October Writing Sample Sanjay Kumar Gupta

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A PLAN TO COUNTER THE EFFECTS OF THE PATIENT PROTECTION AND AFFORDABLE CARE ACT (PPACA) AT NORTH SHORE UNIVERSITY-LONG ISLAND JEWISH HEALTHCARE SYSTEM (NSLIJS), WITH A FURTHER STRATEGIC PROJECT PLAN (SPP) FOR THE NSLIJS INTERNAL MEDICINE DEPARTMENT (NSLIJM) TO DEVELOP A COMPARATIVE EFFECTIVENESS RESEARCH (CER) AND EVIDENCE-BASED MEDICINE (EBM) CENTER, AS ONE MEANS OF COUNTERING THE ANTICIPATED EFFECTS OF THE PPACA Objectives I aim to present, in brief, a plan for NSLIJS to counter the anticipated effects of the PPACA, by presenting an overview of the PPACA, its effects, and the prioritized use of CER/EBM to counter it. I will provide details on the Deloitte Center for Health Solutions Health Reform Pyramid (Deloitte Pyramid Reforms; DPR; REF 1) as a means to counter the PPACA, along with a brief anecdote on the explicatory The Hospital Corporation of America (HCA) case. I will then present a plan for NSLIJM to counter the anticipated effects of the PPACA, with a focus on developing a Comparative Effectiveness Research (CER)/ Evidence-Based Medicine (EBM) Strategic Project Plan (CE-SPP). I will conclude with an overview of CER/EBM, its effects, and the means by which it may be implemented in the form of a Center, by presenting a Harvard Business School-type case-based approach (REF 44) used to develop a “Decision-Making Grid” that will allow me to recommend the optimal NSLIJM CE-SPP.

A Plan for the NSLIJS to Counter the Anticipated Effects of the PPACA An Overview of the PPACA The overall Healthcare Reform Law includes, not only the enactment and implementation of the Budget Control Act of 2011 ("BCA"), but also the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act. The law’s purview also encompasses the possible enactment of additional federal or state health care reforms, possible changes to the Health Reform Law along with other federal, state or local laws or regulations affecting the health care industry (REF 2). The key features of the PPACA are stated firstly in the form of expected changes in risk banding and central health benefits. The second will be the development of the “Exchanges” in whatever form that they may attain. Third, the transition from group coverage to the retail market will result in at least somewhat modified health plans. Finally, strategically, there will be profit margins’ pressures within the commercial health plan industry over the long-term, leading to diversification, or possibly even partnerships (REF 2). Related to revenue generation, there may be (a) bundled payments for hospital care and for the month following discharge (“Capitation Lite”) (§2704 and §3023),(b) Capitation payments instead of Fee-for-Service reimbursement (§2705),(c) incentives for doctors and hospitals to form accountable care organizations (i.e., financial rewards for higher quality and/or lower cost care) (§2706 and §3022) along with (d) adjustments to physician reimbursement based on the quality and cost of care provided (§3001) , (e)incentive payments to hospitals that meet specified performance standards (§3001), (f) expansion of reports to physicians that indicate how their use of resources in patient care compares to use by other physicians (§3003) , (g) lower payments to hospitals with high numbers of patients who become relatively sicker because of their hospital care (§3008) and finally (h) lower payments to hospitals that have excessive numbers of patients readmitted to the hospital after discharge (§3025) (REFS 2, 5). At that point, the question will remain, “Will integrated systems will exploit market power to maintain revenues rather than to introduce efficiencies and reduce costs… (REF 3)?” The Potential Effects of the Current and Forthcoming Enactment of the PPACA (Healthcare Reform) and the Prioritized Use of CER/EBM to Counter Said Effects Between 2009 and 2019, health care spending is projected to increase only 0.2% as a result of PPACA (REF 4). But the total US population’s Health Care coverage is projected to increase by 32.5 million (REF 4). According to the Deloitte Reform Pyramid (detailed below in the Deloitte Pyramid Reforms That Were Recommended In Response to the PPACA…section ; REF 1), its CER/EBM layers will serve to improve NSLIJS’ status in terms of being able to meet the new incentives for NSLIJS’ doctors and hospitals to reap financial rewards for higher quality and/or lower cost care (§2706 and §3022), adjustments to physician reimbursements based on quality and cost of care provided (§3001) , incentive payments to hospitals within NSLIJS that meet specified performance standards (§3001), its physician’s relative use of resources in patient care compared to other physicians (§3003) , lower payments to NSLIJS’ member hospitals with high numbers of patients who become sicker because of their hospital care (§3008) and finally lower payments to its member hospitals that have excessive numbers of patients readmitted to the hospital after discharge (§3025) . In sum, the CER/EBM layer of the DPR will counter many of the effects of the PPACA directly, by improving the cost-effectiveness of care delivered, with a commensurate increase in quality of care delivered using the above parameters (REF 1 and an example that is detailed below in ‘Health Care Reform Pyramid-Consumerism: The “Apex:”’ ‘ The HCA Case, as a Case-Based Example…’ section)

