Analysis Frame

Summary

• Emergent forces focused by the state and federal governments, new technologies, regulation,
  
• The impact of the 2008 financial crisis, an aging population; with
  
• The evolution of the US health care market: Single payer scenario, Singapore scenario. 

• Thematic top down trends described in the pages of the analysis frame, or
  
• The proximity of various detailed observations to look for alternative causal associations.  Detailed observations, described in the PEST is: Politics, Economics, Sociology-Culture, Technology; signals and actions, complex adaptive effects on the business environment. 
  and current business situation, about the operation of the health care network are supported by increasingly high level and abstract assessments of the situation. 

• Frames is a set of HTML files grouped together by a common theme in a dark web. 
  
  • Each page of a frame aims to include only information, and links, relevant to the specific focus of the web page.  A frame of pages allows different points of focus to be constructed, each linked together to provide the reader with a paced and, hopefully, comprehensive perspective.  Other pages of a frame can be reached by clicking the within-frame navigation buttons. 
    
  - providing a list of pages oriented around a particular perspective: the business, its customers, competitors etc. 
  
• Agents - addressable, action oriented, including: Hospitals: Geisinger, Mount Sinai Health; Insurers: Aetna, UHG; New entrants: Amazon, CVS; Government: H.H.S. is the U.S. Department of Health and Human Services.   & its secretary, C.M.S. is the centers for Medicare and Medicaid services.   and its administrator, F.D.A. Food and Drug Administration.   and its commissioner; etc. associated with a model description and PEST is: Politics, Economics, Sociology-Culture, Technology; signals and actions, complex adaptive effects on the business environment. 
  links 
  
• Glossary - evolvable baseline terms: 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. 
    
  , 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.  
  , Economics 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.  , 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. 
  , Hot Spot is a highly connected agent with an outsize influence.  In medicine these are very high cost patients often with very poor personal health care strategies (Sep 2017). The logic of hot spots is reviewed by Atul Gawande.  Glenn Steele & David Feinberg describe how Geisinger has successfully identified and reduced the cost impact of its hot spot patients.  Robert Pearl argues the strategy has limited applicability in the current health care network.  He asserts a revolution can/must happen that will help this strategy to become broadly applicable.  Ezekiel Emanuel asserts practice transformations have allowed chronic care operations: CareMore; to identify and support hotspot patients in the community. 
  , 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. 
    
  , Precision medicine is the integration of molecular research and clinical data through a taxonomy based on a knowledge network 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). 
  ; for example. 
  
• PEST - historic details. 
  

Introduction

• The US patient base is becoming older, and less healthy, developing complex conditions that require chronic and acute health care services.  But the majority of people are also getting poorer.
• Traditional acute care hospitals include a grab bag of inefficient, cross-subsidized, transactional operations, which are being forced by legislation, regulation and the indirect impacts of the competitive strategy of integrated payer providers to improve end-to-end customer focused processes.  The integrated payer providers are leveraging technology to improve quality, reduce costs and line extend from acute care into chronic and Hot Spot is a highly connected agent with an outsize influence.  In medicine these are very high cost patients often with very poor personal health care strategies (Sep 2017). The logic of hot spots is reviewed by Atul Gawande.  Glenn Steele & David Feinberg describe how Geisinger has successfully identified and reduced the cost impact of its hot spot patients.  Robert Pearl argues the strategy has limited applicability in the current health care network.  He asserts a revolution can/must happen that will help this strategy to become broadly applicable.  Ezekiel Emanuel asserts practice transformations have allowed chronic care operations: CareMore; to identify and support hotspot patients in the community. 
  care in the community.  But, due to network effects & switching costs of insurance, it is difficult for an integrated payer provider to invade a new geography.  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). 
  's treatment volume is being targeted by urgent care clinics is an efficient and less costly 'alternative' to the ER.  There is no accepted standard.  Urgent care clinics also compete with Primary care based on extended hours and accessible locations including Medical Malls.  Most have a physician on staff and treat ailments like feavers, sprains and sinus and urinary tract infection, but they also can perform X-rays, stitch up cuts and set broken bones.  Unlike an ER they can not admit patients to a hospital.  Some also offer services like pre-employment drug screening and summer camp physicals. 
  . 
  
• Powerful 'new' entrants: Aetna + CVS health, Amazon, UHG, Walmart; are attacking the health care market with efficient community based chain business models, that aim to replace the patient's 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. 
  relationship and disrupt that business. 
  
• Successive governments have supported the economic forces that are undermining the health of the majority of Americans.  But they differ in their approach to public finance of safety net services and treatment expenses.  There is agreement that health care cost impacts on business must be constrained.  The legislation: HIPAA is the Health Insurance Portability and Accountability Act of 1996.  It added part C (administrative simplifications) to the SSA. 
  
  • CFR 45CFR 160.103 is the general provisions section of the regulations.  HIPAA Transactions and Code Sets Standards regulations 45CFR 162.923(a) Covered entities must use adopted transaction standards for inter and intra covered entity transactions.  
  • HIPAA only applies to health care providers, health insurers, clearinghouses of health care data, and their BAs. 
    
  • Initially HIPAA was designed to specify a secure standardized MPI.  Late in the development of the legislation the MPI was viewed as too risky and was removed from the legislation.  
  • The law does not prohibit health care providers from sharing information with family, friends or caregivers unless the patient specifically objects.  Providers can use 'professional judgement' to disclose information to a relative or friend if it is in the best interest of an incapacitated patient. 
    
  • It is also allowed to share general information about a patient's condition and location in a facility. 
    
  • Family members can provide information.  
  • Caregivers who are a patient's personal representative, such as: a health care proxy or guardian or with power of attorney; or who have had the patient authorize the release of information must be provided with it.  
  • HHS office of Civil Rights enforces HIPAA but typically they try to fix problems rather than applying penalties.  
  , HITECH the Health Information Technology and Economic and Clinical Health Act 2009.  Central to the act is the establishment of the Medicare and Medicaid EHR incentive programs which make available $27 Billion over 10 years to encourage eligible professionals and hospitals to adopt and meaningfully use certified EHR technology.  It is assumed that over time use of the new infrastructure will grow exponentially.  HITECH established a formal mechanism for public input into HIT policy - the HITPC and HITSC.  Hitech is a key evolved amplifier driving the migration to and installation of Epic and Cerner EHR systems. 
  , 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. 
    
  , 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. 
  ; and associated regulations, are reducing government and employer healthcare spending and hospital revenues.  
• 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!
    
  technology has enabled Geisinger's vision of an end-to-end efficient care bundle.  And influenced other health systems HCIT is health care information technology.  The AHRQ argues HCIT consists of a complex set of technologies, policies, standards and user sets.  Technically they represent it as a set of layers: Application: CPOE, CDS, e-prescribing, eMAR, Results reporting, Electronic documentation, Interface engines, etc.; Communication: Messaging standards (HL7, ADT, NCPDP, X12, DICOM, ASTM, etc,) Coding standards (LOINC, ICD10, CPT, NDC, RxNorm, SNOMED CT, etc.), Process: HIE, MPI, HIPAA security & privacy, etc.; Device: Tablet and PC, ASP, PDAs, Bar Coding, etc.; 
  strategies and driven associated regulations.  
• A high technology amplifier is significantly affecting health care through increased leverage of robots, and cloud services.  Big data encompasses the IT systems and processes necessary to do population based data collection, management and analysis.  The very low cost, robust, data storage organized by infrastructure: HADOOP; allows digital data to be stored en mass.  Data scientists then apply assumptions about the world to the data, analogous to evolved mechanisms in vision, in the form of algorithms.  Rather than depending on averages, analysis at Verisk drills down to specifics and then highlights modeling problems by identifying the underlying CAS.  For the analysis to be useful it requires a hierarchy of supporting BI infrastructure:
  • Analytics utilization and integration delivered via SaaS and the Cloud to cope with the silos and data intensive nature. 
    
  • Analytics tools (BI) for PHM will be hard to develop.  
  • Complex data models must include clinical aspects of the patient specific data, including disease state population wide.  
  • A key aspect is providing clear signals about the nature of the data using data visualization. 
    
  • Data communication with the ability to exchange and transact.  HIEs and EMPI alliance approaches are all struggling to provide effective exchange. 
    
  • Data labeling and secure access and retreival.  While HIPAA was initially drafted as a secure MPI the index was removed from the legislation leaving the US without such a tool.  Silos imply that the security architecture will need to be robust. 
    
  • Raw data scrubbing, restructuring and standardization.  Even financial data is having to be restandarized shifting from ICD-9 to -10.  The intent is to transform the unstructured data via OCR and NLP to structured records to support the analytics process. 
    
  • Raw data warehousing is distributed across silos including PCP, Hospital system and network, cloud and SaaS for process, clinical and financial data. 
    
  • Data collection from the patient's proximate environment as well as provider CPOE, EHRs, workflow and process infrastructure.  The integration of the EHR into a big data collection tool is key. 
    
  analytics may help health care impact subscriber driven costs but that is less obvious.  The HITECH act the Health Information Technology and Economic and Clinical Health Act 2009.  Central to the act is the establishment of the Medicare and Medicaid EHR incentive programs which make available $27 Billion over 10 years to encourage eligible professionals and hospitals to adopt and meaningfully use certified EHR technology.  It is assumed that over time use of the new infrastructure will grow exponentially.  HITECH established a formal mechanism for public input into HIT policy - the HITPC and HITSC.  Hitech is a key evolved amplifier driving the migration to and installation of Epic and Cerner EHR systems. 
  , HIPAA is the Health Insurance Portability and Accountability Act of 1996.  It added part C (administrative simplifications) to the SSA. 
  
  • CFR 45CFR 160.103 is the general provisions section of the regulations.  HIPAA Transactions and Code Sets Standards regulations 45CFR 162.923(a) Covered entities must use adopted transaction standards for inter and intra covered entity transactions.  
  • HIPAA only applies to health care providers, health insurers, clearinghouses of health care data, and their BAs. 
    
  • Initially HIPAA was designed to specify a secure standardized MPI.  Late in the development of the legislation the MPI was viewed as too risky and was removed from the legislation.  
  • The law does not prohibit health care providers from sharing information with family, friends or caregivers unless the patient specifically objects.  Providers can use 'professional judgement' to disclose information to a relative or friend if it is in the best interest of an incapacitated patient. 
    
  • It is also allowed to share general information about a patient's condition and location in a facility. 
    
  • Family members can provide information.  
  • Caregivers who are a patient's personal representative, such as: a health care proxy or guardian or with power of attorney; or who have had the patient authorize the release of information must be provided with it.  
  • HHS office of Civil Rights enforces HIPAA but typically they try to fix problems rather than applying penalties.  
  and the ACA have entrenched 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!
    
  systems and their developers, particularly Epic and Cerner, into the core of the hospitals' HCIT is health care information technology.  The AHRQ argues HCIT consists of a complex set of technologies, policies, standards and user sets.  Technically they represent it as a set of layers: Application: CPOE, CDS, e-prescribing, eMAR, Results reporting, Electronic documentation, Interface engines, etc.; Communication: Messaging standards (HL7, ADT, NCPDP, X12, DICOM, ASTM, etc,) Coding standards (LOINC, ICD10, CPT, NDC, RxNorm, SNOMED CT, etc.), Process: HIE, MPI, HIPAA security & privacy, etc.; Device: Tablet and PC, ASP, PDAs, Bar Coding, etc.; 
  infrastructure.  The evolved amplifier the government setup to get EHR systems deployed has set up EHR data silos which provide the developers and hospitals with significant power over patient data.  But these health records, and Epic and Cerner's business model's do not reach across the whole continuum of care to low cost 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. 
    
  : home care agencies and outpatient rehabs; that can't support Epic and Cerner's current margins.  These PAC providers appear essential to making FFV profitable and so they must be integrated into each episode of care and the financial flows.   
  
• Biotechnology advances based on low cost gene sequencing and supporting analytics combines recombinant DNA, DNA sequencing and bioinformatics  to sequence, assemble and analyse genomes.   may turn health care network's patient data into a powerful diagnostic aid.  Hospitals must also develop strategies for the potential support of these diagnoses by augmented intelligence systems like IBM's Watson.  Big Data encompasses the IT systems and processes necessary to do population based data collection, management and analysis.  The very low cost, robust, data storage organized by infrastructure: HADOOP; allows digital data to be stored en mass.  Data scientists then apply assumptions about the world to the data, analogous to evolved mechanisms in vision, in the form of algorithms.  Rather than depending on averages, analysis at Verisk drills down to specifics and then highlights modeling problems by identifying the underlying CAS.  For the analysis to be useful it requires a hierarchy of supporting BI infrastructure:
  • Analytics utilization and integration delivered via SaaS and the Cloud to cope with the silos and data intensive nature. 
    
  • Analytics tools (BI) for PHM will be hard to develop.  
  • Complex data models must include clinical aspects of the patient specific data, including disease state population wide.  
  • A key aspect is providing clear signals about the nature of the data using data visualization. 
    
  • Data communication with the ability to exchange and transact.  HIEs and EMPI alliance approaches are all struggling to provide effective exchange. 
    
  • Data labeling and secure access and retreival.  While HIPAA was initially drafted as a secure MPI the index was removed from the legislation leaving the US without such a tool.  Silos imply that the security architecture will need to be robust. 
    
  • Raw data scrubbing, restructuring and standardization.  Even financial data is having to be restandarized shifting from ICD-9 to -10.  The intent is to transform the unstructured data via OCR and NLP to structured records to support the analytics process. 
    
  • Raw data warehousing is distributed across silos including PCP, Hospital system and network, cloud and SaaS for process, clinical and financial data. 
    
  • Data collection from the patient's proximate environment as well as provider CPOE, EHRs, workflow and process infrastructure.  The integration of the EHR into a big data collection tool is key. 
    
  analytics and artificial intelligence can transform the hospitals' pathology expertise and sample bases into new sources of value.  Immunotherapy is indirect treatment of disease by stimulating the immune system.  Targeted diseases include cancers -- immuno-oncology. 
  supports transformative treatments.  
  
• Hospital suppliers, including the big pharmaceutical and biotechnology companies, are: 
• Still being supported by legislation & associated regulatory and structural constraints on CMS is the centers for Medicare and Medicaid services.  's power to price treatments (1979 court injunction on 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.  
  pricing visibility until Mar 2014, CMS PPS is Prospective payment system a method of CMS reimbursement in which a Medicare payment is made based on a predetermined fixed amount.  The amount is derived based on the classification system of that service (such as a diagnosis related group for an inpatient hospital service).  CMS uses separate PPSs for reimbursement to acute inpatient hospitals, HHAs, hospice, hospital outpatients, inpatient psychiatric facilities, IRF, LTCH and SNFs. 
  product model), medical equipment and drugs (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. 
    
