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Comparative Effectiveness Research under the Patient Protection and Affordable Care Act: Can New Bottles Accommodate Old Wine?

Published online by Cambridge University Press:  06 January 2021

Eleanor D. Kinney
Eleanor D. Kinney*
Affiliation:
Hall Center for Law and Health, Indiana University School of Law—Indianapolis. Duke University School of Law; University of North Carolina School of Public Health
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Abstract

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

Type
Article
Information
American Journal of Law & Medicine , Volume 37 , Issue 4 , December 2011 , pp. 522 - 566
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2011

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References

1 Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-48, 124 Stat. 119 (2010).

2 Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 (2010).

3 A Short History of the National Institutes of Health: WWII and the Ransdell Act of 1930, NAT’L INSTS. OF HEALTH, http://history.nih.gov/exhibits/history/docs/page_04.html (last visited Oct. 1, 2010).

4 See Moses, Hamilton et al., Financial Anatomy of Biomedical Research, 294 JAMA 1333, 1335 (2005)CrossRefGoogle ScholarPubMed; Darren E. Zinner & Eric G. Campbell, Life-Science Research Within US Academic Medical Centers, 302 JAMA 969, 973-75 (2009).

5 Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (codified in scattered sections of 21 U.S.C.).

6 Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified at 21 U.S.C. §§ 360c–k (2006)).

7 Social Security Amendments of 1965, Pub. L. No. 89-97, 79 Stat. 286 (codified as amended at Social Security Act, 42 U.S.C. §§ 1395-1396 (2006)).

8 See Proposed Medicare Reimbursement Formula: Hearings Before the S. Comm. on Finance, 89th Cong. 4 (1966).

9 Marian Gornick et al., Twenty Years of Medicare and Medicaid: Covered Populations, Use of Benefits, and Program Expenditures, 6 HEALTH CARE FIN. REV. 13 (Supp. 1985).

10 See THE ROLE OF HEALTH INSURANCE IN THE HEALTH SERVICES SECTOR (Richard N. Rosett ed., 1976); Arrow, Kenneth J., The Economics of Moral Hazard: Further Comment, 58 AM. ECON. REV. 537 (1968)Google Scholar.

11 See, e.g., ROBERT E. ADLER, MEDICAL FIRSTS: FROM HIPPOCRATES TO THE HUMAN GENOME (2004); JOHN G. SIMMONS, DOCTORS AND DISCOVERIES: LIVES THAT CREATED TODAY's MEDICINE (2004).

12 ALAN B. COHEN & RUTH S. HANFT, TECHNOLOGY IN AMERICAN HEALTH CARE: POLICY DIRECTIONS FOR EFFECTIVE EVALUATION AND MANAGEMENT (2004); PROGRESS IN DRUG RESEARCH (Ernst Jucker ed., 2002); ELAINE WHITMORE, DEVELOPMENT OF FDA-REGULATED MEDICAL PRODUCTS: PRESCRIPTION DRUGS, BIOLOGICS AND MEDICAL DEVICES (2004).

13 MEDICAL TECHNOLOGY: THE CULPRIT BEHIND HEALTH CARE COSTS? PROCEEDINGS OF THE 1977 SUN VALLEY FORUM ON NATIONAL HEALTH (Stuart H. Altman & Robert Blendon eds., 1977); LOUISE B. RUSSELL, TECHNOLOGY IN HOSPITALS: MEDICAL ADVANCES AND THEIR DIFFUSION (1979).

14 See Brooks, Harvey & Bowers, Raymond, The Assessment of Technology, 222 SCI. AM. 13, 14 (1970).CrossRefGoogle Scholar

15 Technology Assessment Act of 1972, Pub. L. No. 92-484, 86. Stat.797 (codified at 2 U.S.C. §§ 471-481 (2006)).

16 OTA Publications 1972-1996, PRINCETON UNIVERSITY (Dec. 28, 1996), http://www.princeton.edu/∼ota/ns20/pubs_f.html; see, e.g., OFF. OF TECH. ASSESSMENT, S. COMM. ON HUMAN RES., NTIS order #PB83-113274, STRATEGIES FOR MEDICAL TECHNOLOGY ASSESSMENT (1982), available at http://www.princeton.edu/∼ota/disk3/1982/8227/8227.PDF; OFF. OF TECH. ASSESSMENT, S. COMM. ON HUMAN RES., NTIS #PB-286929, ASSESSING THE EFFICACY AND SAFETY OF MEDICAL TECHNOLOGIES (1978), available at http://www.princeton.edu/∼ota/disk3/1978/7805/ 7805.PDF.

17 NAT’L INFO. CTR. ON HEALTH SERVS. RES. AND HEALTH CARE TECH., HTA 101: Introduction to Health Technology Assessment, U.S. NAT’L LIBR. OF MED., http://www.nlm.nih.gov/nichsr/ hta101/ta10103.html (last updated Sept. 8, 2008).

18 Health Services Research, Health Statistics, and Health Care Technology Act of 1978, Pub. L. No. 95-623, 92 Stat. 3443 (codified as amended at Public Health Service Act § 304, 42 U.S.C. § 242b (2006)).

19 Dennis Cotter, The National Center for Health Care Technology: Lessons Learned, HEALTH AFF. BLOG (Jan. 22, 2009, 6:54 AM), http://healthaffairs.org/blog/2009/01/22/the-national-center-forhealth- care-technology-lessons-learned/.

20 NAT’L CTR. FOR TECH. ASSESSMENT, THE NATIONAL CENTER FOR HEALTH CARE TECHNOLOGY: PROCESS FOR ASSESSING TECHNOLOGIES DRAFT 6 (1981), available at http://www.mtppi.org/Document.pdf.

21 See id.

22 Eleanor D. Kinney, National Coverage Policy under the Medicare Program: Problems and Proposals for Change, 32 ST. LOUIS U. L.J. 869, 881 (1987-1988).

23 See, e.g., COMM. FOR EVALUATING MED. TECH. IN CLINICAL USE, INST. OF MED., ASSESSING MEDICAL TECHNOLOGIES (National Academy Press ed., 1985); Council on Scientific Affairs & the Council on Med. Serv., Joint Report of the Council on Scientific Affairs and the Council on Medical Service: Technology Assessment in Medicine, 152 ARCHIVES OF INTERNAL MED. 46 (1992); Ezekiel J. Emanuel, Victor R. Fuchs & Alan M. Garber, Essential Elements of a Technology and Outcomes Assessment Initiative, 298 JAMA 1323 (2007).

