Health care reform's wild card: The uncertain effectiveness of comparative effectiveness research

University of Pennsylvania Law Review

Volumn 159, Issue 6, 2011, Pages 2147-2207

  Saver, Richard S ^a,b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

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EID: 79960167674     PISSN: 00419907     EISSN: 19428537     Source Type: Journal    
DOI: None     Document Type: Article

References (192)

1. See, e.g., Elenora E. Connors & Lawrence O. Gostin, Health Care Reform - A Historic Moment in US Social Policy, 303 JAMA 2521, 2522 (2010) ("The United States, however, missed a unique opportunity to significantly reduce medical costs and improve quality.");
2. Douglas Holtz-Eakin & Michael J. Ramlet, Health Care Reform Is Likely to Widen Federal Budget Deficits, Not Reduce Them, 29 HEALTH AFF. 1136, 1136-40 (2010) (detailing methodological problems with government projections that found PPACA would reduce the budget deficit);
3. Jonathan Oberlander & Joseph White, Systemwide Cost Control - The Missing Link in Health Care Reform, 361 NEW ENG. J. MED. 1131, 1131-33 (2009) (emphasizing that the new law does not restrain spending);
4. Gina Kolata, Law May Do Little to Help Curb Unnecessary Care, N.Y. TIMES, Mar. 30, 2010, at D1 (concluding that the new bill does little to help reduce the "nation's chronic overuse of medical care");
5. David A. Hyman, Employment-Based Health Insurance: Is Health Reform a "Game Changer?" 16-21 (Univ. Ill. Law & Econ., Research Paper No. LE10-010, 2010), available at http://ssrn.com/abstract=1624311 (making predictions about the cost implications of the new legislation);
6. Ricardo Alonso-Zaldivar, Health Care Law's Unfinished Business: Cost Curbs, ABC NEWS, Apr. 25, 2010, http://abcnews.go.com/Business/wireStory?id= 10470267 (discussing the failure of the health care bill to control costs). Other commentators, including the former director of the White House Office of Management and Budget (OMB) and the special health policy advisor of the OMB, remain more optimistic.
7. See Peter R. Orszag & Ezekiel J. Emanuel, Health Care Reform and Cost Control, 363 NEW ENG. J. MED. 601 (2010) (responding to concerns that the new law would increase the deficit).
8. See, e.g., THE HENRY J. KAISER FAMILY FOUND., KAISER HEALTH TRACKING POLL 1-4 (2010), available at http://www.kff.org/kaiserpolls/upload/8084-F.pdf (finding forty-six percent of seniors polled had an unfavorable view of the new law and were concerned about high costs and benefit cuts that could harm quality of care);
9. Mark Trumbull, Opinion Polls: Obama's Health Care Reform Law Not a Winner So Far, CHRISTIAN SCI. MONITOR, Mar. 30, 2010, http://www.csmonitor.com/USA/ Politics/2010/0330/Opinion-polls-Obama-s-health-care-reform-law-not-a-winner-so- far (noting voters' concerns that the new law will "erode the quality of care and jack up costs").
10. See, e.g., THE COMMONWEALTH FUND COMM'N ON A HIGH PERFORMANCE HEALTH SYS., BENDING THE CURVE: OPTIONS FOR ACHIEVING SAVINGS AND IMPROVING VALUE IN U.S. HEALTH SPENDING 19-21 (2007), available at http://www.commonwealthfund.org/ Content/Publications/Fund-Reports/2007/Dec/Bending-the-Curve-Options-for- Achieving-Savings-and-Improving-Value-in-U-S-Health-Spending.aspx (projecting the benefits of a CER system);
11. Somnath Saha et al., Giving Teeth to Comparative-Effectiveness Research - The Oregon Experience, 362 NEW ENG. J. MED. e18, e18(1)-(3) (2010), http://www.nejm.org/doi/full/10.1056/NEJMp0912938 (arguing that CER can limit future health care spending by following the example of the health care policies implemented in Oregon).
12. INST. OF MED. OF THE NAT'L ACADS., LEARNING WHAT WORKS BEST: THE NATION'S NEED FOR EVIDENCE ON COMPARATIVE EFFECTIVENESS IN HEALTH CARE 2 (2007).
13. See, e.g., CONG. BUDGET OFFICE, PUB. NO. 2975, RESEARCH ON THE COMPARATIVE EFFECTIVENESS OF MEDICAL TREATMENTS: ISSUES AND OPTIONS FOR AN EXPANDED FEDERAL ROLE 12 (2007) ("[T]he apparent variation in [treatment] norms indicates that there is not sufficient evidence to determine which approach is most appropriate.");
14. FED. COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS RESEARCH, U.S. DEP'T OF HEALTH & HUMAN SERVS., REPORT TO THE PRESIDENT AND THE CONGRESS 3 (2009) [hereinafter FEDERAL CER COUNCIL REPORT] (describing some benefits to patients from CER);
15. INST. OF MED. OF THE NAT'L ACADS., INITIAL NATIONAL PRIORITIES FOR COMPARATIVE EFFECTIVENESS RESEARCH 80-84 (2009) (describing information gaps in research that CER should aim to correct);
16. Elliott S. Fisher et al., Slowing the Growth of Health Care Costs - Lessons from Regional Variation, 360 NEW ENG. J. MED. 849, 850-51 (2009) (discussing how variations in health care spending show that much care is unnecessary).
17. Harold C. Sox & Sheldon Greenfield, Comparative Effectiveness Research: A Report from the Institute of Medicine, 151 ANNALS INTERNAL MED. 203, 204 (2009).
18. Mohammad N. Akhter & Richard A. Levinson, Editorial, Comparative Effectiveness Research and the Future Practice of Medicine, 101 J. NAT'L MED. ASS'N 1301, 1301 (2009).