  ).  The pricing of valuable new drugs is still a huge issue.  Generic supplies suffer from structural shortages (May 2016).  A grand bargain uses the US economic 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.   and political might to drive their products across the globe in exchange for some level of cooperation on R&D and pricing for the home market.  But there are outliers such as Valeant, Questcor, Lannett & even Shire, that have moved, or intend to move, their tax base from the US even as they leverage Hedge Fund and Wall Street Capital.  And the global capital system, described by Piketty, is encouraging more companies to switch to low tax domiciles.  
• Providing health care providers 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). 
    
  which are core to the modern practice of surgery including post-operative recovery.  But they also supply them to the food industry.  And through conflicts between countries about which antibiotics are to be held back as a last resort for cases of broad antibiotic resistance results from 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: 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%. 
  , it is likely that surgery quality may be threatened (May 2016). 
  

• Aggressively move into the unproven, high risk and complex population health aims to segment a patient population by treatment acuity and patient derived impact to raise outcomes efficiently without being rejected like the early HMOs.  Small numbers of patients follow life styles which impact themselves and the health care network very significantly.  Specialized treatment regimens focused on these high impact patients can improve outcomes and lower costs for these patients and the rest of the geographic patient cluster and the health care network.  Population health includes techniques for understanding the health characteristics of a patient population by leveraging analytics, business intelligence etc. so as to determine the patient population's health trends.   arena. 
  
• Promote 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.   as a health care anchored concept. 
  
• Most Americans know they should eat healthily but still few do (Mar 2016).  But
• Pre-diabetes is a condition where the subject's blood sugar levels are higher than normal but they are not yet suffering from irreversible type 2 diabetes. In 2016 the CDC estimates 86 million adults, including at least 22 million people 65 or older, are pre-diabetic increasing their risk of heart disease, stroke and diabetes.  Doctors test for pre-diabetes with a blood test: FPG, OGTT, A1C; with fasting required in the first two.  Pre-diabetes is treatable but only about 10 percent with the condition are aware they have it.  Left untreated, up to one-third of people with pre-diabetes will develop diabetes within five years.  The YMCA developed a pre-diabetes treatment program.  People can use a test devised by the CDC to assess their risk of pre-diabetes.   management shows how management can help (Mar 2016). 
  
• Push to build multi-year relationships with subscribers and their payers, like Intermountain's Selecthealth Share or Vivity (Sep 2014). 
  
• Invest further in gaining the power to control narrow network - 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). 
    
  access to 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. 
  s, independent specialists and profitable subscribers (Apr 2016). 
• Understand losses from referral outside of network.  
• Digital silos generated by 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!
    
  IOP is interoperability.  ONC offers a vision.  Interoperability providers aim to integrate all the HCIT. 
  issues.  National coordinator for HIT the health information technology infrastructure.
  
  • The HIT strategic plan includes 5 goals:
    
  1. Achieve adoption and Information Exchange through Meaningful Use of health IT.  ONC and AHRQ identified best practices will be distributed by HITRC and REC to providers in the community.  HITECH Beacon community grants have created 17 demonstration communities using HIT.  CMMI will test innovative payment and service delivery models.  There are 3 objectives:
  1. Accelerate adoption of EHRs.  Incentives for Meaningful use.  Provide implementation help. Train an implementation workforce.  Add meaningful use to professional certification.  Certify EHR technology that supports meaningful use.  Promote the benefits.  Align federal programs.  Encourage private payers to align. 
     
  2. Facilitate information exchange to support meaningful use of electronic health records.  Support exchange based business models.  Fill gaps in provider options.  Develop standards. 
     
  3. Support heath IT adoption and information exchange for public health and populations with unique needs.  Ensure public health agencies can exchange EHRs.  Track health disparities and promote HIT that reduces them.  Support HIT adoption in post-acute, behavioral health and ER. 
     
  2. Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT.  There are 4 objectives:
  1. Support more sophisticated uses of EHRs (viewed as a necessary step to the three aims) and other health IT to improve health system performance.  ICD-10 migration is viewed as necessary to obtain fine granularity of health care treatments, outcomes and costs.  Enrollment in federal health programs will be improved by development of interoperable and secure standards and protocols for enrollment. 
  2. Better manage care, efficiency, and population health through EHR-generated reporting measures.  HHS National Quality Strategy has 6 priorities which will be the focus of measures.  These will then be incorporated in EHR. 
     
  3. Demonstrate health IT-enabled reform of payment structures, clinical practices, and population health management.  Beacon demonstrator best practices will be replicated into the community.  Payment reforms were also piloted (bundled payments, medical home).  CMS will translate the best practices into policy. 
     
  4. Support new approaches to the use of health IT in research, public and population health, and national health security.  CDC is encouraging deployment of Health IT and communications infrastructure at public health departments. 
     
  3. Inspire Confidence and Trust in Health IT.  There are 3 objectives:
  1. Protect confidentiality, integrity, and availability of health information.  HIPAA is being strengthened by the OCR to match HITECH.  EHRs must be encrypted, with access controls, audit logs, and login timeouts.  EHRs will be made granular so certain aspects can be withheld from sharing (substance abuse notes for example).  Assess security vulnerabilities of EHR systems.  Identify privacy/security requirements and best practices and communicate them. 
     
  2. Inform individuals of their rights and increase transparency regarding the uses of protected health information.  Transparent policy making and explanations of rights. 
     
  3. Improve safety and effectiveness of health IT.  Safety concerns of patients researched and monitored. 
     
  4. Empower Individuals with Health IT to Improve their Health and the Health Care System.  There are 3 objectives:
  1. Engage individuals with health IT.  Most individuals don't use EHR.  HIT argues if they did their health data could become centered on them and enable Tele-health including local sensors reporting back to the HIT infrastructure and applications providing [social] support and advice.  It is also presumed it would enable new classes of health care market.  HIT hopes that involving individuals in the policy making through participation via HITPC and HITSC will increase confidence in EHR.  Ensuring individuals are aware of the benefits of HIPAA privacy and that EHR supports HIPAA may build confidence and use of EHR.  HIT also promotes generating AIDA via social networks and social media. 
     
  2. Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse.  HIT is using Medicare and Medicaid EHR incentives to encourage providers to give individuals and caregivers access to EHRs as PHRs and secure m-Health applications.  Blue Button presents a use case. 
     
  3. Integrate patient-generated health information and consumer health IT with clinical applications to support patient-centered care.  ONC will use device certification to enable the integration of consumer health device data with the individuals EHRs.  HHS is studying how to enable the integration of patient generated insights from blog entries, health journals etc.  Diabetes management is being used to identify tools for benefiting from EHR data. 
     
  5. Achieve Rapid Learning and Technological Advancement.  There are 2 objectives:
     
  1. Lead the creation of a learning health system to support quality, research, and public and population health.  HIT conjectures that electronic records will provide a foundation for learning about the population's health.  Examples include tracking and managing epidemics (CDC) and improving quality and efficiency of prevention and care (FDA sentinel).  New standards (spearheaded by IOM) will be developed for technologies supporting de-identification, aggregation, querying and analysis of population health data.  Individuals and providers will be encouraged to share information with the learning health infrastructure users. 
     
  2. Broaden the capacity of health IT through innovation and research.  CHDI is making many large data sets and tools to analyze them available.  The best practices from SHARP funded (NIH and AHRQ) research programs will be promoted into the practice of medicine.  The focus topics are: usability of EHRs, clinical decision support, consumer health IT, HIEs and Tele-health.  NITRD is developing the programs and strategic plans that HITECH requires to coordinate research and development relating to Heath IT.  VA, DOD and CMS are acting as test beds for Health IT.  
  sees information blocking.  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. 
  s and specialist groups can't integrate with local hospitals.  Lady of Lourdes Medical Center has IOP issues within its network (May 2015)
  
• Epic 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!
    
  at Vidant Roanoak not interconnecting with Independent specialist's Practice fusion EHR (Oct 2014)
  
• Constrain access to the genomic combines recombinant DNA, DNA sequencing and bioinformatics  to sequence, assemble and analyse genomes.   and EMR refers to electronic medical records which are a synonym of EHR.  EMRs have 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!
    
  data about their patients and subscribers.  
• Focus resources on infrastructure to support doctors specialized offers for the wealthy is schematically useful information and its equivalent, schematically useful energy, to paraphrase Beinhocker.  It is useful because an agent has schematic strategies that can utilize the information or energy to extend or leverage control of the cognitive niche.   , assuming inequality increases and 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.  
  deteriorates.  
• Match infrastructure to areas which can differentially service the wealthy, directly or via close by transportation hubs: Boston Children's (Jun 2016). 
  
• Leverage Wall Street
  
• Leverage Internet marketing
  
• Continue as they are:
  
• Focused on:
  
• high profit FFS is fee-for-service payment.  For health care providers the high profits were made in hospitalizations, imaging and surgery.  Due to its inducing excessive treatment activity it may be replaced by FFV bundled payment.   treatment,
  
• Encouraging hospital use with personal genomic testing uses genomic analysis to diagnose genetic disorders - for example Genomic Health's Oncotype DX & Agendia's MammaPrint.  The desire to see the genetic risk factors identified by such tests should depend on the risk * burden * Possibility of intervention.  Early tests look at only single gene mutations, but big data research tools are showing promise with large gene algorithms (Aug 2018).  Genomic testing can be performed direct-to-consumer.  Data is being collated on the genetic components of most diseases to enable more sophisticated diagnosis in the future such as the OPHG (EGAPP initiative), USPSTF recommendations and NCBI (Genetic test registry).  While there is only limited identification of the significant mutations and limited patient bases misdiagnosis is a problem (Aug 2016). 
  linked to treatments (PGD is pre-implantation genetic diagnosis which enhances IVF.  After IVF at the eight-cell stage one cell is removed to perform sensitive DNA testing.  This allows identification of problematic -- or undesired -- characteristics which can be used to screen which embryo to implant.  PGD was initially developed to help prevent severe recessive diseases: Tay-Sachs, Fanconi anemia.  Then its use was broadened to include: Cystic fibrosis, Adult-onset conditions: BRCA1. 
  ),
  
• Trying to drive down costs by replacing costly staff with less skilled alternatives and robots,
  
• Pressure failing competitors with capital investments in infrastructure they must match,
  
• Cope with quality issues of too many specialists, Minimize payment risk is either:
  
  • Restrictive cardiomyopathy, a rare disease where scar tissue makes the heart muscle rigid and reduces the efficiency.  Or
    
  • Revenue Cycle Management aligns treatment with reimbursement.  Customer service will be involved.  IT will architect the core billing, decision support and ad-hoc services, constructed by RCM vendors, into systems to support RCM.  The Hospital's central business office will aim to maximize cash recoveries.  As per Deming, mistakes in the RCM pipeline result in rework and lost cash flow and revenue of between 4 - 12%.  The staff must be trained and fully engaged in the design and operation of the pipeline.  The front end processes are best placed to capture all the information needed to make the cycle successful.  The activities include:
  • Scheduling and Appointments - where visits and procedures are booked and demographic and insurance information is collected.  If this information is incorrect it is likely the claims will not forward to third party payers.  When resources and their states are accurately known an optimal set of plans can be constructed to efficiently and effectively flow patients through the system.  But that is difficult to guarantee because of a number of interrelated problems:
  • Scale - as the number of resources increases the ability of a central scheduling system to represent all of them accurately and reliably becomes impossible. 
    
  • Ubiquity - a CAS strategy for ensuring availability is to have an over-abundance of equivalent resource that can be used for schedule allocation.  But often these resource levels are set by local decision makers who all respond at about the same time to imposed funding changes.  The effect is to suddenly and unpredictably undermine the guarantee of over-abundance.  Sometimes the assumption of equivalence also fails as in the desire of a patient to see only a specific surgeon. 
    
  • Changes can ripple through the plans requiring coordination meetings and notifications or guaranteed receipt of status updates. 
    
  • Verification checks for:
    
  • Referral - Is there PCP authorization?  Is the PCP referred service covered by the patient's plan,
    
  • Authorization - obtain Insurance authorization if required, and
    
  • Pre-certification - is there 'need' for inpatient care or other care before admission by the MCO.  Otherwise could introduce problems including not obtaining/verifying the insurance name, number and eligibility, not securing pre-certification and pre-authorization with time limits, not copying the insurance card, not checking for secondary coverage, not detecting expired referral or authorization,
    
  • Pre-registration - provide advice about their financial obligations and what documents to bring to the procedure.  If there is a copay or an outstanding payment to be paid these should be processed,
    
  • Registration - some patients are scheduled outside of the main admitting process (by OP clinic or E.D.) and this must be detected and the scheduling verification and pre-registration process be performed,
    
  • Time of service payments - co pays and self pays,
    
  • Coding - identify diagnosis (ICD 9 -> ICD-10 codes) and treatment (CPT) activities and charges for the episode.  More than 80% of hospital cases are coded in error. 
    
  • Demographics and billing data entry - enter charges and adjust capitated charges,
    
  • Patient statements - submit primary and secondary claims (following HIPAA formats) with or without involvement of a clearinghouse, produce patient statements including time of service, outstanding balance, charged amount with codes, insurance details, forms used (UB 92/04 and HCFA 1500).  A paper based claims filing has a rejection rate of 30%.  Duplicate claim payment rates of 1 - 2% of medical expenses are common.  Duplicate claims detection is often not part of the process.  Payer's goals are in conflict with Provider goals.  
    
  • Collections and payment posting - Post all payments and adjustments and deposit money into the bank,
    
  • Denials and appeals - resubmission and appeal of claims, denial analysis and bad debts and write offs.  To reduce denial rates and appeals the reimbursement contracts payer processes and actual denials must be analyzed and understood. 
    
  • Account follow up - Patient inquiries, resubmission of claims and issue refunds. 
    
  • Financial counseling;
  , Manage penalties, Lobby for more 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.  
  ; while
  
• Undermined by government cost/margin (price) control measures: 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. 
    
  , 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. 
  , CMS 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. 
  pressure;
  
• Paying for 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!
    
  infrastructure without obtaining the quality transformation and
  
• Watching as new entrants, including retailers, and alternative business models attack their profit, independent specialist/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. 
  and subscriber bases.  
• Maternity - advanced NICU is neonatal ICU also called an intensive care nursery.   support (Dec 2018) and leverage value of IVF is in vitro fertilization.  In the US, in 2018, multiple eggs are deployed during the IVF procedure to maximize the chance of pregnancy.  This practice is driven by the metrics promoted by the CDC.  However, multiple eggs increase the likelihood of multiple births, significantly raising the risk of problems for newborn and mother.  In other advanced economies single egg IVF is encouraged.  More women are delaying having children for education and career goals, with the assumption that they can use IVF if necessary to ensure pregnancy.  But the failure rate becomes 70% to 80% for women over 40 (Oct 2016).  
  /PGD is pre-implantation genetic diagnosis which enhances IVF.  After IVF at the eight-cell stage one cell is removed to perform sensitive DNA testing.  This allows identification of problematic -- or undesired -- characteristics which can be used to screen which embryo to implant.  PGD was initially developed to help prevent severe recessive diseases: Tay-Sachs, Fanconi anemia.  Then its use was broadened to include: Cystic fibrosis, Adult-onset conditions: BRCA1. 
  .  
• 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). 
  . 
  