2 Deloitte Pyramid Reforms That Were Recommended In Response to the PPACA, and Several Examples of Projects That NSLIJS Implemented Related to Said Reforms (REF 1) Strategic Solutions The Strategic Issues are self-evident from the Strategic Solutions, and thus are not presented here, as our focus is more on the problems of the NSLIJM. Additionally, all Strategic Solutions must be employed concurrently, (even those with negative ROIs), as they are highly integrated with each other and potentiate each other in terms of overall outcomes. Introduction: A Summary Business Analysis of the NSLIJS Consumer (Patient)-Attributes Benefits Match and Competitive Factors (REF 6) The US News and World Report (USNWR) ranked competitors of the NSLIJS hospitals, nationally, as follows in terms of “America’s Best Hospitals in 2011:” New York-Presbyterian University Hospital of Columbia and Cornell, N.Y. #11, the NYU Langone Medical Center, New York# 14, and the Mount Sinai Medical Center, New York #14. No NSLIJS hospital was ranked even within the top 50 providers in this publication. Internal Operations (REFS 7,8) HR /GENERAL LEADERSHIP/CORE COMPETENCY The NSLIJS CEO, Michael Dowling, has received top awards from the Center for Healthcare leadership for bringing innovation and accountability to healthcare, and lasting improvement to the field. In terms of Core Competencies, the NSLIJS Mission is stated as follows: “Searching for new advances in medicine through the conduct of research; educating the current and future generations of health care professionals with the latter leading to quality clinical care yet still caring for the entire community regardless of the ability to pay….” Dowling also shows a commitment to a culture of continuous learning and the intent to develop leadership throughout the organization via the NSLIJS Center for Learning and Innovation, the largest corporate university in the health care industry, in service since 2002 (REF 9). FINANCIAL /ACCOUNTING The NSLIJS is the nation's third-largest, non-profit, secular healthcare system, based on number of beds. It serves a catchment population estimated at 2 million persons, primarily in Nassau and Suffolk counties of Long Islands. The NSLIJS has a $6.7B annual operating budget; with NSLIJM representing an estimated $4.7B of those annual revenues (using the national average whereby Medicine departments represent 71% of total revenues (REF 32) . NSLIJS revenues have been growing at ~10% per year from 2009, 2010, onwards, and it has a provision of $80M in annual charity care to the community (not including unreimbursed Medicaid that is another $300M per year). ADMINISTRATIVE/LEGAL COSTS “Unnecessary Care,” comprises 30% of all revenues, or $2.1B per annum (REF 10). The “Administrative Inefficiencies” costs’- component is currently a major part of the latter, comprising 17% or $340M for NSLIJS (REF 10), using averages from national data. Estimates for direct legal costs, from medical malpractice torts, are at approximately 2% of revenues or $13M per annum (REF 11). Indirect legal costs, from “defensive medicine” are stated to be approximately 3%, or $20M per annum (REF 11,12) . MARKETING: CONTROL OVER PRODUCT QUALITY /BRAND POSITION/ BRANDS IMAGE (REF 6) As stated previously based upon the US News and World Report 2011 rankings, all of the NSLIJS’s member hospitals are unranked relative to its local peer- systems, and would like improvements in this ranking. NSLIJS does however rank well within integrated systems, having achieved a rank of #31 by Modern Healthcare in 2011,among the nation’s 100 top Integrated Healthcare Networks, that is the highest of any New York metropolitan area healthcare provider (REF 7). R&D AND EDUCATION In August 2011, NSLIJS opened the Hofstra North Shore-LIJ School of Medicine (HNSLIJ SOM), New York State's first new allopathic medical school in more than 40 years. This school is in fact initiated its inaugural classes with an innovative “Lecture-Less-“ teaching method that requires students to spend most of the time teaching themselves. Thus the standard lecture format is being replaced with small-group discussions and is somewhat similar to the unique Problem Based Learning didactic approach adopted at the recently inaugurated (2002) Cleveland Clinic Lerner College of Medicine Of Case Western Reserve University that employs student-centered problem-based learning groups (Case Inquiry Groups), with no formal syllabus electronic curriculum guides students to multiple sources for study, and essentially an increased emphasis on self-directed learning Finally there are summative essay examinations focus on synthesis and integration of concepts (Ref 34). In fact multiple-choice test- assessments are also no longer being used. Instructors will instead evaluate students both on the quality of what they learn as well as clinical skills performance. “We really want to get way beyond that passive boring memorization model *used by many other medical schools+,” says Dean Smith, who adds that the incoming students “are risk takers who are absolutely enthralled to be going to a new medical school” (REF 13). Additionally, HNSLIJ SOM is creating more ground-breaking academic course content, through an 8-week EMT training course directly before the outset of medical school. It thus offers students the unique opportunity to learn medicine through a unique curriculum that integrates basic science with hands-on clinical experience throughout the four years of medical school (REF 14). Now, for example, an MS-1 will have seen a myocardial infarction patient, well before that student has started the course material relevant to that clinical presentation (e.g., “Chest Pain”). NSLIJS itself, also has the Feinstein Biomedical Research institute that receives $41M in annual NIH grants (41st rank in the USA) that is however, dwarfed locally by the $330M received by Columbia $180 M (ranked #18) received by the top area hospitals Mt Sinai or NYU Medical CenterLangone, respectively ranked #33 each (REF 6). The current research infrastructure and the innovative teaching methods that are paralleled in graduate medical education as well, through a Learner -Centered Approach in Medical Education (Practice-Based Learning & Improvement; REF 15), that will serve as key strengths for NSLIJM in terms of developing my overall CE-SPP through the facilitation of the diffusion of CER/EBM based clinical medical care throughout the practitioner community. OPERATIONS/SERVICE CHAIN MANAGEMENT CONSIDERATIONS/INFORMATION SYSTEMS (IS) In 2009, NSLIJS began a $400M Information Systems Technologies initiative for the creation of an Electronic Health-Record (EHR) system. This is for the NSLIJS-owned hospitals and other facilities, along with the subsidization of the implementation and operation costs for private NSLIJS- linked physicians to integrate the EHR system in their own offices (REF 18).

