will fight the menthol ban (Nov
2018)
- F.D.A. Food and Drug Administration. 's Gottlieb
says Juul +
Altria is renaging on agreement to protect adolescents from vaping (Jan
2019)
- CBER is the F.D.A.'s Center for Biologics Evaluation and Research
- F.D.A. Food and Drug Administration. regulatory
review of regenerative
medicine aims to:
- Replace or regenerate human cells, tissues or organs which have been damaged.
- Grow tissues and organs in the laboratory for implanting when the body can't heal itself. This has already been done with bladder cells formed into bladders in the laboratory of Wake Forest Institute for Regenerative Medicine, and a Trachea grown in the laboratory from a patients own cells.
- Leverage stem cells created for example by researchers at the Spanish National Cancer Research Center inside of a living mouse. Cord blood stem cells are not regected by the donor's immune system introducing the potential for treating type 1 diabetes, myocardial infarction, and Parkinson's disease.
, including gene therapy is the deployment of genes into patient's cells to treat or prevent diseases. It can be performed outside the body (ex vivo) or in place (in vivo). It requires a vector such as a: Virus, Ligandal style nanoparticle, electric field (Jul 2018); to perform the deployment. But viruses are: Difficult to sanitize (bringing in oncogenes etc.) and hard to target as needed, Unable to target where the DNA is deployed into the target cell chromosomes, Key targets of the immune system. The process is disease specific: - Blood cancers: NHL; can be treated with ex vivo CAR-T (Jul 2017, Oct 2017)
- Cystic fibrosis requires a virus that infects the airways and then deploys a non-cystic fibrosis allele into the nucleus of the patient's cells. The obstacles to this process have been challenging:
- The virus must not have any problematic effects. In the case of cystic fibrosis one virus activated a cancer gene leaving several trial subjects with leukemia.
- Efficiency of delivery has to be very high and this has not proved possible as of 2015.
- The newly delivered DNA must remain intact and be replicated and transcribed. This has not proved to be the case.
- The process has not been able to avoid an immune response. Gene therapy has consequently been of limited value for cystic fibrosis.
- Hemophilia A and B; virus delivered in vivo therapies enter final stage trials (Aug 2018)
- ADA based SCID was the first human treatment with gene therapy. A normal ADA gene was inserted ex vivo into immune system cells. Initially the updated cells did not live as long as needed.
- Sickle-cell anemia requires a non-sickle-cell trait allele of the hemoglobin gene to be vectored into the bone marrow of the affected person.
- T-lymphocyte DNA updates for: mutation induced autoimmune diseases, melanoma treatment; using gene editing delivered with an electric field.
,
accelerated by Commissioner
Scott
Gottlieb, but biologics
center director
Peter Marks argues rogue clinics to be targeted (Nov
2017)
- F.D.A. Food and Drug Administration. commissioner
Gottlieb
champions easier
drug approval. But the approach exposes
methodological issues: false positives are correlations between a random variable and markers of some event of interest. Over a statistically significant period the correlation of a false positive will fail but in small sample sizes it may hold. Identifying a statistically significant period is non-trivial. As more data becomes available via the web and it is applied in BI the problem of false positives will become more significant. ,
reduced pressure to innovate is the economic realization of invention and combinatorial exaptation. Keynes noted it provided the unquantifiable beneficial possibility that limits fear of uncertainty. Innovation operates across all CAS, being supported by genetic and cultural means. Creativity provides the mutation and recombination genetic operators for the cultural process. While highly innovative, monopolies: AT&T, IBM; usually have limited economic reach, constraining productivity. This explains the use of regulation, or even its threat, that can check their power and drive the creations across the economy.
,
limited impact on value based drug pricing strategy, reduced
feedback from smaller trials, targeted is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes: - NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies 2%
success rate. Faster approval does not affect the
patient's price experience (Jun
2018)
- F.D.A. Food and Drug Administration. CBER is the F.D.A.'s Center for Biologics Evaluation and Research
extends HPV is human papillomavirus which causes cancer of the cervix in women and is also associated with anal cancer. vaccination are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
Gardasil is Merck's HPV vaccine designed to prevent infections with HPV types 6, 11, 16 and 18. Gardasil will not protect people from a virus type they have already been exposed to, so it is recommended to vaccinate young people. It protects against cervical, vulvar and vaginal cancers caused by HPV types 16 & 18 and anal cancers caused by HPV types 6, 11, 16 & 18. It protects against genital warts caused by HPV 6 & 11. It protects against some cancers of the penis and parts of the throat (oropharyngeal cancers). Gardasil does not prevent cervical cancer in women aged 27 to 45. 9 to men
& women 27 to 45 (Oct
2018)
Regulates:
- $500B food industry
- $350B medical devices
- $100B drugs
- $50B cosmetics
Most of the F.D.A.'s statutory power is based on the Federal Food, Drug and
Cosmetic Act is the federal food, drug and cosmetic act. In 1938 it gave authority to the F.D.A. to oversee the safety of food, drugs and cosmetics. It provided physicians with power over pharmaceutical sale, which had previously been uncontrolled and operated by pharmacists. It replaced the pure food and drug act of 1906. It includes interstate constraints on medical devices and prescription drugs. As of 2016 the act does not enforce testing of cosmetic's components. While the EU has banned or restricted over 1,300 chemicals & chemical groups from use in cosmetics the F.D.A. has prohibited 11 cosmetic ingredients. (1938 with many amendments). It is also
limited by legislation
such as the DSHEA is the Dietary Supplement Health and Education Act of 1994. It prevents the FDA from approving or evaluating most supplements before they are sold. The agency must wait until consumers are harmed before officials can remove them from stores. which
limits its oversight of supplements.
The regulation is based on current legislation. Most of the
regulations are very general and are supported by F.D.A.
publications that explain/interpret these regulations in far greater
details:
- Written guidelines, Letters to Industry and Points to consider
series of documents.
Public Health is the proactive planning, coordination and execution of strategies to improve and safeguard the wellbeing of the public. Its global situation is discussed in The Great Escape by Deaton. Public health in the US is coordinated by the PHS federally but is mainly executed at the state and local levels. Public health includes: - Awareness campaigns about health threatening activities including: Smoking, Over-eating, Alcohol consumption, Contamination with poisons: lead; Joint damage from over-exercise;
- Research, monitoring and control of: disease agents, reservoir and amplifier hosts, spillover and other processes, and vectors; by agencies including the CDC.
- Monitoring of the public's health by institutes including the NIH. This includes screening for cancer & heart disease.
- Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.
- Development, deployment and maintenance of vaccination strategies.
- Development, deployment and maintenance of fluoridation.
- Development, deployment and maintenance of family planning services.
- Regulation and constraint of foods, drugs and devices by agencies including the FDA.
issues include:
- Opioid painkiller abuse epidemic is the rapid spread of infectious disease: AIDS (Oct 2016), Cholera (2010), Clostridium difficile (May 2015), Ebola, Influenza, Polio, SARS, Tuberculosis, Typhoid (Apr 2018), Malaria, Yellow fever, Zika; to large numbers of people in a population within a short period of time -- two weeks or less. Epidemics are studied and monitored by: NIAID, CDC, WHO; but are managed by states in the US. Infection control escalation is supported by biocontainment units: Emory, Nebraska. Once memes are included in the set of infectious schematic materials, human addictions can present as epidemics concludes Dr. Nora Volkow of the NIDA. CEPI aims to ensure public health networks are effectively prepared for epidemics. PHCPI aims to strengthen PCPs globally to improve responsiveness to epidemics. GAVI helps catalyze the development and deployment of vaccines. Sporadic investment in public health enables development of conditions for vector development: Mosquitos. The increasing demands of the global population are altering the planet: Climate change is shifting mosquito bases, Forests are being invaded bringing wildlife and their diseases in contact with human networks. Globalized travel acts as an infection amplifier: Ebola to Texas. Health clinics have also acted as amplifiers: AIDS in Haiti, C. diff & MRSA infections enabled & amplified by hospitals. Haiti earthquake support from the UN similarly introduced Cholera.
(Nov
2015, May
2016, Vermont Sep
2015)
- Obesity is an addictive disorder where the brain is induced to require more eating, often because of limits to the number of fat cells available to report satiation (Jul 2016). Brain images of drug-addicted people and obese people have found similar changes in the brain. Obese people's reward network tends to be less responsive to dopamine and have a lower density of dopamine receptors. Obesity spreads like a virus through a social network with a 171% likelihood that a friend of someone who becomes obese will also become so. Obesity is associated with: metabolic syndrome including inflammation, cancer (Aug 2016), high cholesterol, hypertension, type-2-diabetes, asthma and heart disease. It is suspected that this is contributing to the increase in maternal deaths in the US (Sep 2016). Obesity is a complex condition best viewed as representing many different diseases, which is affected by the: Amount of brown adipose tissue (Oct 2016), Asprosin signalling by white adipose tissue (Nov 2016), Genetic alleles including 25 which guarantee an obese outcome, side effects of some pharmaceuticals for: Psychiatric disorders, Diabetes, Seizure, Hypertension, Auto-immunity; Acute diseases: Hypothyroidism, Cushing's syndrome, Hypothalamus disorders; State of the gut microbiome. Infections, but not antibiotics, appear associated with childhood obesity (Nov 2016).
epidemic
(NIDDK is the National Institute of Diabetes and Digestive and Kidney Diseases. )
- Electronic cigarettes (Sep
2015).
- Tobacco lobby moves to shield e-cigarettes (Sep
2016)
- F.D.A. Food and Drug Administration. 's Gottlieb
delays rule that would regulate sale of e-cigarettes (Jul
2017)
- F.D.A. Food and Drug Administration. institutes
voluntary constraint by: Juul, Altria,
Philip Morris, Imperial; of e-cigarette sales to minors.
Retailers including Walgreens
are being sent warnings. Given nicotine's addictive results from changes in the operation of the brain's reward network's regulatory regions, altering the anticipation of rewards. Addictive drugs mediate the receptors of the reward network, increasing dopamine in the pleasure centers of the cortex. The learned association of the situation with the reward makes addiction highly prone to relapse, when the situation is subsequently experienced. This makes addiction a chronic disease, where the sufferer must remain vigilant to avoid relapse inducing situations. Repeated exposure to the addictive drug alters the reward network. The neurons that produce dopamine are impaired, no longer sending dopamine to the reward target areas, reducing the feeling of pleasure. But the situational association remains strong driving the addict to repeat the addictive activity. Destroying the memory of the pleasure inducer may provide a treatment for addiction in the future. Addiction has a genetic component, which supports inheritance. Some other compulsive disorders: eating, gambling, sexual behavior; are similar to drug addiction.
quality
it seems a weak strategy compared to the regulations Gottlieb
delayed, concluded the NCHR
(Sep
2018)
- F.D.A. Food and Drug Administration. moves to ban
menthol cigarettes
& flavored cigars and limit teen access to vaping products
but does not stop sales of e-cigarettes.
Juul moves to
control its channels. Altria, R.J. Reynolds and Imperial
will fight the menthol ban (Nov
2018)
- F.D.A. Food and Drug Administration. 's Gottlieb
says Juul +
Altria is renaging on agreement to protect adolescents from vaping (Jan
2019)
- F.D.A. constrains ingredients in antibacterial soaps (Sep
2016)
- F.D.A. Food and Drug Administration. proposes
guidelines on salt. Consumer pressure drives food
industry: Wal-mart;
to reduce salt (Jun
2016)
- F.D.A. Food and Drug Administration. criticised,
by HHS is the U.S. Department of Health and Human Services. inspector
general, for leaving food on shelves for too long, even
after the FSMA is the Food Safety Modernization Act of 2011 which provides the F.D.A. with additional powers to police food companies.
provided it with mandatory powers (Dec
2017)
- Global transmission of infectious diseases and vectors (Feb
2016)
Complex trends include:
- Regulation of personalized
medicines is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes:
- NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
- 2013 Stops 23andMe
from presenting health data.
- F.D.A. Food and Drug Administration. CDRH is the F.D.A.'s center for device and radiological health.
approves direct
to consumer genomic testing for three BRCA is breast cancer type 1 or 2 susceptibility gene. The two types provide related cellular functions maintaining the validity of the cell. If either gene product fails there is an increased likelihood of cancer. Still individuals with mutations in BRCA1/2 genes account for only 5 to 10 percent of breast cancers. The: - Type 1 gene codes for a protein that supports DNA repair and where this is not possible can stimulate cell death. Hence if the protein becomes defective one or both of these key caretaker functions may stop and increase the susceptibility to cancer. The BRCA1 protein has multiple actions. It:
- Combines with other tumor suppressors, DNA damage sensors and cellular signal transducers to form the BASC surveillance complex monitoring the health of the cells DNA.
- Associates with RNA pol II to support transcription.
- Interacts with histone deacetylase to regulate transcription.
- It is a marker of high risk of breast and uterine cancer.
- It was collaboratively researched by Dr. Mary-Claire King and Francis Collins's labs studying chromosome 17 using genomics.
- In 1990 Dr. King had reported to ASHG evidence of 'this' single gene linked to a highly heritable form of breast cancer.
- Over the next two years the labs gathered details of BRCA1, allowing families with the mutation to understand their individual risk and plan for their futures.
- In 1993 BRCA1 was identified by Mark Skolnick of Myriad Genetics.
- Type 2 gene codes for a protein that binds both single stranded DNA and the recombinase RAD51 to facilitate homologous recombination.
- Advice from Dr. Collins, for families who have a history of breast or ovarian cancer includes:
- Counselling women with the high risk BRCA mutations, about the risk of breast and ovarian cancer and the treatments available
- Telling women who choose watchful waiting to have periodic MRIs. And warn that watchful waiting is unreliable for ovarian cancer allowing metastasis before detection.
- Prophylactically removing the ovaries and Fallopian tubes on completion of childbearing.
- Teaching about breast reconstruction and recommending prophylactic mastectomy.
- Males with BRCA mutations should have careful surveillance for: Prostate, Pancreatic and breast cancer.
- No one being given the test without being fully counselled beforehand about the implications of the result. Negative results may bring survivor guilt while positive results will need careful management.
1&2 mutations
by 23andMe (Mar
2018)
- Invitae funded
study indicates 23andMe
consumer test is not effective for BRCA is breast cancer type 1 or 2 susceptibility gene. The two types provide related cellular functions maintaining the validity of the cell. If either gene product fails there is an increased likelihood of cancer. Still individuals with mutations in BRCA1/2 genes account for only 5 to 10 percent of breast cancers. The:
- Type 1 gene codes for a protein that supports DNA repair and where this is not possible can stimulate cell death. Hence if the protein becomes defective one or both of these key caretaker functions may stop and increase the susceptibility to cancer. The BRCA1 protein has multiple actions. It:
- Combines with other tumor suppressors, DNA damage sensors and cellular signal transducers to form the BASC surveillance complex monitoring the health of the cells DNA.
- Associates with RNA pol II to support transcription.
- Interacts with histone deacetylase to regulate transcription.
- It is a marker of high risk of breast and uterine cancer.
- It was collaboratively researched by Dr. Mary-Claire King and Francis Collins's labs studying chromosome 17 using genomics.
- In 1990 Dr. King had reported to ASHG evidence of 'this' single gene linked to a highly heritable form of breast cancer.
- Over the next two years the labs gathered details of BRCA1, allowing families with the mutation to understand their individual risk and plan for their futures.
- In 1993 BRCA1 was identified by Mark Skolnick of Myriad Genetics.
- Type 2 gene codes for a protein that binds both single stranded DNA and the recombinase RAD51 to facilitate homologous recombination.
- Advice from Dr. Collins, for families who have a history of breast or ovarian cancer includes:
- Counselling women with the high risk BRCA mutations, about the risk of breast and ovarian cancer and the treatments available
- Telling women who choose watchful waiting to have periodic MRIs. And warn that watchful waiting is unreliable for ovarian cancer allowing metastasis before detection.
- Prophylactically removing the ovaries and Fallopian tubes on completion of childbearing.
- Teaching about breast reconstruction and recommending prophylactic mastectomy.
- Males with BRCA mutations should have careful surveillance for: Prostate, Pancreatic and breast cancer.
- No one being given the test without being fully counselled beforehand about the implications of the result. Negative results may bring survivor guilt while positive results will need careful management.
breast cancer is a variety of different cancerous conditions of the breast tissue. World wide it is the leading type of cancer in women and is 100 times more common in women than men. 260,000 new cases of breast cancer will occur in the US in 2018 causing 41,000 deaths. The varieties include: Hormone sensitive tumors that test negative for her2 (the most common type affecting three quarters of breast cancers in the US, BRCA1/2 positive, ductal carcinomas including DCIS, lobular carcinomas including LCIS. Receptor presence on the cancer cells is used as a classification: Her2+/-, estrogen (ER)+/-, progesterone (PR)+/-. Metastasis classes the cancer as stage 4. Genetic risk factors include: BRCA, p53, PTEN, STK11, CHEK2, ATM, GATA3, BRIP1 and PALB2. Treatments include: Tamoxifen, Raloxifene; where worrying racial disparities have been found (Dec 2013). International studies indicate early stage breast cancer typed by a genomic test: Oncotype DX, MammaPrint; can be treated without chemotherapy (Aug 2016, Jun 2018)
analysis, generating false negatives, - only looking for 3
Ashkenazi Jewish mutations instead of thousands that other women
may suffer from, conflicting with prior F.D.A. Food and Drug Administration. approval
of the direct
to consumer approach (Apr
2019)
- 2015 Oct
Stops Theranos
from providing health data via its 'nanotainer'.
- Approval of drugs based
on testing of: pharmacokinetics, pharmacodynamics, dosing,
stability, safety, efficacy. The F.D.A. Food and Drug Administration. has four
accelerated drug approvals: accelerated allows a drug treating serious conditions or unmet medical needs be approved based on a surrogate endpoint.
,
breakthrough is used to speed the development and review of drugs that may demonstrate substantial improvement compared to current therapies. ,
fast-track is designed to speed the development and expedite the review of drugs to treat serious conditions or fill unmet needs. ,
priority
review designation indicates the FDA aims to act on the drug application within six months. ; for different situations.
- Austin
Frakt explains the network
that generates high spending on drugs in the US is the United States of America. : History shows just
two bumps relative to rest of world: 1997 - 2007, 2013 - 2018;
More drugs developed (1970
- 80s genomics combines recombinant DNA editing with tools: CRISPR; DNA next generation sequencing and bioinformatics to sequence, assemble and analyse genomes.
based disease treatment explosion) and approved (increased fees
from manufactures to F.D.A. Food and Drug Administration.
increased approvals rate, but by 2007 F.D.A. approval rate was
very low, and now approval standards have lowered) in these
periods: TV promotion in 1990s with reduced regulatory
constraints on advertising, New payment mechanisms: CHIP is:
- The Children's Health Insurance Program started in 1997 as part of the BBA as SCHIP. It provides health insurance coverage for children in families with income below 200 percent of the poverty line. The coverage is focused on care specialized for children including: developmental delays, chronic conditions including asthma and obesity. CHIP's funding must be iteratively re-authorized by Congress. CHIP is financed federally, but states must enroll eligible children. In many states one agency administers CHIP and Medicaid. CHIP is leveraged by families that have employer based insurance with costly premiums, so the families only cover the adults.
- Clonal Hematopoiesis of Indeterminate Potential, where stem cells develop a somatic mutation cluster pair often found in leukemia, which is expressed in white blood cells they produce. The mutation clusters give these stem cells a competitive advantage and they accumulate over time. The white blood cells form inflammatory plaques. CHIP increases with age, increasing the risk of dying, of clot fragment induced heart attacks and stroke, over the subsequent 10 years by 54%
/Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births.
expansions, MMA is: - The Medicare Modernization Act of 2003. It includes Medicare part D, the Medicare prescription drug benefit, which constrains Medicare from negotiation of its drug prices and created MAC and RAC. It was sponsored by Senator Bill Tauzin and implemented by Tom Scully.
- Mammalian meat allergy which is induced by a month prior tick bite that introduced the allergen alpha-gal. About 1% of bitten humans develop the allergy & prevalence is increasing. Humans & old world primates & monkeys don't make alpha-gal (Jul 2018). Symptoms can include: hives, anaphylactic shock, low blood pressure.
Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
universal
prescription drug benefit in 2006 is a federal program to subsidize the costs of outpatient prescription drugs for Medicare beneficiaries enacted as part of the MMA and delivered entirely by private companies. It is an evolved amplifier with MMA schematic rules ensuring catalytic tax subsidies: reinsurance; flow to a broad group of elderly voters and a small but influential group of payers: UnitedHealth, Humana, CVS Health; while pharmaceutical companies also benefited from increased sales of reimbursed drugs. It includes: - E-prescribing regulations. Health care providers that electronically prescribe Part D drugs for Part D eligible individuals under 42 CFR 423.160(a)(3)(iii) may use HL7 or NCPDP SCRIPT standard to transmit prescriptions & related information internally but must use NCPDP SCRIPT (or other adopted standard) to transmit information to another legal entity.
- Premium subsidy set by a market average. Medicare collects bids from all plans that reflect their costs of providing the minimum required level of drug coverage. It then sets the subsidy at 74.5% of the average bid.
- Premium coverage gap (doughnut hole) between the 74.5% premium subsidy and the catastrophic-coverage threshold. The BBA of 2018 required Part D insurers cover 5% of the beneficiaries coverage gap and drug companies provide discounts that reduce federal spending by a total of $7.7 billion through 2027.
; supported flows/use;
MMA mandated no Medicare constraints on brand name drug prices
in US - while UK is the United Kingdom of Great Britain and Northern Ireland. and
Germany apply price/value constraints on prescribing, which
other countries, except the US, use as models
for their prescription constraints, between 2000 and 2014 30% of
the rise in drug spending attributed to price increases &
use of higher priced drugs. In 2007 patents on cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies
started to expire shifting US to generic flows. In 2013 MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. s and other precision
medicines is the integration of molecular research: genomics, proteomics, transcriptomics, metabolomics, cell signalling; and clinical data through a taxonomy based on CAS modeling overlaid on an information commons. It aims to support treatment of disease and remove the organ and symptom based methodological flaws in the ICD. Supporters of the D.S.M. note the aggressive shift to precision medicine at the NIMH under Dr. Insel, constrained useful clinical research (Nov 2015). , which are likely to provide focused value,
started to be approved, which suggests US drug spending will
escalate again in the future (Nov
2018)
- Pfizer's Xalkori
approved in the US in 2011 significantly extended the lives of lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types:
- Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
sufferers with a specific genetic mutation.
- Roche/Daiichi
Sankyo's Zelboraf has proved effective in combating the
deadliest form of skin cancer.
- Atopic
dermatitis, is also called eczema is a long lasting inflammation of the skin. It can be successfully treated with dupilumab. (Eczema) biologic are drugs made in living cells. Typically they are proteins developed using genetic engineering to develop the cellular host, and to customize animal source, DNA to produce human target proteins. Such biologics partially solve the problem of previous protein sources, extracted from animals or human sources, of contamination and immune responses. The strategy is very effective for blood transported proteins such as antibodies (MABs), hormones and blood factors. But intra-cellular proteins still demand delivery and accurate cell targeting. This creates analogous problems to those of gene therapy.
MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. drug treatment dupilumab is a monoclonal antibody which blocks two immune system pathways: interleukin 4 and interleukin 13; that are over produced in atopic dermatitis, by binding to the alpha subunit of the interleukin-4 receptor. It was developed by Regeneron and marketed as Dupixent. (Dupixent)
has successful trials (Oct
2016).
- Cuban immunotherapy is indirect treatment of disease by altering the immune system. Targeted diseases include: cancers -- immuno-oncology, organ transplants.
vaccine are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
Cimavax is a non-small cell lung cancer immuno-oncology vaccine. It is an active vaccine, containing the ligand EGF and P64k and Montanide ISA 51 which together stimulate the immune system to generate antibodies targeted at EGF. This results in the EGF concentration in the blood dropping. Many cancers: Lung, Colon, Kidney, Head, Neck; leverage EGFR to stimulate cell growth. is smuggled
to US by non-small cell lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types: - Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
sufferers (Nov
2016).
- Regeneron
studies clinical collection of DNA (DNA), a polymer composed of a chain of deoxy ribose sugars with purine or pyrimidine side chains. DNA naturally forms into helical pairs with the side chains stacked in the center of the helix. It is a natural form of schematic string. The purines and pyrimidines couple so that AT and GC pairs make up the stackable items. A code of triplets of base pairs (enabling 64 separate items to be named) has evolved which now redundantly represents each of the 20 amino-acids that are deployed into proteins, along with triplets representing the termination sequence. Chemical modifications and histone binding (chromatin) allow cells to represent state directly on the DNA schema. To cope with inconsistencies in the cell wide state second messenger and evolved amplification strategies are used. exomes is the 1 ot 2 percent of the genome which codes for the proteins.
with Geisinger
- stored in EHR refers to electronic health records which are a synonym of EMR. EHR analysis suggests strengths and weaknesses: - The EHR provides an integrated record of the health systems notes on a patient including: Diagnosis and Treatment plans and protocols followed, Prescribed drugs with doses, Adverse drug reactions;
- The EHR does not necessarily reflect the patient's situation accurately.
- The EHR often acts as a catch-all. There is often little time for a doctor, newly attending the patient, to review and validate the historic details.
- The meaningful use requirements of HITECH and Medicare/Medicaid specify compliance of an EHR system or EHR module for specific environments such as an ambulatory or hospital in-patient setting.
- As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient. Doctors are allocated 12 minutes to interact with a patient of which less than five minutes was used for recording hand written notes. With the EHR 12 minutes may be required to update the record!
; NHGRI is the NIH's national human genome research institute which aims to advance human health through genomics research. argues the
approach is significant (Jan
2014)
- CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T trials
history detailed, including: Saint
Judes's Dr.
Campana - Juno, University
of Pennsylvania's Dr.
June - Novartis;
Trials progressing (Aug
2016)
but
- Juno Immuno-oncology uses the immune system to treat cancer. Cancer cells often have different molecules on their cell surface. Studies have shown that genetic signatures of tumors can help predict which patients will benefit from treatment with PD-1 checkpoint inhibitors. Checkpoint inhibitor based treatments aim to make the immune system target these antigens. Clinical trial results indicate they are prolonging lives - even if only by a few months. They have reduced side effects relative to generic chemo therapy. There are three main strategies: cellular, antibody and cytokine.
- Antibody therapies target receptors including CD20, CD274, CD279 and CTLA-4. These therapies include MABs: Alemtuzumab, Ofatumumab, Rituximab; and may induce checkpoint inhibition.
- Cellular therapies have typically involved removing the immune cells from the blood or a tumor, activating, culturing and then returning them to the patient. Trials of these CAR and TCR therapies are proceeding, with some significant problems (Jul 2016).
- Cytokine therapies enhance anti-tumor activity through the cytokine's regulation and coordination of the immune system.
- Vaccines, including Sipuleucel-T for prostate cancer and BCG, classically a vaccine for tuberculosis, which is used for treating bladder cancer.
CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T trial
for adult ALL is acute lymphocytic/lymphoblastic leukemia. The cancer starts in the lymphocytes of the bone marrow. Too many lymphocytes are produced instead of mature white blood cells. In 2010 combination chemotherapy, including 6-mercaptopurine, cures 85 to 90% of children suffering from ALL.
suspended after deaths (Jul
2016)
- Gilead to
acquire Kite
Pharma for $11.9 billion (Aug
2017)
- Kite Pharma (Gilead)'s CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T gene therapy is the deployment of genes into patient's cells to treat or prevent diseases. It can be performed outside the body (ex vivo) or in place (in vivo). It requires a vector such as a: Virus, Ligandal style nanoparticle, electric field (Jul 2018); to perform the deployment. But viruses are: Difficult to sanitize (bringing in oncogenes etc.) and hard to target as needed, Unable to target where the DNA is deployed into the target cell chromosomes, Key targets of the immune system. The process is disease specific:
- Blood cancers: NHL; can be treated with ex vivo CAR-T (Jul 2017, Oct 2017)
- Cystic fibrosis requires a virus that infects the airways and then deploys a non-cystic fibrosis allele into the nucleus of the patient's cells. The obstacles to this process have been challenging:
- The virus must not have any problematic effects. In the case of cystic fibrosis one virus activated a cancer gene leaving several trial subjects with leukemia.
- Efficiency of delivery has to be very high and this has not proved possible as of 2015.
- The newly delivered DNA must remain intact and be replicated and transcribed. This has not proved to be the case.
- The process has not been able to avoid an immune response. Gene therapy has consequently been of limited value for cystic fibrosis.
- Hemophilia A and B; virus delivered in vivo therapies enter final stage trials (Aug 2018)
- ADA based SCID was the first human treatment with gene therapy. A normal ADA gene was inserted ex vivo into immune system cells. Initially the updated cells did not live as long as needed.
- Sickle-cell anemia requires a non-sickle-cell trait allele of the hemoglobin gene to be vectored into the bone marrow of the affected person.
- T-lymphocyte DNA updates for: mutation induced autoimmune diseases, melanoma treatment; using gene editing delivered with an electric field.
Yescarta, is
approved is a $6.3 billion bill to increase funding for research into cancer, Alzheimer's disease and other disease, support mental health networks and adjust regulations for drugs and medical devices. The act does not constrain drug prices. It is funded with money taken from a preventative health care fund. It aims to: - Expand the funding of the NIH.
- Allocates an additional $4.8 billion over 10 years. Much of the expanded funding is focused on Alzheimer's and cancer. This funding will still have to be appropriated by Congress.
- Empowers the NIH:
- Provides them with authority to finance high-risk, high-reward research using special procurement procedures instead of grants and contracts,
- Requires the director to establish "Eureka prizes" for biomedical research and treatment improvements.
- Advances the Precision Medicine Initiative,
- Support the moonshot to cure cancer.
- Align the federal drug regulatory structure with the processes of the biotechnology industry. Critics argue it lowers drug and device approval standards, and raises the influence of surrogate endpoints.
- The F.D.A. is allocated half a billion dollars to help staff the expedited processes.
- It provides an expedited pathway for breakthrough medical technologies (offering options for life-threatening conditions with few treatment options).
- F.D.A. must consider the least burdensome means to show device safety.
- Streamline the mental health network. It strengthens the enforcement of the mental health parity law.
- Creates the Presidentially appointed position of assistant secretary for mental health and substance use.
- Directs federal agencies to step up enforcement of laws that require equal insurance coverage for mental and physical illnesses.
- Stem the problem of opioid drug abuse with a $1 billion investment that will allow expanded access of treatment programs.
by F.D.A. Food and Drug Administration. , for adults
with CD19 expressing aggressive forms of NHL is non-Hodgkin lymphoma, It is: - A group of blood cancers that include all (> 60) types of lymphoma except HL.
- Risk factors include: poor immune function, autoimmune disease, Helicobacter pylori infection, hepatitis C, obesity, Epstein-Barr virus infection, HIV infection, radiation therapy, chemotherapy, PCBs, dioxin, phenoxy herbicides.
(Oct
2017)
- AstraZeneca's
Crestor
revenues already impacted by generics, when its Mystic
lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types:
- Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
drug fails trial primary endpoint, putting the company under
more pressure. Collaborates with Merck (Jul
2017)
- Novartis's biologic are drugs made in living cells. Typically they are proteins developed using genetic engineering to develop the cellular host, and to customize animal source, DNA to produce human target proteins. Such biologics partially solve the problem of previous protein sources, extracted from animals or human sources, of contamination and immune responses. The strategy is very effective for blood transported proteins such as antibodies (MABs), hormones and blood factors. But intra-cellular proteins still demand delivery and accurate cell targeting. This creates analogous problems to those of gene therapy.
CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T Tisagenlecleucel
treatment for CD19 expressing unresponsive B-cell acute
lymphoblastic leukemia is a group of cancers of blood forming tissues: bone marrow, lymphatic network; where abnormal white blood cells are generated. One type of leukemia is induced when TAD boundaries near the TAL1 gene fail allowing promotors from across the TAD border to distort the operation of the TAL transcription factor. Mutation clusters common in leukemia have been identified in CHIP. ,
developed at University
of Pennsylvania & deployed at Children's
hospital of Philidelphia & Duke University,
based on research part funded by the Leukemia
& Lymphoma Society recommended for approval by F.D.A. Food and Drug Administration. panel (Jul
2017)
- University
of Pennsylvania's research version of Novartis CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T treatment Kymriah,
manufactured by the university and used at the Children's
Hospital of Philadelphia to treat B cell ALL is acute lymphocytic/lymphoblastic leukemia. The cancer starts in the lymphocytes of the bone marrow. Too many lymphocytes are produced instead of mature white blood cells. In 2010 combination chemotherapy, including 6-mercaptopurine, cures 85 to 90% of children suffering from ALL. , resulted in one leukemia is a group of cancers of blood forming tissues: bone marrow, lymphatic network; where abnormal white blood cells are generated. One type of leukemia is induced when TAD boundaries near the TAL1 gene fail allowing promotors from across the TAD border to distort the operation of the TAL transcription factor. Mutation clusters common in leukemia have been identified in CHIP.
cell
being reengineered along with the T-cells or T lymphocytes, are produced in the thymus & tonsils, and include a T-cell receptor. Alpha beta T cells participate in the adaptive immune system. Gamma delta T cells present antigens to other T cells. CD4+ Helper T cells are activated by MHC class II molecules. They generate cytokines to regulate the immune response. Cytotoxic T cells (CD8+ receptor) destroy virus-infected cells and tumor cells. They can be inactivated to prevent autoimmunity. Memory T cells are formed when undifferentiated T cells are presented with antigen on MHC molecules located on an APC. They are long lived and replicate widely when they detect antigen. Regulatory T cells (suppressor and helper T cells) shut down T cell controlled immunity at the end of an immune reaction. Natural killer T cells respond to CD1d presented glycolipid antigens. MAIT cells defend against microbial infection with targeting by MR1. , and
deployed into the patient, who then died from the CAR-T
resistant leukemia (Oct
2018)
- NCI is the national cancer institute.
research by Stanford
SOM's
Dr. Mackall, reported in Nature Medicine, targets tumor: Leukemia is a group of cancers of blood forming tissues: bone marrow, lymphatic network; where abnormal white blood cells are generated. One type of leukemia is induced when TAD boundaries near the TAL1 gene fail allowing promotors from across the TAD border to distort the operation of the TAL transcription factor. Mutation clusters common in leukemia have been identified in CHIP. , Lymphoma is when lymphocytes continue reproducing, and do not die - a blood cancer. ; cell
surface protein CD22 with CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T,
while Stanford
& Seattle
Children's are testing a CAR-T targeting both CD19 &
CD22 (Nov
2017)
- UCSF
study finds colorectal is also called colon cancer. It:
- Follows a slow, many yearlong, progression from a benign
polyp to a localized cancer to an invasive one. Two
bacteria: Bacteroides fragilis, Escherichia coli variant;
from the gut microbiome have
been implicated in the early stages of tumor induction (Feb
2018). It
- Is often associated with Ras
mutations and the high risk allele TCF7L2.
30 to 50% of colon cancers have KRAS
mutations. Intensive medical surveillance and
removal of polyps can be lifesaving for those at high
risk. Types of colon cancer include the single gene
mutation hereditary: FAP, HNPCC;
- Is linked to obesity.
and prostate is cancer of the prostate gland. Genomics detected several common DNA variants associated with increased risk of prostate cancer. Dr. Francis Collins explains that a cluster of these risk variants lies in a stretch of 1 million DNA base pairs on chromosome 8. The cluster contains seven or more risk variants, each of which can raise the risk of prostate cancer by 10 to 30%. The high risk variants occur more frequently in African-American men than European or Asians. African-Americans die from prostate cancer at more than twice the rate of Europeans. Research in mice may explain a link between obesity and prostate cancer (Jan 2018). The average diagnosis is at age 66. Worldwide in 2012 there were 1.1 million cases from which 307,000 died. A common life-saving (Feb 2017) treatment is androgen deprivation therapy, but it has worrying side effects. Various classically defined types of cancer can occur. The most common is adenocarcinoma associated with the epithelial gland cells that generate seminal fluid. Epithelial cell differentiation potency makes these significant cancer agents. Other very rare types of cancer that can start in the prostate are: - Sarcomas
- Small cell carcinomas
- Neuroendocrine tumors
- Transitional cell carcinomas
cancers is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). remotely
inhibiting the immune
system has to support and protect an inventory of host cell types, detect and respond to invaders and maintain the symbiont equilibrium within the microbiome. It detects microbes which have breached the secreted mucus barrier, driving them back and fortifying the barrier. It culls species within the microbiome that are expanding beyond requirements. It destroys invaders who make it into the internal transport networks. As part of its initialization it has immune cells which suppress the main system to allow the microbiome to bootstrap. The initial microbiome is tailored by the antibodies supplied from the mother's milk while breastfeeding. The immune system consists of two main parts the older non-adaptive part and the newer adaptive part. The adaptive part achieves this property by being schematically specified by DNA which is highly variable. By rapid reproduction the system recombines the DNA variable regions in vast numbers of offspring cells which once they have been shown not to attack the host cell lines are used as templates for interacting with any foreign body (antigen). When the immune cell's DNA hyper-variable regions are expressed as y-shaped antibody proteins they typically include some receptor like structures which match the surfaces of the typical antigen. Once the antibody becomes bound to the antigen the immune system cells can destroy the invader. via a PD-L1 is programmed death-ligand 1, is a ligand for PD-1.
message, where the signal, is an emergent capability which is used by cooperating agents to support coordination & rival agents to support control and dominance. In eukaryotic cells signalling is used extensively. A signal interacts with the exposed region of a receptor molecule inducing it to change shape to an activated form. Chains of enzymes interact with the activated receptor relaying, amplifying and responding to the signal to change the state of the cell. Many of the signalling pathways pass through the nuclear membrane and interact with the DNA to change its state. Enzymes sensitive to the changes induced in the DNA then start to operate generating actions including sending further signals. Cell signalling is reviewed by Helmreich. Signalling is a fundamental aspect of CAS theory and is discussed from the abstract CAS perspective in signals and sensors. In AWF the eukaryotic signalling architecture has been abstracted in a codelet based implementation. To be credible signals must be hard to fake. To be effective they must be easily detected by the target recipient. To be efficient they are low cost to produce and destroy.
is not on the surface of the cancer cells, explaining how these
cancers have undermined current immunotherapy is indirect treatment of disease by altering the immune system. Targeted diseases include: cancers -- immuno-oncology, organ transplants.
drugs uses the immune system to treat cancer. Cancer cells often have different molecules on their cell surface. Studies have shown that genetic signatures of tumors can help predict which patients will benefit from treatment with PD-1 checkpoint inhibitors. Checkpoint inhibitor based treatments aim to make the immune system target these antigens. Clinical trial results indicate they are prolonging lives - even if only by a few months. They have reduced side effects relative to generic chemo therapy. There are three main strategies: cellular, antibody and cytokine. - Antibody therapies target receptors including CD20, CD274, CD279 and CTLA-4. These therapies include MABs: Alemtuzumab, Ofatumumab, Rituximab; and may induce checkpoint inhibition.
- Cellular therapies have typically involved removing the immune cells from the blood or a tumor, activating, culturing and then returning them to the patient. Trials of these CAR and TCR therapies are proceeding, with some significant problems (Jul 2016).
- Cytokine therapies enhance anti-tumor activity through the cytokine's regulation and coordination of the immune system.
- Vaccines, including Sipuleucel-T for prostate cancer and BCG, classically a vaccine for tuberculosis, which is used for treating bladder cancer.
.
