Analysis Frame

Summary

Introduction

• The US health care network has begun to control costs and enable 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.  
  .  But pharmaceuticals have so far escaped most of the cost controls - 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 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 SCOTUS 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 patent-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. 
    
  • A requirement that chain restaurants must report calorie counts on their menus. 
    
  (III is ACA improving the quality and efficiency of the health care delivery system. 
  
  • Subtitle A: Transforming the health care delivery system.  
  • Part I: Linking payment to quality outcomes under the Medicare program.  Annual pay raises to hospitals were cut. 
    
  • Part II: National strategy to improve health care quality. 
    
  • Part III: Encouraging development of new patient care models. 
    
  • Subtitle B: Improving Medicare of patients and providers. 
    
  • Part I: Ensuring beneficiary access to physician care and other services. 
    
  • Part II: Rural protections. 
    
  • Part III: Improving payment accuracy.  
  • Subtitle C: Provisions relating to Part C.  
  • Subtitle D: Medicare Part D Improvements for prescription drug plans and MA-PD plans.  
  • Subtitle E: Ensuring Medicare sustainability.  
  • Subtitle F: Health care quality improvements.  
  • 3403 specifies the IPAB
    
  • Subtitle G: Protecting and improving guaranteed Medicare benefits. 
    
  ) IPAB is the independent payment advisory board, with 15 members which the ACA (III) section 3403 and 10320 is tasked with achieving, CMS determined per capita growth rate goal, focused savings in Medicare without affecting coverage or quality.  It has authority to make the CMS goal driven changes which Congress can only overrule with a supermajority vote.  Prior to the ACA, MedPAC could recommend changes to payment rates and program rules but Congress had to enact them. 
  is feared as a potential control on profits.  And the growth in costs may resume as the economy picks up (Mar 2016, 2, Jul 2016).  The ACA is the Patient Protection and Affordable Care Act amended by the Health Care and Education Reconciliation Act of 2010 (Obama care).  In part it is designed to make the health care system costs grow slower.  It aims to do this by: increasing competition between insurers and providers, offering free preventative services to limit the development of serious illnesses, constraining patients' use of expensive services, constraining the growth of payments to Medicare providers and piloting new ways for PCPs to manage patient care to keep patients away from costly E.D.s.  It funds these changes with increased taxes on the wealthy.  It follows an architecture developed by Heritage Action's Butler, Moffit, Haislmaier extended by White House 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 SCOTUS 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 patent-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. 
    
  • A requirement that chain restaurants must report calorie counts on their menus. 
    
  's leverage of high deductibles is inhibiting effective use of the health care network by many.  And this inhibition is causing resentment.  So it is still possible that the ACA based legal structures will be unwound by a future administration (Nov 2015, Jun 2016).  That possibility only adds to the complexity of the situation. 
  
• To develop an effective business, hospitals must predict and respond to: political, 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, 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.  
  • Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.  
  • Development, deployment and maintenance of vaccination strategies. 
    
  • Regulation and constraint of foods, drugs and devices by agencies including the FDA. 
    
  and health care strategies over the next five years.  Global population growth, economic shifts and resultant climate change introduce a range of significant threats: Terrorism, Epidemics is the rapid spread of infectious disease: AIDS (Oct 2016), Cholera (2010), Clostridium difficile (May 2015), Ebola, Influenza, Polio, SARS, Tuberculosis, Typhoid, 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. 
  , Poverty, Isolation, Financial stress; to health even as powerful broadly entrenched incentives: justice system; encourage alignment with a reduced focus on public health and expanded treatment of the effects.  But public health based strategies can be particularly effective and low cost (longevity).  How can expected CAS responses be managed?
  
• Hospitals are under immense pressure to shift 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.   to FFV is fee-for-value payment.  .  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 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 SCOTUS 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 patent-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. 
    
  • A requirement that chain restaurants must report calorie counts on their menus. 
    
  driven reduction in 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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.  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. 
  revenues are forcing rural systems to seek better capitalized enterprises to sustain them.  Large urban systems with younger, wealthier patient bases must leverage their situation to setup a business model that will win in the FFV environment that only Kaiser really leverages as of 2015. 
  