3 In 2011, Michael Dowling, the CEO, NSLIJS received the 2011 Chief Executive Officer Information Technology Award, co-sponsored by the Healthcare Information and Management Systems Society (REF 16). This IS infrastructure is critical to the long-term success of any type of large organization going forward, and NSLIJS has already commenced on the path to record linkages that will allow for overall better quality as strategic plan outcomes will now be better monitored for their relative efficacy. (REF 30). Chief External Environment-Related Factor REGULATORY SHIFTS/POLITICAL/ECONOMIC: THE PPACA COUPLED WITH THE BUDGET CONTROL ACT (HEALTH CARE REFORM) These have been discussed elsewhere, and although their effects are primarily on insurance providers, large healthcare systems such as the NSLIJS will inevitably be affected across many dimensions, as in fact healthcare reform aims to cover an additional 32M uninsured persons, while maintaining the current overall revenue base (REF 4). Indeed, the effects of Healthcare reform will be and are manifested and affected across numerous disciplines and states, including the Economy, Politics and Regulation in general. Additionally the PPACA clauses, per se, are highly volatile regulations in terms of their susceptibility to political and judicial impeachment, such as that of the recent June 2012 Supreme Court ruling on its very constitutionality (REF 17) as well as the July 2012 attempts to repeal the CER/EBM components (most directly through budget cuts to the agency deemed the Patient-Centered Outcomes Research Institute (PCORI), by abolishing the AHRQ (REF 31). It is clear that is there is a need for the Deloitte Pyramid Reforms to meet these numerous and diverse PPACA challenges face-on in a manner that will convert the Threats from the PPACA into Opportunities for NSLIJS (REF 1). Thus, just as has been true for numerous US industries undergoing major revolution in the USA’s economic history, so must Healthcare systems use improved cost-efficiencies to ensure their very success and respective livelihoods (REF 2). Health Care Reform Pyramid Strategy: Healthcare Information Technology Layer, or the “Base” General Examples Of Such Initiatives Include: E-PRESCRIBING 1.5- fold Return on the initial investment (ROI) over a 6-year period as performed through HER for example. CARE COORDINATION 2 –fold ROI over a 6-year period) as performed through better operations management. ADMINISTRATIVE COST REDUCTION 1.1- fold ROI over a 6-year period as performed through initiatives that reduce waste through reduced staffing, changed billing and the like. Example of an Application to the NSLIJS (REF 18) NSLIJS’ significant investment was $400M in 2009 (i.e., 6% of that year’s total revenues) in Electronic Health Records (EHRs) such that the health system assists community practices by subsidizing 85-percent of the cost of the Allscripts Enterprise EHR. Credentialed physicians will thus have easy digital access to detailed patient medical histories. This is expected to improve the quality of care, reduce medical errors and improve collaboration across service lines. Coupled with the Archimedes software applications (REF 33) and Mayo Clinic’s Enterprise Data Trust Information System (REF 30), I personally believe that the NSLIJM will achieve a new level of monitoring of the outcomes related to the implementation of its final CE-SPP (REF 35). Health Care Reform Pyramid-Middle Strategy: Comparative Effectiveness Research (CER) /Evidence–Based Medicine Layer (EBM) General Examples of Such Initiatives Include: EBM A 4- fold Return on the initial investment (ROI) over a 6-year period (I will use an average of annual return of 60% of the initial investment as an estimate): •More appropriate utilization (decrease mis-/over-use and increase under-use) of health services via a Center for Comparative Effectiveness Research Clearinghouse/Clinical Practice Guidelines (CPG) Clearinghouse PERSONALIZED MEDICINE (PM) 1.25- fold Return on the initial investment (ROI) over a 6-year period Example of Applications to the NSLIJS (REF 7,8) DARTMOUTH INSTITUTE FOR HEALTH POLICY & CLINICAL PRACTICE This project’s purpose is to better control medical and surgical costs, and develop practice care and payment models to enhance patient safety and reduce costs. NSLIJ is the only health system in New York State participating in the initiative. THE JOINT COMMISSION ON ACCREDITATION OF HOSPITALS (JCAH): RANKING OF NSLIJS HOSPITALS AMONG TOP TIER The JCAH named the North Shore University (NSUH), Plainview and Southside hospitals among the nation’s top performers on key quality measures. The selection was based on data reported on EBM-based processes for improving care for conditions, such as heart attack, heart failure, pneumonia, surgical care and children’s asthma. A STRATEGIC ALLIANCE WITH MONTEFIORE MEDICAL CENTER North Shore-LIJ also established with Montefiore Medical Center, for sharing innovative information technology programs, creating “best practices” in medical education, organization and development. EVIDENCE-BASED-MEDICINE DIDACTIC- IN A NSLIJS-BASED PEDIATRIC RESIDENCY (REF 19) The HNSLIJ SOM example is that of a didactic program for pediatrics residents covered methods by which residents may use EBM, systematic reviews, meta-analysis and a critical reading of medical literature to improve their decision-making skills.

4 Health Care Reform Pyramid-Middle Layer Strategy II: Coordination of Care General Examples Of Such Initiatives Include: (Yielding a Negative .75 - fold Return on the initial investment (ROI) over a 6-year period) INCREASE THE NUMBER OF FUNCTIONAL MEDICAL HOMES THE REALIGNMENT OF INCENTIVES FROM VOLUME DRIVEN -REIMBURSEMENT TO EPISODE DERIVED- PAY FOR PERFORMANCE EASE THE PRIMARY CARE WORKFORCE SHORTAGE PHYSICIAN-LED CLINICAL CARE COORDINATION YIELDS SUPERIOR CLINICAL OUTCOMES Example of Application to NSLIJS (REF 7,8) In the New York area, NSLIJS established a strategic alliance with the Montefiore Medical Center in 2011 to promote advances in quality and safety, develop advanced models of care coordination and launch streamlined alliances in pediatrics and transplantation. Health Care Reform Pyramid- The “Apex:” Consumerism General Examples of Such Initiatives Include: (Yielding a Negative 3 - fold Return on the initial investment (ROI) over a 6-year period): RESPONDING TO TRANSPARENCY & PRIMARY CARE 2.0 STRUCTURE •Reduce post-acute admissions via Smart Home/Connected Care •Decrease drug treatment costs via drug re-importation •Decrease medical costs via medical tourism USE OF PUBLIC HEALTH RECORDS (PHR) •Improve inappropriate (over-/mis-/under-, use) utilization and improve adherence via a PHR- embedded Health Dialog like Shared Decision Making model ALIGNMENT OF INCENTIVES •Experience Rating (Utilization-Based) as consumers are offered differential premiums based on their health status and adherence •Decrease medical costs with Healthy Behavior/Reward Incentives GROWTH OF COMPLEMENTARY/ALTERNATIVE MEDICINE •Decrease medical costs Example of Applications to NSLIJS (REF 7,8) TAKING STEPS FOR HEALTH On February 14, 2012, the NSLIJS launched the largest system-wide wellness competition in its history — the “Walk to Paris” designed to bring all employees together to focus on fitness, staying healthy and having fun. NATIONAL PAY-FOR-PERFORMANCE PROJECT RECOGNIZES HIGH QUALITY BY BETTY OLT (REFS 6,7,20) Nine NSLIJS- hospitals earned 68 overall awards for their performance in delivering high-quality care within six clinical areas in a national pay-forperformance project. The US Centers for Medicare and Medicaid Services and the Premier healthcare alliance conducted the Hospital Quality Incentive Demonstration (HQID),which was the first national project designed to determine if economic incentives to hospitals are effective at improving the quality of patient care. The HCA Case, as a Case-Based Example of Means of Improving Quality and Cost-Effectiveness in Large Healthcare Systems Deloitte Pyramid Type Strategic Efficiencies-Improvements’-Measures Related to HCA’s Internal Operations and the Financial and Quality of Care Results in a For-Profit $30B Revenues’- Healthcare System (REF 21) Background I present the HCA case, as being analogous to potential improvements in the NSLIJS (using DPR) with respect to the fact that HCA did improve their operational efficiencies (e.g., increased Net Profit Margin (NPM) from 2.2% to 4.3% from 2010 to 2012 alone on annual revenues of $29B), by employing strategies that focused on figuring out how to get more revenue from private insurance companies, patients and Medicare by billing much more aggressively for its services than ever before. It also found ways to reduce emergency room overcrowding and expenses; and it experimented with new ways to reduce the cost of its medical staff, a move that sometimes led to conflicts with doctors and nurses over concerns about patient care. In late 2008, for instance, HCA changed the billing codes it assigned to sick and injured patients who came into the emergency rooms. Almost immediately, the numbers of patients who HCA said needed more care-that would be paid for at significantly higher levels by Medicare-surged. HCA, which had lagged the industry for those very same high-paying categories, jumped ahead of its competitors and was reimbursed accordingly. This centering around improved cost-efficiencies through various means, both administrative and operational, may show that increased net profit margins serve as a useful measure of improved performance. Analogously in the NSLIJS case, I will first use Charity Care provisions as a means to assess the equivalent of NPM, for NSLIJS that is a non-profit system unlike the for-profit HCA. Thus I will use further savings from cost-efficiencies that will then be applied to the Charity Care provision for NSLIJS. The key point from the HCA case is that concurrent with the HCA reform measures HCA experienced simultaneous improvements in their quality rankings markedly over that same period, such that they rose from the 25th to the 80th percentile across most of the HCA system. And even analogous to the NSLIJ’s mission, HCA through the additional capital raised through better cost-efficiencies was (a) immediately able to increase by 90% over one year, charity care provisions and (b) also is now better-positioned to meet head-on the immediate and forthcoming challenges that the PPACA represents in terms of future reimbursement structures.