Blocking the PD-L1 release from the cancer resulted in attacks
by immune cells (Apr
2019)
- Medical centers driving checkpoint
inhibitor release the immune system's checkpoints: PD-1, CTLA-4; on attacking host cells: by 1) stopping T-cell division and 2) reducing their life spans. They are used in immuno-oncology where, in 2016: They are approved for treatment of: Advanced melanoma, HL, lung, kidney, liver cancer; They have a general success rate of 20 - 40% and higher for melanoma. Checkpoint inhibitors work best for tumors that have many mutations: melanomas, lung and bladder cancers. They are enhanced by adjunct treatments that kill tumor cells generating debris to stimulate the immune system. The drugs include: ipilimumab (CTLA-4 inhbition), nivolumab, pembrolizumab, atezolizumab (PD-1 inhibitors); They are costly and often have high copayments. They cause auto-immune side effects including inflammation, rheumatoid arthritis and damage to glands: Adrenal, Thyroid, Pituitary. Powerful steroids such as prednisone can help reduce the inflammation. Damaged glands require sustained hormone treatment. Checkpoint inhibitor research is funded by the CRI. trials (Aug
2016)
- BMS checkpoint
inhibitor release the immune system's checkpoints: PD-1, CTLA-4; on attacking host cells: by 1) stopping T-cell division and 2) reducing their life spans. They are used in immuno-oncology where, in 2016: They are approved for treatment of: Advanced melanoma, HL, lung, kidney, liver cancer; They have a general success rate of 20 - 40% and higher for melanoma. Checkpoint inhibitors work best for tumors that have many mutations: melanomas, lung and bladder cancers. They are enhanced by adjunct treatments that kill tumor cells generating debris to stimulate the immune system. The drugs include: ipilimumab (CTLA-4 inhbition), nivolumab, pembrolizumab, atezolizumab (PD-1 inhibitors); They are costly and often have high copayments. They cause auto-immune side effects including inflammation, rheumatoid arthritis and damage to glands: Adrenal, Thyroid, Pituitary. Powerful steroids such as prednisone can help reduce the inflammation. Damaged glands require sustained hormone treatment. Checkpoint inhibitor research is funded by the CRI. trials (Jul
2016, Jan
2017)
- BMS/NCI is the national cancer institute.
funded PD-1 is programmed cell death protein 1 (CD279) is encoded by the PDCD1 gene. It is a cell surface receptor that belongs to the immunoglobulin superfamily. It is expressed on T-cells and pro-B cells. It acts as an immune checkpoint preventing the activation of T-cells to help self-tolerance and reduce autoimmunity. When it fails people can suffer from: Lupus, Crohn's disease, Rheumatoid arthritis. PD-1 inhibitor drugs activate the immune system to attack tumors. PD-1 inhibitors are being approved for Melanoma and squamous-cell form of lung cancer. checkpoint
inhibitor release the immune system's checkpoints: PD-1, CTLA-4; on attacking host cells: by 1) stopping T-cell division and 2) reducing their life spans. They are used in immuno-oncology where, in 2016: They are approved for treatment of: Advanced melanoma, HL, lung, kidney, liver cancer; They have a general success rate of 20 - 40% and higher for melanoma. Checkpoint inhibitors work best for tumors that have many mutations: melanomas, lung and bladder cancers. They are enhanced by adjunct treatments that kill tumor cells generating debris to stimulate the immune system. The drugs include: ipilimumab (CTLA-4 inhbition), nivolumab, pembrolizumab, atezolizumab (PD-1 inhibitors); They are costly and often have high copayments. They cause auto-immune side effects including inflammation, rheumatoid arthritis and damage to glands: Adrenal, Thyroid, Pituitary. Powerful steroids such as prednisone can help reduce the inflammation. Damaged glands require sustained hormone treatment. Checkpoint inhibitor research is funded by the CRI. immuno-oncology uses the immune system to treat cancer. Cancer cells often have different molecules on their cell surface. Studies have shown that genetic signatures of tumors can help predict which patients will benefit from treatment with PD-1 checkpoint inhibitors. Checkpoint inhibitor based treatments aim to make the immune system target these antigens. Clinical trial results indicate they are prolonging lives - even if only by a few months. They have reduced side effects relative to generic chemo therapy. There are three main strategies: cellular, antibody and cytokine. - Antibody therapies target receptors including CD20, CD274, CD279 and CTLA-4. These therapies include MABs: Alemtuzumab, Ofatumumab, Rituximab; and may induce checkpoint inhibition.
- Cellular therapies have typically involved removing the immune cells from the blood or a tumor, activating, culturing and then returning them to the patient. Trials of these CAR and TCR therapies are proceeding, with some significant problems (Jul 2016).
- Cytokine therapies enhance anti-tumor activity through the cytokine's regulation and coordination of the immune system.
- Vaccines, including Sipuleucel-T for prostate cancer and BCG, classically a vaccine for tuberculosis, which is used for treating bladder cancer.
study by MD
Anderson's Dr. Hussain Tawbi reports Opdivo & Yervoy combination
used to treat melanoma is a cancer of the melanocytes. It is a less common form of skin cancer but is the most deadly once it has invaded deeply into layers of skin. It is primarily caused by UV light. It is tied to mutations in the signalling pathway (BRAF) and regulatory genes (P53) with a key dependency on crestin reactivation (Jan 2016).
(and likely other cancers of 200,000 people a year) patients
with consequent metastatic brain cancers, at 28 AMC is Academic medical center. They perform education, research and patient care. They include one or more health professions schools, such as a medical school and a hospital. The major AMCs are represented by the United HealthSystem Consortium. The costly strategies of the AMCs and increased difficulty of finding enough targeted patients for research studies (Aug 2017) is forcing integration with larger hospital systems. AMCs offer researchers clinical research support: Virus vectors (Nov 2017); s: MS-KCC;
find survival rate expands beyond a year, like Jimmy Carter
after he was treated with Keytruda.
But 50% of patients had significant side effects of which 20%
quit the treatment (Aug
2018)
- Opdivo fails
broadly targeted advanced lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types:
- Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
trial (Aug
2016)
- NCI is the national cancer institute.
sponsored Washington
University School
of Medicine designed clinical trial - BMS Opdivo treatment
of HTLV-1 is human T-cell leukemia virus type 1, a human retrovirus, which causes adult T-cell leukemia/lymphoma and a demyelinating disease. It infects millions of people in: Japan, Africa, South America, Caribbean, Australia; but only 5% of those infected develop the cancer. It is transmitted between humans by: sex, breast-feeding, needle-sharing, transfusions, and transplants. virus
induced adult T-cell leukemia is a group of cancers of blood forming tissues: bone marrow, lymphatic network; where abnormal white blood cells are generated. One type of leukemia is induced when TAD boundaries near the TAL1 gene fail allowing promotors from across the TAD border to distort the operation of the TAL transcription factor. Mutation clusters common in leukemia have been identified in CHIP. -lymphoma is when lymphocytes continue reproducing, and do not die - a blood cancer. , an immuno-oncology uses the immune system to treat cancer. Cancer cells often have different molecules on their cell surface. Studies have shown that genetic signatures of tumors can help predict which patients will benefit from treatment with PD-1 checkpoint inhibitors. Checkpoint inhibitor based treatments aim to make the immune system target these antigens. Clinical trial results indicate they are prolonging lives - even if only by a few months. They have reduced side effects relative to generic chemo therapy. There are three main strategies: cellular, antibody and cytokine. - Antibody therapies target receptors including CD20, CD274, CD279 and CTLA-4. These therapies include MABs: Alemtuzumab, Ofatumumab, Rituximab; and may induce checkpoint inhibition.
- Cellular therapies have typically involved removing the immune cells from the blood or a tumor, activating, culturing and then returning them to the patient. Trials of these CAR and TCR therapies are proceeding, with some significant problems (Jul 2016).
- Cytokine therapies enhance anti-tumor activity through the cytokine's regulation and coordination of the immune system.
- Vaccines, including Sipuleucel-T for prostate cancer and BCG, classically a vaccine for tuberculosis, which is used for treating bladder cancer.
checkpoint
inhibitor release the immune system's checkpoints: PD-1, CTLA-4; on attacking host cells: by 1) stopping T-cell division and 2) reducing their life spans. They are used in immuno-oncology where, in 2016: They are approved for treatment of: Advanced melanoma, HL, lung, kidney, liver cancer; They have a general success rate of 20 - 40% and higher for melanoma. Checkpoint inhibitors work best for tumors that have many mutations: melanomas, lung and bladder cancers. They are enhanced by adjunct treatments that kill tumor cells generating debris to stimulate the immune system. The drugs include: ipilimumab (CTLA-4 inhbition), nivolumab, pembrolizumab, atezolizumab (PD-1 inhibitors); They are costly and often have high copayments. They cause auto-immune side effects including inflammation, rheumatoid arthritis and damage to glands: Adrenal, Thyroid, Pituitary. Powerful steroids such as prednisone can help reduce the inflammation. Damaged glands require sustained hormone treatment. Checkpoint inhibitor research is funded by the CRI. treatment, failed (Jun
2018)
- Atopic
dermatitis, is also called eczema is a long lasting inflammation of the skin. It can be successfully treated with dupilumab. (Eczema) biologic are drugs made in living cells. Typically they are proteins developed using genetic engineering to develop the cellular host, and to customize animal source, DNA to produce human target proteins. Such biologics partially solve the problem of previous protein sources, extracted from animals or human sources, of contamination and immune responses. The strategy is very effective for blood transported proteins such as antibodies (MABs), hormones and blood factors. But intra-cellular proteins still demand delivery and accurate cell targeting. This creates analogous problems to those of gene therapy.
MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. drug treatment dupilumab is a monoclonal antibody which blocks two immune system pathways: interleukin 4 and interleukin 13; that are over produced in atopic dermatitis, by binding to the alpha subunit of the interleukin-4 receptor. It was developed by Regeneron and marketed as Dupixent. (Dupixent)
has successful trials (Oct
2016).
- The difficulty in finding patients with specific cancer
mutations leaves biotechnology & AMC is Academic medical center. They perform education, research and patient care. They include one or more health professions schools, such as a medical school and a hospital. The major AMCs are represented by the United HealthSystem Consortium. The costly strategies of the AMCs and increased difficulty of finding enough targeted patients for research studies (Aug 2017) is forcing integration with larger hospital systems. AMCs offer researchers clinical research support: Virus vectors (Nov 2017);
s struggling to
increase the patient base. Early F.D.A. Food and Drug Administration. approvals become
significant competitive advantages:
- Dana-Farber's
Matthew Meyerson & University of British Columbia's Robert
Holt found Fusobacterium, always in mouth, is found with colon cancer is a major hereditary cancer also called colorectal cancer. It:
- Follows a slow, many yearlong, progression from a benign polyp to a localized cancer to an invasive one. Two bacteria: Bacteroides fragilis, Escherichia coli variant; from the gut microbiome have been implicated in the early stages of tumor induction (Feb 2018). It
- Is often associated with Ras mutations and the high risk allele TCF7L2. 30 to 50% of colon cancers have KRAS mutations. Intensive medical surveillance and removal of polyps can be lifesaving for those at high risk. Types of colon cancer include the single gene mutation hereditary: FAP, HNPCC;
- Is linked to obesity.
tumors including metastatic. If the bacterium is killed
with antibiotics are compounds which kill bacteria, molds, etc. Sulfur dye stuffs were found to be effective antibiotics. The first evolved antibiotic discovered was penicillin. Antibiotics are central to modern health care supporting the processes of: Surgery, Wound management, Infection control; which makes the development of antibiotic resistance worrying. Antibiotics are: - Economically problematic to develop and sell.
- Congress enacted GAIN to encourage development of new antibiotics. But it has not developed any market-entry award scheme, which seems necessary to encourage new antibiotic R&D.
- Medicare has required hospitals and SNFs to execute plans to ensure correct use of antibiotics & prevent the spread of drug-resistant infections.
- C.D.C. is acting to stop the spread of resistant infections and reduce unnecessary use of antibiotics.
- F.D.A. has simplified approval standards. It is working with industry to limit use of antibiotics in livestock.
- BARDA is promoting public-private partnerships to support promising research.
- Impacting the microbiome of the recipient. Stool banking is a solution (Sloan-Kettering stool banking).
- Associated with obesity, although evidence suggests childhood obesity relates to the infections not the antibiotic treatments (Nov 2016).
- Monitored globally by W.H.O.
- Regulated in the US by the F.D.A. who promote voluntary labeling by industry to discourage livestock fattening (Dec 2013).
- Customer demands have more effect - Perdue shifts to no antibiotics in premier chickens (Aug 2015).
the tumor growth slows (Nov
2017)
- Johns
Hopkins Cynthia Sears & Drew Pardoll report gut microbiome, the trillions of bacteria and viruses that live inside higher animals' guts, on their skin etc. These bacteria and viruses seem to play a role in: immune responses, digesting food, making nutrients, controlling mental health and maintaining a healthy weight. The signals from the gut microbiota are relayed by major nerve fibers: vagus; to the central nervous system. The symbiotic relationship must be actively managed. Human armpits include glands which provide food favoring certain symbionts who build a defensive shield above the skin. In the human gut: Barriers are setup: Mucus secretions form a physical constraint and provide sites for bacteriophages to anchor and attack pathogenic bacteria; Symbiont tailored nourishment: Plant-heavy food creates opportunities for fibre specialists like Bacteroides thetaiotaomicron; is provided, Selective binding sites are provided, Poisons are deployed against the unwelcome, and Temperature, acidity and oxygenation are managed. High throughput sequencing allows the characterization of bacterial populations inside guts. Beginning at birth, as they pass down the birth canal infants are supplied with a microbiome from their mothers. If they are borne via cesarean they never receive some of the key bacteria: Bifidobaterium infantis which is also dependent on oligosaccharides in breast milk; from their mothers. A variety of diseases may be caused by changes in the microbiome:
- Eczema can be related to changes in the skin microbiome.
- Obesity can be induced by changes to the gut microbiome.
- Chronic inflammation
- Allergies
- Type 1 diabetes
:
Bacteriodes fragilis & Escherichia coli; stimulate colon cancer is a major hereditary cancer also called colorectal cancer. It: - Follows a slow, many yearlong, progression from a benign polyp to a localized cancer to an invasive one. Two bacteria: Bacteroides fragilis, Escherichia coli variant; from the gut microbiome have been implicated in the early stages of tumor induction (Feb 2018). It
- Is often associated with Ras mutations and the high risk allele TCF7L2. 30 to 50% of colon cancers have KRAS mutations. Intensive medical surveillance and removal of polyps can be lifesaving for those at high risk. Types of colon cancer include the single gene mutation hereditary: FAP, HNPCC;
- Is linked to obesity.
by invading the mucus is used to cover tissues that are exposed. It is made from mucins. Mucous membranes may secrete mucus to generate a robust barrier.
epithelium is a core cell type that lines cavities and surfaces of blood vessels and organs. All glands are constructed from epithelial cells. Epithelial cells: secrete, absorb, protect, transport and sense. They have no blood supply so they are nourished via diffusion through the basement membrane from underlying connective tissue. Epithelial cell differentiation potency makes these significant cancer agents. of
the colon, developing biofilms is a sheet of bacteria that have invaded the mucus epithelium covering an organ. ,
and damaging the DNA (DNA), a polymer composed of a chain of deoxy ribose sugars with purine or pyrimidine side chains. DNA naturally forms into helical pairs with the side chains stacked in the center of the helix. It is a natural form of schematic string. The purines and pyrimidines couple so that AT and GC pairs make up the stackable items. A code of triplets of base pairs (enabling 64 separate items to be named) has evolved which now redundantly represents each of the 20 amino-acids that are deployed into proteins, along with triplets representing the termination sequence. Chemical modifications and histone binding (chromatin) allow cells to represent state directly on the DNA schema. To cope with inconsistencies in the cell wide state second messenger and evolved amplification strategies are used.
(Feb
2018)
- MS-KCC
sets policy that all outside compensation driven by hospital
research must flow to the hospital. Vice president Dr. Gregory
Raskin: Office
of Technology Development - including hospital ventures
with for-profit companies, formerly of AllianceBernstein
VC is venture capital, venture companies invest in startups with intangable assets
arm vice president
focused on biotechnology; identifies two such cases of
compensation: Y-mAbs
developing MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. s: naxitamab is a humanized anti-GD2 3F8 MAB (IgG1) developed by Memorial Sloan-Kettering cancer center, and commercialized by Y-mAbs Therapeutics, for treatment of high risk neuroblastoma. (F.D.A. Food and Drug Administration. breakthrough is used to speed the development and review of drugs that may demonstrate substantial improvement compared to current therapies.
status) & omburtamab is a is a humanized B7-H3 targeting MAB, developed by Memorial Sloan-Kettering cancer center, and commercialized by Y-mAbs Therapeutics, for treatment of human solid tumors: embryonal tumors, carcinomas, sarcomas and brain tumors. ;
based on MS-KCC pediatric oncologist Dr. Cheung's research
treatments, Sellas Life
Sciences Group - cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016).
vaccine are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
; board
representation policies varies at Integrated systems: Cleveland
Clinic allow; AMC is Academic medical center. They perform education, research and patient care. They include one or more health professions schools, such as a medical school and a hospital. The major AMCs are represented by the United HealthSystem Consortium. The costly strategies of the AMCs and increased difficulty of finding enough targeted patients for research studies (Aug 2017) is forcing integration with larger hospital systems. AMCs offer researchers clinical research support: Virus vectors (Nov 2017); s:
University
of Utah do not allow; and cancer centers: MD
Anderson allows; (Sep
2018)
Gene therapy is the deployment of genes into patient's cells to treat or prevent diseases. It can be performed outside the body (ex vivo) or in place (in vivo). It requires a vector such as a: Virus, Ligandal style nanoparticle, electric field (Jul 2018); to perform the deployment. But viruses are: Difficult to sanitize (bringing in oncogenes etc.) and hard to target as needed, Unable to target where the DNA is deployed into the target cell chromosomes, Key targets of the immune system. The process is disease specific: - Blood cancers: NHL; can be treated with ex vivo CAR-T (Jul 2017, Oct 2017)
- Cystic fibrosis requires a virus that infects the airways and then deploys a non-cystic fibrosis allele into the nucleus of the patient's cells. The obstacles to this process have been challenging:
- The virus must not have any problematic effects. In the case of cystic fibrosis one virus activated a cancer gene leaving several trial subjects with leukemia.
- Efficiency of delivery has to be very high and this has not proved possible as of 2015.
- The newly delivered DNA must remain intact and be replicated and transcribed. This has not proved to be the case.
- The process has not been able to avoid an immune response. Gene therapy has consequently been of limited value for cystic fibrosis.
- Hemophilia A and B; virus delivered in vivo therapies enter final stage trials (Aug 2018)
- ADA based SCID was the first human treatment with gene therapy. A normal ADA gene was inserted ex vivo into immune system cells. Initially the updated cells did not live as long as needed.
- Sickle-cell anemia requires a non-sickle-cell trait allele of the hemoglobin gene to be vectored into the bone marrow of the affected person.
- T-lymphocyte DNA updates for: mutation induced autoimmune diseases, melanoma treatment; using gene editing delivered with an electric field.
has been slow to gain F.D.A. Food and Drug Administration.
approved products:
- Eye are major sensors in primates, based on opsins deployed in the retina & especially fovea, signalling the visual system: Superior colliculi, Thalamus (LGN), Primary visual cortex; and indirectly the amygdala. They also signal [social] emotional state to other people. And they have implicit censorious power with pictures of eyes encouraging people within their view to act more honorably. Eyes are poor scanners and use a saccade to present detail slowly to the fovea. The eye's optical structures and retina are supported by RPE. Eyes do not connect to the brain through the brain stem and so still operate in locked-in syndrome. Evo-devo shows eyes have deep homology. High pressure within the eye can result in glaucoma. Genetic inheritance can result in retinoblastoma. Age is associated with AMD. -treatment: Spark
therapeutics (Oct
2015)
- AstraZenica
fails to protect Crestor
with its ODA is either
- The orphan drug act of 1983 which aims to facilitate development of drugs for rare diseases. The F.D.A. ensures that qualifying manufacturers obtain reduced costs of some parts of the testing process, and has tax incentives, enhanced patent protection, clinical research subsidies and support of a GSE to do research and development. or
- Official development assistance, funds donated by rich country governments to poor countries. ODA is measured by the OECD's DAC.
patent
label argument (Jul
2016).