• The ACA forces the integration of subscribers, payers, doctors, hospitals, 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. 
    
  and suppliers into a competitive network which encourages disintermediation is the shift of operations from one network provider to another lower cost connected network provider.  The first network provider leverages the cost benefits of the shift to increase its profitability but becomes disrupted.  The lower cost network provider gains revenue flows, expertise and increases its active agents.  Over time this disruptive shift will leave the higher cost network as a highly profitable shell, but the agents that performed the operations that migrated to the low cost network will be ejected from the network.  For a company that may imply the costs of layoffs.  For a state the ejected workers imply increased cost impacts and reduced revenue potential which the state are trading off for improved operating efficiency. 
  .  Which has energized the largest providers: HCA - a powerful for profit system, Kaiser the cost leader, Geisinger or Partners for example - applying quality in different ways for differentiation; and payers: Aetna, and Anthem - for profit Insurance plans, the non-profit blues, large self-insured employers - G.E. and Government - Medicare and Medicaid; and they are fighting to control the 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). 
    
  that now connect them together.  
• 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.  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.  EHRs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  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. 
    
  : 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. 
  
• Hospital suppliers, including the big pharmaceutical and biotechnology companies, are: 
• Still being supported by regulatory and structural constraints on CMS is the centers for Medicare and Medicaid services.  's power to price treatments (1979 court injunction on Medicare 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 its drug prices and created MAC and RAC.  IT was sponsored by Senator Bill Tauzin and implemented by Tom Scully. 
  ).  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 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.  The first 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 subscribers (Apr 2016). 
• Understand losses from referral outside of network. 
  
• 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  data about their patients and subscribers.  
• Focus resources on infrastructure to support doctors specialized offers for the wealthy 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, 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.  
  • Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.  
  • Development, deployment and maintenance of vaccination strategies. 
    
  • 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.  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, 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.  
  ; and watch as new entrants, including retailers, and alternative business models attack their profit and subscriber bases.  
• Maternity - advanced NICU is neonatal ICU also called an intensive care nursery.   support and leverage value of IVF is in vitro fertilization.  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. 
  . 
  
• 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. 
  . 
  
• 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 & 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

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. 
   

• The House appropriation committee approved an appropriations bill (Jun 2015) will eliminate money to administer the ACA and prevent use of user fees paid by insurers to support operation of the federal marketplaces. 
  
• The House passed a bill to repeal the tax on makers of medical devices that partly funds the ACA (Jun 2015). 
  
• The House passed a bill to eliminate the independent board that is tasked with ensuring 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • Premiums
  • Part A premium
  • Part B insurance premium
    
  • Part C & D premiums are set by the commercial insurer. 
    
  spending remains within specified targets (Jun 2015). 
  
• The House adopted a budget-reconciliation is a fast-track Senate procedure defined in title III of the CBIC act.  In response to a stagnant economy and President Nixon's spending controls it was hoped this process would help with acting rapidly on the rising budget deficit and increasing entitlement spending.  The process is constrained by Senate rules that limit its use to provisions that deal with government tax and spending activities, but not policy:
  • Senators can object to a reconciliation bill if they see the rules being broken & ask for the parliamentarian to judge if a provision of a bill fails the rules. 
    
  • If the parliamentarian judges the proposal does fail the rules, the bill must be passed by 60 votes to overcome the objections, rather than a simple majority of the Senate or the provision must be stripped from the bill. 
    
  package repealing core elements of the ACA (Oct 2015):
• Remove the requirement for Americans to have health insurance. 
  
• Remove requirement for larger employers to offer coverage to full time employees.  
• Remove requirements for small employers to offer coverage to full time employees.
• NYT Sep 2015 Bipartisan effort to change rule that could raise premiums for some mid-size businesses, approved by Congress and accepted for signature by President Obama  (Oct 2015). 
• Repeal taxes on medical devices. 
  
• Repeal taxes on Cadillac plans.  
• NYT Dec 2015 Proposed tax extender package delays repeal of Cadillac tax and delays start of device tax.  
• Removal of risk corridor funding
• NYT Dec 2015 Rubio provision in the 2014 funding law is undermining 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 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 SCOTUS 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 patent-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. 
    
  • A requirement that chain restaurants must report calorie counts on their menus. 
    
  's risk corridor are a federal program established in 2010 to protect health insurers against the uncertainties they faced in setting the level of insurance premiums when they did not know who would sign up for coverage under the ACA.  HHS collects funds from plans with lower than expected claims and transfers them to plans with higher than expected claims.  The ACA was designed to capture back excess insurance profits while supporting initial losses with the goal of making the corridors tax payer neutral.  They phase out in 2016 (Dec 2015).   provision protection for health insurers. 
  
• New York State's NorthWell is to close CareConnect insurance which has been loosing money after Rubio attacks on 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 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 SCOTUS 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 patent-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. 
    
