Prospects for Comparative Effectiveness Research under Federal Health Reform

Annals of Health Law Volume 21 Issue 1 Special Edition 2012 Article 9 2012 Prospects for Comparative Effectiveness Research under Federal Health Reform Eleanor D. Kinney Indiana University Robert H. McKinney School of Law Follow this and additional works at: http://lawecommons.luc.edu/annals Part of the Health Law and Policy Commons Recommended Citation Eleanor D. Kinney Prospects for Comparative Effectiveness Research under Federal Health Reform, 21 Annals Health L. 79 (2012). Available at: http://lawecommons.luc.edu/annals/vol21/iss1/9 This Article is brought to you for free and open access by LAW eCommons. It has been accepted for inclusion in Annals of Health Law by an authorized administrator of LAW eCommons. For more information, please contact . Kinney: Prospects for Comparative Effectiveness Research under Federal He Prospects For Comparative Effectiveness Research Under Federal Health Reform EleanorD. Kinney, JD., MP.H I. INTRODUCTION Comparative Effectiveness Research is a type of health services research that could possibly transform the health care sector of the United States. At least that is what many federal policy makers and third party payers are hoping as health care costs continue to rise at alarming rates. In 2009, national health expenditures grew four percent to $2.5 trillion, or $8,086 per person, and accounted for 17.6 percent of the Gross Domestic Product ("GDP").' This increase in health care costs threatens the success of newly enacted health reform as well as existing public and private health insurance programs and plans. This paper describes federally sponsored comparative effectiveness research and policy. In addition to laying out aspirations and apprehensions about the use of comparative effectiveness research, the paper addresses the prospects for comparative effectiveness research as a successful strategy for bending the proverbial cost curve in health care expenditures. II. FEDERAL EFFORTS TO PROMOTE COMPARATIVE EFFECTIVENESS RESEARCH The 2009 economic stimulus legislation, the American Recovery and Reinvestment Act of 2009 ("ARRA"), 2 authorized $1.1 billion to the National Institutes of Health, the Agency for Healthcare Research and Quality ("AHRQ") and the Office of the Secretary of the Department of Health and Human Services ("DHHS") to fund comparative effectiveness Hall Render Professor of Law Emeritus, Indiana University Robert H. McKinney School of Law. I would like to thank the Comparative Effectiveness Study Group at Indiana University and my research assistants Mark Harbin and Bobby Courtney. 1. Ctrs. for Medicare & Medicaid Servs., NHE Fact Sheet National Health Expenditure Data (June 14, 2011), https://www.cms.gov/NationalHealthExpendData/25_NHEFact Sheet.asp#TopOfPage. 2. American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5 § 804, 123 Stat. 115 (codified at 42 U.S.C. § 299b-8) [hereinafter ARRA]. 79 Published by LAW eCommons, 2012 1 Annals of Health Law, Vol. 21 [2012], Iss. 1, Art. 9 80 Annals of Health Law - ASLME Special Edition [Vol. 21 research. The ARRA established a Federal Coordinating Council for Comparative Effectiveness Research, which became the basis of Sarah Palin's allegation that the health reform would establish "death panels" to ration care,' but whose actual task is to coordinate comparative effectiveness research across the federal government.4 A. Work of the Institute ofMedicine ARRA also directed and funded the Institute of Medicine ("loM") to develop a definition of comparative effectiveness research as well as research priorities. Congress delegated the task of priority setting for comparative effectiveness to the loM to facilitate consultation with interested stakeholders and to mitigate concerns that the federal government was setting priorities directly. 6 Immediately upon enactment in February 2009, the loM appointed the Committee on Comparative Effectiveness Research Prioritization. The Committee issued its report, Initial National Prioritiesfor Comparative Effectiveness Research, in June 2009.' The Committee's report defined comparative effectiveness research as follows: CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels. 8 Two key elements that are embedded in this definition: (1) direct comparison of effective interventions, and (2) studies involving patients who are typical of day-to-day clinical care.9 The loM Committee then 3. Eleanor D. Kinney, The Real Truth about Death Panels: Comparative Effectiveness Research and the Health Reform Legislation, OKLA. CITY U. L. REV. (forthcoming 2011). 4. ARRA § 804(a) (codified at 42 U.S.C. § 299b-8(a)). See U.S. DEP'T HEALTH & HUMAN SERVS., FED. COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS RESEARCH, REPORT TO THE PRESIDENT AND CONGRESS (June 30, 2009), http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf. 5. ARRA § 804 (codified at 42 U.S.C. § 299b-8). See John K. Iglehart, Prioritizing Comparative-Effectiveness Research - loM Recommendations, 361 NEw ENG. J. MED. 325 (2009); Harold C. Sox & Sheldon Greenfield, Comparative Effectiveness Research: A Report From the InstituteofMedicine, 153 ANNALS INTERNAL MED. 203 (2009). 6. Sox & Greenfield, supra note 5, at 203. 7. Inst. of Med., Comparative Effectiveness Research Prioritization (Sept. 14, 2010), http://iom.edu/Activities/Research/CERPriorities.aspx. 8. INST. OF MED., COMM. ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION, INITIAL NATIONAL PRIORITIES FOR COMPARATIVE EFFECTIVENESS RESEARCH 13 (Nat'l Acad. Press 2009). 9. Sox & Greenfield, supra note 5. http://lawecommons.luc.edu/annals/vol21/iss1/9 2 Kinney: Prospects for Comparative Effectiveness Research under Federal He 2012] Prospects For Comparative Effectiveness Research 81 selected one hundred topics for comparative effectiveness research after obtaining extensive input from professional organizations and the public.o B. The PatientProtectionandAccountable CareAct and Comparative Effectiveness Research In March 2010, Congress enacted and President Obama signed into law the Patient Protection and Affordable Care Act ("PPACA")," as amended by the Health Care and Education Reconciliation Act of 2010.12 The joined legislation is called the Affordable Care Act ("ACA"). This legislation initiated comprehensive health reform for the health care sector of the United States, including increasing access to health care coverage through expansion of public programs and reform of the private health insurance market. Of several initiatives to improve the quality and control the cost of healthcare services in the ACA, the most important is support for comp (...truncated)