5 Examination of the Bioethical Issues Related to Employing Strategic Efficiencies-Improvements’-Measures in a Healthcare System- The Views of the CEO of Steward Healthcare System of New England I note below (see Internal Operational Weaknesses, zFocusing on Legal and Ethical Externalities, …), numerous negative legal and ethical externalities that result from the HCA-type of approach to improving efficiencies within it operational structure. However, I will quote CEO, Ralph De La Torre of Steward Healthcare system that sees no true alternative to such strategies, but instead l believe resolves the ethical concerns by taking a long-term view (that provides for the ‘greater social and public health good’ of the entire population) with this edited anecdote: “The guiding principles of Obamacare were to do two things. One is to expand coverage and the other is to change the fundamental way health care is structured. ..rather than by “after-the-fact care, we will succeed by getting the young involved in health care through the individual mandate, that also facilitates wellness and prevention. However it's going to cost us more for the next seven, to ten years or more. .. we’ve also increased access, and we're shifting our care to include more prevention and more wellness, but we still must deal with those who weren't part of that to begin with, so we're going to be double-paying for a while. In the long-term we need to do so, but we must start that shift now. Additionally, we need to understand that science has to guide our practice of medicine wherein everyone with a headache does not need a CT scan, or with sprained ankle needing an MRI. In terms of consolidation of hospitals, health care is finally maturing as an industry, that requires consolidation that provides economies of scale and in many ways make healthcare a commodity. One means by which cost-effective care may be implemented is through relevant IT investments that allow us to calculate which ones have already paid off as we are now able to track how different hospitals, different doctors, do things differently; which ones work, which don't; which ones are cost-effective, which are not; all through this data element to our system that was never there before. Finally, one of the harder realities is that health care reform is realizing that it is not about public health (i.e., policy) but instead it is public finance that is not intended to guide policy (vis-à-vis screening for colorectal cancer etc.) but instead it's about creating a business plan- for a ten year outlook; but politicians view only the immediate 1-2 year view- and it is the latter that is potentially detrimental towards this picture. . REF 35).” Application of De La Torre’s Principles and Concepts as Related to DPR, CER/EBM and This Paper I personally am applying De La Torres logic-, and reality-based principles throughout this paper. I fully believe in De La Torre’s opinions in terms of the purpose of Healthcare Reform, the need to focus on wellness, and the need to deal with current inevitable healthcare fiscal deficits in this 7-10 year transition phase, due to those baby boomers that were not part of the prevention and wellness-based culture. His suggestion is correct that there is need to apply IT in a manner that facilitates CER/EBM, as IT allows a full monitoring of the latter, and finally I am applying De La Torre’s concept of a healthcare strategies being defined in terms of ‘business plans, and not public health policy edicts,’ towards the need to view the entire CE-SPP as being a business plan vs its being a policy prescription (REF 35). Internal Operational Weaknesses, Focusing on Legal and Ethical Externalities, and the Need for Responsiveness as Part of HCA’s Strategic Efficiencies-Related –Measures of Improvements (REF 21) Negative Externalities from a For-Profit Setting, in General: A Dialysis Example and Other Ramifications Many doctors interviewed at various HCA facilities stated that they felt increased pressure to focus on profits under the private equity ownership (since 2008, that was the start of HCA’s operational and administrative improvement strategies), and this created questions related to the safety of the dialysis programs at two HCA-owned hospitals that further prompted state investigations. The results of the latter were that one HCA facility was fined $8,000 in 2008 and $14,000 in 2011, for delaying the start of dialysis in patients, not administering physician-prescribed drugs and not documenting whether ordered tests had been performed. “You must know that we firmly believe that there is no sustainable business model as a health care delivery system that does not have at its core the provision of high-quality patient care and services,” HCA’s chief executive, Richard M. Bracken, wrote to The New York Times in 2011. However, some experts such as Paul Levy, state that executives at profit-making hospitals are “judged in greater measure by profitability” than the administrators of nonprofit hospitals. [My personal opinion is that the PPACA is going to force non-profits to behave in a cost-efficiency driven manner, similar to the for-profits, going forward into the future]. Negative Externalities from Screening for Higher Paying Billing Codes in the ER: Misdiagnosed Patients in Triage Thus, profit-making systems like HCA are often in a better position, than non-profits, to invest in improving their hospitals through new technology, by virtue of simple operational economies of scale, that allow them to negotiate lower prices for everything from X-ray machines to pharmaceuticals. But HCA also used a new screening system related to the above ER billing codes that turned away certain subsets of patients in triage. Thus, several ER doctors at HCA’s Lawnwood Medical Center (FL), felt compelled to override the screening system in order to treat patients, with one doctor even being told to turn away a young boy with a deep cut in his arm because it was not bleeding profusely and thus did not meet the criteria. Another HCA- Florida doctor had been told by HCA managers that they ‘had targets to hit.’ In 2010, an uninsured patient who entered HCA’s Skyline Medical Center in Nashville, complained of “pain when breathing,” but was sent away, and one hour later, elsewhere was found to have pneumonia. Medicare regulators investigating the case, later cited Skyline for having “failed to ensure that an appropriate medical screening examination was conducted.” Negative Externalities from Insufficient Nurse Staffing at HCA: Bedsores Bedsores are fairly easy to prevent given sufficient nursing staff needed to turn these high-risk patients frequently. Experts even state that there is a direct correlation between bedsores and the quality of hospital staff levels. But HCA owned 8 of the 15 worst hospitals for bedsores, among 545 profit-making hospitals nationwide from late 2008 to late 2010. George Chandler’s case at HCA”s Memorial Hospital in Jacksonville was so severe that post -bariatric surgery, he lay, virtually unattended for weeks, in the hospital’s CCU. One nurse, who quit Memorial after whistle-blowing on these conditions, later testified that Mr. Chandler’s bedsores could have been easily prevented. As per a Medicare investigation, “the system of treatment for wound care places patients at risk for additional medical complications,” the examiners said. Finally, early in 2012, a jury in a civil trial even awarded Mr. Chandler $178 million in damages.