• Medical/Surgical ICU is intensive care unit.  It is now being realized that the procedures and environment of the ICU is highly stressful for the patients.  In particular sedation with benzodiazepines is suspected to enhance the risk of inducing PTSD.  Intubation and catheterization are also traumatic.  Sometimes seperated into MICU and SICU.  eICU skill centralization may bring down costs. 
  .  
• Urology, Colonoscopy & eye specialist driven procedures. 
  
• Orthopedic is the treatment of the musculoskeletal system which supports multi-cell animals and allows them to move about: including correcting deformities, breaks, tears, compression, tendonitis, disc failures, misalignment, fusion to treat damaged discs. 
  inpatient, outpatient & rehabilitation. 
  

• Applies models to the data gathered about the business environment; customers (patients), competitors, suppliers and governments power and the amplifiers driving the business. 
• Presents a high level view of the situation based on the conclusions of the modelling. 
  

Trends in the Environment

• Concentrating wealth is schematically useful information and its equivalent, schematically useful energy, to paraphrase Beinhocker.  It is useful because an agent has schematic strategies that can utilize the information or energy to extend or leverage control of the cognitive niche.    in private equity is the pooling of money from partners to: buy companies, improve their acquisition's value and sell them again.  They gain competitive advantage from being lightly regulated.  Private equity companies were initially corporate raiders. 
  and hedge funds is an investment fund that accepts investments from a limited number of accredited individual or institutional investors.  Hedge funds are able to use investment methods that are not allowed for other types of fund. 
  leveraging gaps in the new regulatory structures; which have provided
  
• Benefits including:
  
• An educated population,
  
• Effective waste treatment plants,
  
• Clean drinking water, 
• 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 other pharmaceuticals,
  
• Corn based factory farm produce and the Green Revolution refers to a set of social technologies: new methods of cultivation; initially used in Mexico during the 1950s to 1970s and then deployed globally, during the 1970s, that increased agricultural production worldwide, and acted as a political constraint on famine and Communism.  It was sponsored by Mexico, the Ford and Rockefeller Foundations, with leadership from Norman Borlaug and it built on the work of geneticist, Nazareno Strampelli.  The improved production leveraged the development of:
  • High yielding varieties of wheat and rice based on:
  • High rates of nitrogen metabolism (cross breading, genetic engineering) allowing high yield when combined with
    
  • Strong short stems to resist bending and
    
  • Supplied with
    
  • Chemical fertilizers, and agro-chemicals
  • Irrigation
    
  • Disease resistance based on cell level breeding and genetic engineering
    
  ; and
  
• Issues: such as
  
• Chronic diseases - some induced by: smoking, alcohol, fast food, sitting to much;
  
• 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. 
  ,
  
• Climate change (VW Sep 2105)
• 13 US is the United States of America.   government agencies issue a detailed report showing current climate change trends will reduce the US is the United States of America.   economy 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.   10% by 2100.  Global supply chains will be impacted: flooding stopping manufacturing etc. slowing US supplies.  Increasing poverty will reduce the opportunity in foreign markets.  Agriculture will be impacted by: heat, drought, wild fires, heavy rain; reducing crop yields & livestock health, and so slowing to levels seen in 1980s.  Puerto Rico and Virgin Islands will lose fresh water supplies to salination.  Heat & vectored diseases will increase deaths and health crisis.  Hydro-power will reduce in the Southwest & the Southeast will become prone to wild fires without the experience to cope.  Alaska will flood.  The farm bill - designed to help with climate change mitigation of agriculture has stalled in Congress.  Trump administration policy ignores the agencies conclusions, which will undermine its case in court battles (Nov 2018)
• Trapped smoke plume from Paradise fire flows to California North Bay Area, making air quality worse than Chinese & Indian cities.  Breathing the increasing volumes of fine particle polution: smoke and increased pollen; from climate change, results in immune 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. 
  responses which build tissue in lungs: causing respiratory infections seen at 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). 
  s; and increase likelihood of subsequent allergic include various conditions: hay fever, food allergies, atopic dermatitis, asthma, anaphylaxis; caused by over activity of the immune system in response to antigens in the proximate environment. 
  events: inflammation & constricted air flow intensifying 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. 
    
  & 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). 
  .  Use P100 masks (or N95 respirators next to fire source) if must go outside, although these increase breathing stress which adds to 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. 
  (Nov 2018)
• C.D.C. is the HHS's center for disease control and prevention based in Atlanta Georgia.  
  report indicates 3 fold increase in [detection of] Deer/Rodents/Ticks: Anaplasmosis, in humans, is a lxodes ricinus tick vectored disease caused by Anaplasma phagocytophilum bacteria infecting neutrophils. 
  , babesiosis is a parasitic disease, vectored by ticks, transmitting babesia protozoa blood parasites in the human infection. 
  , Heartland virus is a Lone Star Tick vectored phlebovirus infection in humans.  The host is not known. 
  , RMSF is Rocky Mountain Spotted Fever, a tick vectored, rickettsia bacterial infection. 
  , Rabbit fever is a tick vectored rodent hosted Francisella tularensis bacterial infection, causing fever, skin ulcers and enlarged lymph nodes in humans. 
  
  , Powassan virus is a tick vectored flavivirus disease in humans. 
  , Lyme is an Ixodes tick vectored borrelia bacterial infection. 
  ; flea: Plague is a Yersinia pestis bacterial infection of humans, typically vectored by fleas, although it can be spread through the air between humans via infected droplets.  ; & mosquito: Chikungunya is a mosquito vectored viral infection in humans, causing fever and joint pain. 
  , Dengue is a mosquito vectored virus that can cause high temperature, intense joint and muscle pain, hemorrhagic fever and hence death.  The number of cases has been growing sharply and spreading out beyond its traditional base in the tropics and subtropics to Hawaii, Japan and the Florida Keys.  Between 50 and 100 million people are estimated to be sickened by dengue fever a year. 
  , 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)
  , Malaria, WNV is West Nile virus a single-stranded RNA viral disease, vectored by mosquitoes. 
  ; based infections in the US.  Reasons include: lack of 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). 
    
  , climate change, air travel, reforestation, lack of foxes that kill rodents, under investment in 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.  
  at local & state level; with no identified solutions and complex eco-systems (May 2018)


• Powerful recessions (ECB Apr 2016),
  
• Social media impacts on personal and societal behavior,
  
• Expanding national debt driven by mass-production health care and Social Security (Jul 2016) costs,
  
• 911 infrastructure collapse (Jun 2016),
  
• War and Parasitism/Cronyism (VW Sep 2015);
  
• to both the nation and the western economic 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.   network. 

• VA - Department of Veterans Affairs.  Includes the Veterans Health Administration. 
  uses a 5 star rating 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
    
  system, SAIL is Strategic Analytics for Improvement  and Learning, the VA's 5 star rating system that rolls up various metrics into a single number. 
  initially developed to monitor and enhance patient care, but subsequently used, to rate and punish hospital administrators: Atlanta, and West Haven.  Dr. Ken Kizer notes that punishing people instead of fixing the system architecture, causes hospitals to hide errors and distort statistics (Nov 2018)
  

1. Expand health coverage to millions of Americans without insurance. 
   
2. Make the healthcare system more efficient by forcing doctors and hospitals to deliver care in a more cost-effective way. 
   

• Growth in U.S. is the United States of America.   healthcare spending slowed in 2017 to 3.9% - back to levels of 2008-13: Total federal healthcare spending of $1 trillion + huge tax subsidies for healthcare and coverage to a total of $3.5 trillion - 17.9% of the economy; total 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. 
  spending, for 70 million people, increased 2.9% to $582 billion, vs. 4.2% in 2016, 9% in 2015, 11.8% in 2014; federal Medicaid payments increased < 1%, vs. 4.6% in 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.  
  spending growth slowed with a shift to 1/3 using private 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, which use more 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. 
  and less hospital services, Growth in hospital prescribed drugs slowed, Growth in retail spending on prescription drugs was 0.4% (totaling $333 billion), Drug prices - generics declined, brand-name drug increases slowed, pain killer prescription volume growth slowed; household spending grew 3.8%, vs. 4.8% in 2016, Out-of-pocket spending grew 2.6%, vs. 4.4% in 2016, to $365.5 billion.  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. 
    
  driven spending grew rapidly in 2014/15: Medicaid expansion, Added public insurance coverage; hepatitis C is a virus which destroys the liver during infection.  In 2016 it affects 185 million people worldwide.  Once the virus genome was sequenced in 1989 Dr. Bartenschlager and Dr. Rice worked to replicate the virus in the laboratory.  Rice realized the genome sequence was missing details that stopped the lab replication.  Bartenschlager was then successful at replicating the virus in cells in his laboratory.  The replication technique allowed Pharmasset's Dr. Sofia to develop a new hepatitis C drug, by enhancing an RNA-polymerase inhibitor with a coat that allowed the drug to enter the liver, where the coat was destroyed and the polymerase inhibitor was activated.  With high concentrations of the drug, sofosbuvir, in the liver it could eradicate the hepatitis C virus.   Sovaldi was the first sofosbuvir approved by the F.D.A. 
  drugs also generated high spending in 2014/15; Health insurance coverage dropped slightly in 2017 & more people selected HDHP is a high-deductible health plan which has lower premiums and a higher deductable than traditional health insurance plan such as a HMO plan or PPO plan. 
  s (Dec 2018)
  

• Republican led Congress developed a small government tax bill that will need reduced health care funding to limit expansion of the national debt. 
  
• Tax bill written by Kevin Brady, passes Senate 51-48 allowing House to vote to send it to President Trump's Desk.  The bill sets up an evolved amplifier.  It contains: Removal of 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 pushing insurers out of the markets as risk pools collapse, Opening of the Arctic Wildlife Refuge for oil & gas drilling, $1.5 trillion allowed deficit justifying 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.  
  & 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. 
  defunding, limits to state & local tax deductions impacting large Democratic states: California, New York, New Jersey; of $10,000, Top corporate tax rate reduced from 35% to 21%, Individual rates reduced from 39.6% to 37% but with sunsets in 2025, Inheritances of $22 million shielded from tax, Pass-through businesses able to deduct 20% of their business income (Dec 2017)
• President Trump will sign the legislation
• White House OMB is the Office of Management and Budget.  It:
  • Creates and promotes the President's federal budget and hence indirectly his priorities. 
    
  • Has the power to advance or constrain federal regulation as many proposed rules must be signed off by the O.M.B. (OIRA) before they are issued.  The rules it can constrain include those relating to:
  • Energy
  • Environmental standards
  • Labor protections
  • Food safety
  • All administration policies affect the budget directly or indirectly so they are constrained by the O.M.B.  
  , admits debt is climbing much faster than they had assumed, but CEA remains upbeat.  Government revenues have been reduced by the tax cuts and jobs act of 2017 is the Republican tax cut signed into law by President Trump.  The act includes:
  • Permanent tax cuts for corporations
  • Temporary tax cuts for individuals expiring in 2025; and will increase the size of the economy 0.7% between 2018 and 2028.  It will add $1.8 trillion to the deficits during that period from reduced tax revenue and higher interest payments.  
  • Repeal of the individual mandate of the ACA.  
  • Limiting deductions for state and local income tax and property taxes - impacting high tax Democratic leaning states
  • Reducing the AMT for individuals and eliminating it for corporations
    
  • Reducing the number of states affected by the estate tax
    
  to a historically low level, even as the economy 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.   is at the top of a cycle (Jul 2018)

• King v. Burwell was rejected by the Supreme Court (Jun 2015)
• House of Representatives v. Burwell (Aug 2015, Sep 2015)
• Texas, along with 19 other states, argues removal of the revenue collecting aspects of the individual mandate makes key parts of 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. 
    
  unconstitutional.  Trump DOJ - U.S. Department of Justice.   concludes it cannot defend the constitutionality of the ACA pre-existing conditions clauses (Jun 2018)

• 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)
  
• 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)
• Judge rules Kentucky policy is illegal & HHS is the U.S. Department of Health and Human Services.   Secretary Azar is remiss in not considering data that should have stopped CMS is the centers for Medicare and Medicaid services.   administrator Verma allowing the work requirements (Jul 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)
  

• Chronic kidney disease or CKD is
  
  • Where there is permanent damage to the Kidneys.  Diabetes and high blood pressure are the leading causes of CKD.  This has driven up the percentage of American's suffering from CKD. 
    
  •  CKD is diagnosed via a GFR of less than 60, or another marker such as protein in the urine, for atleast three months. 
    
  • The disease, classed as having five stages, causes no symptoms until the later stages.  The fifth stage of CKD is ESRD.  CKD is associated with: Atherosclerosis, Cardiovascular disease, Iron deficiency anemia from reduced EPO synthesis, Fluid volume overload, Hyperphosphatemia, Hypertension, Metabolic acidosis, Mineral bone disorder, Potassium accumulation, & Urea accumulation. 
    
  affects 50 percent of the elderly and the diagnosis encourages them to demand treatment but it is not likely to reach stage 5 and kill them so why treat it? Maybe due to its effects on cardiovascular disease refers to:
  
  • Conditions where narrowed and blocked blood vessels result in angina, hypertension, CHD and heart attacks and hemorrhagic/ischemic strokes.  Mutations of the gene PCSK9 have been implicated in cardiovascular disease.  Rare families with dominant inheritence of the mutations have an overactive protein, very high levels of blood cholesterol and cardiac disease. Other rare PCSK9 mutations result in an 88% reduced risk from heart disease.  Inflammation is associated with cardiovascular disease (Aug 2017). 
    
  .  (Sep 2015) 
• 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 memory and thinking problems (MCI).  Variants include: late-onset sporadic; with risk factors - ApoE4, presenilin, androgen deprivation therapy (Dec 2015).  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; 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 and set off the formation of tangled thread-like tau protein.
  • Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).  
  • BACE inhibitors block an enzyme needed to form amyloid. 
    
  • 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. 
    
  , 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.  But poisoning from MPTP has also been shown to destroy dopamine system neurons.  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. 
  , 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, 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)

• Humana partners with private equity is the pooling of money from partners to: buy companies, improve their acquisition's value and sell them again.  They gain competitive advantage from being lightly regulated.  Private equity companies were initially corporate raiders. 
  firms: TPG, and Welsh, Carson, Anderson & Stowe; to become the largest player in hospice has the key goal of helping people with a fatal illness to have the fullest possible life right now.  There are major hospice chains focused on providing palliative care. 
  care, by acquiring a Kindred Healthcare hospice division and Curo Health Services.  UHG has already entered & exited the market, in which the government is enforcing quality measures (Jun 2018)
  

Public health and health care

Technology invasion

The health care pseudo market

• Discussion of single-payer. 
  