  • A requirement that chain restaurants must report calorie counts on their menus. 
    
  insurance risk corridors are a federal program established in 2010 to protect health insurers against the uncertainties they faced in setting the level of insurance premiums when they did not know who would sign up for coverage under the ACA.  HHS collects funds from plans with lower than expected claims and transfers them to plans with higher than expected claims.  The ACA was designed to capture back excess insurance profits while supporting initial losses with the goal of making the corridors tax payer neutral.  They phase out in 2016 (Dec 2015).   & ACA risk adjustment aims to lessen the: Influence of risk selection on the premiums that health insurance plans charge, Incentive for plans to avoid sicker enrollees.  ACA legislated risk adjustment also has three additional issues: New populations, Cost & rating factors, Balanced transfers within a state/market.  CMS developed a methodology that includes a risk adjustment model and a risk transfer formula to ensure premiums reflect the insurance plans scope of coverage rather than health status.  Companies with healthier client pools have to transfer money to insurers with sicker populations. 
  drained reserves (Aug 2017)
  
• The Senate Appropriations Committee approved a bill that substantially cuts funding of CMS is the centers for Medicare and Medicaid services.   and weakens its ability to operate the ACA and manage 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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.  Less than 10 percent of Medicaid recipients, those in long-term care including nursing homes where 64% are dependent on Medicaid, use one-third of all Medicaid spending which is a problem.  The ACA's Medicaid expansion program made state optional by the SCOTUS decision was initially taken up by fifty percent of states.  As of 2016 it covers 70 million Americans at a federal cost of $350 billion a year.  In 2017 it pays for 40% of new US births. 
  (Jun 2015).   
• Senate Republicans aim to dismantle or defund the ACA using a fast-track procedure needing only a simple majority but
  
• Senate rules may constrain Republican moves to fast-track the repeal the ACA (Nov 2015) &
  
• President Obama said he would veto any such law. 
  

• King v. Burwell was rejected by the Supreme Court (Jun 2015)
• House of Representatives v. Burwell (Aug 2015, Sep 2015)
  

• 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.  
  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) 

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. 
  '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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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 as a vision of a well-functioning state and health care system:
• For thirty years Singapore has planned and executed strategies requiring cooperation and coordination across most government ministries.  It is exceptional in maintaining the People's Action Party consistently in power which resulted in political stability.  This allowed unity and constancy of purpose focused by a vision of 'first world standards'.  A successful economic strategy allowed subsequent investment in health.  The leaders felt health would be affected by almost every aspect of urban life: housing, water supply, food supply, air quality, waste disposal, road traffic, parks, tree planting etc. so health goals were built into every aspect of urban planning.  Their early focus was on 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, 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.  
  • Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.  
  • Development, deployment and maintenance of vaccination strategies. 
    
  • Regulation and constraint of foods, drugs and devices by agencies including the FDA. 
    
  and housing.  But they also financed postgraduate medical education and opened public outpatient dispensaries and maternal and child health clinics close to where the people lived.  Citizen concerns are used to adapt the plans over time. Its key 21st century goals are:
1. Become a healthy nation by promoting good health
2. Promote individual responsibility.
3. Ensure good and affordable basic medical services for all Singaporeans
4. Engage competition and market forces to improve service and raise efficiency. 
   
5. Intervene directly in the healthcare sector when necessary, where the market fails to keep healthcare costs down. 
   
• Singapore's successful economic strategy has ensured its citizens a high standard of living.  And Singapore has provided infrastructure for supporting wellness: an inexpensive and affordable mass transit system, neighborhood fresh food markets with affordable fresh fruit and vegetables, island-wide park connectors, exercise stations, funded community centers;
  
• Singapore insists the population contribute directly to their health care costs, which maintains awareness of the benefits and costs.  Singapore developed a financing infrastructure which allowed it to redistribute national income and incent the behavior of its people.  It supports home buying and saving for health care payments and catastrophic health insurance cover.  The funds of the compulsory government saving scheme Medisave can only be used to purchase health insurance which includes both 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);
  . 
  