24 Partnership for Health Amendments of 1967, Pub. L. No. 90-174, § 304, 81 Stat. 539 (codified at 42 U.S.C. § 242b (2006)); see Flook, Evelyn, Health Services Research and Development, 84 PUB. HEALTH REP. 358, 359-60 (1969).CrossRefGoogle ScholarPubMed

25 What is HSR, ACAD. HEALTH, http://www.academyhealth.org/About/content.cfm?ItemNumber =831 (last visited Oct. 1, 2011); see Lohr, Kathleen N. & Steinwachs, Donald M., Health Services Research: An Evolving Definition of the Field, 37 HEALTH SERVS. RES. 15 (2002).Google Scholar

26 ROBERT H. BROOK ET AL., QUALITY OF MEDICAL CARE ASSESSMENT USING OUTCOME MEASURES: AN OVERVIEW OF THE METHOD (1976); Brook, Robert H. & Lohr, Kathleen N., Monitoring Quality of Care in the Medicare Program, 258 JAMA 3138 (1987)CrossRefGoogle ScholarPubMed; Ellwood, Paul M., Shattuck Lecture – Outcomes Management: A Technology of Patient Experience, 318 NEW ENG. J. MED. 1549 (1988).CrossRefGoogle ScholarPubMed

27 See, e.g., Brook, Robert H. & Lohr, Kathleen N., Efficacy, Effectiveness, Variations, and Quality: Boundary-Crossing Research, 23 MED. CARE 710, 718-19 (1985)CrossRefGoogle ScholarPubMed; Eddy, David M., Variation in Physician Practice: The Role of Uncertainty, 3 HEALTH AFF. 74, 85-86 (1984)CrossRefGoogle Scholar; Eddy, David M. & Billings, John, The Quality of Medical Evidence: Implications for Quality of Care, 7 HEALTH AFF. 19, 27 (1988).CrossRefGoogle ScholarPubMed

28 Social Security Act, 42 U.S.C. §§ 1301-1320e-2 (2006).

29 See infra notes 50-56 and accompanying text. Roper, William L. et al., Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice, 319 NEW ENG. J. MED. 1197, 1198-99 (1988);CrossRefGoogle ScholarPubMed Roper, William L. & Hackbarth, Glenn M., HCFA's Agenda for Promoting High-Quality Care, 7 HEALTH AFF. 91, 95-97 (1988).CrossRefGoogle ScholarPubMed

30 See, e.g., PAUL L. JOSKOW, CONTROLLING HOSPITAL COSTS: THE ROLE OF GOVERNMENT REGULATION (1981); Martin S. Feldstein, Hospital Cost Inflation: A Study of Nonprofit Price Dynamics, 61(5) AM. ECON. REV. 853, 870 (1971).

31 See Wennberg, John E. et al., Professional Uncertainty and the Problem of Supplier-Induced Demand, 16 SOC. SCI. & MED. 811 (1982)CrossRefGoogle ScholarPubMed; Wennberg, John E. & Gittelsohn, John, Small Area Variation in Health Care Delivery, 182 SCI. 1102, 1004 (1973)Google Scholar; Wennberg, John E. & Gittelsohn, John, Variations in Medical Care Among Small Areas, 246 SCI. AM. 120, 122-23 (1982).CrossRefGoogle ScholarPubMed

32 THE DARTMOUTH ATLAS OF HEALTH CARE, http://www.dartmouthatlas.org/ (last visited Sept. 30, 2011).

33 Omnibus Budget Reconciliation Act (OBRA) of 1989, Pub. L. No. 101-239, § 6103, 103 Stat. 2189 (codified as amended Public Health Service Act § 901, 42 U.S.C. § 299 (2006)) (adding Title IX to the Public Health Service Act and 42 U.S.C. § 1142 to the Social Security Act); see generally U.S. DEP't HEALTH AND HUMAN SERVS., AGENCY FOR HEALTH CARE POL’Y AND RES., AHCPR PROGRAM NOTE: CLINICAL GUIDELINE DEVELOPMENT (1990); Gray, Bradford H., The Legislature Battle over Health Services Research, 11 HEALTH REG. 38, 39 (1992).Google Scholar

34 42 U.S.C. § 299(b) (1989).

35 Id. § 299a(a)(1-8).

36 Id. § 299a(b).

37 Id. § 299a(c).

38 Id. § 299a-1(a).

39 Id. § 299a-2.

40 Id. § 299a-2(a).

41 Id. § 299a-2(b)(2).

42 Id. § 299a-2(d).

43 Id. § 299a-2(d)(2).

44 See infra Section IV.B.

45 42 U.S.C. § 299b.

46 Id. §§ 299b-1(b), 299b-2.

47 Id. § 299b-1(a).

48 See H.R. REP. NO. 101-247, at 3 (1989), reprinted in 1989 U.S.C.C.A.N. 2101, 2104.

49 42 U.S.C. § 1320b-12.

50 Id. § 1320b-12(a)(1)(A).

51 Id. § 1320b-12(a)(1)(B).

52 Id. § 1320b-12(a)(2).

53 See John E. Wennberg, The More Things Change … : The Federal Government's Role In The Evaluative Sciences, HEALTH AFF. W3-309 (June 25, 2003), http://content.healthaffairs.org/content/ early/2003/06/25/hlthaff.w3.308.full.pdf.

54 42 U.S.C. § 1320b-12 (1989).

55 Id.

56 Clifton R. Gaus, Perspective: An Insider's Perspective on the Near-Death Experience of AHCPR, HEALTH AFF. W3-311 (June 25, 2003), http://content.healthaffairs.org/content/early/2003/ 06/25/hlthaff.w3.311.full.pdf; Bradford H. Gray, Michael K. Gusmano & Sara R. Collins, AHCPR and the Changing Politics of Health Services Research, HEALTH AFF. W3-283 (June 25, 2003), http://content.healthaffairs.org/content/early/2003/06/25/hlthaff.w3.283.full.pdf. See generally Wennberg, supra note 53.

57 See STANLEY J. BIGOS ET AL., AGENCY FOR HEALTH CARE POL’Y AND RES. PUBLICATION NO. 95-0642, CLINICAL PRACTICE GUIDELINES, ACUTE LOW BACK PROBLEMS IN ADULTS: CLINICAL PRACTICE GUIDELINE NO. 14 (1994); see also Richard A. Deyo, Back Pain Patient Outcomes Assessment Team (BOAT), AGENCY FOR HEALTHCARE QUALITY AND RES., http://www.ahcpr.gov/clinic/medtep/backpain.htm (last visited Sept. 30, 2010).

58 See Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1996: Hearings Before the Subcomm. of the House Comm. on Appropriations, 104th Cong. 170-72 (1995); Neil A. Lewis, Agency's Report Provokes a Revolt, N.Y. TIMES, Sept. 14, 1995, at A16.

59 5 U.S.C. app. §§ 1-5 (2007).

60 Sofamor Danek Group, Inc. v. Gaus, 61 F.3d 929 (D.C. Cir. 1995).

61 H.R. REP. NO. 104-209, at 103-04.

62 Health Care Research and Quality Act of 1999 § 2(a), Pub. L. No. 106-129, § 2(a), 113 Stat. 1653 (1999) (codified as amended Public Health Service Act § 901(a), 42 U.S.C. §299(a) (2010)).