• Search for more efficiency and effectiveness.  Constraints such as the BBA is the Balanced Budget Act of 1997.  This act aimed to balance the federal budget by 2002.  It was enacted using the budget reconciliation process.  In part it reduced Medicare (replacing MVPS with the SGR and commissioning the MedPAC) and Hospital inpatient and outpatient payment cuts to do this.  It also enacted Medicare Advantage and SCHIP.  BBA mandated risk adjustment and the HCC coding payment model, through CMS rules.  's SGR is medical Sustainable Growth Rate.  It is a CMS method to control Medicare spending on physician services.  It aims to ensure the yearly increase in expense per Medicare beneficiary does not exceed the growth in GDP.  To do this CMS reports to the MedPAC which advises the U.S. Congress on the previous year's total expenditures and the target expenditures.  The report includes a conversion factor that constrains the payments for physician services to match the target SGR.  On March 1st of each year the physician fee schedule is updated accordingly.  Congress can and does adjust the target SGR outside of these bounds.  SGR replaced MVPS.  It was introduced via the BBA.   attempt to limit 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.  
  payments threatening physician finance (Doc fix constraint removed Apr 2015) and forcing Congress to reduce the constraints impacts each year.  William Haseltine highlights Singapore as a more efficient system (2000 operations in Singapore hospitals vs 200 in US is the United States of America.  ) with better planning for the future.  It spends less on health care than any other high-income country but ranks sixth in world outcomes.  But it is a small city state.  Haseltine sees Japan's health system as a logical direction for the US to move towards to gain more efficiency and effectiveness.  
• Singapore is a vision of a well-functioning state and health care system: Initially weak, it uses focus to succeed.  It plans for the long term, using cost effective public health strategies, backed up by government funded insurance.  Protected public hospitals and clinics constrain prices in the private sector. 
  
• In comparison to Singapore the US system has:
• A complex adaptive political network with a diverse set of state economies each with conflicting goals for the various aspects of the US federation that contributes to the health of the nation. 
  
• Housing access has been constrained creating a two tier system of those who own houses - mainly white and those who could not and now do not have the capital to gain access and so are trapped in rural and urban ghettos. 
  
• Food supply that matches the housing structure.  High income housing correlates with supplies of good food.  Low income neighborhoods have limited access to good food choices.  Instead they are offered foods enriched with fructose! 
  
• The US economy is built from a patchwork of states with differing economic strategies.  Some states follow a low cost strategy with a minimal safety net and low average salary.  Others have adopted a high cost strategy.  The result is that sections of the US population live in poor stressed is a multi-faceted condition reflecting high cortisol levels.  Dr. Robert Sapolsky's studies of baboons indicate that stress helps build readiness for fight or flight.  As these actions occur the levels of cortisol return to the baseline rate.  A stressor is anything that disrupts the regular homeostatic balance.  The stress response is the array of neural and endocrine changes that occur to respond effectively to the crisis and reestablish homeostasis. 
  
  • The short term response to the stressor
    
  • activates the amygdala which: Stimulates the brain stem resulting in inhibition of the parasympathetic nervous system and activation of the sympathetic nervous system with the hormones epinephrine and norepinephrine deployed around the body, Activates the PVN which generates a cascade resulting in glucocorticoid secretion to: get energy to the muscles with increased blood pressure for a powerful response.  The brain's acuity and cognition are stimulated.  The immune system is stimulated with beta-endorphin and repair activities curtail.  But when the stressor is
    
  • long term: loneliness, debt; and no action is necessary, or possible, long term damage ensues.  Damage from such stress may only occur in specific situations: Nuclear families coping with parents moving in.  Sustained stress provides an evolved amplifier of a position of dominance and status.  It is a strategy in female aggression used to limit reproductive competition.  Sustained stress:
    
  • Stops the frontal cortex from ensuring we do the harder thing, instead substituting amplification of the individual's propensity for risk-taking and impairing risk assessment! 
    
  • Activates the integration between the thalamus and amygdala. 
    
  • Acts differently on the amygdala in comparison to the frontal cortex and hippocampus: Stress strengthens the integration between the Amygdala and the hippocampus, making the hippocampus fearful. 
    
  • BLA & BNST respond with increased BDNF levels and expanded dendrites persistently increasing anxiety and fear conditioning. 
    
  • Makes it easier to learn a fear association and to consolidate it into long-term memory.  Sustained stress makes it harder to unlearn fear by making the prefrontal cortex inhibit the BLA from learning to break the fear association and weakening the prefrontal cortex's hold over the amygdala.  And glucocorticoids decrease activation of the medial prefrontal cortex during processing of emotional faces.  Accuracy of assessing emotions from faces suffers.  A terrified rat generating lots of glucocorticoids will cause dendrites in the hippocampus to atrophy but when it generates the same amount from excitement of running on a wheel the dendrites expand.  The activation of the amygdala seems to determine how the hippocampus responds. 
    
  • Depletes the nucleus accumbens of dopamine biasing rats toward social subordination and biasing humans toward depression. 
    
  • Disrupts working memory by amplifying norepinephrine signalling in the prefrontal cortex and amygdala to prefrontal cortex signalling until they become destructive.  It also desynchronizes activation in different frontal lobe regions impacting shifting of attention.  
  • Increases the risk of autoimmune disease (Jan 2017) 
  • During depression, stress inhibits dopamine signalling.  
  • Strategies for stress reduction include: Mindfulness. 
    
  conditions that undermine wellbeing is described by Angus Deaton as all the things that are good for a person:
  • Material wellbeing includes income and wealth and its measures: GDP, personal income and consumption.  It can be traded for goods and services which recapture time.  Material wellbeing depends on investments in:
  • Infrastructure
    
  • Physical
    
  • Property rights, contracts and dispute resolution
    
  • People and their education
    
  • Capturing of basic knowledge via science.  
  • Engineering to turn science into goods and services and then continuously improve them. 
    
  • Physical and psychological wellbeing are represented by health and happiness; and education and the ability to participate in civil society through democracy and the rule of law.  Life expectancy as a measure of population health, highly weights reductions in child mortality. 
    
  . 
  
• A highly segmented population with some segments having no financial ability to access to the health care network:
• Super rich who can leverage the best aspects of the US/Global system to get superb care. 
  
• Shrinking middle class
  
• African-American population that has been subjected to inhuman medical experimentation and constraints on access to care.  It still does not trust the 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.  
  and health care provider infrastructure (Dec 2013).
  
• The US spends 18% of GDP is:
  • Gross domestic product which measures the total of goods and services produced in a given year within the borders of a given country (output) according to Piketty.  Gordon argues to include products produced in the home & market-purchased goods and services, following Becker's theory of time use.  Gordon stresses innovation is the ultimate source of all growth in output per worker-hour.  GDP growth per person is equal to the growth in labor productivity + growth in hours worked per person.  GDP has many problems.  Gordon concludes that between 1870 and 1940 all available measures GDP is hugely understated because:
  • GDP is a poor measure of:
  • Value & wealth
    
  • Who gets what
  • Global supply chains
    
  • GDP excludes:
  • Reduction in infant mortality between 1890 (22%) and 1950 (1%)
    
  • Brightness & safety of electric light,
    
  • Increased variety of food including refrigeration transported fresh meat and processed food
  • Convenience and economies of scale of the department store and mail order catalog and resulting product price reductions
    
  • Services by house makers
  • Time & health gains from having flush toilets, integrated sewer networks; rather than having to physically remove effluent and cope with fecal-oral transmission
    
  • Leisure
  • Costs & benefits of different length work weeks
    
  • Speed and flexibility of motor vehicles - which were not included in the CPI until 1935, after the transformation had occurred.  And competition from improved foreign vehicles, while it provides purchaser/user with improved standard of living (less breakdowns, repairs, etc.) is measured as reduced domestic manufacture
    
  • Coercion and corruption to obtain resources 
  • Consumption impact of finite resources: coal, oil;
  • Destruction impact of loss of entire irreplaceable species
    
  • GDP includes items that should be excluded:
  • Cost of waste - cleaning up pollution (single use indestructible plastic bags), building prisons, commuting to work, and cars left parked most of the time; should be subtracted
    
  • Guanine-di-phosphate is a nucleotide base. 
    
  on health care.  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. 
    
  is shifting the population to private insurance with high deductibles, and copayments is a fixed payment for a covered service after any deductible has been met.  It is a key strategy of the ACA to make subscribers aware of the costs of treatment and to put pressure on high cost health services.  As such suppliers and providers are keen to undermine the copayment: value based health insurance, Paying the copayment (Oct 2015), Place on the USPSTF list of preventative services (Sep 2016);
  .   While this will constrain American's use of health care provision it will not limit cost escalation while prices remain opaque (Aug 2013, Sep 2015). 
  
• The ACA is designed to generate a national network with teleodynamic properties of contension between suppliers, prividers and payers.  But the extended phenotypic alignment (May 2016) of such a fully, and permanently, connected network of power and profit seeking competitors will reward large well connected nodes and undermine innovation is the economic realization of invention and combinatorial exaptation.  While highly innovative, monopolies: AT&T, IBM; usually have limited economic reach, constraining productivity and supporting the use of regulation, or even its threat, that can drive their creations across the economy. 
  .  
• The SCOTUS decision provides some local separation from the network as illustrated in Independence Kansas. 
  
• The US system includes public and private health care components.  But the regulatory environment has blunted the impact of the large public elements allowing private companies to gain scale, scope and influence with the government. 
  
• Opaque pricing including legal constraints, such as 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. 
    
  , on the public infrastructure from competing or revealing costs and prices.  
• The ACA title IV is ACA preventing of chronic disease and improving public health. 
  
  • Subtitle A: Modernizing disease prevention and public health systems. 
    
  • Subtitle B: Increasing access to clinical preventative services. 
    
  • Subtitle C: Creating healthier communities. 
    
  • Subtitle D: Support for prevention and public health innovation. 
    
  • Subtitle E: Miscellaneous provisions. 
    
  focuses on chronic disease management.  
• An aging population is a significant demographic shift in the U.S. too.  Immigration has offset the retirement bulge, although globalization and offshoring have built resentment of immigration.  But the size and complexity of the US and the inherent tension between the needs of the different states and the nation as a whole undermines the value of a coordinated central plan.  Various laws have been enacted to help the US health care network adapt to these demographic changes.  Most notable are the HITECH the Health Information Technology and Economic and Clinical Health Act 2009.  Central to the act is the establishment of the Medicare and Medicaid EHR incentive programs which make available $27 Billion over 10 years to encourage eligible professionals and hospitals to adopt and meaningfully use certified EHR technology.  It is assumed that over time use of the new infrastructure will grow exponentially.  HITECH established a formal mechanism for public input into HIT policy - the HITPC and HITSC.  Hitech is a key evolved amplifier driving the migration to and installation of Epic and Cerner EHR systems. 
  and 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. 
    
  .  HITECH initiated a shift to 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!
    
  systems from paper.  The ACA undermined the FFS is fee-for-service payment.  For health care providers the high profits were made in hospitalizations, imaging and surgery.  Due to its inducing excessive treatment activity it may be replaced by FFV bundled payment.   strategy of many health care providers (Rural hospital impact Oct 2015), instead encouraging them to seek cost effective ways to profitably deliver patient focused care.  
• The ACA medical home models are primary care architectures which deliver: patient-centered, accessible, coordinated, comprehensive care of high quality and safety (Dec 2015).  The models have been made more significant due to Affordable Care Act payment reform requirements.  The goal is to reduce treatment costs and improve population health by reengineering of the traditional silo'd provider network.  See PCMH. 
  and associated CMS is the centers for Medicare and Medicaid services.   rules (CPC is the CMS comprehensive primary care initiative.  Medicare is working with commercial and state health insurance plans and offer bonus payments to primary care doctors who better coordinate care for their patients.  PCPs that participate are given resources to better coordinate primary care for their Medicare patients. 
  ) encourage the use of PCMH (PCMH) The Patient-centered medical home
  
  • Describes a reorganization of the health care delivery system to focus on the patient and care giver supported by EHR infrastructure and some form of process management which will be necessary to coordinate interventions by each of the functional entities resources to treat the patients specific problems.   The disadvantage of a PCMH is the administrative and technology cost needed to support its complex processes.  The PCMH
    
  • Was promoted as a way to incent more PCP which had been seen as a low reward role by medical students.  HCI3 argues this use of PCMH is flawed.  PCMH is driven by the medical home models of the ACA.  In this model the PCMH is accountable for meeting the vast majority of each patients physical and mental health care needs including prevention and wellness, acute care, and chronic care.  It is focused on treating the whole person.  It is tasked with coordinating the care across all elements of the health care system, including transitions and building clear and open communications.  It must ensure extended access and availability of its services and patients preferences about access.  It must continuously improve quality by monitoring evidence-based medicine and clinical decision support tools (NCQA).  Many argue that to be effective it must be connected to a 'medical neighborhood'.  The PCMH brings together the specialized resources and infrastructure required to develop and iteratively maintain the care plans and population oriented system descriptions that are central to ACA care coordination. 
    
  .  But even as urgent care is an efficient and less costly 'alternative' to the ER.  There is no accepted standard.  Urgent care clinics also compete with Primary care based on extended hours and accessible locations including Medical Malls.  Most have a physician on staff and treat ailments like feavers, sprains and sinus and urinary tract infection, but they also can perform X-rays, stitch up cuts and set broken bones.  Unlike an ER they can not admit patients to a hospital.  Some also offer services like pre-employment drug screening and summer camp physicals. 
  and retail clinics bring health care closer to the communities House Calls are missing (Oct 2015). 
  
• 85 rural hospitals (5% of them) have closed since 2010: CHY strategy.  Less than half the US is the United States of America.  's rural counties have a hospital that covers maternity, due to business model issues: collapsing birth rate, specialists clustered in large cities; which cascades added risks, 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. 
  : medical visits cost more & take up more time - NICU is neonatal ICU also called an intensive care nursery.   babies need to be visited regularly increasing the impact on mother and family, women go less often to visit doctors, more babies born prematurely, deliveries occur outside hospital or at 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). 
  , hospital is often a large employer and closure impacts the community economics (Oct 2015), but eventually rebalancing occurs with urgent care is an efficient and less costly 'alternative' to the ER.  There is no accepted standard.  Urgent care clinics also compete with Primary care based on extended hours and accessible locations including Medical Malls.  Most have a physician on staff and treat ailments like feavers, sprains and sinus and urinary tract infection, but they also can perform X-rays, stitch up cuts and set broken bones.  Unlike an ER they can not admit patients to a hospital.  Some also offer services like pre-employment drug screening and summer camp physicals. 
  units opening, maternity opening at a remaining hospital in the region, helicopters taking serious cases to hub hospitals (Jul 2018)
  
• Florida's rural Immokalee, in Collier County, needs a hospital, with increasing: births (in ambulances|out of hospital), baby death rate, deaths in fields and parking lots, 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). 
  death rate, no nearby 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). 
  , lack of ambulance service; only a 9 to 5 weekday federal health clinic, regulators granted a certificate of need, but Naples Hospital wants the patient base and is objecting to the hospital development as rural hospitals close (Sep 2018)
• And surveys, comparing access to health care in the US to a basket of other wealthy is schematically useful information and its equivalent, schematically useful energy, to paraphrase Beinhocker.  It is useful because an agent has schematic strategies that can utilize the information or energy to extend or leverage control of the cognitive niche.    health care networks, show the US continuing to perform badly.  Only Canada is consistently worse (Oct 2016). 
  