- 21st
Century Cures Act is a $6.3 billion bill to increase funding for research into cancer, Alzheimer's disease and other disease, support mental health networks and adjust regulations for drugs and medical devices. The act does not constrain drug prices. It is funded with money taken from a preventative health care fund. It aims to:
- Expand the funding of the NIH.
- Allocates an additional $4.8 billion over 10 years. Much of the expanded funding is focused on Alzheimer's and cancer. This funding will still have to be appropriated by Congress.
- Empowers the NIH:
- Provides them with authority to finance high-risk, high-reward research using special procurement procedures instead of grants and contracts,
- Requires the director to establish "Eureka prizes" for biomedical research and treatment improvements.
- Advances the Precision Medicine Initiative,
- Support the moonshot to cure cancer.
- Align the federal drug regulatory structure with the processes of the biotechnology industry. Critics argue it lowers drug and device approval standards, and raises the influence of surrogate endpoints.
- The F.D.A. is allocated half a billion dollars to help staff the expedited processes.
- It provides an expedited pathway for breakthrough medical technologies (offering options for life-threatening conditions with few treatment options).
- F.D.A. must consider the least burdensome means to show device safety.
- Streamline the mental health network. It strengthens the enforcement of the mental health parity law.
- Creates the Presidentially appointed position of assistant secretary for mental health and substance use.
- Directs federal agencies to step up enforcement of laws that require equal insurance coverage for mental and physical illnesses.
- Stem the problem of opioid drug abuse with a $1 billion investment that will allow expanded access of treatment programs.
targets $6.3 billion for cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). & Alzheimer's is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
research, expanding the NIH is the National Institute of Health, Bethesda Maryland. It is the primary federal agency for the support and conduct of biomedical and behavioral research. It is also one of the four US special containment units of the CDC.
budget, mental health deployment and F.D.A. Food and Drug Administration. regulation of
medical devices & drugs (Nov
2016)
- F.D.A. Food and Drug Administration. approves Biogen's high
priced Spinraza
for SMA is spinal muscular atrophy, a recessive condition that typically results in paralysis and death by age two due to loss-of-function mutations in the SMN1 gene which codes for the SMN protein required by motor neurons. One in 40 individuals is a carrier of the SMA allele. 400 babies are born with SMA in the US each year. Treatments include: Spinraza (nusinersen).
(Dec
2016)
- Rare disease drugs are a focus for patients, specialty
pharmacies dispense specialty medications. They aim to save health plans money by: teaching patients how to apply their medicines and deal with side effects, ensure they take the full course and limit waste. These specialized channels can be used by drug companies to limit competition to their drugs since access in constrained. Generic drugs rebranded as specialty medications may escape competition, remove copayment and formulary exclusion sales inhibitors and obtain considerable pricing power.
and manufacturers.
- J&J's
Sylvant MAB as a terminator in medication names indicates the drug is a monoclonal antibody biologic. , Pfizer's Rapamune
used in treatment of Mayo Clinic
diagnosed Castleman
disease is a rare condition with symptoms of: Enlarged lymph nodes, hyperactivation of the immune system, excessive releases of cytokines, proliferation of lymphocytes and organ disfuction. It can affect subcomponents of the body or be multicentric when it is severe and deadly. Its cause is not defined: some argue it is viral, others an inherited genetic disorder or a cancer. It has been treated with: steroids, chemotherapy, J&J's targeted neoplastic disease therapy Sylvant (siltuximab) & Pfizer's Rapamune (sirolimus). . CDCN
at University
of Pennsylvania formed by Dr. Fajgenbaum to improve
research coordination; Everylife
advocates to F.D.A. Food and Drug Administration. (Feb
2017)
- Novartis's biologic are drugs made in living cells. Typically they are proteins developed using genetic engineering to develop the cellular host, and to customize animal source, DNA to produce human target proteins. Such biologics partially solve the problem of previous protein sources, extracted from animals or human sources, of contamination and immune responses. The strategy is very effective for blood transported proteins such as antibodies (MABs), hormones and blood factors. But intra-cellular proteins still demand delivery and accurate cell targeting. This creates analogous problems to those of gene therapy.
CAR is chimeric antigen receptor. Killer T lymphocytes are genetically engineered to produce a novel protein, composed of pieces from different parts of the immune system such as: antibody components to construct a new receptor binding site on the T cell that targeted an antigen exposed on the cell surface of cancer cells, and two receptor associated signals that switch the T-cell into kill mode and sustain it in that mode. Small clinical trials of CAR-T cells have shown substantial remissions among patients with various blood cancers (Aug 2016, Jul 2017, Oct 2017, Nov 2017). But there are severe side effects. -T Tisagenlecleucel
treatment for CD19 expressing unresponsive B-cell acute
lymphoblastic leukemia is a group of cancers of blood forming tissues: bone marrow, lymphatic network; where abnormal white blood cells are generated. One type of leukemia is induced when TAD boundaries near the TAL1 gene fail allowing promotors from across the TAD border to distort the operation of the TAL transcription factor. Mutation clusters common in leukemia have been identified in CHIP. ,
developed at University
of Pennsylvania & deployed at Children's
hospital of Philidelphia & Duke University,
based on research part funded by the Leukemia
& Lymphoma Society recommended for approval by F.D.A. Food and Drug Administration. panel (Jul
2017)
- Identifying gene issues and mechanisms, from precision
medicine is the integration of molecular research: genomics, proteomics, transcriptomics, metabolomics, cell signalling; and clinical data through a taxonomy based on CAS modeling overlaid on an information commons. It aims to support treatment of disease and remove the organ and symptom based methodological flaws in the ICD. Supporters of the D.S.M. note the aggressive shift to precision medicine at the NIMH under Dr. Insel, constrained useful clinical research (Nov 2015).
mutation data, allows rapid association of
current medicines with rare diseases (Sep
2018)
- Generic EpiPen
from Teva
gets F.D.A. Food and Drug Administration. approval
(Aug
2018)
- Personalized
medicine is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes:
- NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
& immunotherapy is indirect treatment of disease by altering the immune system. Targeted diseases include: cancers -- immuno-oncology, organ transplants.
clinical trials are constrained by: Limited patient base argue:
Yale CC,
MS-KCC,
Genentech;
Companies with me-too products requesting trials -- a situation
companies with F.D.A. Food and Drug Administration.
approval: Merck; are
happy to see. Targeted therapies: GSK, Pfizer, Loxo Oncology;
have even less potential patients which is a concern at Fred
Hutchinson (Aug
2017)
- F.D.A. Food and Drug Administration. commissioner
Gottlieb
champions easier
drug approval. But the approach exposes
methodological issues: false positives are correlations between a random variable and markers of some event of interest. Over a statistically significant period the correlation of a false positive will fail but in small sample sizes it may hold. Identifying a statistically significant period is non-trivial. As more data becomes available via the web and it is applied in BI the problem of false positives will become more significant. ,
reduced pressure to innovate is the economic realization of invention and combinatorial exaptation. Keynes noted it provided the unquantifiable beneficial possibility that limits fear of uncertainty. Innovation operates across all CAS, being supported by genetic and cultural means. Creativity provides the mutation and recombination genetic operators for the cultural process. While highly innovative, monopolies: AT&T, IBM; usually have limited economic reach, constraining productivity. This explains the use of regulation, or even its threat, that can check their power and drive the creations across the economy.
,
limited impact on value based drug pricing strategy, reduced
feedback from smaller trials, targeted is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes: - NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies 2%
success rate. Faster approval does not affect the
patient's price experience (Jun
2018)
- Kate
Robbins - Metastasized lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types:
- Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
induced by EGFR is epidermal growth factor receptor. It is the cell-surface receptor for EGF family signals.
mutations, treated successfully outside of the brain with Iressa
(Gefitinib is an EGFR inhibitor, interupting signalling. It has been used to successfully treat cancer's that are occuring because of uncontrolled EGFR activation. ).
The F.D.A. Food and Drug Administration. 's
subsequent large randomized Iressa lung cancer trial failed
illustrating the incompatibility of this type of trial design
and targeted genomics combines recombinant DNA editing with tools: CRISPR; DNA next generation sequencing and bioinformatics to sequence, assemble and analyse genomes. .
The F.D.A.'s breakthrough is used to speed the development and review of drugs that may demonstrate substantial improvement compared to current therapies.
status may help (Jul
2015).
- Approval of drugs with limited benefit & identified risks
from trials
- F.D.A. Food and Drug Administration. panel splits
8:8 on Sanofi &
Lexicon
Pharmaceutical's sotagliflozin is a SGLT1/SGLT2 inhibitor, which controls blood sugar levels by inhibiting reabsorption of glucose and so increasing excretion by the kidneys. It is targeted as a treatment for type 1 diabetes, by Sanofi & Lexicon Pharmaceuticals. In trials it was found associated with increased risk of diabetic ketoacidosis.
(Zynquista),
an oral medicine for blood sugar management, for 1.25 million
Americans with type 1 diabetes is also called juvenile diabetes. It is an autoimmune disease that destroys the insulin producing beta cells of the islets of Langerhans. It normally presents with high levels of glucose in the blood. SGLT2 inhibition is being used to increase glucose excretion from the kidneys: sotagliflozin. More than a dozen genetic risk factors have been identified: Some associated with the immune system, others with other aspects. There are a growing number of children with type 1 diabetes throughout the world. Finland has the highest prevalence -- nearly one in 200 under the age of 15 of type 1 diabetes. In the United States one in 300 under 15 have the disease and an estimated 167,000 children developed the condition in 2009. A societal shift in the microbiome appears to be one facet driving the trend (Jun 2016). .
But the patients will still need to take insulin regulates the metabolism of carbohydrates, fats and protein by signalling the absorption of glucose by fat, liver and skeletal muscle cells. It is a peptide hormone generated in the islets of Langerhans beta cells of the pancreas. Peter Medawar explains it was an early drug therapy success. As manufacturers have shifted from products developed by extraction to biologics: Humulin, Lantus, Levemir; safety has improved. But the US list price has risen steeply (Feb 2016, Jan 2017) , and in
trials, 3% of patients suffered from diabetic
ketoacidosis occurs when diabetes sufferers don't get enough insulin, at which point the body converts fatty acids to ketones for energy. It can cause death. It may be triggered by infection, stroke, and medications. . NIH is the National Institute of Health, Bethesda Maryland. It is the primary federal agency for the support and conduct of biomedical and behavioral research. It is also one of the four US special containment units of the CDC. 's
Yanovski felt the risk, is an assessment of the likelihood of an independent problem occurring. It can be assigned an accurate probability since it is independent of other variables in the system. As such it is different from uncertainty.
out-weighed the small benefit (Jan
2019)
- Approval of generic high volume supplies & management of
shortages
- Hospira (Pfizer), Amphastar generic
injectable base sodium bicarbonate is in shortage at hospitals:
Duke University
Medical
Center pharmacy.
FDA Food and Drug Administration. is discussing the
situation with the suppliers (May
2017)
- F.D.A. Food and Drug Administration. inspector,
Peter Baker, uses unannounced visits to Indian and Chinese
generic drug suppliers to the US market. He found 29 of 38
Indian plants were modifying data to suggest their products were
acceptable, when they were not. The system was driven by
then current F.D.A. policy of pre-arranging dates for
inspections: which also resulted in companies upgrading the
perks for the inspectors; a policy which F.D.A. subsequently
stopped until July 2015 when they abandoned Baker's pilot
program. Poor quality Indian generic drugs were then
allowed to flow to the US again. Baker moved to
inspections in China in 2015, where he found the same problems
at 38 of 48 plants he inspected. He left the F.D.A. in
March 2019 shocked at what he had seen (May
2019)
- Regulation of microbiome, the trillions of bacteria and viruses that live inside higher animals' guts, on their skin etc. These bacteria and viruses seem to play a role in: immune responses, digesting food, making nutrients, controlling mental health and maintaining a healthy weight. The signals from the gut microbiota are relayed by major nerve fibers: vagus; to the central nervous system. The symbiotic relationship must be actively managed. Human armpits include glands which provide food favoring certain symbionts who build a defensive shield above the skin. In the human gut: Barriers are setup: Mucus secretions form a physical constraint and provide sites for bacteriophages to anchor and attack pathogenic bacteria; Symbiont tailored nourishment: Plant-heavy food creates opportunities for fibre specialists like Bacteroides thetaiotaomicron; is provided, Selective binding sites are provided, Poisons are deployed against the unwelcome, and Temperature, acidity and oxygenation are managed. High throughput sequencing allows the characterization of bacterial populations inside guts. Beginning at birth, as they pass down the birth canal infants are supplied with a microbiome from their mothers. If they are borne via cesarean they never receive some of the key bacteria: Bifidobaterium infantis which is also dependent on oligosaccharides in breast milk; from their mothers. A variety of diseases may be caused by changes in the microbiome:
- Eczema can be related to changes in the skin microbiome.
- Obesity can be induced by changes to the gut microbiome.
- Chronic inflammation
- Allergies
- Type 1 diabetes
- Battle starts between doctors and pharmaceutical companies: Finch
Therapeutics, Rebiotix,
Seres
Therapeutics, Vedanta
Biosciences; over the impending F.D.A. Food and Drug Administration. decision about
how to regulate the development and use of FMT is fecal microbiota transplants, where human gut microbiome, fecal matter, is transferred from a donor's bowel to another person.
medicines, as a:
drug, giving power to pharmaceutical companies, or some other
regime, helping doctors and patients. Currently OpenBiome, founded
by microbiologist Dr. Mark Smith & Ms. Carolyn Edelstein, is
the sole provider, and only for Clostridium
difficile usually competes with other bacteria in the human gut microbiome. But antibiotic treatments provide it with an advantage where it becomes the predominant gut bacteria causing diarrhea, abdominal pain, and toxic megacolon. Repeated treatments select for infections that are progressively more difficult to treat. C. difficile infections kill more than 25,000 people a year in the US. Fecal transplants, especially enabled by stool-banking, reintroduce competitive bacteria that limit the success of C. difficile and cure patients with previously recurrent infections. But the F.D.A. has not approved such transplants as a treatment and the procedure is not covered by insurance. infections (Mar
2019)
- Approval of medical devices
- Blood-tests: Startup Theranos run into
F.D.A. Food and Drug Administration. scrutiny (Oct
2015)
- 21st
Century Cures Act is a $6.3 billion bill to increase funding for research into cancer, Alzheimer's disease and other disease, support mental health networks and adjust regulations for drugs and medical devices. The act does not constrain drug prices. It is funded with money taken from a preventative health care fund. It aims to:
- Expand the funding of the NIH.
- Allocates an additional $4.8 billion over 10 years. Much of the expanded funding is focused on Alzheimer's and cancer. This funding will still have to be appropriated by Congress.
- Empowers the NIH:
- Provides them with authority to finance high-risk, high-reward research using special procurement procedures instead of grants and contracts,
- Requires the director to establish "Eureka prizes" for biomedical research and treatment improvements.
- Advances the Precision Medicine Initiative,
- Support the moonshot to cure cancer.
- Align the federal drug regulatory structure with the processes of the biotechnology industry. Critics argue it lowers drug and device approval standards, and raises the influence of surrogate endpoints.
- The F.D.A. is allocated half a billion dollars to help staff the expedited processes.
- It provides an expedited pathway for breakthrough medical technologies (offering options for life-threatening conditions with few treatment options).
- F.D.A. must consider the least burdensome means to show device safety.
- Streamline the mental health network. It strengthens the enforcement of the mental health parity law.
- Creates the Presidentially appointed position of assistant secretary for mental health and substance use.
- Directs federal agencies to step up enforcement of laws that require equal insurance coverage for mental and physical illnesses.
- Stem the problem of opioid drug abuse with a $1 billion investment that will allow expanded access of treatment programs.
targets $6.3 billion for cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). & Alzheimer's is a dementia which correlates with deposition of amyloid plaques in the neurons. As of 2015 there are 5 million Alzheimer's patients in the USA. It was originally defined as starting in middle age which is rare, so it was a rare dementia. But in 1980s it was redefined as any dementia without another known cause. Early indications include mood and behavioral changes (MBI) and declarative memory and thinking problems (MCI). Specific cells within the hippocampal circuitry and its gateway, the entorhinal cortex, are damaged. The amygdala, cerebelum and other areas supporting implicit memory are not impacted during the early stages of the disease. Grid cell destruction results in a sense of being lost. The default mode network is disrupted. Variants include: late-onset sporadic; with risk factors - ApoE4 for late onset Alzheimer's, presenilin, androgen deprivation therapy (Dec 2015), type 2 diabetes. There are multiple theories of the mechanism of Alzheimer's during aging: Allen Roses argues that it is due to gene alleles that limit the capacity of mitochondria to support neuron operation, Neurons of sporadic Alzheimer's sufferers show greater APP gene diversity due to somatic recombination; It may be initiated by: stress induced HHV-6a, HHV7 herpes activation (Jun 2018) and or an increasingly leaky blood-brain barrier; and a subsequent innate immune response to the infections (May 2016). The Alzheimer's pathway follows: - Plaques form. These are seen in fMRIs 10 to 15 years prior to detecting memory and thinking changes. APP deployed in the cell membrane is cut into three parts. The external part becomes amyloid-beta peptide which aggregates into Amyloid plaques, external to the neurons, if too much is generated or it is not removed fast enough.
- Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).
- Encouraging the garbage collection of amyloid and tau with gamma rhythms stimulation retards Alzheimer's in mice studies (Mar 2019)
- BACE inhibitors block an enzyme needed to form amyloid.
- Mutation driven misfolded Tau proteins can form tangles within the cytoplasm of neurons. The Tau tangles kill nerve cells. LMTX is a drug treatment targeted at these tangles.
- The brain becomes inflamed resulting in the killing of many more nerve cells. The hippocampus disintegrates and the brain loses critical functions and memory loss becomes noticeable.
research, expanding the NIH is the National Institute of Health, Bethesda Maryland. It is the primary federal agency for the support and conduct of biomedical and behavioral research. It is also one of the four US special containment units of the CDC.
budget, mental health deployment and F.D.A. Food and Drug Administration. regulation of
medical devices & drugs (Nov
2016)
- Morcellator, a tool to shred tissue via spinning blades, used for example in the removal of uterine fibroids, so that the tissue can be easily removed using MIS techniques. It has been found to spread cancerous cells around the surgery site reducing long-time survival rates and worsening the disease (Feb 2017).
issues underreported for years allowing MIS is minimally invasive surgery, which aims to replace open surgery with techniques that reduce pain and recovery time by use robots or laparoscopes. to spead cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). within the
uterus of patients (Feb
2017)
- Reporting rules for medical device AE is an F.D.A. adverse event, a problem identified in a medical process involving a patient or clinical investigation and reported to the F.D.A. s agreed between AdvaMed
& F.D.A. Food and Drug Administration. CDRH is the F.D.A.'s center for device and radiological health.
(Jul
2017)
- Device issues: J&J's
discontinued hip-replacement ASR XL & Pinnacle, Medtronic cardiac
implants - sprint fidelis defibrillator, Cyberonics vagus
nerve stimulator; demonstrate weaknesses of F.D.A. Food and Drug Administration. device
regulation: 510(k) refers to section 510(k) of the FFDCA. It is a premarketing submission made to the FDA to demonstrate that a device to be marketed is as safe and effective (substantially equivalent to) another device that is not subject to PMA.
;
and the F.D.A.'s legislated structure (Jan
2018)
- F.D.A. Food and Drug Administration. CDRH is the F.D.A.'s center for device and radiological health.