• Singapore spends only four percent 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 according to Piketty.  GDP has many problems:
  • GDP is a poor measure of:
  • Value
    
  • Who gets what
    
  • GDP excludes:
  • Services by house makers
  • Leisure
  • GDP includes items that should be excluded:
  • Cost of waste - cleaning up pollution, building prisons, commuting to work;
  • Guanine-di-phosphate is a nucleotide base. 
    
  on healthcare while getting first world results.  Singapore's health care provision Shewhart cycle has matched 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). 
  commitments to preconditions.  Most of the Government's spending comprises: subsidies allocated to the hospitals and clinics, spending on construction of health care facilities, and human resources.  It maintains rigorous cost controls by: wide-scale management of the market and regulations on how new technology is introduced to the public hospitals.  Singapore allows a free market in prescription drugs but they do use group procurement to limit costs.  Most citizens pay 65 percent of the cost of health care provision themselves.  Prices charged for health care provision are generally a quarter of those paid in the US.  Patients limit their consumption of health care because of the deductibles and copayments.  In comparison patients in other middle income countries in the region spend a lot on health care because their under developed public infrastructure and lack of trust in it which empowers the private providers who are able to increase prices substantially. 
  
• Singapore maintains a mix of public and private sector health care but insists the public sector be larger to limit private domination.  In the view of the Singapore government private sector dominance enables influence of the government and public policy to serve the sector's own ends. Sophisticated costly services are not subsidized.  Technology deployment in the public infrastructure is constrained.  Singapore is focused on adding EHR refers to electronic health records which are a synonym of EMR.  EHRs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  and 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. 
  .  The Deputy Prime Minister noted that Singapore intends to increase the priority of long term care over acute care.  He added "Most importantly, we must make it easier and more affordable for the elderly to stay at home, with access to quality care services when needed." 
  
• Singapore maintains a transparent pricing system in the public sector which forces the private sector to maintain transparent pricing too.  The leaders assumed health care providers would have a powerful influence on the demand for services so pricing is transparent and public hospitals are influential enough to constrain prices. 
• Singapore is seeing increasing chronic disease including 11% 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 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). 
  and type-2-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
  (DM is diabetes mellitus or disease management in health care. 
  ).  Most DM sufferers don't keep the disease under control due to time constraints, distance to travel to medical appointments, no care givers and a lack of motivation.  Singapore has consequently adopted a cluster system of six regional hospitals leveraging EHRs to allow diabetes includes type 1 and type 2.   sufferers to migrate from acute care at the regional hospital to intermediate and long-term care facilities and local clinics to ensure easy access and utilization of the range of services they need.  
• Singapore's population is both aging and living longer.  Although Singapore families traditionally support their aging parents this new scenario adds additional pressures described by Atul Gawande for traditional families in India in Being Mortal.  Haseltine explains how Singapore has updated its central plans to cope:
• Ministerial Committee on Ageing to ensure awareness across the government. 
  
• Agency for Integrated Care - to develop and coordinate aims to transfer information between the patient and each care participant as required and establish accountability by defining who is responsible for each care delivery activity, the extent of that responsibility and when that responsibility will be transferred to other care participants or the patient and family.  Successful care coordination requires face-to-face interactions.  It also requires aligned incentives (ACO, Bundled payments).  AHRQ defines quality measures for care coordination.  The situation is usually complex and adaptive due to the interactions of all the providers, settings, the patients' preferences, and the number of physical health problems, treatments, and the patients' social situation.  The potentially exponential increase in complexity as the number of these factors present increases leads to patient hot spots requiring explicit proactive coordination of care.  It is argued that care coordination must include six specific activities:
  1. Determination and updating of care coordination needs: Needs assessment should identify preferences and goals, current situation and past history.  It needs to be updated periodically and after new diagnosis and other changes in health or functional status. 
     
  2. Creation and updating of proactive plan of care
     
  3. Communication
  4. Facilitation of transitions: typical transition problems are detailed by Project Boost.  A challenging issue with transitions is what to do when there is no resource to take over the coordination role in the handoff. 
     
  5. Connection to community resources: Community resources are any service or program outside the health care system that may support a patient's health and wellness. 
     
  6. Alignment of resources with population needs: need to see the system-level, assess the needs of populations to identify and address gaps in services.  
  a continuum of care centered on the patient with improved 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
  , transportation and follow-up.  
• Center for Enabled Living - to provide outreach for the elderly and disabled of: social care services to minimize institutionalization encourage compassion and deliver health education. 
• Extend the provider infrastructure to push the whole continuum of care close to the elderly populous.  It is assumed that this will help the population manage any diseases effectively.  
• Focus elderly community care on the patient's home.  But citizens have pushed back against the politicians when long-term care facilities were deployed in their neighborhoods. 
  
• The capacity of the whole hospital system is being expanded.  And long term care facilities are being repositioned to be near the major residential towers.  
• The number of health care professionals and the scope of skills (adding speech therapists, dietitians, case managers, psychologists, dentists, optometrists and podiatrists) have been expanded in the budget.  And the government is encouraging the private 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 low FFS leverage of the PCP compared to specialists. 
  s to expand preventative and monitoring services. 
  