• Regulating in value.  Congressional constraints on health care market pricing have been weakened.  98% of AHA is the American_hospital association. 
  /ACHE is the American College of Healthcare Executives.   CEOs expect to provide cost/quality transparency data to the public. 
  

Single-payer scenario

Health care complex adaptive system scenario

Key influences of the health care network

• Patients to select low cost transactions (Henry Ford Health System) and to stay within the contracted narrow network - 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 service providers/doctors (working as planned in 2015).  It also encourages
  
• Referral based integration of the network agents.  But it also enables network integration. 
  
• Hospital mergers can be seen concentrating power by limiting choice and accentuating brand (Jul 2014): Harvard's Partners HealthCare. 
  
• Restructuring of the care - payment transaction.  ACA support of 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.  
  structures and startup insurance co-ops may not be enough to overcome network effects that leave power with large payers which have 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). 
    
  .  
• UnitedHealth purchases DaVita's physician group for Optum for $4.9 Billion.  US is the United States of America.   needs a Value Delivery System (VDS is value delivery system.  ) for chronic disease: asthma is inflammation of the airways resulting in their narrowing, swelling and generating additional mucus which inhibits breathing.  Its prevalence doubled in the US between 1980 and 2000.  Asthma is the most common chronic disease in childhood, the most common reason for being away from school and the most common reason for hospitalization.  10 to 13% of children's asthma cases are due to obesity.  Among obese children 23 to 27% of asthma cases are due to obesity.  Diagnosis: Propeller Health; Treatments include: Xolair;
  , and diabetes is the leading cause of blindness, limb amputations and kidney failure.  Insulin and glucose levels are regulated by the pancreas, liver, muscle, brain and fat.  Diabetes occurs when the insulin level is insufficient to regulate the glucose in the system.  Increased fat levels in obesity demand more insulin overloading the pancreas.  Persistent high glucose levels are also toxic to the pancreas beta cells.  High glucocorticoid levels have been associated with type 2 diabetes.  There are genetic risk factors since siblings of someone with the disease have three times the baseline risk (about 50% of the risk of getting type 2 diabetes is genetic).  The inheritance is polygenic.  More than 20 genes have been identified as risk factors, but that is too few to account for the 50% weighting so many more will be identified.  Of those identified so far many are associated with the beta cells.  The one with the strongest relative risk is TCF7L2.  The disease can be effectively controlled through a diligent application of treatments and regular checkups.  Doctors are monitored for how under control their patients' diabetes is (Sep 2015).  Treatments include:
  • Metformin - does not change the course of pre-diabetes - if you stop taking it, it is as if it hasn't been taken. 
    
  • Diet
  • Exercise
  .  Northwestern's Garthwaite asks: is Kaiser's business model under threat? (Dec 2017)
• 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 memory and thinking problems (MCI).  Variants include: late-onset sporadic; with risk factors - ApoE4, presenilin, androgen deprivation therapy (Dec 2015).  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; 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 and set off the formation of tangled thread-like tau protein.
  • Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).  
  • BACE inhibitors block an enzyme needed to form amyloid. 
    
  • 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. 
    
  , 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.  But poisoning from MPTP has also been shown to destroy dopamine system neurons.  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. 
  , 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, 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)
• The implementation is seen as undermining traditional 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.  
  with 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. 
    
  & Medigap is additional private insurance purchased to cover health care costs not covered by Medicare: copayments, deductibles and foreign travel insurance. 
  , and generating confusion in the 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. 
  subscribers (Jul 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)
  
• The 2015 bill to alter Medicare payments for doctors also pushes them towards larger groups, PCMH is patient centered medical homes:
  • Describes a reorganization of the health care delivery system to focus on the patient and care giver supported by EHR infrastructure and some form of process management which will be necessary to coordinate interventions by each of the functional entities resources to treat the patients specific problems.   The disadvantage of a PCMH is the administrative and technology cost needed to support its complex processes.  The PCMH
    
  • Was promoted as a way to incent more PCP which had been seen as a low reward role by medical students.  HCI3 argues this use of PCMH is flawed.  PCMH is driven by the medical home models of the ACA.  In this model the PCMH is accountable for meeting the vast majority of each patients physical and mental health care needs including prevention and wellness, acute care, and chronic care.  It is focused on treating the whole person.  It is tasked with coordinating the care across all elements of the health care system, including transitions and building clear and open communications.  It must ensure extended access and availability of its services and patients preferences about access.  It must continuously improve quality by monitoring evidence-based medicine and clinical decision support tools (NCQA).  Many argue that to be effective it must be connected to a 'medical neighborhood'.  The PCMH brings together the specialized resources and infrastructure required to develop and iteratively maintain the care plans and population oriented system descriptions that are central to ACA care coordination. 
    
   
  , 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 and 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. 
  .  
• However, the ACA requires balanced treatment of mental disorders including addictions.  NIDA director Nora Volkow sees this regulatory shift as a key opportunity to counter chronic behaviors including addictions and over eating. 
  

• Payers become focused on short term health efforts.  Long term investments might benefit competitors. 
  
• Gilead's Sovaldi (sofosbuvir) is Gilead Sciences hepatitis-C drug.  It is the first effective cure with acceptable side effects.  Sofosbuvir was originally developed by Pharmasset which sold the rights to Gilead for $11 billion.  In 2014 Sovaldi costs $84,000 for a typical course of treatment. 
  pricing aims to capture its revenue stream over the time of treatment impacting payer budgets (States' 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 making the treatment price per pill astronomical.  A better goal would be for the payers to be able to agree with drug suppliers like Gilead that they can pay the total treatment cost for drugs like Sovaldi over a multi-year period.  
• Plans are often missing leading edge coverage:
•  Mindfulness is an active meditative state of non-doing, attentively seeking each 'present moment' with ones body and mind 'being' at rest and so cultivating awareness.  The thinking mind usually spends a lot of time relating to the future and past which Kabat-Zinn argues limits its ability to become fully aware of the present.  In times of stress those thoughts are so overpowering that they crowd out awareness and appreciation of the present.  Mindfulness shifts attention to calming internal feelings.  It allows review and prioritization of thoughts as they are recognized.  Major attitude based pillars of successful mindfullness are: impartial to judging, patience, a beginner's mind, trust, non-striving, acceptance of seeing things the way they are, and letting go.  An awareness of the body's state can be built from attention to:
  • Breathing - which is a proxy for the environmental situation and through its rhythms is a model of our emotional state.  Attention to breathing reminds people to feel their bodies too.  Belly breathing is particularly relaxing.  
  • Sitting - erect with head, neck and back aligned vertically.  Then attend to breathing moving back to it each time you observe the mind has wandered.  When the body becomes uncomfortable direct attention to the discomfort and observe and welcome it.  
  • Experience our body - rather than model, judge or hate it relative to an ideal - with a body scan. 
    
  • Hatha yoga - very slow stretching and strengthening exercises with moment-to-moment awareness supports being in your body.  
  • Walking meditation - Intentionally attend to the immediate experience of walking.  
  relief for 65 million lower back 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.  Pain is the main reason people visit the ED in the US.   sufferers (Mar 2016)

• Acute diseases including: Dengue is a mosquito vectored virus that can cause high temperature, intense joint and muscle pain, hemorrhagic fever and hence death.  The number of cases has been growing sharply and spreading out beyond its traditional base in the tropics and subtropics to Hawaii, Japan and the Florida Keys.  Between 50 and 100 million people are estimated to be sickened by dengue fever a year. 
  (Feb 2016), 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.  (CDC is the HHS's center for disease control and prevention based in Atlanta Georgia.  
  response), 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)
  (Mar 2016);  Outbreaks are often in budget constrained areas with low income populations.  Climate change is expected to exacerbate the problems.  Pharmaceutical incentives for developing solutions may improve with public/private finance of GAVI. 2015 US Budget added $100 million funding to 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.   for antibiotic resistance results from 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: 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%. 
  research, and $96 million for BARDA to use for new drug discovery.   
• Food poisoning constrained by F.D.A. Food and Drug Administration.  :
• Rate and count of food poisoning is increasing in the US: 40 million cases, & 3,000 deaths each year.  Problem foods: Raw egg, undercooked meat & poultry, organisms on: rasperries, cantaloupe, ice cream, salami, scallions, parsley, cider, toasted oatmeal.  Some steps can be taken to minimize risk (May 2018)
• 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)
  
• Toxic stress is a multi-faceted condition reflecting high cortisol levels.  Dr. Robert Sapolsky's studies of baboons indicate that stress helps build readiness for fight or flight.  As these actions occur the levels of cortisol return to the baseline rate.  A stressor is anything that disrupts the regular homeostatic balance.  The stress response is the array of neural and endocrine changes that occur to respond effectively to the crisis and reestablish homeostasis. 
  
  • The short term response to the stressor
    
  • activates the amygdala which: Stimulates the brain stem resulting in inhibition of the parasympathetic nervous system and activation of the sympathetic nervous system with the hormones epinephrine and norepinephrine deployed around the body, Activates the PVN which generates a cascade resulting in glucocorticoid secretion to: get energy to the muscles with increased blood pressure for a powerful response.  The brain's acuity and cognition are stimulated.  The immune system is stimulated with beta-endorphin and repair activities curtail.  But when the stressor is
    
  • long term: loneliness, debt; and no action is necessary, or possible, long term damage ensues.  Damage from such stress may only occur in specific situations: Nuclear families coping with parents moving in.  Sustained stress provides an evolved amplifier of a position of dominance and status.  It is a strategy in female aggression used to limit reproductive competition.  Sustained stress:
    
  • Stops the frontal cortex from ensuring we do the harder thing, instead substituting amplification of the individual's propensity for risk-taking and impairing risk assessment! 
    
  • Activates the integration between the thalamus and amygdala. 
    
  • Acts differently on the amygdala in comparison to the frontal cortex and hippocampus: Stress strengthens the integration between the Amygdala and the hippocampus, making the hippocampus fearful. 
    
  • BLA & BNST respond with increased BDNF levels and expanded dendrites persistently increasing anxiety and fear conditioning. 
    
  • Makes it easier to learn a fear association and to consolidate it into long-term memory.  Sustained stress makes it harder to unlearn fear by making the prefrontal cortex inhibit the BLA from learning to break the fear association and weakening the prefrontal cortex's hold over the amygdala.  And glucocorticoids decrease activation of the medial prefrontal cortex during processing of emotional faces.  Accuracy of assessing emotions from faces suffers.  A terrified rat generating lots of glucocorticoids will cause dendrites in the hippocampus to atrophy but when it generates the same amount from excitement of running on a wheel the dendrites expand.  The activation of the amygdala seems to determine how the hippocampus responds. 
    
  • Depletes the nucleus accumbens of dopamine biasing rats toward social subordination and biasing humans toward depression. 
    
  • Disrupts working memory by amplifying norepinephrine signalling in the prefrontal cortex and amygdala to prefrontal cortex signalling until they become destructive.  It also desynchronizes activation in different frontal lobe regions impacting shifting of attention.  
  • Increases the risk of autoimmune disease (Jan 2017) 
  • During depression, stress inhibits dopamine signalling.  
  • Strategies for stress reduction include: Mindfulness. 
    
  : Failing water supply infrastructure, Collapsing abandoned mining and manufacturing plant, Opioid addictions, Toxic chemicals (Jul 2016), Smoke from wild fires (Nov 2018); 
• Screening, where levels are contentious (Dec 2013 (2), Sep 2015).  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 are popular and powerful, but induce high radiation accumulation.  
• Violence: Exponential population expansion and the increasing disparity in wealth is schematically useful information and its equivalent, schematically useful energy, to paraphrase Beinhocker.  It is useful because an agent has schematic strategies that can utilize the information or energy to extend or leverage control of the cognitive niche.    may catalyze an increase in terrorist and other violent acts as stressed areas collapse.  Hospitals must ensure they can respond effectively to the trauma. 
  

Digital networks connecting patients to the health care network and each other.  Smart phones and appliances offering integration with cloud based applications allowing:

• Collaboration,
  
• Control,
  
• Crowd sourcing, 
• Modeling,
  
• Sensing, 
• 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. 
  ;
  

Inhibition of digital data flow by:

• HIPAA is the Health Insurance Portability and Accountability Act of 1996.  It added part C (administrative simplifications) to the SSA. 
  
  • CFR 45CFR 160.103 is the general provisions section of the regulations.  HIPAA Transactions and Code Sets Standards regulations 45CFR 162.923(a) Covered entities must use adopted transaction standards for inter and intra covered entity transactions.  
  • HIPAA only applies to health care providers, health insurers, clearinghouses of health care data, and their BAs. 
    
  • Initially HIPAA was designed to specify a secure standardized MPI.  Late in the development of the legislation the MPI was viewed as too risky and was removed from the legislation.  
  • The law does not prohibit health care providers from sharing information with family, friends or caregivers unless the patient specifically objects.  Providers can use 'professional judgement' to disclose information to a relative or friend if it is in the best interest of an incapacitated patient. 
    
  • It is also allowed to share general information about a patient's condition and location in a facility. 
    
  • Family members can provide information.  
  • Caregivers who are a patient's personal representative, such as: a health care proxy or guardian or with power of attorney; or who have had the patient authorize the release of information must be provided with it.  
  • HHS office of Civil Rights enforces HIPAA but typically they try to fix problems rather than applying penalties.  
  , 
• Silos of incompatible database schemas, 
  
• Silo 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!
    
  vendor business model. 
• Licensing constraints on interstate tele-health is the use of remote health care.  It includes telepharmacy and clinical telehealth for stroke and psychiatry.  It also includes sessions between primary care providers and patients and assisted caregiving such as medication reminders and DME usage monitors. 
  . 
  

• Precision diagnosis and treatment
  
• Needed and in progress for 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
  (Nov 2015)
  
• Recommended for brain tumors (Jun 2015).  
• Powerful genetic engineering techniques allow development of custom animals and plants but with potentially catastrophic risks. 
  
• 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. 
  -Cas9 gene drive is a biochemical technique to turbo-charge a genetic chain reaction, forcing a mutation across the gene pool.  It leverages homing endonuclease genes which generate an endonuclease that supports the selects for their own gene sequence by cutting DNA sequences that do not include its sequence.  The Cas9 endonuclease is an example that has been combined with CRISPR to drive a desired gene edit throughout a gene pool. 
  (Nov 2015).  
• Nanoparticle drug delivery is slowly moving towards a targeted metastatic 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).   killer (Mar 2016). 
• Ligandal uses logically similar model for 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. 
  deployment (Nano conference). 
  

• 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 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. 
  and biosimilars are generic drugs made to copy biologics.  They could undermine the pharmaceutical industry's biologic profit model and so are subject to trade constraints: TRIPS, TPP. 
  .  Completion of the TPP is the Trans Pacific Partnership, a twelve country, Pacific regional, trade deal between: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, Vietnam;  The U.S. aims to use the agreement to constrain competition from China.  The initial 12 countries account for more than a quarter of global seafood trade and a quarter of the World's timber and pulp production.  Five of the nations are among the World's most biologically diverse.  The TPP includes:
  • Patents and copyrights chapters. 
    
  • State-owned businesses chapter. 
    