's Jeffrey
Shuren is struggling to regulate: with too few resources,
approval processes that allow 'updated' devices to be marketed
untested, under resourced screening, skimpy post-market
monitoring, patient issues generating a tepid response from
regulators; in the medical device market: Morcellators, a tool to shred tissue via spinning blades, used for example in the removal of uterine fibroids, so that the tissue can be easily removed using MIS techniques. It has been found to spread cancerous cells around the surgery site reducing long-time survival rates and worsening the disease (Feb 2017). (Feb
17), Essure
(Oct
16), Pelvic
Mesh are medical devices, surgically deployed to support organs that are prolapsing because of weakened pelvic muscles. They are built from fiber that is designed to bond with the proximate tissue. (Apr
18), textured silicon
implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019) (Mar
19, May
19); placing patients at risk: 80,000 deaths & 2
million injuries. F.D.A. under pressure from press
suggested it could do better - but its proposed changes are
meager or counter productive: speedup approvals; because of
Congress pushing quality responsibility and funding to device
companies which benefit from lax regulation and light
punishments (May
2019)
- 2015 F.D.A. is pushing to regulate tests that are developed
and manufactured in a single laboratory (Dec
2015). It issued a report in
Nov 2015 criticizing 20 lab-developed tests for various
diseases including Myriad's Prolaris prostate
cancer is cancer of the prostate gland. Genomics detected several common DNA variants associated with increased risk of prostate cancer. Dr. Francis Collins explains that a cluster of these risk variants lies in a stretch of 1 million DNA base pairs on chromosome 8. The cluster contains seven or more risk variants, each of which can raise the risk of prostate cancer by 10 to 30%. The high risk variants occur more frequently in African-American men than European or Asians. African-Americans die from prostate cancer at more than twice the rate of Europeans. Research in mice may explain a link between obesity and prostate cancer (Jan 2018). The average diagnosis is at age 66. Worldwide in 2012 there were 1.1 million cases from which 307,000 died. A common life-saving (Feb 2017) treatment is androgen deprivation therapy, but it has worrying side effects. Various classically defined types of cancer can occur. The most common is adenocarcinoma associated with the epithelial gland cells that generate seminal fluid. Epithelial cell differentiation potency makes these significant cancer agents. Other very rare types of cancer that can start in the prostate are:
- Sarcomas
- Small cell carcinomas
- Neuroendocrine tumors
- Transitional cell carcinomas
biomarker test. Its aim is to make sure the
tests are:
- Accurate
- Reliable
- Clinically meaningful
- Price of generic drugs - Hundreds of old generic drugs with no
competitors have been purchased by Entrepreneurs that have
raised the prices hugely. Often these drugs flow through
hospital pharmacies and the price changes are opaque.
However, in Sep
2015 massive price changes have become a political concern.
Entry to the market for new competitors is restricted since a
generic copy must:
- Get samples of the current drug - Turing
pharmaceutical moved its drug Daraprim
from retail pharmacies to one contracted specialty
pharmacy dispense specialty medications. They aim to save health plans money by: teaching patients how to apply their medicines and deal with side effects, ensure they take the full course and limit waste. These specialized channels can be used by drug companies to limit competition to their drugs since access in constrained. Generic drugs rebranded as specialty medications may escape competition, remove copayment and formulary exclusion sales inhibitors and obtain considerable pricing power.
to limit access to samples. States are
responding:
- Show in testing that the amounts of drug released into
patients bodies is the same as for the current drug.
- Gain approval for its manufacturing process
- Get F.D.A. approval to sell its product.
- Huge price drops impact generic suppliers: Teva;
and distributors:
Cardinal Health;
as pharmacies, distributors & PBM is pharmacy benefit manager. These companies, such as Caremark, were often originally PPMs. PBMs are used by payers, such as insurance plans, to manage drug provision from pharmacies to the payer's plans subscribers. PBMs can constrain drug flow to the pharmacies: CVS, Rite-Aid, Walgreens; through the PBM's formularies.
s: Express Scripts
+ Walgreens;
cooperate to buy generics at lower prices. FDA Food and Drug Administration. commissioner
Gottlieb
says he will make it easier for generics to get to market.
Consumers don't see the savings (Aug
2017)
- Teva
restructures, cutting 25% of jobs, as Copaxone
attacked by generics & Teva's generics suffer from power of
buying groups formed by pharmacy
chains, wholesalers
& PBM is pharmacy benefit manager. These companies, such as Caremark, were often originally PPMs. PBMs are used by payers, such as insurance plans, to manage drug provision from pharmacies to the payer's plans subscribers. PBMs can constrain drug flow to the pharmacies: CVS, Rite-Aid, Walgreens; through the PBM's formularies.
s (Dec
2017, 2)
- Food supply and gene editing
- Crispr is clustered replicating interspersed silent palindromic repeats; a technique for exact targeting, cutting and editing of DNA based on leveraging bacterial enzymatic defenses against viruses generalized to any DNA sequence in a prokaryotic or eukaryotic cell. It was identified during studies of a bacterial adaptive immune system. In that system bacterial proteins grab parts of a virus that has infected them and record it within the palindromic structures that mark an array of inserted viral DNA used as a log persisted over generations. If a new infection occurs the viral DNA is compared with the sequences and if a match exists the CAS proteins break up the viral DNA initiating its destruction. This bacterial system was then updated and repurposed by the researchers to support targeted genetic engineering. As explained by Dr. Doudna, the CRISPR proteins and the 20 nucleotide RNA template migrate into the nucleus where they rapidly target DNA which complements the RNA template and the Cas9 enzyme performs the edits. Being a bacterial system CRISPR Cas9 does not target eukaryotic heterochromatic DNA well. It is not fully understood how they find the target sequence so quickly. It has been shown that Cas9 will bind to sites with a 5-8 base match but then it releases rapidly without cutting. To cut, Cas9 has to reconfigure, which does not occur in the mismatch situations. and Talen is transcription activator-like effector nuclease. These are restriction enzymes that function as a dimer with unique DNA binding domains.
gene editing
by:Cellectis,
DuPont Pioneer, Monsanto,
Recombinetics;
to produce new foods not currently considered a genetic
modification by 2016
labeling law of 2016 specifies what foods must declare on a label as genetically modified. It replaces all state labeling laws. , the U.S.D.A. - U.S. Department of Agriculture.
or F.D.A. Food and Drug Administration. (Jan
2017)
- F.D.A. Food and Drug Administration. constraints
on leghemoglobin, loved by VCs: Khosla Ventures,
Bill Gates; Impossible
Foods burger ingredient may become complex to certify (Aug
2017)
- Weakening of
regulatory schemes (Jul
2015, Essure
fast track issues Sep
2015, Oct
2015, Amarin
drug promotion agreement (Mar
2016))
F.D.A. structure
Office of the Commissioner
F.D.A.
Center for Drugs Evaluation and Research
F.D.A.
Center for Biologics Evaluation and Research
- F.D.A. Food and Drug Administration. regulatory
review of regenerative
medicine aims to:
- Replace or regenerate human cells, tissues or organs which have been damaged.
- Grow tissues and organs in the laboratory for implanting when the body can't heal itself. This has already been done with bladder cells formed into bladders in the laboratory of Wake Forest Institute for Regenerative Medicine, and a Trachea grown in the laboratory from a patients own cells.
- Leverage stem cells created for example by researchers at the Spanish National Cancer Research Center inside of a living mouse. Cord blood stem cells are not regected by the donor's immune system introducing the potential for treating type 1 diabetes, myocardial infarction, and Parkinson's disease.
, including gene therapy is the deployment of genes into patient's cells to treat or prevent diseases. It can be performed outside the body (ex vivo) or in place (in vivo). It requires a vector such as a: Virus, Ligandal style nanoparticle, electric field (Jul 2018); to perform the deployment. But viruses are: Difficult to sanitize (bringing in oncogenes etc.) and hard to target as needed, Unable to target where the DNA is deployed into the target cell chromosomes, Key targets of the immune system. The process is disease specific: - Blood cancers: NHL; can be treated with ex vivo CAR-T (Jul 2017, Oct 2017)
- Cystic fibrosis requires a virus that infects the airways and then deploys a non-cystic fibrosis allele into the nucleus of the patient's cells. The obstacles to this process have been challenging:
- The virus must not have any problematic effects. In the case of cystic fibrosis one virus activated a cancer gene leaving several trial subjects with leukemia.
- Efficiency of delivery has to be very high and this has not proved possible as of 2015.
- The newly delivered DNA must remain intact and be replicated and transcribed. This has not proved to be the case.
- The process has not been able to avoid an immune response. Gene therapy has consequently been of limited value for cystic fibrosis.
- Hemophilia A and B; virus delivered in vivo therapies enter final stage trials (Aug 2018)
- ADA based SCID was the first human treatment with gene therapy. A normal ADA gene was inserted ex vivo into immune system cells. Initially the updated cells did not live as long as needed.
- Sickle-cell anemia requires a non-sickle-cell trait allele of the hemoglobin gene to be vectored into the bone marrow of the affected person.
- T-lymphocyte DNA updates for: mutation induced autoimmune diseases, melanoma treatment; using gene editing delivered with an electric field.
,
accelerated by Commissioner
Scott
Gottlieb, but biologics
center director
Peter Marks argues rogue clinics to be targeted (Nov
2017)
- F.D.A. Food and Drug Administration. commissioner
Gottlieb
champions easier
drug approval. But the approach exposes
methodological issues: false positives are correlations between a random variable and markers of some event of interest. Over a statistically significant period the correlation of a false positive will fail but in small sample sizes it may hold. Identifying a statistically significant period is non-trivial. As more data becomes available via the web and it is applied in BI the problem of false positives will become more significant. ,
reduced pressure to innovate is the economic realization of invention and combinatorial exaptation. Keynes noted it provided the unquantifiable beneficial possibility that limits fear of uncertainty. Innovation operates across all CAS, being supported by genetic and cultural means. Creativity provides the mutation and recombination genetic operators for the cultural process. While highly innovative, monopolies: AT&T, IBM; usually have limited economic reach, constraining productivity. This explains the use of regulation, or even its threat, that can check their power and drive the creations across the economy.
,
limited impact on value based drug pricing strategy, reduced
feedback from smaller trials, targeted is a medical strategy where decisions, practices, and products are tailored to the individual patient. Research is looking at the impact of providing potentially deleterious genomic testing information to people: The REVEAL study found no increased anxiety induced by hearing that one's genome implied increased risk of developing late onset Alzheimer's disease. The take-up of personalized medicine benefits from the focus on genomics, enabled by next generation sequencing of DNA, and detailed by the NIH director Francis Collins and includes: - NCCN intensive cell therapies
- Direct to consumer genomic testing
- Direct to consumer diagnostics
- Pharmacogenomics tailored drug treatments reducing the risk and cost of adverse drug reactions.
cancer is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). therapies 2%
success rate. Faster approval does not affect the
patient's price experience (Jun
2018)
- F.D.A. Food and Drug Administration. CBER is the F.D.A.'s Center for Biologics Evaluation and Research
extends HPV is human papillomavirus which causes cancer of the cervix in women and is also associated with anal cancer. vaccination are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
Gardasil is Merck's HPV vaccine designed to prevent infections with HPV types 6, 11, 16 and 18. Gardasil will not protect people from a virus type they have already been exposed to, so it is recommended to vaccinate young people. It protects against cervical, vulvar and vaginal cancers caused by HPV types 16 & 18 and anal cancers caused by HPV types 6, 11, 16 & 18. It protects against genital warts caused by HPV 6 & 11. It protects against some cancers of the penis and parts of the throat (oropharyngeal cancers). Gardasil does not prevent cervical cancer in women aged 27 to 45. 9 to men
& women 27 to 45 (Oct
2018)
2017 CBER
Director Dr. Peter Marks
In relation to the drug development process, CDER is the F.D.A.'s Center for Drug Evaluation and Research. oversees and
regulates the development and marketing approval of mainly chemical
based drugs. CBER is the F.D.A.'s Center for Biologics Evaluation and Research
is more concerned traditionally with Vaccines are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
and Viruses,
blood and blood products, as well as antiserum, toxins and
antitoxins used for therapeutic purposes. Hence
biopharmaceuticals typically fall under CDER.
F.D.A.
Center for Devices & Radiological Health
- Puerto Rico hurricane damage disrupts producers: AdvaMed,
Baxter,
J&J/Janssen, Mylan; medical supply
chain for 40 drugs: Humira, Xarelto,
methotrexate is a chemotherapy drug developed in 1947 and used to treat cancer: breast, leukemia, lung, lymphoma, osteosarcoma; suppress the immune system, and as a treatment for ectopic pregnancy. It is a W.H.O. essential medicine.
,
Tylenol, Prezista,
Baxter
small saline, including 13 sole-source; and AdvaMed
medical devices, produced by 10 companies, concerning F.D.A. Food and Drug Administration. 's Gottlieb
(Oct
2017)
- F.D.A. Food and Drug Administration. CDRH is the F.D.A.'s center for device and radiological health.
's Jeffrey
Shuren is struggling to regulate: with too few resources,
approval processes that allow 'updated' devices to be marketed
untested, under resourced screening, skimpy post-market
monitoring, patient issues generating a tepid response from
regulators; in the medical device market: Morcellators, a tool to shred tissue via spinning blades, used for example in the removal of uterine fibroids, so that the tissue can be easily removed using MIS techniques. It has been found to spread cancerous cells around the surgery site reducing long-time survival rates and worsening the disease (Feb 2017). (Feb
17), Essure
(Oct
16), Pelvic
Mesh are medical devices, surgically deployed to support organs that are prolapsing because of weakened pelvic muscles. They are built from fiber that is designed to bond with the proximate tissue. (Apr
18), textured silicon
implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019) (Mar
19, May
19); placing patients at risk: 80,000 deaths & 2
million injuries. F.D.A. under pressure from press
suggested it could do better - but its proposed changes are
meager or counter productive: speedup approvals; because of
Congress pushing quality responsibility and funding to device
companies which benefit from lax regulation and light
punishments (May
2019)
- F.D.A. Food and Drug Administration. reviews
safety concerns hidden by ineffective long term studies of
health impacts of breast implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019)
,
studies required after 1960s debacle where implants were banned,
even as 4 manufacturers were allowed to then deploy them.
There are now 10 million implants world wide, 400,000 women get
implants a year in the US with 1/4 after mastectomies is removal of the whole breast. Surgeons perform total, modified radical, radical, partial and subcutaneous variants. Typically performed as part of breast cancer treatment. ;
and the F.D.A. is sending warning letters to J&J's Mentor, and
Sientra, seeing
tissue changes, anaplastic large cell lymphoma is when lymphocytes continue reproducing, and do not die - a blood cancer.
associated with textured implants, and inflammatory responses to
silicone. Doctors have ignored womens complaints: meta
analysis by National
Center for Health Research's Dr. Zuckerman indicated that
long term studies had not tracked long term outcomes and lost
too many participants to be meaningful. Allergan consultant
and Mass.
Gen. plastic surgeon Dr. Amy Colwell criticized the study,
but social media has allowed the patients to find one another
and pressure the F.D.A. and a study by M.D.
Anderson plastic surgeon Mark Clemens, reported in the
Annals of Surgery that the long term outcomes of 99,993 women
with silicone implants were associated with six to eight times
the normal rates of rheumatoid
arthritis is an autoimmune disorder where the immune system attacks the joints and can generate inflammation around the lungs and heart. It can be treated with: Enbrel, Humira, Ilaris, Xeljanz; , scleroderma is an autoimmune disease, with symptoms: thickened skin, stiffness, tiredness, poor blood flow; caused by growth of connective tissues. It appears to be induced by exposure to silica.
and sjogren
syndrome is a chronic autoimmune disease affecting moisture-producing glands. Typical symptoms: dry eyes, dry mouth, problems swallowing; (Mar
2019)
- F.D.A. Food and Drug Administration. says not
enough evidence to block sale of textured implants are silicone medical devices, used to replace or enhance breast tissue after cosmetic surgery or mastectomy. ADM has allowed improved surgical strategies to be used with implants (Sep 2018). There are contoured and smooth silicon shells filled with silicone or brine. Contoured implants have been associated with anaplastic large cell lymphoma. Breast implants have a history of inducing medical problems in patients. Manufacturers include: Allergan, Mentor, Sientra; (Mar 2019)
in
the US is the United States of America. .
Principal deputy commissioner Abernathy & CDRH is the F.D.A.'s center for device and radiological health. director
Shuren now require a warning of the risks, that the
patient will see. F.D.A.'s new Voluntary Malfunction
Summary Report Program may still allow manufacturers to hide the
failures from the public (May
2019)
2017 CDRH
Director Dr. Jeffrey Shuren
The device reporting system is renegotiated every five years (Jul
2017)
CDRH is the F.D.A.'s center for device and radiological health. Director
Shuren suggested the current reporting system is "passive
surveillance." And he concludes failure to report is "likely
common." But he argues that the reports will be less important
as the agency moves to a new system that will mine EHR refers to electronic health records which are a synonym of EMR. EHR analysis suggests strengths and weaknesses: - The EHR provides an integrated record of the health systems notes on a patient including: Diagnosis and Treatment plans and protocols followed, Prescribed drugs with doses, Adverse drug reactions;
- The EHR does not necessarily reflect the patient's situation accurately.
- The EHR often acts as a catch-all. There is often little time for a doctor, newly attending the patient, to review and validate the historic details.
- The meaningful use requirements of HITECH and Medicare/Medicaid specify compliance of an EHR system or EHR module for specific environments such as an ambulatory or hospital in-patient setting.
- As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient. Doctors are allocated 12 minutes to interact with a patient of which less than five minutes was used for recording hand written notes. With the EHR 12 minutes may be required to update the record!
to detect
problems. The EHRs will gather data from medical device
registries run by professional societies.
F.D.A. Center
for Tobacco Products
- Electronic cigarettes (Sep
2015).
- Tobacco lobby moves to shield e-cigarettes (Sep
2016)
- F.D.A. Food and Drug Administration. 's Gottlieb
delays rule that would regulate sale of e-cigarettes (Jul
2017)
- F.D.A. Food and Drug Administration. institutes
voluntary constraint by: Juul, Altria,
Philip Morris, Imperial; of e-cigarette sales to minors.
Retailers including Walgreens
are being sent warnings. Given nicotine's addictive results from changes in the operation of the brain's reward network's regulatory regions, altering the anticipation of rewards. Addictive drugs mediate the receptors of the reward network, increasing dopamine in the pleasure centers of the cortex. The learned association of the situation with the reward makes addiction highly prone to relapse, when the situation is subsequently experienced. This makes addiction a chronic disease, where the sufferer must remain vigilant to avoid relapse inducing situations. Repeated exposure to the addictive drug alters the reward network. The neurons that produce dopamine are impaired, no longer sending dopamine to the reward target areas, reducing the feeling of pleasure. But the situational association remains strong driving the addict to repeat the addictive activity. Destroying the memory of the pleasure inducer may provide a treatment for addiction in the future. Addiction has a genetic component, which supports inheritance. Some other compulsive disorders: eating, gambling, sexual behavior; are similar to drug addiction.
quality
it seems a weak strategy compared to the regulations Gottlieb
delayed, concluded the NCHR
(Sep
2018)
- F.D.A. Food and Drug Administration. moves to ban
menthol cigarettes
& flavored cigars and limit teen access to vaping products
but does not stop sales of e-cigarettes.
Juul moves to
control its channels. Altria, R.J. Reynolds and Imperial
will fight the menthol ban (Nov
2018)
- F.D.A. Food and Drug Administration. 's Gottlieb
says Juul +
Altria is renaging on agreement to protect adolescents from vaping (Jan
2019)
2016 CFTP
Director Mitch Zeller
The development of the Deeming Rule allowing F.D.A. control of
e-cigarettes and cigars is being faught by the tobacco
industry. (Sep
2016)
The F.D.A. accepts that e-cigarettes may be less harmful than
cigarettes. But they insist they should be able to examine if
the products:
- Contain harmful toxic chemicals such as diethyl glycerol
- Devices are safe.
Zeller notes "In the absence of science based regulation of all
tobacco products, the market place has been the wild wild
west. Companies were free to introduce any product they
wanted, make any claim they wanted, and that is how we wound up with
a 900 percent increase in high schoolers using e-cigarettes and as
well as all these reports of exploding e-cigarette batteries and
products that have caused burns and fires and disfigurement."
F.D.A. Center
for Vetinary Medicine
2015 F.D.A. CVM
working on Oxitec Transgenic Mosquito release request.
CVM must decide if the release of a transgenic mosquito into the
Florida Keys by Oxitec
will be safe for the environment.