• 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. 
    
  • During depression, stress inhibits dopamine signalling. 
    
  • Strategies for stress reduction include: Mindfulness. 
    
  conditions that undermine 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.  . 
  
• 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, 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.  
  • Development, deployment and maintenance of infrastructure including: sewers, water plants and pipes.  
  • Development, deployment and maintenance of vaccination strategies. 
    
  • 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 according to Piketty.  GDP has many problems:
  • GDP is a poor measure of:
  • Value
    
  • Who gets what
    
  • GDP excludes:
  • Services by house makers
  • Leisure
  • GDP includes items that should be excluded:
  • Cost of waste - cleaning up pollution, building prisons, commuting to work;
  • 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 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 SCOTUS 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 patent-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. 
    
  • 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.  
• 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 its drug prices and created MAC and RAC.  IT was sponsored by Senator Bill Tauzin and implemented by Tom Scully. 
  , 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.  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 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 SCOTUS 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 patent-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. 
    
  • 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.  EHRs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  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.  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).  
• And surveys, comparing access to health care in the US to a basket of other wealthy 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 Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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). 
    
  . 
  
• The 2015 bill to alter Medicare payments for doctors also pushes them towards larger groups, PCMH is patient centered medical homes. 
  , ACO is an Accountable Care Organization. These are accredited bundles of companies which together try to offer Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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.  .  
• 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 is Gilead Sciences hepatitis-C drug.  It is the first effective cure with acceptable side effects.  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.  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.  
  
• Toxic stress: Failing water supply infrastructure, Collapsing abandoned mining and manufacturing plant, Opiod addictions, Toxic chemicals (Jul 2016); 
• 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). 
  scans are popular and powerful, but induce high radiation accumulation.  
• Violence: Exponential population expansion and the increasing disparity in wealth 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;
  

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.  EHRs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  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.  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.  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, 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 is initiated by an increasingly leaky blood-brain barrier and the innate immune response to subsequent 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 of success (Sep 2015, May 2016).  
• Immune checkpoint inhibition release the immune system's checkpoints 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, nivolumab, pembrolizumab, atezolizumab;  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. 
  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.  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 carinomas 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). 
  
  drug trials.  
• Paxil is unsafe for teenagers; trial re-analysis concludes (Sep 2015)
  

• 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.  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 (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 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 SCOTUS 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 patent-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. 
    
  • 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 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 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.   (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 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
• 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 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 - 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 low FFS leverage of the PCP compared to specialists. 
  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 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 SCOTUS 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 patent-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. 
    
  • 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 low FFS leverage of the PCP compared to specialists. 
  .  
• S10: Accountable care is an Accountable Care Organization. These are accredited bundles of companies which together try to offer Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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 low FFS leverage of the PCP compared to specialists. 
  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
  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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  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.  The first 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 Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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 low FFS leverage of the PCP compared to specialists. 
   
• 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 low FFS leverage of the PCP compared to specialists. 
  with the health care network and lower costs (Aug 2017)
  
• 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 internists would go to a hospital if one of their patients needed them.  Instead hospitalists would support the patients while they were at the hospital.  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 Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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 to allow the value delivery system to optimize around low cost high quality long term health care.  This 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.  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. 
  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 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 SCOTUS 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 patent-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. 
    
  • 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. 
• 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.  EHRs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  ) 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. 
• 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 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 SCOTUS 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 patent-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. 
    
  • 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 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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 low FFS leverage of the PCP compared to specialists. 
  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 undermining the quality of health care:
  
• Emergency services can't be trusted or depended on (Jun 2016).  
  
• 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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 Kaiser like business models (Dec 2015, Sep 2016) focused on wellness, and rewarding doctors for preventing problems.  Advocate health illustrates the idea.  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 programs 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-patent setting. 
    
  • As of 2016 interfacing with the EHR is cumbersome and undermines face-to-face time between doctor and patient.  
  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 low FFS leverage of the PCP compared to specialists. 
  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)
• 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 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 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 hosptial. 
    
  • Part B: Medical insurance
    
  • Part C: Medicare Advantage 
  • Part D: Prescription drug coverage 
  • 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. 
    
  • 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.  
    
  • 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.  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 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 SCOTUS 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 patent-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. 
    
  • 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 graduate medical education funding. 
  
• Court strikes down Obama administration rule on allowable health insurance policies (Jul 2016). 
  
• 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 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 SCOTUS 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 patent-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. 
    
  • 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.  
• 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 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)

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.