63 Id. § 299(b), (b)(1).

64 Id. § 299(b)(2).

65 Id. § 299(b)(3).

66 Id. § 299(c).

67 Id. § 299a(a).

68 Id. § 299a(d).

69 Id. § 299a(e).

70 Id. §299(f).

71 Medicare Prescription Drug, Improvement, & Modernization Act of 2003, Pub. L. No. 108- 173, § 1013, 117 Stat. 2066 (2003) (codified as amended at 42 U.S.C. § 299b-7); see Steven M. Teutsch, Berger, Marc L. & Weinstein, Milton C., Comparative Effectiveness: Asking the Right Questions, Choosing the Right Method, 24 HEALTH AFF. 128, 128 (2005)Google Scholar.

72 Bunker, John P. et al., Evaluation of Medical-Technology Strategies: Effects of Coverage and Reimbursement, 306 NEW ENG. J. MED. 620, 621 (1982)CrossRefGoogle ScholarPubMed; Bunker, John P. et al., Evaluation of Medical-Technology Strategies: Proposal for an Institute for Health-Care Evaluation, 306 NEW ENG. J. MED. 687, 688 (1982)CrossRefGoogle ScholarPubMed; Greenberg, Barbara & Derzon, Robert A., Determining Health Insurance Coverage of Technology: Problems and Options, 19 MED. CARE 967 (1981)CrossRefGoogle ScholarPubMed; Iglehart, John K., The Cost and Regulation of Medical-Technology: Future Policy Directions, 55 MILBANK MEMORIAL FUND Q. HEALTH & SOC’Y 25 (1977).CrossRefGoogle ScholarPubMed

73 Kinney, supra note 22, at 869.

74 See Exclusion of Heart Transplantation Procedures From Medicare Coverage, 45 Fed. Reg. 52,296, 52,297 (Aug. 6, 1980); Casscells, Ward, Heart Transplantation: Recent Policy Developments, 315 NEW ENG. J. MED. 1365 (1986).CrossRefGoogle ScholarPubMed

75 Medicare Program; Criteria for Medicare Coverage of Heart Transplants, 52 Fed. Reg. 10,935 (Apr. 6, 1987).

76 Kinney, supra note 22, at 879–83.

77 See id. at 880.

78 See id.

79 Id. at 881.

80 No. CV-F-83-547, 1987 WL 108970, at *1 (E.D. Cal. Feb. 20, 1987).

81 See Medicare Program; Procedures for Medical Services Coverage Decisions, 52 Fed. Reg. 15,560, 15,561-63 (Apr. 29, 1987) (request for comments).

82 Medicare Program: Criteria and Procedures for Making Medical Services Coverage Decisions that Relate to Health Care Technology, 54 Fed. Reg. 4302 (proposed Jan. 30, 1989) (to be codified at 42 C.F.R. pts. 400 and 405); see also Medicare Program: Procedures for Medical Services Coverage Decisions, 52 Fed. Reg. 15,560 (Apr. 29, 1987) (request for comments).

83 See Darrel J. Grinstead, Evolution of the Medicare Coverage Policy-Making Process, in GUIDE TO MEDICARE COVERAGE DECISION-MAKING AND APPEALS 1, 9-13 (Eleanor D. Kinney ed., 2002).

84 42 U.S.C. § 1395y(a)(1)(A) (2006).

85 See Bradley Merrill Thompson & Brian A. Dahl, The Food and Drug Administration Review Process for Medical Devices, in GUIDE TO MEDICARE COVERAGE DECISION-MAKING AND APPEALS, supra note 83, at 41.

86 Tunis, Sean R., Why Medicare Has Not Established Criteria for Coverage Decisions, 350 NEW ENG. J. MED. 2196 (2004).CrossRefGoogle Scholar

87 Medicare Provisions in the President's Budget: Hearing Before the Health Subcomm. of the H. Comm. on Ways and Means, 105th Cong. 12 (1997) (statement of Hon. Bruce C. Vladeck, Administrator, Health Care Fin. Admin.); see Grinstead, supra note 83, at 14.

88 See Thompson & Dahl, supra note 85, at 41.

89 Medicare Program; Criteria and Procedures for Extending Coverage to Certain Devices and Related Services, 60 Fed. Reg. 48,417 (Sept. 19, 1995) (to be codified at 42 C.F.R. pts. 405 and 411).

90 U.S. GOV't ACCOUNTABILITY OFF., GAO-B-278940 ADVISORY COMMITTEE ACT: VIOLATION BY HEALTH CARE FINANCING ADMINISTRATION 1-2 (1998).

91 Medicare Program; Establishment of the Medicare Coverage Advisory Committee and Request for Nominations for Members, 63 Fed. Reg. 68,780 (Dec. 14, 1998) (notice). In 2007, CMS changed the name of this advisory council to MedCAC; see Renewal and Renaming of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC) and a Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 72 Fed. Reg. 3,853 (Jan. 26, 2007) (notice).

92 See Patient Appeals in Health Care: Hearing Before the Subcomm. on Health of the H. Comm. on Ways and Means, 105th Cong. 4-76 (1998); The Medicare Coverage Decisions and Beneficiary Appeals: Hearings Before the Subcomm. on Health of the H. Comm. on Ways and Means, 106th Cong. 21-128 (1999) [hereinafter Medicare Coverage Decisions].

93 Medicare Program; Procedures for Making National Coverage Decisions, 64 Fed. Reg. 22,619 (April 27, 1999) (notice), revised, Medicare Program; Revised Process for Making Medicare National Coverage Determinations, 68 Fed. Reg. 55,634 (Sept. 26, 2003).

94 Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub. L. No. 106-554, Consolidated Appropriation-FYF 2001, Appendix F, § 522(a) (2000), 114 Stat. 2763, 2763H-72–H-85 (Social Security Act § 1862(a), 42 U.S.C. § 1395y(a) (2006)).

95 42 U.S.C. § 1395y(a).

96 Id.

97 Id.

98 Id.; see U.S. DEP't OF HEALTH & HUMAN SERVS., NATIONAL COVERAGE DETERMINATIONS, REPORT SUBMITTED TO CONGRESS IN RESPONSE TO REQUIREMENTS OF SECTION 522(A) OF THE MEDICARE, MEDICAID, AND SCHIP BENEFITS IMPROVEMENT AND PROTECTION ACT (BIPA) OF 2000, P.L. 106-554 (June 2002).

99 BIPA § 552(c), 42 U.S.C. § 1314(i)(1).

100 Id. Nonvoting members include six industry representatives, six consumer representatives, and six patient advocates appointed to the committee.

101 Id. § 521, 42 U.S.C. § 1395ff(f) (2006).

102 Id. § 522(a), 42 U.S.C. § 1395ff(f) (2006).

103 See Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173 §§ 931-940A, 117 Stat. 2066 (codified as amended in scattered sections of 42 U.S.C. § 1395y (2006)).