  • Investor-state dispute settlement chapter which enforces extrajudicial tribunals for arbitrating disputes.  The tribunals give investors legal recourse if a government changes policies in ways that hurt the value of their investments. 
    
  • An environmental chapter that covers illegal wildlife trafficking, forestry management, overfishing and marine protection.  Environmentally destructive subsidies, such as cheap fuel for illegal fishing boats and subsidies for boat building in overfished waters are banned.  The chapter enforces Cites with economic sanctions and disallows trade in wildlife taken illegally from a country. 
    
  • Requirements that member countries strengthen port inspections and document checks. 
    
  • Requirements that a country in the agreement take action if they discover contraband that has been harvested illegally, even if the product is not illegal in that country. 
    
  may provide pharmaceutical giants with global enforcement of their clinical trial entry barrier.  So US is working to remove barriers to signing:
• US proposes to exclude tobacco companies from using legal apparatus (Oct 2015).  
• Alzheimer 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 memory and thinking problems (MCI).  Variants include: late-onset sporadic; with risk factors - ApoE4, presenilin, androgen deprivation therapy (Dec 2015).  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; 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 and set off the formation of tangled thread-like tau protein.
  • Solanezumab aimed to inhibit plaque formation but clinical trials failed (Nov 2016).  
  • BACE inhibitors block an enzyme needed to form amyloid. 
    
  • 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. 
    
  's - Eli Lilly;
  
• 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. 
    
  therapy with major investments from: Merck, Bristol-Myers, Roche, AstraZeneca, Celgene, Sanofi; and signals, 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. 
  of success (Sep 2015, May 2016).  
• Immune checkpoint inhibition 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.  is a broad based expansion into a new evolved niche (Aug 2016).  The strategy is driven by:
• Alignment with classical pharmaceutical business model
• CRI is the cancer research institute. 
  alignment
  
• Strategic continuation of traditional cancer therapies, and applicable to most cancers that mutate rapidly. 
  
• Cellular therapies captures cells from a particular patient, modifies them, clones them and then deploys them back into the patient.  Platforms include CAR and TCR.  In 2016: The pricing schemes for cell therapies have not been announced but are expected to be expensive, The therapies are successful between 25 and 90% of the time for lymphoma and leukemia but patients may relapse after months or years of remission;  There are a number of challenges to the approach, some of which may require treatment in an ICU, including:
  • Lack of scale being specific to each patient. 
    
  • Immune system over reaction
    
  • Neurological toxicity including cerebral edema (Jul 2016). 
    
  are personalized (Aug 2016).  They have strengths and weaknesses:
  
• They may be able to avoid off target activity by the activated 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. 
  . 
  
• Leverage advances in gene sequencing describes methods of DNA sequencing, that replace traditional Sanger sequencing, which have been implemented in commercial DNA sequencers after 2000.  The methods include:
  • Base-by-base is stepwise sequencing where there are 3' removable blockers on the DNA arrays. 
    
  • Pyrosequencing,  
  • Sequencing by synthesis,
    
  • Sequencing by ligation,
    
  • SMRT,
    
  • DNA colony sequencing,
  • DNA nanoball, 
  • Nanopore sequencing,
    
  • MPSS was the first of the next generation sequencing methods,
  • Polony sequencing.  
  and 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 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.   
  . 
  
• They currently have limited application to solid tumors which are 90% of deadly cancers. 
  
• They are miss-aligned with the big pharmaceutical business model.  
• Hepatitis-C is a virus which destroys the liver during infection.  In 2016 it affects 185 million people worldwide.  Once the virus genome was sequenced in 1989 Dr. Bartenschlager and Dr. Rice worked to replicate the virus in the laboratory.  Rice realized the genome sequence was missing details that stopped the lab replication.  Bartenschlager was then successful at replicating the virus in cells in his laboratory.  The replication technique allowed Pharmasset's Dr. Sofia to develop a new hepatitis C drug, by enhancing an RNA-polymerase inhibitor with a coat that allowed the drug to enter the liver, where the coat was destroyed and the polymerase inhibitor was activated.  With high concentrations of the drug, sofosbuvir, in the liver it could eradicate the hepatitis C virus.   Sovaldi was the first sofosbuvir approved by the F.D.A. 
  : Gilead; where the drug prices are impacting state budgets, but constraining pressure from 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/drug distributors is pushing prices down by Sep 2015).  
• Atherosclerosis is the thickening of an artery wall due to invasion and accumulation of leukocytes. 
  CETP is cholestrylester transfer protein facilitates the transfer of cholesteryl esters and triglycerides between very low density and high density lipoproteins. 
  inhibitors - have largely failed during late trials: Eli Lilly, Pfizer; 
  
• Variations in corporate tax rates have stimulated US pharmaceutical company inversions allows a U.S. company to move its tax domicile overseas by purchasing a foreign company.  In 2015 the U.S. Treasury department adjusted the inversion rules to require 40% of the combined company is owned by the shareholders of the purchased foreign entity.  In Apr 2016 they clamped down on the option to serially acquire American companies.  In section 7874 of the tax code, Congress defined statutory hurdles that must be cleared to gain tax benefits: Shareholders of foreign acquirers owning less than 20% of the combined entity the inversion fails, If less than 40% and the acquirer does substantial business in the foreign jurisdiction the inversion works but with some pain, If they own more than 40% there are few negative consequences.  Companies purchased serially within three years would be disregarded by the new rules.  Companies invert because of lower foreign tax rates and earnings stripping.  Once foreign, the parent loans the US subsidiary money.  The loan repayments offset the US income and the US tax bill is vastly reduced.  : Pfizer with Allergan; and catalyzed 'Roman empire' acquisition oriented business models: Valeant.  As with the Roman empire as growth was impeded the Valeant strategy collapsed (Mar 2016). 
  

• I-SPY 2 is the investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2.  It aims to significantly reduce the cost, time and number of patients required for efficiently bringing new drug therapies to breast cancer patients who need them urgently. 
  
  • It:
  1. Uses tissue and imaging markers from individual cancer patients' tumors to determine eligibility, guide/screen promising new treatments and identify which treatments are most effective in specific tumor subtypes. 
     
  2. The trial's adaptive design allow the I-SPY 2 team to 'learn as we go,' enabling researchers to use data from patients early in the trial to guide decisions about which treatments might be more useful for patient who enter the trial later.  I-SPY 2 provides a scientific basis for researchers to eliminate ineffective treatments and graduate effective treatments more quickly. 
     
  3. The I-SPY 2 neoadjuvant treatment approach, where chemotherapy is applied prior to surgery, allows the team to evaluate tumor response with MRI before removing the 'evidence'.  This approach is as safe as treating after surgery, allowing tumors to shrink, and most importantly, it enables critical learning early on about how well treatments work. 
     
  4. Key to the trial's distinctive design, the team will screen multiple drug candidates developed by multiple companies--up to 12 different investigational drugs over the course of the trial.  New drug agents will be selected and added as those used initially either graduate to Phase III or are dropped for futility, based on their Bayesian predicted efficacy in targeted patient subgroups.  Not only does this enable an enormous improvement in efficiency but, by using only one standard arm for comparison throughout the trial, it also immediately saves 35% of the costs of standard Phase III trials. 
     
  5. The trial incorporates a robust informatics system that allows data to be collected, verified and shared real-time and to be accessed early and in an integrated fashion--enhancing and encouraging pre-competitive collaboration.  
  • By using the cellular signalling pathways as targets of 'targeted' therapies.  In I-SPY 2 the pathway information forms the basis of rationalized therapeutic guidance for patient selection, stratification and further exploration to find response-predictive biomarkers.  From an overview of gene mutations, gene copy number, gene expression as mRNA and protein and protein phosphorylation of both tumor and background tissue and blood a patient and tumor sub-group specific set of diagnostics and therapies.  The biomarkers include:
    
  • Standard, FDA approved, biomarkers to determine patient eligibility and allow randomization. 
    
  • CLIA biomarkers to aid hypothesis testing. 
    
  • Exploratory biomarkers to aid hypothesis generation. 
    
  • I-SPY 2 adaptively randomizes its iterative allocation of the initial/current patient population to either:
  • Existing standard of care or
  • Various experimental arms which eventually should graduate to phase III, or be abandoned, for some patient subgroup.  Abandoned arms are replaced by alternative experimental regimes in a new randomized arm.  Deciding to graduate or abandon uses Bayesian modeling.  That requires (1) a reasonable model that allows simulation to assess behavior and (2) a simulation.  Want to favor treatments that, on average, have superior interim results for specific biomarkers (patient segments).  Aim to graduate experimental treatments with the largest signature that is likely to benefit.  Graduate small signatures if it is unlikely that a larger signature benefits.  Want to evaluate many drugs and combinations. 
    
  • I-SPY 2 collects data from each patient:
    
  • Biomarkers (HR+/-, HER2+/-, MP1/2) -> 2(8) combinations but treated as 10 subgroups (1. All, 2. HR+, 3. HR-, 4. HER2+, 5. HER2-, 6. MP2, 7. HR-HER2-, 8. HR-HER2+, 9. HR+HER2+, 10. HR+HER2-;
    
  • MRI volume at baseline, 2, 4 & 6 months; 
  • pCR at 6 months;
    
  • Treatment. 
    
  • I-SPY 2 benefits:
  • Reduce the cost of bringing a drug from discovery to market. 
    
  • Reduce the time to conclusive results.
    
  • Reduce the number of patients needed to enroll in the trial.  There is a tenfold reduction for Phase III. 
    
  • Improve the pace of innovation. 
    
  • Improve the success rate of Phase III trials (85% vs. 25%)
  • Improve pre-competitive collaboration for applying molecular and protein pathway profiling and imaging in clinical trials. 
    
  • Improve the efficiency of drug evaluation and approval in concert with the FDA, and provide support for innovation in regulatory decision-making.  
  demonstrates the potential to reduce cost, time and number of patients required in 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) drug trials.  
• Paxil is unsafe for teenagers; trial re-analysis concludes (Sep 2015)
• Trials funded by pharmaceutical companies and constrained by F.D.A. Food and Drug Administration.   typically lock in treatment protocols.  A UK is the United Kingdom of Great Britain and Northern Ireland.   government funded Cambridge University study, shows Herceptin: breast tumors grow rapidly because they respond via the human EGF receptor (HER), coded for by the gene 'Her2', to cell growth signal epidermal growth factor (EGF).  Herceptin inhibits the growth of the Her-2+ tumors by inhibiting the EGFR.   treatment for early stage 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) works best after 6 months, rather than the current 12 month protocol (May 2018)

• EHR have been driven into the health care network.  But our analysis suggests the process adopted has limited the immediate potential for emergent amplification of the new infrastructure.  Instead extended phenotypic alignment will increasingly occur.  Further the way they are used is typically counterproductive (Oct 2014)
  

• Today anesthesiologists is a physician who has completed an accredited residency program in anesthesiology and is trained in anesthesia and perioperative medicine. 
  are included in many routine operations.  But 80% of a cardiac anesthesiologist's role is to interpret a stream of simple biosensors by applying simple pattern recognition.  As these sensors become associated with effective modeling applications one anesthesiologist will be able to perform five current roles. 
  

• IBM's Watson and alternative big data approaches (Epic (Healtheway), Cerner (CommonWell), FlatIron, Allscripts (dbMotion)) aim to improve diagnosis by associating all instances of a situation from historic data sources and then resolving them appropriately and insightfully to the individual (PHM is population health management.  It aims to use big data to extend the EHR infrastructure to provide cost effective personal treatment.  This implies reengineering the health care payment and delivery process.  
  • IT tools must be developed. 
    
  • Administrative structures must be updated. 
    
  • Clinical processes must be redesigned and accepted.  Successful workflow process reengineering will depend on integration with existing workflows and presence of added value! 
    
  • Payment mechanisms must be overhauled ensuring that the physicians get incented to move on from FFS.  
  • It must be financed.  It is not obvious where this will come from!  Providers like fixed costs.  ROI seems limited atleast initially.  Subscriptions may work for both vendors and providers. 
    
  ).  To be successful silos of health data, see UPMC, will need to be integrated together. 
  
• Big data encompasses the IT systems and processes necessary to do population based data collection, management and analysis.  The very low cost, robust, data storage organized by infrastructure: HADOOP; allows digital data to be stored en mass.  Data scientists then apply assumptions about the world to the data, analogous to evolved mechanisms in vision, in the form of algorithms.  Rather than depending on averages, analysis at Verisk drills down to specifics and then highlights modeling problems by identifying the underlying CAS.  For the analysis to be useful it requires a hierarchy of supporting BI infrastructure:
  • Analytics utilization and integration delivered via SaaS and the Cloud to cope with the silos and data intensive nature. 
    
  • Analytics tools (BI) for PHM will be hard to develop.  
  • Complex data models must include clinical aspects of the patient specific data, including disease state population wide.  
  • A key aspect is providing clear signals about the nature of the data using data visualization. 
    
  • Data communication with the ability to exchange and transact.  HIEs and EMPI alliance approaches are all struggling to provide effective exchange. 
    
  • Data labeling and secure access and retreival.  While HIPAA was initially drafted as a secure MPI the index was removed from the legislation leaving the US without such a tool.  Silos imply that the security architecture will need to be robust. 
    
  • Raw data scrubbing, restructuring and standardization.  Even financial data is having to be restandarized shifting from ICD-9 to -10.  The intent is to transform the unstructured data via OCR and NLP to structured records to support the analytics process. 
    
  • Raw data warehousing is distributed across silos including PCP, Hospital system and network, cloud and SaaS for process, clinical and financial data. 
    
  • Data collection from the patient's proximate environment as well as provider CPOE, EHRs, workflow and process infrastructure.  The integration of the EHR into a big data collection tool is key. 
    
  results in vast expansion of potential for 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.   and regression-to-the-mean is an artifact of limited sampling in a statistical study.  In a short time period exceptional scores are possible.  But as more samples are taken the results will shift back to the mean.  Two illustrative examples are Kahneman's explanation of Israeli fighter pilot trail scores and Deming's paddle wheel. 
  .  Continued confusion about the difference between the realms of physical processes, chaos, and complexity.  Aetna has discontinued its CarePass personalized health data platform. 
  

• Drug delivery
  
• Pharmacy
• Surgery 
• Delivery (reducing transportation costs: Aethon Tugs at UCSF)
  

• Movie special effects companies provide realistic artificial patients for surgery practice (Nov 2015). 
  

PEST is: Politics, Economics, Sociology-Culture, Technology; signals and actions, complex adaptive effects on the business environment. 
ranking

• P1: Deregulation
• P2: Globalization and extended phenotypic alignment.  Disruption, low cost and differentiation implications.  Power shifts to the rich and the separated militias. 
  
