“ The chief obstacle to the progress of the human race is the human race.” Don Marquis (1878 - 1937)

“Every day you may make progress. Every step may be fruitful. Yet there will stretch out before you an ever-lengthening, ever-ascending, ever-improving path. You know you will never get to the end of the journey. But this, so far from discouraging, only adds to the joy and glory of the climb.” Sir Winston Churchill (1874 - 1965)

America is embarking on an unprecedented effort to comprehensively reform health care, addressing three critical concerns: quality, insurance coverage, and affordability. This commentary summarizes those concerns, the reform options being debated, and the proposals for financing the reforms. I further 1) comment on an important issue, level of educational attainment, that seems buried amidst the debate, and 2) conclude with a vision for ISPOR’s involvement and vital role in helping the proposed reforms make real progress towards solving America’s health care problems.

The Concerns Quality and Safety
More than 80% of insured Americans rate their health coverage and care positively [1]. However polls also find Americans increasingly concerned about the availability and affordability of health care (Kaiser Health Tracking Poll of 2009). A substantial body of research has documented for many years that America lags behind many other developed countries on measures of population health, such as life expectancy and infant mortality. Other indicators of poor health, especially obesity, increased in the past 20 years at an alarming rate [2]. Murray et al. report marked disparities in mortality across America that cannot be explained by race, income, or basic health-care access and utilization alone (i.e., 35-year difference between the highest and low life expectancies [3]. The 2001 Institute of Medicine’s report “Crossing the Quality Chasm: A New Health System for the 21st Century” highlighted the safety concerns associated with American medicine, in which each year more than 40,000 Americans suffer from a preventable hospital death. The mountain of evidence makes it difficult to assure each and every American of a predictable opportunity to experience the best outcome that medicine has to offer.

Insurance Coverage
Approximately one of three Americans under age 65 was estimated to be without insurance coverage at some point during the years 2007 to 2008. Forty-five million Americans are expected to be without insurance at some point in 2009 [4]. Schoen et al. estimated that in 2007 approximately 25 million Americans were insured, but the insurance was inadequate (underinsured; e.g., out-of-pocket expenses for medical care amounted to 10% of income or more [5]). Not only do many citizens face the prospects of bankruptcy and financial ruin because of under- or no insurance, but they are less likely to receive the same care as persons with insurance, nor do they enjoy the same expectations in health outcomes.

Affordability
Americans spend per year more than $2,000 per capita on health care relative to other OECD countries, even after adjusting for the US’s higher national wealth [6]. In 2007, we spent over 16% of our per capita income on health care, which is expected to increase to more than 20% by 2018. Peter Orszag (previously Director of the Congressional Budget Office and now the White House Budget Director) estimates that more than $700 billion of US health care costs is spent on services that do not improve outcomes [7]. Small business owners claim that rising healthcare cost is their number one concern; 36% report that they intend to cut health benefits (Robert Wood Johnson). Policy experts’ opinions seem to have converged, after long debate, that the US’s long-term fiscal balance is associated with health care costs, and few, if any, constituencies take a position that maintaining the status quo in health care is acceptable.

The Options
The debate has clearly centered on the questions of what to do and what is feasible. Some argue that America should go the route of many other countries, where health care is organized under one, federally sponsored, program. Others prefer options that retain the plurality of choices that do not involve dismantling certain aspects of health care that many Americans still believe serves their needs. The proposals being entertained in the US Congress and by the Obama administration appear to be focusing on three key solutions. The first solution involves increasing funding for existing federal agencies to: 1) accelerate approval of more effective technologies; 2) increase access to more affordable generic drugs; and 3) identify practices that are more effective. The National Institutes of Health is slated to see a doubling of it funding for cancer research. The 2009 American Recovery and Reinvestment Act (ARRA) authorizes more than $180 billion to enhance Medicaid services, provide funding for comparative effectiveness research to be conducted by AHRQ and NIH, lengthen COBRA insurance, and enhance funding for community health clinics. The second solution would increase authority of federal agencies to address the concerns summarized above. Congress is debating giving the Centers for Medicare and Medicaid Services (CMS) more authority to: 1) differentially pay providers based on performance measures; 2) reduce update factors for inpatient hospital payments; and 3) establish competitive bidding on Medicare Advantage program. FDA may be given more authority to prohibit anticompetitive agreements and collusion between brand name and generic drug manufacturers. The third solution involves the creation of new federally sponsored entities. Under ARRA, a new federal policy board was established to set priorities for comparative effectiveness research. Congress is debating the establishment of a new federal insurance program that would provide a low-cost, high-quality option for uninsured or underinsured Americans.