F.D.A. Center
for Food Safety and Applied Nutrition (CFSAN)
2015 CFSAN
Director Susan Mayne
Susan Mayne supported changes to sugar labeling supported by the
dietary guidelines advisory committee.
Mayne also supported voluntary guidelines for salt in the processed
food supply. She noted "The science has been well
vetted."
Jun
2016 F.D.A. Food and Drug Administration.
proposes salt guidelines for food.
FDA Dietary
guidelines advisory committee
Nov
2015 F.D.A. Food and Drug Administration.
proposes daily cap on sugar and change in food labeling.
Nearly half the added sugar consumed in the U.S. comes from
sweetened drinks: sodas, sports drinks, fruit drinks and sweetened
tea and coffee.
CFSAN
Office of Cosmetics and Colors
F.D.A
diagnostic testing regulations
Diagnostc tests are regulated differently depending on where they
are produced and manufactured:
- Commercial test kits sold to multiple labs are subject to an F.D.A. Food and Drug Administration. review before
they get access to the market. If there are deaths or
serious injuries related to use of the kits the manufacturer
must inform the F.D.A. If they recall defective product
they must inform the F.D.A.
- For tests manufactured and used within a single laboratory the
agency has not actively enforced regulatory requirements.
But this may change with the Obama administration, concluding
that these situations occur exponentially more often and have
become more complex, asserting its enforcement authority over
these tests.
The F.D.A. is also worried about the number of testing errors that
it has detected (Nov
2015).
post-trial
monitoring infrastructure
Dec 2004 The F.D.A. has reduced its investments in laboratories and
support for a network of independent drug safety experts during the
last eight years in favor of hiring more people to approve
drugs. The changes arose after an agreement between the White
House and Congress that left the agency increasingly reliant on and
bound by drug company money.
The 1992 agreement pledged the industry to give the F.D.A. $200M per
year - in 1992 dollars if the agency spending on new drug approvals
did not fall below the 1992 amount. As congressional support
for funding the F.D.A. fell the result has been for all other
aspects except approvals to be cut back. Approvals are now 4/5
of the spending of the F.D.A. Hence problems with in market
drugs can only be found by non-F.D.A. action.
The 1992 spending requirement was designed to ensure that the drug
companies funding were not used for other F.D.A. activities.
With congress cutting the budget of the F.D.A. the result was for
the constraint to pull the entire budget towards drug
approval.
With the revelations of Merck's
suppression of negative Vioxx trial results, the F.D.A. asked the
National Academy of Science's Institute of
medicine to review it drug safety processes.
The report's conclusions are mostly damning. It describes the
food and drug Administration as rife with internal squabbles and
hobbled by underfinancing, poor management and outdated
regulations. "Every organization has its share of
dysfunctions, unhappy is an emotion which functions to mobilize the mind to seek capabilities and resources that support Darwinian fitness. Today happiness is associated with Epicurean ideas that were rediscovered during the renaissance and promoted by Thomas Jefferson. But natural selection has 'designed' happiness to support hunter-gatherer fitness in the African savanna. It is assessed: Relative to other's situations, Based on small gains or losses relative to one's current situation; and so what makes us [un-]happy and our responses can seem a counter-productive treadmill. For Pleistocene hunter-gatherers in the savanna there were many ways for losses to undermine fitness and so losses still make us very unhappy. Smoking, drinking and excessive eating were not significant and so don't make us unhappy even though they impact longevity.
staff members and internal disputes," the report said, but panel
members said that they were deeply concerned about the agency's
"organizational health" and its ability to ensure the safety of the
nation's drug supply.
The report described fierce disagreements between those who approve
drugs and those who study their effects after approval which
repeated F.D.A. Food and Drug Administration. efforts
have not resolved. Critics of the F.D.A. are in two camps:
- Some saying the agency fails to approve life-saving drugs
quickly enough
- Others say it is so intent on rapid approvals that it fails to
ensure the safety of the drugs. The new report agrees with
this position calling for greater caution, and highlighting the
1992 agreement
as a central problem. It sees the agency left with
all-or-nothing tools. It suggests "The agency needs a more
nuanced set of tools to signal uncertainties, to reduce
advertising that drives rapid uptake of new drugs, or to compel
additional studies in the actual patient populations who take
the drug after its approval."
The report recommended:
- Newly approved drugs should display a black triangle on their
labels for two years to warn consumers that their safety is more
uncertain than that of older drugs.
- Drug advertisements should be restricted during this initial
period.
- The F.D.A. should be given the authority to issue fines,
injunctions and withdrawals when drug makers fail -- as they
often do -- to complete the required safety studies.
- The F.D.A. commissioner should be appointed to a six year
term. For the last ten years no commissioners have held
the job for more than two years. One was forced to
resign.
- Drug makers should be required to post publically the results
of nearly all human drug trials.
- An independent board should be sponsored by Michael
O. Leavitt, Secretary of HHS is the U.S. Department of Health and Human Services. to help the
commissioner implement and sustain changes necessary to
transform the agencies culture is how we do and think about things, transmitted by non-genetic means as defined by Frans de Waal. CAS theory views cultures as operating via memetic schemata evolved by memetic operators to support a cultural superorganism. Evolutionary psychology asserts that human culture reflects adaptations generated while hunting and gathering. Dehaene views culture as essentially human, shaped by exaptations and reading, transmitted with support of the neuronal workspace and stabilized by neuronal recycling. Damasio notes prokaryotes and social insects have developed cultural social behaviors. Sapolsky argues that parents must show children how to transform their genetically derived capabilities into a culturally effective toolset. He is interested in the broad differences across cultures of: Life expectancy, GDP, Death in childbirth, Violence, Chronic bullying, Gender equality, Happiness, Response to cheating, Individualist or collectivist, Enforcing honor, Approach to hierarchy; illustrating how different a person's life will be depending on the culture where they are raised. Culture:
- Is deployed during pregnancy & childhood, with parental mediation. Nutrients, immune messages and hormones all affect the prenatal brain. Hormones: Testosterone with anti-Mullerian hormone masculinizes the brain by entering target cells and after conversion to estrogen binding to intracellular estrogen receptors; have organizational effects producing lifelong changes. Parenting style typically produces adults who adopt the same approach. And mothering style can alter gene regulation in the fetus in ways that transfer epigenetically to future generations! PMS symptoms vary by culture.
- Is also significantly transmitted to children by their peers during play. So parents try to control their children's peer group.
- Is transmitted to children by their neighborhoods, tribes, nations etc.
- Influences the parenting style that is considered appropriate.
- Can transform dominance into honor. There are ecological correlates of adopting honor cultures. Parents in honor cultures are typically authoritarian.
- Is strongly adapted across a meta-ethnic frontier according to Turchin.
- Across Europe was shaped by the Carolingian empire.
- Can provide varying levels of support for innovation. Damasio suggests culture is influenced by feelings:
- As motives for intellectual creation: prompting
detection and diagnosis of homeostatic
deficiencies, identifying
desirable states worthy of creative effort.
- As monitors of the success and failure of cultural
instruments and practices
- As participants in the negotiation of adjustments
required by the cultural process over time
- Produces consciousness according to Dennet.
. It
specifically rejected proposals from Senator Grassley to
separate the drug certification and monitoring processes.
It argued "Achieving a balanced approach to the assessment of
risks and benefits would be greatly complicated, or even
compromised, if two separate organizations were working in
isolation from one another."
While the F.D.A. sponsored the report the deputy director of the
Office of New Drugs, Sandra Kweder, bemoaned the report's criticism
of what it described as the agency's dysfunctional culture.
"It is a long, inflammatory section of the report that will
certainly generate the most public attention and hit our people
hard," Dr. Kweder wrote.
Senator Grassley
chairman of the Finance Committee that has overseen investigations
into drug safety problems suggested the report validates what the
watchdog community has been saying for the last two years.
"Problems are systemic, and solutions must reflect a new mind-set by
the agency leadership now aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group. Pinker notes the evolved pressure of social rivalry associating power with leadership. Different evolved personality types reinforced during development provided hunter-gatherer bands with alternate adult capabilities for coping with the various challenges of the African savanna. As the situation changed different personalities would prove most helpful in leading the band. Big men, chiefs and leaders of early states leveraged their power over the flow of resources to capture and redistribute wealth to their supporters. As the environmental state changed and began threatening the polity's fitness, one leader would be abandoned, replaced by another who the group hoped might improve the situation for all. Sapolsky observes the disconnect that occurs between power hierarchies and wisdom in apes. In modern Anglo-American style corporations, which typically follow Malthus, and are disconnected from the superOrganism nest site, the goal of leadership has become detached from the needs of this broader polity, instead: seeking market and revenue growth, hiring and firing workers, and leveraging power to reduce these commitments further. Dorner notes that corporate executives show an appreciation of how to control a CAS. Robert Iger with personality types: Reformer, Achiever, Investigator; describes his time as Disney CEO, where he experienced a highly aligned environment, working to nurture the good and manage the bad. He notes something is always coming up. Leadership requires the ability to adapt to challenges while compartmentalizing. John Boyd: Achiever, Investigator, Challenger; could not align with the military hierarchy but developed an innovative systematic perspective which his supporters championed and politicians leveraged. John Adair developed a modern leadership methodology based on the three-circles model. ."
Grassley & Dodd are writing a bill for congress to address the F.D.A. Food and Drug Administration. problems. An
alternative bill is being written by Enzi & Edward
Kennedy.
The drug industry's trade association Pharmaceutical
Research and Manufacturers of America commented "Though there
is always room for improvements, it would be a mistake to accept the
notion that the F.D.A. drug safety system is seriously flawed," said
Caroline Loew senior VP.
NYT Oct 31 2013
Iclusig suspended
Sales of Iclusig (Ponatinib) from Ariad Pharmaceuticals were
suspended after the F.D.A. concluded that the medicine increased the
risk of heart attack is an AMI. It can induce cardiac arrest. Blocking the formation of clots with platelet aggregation inhibitors, can help with treating and avoiding AMI. Risk factors include: taking NSAID pain killers (May 2017). There is uncertainty about why AMI occur. Alternative hypotheses include: - Plaques started to gather in the coronary arteries and grew until no blood flow was possible. If this is true it makes sense to preventatively treat the buildup with angioplasty.
- Plaques form anywhere in the body due to atherosclerosis and then break up and get lodged in the coronary artery and start to clot. If this is true it makes sense to preventatively limit the buildup of plaques with drugs like statins or PCSK9 inhibitors.
s,
strokes is when brain cells are deprived of oxygen and begin to die. 750,000 patients a year suffer strokes in the US. 85% of those strokes are caused by clots. There are two structural types: Ischemic and hemorrhagic. Thrombectomy has been found to be a highly effective treatment for some stroke situations (Jan 2018). (Ischemic is a clot that occurs as a result of an Ischemia within a blood vessel supplying blood to the brain. They account for 87% of all strokes. There are two main types: - Thrombotic - where cerebral arteries become diseased or damaged and then blocked by a blood clot within the brain.
- Embolic - where a blood clot or plaque fragment forms outside the brain (usually the heart) and travels to the brain where it blocks a blood vessel.
&
Hemorragic is the hemorrhage of a weakened blood vessel causing blood to leak into and around the brain creating swelling and pressure, damaging cells and tissue in the brain. There are two main types: - Intracerebral - where the hemorrhage is in small arteries or arterioles within the brain.
- Subarachnoid - where the hemorrhage is in a blood vessel just outside the brain leading to the skull filling with blood.
),
blindness, amputations and death.
Iclusig is used mainly to treat CML is chronic myelogenous leukemia. It is a leukemia characterized by the unregulated growth of myeloid cells in the bone marrow. The growth is encouraged by the cellular signalling system (gene change that generates a faulty tyrosine kinase) being locked on. Visual methods allowed Dr. Janet Rowley's team to recognize that most CML includes the Philadelphia chromosome. It encodes the chimeric always on tyrosine kinase protein seen only in CML. Targeted treatments such as Gleevec block the pathway for the tyrosine kinase. . 640 patients
were using the drug.
Iclusig cost $115,000 for a years course. It is Ariads only
product. They laid off 160 rmployees as a result.
NYT Dec 2013 After Brief Halt, F.D.A. Allows Sales of Drug For
Cancer to Resume
F.D.A. Food and Drug Administration. announced it would
allow sales to resume of Iclusig, from Ariad Pharamaceuticals.
It had been suspended
on Oct 31. But Ariad and the F.D.A. said the drug could
be marketed for a narrower patient population (where no other drug
works) and with stronger warnings of the side-effects. It
notes that clots or coagulation is formation of a clot: - Platlets become activated, adhere and aggregate supported by
- Fibrin polymerization, deposition and maturation.
or
significant narrowing of the arteries have occurred in at least 27%
of patients causing fatal heart attack is an AMI. It can induce cardiac arrest. Blocking the formation of clots with platelet aggregation inhibitors, can help with treating and avoiding AMI. Risk factors include: taking NSAID pain killers (May 2017). There is uncertainty about why AMI occur. Alternative hypotheses include: - Plaques started to gather in the coronary arteries and grew until no blood flow was possible. If this is true it makes sense to preventatively treat the buildup with angioplasty.
- Plaques form anywhere in the body due to atherosclerosis and then break up and get lodged in the coronary artery and start to clot. If this is true it makes sense to preventatively limit the buildup of plaques with drugs like statins or PCSK9 inhibitors.
s and
stroke is when brain cells are deprived of oxygen and begin to die. 750,000 patients a year suffer strokes in the US. 85% of those strokes are caused by clots. There are two structural types: Ischemic and hemorrhagic. Thrombectomy has been found to be a highly effective treatment for some stroke situations (Jan 2018). s and other
problems. Heart failure is congestive heart failure which occurs when the heart is unable to generate enough blood flow to meet the body's demands. There are two main types: failure due to left ventricular dysfunction and abnormal diastolic function increasing the stiffness of the left ventricle and decreasing its relaxation. Heart expansion in CHF distorts the mitral valve which exacerbates the problems. MitraClip surgery trials found effective in correcting the mitral valve damage (Sep 2018). Treatments include: digoxin;
occured in 8% of patients with some fatalities. Iclusigs
suspension had set off protests from doctors, patients and patient
advocates, who said Iclusig was the only medicine that worked for
some people, the only thing keeping them alive. For these
patients the loss of the drug was a greater safety concern than the
cardiovascular risks. During the suspension 350 applications
for its use were approved.
NYT Dec
2013 The Peril of Antibiotic Use on Farms
F.D.A. Food and Drug Administration. announced a new
policy asking drug companies to revise their labels voluntarily to
remove statements indicating that the antibiotics can be used to
promote growth in livestock. such a labeling change makes it
illegal to use the antibiotics for that purpose. Companies
that comply will also have to ensure that the use of the drugs to
treate, control or prevent disease in animals is authorized and
overseen by veterinarians.
The drug companies have three months to tell the F.D.A. if they are
going to change their labels. Two major manufacturers have
said they will do so as of 22 Dec 2013.
Equal Employment
Opportunities Commission (EEOC)
The EEOC is the federal agency that enforces federal employment
discrimination laws.
- ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
compliant wellness is a health care oriented employer based strategy for reducing health care costs and encouraging wellbeing. Wellbeing has traditionally been a focus of public health. programs
can impose significant financial penalties on employees (Oct
2015).
- AARP challenges EEOC is the equal employment opportunity commission. It is the federal agency with oversight of employer actions and develops the rules that implement employment legislation, including: wellness.
final rules on wellness is a health care oriented employer based strategy for reducing health care costs and encouraging wellbeing. Wellbeing has traditionally been a focus of public health. programs
(Oct
2016)
EEOC, wellness
programs and the ACA
The EEOC is the equal employment opportunity commission. It is the federal agency with oversight of employer actions and develops the rules that implement employment legislation, including: wellness. tried to stop Honeywell
from penalizing employees who did not take medical tests as part of
a wellness program is a health care oriented employer based strategy for reducing health care costs and encouraging wellbeing. Wellbeing has traditionally been a focus of public health.
with a restraining order. They argued Honeywell was requiring the
tests and was violating the ADA is either the Americans with Disabilities Act of 1990 or a label for the gene that encodes the enzyme adenosine deaminase. .
A federal district court judge denied the motion.
The EEOC then produced its own ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes: - Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
compliant rules.
That included updating the Genetic Information Nondiscrimination Act
to permit employers to provide rewards or impose penalties on
workers' spouses in exchange for data on their current or past
health status, through their family history or genetic information.
Health Resources &
Services Administration (HRSA)
HRSA Structure
HRSA Bureaus:
- Bureau of Health Workforce
- Bureau fo Primary Health Care
- Healthcare Systems Bureau
- HIV/AIDS Bureau
- Maternal and Child Health Bureau
HRSA Offices
- Federal Office of Rural Health Policy
- Office of Communications
- Office of Civil Rights, Diversity, and Inclusion
- Office of Federal Assistance Management
- Office of Global Health
- Office of Health Equity
- Office of Legislation
- Office of Operations
- Office of Planning, Analysis, and Evaluation
- Office of Regional Operations
- Office of Women's Health
Massachusetts Group Insurance Commission (GIC)
The GIC oversees Massachusetts state employees, retirees and
dependents healthcare programs.
In 2012 it offered some of its subscribers the chance to waive three
months of employee premium contributions if they enrolled in new,
narrow network plans (Oct
2016)
In 2012 the Massachusetts
Group Insurance Commission offered some of its government
employees a premium holiday of $500 if they enrolled in a narrow
network with:
- half the physicians
- one third fewer hospitals
Economists is the study of trade between humans. Traditional Economics is based on an equilibrium model of the economic system. Traditional Economics includes: microeconomics, and macroeconomics. Marx developed an alternative static approach. Limitations of the equilibrium model have resulted in the development of: Keynes's dynamic General Theory of Employment Interest & Money, and Complexity Economics. Since trading depends on human behavior, economics has developed behavioral models including: behavioral economics. could
compare the subscribers in the narrow and broad network plans.
The people who switched spent 36% less. The economists
concluded the reduction in cost was at least partly due to more
efficient use of health care.
It is concluded that narrow networks which reduce the set of costly
specialists but retain a broad offering of PCP will be more
effective.
National
Association of Insurance Commissioners (NAIC)
The NAIC represents state officials issues guidance and template
regulations for states to follow.
- Nov
2015 State health insurance regulators NAIC
release model
law to constrain narrow networks - When all health insurance plans are comparable on line people are expected to choose narrower less costly plans. This has the effect of encouraging providers and PCP to compete to be part of the narrow plan by reducing their charges and driving down the prices of the plans. By limiting the number of providers/doctors offered in the plans the few that are included should get more business. Across the US in 2015 39% of health plans offered in public exchanges are narrow (30 - 70% of areas providers) or ultra-narrow (30% or less of providers). In large cities narrow networks are even more common. Typically if consumers go outside of the choices offered in their narrow network they will be responsible for the high bills. There are problems induced by narrow network constraints:
- Queuing issues - while a surgeon and a hospital may be in-network other agents in an operation, such as anesthesiologists or anesthetists, may not have the same set of insurance contracts. Even if a subset do, once these are allocated to a task the hospital must then manage a complex set of resource constraints to keep its ORs running. If it does this by ignoring the 'out of network' status of these necessary resources the patient will be impacted by a high bill.
- Success is more likely when the plan maintains a broad list of PCPs but a narrow list of specialists and hospitals (Oct 2016).
.
- Nov
2015 NAIC asked by consumer advocates and antitrust
experts to review health
insurers' merger proposals
- President Trump's executive order concerns state
regulators and the Kaiser
Family Foundation but gains applause from the USCOC
(Oct
2017):
- Relaxes legislated:
ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes:
- Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
, ERISA is the Employee Retirement Income Security Act of 1974 signed by President Ford. It regulated both pension and health benefit plans once an employer had established one. It setup the PBGC to support voluntary private defined benefit pension plans. Where self-funded health plans under ERISA are exempt from a state's insurance regulation there will be no solvency or consumer protection in place to support providers that do business with ERISA plans. States may consequently require provider networks that do business with employer self-insured ERISA plans be licensed as an insurance company (an HMO, medical insurance plan, preferred provider arrangement or general casualty insurer). ERISA section 404(a)(1)(B) defines the prudent person rule associating prudence with portfolio theory allowing pension funds to invest in stocks (index funds). The labor department's interpretation of an ERISA employer has been modified to support President Trump's executive order to enable more use of AHPs (Jan 2018). ; implementation
of federal insurance regulations and pushes for AHP is association health plan:
- Allow small businesses and individuals in particular
professions, trades or interest groups to join
associations that offer insurance to members.