6 A Plan for NSLIJM to Counter the Anticipated Effects of the PPACA: A Focus on a CER/EBM Project An Overview of CER/EBM As the supply of effective new technologies expands and barriers to access to care are broken down (e.g., through the PPACA), strains on current health care resources will force a closer examination of what we are willing to pay for health gains (REF 5,22). Although gradual, public and private decision makers are beginning to collect evidence of cost-effectiveness (5,22). Society has long used a $50,000/ QALY standard, above which a protocol is deemed not cost-effective, however most CER experts believe that for the USA, this level is too low.(Ref 22) and should be closer to $200,000/QALY (the level that I will use for this paper;REF 26). However the Center for Medicare and Medicaid services (CMS), even as of 2011, although agreeing to review the CER information at the time of determining reimbursement levels for various medical and surgical interventions, still refuses to legislate CER data into law (REF 22). This evoked CER experts Peter Neumann and Milton Weinstein (REF 22) response : “At a time when health care costs loom as the greatest challenge facing our country’s well-being, legislating against the use of the standard metric in the field of cost-effectiveness analysis is regrettable. .. “ I present some examples of thresholds for CER to demonstrate that the range is wide, and that its use in decision-making is imperative for the appropriate practice of medicine. (REF 23): “Reasonable”

$50,000/QALY (UK upper limit ~ $47,000)

“Very Efficient”

less than $25,000/QALY

Most writers use $50-100,000 as upper limit of good value, but public preferences suggest upper limit over $200,000. (I have chosen $200,000/QALY as the threshold to be used in this paper REF 26) < $0 (If the cost per QALY is less than zero, the intervention actually saves money): Physician counseling for smoking $7,000: Flu vaccine for the elderly Under $10,000: Outreach for pneumonia $13,000:Beta-blocker drugs post-heart attack in high-risk patients $10,000 to $20,000:Combination antiretroviral therapy for certain patients infected with the AIDS virus $15,000 to $20,000:Colonoscopy every five to 10 years for women age 50 and up “Cost-effective” $20,000 to $50,000: Antihypertensive medications in adults age 35-64 with high blood pressure but no coronary heart disease Borderline (using our criteria): $200,000/QALY Lipid lowering medications in a patient with one risk factor (REF 24) “Not Cost-effective” $270,000/QALY Resuscitation after cardiac arrest $700,000 /QALY, Women with low risk for cervical cancer –annual PAP smears (REF 48) $900,000/QALY Left Ventricular Assist Device $1,400,000/QALY Aggressive statin protocols in hypercholesterolemia patients with no cardiovascular risk factors Taken in real-life type examples, drugs that are used to treat elevated lipid levels (e.g., statins) are far more cost effective when used for patients at high risk of disease (e.g., had a previous heart attack) or when the treatment goal is modest (e.g., reducing LDL cholesterol levels below 130 mg/dL) than when the patient has no history of cardiovascular disease and/or when very low treatment targets (e.g., less than 100 mg/dL) are pursued. Thus the most aggressive statin protocols can cost as much as $1.4 million per QALY, and unfortunately many practitioners do not realize this at the time of prescribing drugs in this patient subset. (REF 24) .Therefore, with the above as our context, Peter Neumann states “effectiveness or 'value' analyses show us how much health bang we get for our buck... We can assess medical services--a drug, say, or a surgical procedure--in terms of the net costs to society for each year of life gained. In an ideal society, services that offer the most health value for the money would be delivered the most widely. Other services would be dispensed starting from the top of the list on down, until the money runs out. Health care would be rationed rationally…” (REF 25) CER/EBM’s Dependence Upon “Fickle” Future PPACA Implementations of its CER/EBM Budget I personally view the Deloitte Pyramid CER/EBM as representing either a means of employing the PPACA’S CER/EBM grant component as an Opportunity for NSLIJM, or if it were to fail, as a Threat. Currently the PPACA provides $1.3B in grants for CER/EBM, of which under the Agency for Healthcare Quality and Research (AHRQ), the new Patient-Centered Outcomes Research Institute (PCORI; this would most directly affect the NSLIJM CER/EBM project) created by the health care bill has a $320 million 2013 budget (REF 31). But for example, in July 2012, Congress attempted to abolish the AHRQ, and then reduce the PCORI budget to $150M (REF 31). Additionally given CER/EBM’s low priority- status in terms