• P3: GATT and regional trade deals
  
• P4: Anti-trust - Microsoft, IBM & AT&T
• P5: Intellectual property rights
• P6: Euro
• P7: China successfully pairing communist government with Free Capital economy 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.   (Making the world safe for markets - HBR volume 81 no 8)
• P8: (2002) Terrorism & Ethnic/religious factional wars
  
• P9: 8 Billion people increasingly in cities implies more demand for resources such as hospital beds
  
• P10: US democracy log jam keeps strategies short term
  
• P11: US Democrats gain increasing control from demographic shifts
  
• P12: HITECH the Health Information Technology and Economic and Clinical Health Act 2009.  Central to the act is the establishment of the Medicare and Medicaid EHR incentive programs which make available $27 Billion over 10 years to encourage eligible professionals and hospitals to adopt and meaningfully use certified EHR technology.  It is assumed that over time use of the new infrastructure will grow exponentially.  HITECH established a formal mechanism for public input into HIT policy - the HITPC and HITSC.  Hitech is a key evolved amplifier driving the migration to and installation of Epic and Cerner EHR systems. 
  and Affordable Care Act 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. 
    
  rules and incentives - resulting in: Deceleration in health spending forcing providers to eliminate costs (Oct 2015), Provider partnering with health plans (Vivity).   
  
• P13: Processed food industry's dependence on sugar:
  
• Promotes distortions (Aug 2015), 
• Promotes protection (Oct 2015, Mar 2016), 
• Harvard school of public health/D.O.A. - U.S. Department of Agriculture. 
  academics were financed clandestinely by the sugar association to shift blame for obesity is a 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).  It 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). 
  from sugar to fat in the 1960s (Sep 2016)
• Results in enhancement of political evolved amplifiers - Youth obesity is a 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).  It 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). 
  -> diabetes includes type 1 and type 2.  Common side effects include: increased heart disease, hypertension, kidney disease, vision loss, nerve damage, and infections.   (Mar 2016) -> heart disease is cardiovascular disease which refers to:
  • Conditions where narrowed and blocked blood vessels result in angina, hypertension, CHD and heart attacks and hemorrhagic/ischemic strokes.  Mutations of the gene PCSK9 have been implicated in cardiovascular disease.  Rare families with dominant inheritence of the mutations have an overactive protein, very high levels of blood cholesterol and cardiac disease. Other rare PCSK9 mutations result in an 88% reduced risk from heart disease.  Inflammation is associated with cardiovascular disease (Aug 2017). 
    
  bulge
  
• E1: Positive return infrastructure build out
  
• E2: Transaction cost economics 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.   and the shift from M-form to E-form business
  
• E3: Swarms & Communities
• E4: Financial measurement system and stock assessment
• E5: Friction free electronic business economics 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.  
• E6: Disaggregation/rationalization of vertical/horizontal integrated firms
• E7: Low skilled unemployed can't compete with computers, robots, and lower cost offshore strategies (4.3 million jobs lost for high-school graduates & less qualified)
  
• E8: Malthusian down cycle promotes income inequality
  
• E9: Not enough skilled IT people (3.1 million new jobs for college graduates)
  
• E10: Global business cycles
• E11: China as the economic 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.   challenger of 2013
  
• E12: Tragedy of the commons - Internet, Forests, Fish, ....
• E13: Oil sourcing food for 8 Billion supported by US farm bill 
• E14: Internet economy 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.   - growth & taxation
• E15: Pressure on low growth aspects of enterprises
• E16: Aging of US population creates chronic health care bulge
  
• E17: Human energy capture still dependent on carbon (traditional + fracturing and horizontal drilling) rather than wind, solar, nuclear; or carbon sequestration.  
• E18: Infrastructure investment leverage constrained by debt reduction. 
• E19: Retirement of 80% of US nurses - all aged > 55 years
  
• E20: 25,000 shortage of 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. 
  in 2020: (Nov 2016). 
  
• E21: Will the collapse of weak hospital systems (Oct 2015) strengthen the most powerful
  
• E22: Scale of employer shift of workers health care coverage to health exchanges (Trader Joe's) and its consequent impact on pricing, 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. 
    
  ... 
• E23: HDHP is a high-deductible health plan which has lower premiums and a higher deductable than traditional health insurance plan such as a HMO plan or PPO plan. 
  and copayments is a fixed payment for a covered service after any deductible has been met.  It is a key strategy of the ACA to make subscribers aware of the costs of treatment and to put pressure on high cost health services.  As such suppliers and providers are keen to undermine the copayment: value based health insurance, Paying the copayment (Oct 2015), Place on the USPSTF list of preventative services (Sep 2016);
  introduce pricing pressure on providers 
• E24: Payers increase power forcing shift away from FFS is fee-for-service payment.  For health care providers the high profits were made in hospitalizations, imaging and surgery.  Due to its inducing excessive treatment activity it may be replaced by FFV bundled payment.  , leverage RAC is recovery audit contractor program created by the MMA of 2003.  It is intended to identify and recover invalid FFS Medicare claims payments.   which both increase provider risk and narrowing 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). 
    
  . 
• E25: FFS is fee-for-service payment.  For health care providers the high profits were made in hospitalizations, imaging and surgery.  Due to its inducing excessive treatment activity it may be replaced by FFV bundled payment.   remains dominant until atleast 2020
  
• S1: Cyber communities
• S2: Market to one but sell to the whole world (Getting real about virtual commerce -HBR volume 77 no 6)
• S3: Hierarchies and evolutionary psychology asserts that human culture reflects adaptations that developed during human's long hunter-gatherer past living on the African savanna.  Its implications are described in The Adapted Mind.  Subsequent studies of the effects of selection on the human genome show significant changes due to our more recent history as well. 
  
  
• S4: Open source
• S5: 80 year down cycle (1980 - 2050)
• S6: Environmental stress removes glaciation and mountain snowpack directly generating floods and lack of water and indirectly expanding conflict 
• S7: US Job skills training not focused on transforming the unskilled while Germany use government funding to support apprenticeships into differentiated industry
  
• S8: Ineffective population health care - How fast will PHM is population health management.  It aims to use big data to extend the EHR infrastructure to provide cost effective personal treatment.  This implies reengineering the health care payment and delivery process.  
  • IT tools must be developed. 
    
  • Administrative structures must be updated. 
    
  • Clinical processes must be redesigned and accepted.  Successful workflow process reengineering will depend on integration with existing workflows and presence of added value! 
    
  • Payment mechanisms must be overhauled ensuring that the physicians get incented to move on from FFS.  
  • It must be financed.  It is not obvious where this will come from!  Providers like fixed costs.  ROI seems limited atleast initially.  Subscriptions may work for both vendors and providers. 
    
  evolve?  It needs effective incentives, analytics, and new management, legal contracts applicable to populations
  
• S9: Hot spots in US population have outsize costs complicated by housing issues, substance abuse, legal problems, language barriers, education level and lack of contact with 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. 
  .  
• S10: Accountable care 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.  
  pushes uncertainty is when a factor is hard to measure because it is dependent on many interconnected agents and may be affected by infrastructure and evolved amplifiers.  This is different from Risk.   onto providers, payers and 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. 
  s. 
  
• S11: Taylorism or scientific management was advocated by Fredrick Taylor.  He viewed operatives as machines that were to follow precise instructions optimized by designers.  Deming followers such as Toyota rejected this approach and improved quality and cost management by training the operatives and treating them as skilled 'agents' who were key to detecting problems and improving the processes they participated in. 
  fights Florence Nightingale
  
• S12: Stock option and venture capital is venture capital, venture companies invest in startups with intangable assets
  rewards
• S13: Death decoupled from treatment 
• S14: Consumer empowerment's impact on health care and its HCIT is health care information technology.  The AHRQ argues HCIT consists of a complex set of technologies, policies, standards and user sets.  Technically they represent it as a set of layers: Application: CPOE, CDS, e-prescribing, eMAR, Results reporting, Electronic documentation, Interface engines, etc.; Communication: Messaging standards (HL7, ADT, NCPDP, X12, DICOM, ASTM, etc,) Coding standards (LOINC, ICD10, CPT, NDC, RxNorm, SNOMED CT, etc.), Process: HIE, MPI, HIPAA security & privacy, etc.; Device: Tablet and PC, ASP, PDAs, Bar Coding, etc.; 
  needs 
• T1: Computerized brain which can talk
  
• T2: Global Network (Data, Flight, Disease, Food, Energy, Finance: Circuit, Packet)
• T3: Standards
• T4: Genetically engineered crops with insecticides, herbicides ingested by the food chain (Sep 2015, Oct 2015)
  
• T5: Data > Voice
• T6: Modularity fails when merge systems with disjoint design rules
• T7: Complexity of growing set of scientific data
  
• T8: Appliances 
• T9: Moore's law, Gordon Moore characterized the two yearly doubling of the number of transistors in each new generation of integrated circuit. 
  at > 64 doublings (May 2016, Oct 2016)
• T10: Cloud
• T11: Immune system leverage in medicine 
• T12: Effective Process management infrastructure for health care 
• T13: Interoperable EMR refers to electronic medical records which are a synonym of EHR.  EMRs have 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!
    
  infrastructure deployed and operational across the health care continuum and relative power of mediation 
• T14: Epic and Cerner will increase market share, increasing their influence on HCIT is health care information technology.  The AHRQ argues HCIT consists of a complex set of technologies, policies, standards and user sets.  Technically they represent it as a set of layers: Application: CPOE, CDS, e-prescribing, eMAR, Results reporting, Electronic documentation, Interface engines, etc.; Communication: Messaging standards (HL7, ADT, NCPDP, X12, DICOM, ASTM, etc,) Coding standards (LOINC, ICD10, CPT, NDC, RxNorm, SNOMED CT, etc.), Process: HIE, MPI, HIPAA security & privacy, etc.; Device: Tablet and PC, ASP, PDAs, Bar Coding, etc.; 
   
• T15: Antibiotic resistant results from 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: 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%. 
  superbugs (May 2015) undermine health care processes, such as surgery and inpatient care which depend on 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). 
    
  
  

2013 SWOT Analysis

1. The legislative rule changes and executive action creates opportunities for new business strategy

Porter value delivery system relations

• Porter Power Relationships
• Biotech
  
• Physicians - Porter Research 2012 suggests that survey respondents see 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 as an effective power grab by Hospitals. 
  
• 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. 
   
• Startup Aledade demonstrates a way to integrate the 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. 
  with the health care network and lower costs (Aug 2017)
  
• Business model for individual 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. 
  collapses under pressure from various large organizations executing acquisitions and mergers: Apple running own clinics for employees, Large hospitals setting up urgent care: HCA, Dignity Health, Northwell Health (GoHealth); CVS Health & Aetna, Wal-Mart & Humana, United Health employs 30,000 physicians and owns one of the  largest urgent care is an efficient and less costly 'alternative' to the ER.  There is no accepted standard.  Urgent care clinics also compete with Primary care based on extended hours and accessible locations including Medical Malls.  Most have a physician on staff and treat ailments like feavers, sprains and sinus and urinary tract infection, but they also can perform X-rays, stitch up cuts and set broken bones.  Unlike an ER they can not admit patients to a hospital.  Some also offer services like pre-employment drug screening and summer camp physicals. 
  groups (MedExpress); who can leverage employed PCP prescriptions for their 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, driving some PCPs to compete with urgent care: Healthy Now; and or leverage nurse practitioners, and others to explore One Medical & Aledade (Apr 2018)
  
• Hospitals have low margins, political power and connections and are large employers.  There is increased competition among providers.  The pressure to integrate brings financial uncertainty (Advocate, Essence) and implementation and operational 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. 
  but also revenue, power (Mar 2013, Jan 2013, Jul 2014) and reimbursement opportunities.  Hospitalists are internists based at a hospital, where they handle the care of all the patients on site.  It's a recently created role developed in response to the economic pressure of managed care in the mid-1990s.  Formerly doctors saw patients at the hospital in the morning before heading to the office for the next eight hours.  Internists would go to a hospital if one of their patients needed them.  Dr. Diane Craig argued it would be better for dedicated physicians to be available to care for hospital patients throughout the day.  And hospitalists were initially very profitable for hospitals.  Even though the hospitals had the additional cost of their salaries the hospitalists were able to discharge patients as soon as possible emptying beds that could be used to get more revenue.  But hospitalists' Medicare treatment reimbursements are typically less than the hospital must pay them.  This is the opposite of the situation with surgeons.  Hospitalists are responsible for maintaining accurate metrics on their patients: readmission rates, HAI.  As of 2015 there are 50,000 hospitalists. 
  , under pressure from hospitals to outsource, move to unionize at Sacred Heart (Jan 2016).  Privately owned chains have better access to capital is the sum total nonhuman assets that can be owned and exchanged on some market according to Piketty.  Capital includes: real property, financial capital and professional capital.  It is not immutable instead depending on the state of the society within which it exists.  It can be owned by governments (public capital) and private individuals (private capital). 
  and should see integration as an opportunity to leverage this benefit.  In a declining 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.  
  environment hospitals are likely to focus on core competences and choose to outsource RCM is either:
  
  • Restrictive cardiomyopathy, a rare disease where scar tissue makes the heart muscle rigid and reduces the efficiency.  Or
    
  • Revenue Cycle Management aligns treatment with reimbursement.  Customer service will be involved.  IT will architect the core billing, decision support and ad-hoc services, constructed by RCM vendors, into systems to support RCM.  The Hospital's central business office will aim to maximize cash recoveries.  As per Deming, mistakes in the RCM pipeline result in rework and lost cash flow and revenue of between 4 - 12%.  The staff must be trained and fully engaged in the design and operation of the pipeline.  The front end processes are best placed to capture all the information needed to make the cycle successful.  The activities include:
  • Scheduling and Appointments - where visits and procedures are booked and demographic and insurance information is collected.  If this information is incorrect it is likely the claims will not forward to third party payers.  When resources and their states are accurately known an optimal set of plans can be constructed to efficiently and effectively flow patients through the system.  But that is difficult to guarantee because of a number of interrelated problems:
  • Scale - as the number of resources increases the ability of a central scheduling system to represent all of them accurately and reliably becomes impossible. 
    
  • Ubiquity - a CAS strategy for ensuring availability is to have an over-abundance of equivalent resource that can be used for schedule allocation.  But often these resource levels are set by local decision makers who all respond at about the same time to imposed funding changes.  The effect is to suddenly and unpredictably undermine the guarantee of over-abundance.  Sometimes the assumption of equivalence also fails as in the desire of a patient to see only a specific surgeon. 
    
  • Changes can ripple through the plans requiring coordination meetings and notifications or guaranteed receipt of status updates. 
    
  • Verification checks for:
    
  • Referral - Is there PCP authorization?  Is the PCP referred service covered by the patient's plan,
    
  • Authorization - obtain Insurance authorization if required, and
    
  • Pre-certification - is there 'need' for inpatient care or other care before admission by the MCO.  Otherwise could introduce problems including not obtaining/verifying the insurance name, number and eligibility, not securing pre-certification and pre-authorization with time limits, not copying the insurance card, not checking for secondary coverage, not detecting expired referral or authorization,
    
  • Pre-registration - provide advice about their financial obligations and what documents to bring to the procedure.  If there is a copay or an outstanding payment to be paid these should be processed,
    
  • Registration - some patients are scheduled outside of the main admitting process (by OP clinic or E.D.) and this must be detected and the scheduling verification and pre-registration process be performed,
    
  • Time of service payments - co pays and self pays,
    
  • Coding - identify diagnosis (ICD 9 -> ICD-10 codes) and treatment (CPT) activities and charges for the episode.  More than 80% of hospital cases are coded in error. 
    