104 Id. § 1395y.

105 Id. § 1395y(l)(1).

106 Id. (referencing 21 U.S.C. 371(h)).

107 Id. § 1395y(l)(2)(A)-(B).

108 Id. § 1395y(l)(3)(A)-(C).

109 Id. § 1395y(l)(3)(A).

110 Id. § 1395y(l)(3)(B).

111 Id. § 1395y(l)(3)(C)(i).

112 Id. § 1395y(l)(3)(C)(ii)-(iv).

113 See id. § 1395y(l)(5).

114 Id. § 1395y(l)(5)(A).

115 Id. § 1395y(l)(5)(C).

116 See Foote, Susan B., Focus on Locus: Evolution of Medicare's Local Coverage Policy, 22 HEALTH AFF., 137, 138 (2003).CrossRefGoogle ScholarPubMed

117 See U.S. GOV't ACCOUNTABILITY OFF., GAO-03-175, MEDICARE: DIVIDED AUTHORITY FOR POLICIES ON COVERAGE OF PROCEDURES AND DEVICES RESULT IN INEQUITIES 12-16 (2003), available at http://www.gpo.gov:80/fdsys/pkg/GAOREPORTS-GAO-03-175/pdf/GAOREPORTS-GAO-03- 175.pdf.

118 Id. at 4.

119 See id. at 10-12.

120 See id. at 13.

121 Medicare Program; Criteria for Making Coverage Decisions, 65 Fed. Reg. 31,124 (proposed May 16, 2000) (to be codified at 42 C.F.R. pt. 405), available at http://www.gpo.gov:80/fdsys/ pkg/FR-2000-05-16/pdf/00-12237.pdf.

122 Medicare Program; Revised Process for Making Medicare National Coverage Decisions, 68 Fed. Reg. 55,634, 55,634-35 (notice) (Sept. 26, 2003), available at http://www.gpo.gov:80/fdsys/ pkg/FR-2003-09-26/pdf/03-24361.pdf.

123 See Guidance for the Public, Industry, and CMS Staff: Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee, CTRS. FOR MEDICARE AND MEDICAID SERVS. (Dec. 12, 2006), http://www.cms.gov/medicare-coverage-database/ details/medicare-coverage-document-details.aspx?MCDId=10&McdName=Factors+CMS+Considers+ in+Referring+Topics+to+the+Medicare+Evidence+Development+%26+Coverage+Advisory+Committ ee&mcdtypename=Guidance+Documents&MCDIndexType=1&bc=BAAIAAAAAAAA&?fromdb=true.

124 Foote, Susan B., Why Medicare Cannot Promulgate a National Coverage Rule: A Case of Regula Mortis, 27 J. HEALTH POL., POL’Y & L. 707, 708 (2002).Google ScholarPubMed

125 See Alan M. Garber, Cost-Effectiveness and Evidence Evaluation as Criteria for Coverage Policy, HEALTH AFF. W4-284, W4-288 to -89 (2004), http://content.healthaffairs.org/ content/early/2004/05/19/hlthaff.w4.284.citation; Muriel R. Gillick, Medicare Coverage for Technological Innovations, 350 NEW ENG. J. MED. 719, 720 (2004); Peter J. Neumann, Why Don't Americans Use Cost-Effectiveness Analysis?, 10 AM. J. MANAGED CARE 308 (2004); Tunis, Sean R., Why Medicare Has Not Established Criteria for Coverage Decision, 350 NEW ENG. J. MED. 2196, 2197-98 (2004)CrossRefGoogle ScholarPubMed; Tunis, Sean R., Economic Analysis in Health Care Decisions, 10 AM. J. MANAGED CARE 301, 301 (2004).Google Scholar

126 See, e.g., Gold, Marthe R. et al., Medicare and Cost-Effectiveness Analysis: Time to Ask the Taxpayers, 26 HEALTH AFF. 1399, 1400-02 (2007)CrossRefGoogle ScholarPubMed; Neumann, Peter J. et al., Medicare and Cost- Effectiveness Analysis, 353 NEW ENG. J. MED. 1516, 1519-20 (2005)CrossRefGoogle ScholarPubMed; see also Fox, Jacqueline, Medicare Should, but Cannot, Consider Cost: Legal Impediments to Sound Policy, 53 BUFF. L. REV. 577, 578 (2005).Google Scholar

127 See Foote, Susan B. & Town, Robert J., Implementing Evidence-Based Medicine Through Medicare Coverage Decisions, 26 HEALTH AFF. 1634, 1635-36 (2007)CrossRefGoogle ScholarPubMed; Neumann, Peter J. et al., Medicare's National Coverage Decisions for Technologies, 1999-2007, 27 HEALTH AFF. 1620, 1621- 22 (2008);CrossRefGoogle ScholarPubMed Sean R. Tunis et al., Federal Initiatives to Support Rapid Learning About New Technologies, 26 HEALTH AFF. w140, w141-42 (2007).

128 National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development, CTRS. FOR MEDICARE AND MEDICAID SERVS. (Jul. 12, 2006), https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx? MCDId=8&McdName=National+Coverage+Determinations+with+Data+Collection+as+a+Condition+ of+Coverage%3A+Coverage+with+Evidence+Development&mcdtypename=Guidance+Documents& MCDIndexType=1&bc=BAAIAAAAAAAA&; see Tunis, Sean R. & Pearson, Steven D., Coverage Options for Promising Technologies: Medicare's Coverage with Evidence Development, 25 HEALTH AFF. 1218, 1218 (2006).CrossRefGoogle Scholar

129 See, e.g., Carino, Tanisha et al., Medicare's Coverage of Colorectal Cancer Drugs: A Case Study in Evidence Development and Policy, 25 HEALTH AFF. 1231, 1237 (2006)CrossRefGoogle ScholarPubMed; Carino, Tanisha et al., Using Clinical Trials as a Condition of Coverage: Lessons from the National Emphysema Treatment Trial, 1 CLINICAL TRIALS 108, 109 (2004)CrossRefGoogle ScholarPubMed; Lindsay, Mathew J. et al., The National Oncologic PET Registry: Expanded Medicare Coverage for PET Under Coverage with Evidence Development, 188 AM. J. ROENTGENOLOGY 1109, 1111 (2007)CrossRefGoogle ScholarPubMed; Tunis, Sean R., A Clinical Research Strategy to Support Shared Decision Making, 24 HEALTH AFF. 180, 181-82 (2005).CrossRefGoogle ScholarPubMed

130 See Editorial, Comparative Effectiveness: Its Origin, Evolution, and Influence on Health Care, 5 J. ONCOLOGY PRAC. 80, 80 (2009).CrossRefGoogle Scholar

131 See Conway, Patrick H. & Clancy, Carolyn, Charting a Path from Comparative Effectiveness Funding to Improved Patient-Centered Health Care, 303 JAMA 985, 985 (2010)CrossRefGoogle ScholarPubMed; Conway, Patrick H. & Clancy, Carolyn, Transformation of Health Care at the Front Line, 301 JAMA 763, 765 (2009)CrossRefGoogle Scholar; O’Kane, Margaret et al., Crossroads in Quality, 27 HEALTH AFF. 749, 751-55 (2008)CrossRefGoogle ScholarPubMed; J. W. Rowe et al., The Emerging Context for Advances in Comparative Effectiveness Assessment, 25 HEALTH AFF. w593, w595 (2006), http://content.healthaffairs.org/content/25/6/w593.full.pdf+html; Tunis et al., supra note 127, at w148; Gail R. Wilensky, Developing a Center for Comparative Effectiveness Information, 25 HEALTH AFF. w572, w577 (2006), http://content.healthaffairs.org/ content/25/6/w572.long.