7 of PPACA budgetary constraints, if the future PPACA budgets resemble those of its modeled after Massachusetts model, then within 4 years we may expect EBM/CER to be slashed almost entirely (REF 27,28). The reason for this is that the health care plan Mitt Romney signed into law in Massachusetts is the closest parallel to the Obama plan. Since 2006, costs in Massachusetts have outpaced the original projections by more than 8%. If the Obama plan experiences similar overruns, the shortfall would be greater than $110 billion a year, and hence the External Environmental threat to CER/EBM as a viable entity (REF 28). A Plan for NSLIJM to Counter the Anticipated Effects of the PPACA, Through the Implementation of a Specific CER/EBM Strategic Action Plan The Deloitte Pyramid Reform –Elaborated (REF 1) Strategic Issues An Elaboration of CER/EBM/Personalized Medicine Problems’ Assumptions GENERAL CONTEXT –20 –30% of all care is unnecessary –Only a 55% adherence to recommended outpatient care management guidelines –Move inpatient utilization rate is too low CENTER FOR CER –Need to launch some type of Center for Comparative Effectiveness (or one of the other alternatives presented below at length)  Need to then annually fund some type of Center for Comparative Effectiveness (or one of the other alternatives presented below at length) –Need better clinical and CER and EBM data maintenance –Develop a model Clinical Practice Guidelines (CPG) clearinghouse annually –Need to expend upon MD Detailing/ and MD Education in CER/EBM Strategic Solutions An Elaboration of CER/EBM/Personalized Medicine Solutions GENERAL STEPS –Reduce the 20 –30% of all care that is unnecessary to a minimum of 5-10% of all care. –Move 55% adherence to 60% for outpatient care in 10 years –Move inpatient utilization rate to 50%-ile (Rochester, MN average) in 10 years CENTER FOR CER/MD EDUCATION – Large seed funding source needed to launch Center for Comparative Effectiveness or one of the other alternatives presented below at length – Fund for maintenance of Center for Comparative Effectiveness (or one of the other alternatives presented below at length) – Fund annual data maintenance – Develop Clinical Practice Guidelines (CPG) clearinghouse annually –Fund annually MD detailing/education (800K * 12 hrs * $100/hr) Means of Implementing the CER/EBM Strategic Project Plan Strategic Issues Overview of NSLIJM Revenue Projection Assumptions Using Kelley’s information (REF 10), I assumed that this national level data readily applied to NSLIJS, (and its subsystem, NSLIJM), a large health care system (third largest non-secular nonprofit healthcare system in the USA: NSLIJS Revenues ~$6.7B with revenues growing at ~10% per year from 2009, 2010; REF 7) with $80M in annual charity care (not including unreimbursed Medicaid). Now, national level data state that internal medicine and its subspecialties account for 70% of revenues (REF 32). Thus we will estimate that NSLIJM revenues are $4.7B per annum. However, as the entire US Healthcare system is under the tenets of Healthcare Reform, with a projected fixed total expenditure base, I will conservatively assume no revenue growth for NSLIJM over the first six year period (REF 4). Categorizing the Strategic Issues that May be Remedied by CER/EBM But 30% of all medical care is “Unnecessary Care” according to Kelley (REF 10). For NSLIJM, Unnecessary care is thus estimated at $1.4B per annum. Kelley further states that within the total Unnecessary Care rubric, “Unwarranted Use” comprises 40% (e.g., Diagnostic lab or imaging tests performed to protect against malpractice exposure, high-cost diagnostic procedure used for patients at low risk for the condition, a diagnostic test with no expected impact on the course of treatment), along with Preventable Conditions and Avoidable care comprising 6%, both being labeled under the “CER/EBM” rubric (although I will, for the sake of simplicity and conservativeness in calculation, not add Preventable Conditions and Avoidable Care in my current assessment for the NSLIJM CE-SPP). Additional categories covered directly or indirectly by the other layers of the Deloitte Pyramid are Fraud and abuse 20%, Administrative System Inefficiencies (17%), Provider Inefficiency and Errors (12%) and Lack of care coordination (12%). We may note now, as a potential ancillary benefit to be described later, but not classified into any of the Unnecessary Care categories by Kelley, is the Behavioral Risk factors category, including those such as Tobacco use-related, Obesity-related, Alcohol use-related Behaviorally –Preventable morbidity (BPM) , contribute to 50% of all preventable mortality (and 80% of all healthcare costs by virtue of chronic illness REF 29) in the U.S. Thus the BPM accounts for disease-related mortality that is truly “unnecessary” and wholly preventable through behavioral modifications.

