Government constraints
Customer frame
General customer
Government constraints
General patient
Disease systems

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


AIDS Institute


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. 


Alzheimer's Association


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. 


American Association for the Study of Liver Diseases





Blue Cross Blue Shield Association

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. 




Diabetes Patient Advocacy Coalition




Joint Commission 

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.  . 


ACR-Nema

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. 


Infectious Diseases Society of America (IDSA)

IDSA is working with Express Scripts to replace Turing's Daraprim prescriptions with lower cost alternative generics from Imprimis (Dec 2015). 

Integrated Healthcare Association (IHA)

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. 
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 program

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 aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group.  John Adair developed a 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.  It mainly infects rodents and other mammals.  A West African epidemic was probably hosted by bats and transferred to a boy.  The 1976 strain was able to infect man.  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 outcompetition 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." 



Pharmacy Health Information Technology Collaborative

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:
    1. Tranformational leadership
    2. Structural empowerment
    3. Exemplary professional practice
    4. New knowledge, innovation & improvements
    5. 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:


    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." 




    Centers for Medicare and Medicaid Services (CMS is the centers for Medicare and Medicaid services.  )

    CMS is shaping publically funded health care through regulation:

    2017 CMS administrator Seema Verma
    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. 
    . 
    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:




    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, 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:
    Complex trends include:




    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
    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);  
      • Coding : CVX, MVX;
    • 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

    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

    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. 
    Sep 2006 Review of drug monitoring condemns post 92 F.D.A. processes
    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:
    1. Some saying the agency fails to approve life-saving drugs quickly enough
    2. 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:
    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 aims to develop plans and strategies which ensure effective coordination to improve the common good of the in-group.  John Adair developed a 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:
    1. Thrombotic - where cerebral arteries become diseased or damaged and then blocked by a blood clot within the brain. 
    2. 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:
    1. Intracerebral - where the hemorrhage is in small arteries or arterioles within the brain. 
    2. 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. 

    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. 

    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:
    1. Financial Stability creates the FSOC and OFR. 
    2. Orderly Liquidation Authority
      • Section 619 is the Volcker Rule: prohibitions on proprietary trading and certain relationships. 
    3. Transfer of Powers to the Comptroller, the FDIC, and the Fed
    4. Regulation of Advisers to Hedge Funds and Others - which updated the powers of the Investment Company Act. 
    5. Insurance
    6. Improvements to Regulation
    7. Wall Street Transparency and Accountability
    8. Payment, Clearing and Settlement Supervision
    9. Investor Protections and Improvements to the Regulation of Securities
    10. Bureau of Consumer Financial Protection
    11. Federal Reserve System Provisions
    12. Improving Access to Mainstream Financial Institutions
    13. Pay It Back Act
    14. Mortgage Reform and Anti-Predatory Lending Act
    15. Miscellaneous Provisions
    16. 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:
      • SSA
      • FFDCA 
      • IRC
    • 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.  

    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.  
    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. 

    The W.H.O. manages and supports global health actions:

    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, 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:

    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:
    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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