132 See, e.g., David Atkins, Creating and Synthesizing Evidence with Decision Makers in Mind: Integrating Evidence from Clinical Trials and Other Study Designs, 45 MED. CARE S16, S17-S20 (Supp. 2007); Susan D. Horn & Julie Gassaway, Practice-Based Evidence Study Design for Comparative Effectiveness Research, 45 MED. CARE S50, S52-S55 (Supp. 2007); Kathleen N. Lohr, Emerging Methods in Comparative Effectiveness and Safety: Symposium Overview and Summary, 45 MED. CARE S5, S6-S7 (Supp. 2007); Schneeweiss, Sebastian & Avorn, Jerry, A Review of Uses of Health Care Utilization Databases for Epidemiologic Research on Therapeutics, 58 J. CLINICAL EPIDEMIOLOGY 323, 324-34 (2005)CrossRefGoogle ScholarPubMed; Brian L. Strom, Methodologic Challenges to Studying Patient Safety and Comparative Effectiveness, 45 MED. CARE S13, S13-S15 (Supp. 2007).

133 See, e.g., Kirschner, Neil et al., Information on Cost-Effectiveness: An Essential Product of a National Comparative Effectiveness Program, 148 ANNALS OF INTERNAL MED. 956 (2008)Google Scholar; Wilensky, Gail R., Cost-Effectiveness Information: Yes, It's Important, but Keep It Separate, Please!, 148 ANNALS OF INTERNAL MED. 967, 967-8 (2008).CrossRefGoogle ScholarPubMed

134 RICHARD HODES, NAT’L INST. ON AGING, ROLE OF THE NIH IN COMPARATIVE EFFECTIVENESS (2009), available at http://www.ctsaweb.org/uploadedfiles/4_CER%20Research _Hodes.pdf.

135 See, e.g., Andriole, Gerald L. et al., Mortality Results from a Randomized Prostate-Cancer Screening Trial, 360 NEW ENG. J. MED 1310 (2009)CrossRefGoogle ScholarPubMed; Bardy, Gust H. et al., Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure, 352 NEW ENG. J. MED 225 (2005)CrossRefGoogle ScholarPubMed; Lieberman, Jeffrey A. et al., Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia, 353 NEW ENG. J. MED. 1209 (2005)CrossRefGoogle ScholarPubMed; Diabetes Prevention Program Research Group, Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin, 346 NEW ENG. J. MED. 393 (2002)CrossRefGoogle Scholar; The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Officers and Coordinators for the ALLHAT Collaborative Research Group, Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic, 288 JAMA 2981 (2002).

136 See American Recovery and Reinvestment Act of 2009 (ARRA), Pub. L. No. 111-5, § 804, 123 Stat. 115, 187-88 (codified at 42 U.S.C. § 299b-8(2006)).

137 See infra notes 162-64 and accompanying text. 138 CERTs Overview: Fact Sheet, AGENCY FOR HEALTHCARE RES. AND QUALITY, http://certs.hhs.gov/about/certsovr.htm (last updated Jan. 2008).

139 Id.

140 Developing Evidence to Inform Decisions About Effectiveness: The DEcIDE Network: Request for Proposals, AGENCY FOR HEALTHCARE RES. AND QUALITY http://archive.ahrq.gov/fund/ contarchive/rfp050010.htm (last updated July 2005).

141 Evidence-based Practice Centers Overview, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, http://www.ahrq.gov/clinic/epc/ (last updated May 2011).

142 The Comparative Effectiveness Research Act of 2008, S. 3408, 110th Cong. (2008); Medicare Fair Prescription Drug Price Negotiation Act of 2007, 110th Cong. §§ 4-5 (2007); Children's Health and Medicare Protection Act of 2007, H.R. 3162, 110th Cong. § 904 (2008); Enhanced Health Care Value for All Act, H.R. 2184, 110th Cong. §§ 2-3 (2007); see U.S. CONG. BUDGET OFF., PUB. NO. 2975, RESEARCH ON THE COMPARATIVE EFFECTIVENESS OF MEDICAL TREATMENTS: ISSUES AND OPTIONS FOR AN EXPANDED FEDERAL ROLE (2007), available at http://www.cbo.gov/ ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdf; GRETCHEN A. JACOBSON, CONG. RES. SERV., RL34208, COMPARATIVE CLINICAL EFFECTIVENESS AND COST-EFFECTIVENESS RESEARCH: BACKGROUND, HISTORY, AND OVERVIEW 2-3 (2007), available at http://assets.opencrs.com/ rpts/RL34208_20071015.pdf; see also Gail R. Wilensky, The Policies and Politics of Creating a Comparative Clinical Effectiveness Research Center, 28 HEALTH AFF. w719 (2009).

143 S. 3408, supra note 142.

144 See infra Section III.D.

145 H.R. 3162, supra note 142.

146 Id.

147 H.R. 2184, supra note 142.

148 See infra Section III.D.

149 See American Recovery and Reinvestment Act of 2009 (ARRA), Pub. L. No. 111-5, § 804, 123 Stat. 115 (2009) (codified at 42 U.S.C. § 299b-8 (2009)).

150 Id. § 804(a) (codified at 42 U.S.C. § 299b-8(a)).

151 Id. § 804(b) (codified at 42 U.S.C. § 299b-8(b)).

152 Id. § 804(c)(1) (codified at 42 U.S.C. § 299b-8(c)(1)).

153 Id. § 804(c)(2) (codified at 42 U.S.C. § 299b-8(c)(2)).

154 Id. § 804(d)(1)-804(d)(2)(A) (codified at 42 U.S.C. § 299b-8(d)(2)(A)).

155 Id. § 804(d)(2)(B) (codified at 42 U.S.C. § 299b-8(d)(2)(B)).

156 Id. § 804(d)(3) (codified at 42 U.S.C. § 299b-8(d)(3)).

157 Id. § 804(e) (codified at 42 U.S.C. § 299b-8(e)); see Conway, Patrick H. & Clancy, Carolyn, Comparative-Effectiveness Research—Implications of the Federal Coordinating Council's Report, 361 NEW ENG. J. MED. 328 (2009).CrossRefGoogle ScholarPubMed

158 Id.

159 FED. COORDINATING COUNCIL FOR COMP. EFFECTIVENESS RES., U.S. DEP't OF HEALTH AND HUMAN SERVS., REPORT TO THE PRESIDENT AND CONGRESS (2009), available at http://www.hhs.gov/ recovery/programs/cer/cerannualrpt.pdf; see Conway & Clancy, supra note 157, at 328.