- Are a form of MEWA
s, in move that NAIC
& BCBS
and other insurance plans will resist (Oct
2017)
- Labor department acts on executive order issuing proposed
new rules for AHP is association health plan:
- Allow small businesses and individuals in particular
professions, trades or interest groups to join
associations that offer insurance to members.
- Are a form of MEWA
s,
updating its ERISA is the Employee Retirement Income Security Act of 1974 signed by President Ford. It regulated both pension and health benefit plans once an employer had established one. It setup the PBGC to support voluntary private defined benefit pension plans. Where self-funded health plans under ERISA are exempt from a state's insurance regulation there will be no solvency or consumer protection in place to support providers that do business with ERISA plans. States may consequently require provider networks that do business with employer self-insured ERISA plans be licensed as an insurance company (an HMO, medical insurance plan, preferred provider arrangement or general casualty insurer). ERISA section 404(a)(1)(B) defines the prudent person rule associating prudence with portfolio theory allowing pension funds to invest in stocks (index funds). The labor department's interpretation of an ERISA employer has been modified to support President Trump's executive order to enable more use of AHPs (Jan 2018).
interpretation, and weakening the ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care). In part it is designed to make the health care system costs grow slower. It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s. It funds these changes with increased taxes on the wealthy. It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House OMB health policy advisor Ezekiel Emanuel & architect Jeanne Lambrew. The Obama administration drafting team included: Bob Kocher; allowing it to integrate ideas from: Dartmouth Institute's Elliot Fischer (ACO). The ACA did not include a Medicare buy in (May 2016). The law includes: - Alterations, in title I, to how health care is paid for and who is covered. This has been altered to ensure
- Americans with preexisting conditions get health insurance cover - buttressed by mandating community rating and
- That they are constrained by the individual mandate to have insurance but the requirement was supported by subsidies for the poor (those with incomes between 100 & 400% of the federal poverty line).
- Children, allowed to, stay on their parents insurance until 26 years of age.
- Medicare solvency improvements.
- Medicaid expansion, in title II: to poor with incomes below 138% of the federal poverty line; an expansion which was subsequently constrained by the Supreme Court's ruling making expansion an optional state government decision.
- Hospital Readmissions Reduction Program (HRRP) which was enforced by CMS mandated rules finalized in 2011 and effected starting Oct 2012.
- Medical home models.
- Community transformation grants support the transformation of low income stressed neighborhoods to improve their lifestyles and health.
- Qualifications for ACOs. Organizations must:
- Establish a formal legal structure with shared governance which allows the ACO to distribute shared savings payments to participating providers and suppliers.
- Participate in the MSSP for three or more years.
- Have a management structure.
- Have clinical and administrative systems.
- Include enough PCPs to care for Medicare FFS patient population (> 5000) assigned to the ACO.
- Be accountable for the quality and cost of care provided to the Medicare FFS patient population.
- Have defined processes to promote: Evidence-based medicine, Patient-centeredness, Quality reporting, Cost management, Coordination of care;
- Demonstrate it meets HHS patient-centeredness criteria including use of patient and caregiver assessments and individualized care plans.
- CMMI Medicare payment experimentation.
- Requirements that pharmaceutical companies must report payments made to physicians (Sunshine Act).
- A requirement that chain restaurants must report calorie counts on their menus.
's constraints on skimpy health
insurance coverage (Jan
2018)
- State health insurance regulators & government officials:
California, Maryland, Nebraska, Pennsylvania, Vermont; block
deployment of 3 year limited-duration health plans, seeing them
as substandard products. Insurers: Health
Insurance Innovations; leverage former NAIC
leaders: Senator Ben Nelson; to demonstrate compliance.
Regulators at NAIC meeting expressed deep concern about the
aggressive and misleading marketing. New York banned the
products to limit confusion (Aug
2018)
NAIC Nov
2015 recommendation on broader networks
The recommendations, in the form of a model state law, would
require:
- Insurers have enough doctors and hospitals in their networks
to provide all covered services to comsumers without
unreasonable travel or delay.
- Insurers and hospitals would be required to inform patients of
any possibility that they may be charged extra by a health care
professional, such as an anesthesiologist, pathologist or
radiologist, who does not participate in the insurer's
network. In such situations patients should not have to
pay more than their usual share of the bill for services
provided by doctors affiliated with their health plans.
Doctors who object to the amount can take the insurer to
arbitration but the patient would be held harmless.
- To determine if a network of providers is sufficient the
commissioners would consider:
- Ratio of people enrolled to specialists
- Geographic accessibility of providers
- Waiting times for appointments
- Ability of health plans to meet the needs of low income
people and children and adults with serious, chronic or
complex health conditions or physical or mental
disabilities.
- Insurers would be required to update their provider
directories monthly. Federal investigators have found
these directories full of errors - doctors who have died, are no
longer practicing at the specified location or are not taking on
new patients.
The recommendations were developed over 18 months in an open
process.
NAIC argue against AHPs
NAIC argue against AHP is association health plan:
- Allow small businesses and individuals in particular
professions, trades or interest groups to join
associations that offer insurance to members.
- Are a form of MEWA
s
which are being pushed by President Trump (Oct
2017)
NAIC
argue AHP is association health plan:
- Allow small businesses and individuals in particular
professions, trades or interest groups to join
associations that offer insurance to members.
- Are a form of MEWA
s operate
outside state consumer-protection laws and may increase the cost of
insurance for small businesses that don't belong to AHPs.
National
Credit Union Administration (NCUA)
The NCUA is an independent federal agency that charters and
supervises federal credit unions and insures savings in federal and
state-chartered credit unions.
NCUA Vice Chairman Rick Metsger
Metsger commented on the roleout of Dodd-Frank is the 2010 Dodd-Frank Wall Street Reform and Consumer Protection Act. Its titles include: - Financial Stability creates the FSOC and OFR.
- Orderly Liquidation Authority
- Section 619 is the Volcker Rule: prohibitions on proprietary trading and certain relationships.
- Transfer of Powers to the Comptroller, the FDIC, and the Fed
- Regulation of Advisers to Hedge Funds and Others - which updated the powers of the Investment Company Act.
- Insurance
- Improvements to Regulation
- Wall Street Transparency and Accountability
- Payment, Clearing and Settlement Supervision
- Investor Protections and Improvements to the Regulation of Securities
- Bureau of Consumer Financial Protection
- Federal Reserve System Provisions
- Improving Access to Mainstream Financial Institutions
- Pay It Back Act
- Mortgage Reform and Anti-Predatory Lending Act
- Miscellaneous Provisions
- Section 1256 Contracts
rules on
executive compensation (Apr
2016).
New York
State Department of Health
NYT Aug 2013
NYSDOH and Price gouging for supplies
New York Times journalist asked the DOH for help in mapping medical
supplies charges at New York State hospitals including St.
Lukes and White Plains,
for rehydrating patients with IV Saline after a food
poisoning. Deploying software usually used to detect Medicaid is the state-federal program for the poor. Originally part of Lyndon Johnson's 1965 Bill, eligibility and services vary by state. Medicaid currently pays less for care than Medicare, resulting in many care providers refusing to participate in the program. Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem. The ACA's Medicaid expansion program, made state optional by the SCOTUS decision, was initially taken up by fifty percent of states. As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year. In 2017 it pays for 40% of new US births. fraud, a team
compiled a chart of what Medicaid and Medicare is a social insurance program that guarantees access to health insurance for Americans aged 65 and over, and younger people with disabilities and end stage renal disease or ALS. Medicare is currently missing a cap on out-of-pocket costs and direct prescription drug coverage. It includes: - Benefits
- Part A: Hospital inpatient insurance. As of Dec 2013 Medicare pays for home care in only limited circumstances, such as when a person needs temporary nursing care after a hospitalization. Part A covers 20 days of inpatient rehabilitation at a SNF after discharge from inpatient care at a hospital.
- Part B: Medical insurance for non-hospital services including: doctor visits, tests, injectable drugs, ambulances, physical therapy;
- Part C: Medicare Advantage
- Part D: indirect prescription drug coverage The MMA prohibits Medicare from directly negotiating drug prices.
- Eligibility
- All persons 65 years of age or older who are legal residents for at least 5 years. If they or a spouse have paid Medicare taxes for 10 years the Medicare part A payments are waived. Medicare is legislated to become the primary health plan.
- Persons under 65 with disabilities who receive SSDI.
- Persons with specific medical conditions:
- Have end stage renal disease or need a kidney transplant.
- They have ALS.
- Some beneficiaries are dual eligible.
- Part A requires the person has been admitted as an inpatient at a hospital. This is constrained by a rule that they stay for three days after admission.
- Sign-up
- Part A has automatic sign-up if the person is drawing social security. Otherwise the person must sign-up for Part A and Part B.
- Should sign-up for Part B during the Initial Enrollment Period, of seven months centered around 65th birthday, online or at a social security office. But if still covered by spouse's insurance or not yet retired then may only join during the 3 month general enrollment period (January to March) each year, with coverage initiated the following July. Incremental yearly 10% penalties apply for not signing up at 65. These penalties apply to all subsequent premiums.
- Premiums
- Part A premium
- Part B insurance premium
- Part C & D premiums are set by the commercial insurer.
were billed
in six of the cases.
But the department has yet to release the chart. It is under
indefinite review, Bill Schwartz, a department spokesmen, said, "to
ensure confidential information is not compromised."
United Nations (UN)
The United Nations was part of FDR is President Franklin Delano Roosevelt. He is notable for his contributions to the US CAS: - New Deal strategies including:
- Lend-lease which pushed the US and Japan into World War 2 and helped the US to become the world's predominant military power.
- Bretton Woods's agreement which economically constrained any politically driven collapse of the world economy after the war and helped the US to become the world's predominant economic power.
's post second-world-war
global infrastructure. It is headquartered in New York
City. It is an intergovernmental organization designed to
facilitate international cooperation.
- W.H.O. is World Health Organization a United Nations organization. supports
world leaders now aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group. Pinker notes the evolved pressure of social rivalry associating power with leadership. Different evolved personality types reinforced during development provided hunter-gatherer bands with alternate adult capabilities for coping with the various challenges of the African savanna. As the situation changed different personalities would prove most helpful in leading the band. Big men, chiefs and leaders of early states leveraged their power over the flow of resources to capture and redistribute wealth to their supporters. As the environmental state changed and began threatening the polity's fitness, one leader would be abandoned, replaced by another who the group hoped might improve the situation for all. Sapolsky observes the disconnect that occurs between power hierarchies and wisdom in apes. In modern Anglo-American style corporations, which typically follow Malthus, and are disconnected from the superOrganism nest site, the goal of leadership has become detached from the needs of this broader polity, instead: seeking market and revenue growth, hiring and firing workers, and leveraging power to reduce these commitments further. Dorner notes that corporate executives show an appreciation of how to control a CAS. Robert Iger with personality types: Reformer, Achiever, Investigator; describes his time as Disney CEO, where he experienced a highly aligned environment, working to nurture the good and manage the bad. He notes something is always coming up. Leadership requires the ability to adapt to challenges while compartmentalizing. John Boyd: Achiever, Investigator, Challenger; could not align with the military hierarchy but developed an innovative systematic perspective which his supporters championed and politicians leveraged. John Adair developed a modern leadership methodology based on the three-circles model.
'
UN is the United Nations. plan to curb drug
resistance (Oct
2016).
- Cholera epidemic is the rapid spread of infectious disease: AIDS (Oct 2016), Cholera (2010), Clostridium difficile (May 2015), Ebola, Influenza, Polio, SARS, Tuberculosis, Typhoid (Apr 2018), Malaria, Yellow fever, Zika; to large numbers of people in a population within a short period of time -- two weeks or less. Epidemics are studied and monitored by: NIAID, CDC, WHO; but are managed by states in the US. Infection control escalation is supported by biocontainment units: Emory, Nebraska. Once memes are included in the set of infectious schematic materials, human addictions can present as epidemics concludes Dr. Nora Volkow of the NIDA. CEPI aims to ensure public health networks are effectively prepared for epidemics. PHCPI aims to strengthen PCPs globally to improve responsiveness to epidemics. GAVI helps catalyze the development and deployment of vaccines. Sporadic investment in public health enables development of conditions for vector development: Mosquitos. The increasing demands of the global population are altering the planet: Climate change is shifting mosquito bases, Forests are being invaded bringing wildlife and their diseases in contact with human networks. Globalized travel acts as an infection amplifier: Ebola to Texas. Health clinics have also acted as amplifiers: AIDS in Haiti, C. diff & MRSA infections enabled & amplified by hospitals. Haiti earthquake support from the UN similarly introduced Cholera.
generated by UN is the United Nations.
infrastructure in Haiti (2010)
Key initiatives:
- Cities: New Urban Agenda - Habitat conferences (I 1976, II,
III 2016)
- Climate change:
- Sustainable development:
United Natons
Children's Fund (Unicef)
Unicef head of immunization Robin Nandy
Unicef is the United Nations Childrens Fund. , W.H.O. is World Health Organization a United Nations organization. , CDC is the HHS's center for disease control and prevention based in Atlanta Georgia. and GAVI alliance
report on measles, or rubeola, is a highly contagious respiratory viral infection that can be dangerous in young children. It is easily avoided by M.M.R. vaccination. The virus floats in the air and can rapidly infect people who have not previously encountered measles. However, once infected the human host develops resistance. This limited the persistance of measles as a desease of humans until people began living in cities of five hundred thousand or more. At that critical community size, there were enough newborns to continuously provide additional hosts.
global eradication status (Nov
2016)
World Health
Organization (W.H.O.)
Headquartered in Geneva Switzerland
The W.H.O. is the only agency that can declare a global public
health emergency. It sets global medical standards. It
coordinates cooperation among national public health
laboratories.
- WHO is World Health Organization a United Nations organization. 's Ghebreyesus
announces reorganization to get affordable health care to the
world's poorest 1 billion people, protect them from epidemics is the rapid spread of infectious disease: AIDS (Oct 2016), Cholera (2010), Clostridium difficile (May 2015), Ebola, Influenza, Polio, SARS, Tuberculosis, Typhoid (Apr 2018), Malaria, Yellow fever, Zika; to large numbers of people in a population within a short period of time -- two weeks or less. Epidemics are studied and monitored by: NIAID, CDC, WHO; but are managed by states in the US. Infection control escalation is supported by biocontainment units: Emory, Nebraska. Once memes are included in the set of infectious schematic materials, human addictions can present as epidemics concludes Dr. Nora Volkow of the NIDA. CEPI aims to ensure public health networks are effectively prepared for epidemics. PHCPI aims to strengthen PCPs globally to improve responsiveness to epidemics. GAVI helps catalyze the development and deployment of vaccines. Sporadic investment in public health enables development of conditions for vector development: Mosquitos. The increasing demands of the global population are altering the planet: Climate change is shifting mosquito bases, Forests are being invaded bringing wildlife and their diseases in contact with human networks. Globalized travel acts as an infection amplifier: Ebola to Texas. Health clinics have also acted as amplifiers: AIDS in Haiti, C. diff & MRSA infections enabled & amplified by hospitals. Haiti earthquake support from the UN similarly introduced Cholera.
and
enjoy better health - but it only indirectly
attacks the largest problem: regional offices are independent in
the original charter, due to competing power strategies, and
resist the leadership in Geneva which is focused on power and
perks of living in the Swiss Alps; by forcing staff to rotate
between central and regional offices (Mar
2019)
The W.H.O. manages and supports global health actions:
- W.H.O. is World Health Organization a United Nations organization. supports
world leaders now aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group. Pinker notes the evolved pressure of social rivalry associating power with leadership. Different evolved personality types reinforced during development provided hunter-gatherer bands with alternate adult capabilities for coping with the various challenges of the African savanna. As the situation changed different personalities would prove most helpful in leading the band. Big men, chiefs and leaders of early states leveraged their power over the flow of resources to capture and redistribute wealth to their supporters. As the environmental state changed and began threatening the polity's fitness, one leader would be abandoned, replaced by another who the group hoped might improve the situation for all. Sapolsky observes the disconnect that occurs between power hierarchies and wisdom in apes. In modern Anglo-American style corporations, which typically follow Malthus, and are disconnected from the superOrganism nest site, the goal of leadership has become detached from the needs of this broader polity, instead: seeking market and revenue growth, hiring and firing workers, and leveraging power to reduce these commitments further. Dorner notes that corporate executives show an appreciation of how to control a CAS. Robert Iger with personality types: Reformer, Achiever, Investigator; describes his time as Disney CEO, where he experienced a highly aligned environment, working to nurture the good and manage the bad. He notes something is always coming up. Leadership requires the ability to adapt to challenges while compartmentalizing. John Boyd: Achiever, Investigator, Challenger; could not align with the military hierarchy but developed an innovative systematic perspective which his supporters championed and politicians leveraged. John Adair developed a modern leadership methodology based on the three-circles model.
'
UN is the United Nations. plan to curb drug
resistance (Oct
2016).
The W.H.O. issues public
health is the proactive planning, coordination and execution of strategies to improve and safeguard the wellbeing of the public. Its global situation is discussed in The Great Escape by Deaton. Public health in the US is coordinated by the PHS federally but is mainly executed at the state and local levels. Public health includes: - Awareness campaigns about health threatening activities including: Smoking, Over-eating, Alcohol consumption, Contamination with poisons: lead; Joint damage from over-exercise;
- Research, monitoring and control of: disease agents, reservoir and amplifier hosts, spillover and other processes, and vectors; by agencies including the CDC.
- Monitoring of the public's health by institutes including the NIH. This includes screening for cancer & heart disease.
- Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.
- Development, deployment and maintenance of vaccination strategies.
- Development, deployment and maintenance of fluoridation.
- Development, deployment and maintenance of family planning services.
- Regulation and constraint of foods, drugs and devices by agencies including the FDA.
reports and emergency notices:
- Africa and Asia most impacted by environmental risk factors
like air and water pollution causing preventable deaths (Mar
2016).
- Vietnam
coping better than most with tuberculosis, consumption or otherwise TB, is mostly an airborn bacterial lung infection, but it can also infect the brain, kidneys and other parts of the body. The only vaccine is still the BCG. The deployment of antibiotics during the 1940s allowed effective treatment: Streptomycin. In 1963 epidemiologist George Comstock realized why 30% of Alaskan adults were infected with TB - it grows slowly and is transmitted to other people before symptoms occur. Treatment was expanded to all contacts of a person with symptoms, who tested positive for TB. This strategy eradicated TB in the West, but was considered impractical in poor countries. Diagnostic tools for TB are insufficient. And because TB grows slowly in walled off pockets in the lungs it takes many months of treatment for antibiotics to eradicate the infection. TB benefits from compromised hosts and has benefited from HIV/AIDS. TB is also leveraging the plasmids that now carry immunity to all current antibiotics. In 2016 it is estimated to latently infect two billion people. 9.6 million worldwide became infected in 2014. 1.5 million people will die from TB in 2016. Deaths from the disease have fallen drastically since 2000. TB has been halted or reversed in 16 of the 22 countries: India (Sep 2016, Infection base estimate increased Oct 2016), Vietnam, Indonesia; that have the majority of cases. But it is still the infectious disease causing the most deaths world-wide. In 2018 W.H.O. asserts there is a $3.5 billion shortfall in funding for TB public health control efforts, a gap that will double by 2023. Nano scale drug delivery has the potential to push back on TB and is being actively researched (May 2016). (Mar
2016).