  • Demographics and billing data entry - enter charges and adjust capitated charges,
    
  • Patient statements - submit primary and secondary claims (following HIPAA formats) with or without involvement of a clearinghouse, produce patient statements including time of service, outstanding balance, charged amount with codes, insurance details, forms used (UB 92/04 and HCFA 1500).  A paper based claims filing has a rejection rate of 30%.  Duplicate claim payment rates of 1 - 2% of medical expenses are common.  Duplicate claims detection is often not part of the process.  Payer's goals are in conflict with Provider goals.  
    
  • Collections and payment posting - Post all payments and adjustments and deposit money into the bank,
    
  • Denials and appeals - resubmission and appeal of claims, denial analysis and bad debts and write offs.  To reduce denial rates and appeals the reimbursement contracts payer processes and actual denials must be analyzed and understood. 
    
  • Account follow up - Patient inquiries, resubmission of claims and issue refunds. 
    
  • Financial counseling;
  operations to save costs and enhance collection.  This trend should be increased as 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.  
  ,  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. 
  
  1. It is argued that effective pricing of the bundle requires marketing data which must be extracted from the historic transaction base.  
  2. Billing and payment systems must be updated to handle the receipt and distribution of the bundled payments. 
     
  3. Care delivery must be re-architected to reduce costs and improve quality. 
     
  4. Monitoring sensors can be used to feed reports to ensure re-architected operations conform.  
  , value-based purchasing Value-Based Purchasing is a Medicare program which predefines process and outcome performance measures and then rewards or punishes hospitals through payment adjustments based on their performance.  Its purpose is to create a material link between reimbursement and clinical quality and patient satisfaction scores.  CMMI is dedicating $500M to Partnership for Patients, targeting HAC readmissions.  It is part of a broad push towards pay-for-performance. 
  
  • Phase 1 2012 - 2014 focuses on quality.
  • Phase 2 2014 - 2020 focuses on efficiency.
  and ICD-10 is the 2009 iteration of the ICD.  ICD is mainly focused on billing.  ICD-10 allows for greater specificity which is assumed to translate into lower rejection rates, easier audit compliance, and better data mining.  ICD is seen as less rich as a representation for clinical record keeping than SNOMED-CT which becomes a concern if the EHR standards force ICD-9 codes to be the required but insufficient representation of a medical procedure.   code conversions become the focus of IT and these programs place additional requirements on RCM.  ICD-10 has imposed considerable extra processing in Canada where the conversion occurred in 2002. 
  
• Acute
  
• Post-acute
  
• Chronic care 
• Instead many hospitals are restructuring to capture the higher margin patient bases: Boston Children's Hospital (Jun 2016), El Camino Hospital group. 
• 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.  
   
• Commercial insurers protected by 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.  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). 
  and with only yearly contracts with their customers are motivated to maximize their short term financial benefit, rather than the long term wellness of the insured patient.  By encouraging the use of low cost treatments with side effects rather than more expensive treatments without these same issues additional conditions can be induced in the patient population which complicate the treatment and increase overall cost. 
  
• Large commercial insurers 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. 
    
  with plans to merge (Jun 2015) but the Attorney General moved to block the mergers on anti-trust grounds (Jul 2016).  
• UnitedHealth (Nov 2015), Humana and Aetna (Aug 2016) announce plans to leave the insurance marketplaces. 
• Judges block Humana+Aetna & Cigna+Anthem insurer mergers (Feb 2017)
• CMS is the centers for Medicare and Medicaid services.   with its long term relationships with providers and their patients is using its position and power to:
  
• Drive sensors (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!
    
  ) into the provider networks is the owned health system and its extended network of partners.   and shift uncertainty onto the providers through 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:
  1. 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. 
     
  2. 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. 
    
  3. 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.  
  . 
  
• Increase state insurance plan competition by supporting the startup costs of non-profit co-op insurers.  Nov 2015 over half of these co-ops have failed. 
• 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)
• Employers continue to fund health care but their workers pay a bigger share (Sep 2016)
  
• CalPERS sets caps on prices of commodity operations and provides 2013 list of hospitals which have agreed to the cap.  
• CalPERS drives prices for elective surgery down in California (Aug 2016). 
• Patients 
• Patients select hospitals based on 'patient experience' assessments provided by their trusted social networks (Aug 2016). 
• Bad debt from non-payment is expected to crest at 11% of revenue in 2013 and then reducing due to 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. 
    
  .  
• Dec 2013 The enrollment of young adults for health insurance appears to be lagging behind the expectations of federal officials and insurers.  Obama administration delays in implementaton of the ACA provisions sent a mixed message to consumers about the significance of the Dec 22 2013 signup deadline.  CMS is the centers for Medicare and Medicaid services.   said the agency was adding staff, training and outreach to encourage consumers to beat the deadline.  Officials said there had been a surge in use of the ACA web site.  The enrollment period continues through to March 31.  The administration is encouraging insurers to accept payments that are submitted by Jan 10th 2014.  
• Benefits of breast-feeding is a mammalian adaptation which delivers breast milk to the infant and supports the mother's body in its transformation after birth.  It is known to reduce the risk of: breast cancer: BRCA1, triple negative tumors; ovarian cancer, type 2 diabetes, rheumatoid arthritis; and may reduce the risk of cardiovascular disease. 
  
  could reach more mothers & children with expanded maternity leave (Dec 2015). 
  
• New cases of diabetes is the leading cause of blindness, limb amputations and kidney failure.  Insulin and glucose levels are regulated by the pancreas, liver, muscle, brain and fat.  Diabetes occurs when the insulin level is insufficient to regulate the glucose in the system.  Increased fat levels in obesity demand more insulin overloading the pancreas.  Persistent high glucose levels are also toxic to the pancreas beta cells.  High glucocorticoid levels have been associated with type 2 diabetes.  There are genetic risk factors since siblings of someone with the disease have three times the baseline risk (about 50% of the risk of getting type 2 diabetes is genetic).  The inheritance is polygenic.  More than 20 genes have been identified as risk factors, but that is too few to account for the 50% weighting so many more will be identified.  Of those identified so far many are associated with the beta cells.  The one with the strongest relative risk is TCF7L2.  The disease can be effectively controlled through a diligent application of treatments and regular checkups.  Doctors are monitored for how under control their patients' diabetes is (Sep 2015).  Treatments include:
  • Metformin - does not change the course of pre-diabetes - if you stop taking it, it is as if it hasn't been taken. 
    
  • Diet
  • Exercise
  , in better educated, starts to trend down (Dec 2015).  
• 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.  
  expanded to treat pre-diabetes is a condition where the subject's blood sugar levels are higher than normal but they are not yet suffering from irreversible type 2 diabetes. In 2016 the CDC estimates 86 million adults, including at least 22 million people 65 or older, are pre-diabetic increasing their risk of heart disease, stroke and diabetes.  Doctors test for pre-diabetes with a blood test: FPG, OGTT, A1C; with fasting required in the first two.  Pre-diabetes is treatable but only about 10 percent with the condition are aware they have it.  Left untreated, up to one-third of people with pre-diabetes will develop diabetes within five years.  The YMCA developed a pre-diabetes treatment program.  People can use a test devised by the CDC to assess their risk of pre-diabetes.   (Mar 2016).
  
• New technology and new entrants
• The promotion of ACOs 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.  
  makes the deployment of cross business IT flows more important in US Health care.  But the centralization of business rules appears in conflict with the flexible nature of the ACO.  
• Startup Aledade demonstrates a way to integrate the 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. 
  with the health care network and lower costs (Aug 2017)
  
• The transformation of the health care financial sub-network from banks to private equity is the pooling of money from partners to: buy companies, improve their acquisition's value and sell them again.  They gain competitive advantage from being lightly regulated.  Private equity companies were initially corporate raiders. 
  is undermining the quality of health care:
  
• Emergency services can't be trusted or depended on (Jun 2016).   
• Private equity is the pooling of money from partners to: buy companies, improve their acquisition's value and sell them again.  They gain competitive advantage from being lightly regulated.  Private equity companies were initially corporate raiders. 
  is buying up high profit dermatology is the branch of medicine dealing with skin, hair, nails and their diseases.  Dermatology includes cosmetic and medical branches including pathology.  Mohs surgery focuses on skin cancer.  Tele medicine is allowing non-dermatologists to send details of a patient to an off-site dermatologist.   practices: Advanced Dermatology and Cosmetic Surgery, Schweiger Dermatology, United Skin Specialists.  A peer reviewed paper describing the purchase of high throughput, and high billing, practices, that generate significant profit, was removed from the AAD is the American academy of Dermatology. 
  website after powerful dermatologists linked to private equity complained (Oct 2018)
  
• Regulation and the courts:
  
• 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:
  1. 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. 
     
  2. 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. 
    
  3. 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.  
• If EMR refers to electronic medical records which are a synonym of EHR.  EMRs have 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!
    
  s and ACOs take hold network effects will increase.  But is the activity ISO/CCITT (evolving) or IETF, the internet engineering task force controls the processes that manage the architecture of the internet.   (disruptive) like in its adoption capabilities? 
• Startup Aledade demonstrates a way to integrate the 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. 
  with the health care network and lower costs (Aug 2017)
  
• 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.  
• Disaster preparedness rule (Sep 2016)
• 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)
• Malpractice liability risk obscures medical errors and their restriction and removal from the healthcare system.  Reform of malpractice policy can save money and enhance process visibility. 
  
• Supreme Court gives FTC - is either:
  
  • Federal Trade Commission.  Setup during the Wilson administration.  Its powers include blocking mergers due to antitrust concerns using the powers of the Clayton act. 
    
  • Follicular thyroid cancer. 
    
  the power to block hospital mergers Feb 2013.  But judge disallows block on Illinois's NorthShore & Advocate (Jun 2016). 
  
• Republican 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. 
  keen to reduce and restructure 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. 
  .  They see opportunity to do so in long term US is the United States of America.   debt negotiations.  Hospitals are the target of some of these planned cuts, as well as 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 Fiscal cliff legislated cuts.  Non-profit and teaching hospitals will be impacted by reductions in GME is graduate medical education
  funding. 
  
• Court strikes down Obama administration rule on allowable health insurance policies (Jul 2016).  
• Judicial bias
  
• Harvard law school's Alma Cohen & Crystal Yang's study found black Americans get longer sentences from Republican appointed judges (May 2018)
  
• State health strategies
  
• Democratic implementing Medicaid under 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. 
    
  .  
• In New York where the hospitals are funded by the state but struggling hospitals serve the city, politically significant developments include:
• LICH sale to Fortis property, which is being investigated by federal authorities (Jul 2016).  
• Scaling down of Mount Sinai Beth Israel (May 2016). 
• Republican not implementing Medicaid under ACA, but some pressure from Governors to change position. 
  
• 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). 
  
• Senate introduces CSI act of 2013 to strengthen toxic chemical regulation (TSC is the Toxic Substances Control Act of 1976 which governs the regulation of chemicals used in consumer products and manufacturing processes.  It was updated in 2016 and signed into law by President Obama.  But it still mainly reflects the needs of the chemical industry (Jul 2016).  ). 
  
• F.D.A. Food and Drug Administration.   does not certify end-to-end. 
• S.E.C. is the Securities and Exchange Commission.  It was provided with power to regulate the securities industry by the Securities act and Securities Exchange act.   moves against corporate inversions allows a U.S. company to move its tax domicile overseas by purchasing a foreign company.  In 2015 the U.S. Treasury department adjusted the inversion rules to require 40% of the combined company is owned by the shareholders of the purchased foreign entity.  In Apr 2016 they clamped down on the option to serially acquire American companies.  In section 7874 of the tax code, Congress defined statutory hurdles that must be cleared to gain tax benefits: Shareholders of foreign acquirers owning less than 20% of the combined entity the inversion fails, If less than 40% and the acquirer does substantial business in the foreign jurisdiction the inversion works but with some pain, If they own more than 40% there are few negative consequences.  Companies purchased serially within three years would be disregarded by the new rules.  Companies invert because of lower foreign tax rates and earnings stripping.  Once foreign, the parent loans the US subsidiary money.  The loan repayments offset the US income and the US tax bill is vastly reduced.   (Nov 2015).  Treasury is the department of the treasury.  it is a federal government executive department created by Act of Congress in 1789 to manage government revenue.  The Secretary of the Treasury is a Cabinet officer.  To support funding of high cost investments: Disaster recovery, Wars, Famines; the treasury can issue debt instruments and manage the national debt. 
  & IRS is the Internal Revenue Service. 
  add rules (Apr 2016). 
• S.E.C. is the Securities and Exchange Commission.  It was provided with power to regulate the securities industry by the Securities act and Securities Exchange act.   continues to nominally fine private equity is the pooling of money from partners to: buy companies, improve their acquisition's value and sell them again.  They gain competitive advantage from being lightly regulated.  Private equity companies were initially corporate raiders. 
  firms for short changing investors (Aug 2016). 
• In September 2016 the S.E.C. is the Securities and Exchange Commission.  It was provided with power to regulate the securities industry by the Securities act and Securities Exchange act.   charged Cooperman and Omega with insider trading.  Cooperman denied the charges. 
  
• S.E.C. is the Securities and Exchange Commission.  It was provided with power to regulate the securities industry by the Securities act and Securities Exchange act.   prosecutes major hedge fund is an investment fund that accepts investments from a limited number of accredited individual or institutional investors.  Hedge funds are able to use investment methods that are not allowed for other types of fund. 
  Och-Ziff (Sep 2016). 
• 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
  process (FSOC is the Financial Stability Oversight Council.  It was created by Title I of Dodd Frank, with Treasury Secretary as chair, to:
  
  • Facilitate communication among regulators
  • Identify and monitor excessive risks to the U.S. financial system from the failure of large companies.  It can promote market discipline by eliminating expectations that the Government will shield losses.  It can also respond to emerging threats. 
    
  • It can set aside certain financial regulations published by the CFPB it those rules threaten financial stability. 
    
  ) for constraining systemically important is a Dodd-Frank financial reform act designation for the largest companies which would have a catastrophic impact on the global financial system and can not be allowed to fail. 
  non-financial companies weakened by courts (Apr 2016). 
• Financial regulations: Europe, US; are weak and getting weaker takeover of Banco Popular by Banko Santander shows (Jun 2017)
• Northern District of Ohio Judge Dan Polster's opioid MDL is multidistrict litigation, where many legal cases are consolidated to improve efficiency & reduce costs. 
  has multiple types of defendent: Pharmaceutical companies: Purdue Pharma, J&J, and others; Distributors: McKesson, Cardinal Health; Pharmacy chains: Walgreens, CVS Health; and includes a DOJ - U.S. Department of Justice.   statement of interest (Mar 2018)

Amplifiers

Evolved amplifiers support high margins in US is the United States of America.   health care.  They promote the selection of expensive treatments, price opacity, and cost management constraints.