160 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6302, 124 Stat. 119, 747 (2010).

161 Comparative Effectiveness Research Funding, U.S. DEP't OF HEALTH AND HUMAN SERVS., http://www.hhs.gov/recovery/programs/cer/index.html (last visited Sept. 22, 2010).

162 Id.

163 Fiscal Year 2009 Budget at a Glance, AGENCY FOR HEALTHCARE RES. AND QUALITY (MAY 2009), http://www.ahrq.gov/about/fy09glance.htm.

164 Iglehart, John K., Prioritizing Comparative-Effectiveness Research—IOM Recommendations, 361 NEW ENG. J. MED. 325, 325 (2009)CrossRefGoogle ScholarPubMed; Sox, Harold C. & Greenfield, Sidney, Comparative Effectiveness Research: A Report From the Institute of Medicine, 153 ANNALS OF INTERNAL MED. 203, 203 (2009).CrossRefGoogle Scholar

165 COMM. ON COMP. EFFECTIVENESS RES. PRIORITIZATION, INST. OF MED. OF THE NAT’L ACADS., INITIAL NATIONAL PRIORITIES FOR COMPARATIVE EFFECTIVENESS RESEARCH (2009).

166 Id. at 13.

167 100 Initial Priority Topics for Comparative Effectiveness Research, INST. OF MED. OF THE NAT’L ACADS. (2009), http://www.iom.edu/∼/media/Files/Report%20Files/2009/Comparative EffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20- %20for%20web.pdf.

168 Id.

169 Highest Priority Challenge Topics (2009), NAT’L INSTS. OF HEALTH, http://grants.nih.gov/ grants/funding/challenge_award/High_Priority_Topics.pdf (last visited Sept. 22, 2011).

170 Recovery Grant Information: Supported by the American Recovery & Reinvestment Act of 2009 (ARRA), NAT’L INSTS. OF HEALTH, http://grants.nih.gov/recovery/ (last visited Sept. 22, 2010).

171 Recovery Act Limited Competition for NIH Grants: Research and Research Infrastructure “Grand Opportunities,” NAT’L INSTS. OF HEALTH, http://grants.nih.gov/grants/guide/rfa-files/ RFA-OD-09-004.html (last visited Sept. 22, 2011).

172 See Lauer, Michael S. & Collins, Francis S., Using Science to Improve the Nation's Health System: NIH's Commitment to Comparative Effectiveness Research, 303 JAMA 2182 (2010).CrossRefGoogle ScholarPubMed

173 See Science Board Meeting, U.S. FOOD AND DRUG ADMIN., Comparative Effectiveness Research Plan (Nov. 15, 2010), http://www.fda.gov/AdvisoryCommittees/Committees MeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm233252.htm.

174 Id.

175 Id.

176 See AHRQ and the Recovery Act, DEP't OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTHCARE RES. AND QUALITY, http://www.ahrq.gov/fund/cefarra.htm (last visited Sept. 30, 2011); Effective Health Care Program, What Is Comparative Effectiveness Research, DEP't OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTHCARE RES. AND QUALITY, http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/ (last visited Sept. 30, 2011).

177 Effective Health Care Program, Comparative Effectiveness Research Grant and ARRA Awards, DEP't OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTHCARE RES. AND QUALITY, http://www.effectivehealthcare.ahrq.gov/index.cfm/comparative-effectiveness-research-grant-andarra- awards/ (last visited Sept. 29, 2011). See generally Effective Health Care Program, DEP't OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTHCARE RES. AND QUALITY, http://www.effectivehealthcare.ahrq.gov/ (last visited Sept. 29, 2011).

178 DEP't OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTHCARE RESEARCH AND QUALITY: COMPARATIVE EFFECTIVENESS RESEARCH (2010), available at http://www.hhs.gov/recovery/ reports/plans/pdf20100610/AHRQ%20CER%20June%202010.pdf; see also Harold C. Sox, Comparative Effectiveness Research: A Progress Report, 153(7) ANNALS OF INTERNAL MED. 469 (2010).

179 Sarah Palin, Statement on the Current Health Reform Debate, Note on FACEBOOK (Aug. 7, 2009, 4:26 PM), http://www.facebook.com/note.php?note_id=113851103434.

180 Ezra Klein, Ezra Klein Interviews Ezekiel Emanuel on ‘Death Panels’ and D.C. Food, WASH. POST (Aug. 16, 2009), http://www.washingtonpost.com/wp-dyn/content/article/2009/08/14/ AR2009081401666.html.

181 Betsy McCaughey, Deadly Doctors, O Advisers Want to Ration Care, N.Y. POST, July 24, 2009, http://www.nypost.com/p/news/opinion/opedcolumnists/item_PU6S0iok2FbS368B7d7mAM.

182 See, e.g., Joseph Ashby, ‘Death Panel’ Is Not in the Bill … It Already Exists, THE AM. THINKER (Aug. 15, 2009), http://www.americanthinker.com/2009/08/ death_panel_is_not_in_the_bill.html.

183 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6301(a), 124 Stat. 119, 726 (2010) (amending Social Security Act §§ 1181-1183, codified at 42 U.S.C. § 1320e).

184 See id. § 1320e(b).

185 Id. § 1320e(b)(3), (d).

186 Patient Protection and Affordable Care Act § 938, 26 U.S.C. § 9511 (creation and federal funding of trust fund); see also PPACA § 4375-4377, 26 U.S.C. 4375-4377 (taxation of private health plans to support the trust fund).

187 See Clancy, Carolyn & Collins, Francis S., Patient-Centered Outcomes Research Institute: The Intersection of Science and Health Care, 2 SCI. TRANSLATIONAL MED. 37 (2010).CrossRefGoogle ScholarPubMed

188 PCORI Seeks Your Input On … Working Definition of “Patient-Centered Outcomes Research”, PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE, http://www.pcori.org/assets/ Summary-of-PCOR-Definition-Input-Opportunity-.pdf (last visited Oct. 30, 2011).

189 PCORI Seeks Your Input On … Initial Topics for PCORI's Tier 1 Pilot Projects, PATIENTCENTERED OUTCOMES RESEARCH INSTITUTE, http://www.pcori.org/assets/Pilot-Projects-Topics-Input- Opportunity-Description.pdf (last visited Oct. 30, 2011).