Financing Reform
Estimates vary on what it will take to finance healthcare reform, with a lower bound starting at about $650 billion in net increase in government outlays over the next 10 years. Proposals to generate revenue include; 1) replacing income-tax exclusion for employer-sponsored health plan with a deduction; 2) raising ‘sin taxes’ on cigarettes, alcohol, and sugar-sweetened beverage; and 3) imposing ‘play-or-play’ requirements on large employers. Other proposals include CMS generating savings by 1) reducing Medicare Advantage payments to private insurers; 2) paying hospitals based on performance; 3) reducing payments to regions that are comparatively high spenders; 4) reducing Medicare update factor for hospital inpatient payments; and 5) establishing competitive bidding in Medicare Advantage program. The exact details of these, and perhaps other, proposals are still being debated in Congress; President Obama and Congress want to pass this ground-breaking legislation before Congress leaves for the August recess.

Missing in all the debate
Despite the much-needed attention on reform, what is surprising is how little discussion there is about one of the most influential factors associated with the uneven health outcomes for Americans and the high cost of health care. More than 20 years ago, Victor Fuchs (Professor Emeritus of Economics, Stanford University) taught us new and eager health services researchers that the single most important determinant of population health is level of educational attainment. Despite what seems to a self-evident truth about the importance of education (a truth embraced by America’s founding fathers), America’s education system has declined to such an extent that in many states more than 20% of students fail to graduate from high school (Cities in Crisis 2009: Closing the Graduation Gap, prepared for America’s Promise Alliance, funded in part by the Bill & Melinda Gates Foundation). Experts generally agree that an uneven and poorly educated populace threatens America’s competitiveness. However, attention seems so focused on reforming the health care system itself that the importance of education on the public’s health seems lost amidst the cacophony.

ISPOR’s Role in Health Care Reform
What role can ISPOR have in this historic period? Already, ISPOR’s members have had an impact by the nature, scope, and volume of their research activities, providing much-needed information and insight on various aspects of the problems and possible solutions. Reform necessarily requires that the many constituencies, with diverse interests and perspectives, seek common ground. In this respect, ISPOR has a solid foundation for inviting diversity of research and policy perspectives. ISPOR’s meetings – with the ISPOR 2009 14th Annual International Meeting in Orlando, Florida, USA being no exception - are highly attended, providing important forums for all to share knowledge, new ideas, and brainstorm solutions. ISPOR’s journal, Value in Health, is among the highest rated peer-reviewed journals, dedicated to exploring what works and doesn’t work in health care. In 2009, ISPOR’s leadership assessed new approaches to interact and network with other organizations, including health services and outcomes research societies, government agencies, professional societies, and patient/consumer groups.

There is no denying that the current economic crisis has generated great uncertainty and anxiety about how to proceed as a nation. Discerning what will and will not produce progress towards solving the problems of quality, coverage, and affordability in America is essential, but it will be no easy task. ISPOR has much to add to this discourse as America embarks on a historic journey to reform health care, and will have much to add for many years afterwards in the implementation of health care reform.

References
[1] ABCNEWS/Washington Post poll, Oct 20, 2008.

[2] http://www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm

[3] Murray CJL, et al. Eight Americas: Investigating mortality disparities across races, counties, and race-counties in the United States. Plos Medicine 2006;3:e260.

[4] http://ww.covertheuninsured.org/content/overview

[5] Schoen C et al. How many are underinsured? Trends among U.S. adults, 2003 and 2007. Health Affs 2008;27:w298-309.