- Estimate of new patients with TB, consumption or otherwise TB, is mostly an airborn bacterial lung infection, but it can also infect the brain, kidneys and other parts of the body. The only vaccine is still the BCG. The deployment of antibiotics during the 1940s allowed effective treatment: Streptomycin. In 1963 epidemiologist George Comstock realized why 30% of Alaskan adults were infected with TB - it grows slowly and is transmitted to other people before symptoms occur. Treatment was expanded to all contacts of a person with symptoms, who tested positive for TB. This strategy eradicated TB in the West, but was considered impractical in poor countries. Diagnostic tools for TB are insufficient. And because TB grows slowly in walled off pockets in the lungs it takes many months of treatment for antibiotics to eradicate the infection. TB benefits from compromised hosts and has benefited from HIV/AIDS. TB is also leveraging the plasmids that now carry immunity to all current antibiotics. In 2016 it is estimated to latently infect two billion people. 9.6 million worldwide became infected in 2014. 1.5 million people will die from TB in 2016. Deaths from the disease have fallen drastically since 2000. TB has been halted or reversed in 16 of the 22 countries: India (Sep 2016, Infection base estimate increased Oct 2016), Vietnam, Indonesia; that have the majority of cases. But it is still the infectious disease causing the most deaths world-wide. In 2018 W.H.O. asserts there is a $3.5 billion shortfall in funding for TB public health control efforts, a gap that will double by 2023. Nano scale drug delivery has the potential to push back on TB and is being actively researched (May 2016). in India
increased (Oct
2016).
- Obesity is an addictive disorder where the brain is induced to require more eating, often because of limits to the number of fat cells available to report satiation (Jul 2016). Brain images of drug-addicted people and obese people have found similar changes in the brain. Obese people's reward network tends to be less responsive to dopamine and have a lower density of dopamine receptors. Obesity spreads like a virus through a social network with a 171% likelihood that a friend of someone who becomes obese will also become so. Obesity is associated with: metabolic syndrome including inflammation, cancer (Aug 2016), high cholesterol, hypertension, type-2-diabetes, asthma and heart disease. It is suspected that this is contributing to the increase in maternal deaths in the US (Sep 2016). Obesity is a complex condition best viewed as representing many different diseases, which is affected by the: Amount of brown adipose tissue (Oct 2016), Asprosin signalling by white adipose tissue (Nov 2016), Genetic alleles including 25 which guarantee an obese outcome, side effects of some pharmaceuticals for: Psychiatric disorders, Diabetes, Seizure, Hypertension, Auto-immunity; Acute diseases: Hypothyroidism, Cushing's syndrome, Hypothalamus disorders; State of the gut microbiome. Infections, but not antibiotics, appear associated with childhood obesity (Nov 2016).
associated with more than 13 cancers is the out-of-control growth of cells, which have stopped obeying their cooperative schematic planning and signalling infrastructure. It results from compounded: oncogene, tumor suppressor, DNA caretaker; mutations in the DNA. In 2010 one third of Americans are likely to die of cancer. Cell division rates did not predict likelihood of cancer. Viral infections are associated. Radiation and carcinogen exposure are associated. Lifestyle impacts the likelihood of cancer occurring: Drinking alcohol to excess, lack of exercise, Obesity, Smoking, More sun than your evolved melanin protection level; all significantly increase the risk of cancer occurring (Jul 2016). (Aug
2016).
- Verily
deploys deep
neural networks are representational models that achieve high performance on difficult pattern recognition problems in vision and speech. But they need specialized training methods such as greedy layerwise pre-training or HF optimization. Researchers are gaining access to the participation of the individual 'neurons' using: visualization, attribution, dimensionality reduction, interpretability; (Mar 2018)
to detect diabetic
retinopathy is damage to the blood vessels of the retina due to high blood sugar levels associated with type 2 diabetes. with retinal scan assistance. W.H.O. is World Health Organization a United Nations organization. reports 70
million Indians have diabetes includes type 1 and type 2. Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections. .
Technology used in Indian hospitals: Avarind Eye Hospital; and
clinics, supports the very low levels of trained doctors: 11 eye
doctors per million people, so an A.I. system may massively
improve screening. Currently needs a clear lens for the
neural networks to detect problems. Europe's regulators
have allowed the Verily system on to the market. The US is the United States of America. F.D.A. Food and Drug Administration. also approved a
system, but Verily's is still awaiting approval (Mar
2019)
- Unicef is the United Nations Childrens Fund.
, W.H.O. is World Health Organization a United Nations organization. , CDC is the HHS's center for disease control and prevention based in Atlanta Georgia. and GAVI alliance
report on measles, or rubeola, is a highly contagious respiratory viral infection that can be dangerous in young children. It is easily avoided by M.M.R. vaccination. The virus floats in the air and can rapidly infect people who have not previously encountered measles. However, once infected the human host develops resistance. This limited the persistance of measles as a desease of humans until people began living in cities of five hundred thousand or more. At that critical community size, there were enough newborns to continuously provide additional hosts.
global eradication status (Nov
2016)
- Cuban immunotherapy is indirect treatment of disease by altering the immune system. Targeted diseases include: cancers -- immuno-oncology, organ transplants.
vaccine are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
Cimavax is a non-small cell lung cancer immuno-oncology vaccine. It is an active vaccine, containing the ligand EGF and P64k and Montanide ISA 51 which together stimulate the immune system to generate antibodies targeted at EGF. This results in the EGF concentration in the blood dropping. Many cancers: Lung, Colon, Kidney, Head, Neck; leverage EGFR to stimulate cell growth. is smuggled
to US by non-small cell lung cancer affects 200,000 Americans each year. Inflammation is a driver of lung cancer spread (Aug 2017). All these cancers are carcinomas. There are two main hystological types: - Non-small-cell carcinomas are of three sub-types:
- Adenocarcinomas (40% of lung cancers) are typically peripherally situated and mostly induced by smoking.
- Squamous-cell carcinomas (30% of lung cancers) arise in the large bronchi an are highly correlated with smoking.
- Large-cell carcinomas (5 to 10% of lung cancers).
- Small-cell carcinomas.
sufferers (Nov
2016).
- W.H.O. is World Health Organization a United Nations organization. reports that
Paraguay eradicates malaria, but
even as the: Gates,
Slim
Foundations; & IDB is the inter-American development bank, established by the Organization of American States, as a source of financing to member governments within the Latin American and Caribbean region.
push further, malaria is gaining ground in the rest of the
world, where domestic resourcing is directed elsewhere (Jul
2018)
- W.H.O. is World Health Organization a United Nations organization. assessment
reports malaria progress stalls with
some countries going backwards: Nigeria, Madagascar, DRC,
Mozambique, Mali, Niger, Indonesia, Burkina Faso, Venezuela;
with 230 million cases in 2017 and 435,000 deaths - roughly the
same since 2013, and donations have been flat since 2008.
Triple therapy is able to cure sufferers - even in Artemisinin
resistant parts of Southeast Asia, and a new mosquito net is
protecting children (Nov
2018)
- Zika is a Flaviviridae family virus. It came from the Zika Forest of Uganda isolated in 1947. It is related to dengue, yellow fever, Japanese encephalitis and West Nile. Zika is transmitted sexually or via a daytime mosquito vector such as the Aedes genus. It has resulted in a pandemic in South America. Zika fever has been associated with a number of troubling complications:
- Guillain-Barre syndrome
- Microcephaly. The mechanism may have been identified (May 2016)
virus (Mar
2016)
- Brazil yellow
fever is an infectious disease of primates caused by a flavivirus, yellow fever virus. The virus is vectored by mosquitos: In the canopies of Rain Forest trees where monkeys are infected, Aedes aegypti in cities; but hunters can act as a reservoir for infection into aegypti. Monkeys are tracked by public health officials as signals for outbreaks of the disease. Often asymptomatic but patients who develop severe symptoms die within 10 days. Symptoms include: Jaundice, High fever and multiple organ failure.
outbreak causes alarm. Limited initial public health is the proactive planning, coordination and execution of strategies to improve and safeguard the wellbeing of the public. Its global situation is discussed in The Great Escape by Deaton. Public health in the US is coordinated by the PHS federally but is mainly executed at the state and local levels. Public health includes: - Awareness campaigns about health threatening activities including: Smoking, Over-eating, Alcohol consumption, Contamination with poisons: lead; Joint damage from over-exercise;
- Research, monitoring and control of: disease agents, reservoir and amplifier hosts, spillover and other processes, and vectors; by agencies including the CDC.
- Monitoring of the public's health by institutes including the NIH. This includes screening for cancer & heart disease.
- Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.
- Development, deployment and maintenance of vaccination strategies.
- Development, deployment and maintenance of fluoridation.
- Development, deployment and maintenance of family planning services.
- Regulation and constraint of foods, drugs and devices by agencies including the FDA.
response blamed. NIAID is the national institute of allergy and infectious diseases, a part of the NIH.
is worried about disease penetrating US is the United States of America. via Puerto
Rico. W.H.O. is World Health Organization a United Nations organization.
has supplied Brazil with vaccine are a core strategy of public health and have significantly extended global wellbeing over 200 years. Smallpox & polio were virtually eradicated. Recent successes include: HPV vaccine: Gardasil. They induce active acquired immunity to a particular disease. But the development and deployment of vaccines is complex: - The business model for vaccine development has been failing (Aug 2015):
- No Zika vaccine was available as the epidemic grew (Mar 2016). No vaccine for: CMV;
- Major foundations: Michael J. Fox, Gates, Wellcome; are working to improve the situation including sponsorship of the GAVI alliance. A geographic cluster is forming in Seattle including PATH (Apr 2016).
- Commercial developers include: Affiris, Cell Genesis, Chiron, CSL, Sanofi, Valeant;
- Vaccine deployment traditionally benefited from centrally managed vertical health programs. But political issues are now constraining success with less than 95-99% coverage required for herd immunity (Aug 2015, Sep 2015, Nov 2015, Nov 2016, Jul 2018).
- Where clinics have been driven into local neighborhoods health improves (Apr 2016).
- Retail clinics (Mar 2016): CVS Minute Clinics focus on vaccination.
- NNT is a useful metric for vaccine benefit. Influenza vaccine has an NNT of between 37 and 77, is cheap and causes little harm, so it is very beneficial.
- Key vaccines include: BCG, C. difficile (May 2015), Cholera (El Tor), Cervical Cancer (Gardasil HPV Jun 2018, Oct 2018), Dengvaxia (Mexico Dec 2015), Gvax, Influenza, Malaria vaccine, Provenge, Typbar-TCV (XDR typhoid Pakistan Apr 2018);
- Regulation involves: FDA (CBER), with CMS monitoring (star ratings, PACE (Aug 2016), Report cards (Sep 2015)) & CDC promoting vaccines: as a sepsis measure, To control C. difficile (May 2015);
- Research on vaccines includes:
- NIH: AIDS vaccines (AVRC), Focus on using genetic analysis to improve vaccine response.
- NCI:
- Roswell Park clinical trial of immuno-oncology vaccine cimavax.
- Geisinger: effective process leverage in treatment.
- Stanford Edge immuno-oncology for cancer vaccines.
- P53-driven-cancer focused, gene therapy (Jun 2015).
. CDC is the HHS's center for disease control and prevention based in Atlanta Georgia. warns of limited
vaccine in US (May
2017)
In 2017 the W.H.O. budget is $2.2 billion. Less than one third
comes from member dues. The majority is from major donors: US is the United States of America. , Britain, Bill
& Melinda Gates Foundation, Rotary International,
Norway;
The W.H.O. has been criticized for diverting much of its budget to
support a grand life-style for its executives in Switzerland.
It spends $200 million on staff travel -- more than it devoted to AIDS is acquired auto-immune deficiency syndrome, a pandemic disease caused by the HIV. It also amplifies the threat of tuberculosis. Initially deadly, infecting and destroying the T-lymphocytes of the immune system, it can now be treated with HAART to become a chronic disease. And with an understanding of HIV's mode of entry into the T-cells, through its binding to CCR5 and CD4 encoded transmembrane proteins, AIDS may be susceptible to treatment with recombinant DNA to alter the CCR5 binding site, or with drugs that bind to the CCR5 cell surface protein preventing binding by the virus. Future optimization of drug delivery may leverage nanoscale research (May 2016). , tuberculosis, consumption or otherwise TB, is mostly an airborn bacterial lung infection, but it can also infect the brain, kidneys and other parts of the body. The only vaccine is still the BCG. The deployment of antibiotics during the 1940s allowed effective treatment: Streptomycin. In 1963 epidemiologist George Comstock realized why 30% of Alaskan adults were infected with TB - it grows slowly and is transmitted to other people before symptoms occur. Treatment was expanded to all contacts of a person with symptoms, who tested positive for TB. This strategy eradicated TB in the West, but was considered impractical in poor countries. Diagnostic tools for TB are insufficient. And because TB grows slowly in walled off pockets in the lungs it takes many months of treatment for antibiotics to eradicate the infection. TB benefits from compromised hosts and has benefited from HIV/AIDS. TB is also leveraging the plasmids that now carry immunity to all current antibiotics. In 2016 it is estimated to latently infect two billion people. 9.6 million worldwide became infected in 2014. 1.5 million people will die from TB in 2016. Deaths from the disease have fallen drastically since 2000. TB has been halted or reversed in 16 of the 22 countries: India (Sep 2016, Infection base estimate increased Oct 2016), Vietnam, Indonesia; that have the majority of cases. But it is still the infectious disease causing the most deaths world-wide. In 2018 W.H.O. asserts there is a $3.5 billion shortfall in funding for TB public health control efforts, a gap that will double by 2023. Nano scale drug delivery has the potential to push back on TB and is being actively researched (May 2016). and malaria.
Donors have shifted funding to W.H.O. competitors including: Global
Fund to fight AIDs, Institute for health metrics and
evaluation;
WHO Director
General 2017 Dr. Tedros Adhanom Ghebreyesus of Ethiopia
Dr. Tedros is a malaria expert. As
Ethiopia's health minister he:
- Helped cut deaths from malaria, AIDS is acquired auto-immune deficiency syndrome, a pandemic disease caused by the HIV. It also amplifies the threat of tuberculosis. Initially deadly, infecting and destroying the T-lymphocytes of the immune system, it can now be treated with HAART to become a chronic disease. And with an understanding of HIV's mode of entry into the T-cells, through its binding to CCR5 and CD4 encoded transmembrane proteins, AIDS may be susceptible to treatment with recombinant DNA to alter the CCR5 binding site, or with drugs that bind to the CCR5 cell surface protein preventing binding by the virus. Future optimization of drug delivery may leverage nanoscale research (May 2016).
, tuberculosis, consumption or otherwise TB, is mostly an airborn bacterial lung infection, but it can also infect the brain, kidneys and other parts of the body. The only vaccine is still the BCG. The deployment of antibiotics during the 1940s allowed effective treatment: Streptomycin. In 1963 epidemiologist George Comstock realized why 30% of Alaskan adults were infected with TB - it grows slowly and is transmitted to other people before symptoms occur. Treatment was expanded to all contacts of a person with symptoms, who tested positive for TB. This strategy eradicated TB in the West, but was considered impractical in poor countries. Diagnostic tools for TB are insufficient. And because TB grows slowly in walled off pockets in the lungs it takes many months of treatment for antibiotics to eradicate the infection. TB benefits from compromised hosts and has benefited from HIV/AIDS. TB is also leveraging the plasmids that now carry immunity to all current antibiotics. In 2016 it is estimated to latently infect two billion people. 9.6 million worldwide became infected in 2014. 1.5 million people will die from TB in 2016. Deaths from the disease have fallen drastically since 2000. TB has been halted or reversed in 16 of the 22 countries: India (Sep 2016, Infection base estimate increased Oct 2016), Vietnam, Indonesia; that have the majority of cases. But it is still the infectious disease causing the most deaths world-wide. In 2018 W.H.O. asserts there is a $3.5 billion shortfall in funding for TB public health control efforts, a gap that will double by 2023. Nano scale drug delivery has the potential to push back on TB and is being actively researched (May 2016).
and neonatal problems.
- Had 40,000 female health workers trained
- Hired outbreak investigators
- Improved the Ethiopian National Laboratory
- Setup an ambulance network
- Expanded the output of the medical schools.
As DG Dr. Tedros promised to:
Dr. Tedros is a supporter of:
- Birth control
- Preventative care for women
- Improving gender and ethnic diversity
- Combating climate change's health effects.
During the campaign Dr. Tedros was accused of:
- Covering up cholera outbreaks in Ethiopia.
- Complicity in Ethiopia's poor human rights record.
WHO
Director General Dr. Margaret Chan 2007 - 2017
W.H.O. and antibiotic drug resistance
Dr. Margaret Chan comments on UN plan to curb drug resistance (Oct
2016).
W.H.O. is World Health Organization a United Nations organization. 's Dr. Margaret Chan
called the problem a "slow-moving tsunami. The misuse of
antimicrobials, including their underuse and overuse, is causing
these fragile medicines to fail. The emergence of bacterial
resistance is outpacing the world's capacity for antibiotic are compounds which kill bacteria, molds, etc. Sulfur dye stuffs were found to be effective antibiotics. The first evolved antibiotic discovered was penicillin. Antibiotics are central to modern health care supporting the processes of: Surgery, Wound management, Infection control; which makes the development of antibiotic resistance worrying. Antibiotics are: - Economically problematic to develop and sell.
- Congress enacted GAIN to encourage development of new antibiotics. But it has not developed any market-entry award scheme, which seems necessary to encourage new antibiotic R&D.
- Medicare has required hospitals and SNFs to execute plans to ensure correct use of antibiotics & prevent the spread of drug-resistant infections.
- C.D.C. is acting to stop the spread of resistant infections and reduce unnecessary use of antibiotics.
- F.D.A. has simplified approval standards. It is working with industry to limit use of antibiotics in livestock.
- BARDA is promoting public-private partnerships to support promising research.
- Impacting the microbiome of the recipient. Stool banking is a solution (Sloan-Kettering stool banking).
- Associated with obesity, although evidence suggests childhood obesity relates to the infections not the antibiotic treatments (Nov 2016).
- Monitored globally by W.H.O.
- Regulated in the US by the F.D.A. who promote voluntary labeling by industry to discourage livestock fattening (Dec 2013).
- Customer demands have more effect - Perdue shifts to no antibiotics in premier chickens (Aug 2015).
discovery."
Dr. Chan said the W.H.O. had to change its guidelines on treating:
chlamydia, syphilis, gonorrhea; in Sep 2016, because they are fast
becoming resistant results from evolutionary pressure of antibiotics, supported by plasmids and R factors: NDN1; which encode resistance properties for otherwise lethal antibiotics. World leaders hope cooperation can preserve the power of last resort antibiotics: Carbapenems, Colistin (Oct 2016). Worrying trends include: C. auris resistance to medical antifungals: itraconazole; as well as azole agricultural fungicides (Apr 2019), CRE (May 2016), C. diff (May 2015), MDR & XDR TB; resulting in increased risk of sepsis and death. The World Bank estimates full resistance would reduce the global economy in 2050 by between 1.1 and 3.8%.
to many common drugs. "On current trends, a common disease
like gonorrheaa may become untreatable. Doctors facing
patients will have to say, 'Sorry, there is nothing I can do for
you.'"
W.H.O. and checklists
The W.H.O. successfully used checklists
to reduce the medical errors from
surgery.
W.H.O. Zika Emergency
Committee
Chairman of the Zika Emergency Committee, London school of Hygene
and Tropical Medicine professor of infectious disease epidemiology
Dr. David Heymann, noted "The onus is on countries to report where
they are having outbreaks [of Zika is a Flaviviridae family virus. It came from the Zika Forest of Uganda isolated in 1947. It is related to dengue, yellow fever, Japanese encephalitis and West Nile. Zika is transmitted sexually or via a daytime mosquito vector such as the Aedes genus. It has resulted in a pandemic in South America. Zika fever has been associated with a number of troubling complications: - Guillain-Barre syndrome
- Microcephaly. The mechanism may have been identified (May 2016)
]. Then it's up
to the pregnant women to decide whether they want to travel
there."
The committee has called for (Mar
2016):
- More research on the virus and better surveillance to track
its spread.
- Countries intensively control mosquitoes near airports and
consider spraying insecticide inside planes before
taekoff.
- They recommend that women who decide to delay getting pregnant
because of Zika risk in their area should be given access to
contraceptives.
Includes: IARC;
.
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