190 Patient Protection and Affordable Care Act § 6301(a), 42 U.S.C. § 1320e(a)(2)(A).

191 Id. § 1320e(a)(2)(B).

192 Id. § 1320e(a)(3), (4).

193 Id. § 1320e(a)(3).

194 Id. § 1320e(c).

195 Id. § 1320e(d).

196 Id. § 1320e(d)(1).

197 Id. § 1320e(d)(2).

198 Id. § 1320e(d)(6)(C)(1).

199 Id. § 1320e(d)(2)(A).

200 Id. § 1320e(d)(2)(B).

201 Id. § 1320e(d)(2)(B)(i).

202 Id. § 1320e(d)(2)(B)(ii).

203 Id. § 1320e(d)(2)(B)(ii)(IV).

204 Id. § 1320e(d)(2)(B)(iii).

205 Id. § 1320e(d)(2)(B)(iv).

206 Id. § 1320e(d)(2)(C).

207 Id. § 1320e(d)(2)(D).

208 Id.

209 Id. § 1320e(d)(2)(E).

210 Id. § 1320e(d)(3).

211 Id. § 1320e(d)(3)(A).

212 Id.

213 Id. § 1320e(d)(4)(A)(i).

214 Id. § 1320e(d)(4)(A)(ii).

215 Id.

216 Id. § 1320e(d)(4)(A)(iii).

217 Id. § 1320e(d)(4)(B).

218 Id.

219 Id. § 1320e(d)(5).

220 Id. § 1320e(d)(6)(A).

221 Id. § 1320e(d)(6)(B).

222 Id.

223 Id.

224 Id.

225 Id. § 1320e(d)(6)(C).

226 Id.

227 Id. § 1320e(d)(6)(C)(i).

228 Id.

229 Id.

230 Id.

231 Id. § 1320e(d)(6)(C)(ii).

232 Id. § 1320e(d)(6)(D).

233 Id. § 1320e(d)(6)(E).

234 Id. § 1320e(d)(7)(A).

235 Id. § 1320e(d)(7)(A)(i).

236 Id. § 1320e(d)(7)(A)(ii).

237 Id. § 1320e(d)(7)(B).

238 Id. § 1320e(d)(7)(C)(i).

239 Id. § 1320e(d)(8)(A).

240 Id. § 1320e(d)(8)(B).

241 Id. § 1320e(d)(9).

242 Id.

243 Id. § 1320e(d)(10).

244 Patient Protection and Affordable Care Act § 6301(b)(1)-(2), 42 U.S.C. § 1320e(b)(1), (2).

245 Patient Protection and Affordable Care Act § 6301(b)(3), 42 U.S.C. § 1320e(b)(3).

246 Patient Protection and Affordable Care Act § 6301(a), 42 U.S.C. § 1320e(e).

247 Id. § 1320e(e)(2).

248 Patient Protection and Affordable Care Act § 6301, 42 U.S.C. § 1320e(f)(1); see Press Release, U.S. Gov't Accountability Off., GAO Announces Appointments to New Patient-Centered Outcomes Research Institute (PCORI) Board of Governors (Sept. 23, 2010), http://www.gao.gov/ press/pcori2010sep23.html.

249 Patient Protection and Affordable Care Act § 6301, 42 U.S.C. § 1320e(d)(6)(B).

250 Id. § 1320e(f)(1)(C).

251 Id. § 1320e(f)(2).

252 Id.

253 Id.

254 Id. § 1320e(f)(3) (vacancies are filled in the same manner as the original appointment was made).

255 Id. § 1320e(f)(4).

256 Id. § 1320e(f)(6).

257 Id. § 1320e(f)(7).

258 Id. § 1320e(g)(1).

259 Id. § 1320e(g)(1)(A)(i).

260 Id. § 1320e(g)(1)(A)(ii).

261 Id. § 1320e(g)(1)(B).

262 Id. § 1320e(h).

263 Id. § 1320e(h)(1).

264 Id. § 1320e(h).

265 Id. § 1320e(h)(4).

266 Id. § 1320e(i).

267 Id. § 1320e(g) (amending Public Health Service Act § 937 (codified at 42 U.S.C. § 299)).

268 Patient Protection and Affordable Care Act § 937, 42 U.S.C. § 299b-37(a)(1).

269 Id. § 299b-37(a).

270 Id. § 299b-37(a)(1).

271 Id. § 299b-37(a)(2)(A).

272 Id. § 299b-37(a)(2)(B).

273 Id. § 299b-37(b).

274 Id. § 299b-37(c).

275 Id. § 299b-37(g).

276 Id. § 299b-37(e).

277 Id. § 299b-37(e).

278 Id. § 299b-37(f).

279 Id.

280 Id.

281 Patient Protection and Affordable Care Act § 6301, 42 U.S.C. § 1320e(j)(1).

282 Patient Protection and Affordable Care Act § 6301(c), 42 U.S.C. § 1320e-1.

283 Id. § 1320e-1(a).

284 Id. § 1320e-1(b).

285 Id. § 1320e-1(c)(1).

286 Id. § 1320e-1(c)(2).

287 Id. § 1320e-1(d)(1).

288 Id. § 1320e-1(d)(2).

289 Id. § 1320e-1(2)(A)(ii).

290 Id. § 1320e-1(e).

291 Id.

292 Patient Protection and Affordable Care Act § 6301(e)(1)(A), I.R.C. § 9511(a) (West 2010).

293 Id. § 9511(c).

294 Id. § 9511(f).

295 Id. § 9511(d)(1).

296 Id. § 9511(d)(2)(A).

297 Id. § 9511(d)(2)(b).

298 Patient Protection and Affordable Care Act § 6301(d), I.R.C. § 9511(b)(2).

299 Id. § 9511(b)(1)(D)(i), (E)(i).

300 Patient Protection and Affordable Care Act § 6301(e)(1)(A), I.R.C. § 9511(d)(b).

301 Id. § 9511 (b)(3).

302 Id. § 9511 (b)(3)(A)-(B).

303 See supra notes 56-61 and accompanying text.

304 Patient Protection and Affordable Care Act § 6301(e)(2)(A), I.R.C. §§ 4375-4377.

305 Id. §4375(a).

306 Id. §4375(b).

307 Id. §4375(c).

308 Id. §4375(d).

309 Id. §4375(e).

310 Id. §4376(a).

311 Id. §4376(b).

312 Id. §4376(c).

313 Id. §4376(d).

314 Id. §4375(e).

315 See supra notes 56-61 and accompanying text.

316 Kinney, Eleanor D., The Brave New World of Medical Standards of Care, 29 J.L. MED. & ETHICS 323, 325 (2002)Google Scholar; Kinney, Eleanor D. & Wilder, Marilyn M., Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities, 22 U.C. DAVIS L. REV. 421, 423 (1989).Google Scholar

317 See generally Kinney & Wilder, supra note 316, at 423 (explaining the change in the medical communities attitudes towards standards of care); Kinney, supra note 316, at 325 (discussing the evolution of standards of care).