8 Estimating the ROI of a CER/EBM Center at NSLIJM and Proposing an Innovative Information System-based Data Monitoring Application that will Rechannelize Gains Towards Highly Cost-Effective Programs (HCEPs) ROI OF A CER/EBM CENTER AT NSLIJM Methodology used to Develop a CER/EBM-Based Center and Several Preliminary Calculations For my calculations, I will now focus on the Unwarranted Use category, and state that it is our current focus for the CER/EBM rubric, and I will estimate this amount for NSLIJM to be .4 x $1.4B= $560M. I will consider that NSLIJM has a catchment population of 2M persons (REF 36) I will further define Unwarranted Use by stating that it is use of Healthcare in which the Cost/QALY (Quality Adjusted Life Year) gained exceeds $200,000/QALY gained (REF 26). Thus, that $560M wasted should yield at least 2800 QALYs in order for it to be not be rated in that category. I will assume that Unwarranted Use instead yields only 60% as much of 2800 QALYs, or 1680 QALYs, assuming that wasted care costs $334,000 /QALY. NSLIJM will build a CER/EBM center with a one-time start-up cost of $15M and yield $9M /year in net gains (REF 1). From the outset of the Strategic Planning process, these projections of gains will be verified by innovative software programs such as Archimedes are software systems (REF 33) that would be employed to keep track of such data and provide relevant modeling results for the CE-SPP and Leadership teams to periodically review in real-time. Quoting Archimedes founder David Eddy directly “Archimedes is a powerful simulation platform that enables policy makers to test assumptions, compare scenarios, and quantify the outcomes of policy options before implementing them….Advantages are that it incorporates multiple diseases, interventions, and protocols important to policy makers; it can be tailored to represent any population, disease state, or intervention;users can evaluate the effects of their programs in different populations to gain an understanding of the true impact of policy decisions… and, costs and quality-adjusted life year (QALY) dis-utilities can be changed post-hoc, to facilitate flexible and robust sensitivity analyses without having to re-run the simulation (REF 33). “ Further, to develop our IS infrastructure for the future enhancement of Quality Control, we will also implement a version of Mayo Clinic’s Enterprise Data Trust (MCEDT; in coordination with the Deloitte Pyramid Reform IT “Base” strategy; Ref 30). The latter is a “Collection of data from patient care, education, research, and administrative transactional systems, organized to support information retrieval, business intelligence, and high-level decision making. Structurally it is a top-down, subject-oriented, integrated, time-variant, and non-volatile collection of data in support of Mayo Clinic's analytic and decision-making processes. It is an interconnected piece of Mayo Clinic's Enterprise Information Management initiative, which also includes Data Governance, Enterprise Data Modeling, the Enterprise Vocabulary System, and Metadata Management. These resources enable unprecedented organization of enterprise information about patient, genomic, and research data...” (REF 30). Using the MCEDT type of IS, NSLIJM may then track, in “real-time” the actual application of CER/EBM and link its results to the current CE-SPP (REF 35). To quote the MCEDT creators again directly “Functionally, the impact of well-structured, easily queriable information about clinical events, risks, outcomes, and resource utilization fundamentally transforms a healthcare organization's capacity for quality improvement, research productivity, and best-practice monitoring…. A transformation so profound that understanding the data-intensive opportunities for improvement requires a cultural transition away from a process-oriented improvement system to a holistic systems orientation. ..Internalizing the new opportunities for systems improvement will require education, engagement, and most importantly, visible success… (REF 30)” With this innovative information system of verification of the gains that are related directly to CER/EBM, I will move one step further, and state that the net fiscal gains through CE-SPP should be spent as a first priority, to the underserved (Charity Care with the caveat that it be costeffective) as the first priority. One example of such a target group would be the indigent 35% of all elderly that due to lack of influenza or pneumococcal immunization, account for approximately 300 deaths (Ref 37,38), or an estimated 1500 QALYs lost per annum in the NSLIJM catchment area of 2M persons) . Now many of the latter deaths/ or correlated morbidity in the underserved elderly, could be cost-effectively prevented using interventions that yield QALYs in descending order (REF 25) from cost-saving such as influenza or pneumonia vaccinations at $913,000/ QALY, or that were previously deemed “Highly Cost-Effective programs (HCEPs;REF 23). Thus the CE-SPP will be the embodiment of Neumann’s aforementioned statement REF 25 ‘In an ideal society, services that offer the most health value for the money would be delivered the most widely. .. with others dispensed…starting from the top of the list on down, until the money runs out…’ With this caveat, all future gains that are causally linked to the CE-SPP, that I speak of must be prioritized to be spent on even more HCEPs. Sample Projections of the NSLIJM CER/EBM Center in Terms of a Rechannelization of Projected Gains Towards Highly Cost-Effective Programs I will now proceed to calculated projected gains, namely, annually CE-SPP projected net gains as acquired through the CE-SPP alternative options. I will use the Pennsylvania Health System’s Center for Evidence-based Prevention (REF 42) model to develop the program and refer to it as the CESPP-CEP. Note that this is the “PPACA-independent-“ case as it does not depend on the AHRQ’s PCORI for continued funding into the future (REF 31). but instead recycles all gains back into the Health System and uses the gains to continue to finance the operations of the CE-SPP CEP.. Thus for these calculations, and assume that Deloitte’s Evidence Based Pyramid ROI (REF 1) data apply here:: Desired Threshold for $/QALY (i.e., lower than this level is better): $200,000/QALY Current Unwarranted Use category: $/QALY= $334,000/QALY Current Unwarranted Use category total #QALYs gained: 1680 QALY Gains by CE-SPP based rechannelization into more cost-effective programs) with< $10,000/QALY average) gain: 900 QALYS New Average $/QALY by combining Current Unwarranted Use and QALY Gains by CE-SPP based rechannelization: $560M/2580= $217,000/QALY At this point, I assume that due to our use of Archimedes software (REF 33) and the MCEDT type IS-infrastructure, other less tangible benefits may accrue, such as through a reduced Behaviorally –Preventable Morbidity (BPM). Assume for example, that if the administration of HCEPs to the underserved within the catchment area, yield 100,000 additional annual primary care interactions this community, then additional ancillary HCEPtype interventions may ensue, as inadvertent benefits such as from tobacco cessation counseling ( less than $0/QALY as it is a cost-saving measure) , obesity, alcoholism, high-risk group screening, falls in the elderly etc.). Even if from the 100,000 number, conservatively an additional 1000 individuals receive an average of 0.2 QALYs per individual, then the number of QALYs gained is 200/year from BPM interactions –related health care provision or BPM-related gains= 200. The final Average $/QALY by combining Current Unwarranted Use, QALY Gains by CE-SPP based rechannelization, and BPMrelated gains: $560M/2780=$200,000/QALY (meets predetermined criteria for CE-SPP’s success)

9 For our Yale New Haven Health System’s Center for Outcomes Research (REF 41) calculations I will assume that the initial cost will be $30M. Note that this is the “PPACA-dependent-“ case as it is almost entirely dependent on the rather unstable AHRQ PCORI granting source for continued funding for its operations going forward into the future (REF 41). I will refer to this program as the CE-SPP-CORE. In order to maintain a conservative representation of the financial projections for this case, I will multiply all of the aforementioned CE-SPP-CEP data by a factor of 1.75 even though the initial outlay is double of the CE-SPP-CEP. Therefore, after performing relevant calculations that are not shown here: For CE-SPP CORE New Average $/QALY by combining Current Unwarranted Use and QALY Gains by CE-SPP based rechannelization: $560M/3250= $172,000/QALY For CE-SPP CORE the Final Average $/QALY by combining Current Unwarranted Use, QALY Gains by CE-SPP based rechannelization, and BPM-related gains: $560M/3600= $156,000/QALY The most important point here is that although the average cost per QALY is lower, and prima facie this appears to be a better outcome-by 22%than CE-SPP-CEP, in fact, $200,000/QALY is a predetermined threshold, for which once the threshold is achieved, the question of whether it is Unwarranted Use or not becomes irrelevant (REF 46) as the cost per QALY is a measure of efficiency and not of fairness or distributive justice; also it is a measure of health and not well-being. The latter is the system that has been adopted by NICE in the implementation of the National Health Service health plans in UK, wherein studies show that there is a “broad notion of a threshold, where the probability of rejection increases as the cost per QALY increases…” and I will adopt the same approach (REFS 45,49). Thus in effect, even the CE-SPP CEP case has reduced the amount of Unwarranted Use from $560M to zero, in a manner that is the same as that of the CE-SPP CORE, as per our definition. Finally, for both CE-SPP CEP and CE-SPP CORE cases the truest measure of quality of care delivered have been measured, at least the best that is available, and that is the increase in the number of QALYs. As my major concern was to meet NSLIJM’s mission of maximizing the number of QALYs as a factor of charity care in a cost-effective manner that reduces Unwarranted Use, I believe that both CE-SPPs meet this mission’s goal. Strategic Solutions Special “Real-World” Decision-Making Grid Used to Choose One Actual Strategic Project Plan: The CE-SPP CEP (“PPACA –Independent” Model) vs The CE-SPP CORE (“PPACA-Dependent” Model) of Developing the Final NSLIJM CER/EBM Center. OVERVIEW I will compare the CE-SPP CEP vs the CE-SPP CORE options by first describing the “Case-Based Method” (or Problem Based Learning as developed at Ohio State University in the 1960s; PBL 43) in corporate strategic planning (e.g., a variant of that developed by Harvard Business School REF 44) . I will then, noting that after a thorough systematic analysis of the case, several of the parameters relevant to the decision are quantitatively weighted, and the rest are qualitative in nature, score both options, and then select the best of the two. RE-STATEMENT OF THE PROBLEM NSLIJM would like to pursue the CE-SPP option that best accomplishes the NSLIJM mission of maximizing the number of QALYs as a factor of charity care in a cost-effective manner that reduces the new Unwarranted Use (i.e., sum and then take the average of Current Unwarranted Use, QALY Gains by CE-SPP based rechannelization, and BPM-related gains) total to zero. I will use a modified HBS-case-based approach (REF 44) assessing (i) Consumer-attributes benefits match, (ii) Internal Operations (iii) Industry Competition and (iv) External Environment-Related factors. In order to choose the best alternative. PRESENTATION OF THE ALTERNATIVES One option will be to pursue CE-SPP CEP (“PPACA –Independent” Model REF done above and the other will be to pursue CE-SPP CORE (“PPACADependent” Model) (REFS 41,42,47). A BUSINESS ANALYSIS USING A DECISION-MAKING GRID Quantitative Analysis Approach. I will use the HBS- Case-Based Method (REF 44) and employ a Decision-Making grid that will provide a cost –benefit- analysis of the various options, using various assumptions. I will focus on these categories as correlated to our basic problem, NSLIJM’s mission of maximizing the number of QALYs as a factor of charity care in a cost-effective manner that reduces Unwarranted Use to zero. The weights will sum to 1.0. I will assign a weight of .4 to Financial/Accounting aspects of the respective cases, 0.1 to Patient Attributes –Benefit match, 0.1 to Marketing (focusing on brand image and national and local overall brand rankings) , 0.4 to External Environmental threats resulting from the PPACA’s relatively unstable nature as of the time of this paper. Calculations. Given a 0.4 weight to Financial/Accounting aspects of the respective cases: I will assign CE-SPP CEP a “7” vs CE-SPP CORE a “9” for reasons that are described above, as although the ,mission is achieved in both cases, yet the latter still delivered an additional 820 QALYs. Given a 0.1 weight to Patient Attributes –Benefit match, I will assign CE-SPP CEP a “7,” vs CE-SPP CORE a “9,” as the Quality of Care will be better for a greater number of individuals in the CE-SPP CORE case. Given a 0 .1 weight to Marketing (Brand Image etc.) aspects of the respective cases, I will assign CE-SPP CEP a “6,” vs CE-SPP CORE a “10,” for reasons that include an internationally recognized research culture that helps the entire NSLIJM to continue to rank in the top healthcare systems echelon nationally (if hospitals are considered specifically) . Given a 0.4 weight to External Environmental threats from the PPACA ,I will assign CE-SPP CEP a “9,” vs CE-SPP CORE a “1,” for reasons that are described above, including the June 2012 Supreme Court ruling on the PPACA’s very constitutionality (REF 17) as well as the July 2012 attempts to repeal the CER/EBM components by abolishing the AHRQ (REF 31;47). Clearly the CEP case, although providing lower net QALY gains, still has a large advantage in terms of its relative independence that also provides it with greater flexibility in terms of application of its CE-SPP program plan per se.

