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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

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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.

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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

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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.

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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

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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.

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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

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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