318 See Chassin, Mark R., Standards of Care in Medicine, 25 INQUIRY 437, 442 (1988)Google ScholarPubMed (discussing the involvement of the American College of Physicians and the Joint American College of Cardiology/American Heart Association in creating guidelines); Linda Johnson White & Ball, John, Clinical Efficacy Assessment Project of the American College of Physicians, 1 INT’L J. TECH. ASSESSMENT IN HEALTH CARE 67 (1985)Google Scholar (explaining the American Medical Association, American Academy of Opthalmology, and American College of Cardiology's participation in developing practice parameters); Kelly, John & Swartwout, Joanna, Development of Practice Parameters by Physician Organizations, 16 QUALITY REV. BULL. 54, 54 (1990)CrossRefGoogle ScholarPubMed; Schwartz, J. Sanford, The Role of Professional Medical Societies in Reducing Practice Variations, 3 HEALTH AFF. 90, 92-96 (1984)CrossRefGoogle ScholarPubMed (discussing the American College of Physicians’ role in creating standards of care).

319 See Miriam J. Laugesen and Rice, Thomas, Is the Doctor In? The Evolving Role of Organized Medicine in Health Policy, 28 J. HEALTH POL., POL’Y AND L. 289 (2003).Google Scholar

320 See Kinney, Eleanor D., The New Medicare Coverage Decision-Making and Appeal Procedures: Can Process Meet the Challenge of New Medical Technology?, 60 WASH. & LEE L. REV. 1461, 1501-02 (2003)Google Scholar (explaining the effect of CMS regulations on medical device manufacturers and suppliers).

321 See Thompson & Dahl, supra note 85, at 41.

322 See supra notes 121-26 and accompanying text.

323 See supra notes 88-89 and accompanying text.

324 See supra notes 123-28 and accompanying text.

325 Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, Pub. L. 108-173, § 101, 117 Stat. 2066, 2071 (2003), 42 U.S.C. § 1395w-101.

326 See JENNIFER O’SULLIVAN, CONG. RES. SERV., RL 34280, MEDICARE PART D PRESCRIPTION DRUG BENEFIT: A PRIMER (2008), available at http://aging.senate.gov/crs/medicare12.pdf; see also John K. Iglehart, The New Medicare Prescription-Drug Benefit—A Pure Power Play, 350 NEW ENG. J. MED. 826 (2004).

327 Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (2006) (codified as amended 21 U.S.C. § 301 et seq.).

328 See generally Gottlieb, Scott, The FDA Should not Mandate Comparative-Effectiveness Trials, 5 HEALTH POL’Y OUTLOOK 1 (2011)Google Scholar, http://www.aei.org/docLib/HPO-2011-05-g.pdf.

329 See Adams, Christopher P. & Brantner, Van V., Estimating The Cost Of New Drug Development: Is It Really $802 Million?, 25 HEALTH AFF. 420, 420 (2006).CrossRefGoogle ScholarPubMed

330 See Berndt, Ernst R., Pharmaceuticals in U.S. Health Care: Determinants of Quantity and Price, 16 J. ECON. PERSP. 45, 59 (2002).Google Scholar

331 See Aidan Hollis, Me-Too Drugs: Is There A Problem?, World Health Organization 1, 1 (2004), http://www.who.int/intellectualproperty/topics/ip/Me-tooDrugs_Hollis1.pdf.

332 See Garber, Alan M. & Tunis, Sean R., Does Comparative-Effectiveness Research Threaten Personalized Medicine?, 360 NEW ENG. J. MED. 1925, 1925 (2009).CrossRefGoogle ScholarPubMed

333 Id. at 1927 n.1.

334 See supra Section III.F.

335 See supra notes 282-83 and accompanying text.

336 See supra note 290 and accompanying text.

337 See supra note 291 and accompanying text.

338 See supra Section III.F.

339 Patient Protection and Affordable Care Act § 1302(a).

340 Id.

341 INST. OF MED., ACTIVITY: DETERMINATION OF ESSENTIAL HEALTH BENEFITS (Jan. 19, 2011), http://www.iom.edu/Activities/HealthServices/EssentialHealthBenefits.aspx (last visited Apr. 23, 2011).

342 COMM. ON DEFINING AND REVISING AN ESSENTIAL HEALTH BENEFITS PACKAGE FOR QUALIFIED HEALTH PLANS, ESSENTIAL HEALTH BENEFITS: BALANCING COVERAGE AND COSTS (Cheryl Ulmer, John Ball, Elizabeth McGlynn, and Shadia Bel Hamdounia eds., 2011), available at http://www.nap.edu/ catalog.php?record_id=13234.

343 Id. § 1302(b)(1).

344 Id. § 1302(c).

345 Id. § 1302(d).

346 Id. § 1302(b)(4).

347 See supra notes 282-83 and accompanying text.

348 See generally Kinney, Eleanor D., Behind the Veil Where the Action Is: Private Policy Making and American Health Care, 51 ADMIN. L. REV. 145 (1999).Google Scholar

349 See generally ADVISORY COMMISSION ON CONSUMER PROTECTION AND QUALITY IN THE HEALTH CARE INDUSTRY, CONSUMER BILL OF RIGHTS AND RESPONSIBILITIES: REPORT TO THE PRESIDENT OF THE UNITED STATES (1997); Annas, George J., Patients’ Rights in Managed Care— Exit, Voice, and Choice, 337 NEW ENG. J. MED. 210 (1997)CrossRefGoogle Scholar; Zelman, Walter A., Consumer Protection in Managed Care: Finding the Balance, 16 HEALTH AFF. 158, 158 (1997)CrossRefGoogle ScholarPubMed; Rodwin, Marc A., Consumer Protection and Managed Care: Issues Reform Proposals, and Trade-Offs, 32 HOUS. L. REV. 1319 (1996)Google Scholar; David Mechanic & Mark Schlesinger, The Impact of Managed Care on Patients’ Trust in Medical Care and Their Physicians, 275 JAMA 1693 (1996); Ezekiel J. Emanuel & Nancy N. Dubler, Preserving the Physician-Patient Relationship in the Era of Managed Care, 273 JAMA 323 (1995); see also Bloche, M. Gregg, Consumer-Directed Health Care, 355 NEW ENG. J. MED. 1756, 1756 (2006).CrossRefGoogle ScholarPubMed

350 See Avorn, Jerry, Debate about Funding Comparative-Effectiveness Research, 360 NEW ENG. J. MED. 1927, 1928-29 (2009).CrossRefGoogle ScholarPubMed

351 See supra Section II.D.1.

352 See supra notes 179-82 and accompanying text.

353 See supra notes 56-61 and accompanying text.

354 PATIENT CENTERED OUTCOMES RES. INST., http://pcori.org/aboutus.html (last visited Sept. 30, 2011); U.S. GEN. ACCOUNTABILITY OFFICE, Patient Centered Outcomes Research (PCOR) Institute Governing Board (2010), http://www.gao.gov/hcac/patientcentered_outcomes.html.

355 Kinney, Eleanor D., For Profit Enterprise in Health Care: Can It Contribute to Health Reform?, 36 AM. J.L. & MED. 405 (2010).CrossRefGoogle ScholarPubMed