10 Qualitative Analysis (see Table) I will again use the “case-based method,” (REF 44) and employ a decision-making grid for the remaining case-based parameters that will provide a relative analysis of the various options, using various assumptions. I will assign equal weights to these parameters and note that as these lack numerical backing, they will be used in the final stage of CE-SPP option selection. Also, generally speaking, the scale used is: + = poor,++ = fair, +++ = th good, and ++++ = excellent, and +++++= top 5 percentile. Additionally the convention used here is that “more stars,” means that proportionately less added expenditure/resources are required to initiate as well as maintain cost-effective activities within that parameter. Table Decision-Making Grid: The CE-SPP CEP (“PPACA –Independent” Model) vs the CE-SPP Final NSLIJM CER/EBM Center Weight CEP Score CEP (i) Patient-attributes benefits match .1 7 0.7 (ii) Internal Operations(a) HR /General Leadership/Core +++ Competency (improvement) (b)Financial Six Year projections (as .4 7 2.8 of third year in certain cases)-1 Sub-category: Maximizing the 10/10 number of QALYs as a factor of charity care in a cost-effective manner that reduces Unwarranted Use to zero. Sub-category: Final Average $/QALY $200,000/QALY by combining Current Unwarranted Use, QALY Gains by CE-SPP based rechannelization, and BPM-related gains (c) Administrative/Legal Issues (e.g., + see HCA cases) (d) Marketing Product Quality /Brands Image that .1 6 0.6 includes Industry Competition (USNWR rankings) (e) Research Force Strength Needed +++ (f)R&D Status- Improvement ++ (g) Operations/Service ++ Management/Information System Requirements’ -considerations. (iii) External Environment-Related factors. (a) Regulatory/Political/Economic .4 9 3.6 Shifts PPACA and Healthcare Reform in General TOTALS 1.0 7.7

CORE (“PPACA-Dependent” Model) Of Developing the CORE 9

Score CORE 0.9

+++++ 9

3.6

10/10

$156,000/QALY

++

10

1.0

+ +++++ ++

1

.4

5.9

Note. Scale: + = poor,++ = fair, +++ = good, ++++ = excellent, and +++++= top 5th percentile .Quantitative data are also supplied as relevant. Selecting the Best CE-SPP Alternative Results Scoring, we find that CE-SPP CEP scores a “7.7” total vs The CE-SPP CORE scoring a “5.9.” Thus both are very close-within a 20% margin of difference- given that we used estimates and projections. This is extraordinarily close also in light of the fact that the financial projections subcategory of Final Average $/QALY were heavily weighted in favor of CE-SPP CORE at $156,000/QALY vs CE-SPP CEP’s $200,000/QALY . Thus, the complex nature of this, and most such case-based decision-making processes, comes to light in this simple analysis. Further using qualitative measures that will assume equal weights, as a tie-breaker, we again find that there remains a near –tie. Final Recommendation for NSLIJM Given that we have a near-tie, my final recommendation will depend upon the actual NSLIJM final total annual budget, and a possible expected temporal variation in in terms of the External Environment-related instability of the PPACA’s funding of CER/EBM through the fickle politicallydriven budgeting of AHRQ/PCORI (at a time that USA is experiencing a ‘fiscal cliff’ with potential “sequestration” of NIH research funds and Medicare cuts and cuts in Hospital reimbursements; REFS 31 &47). Also, if the PPACA instability effect is later weighted down to a 0.2, e.g., with a Democrat president elected in 2013, if we truly have $30M budget surplus for 2014, and our opportunity costs for potentially more cost-beneficial $30M projects in other DPR areas permit, we would proceed with the CE-SPP CORE option. Otherwise we may choose the CE-SPP CEP option as a pilot for 2 years and then modify according to actual CE-SPP outcomes.

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