[6] OECD Health Data, 2007.

[7] Budget Chief: For Health Care, More Is Not Better; NPR interview, April 16, 2009.

Menlo Park, CA, USA  April 23, 2009–A manuscript titled "Obstacles and proposed solutions to effective antiretroviral therapy in resource-limited settings," co-authored by Ashwini Shewade, MS, and John Hornberger, MD, MS, with John Bartlett, MD, of the Duke University Medical Center, has been accepted for publication by the Journal of International Association of Physicians in AIDS Care. 

More than 3 million people were receiving antiretroviral therapy (ART) at the end of 2007, but this number represents only 31% of people needing ART in resource-limited settings. The primary objective of this study was to summarize the key obstacles that impede the goal of universal access. The authors performed a systematic literature search to review studies that reported barriers to diagnosis and access to treatment of HIV/AIDS in resource-limited settings. 

Persons living with HIV/AIDS commonly face economic, socio-cultural, and behavioral obstacles to access treatment and care for HIV. A variety of programs to overcome these barriers have been implemented including efforts to de-stigmatize HIV/AIDS, enhance treatment literacy, provide income-generation skills, decentralize HIV services, promote gender equality, and adopt a multi-sectoral approach to optimize limited resources. 

An understanding of these obstacles and suggested methods to overcome them must be addressed by global policy makers before universal ART access can be achieved. This manuscript will be an important piece cited by agencies worldwide (World Bank, WHO, UNAIDS) that provides a blueprint on how to help the millions of people who need HIV/AIDS care and are struggling to get it. 

This research was funded by Abbott Laboratories through an independent research grant and Abbott scientists (Menaka, Bhor, PhD; Rukmini Rajagopalan, DrPH, MBA, RN4) contributed to the research.

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Cedar Associates LLC provides life sciences organizations and companies with scientifically reliable and credible evidence on clinical outcomes and economics of services and technologies. We use state-of-the-art analytical techniques and seek to present our findings in a manner that is readily understood by a diverse audience, such as physicians, patients, managers, and third-party payers and decision-makers. We have close collaborations with numerous international renowned experts at local, regional and national institutions (e.g., Stanford University, UC Berkeley, California State University – East Bay, Sutter Health, Veterans’ Affairs Hospitals). These collaborations not only expand the scope of state-of-the-art expertise on projects, but increase our capacity to readily staff projects. 

The DIA Annual Meeting is the biopharmaceutical industry's largest, longest running, best-value, global, multidisciplinary event. This year's program offers learning opportunities for everyone and features the biggest names from industry, regulatory, and academia.

John Hornberger will deliver a presentation on Pharmacoeconomics, Cost Effectiveness, and Outcome Analysis for Personalized Medicine. Policy and evidence evaluation in the US by Medicare, third-party payers, and technology assessment groups are poised for dramatic changes in relation to innovative therapeutics and diagnostics products. Changing expectations and informational requirements by evaluators and regulators will require manufacturers develop, compile, present, and compare/contrast evidence of cost-effectiveness and demonstrated utility before positive coverage and pricing decisions are made. Cost-effectiveness analysis will shift from being an academic curiosity to an essential tool for health care decision making. The Session will (1) review models for evidence development, evaluation, and dissemination for genomic-based medicine products; (2) discuss approaches to meet the evolving needs of the various stakeholders; and (3) understand how innovative personalized medicine developers are articulating evidence, clinical performance, and value.

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About Cedar Associates LLC

Cedar Associates LLC provides life sciences organizations and companies with scientifically reliable and credible evidence on clinical outcomes and economics of services and technologies. We use state-of-the-art analytical techniques and seek to present our findings in a manner that is readily understood by a diverse audience, such as physicians, patients, managers, and third-party payers and decision-makers. We have close collaborations with numerous international renowned experts at local, regional and national institutions (e.g., Stanford University, UC Berkeley, California State University – East Bay, Sutter Health, Veterans’ Affairs Hospitals). These collaborations not only expand the scope of state-of-the-art expertise on projects, but increase our capacity to readily staff projects.