19. Bob Wachter, Are We Mature Enough to Make Use of Comparative Effectiveness Research?, WACHTER'S WORLD (Feb. 21, 2009, 5:48 AM), http://community.the-hospitalist.org/blogs/wachters-world/archive/2009/02/21/ are-we-mature-enough-to-make-use-of-comparative-effectiveness-research.aspx.
20. Joe Jancsurak, Ushering in an Era of "Comparative Effectiveness," MED. DESIGN (Feb. 19, 2009, 9:23 AM), http://medicaldesign. com/letters/comparative-effectiveness-0209 (internal quotation marks omitted);
21. see also Susan Dentzer, Comparative Effectiveness: Coherent Health Care at Last?, 29 HEALTH AFF. 1756, 1756 (2010) (describing comparative effectiveness research as a "turning point" for American society).
22. See, e.g., George F. Will, Op-Ed., Stimulus Math for the GOP, WASH. POST, Jan. 29, 2009, at A19 ("The CER⋯ would dramatically advance government control - and rationing - of health care⋯.");
23. see also Jerry Avorn, Debate About Funding Comparative-Effectiveness Research, 360 NEW ENG. J. MED. 1927, 1928-29 (2009) (discussing other political charges made against CER during the debate over health care reform).
24. See, e.g., Betsy McCaughey, Ruin Your Health with the Obama Stimulus Plan (Feb. 9, 2009), http://www.bloomberg.com/apps/news?pid=newsarchive&sid= aLzfDxfbwhzs (objecting to provisions that would "guide" doctors' decisions).
25. See, e.g., Victoria Colliver, Stimulus Prompts Talk of Health Care Rationing, S.F. CHRON., Feb. 12, 2009, at A12 (explaining the views of CER opponents);
26. Joseph Ashby, "Death Panel" Is Not in the Bill⋯ It Already Exists, AM. THINKER (Aug. 15, 2009), http://www.americanthinker.com/ 2009/08/death-panel-is-not-in-the-bill.html (characterizing CER as leading to "death panels");
27. Peter Ferrara, The Absolutely Worst Bill Ever, AM. SPECTATOR (Nov. 11, 2009, 6:08 AM), http://spectator.org/archives/2009/11/11/the-absolutely-worst- bill-ever (describing "death panels" as groups that "have the power to ration and deny you health care").
28. See infra Section I.C. Other proposals for administering a national CER program have included folding CER activities into existing agencies such as the National Institutes of Health or the Agency for Healthcare Research and Quality. See, e.g., CONG. BUDGET OFFICE, supra note 7, at 15-19 (suggesting organizational strategies for CER oversight); Gail R. Wilensky, Developing a Center for Comparative Effectiveness Information, 25 HEALTH AFF. 572 (2006) (describing necessary attributes for CER oversight).
29. For example, the now-defunct Agency for Health Care Policy and Research (AHCPR) issued reports in the mid-1990s questioning the efficacy of common back surgeries. A political backlash, led by surgeon groups and medical device manufacturers, resulted in considerable budget reductions for AHCPR and new limitations on the agency's authority. See MICHAEL F. CANNON, CATO INST., POLICY ANALYSIS NO. 632, A BETTER WAY TO GENERATE AND USE COMPARATIVE-EFFECTIVENESS RESEARCH 7-8 (2009) (cautioning about the dangers of politicization when a federal agency controls research).
30. See, e.g., FEDERAL CER COUNCIL REPORT, supra note 7, at 3-4 ("Patients increasingly and appropriately want to take responsibility for their care. Therefore we have a responsibility to provide comparative information to enable informed decision-making. This patient-centered, pragmatic, 'real world' research is a fundamental requirement for improving care for all Americans.");
31. INST. OF MED. OF THE NAT'L ACADS., supra note 6, at 6 ("Insurers perhaps most acutely feel the need for much more reliable, rigorous, transparent, and impartial comparative effectiveness information to make decisions in the growing marketplace of medical interventions.").
32. "Shared decisionmaking" refers to a process in which the physician and patient consider outcomes, probabilities, and the patient's value preferences to reach mutual agreement on a treatment plan. Shared decisionmaking is particularly recommended for situations of medical uncertainty, as the process in part aims to inform the patient about the limited predictive evidence and then determine how to proceed, accounting for the patient's personal value preferences. Shared decisionmaking differs from the traditional legal-bioethics model of informed consent, which has emphasized the physician's duty to disclose over joint participation in the decisionmaking. See generally Dominick L. Frosch & Robert M. Kaplan, Shared Decision Making in Clinical Medicine: Past Research and Future Directions, 17 AM. J. PREVENTIVE MED. 285, 285 (1999) (reviewing literature on shared decisionmaking and concluding that the process is "an important development in health care");
33. Stacey L. Sheridan et al., Shared Decision Making About Screening and Chemoprevention: A Suggested Approach from the U.S. Preventive Services Task Force, 26 AM. J. PREVENTIVE MED. 56, 59-60 (2004) (defining shared decisionmaking).
34. See Gail B. Agrawal, Resuscitating Professionalism: Self-Regulation in the Medical Marketplace, 66 MO. L. REV. 341, 356 (2001) ("Physicians influence or control approximately seventy-five percent of health care spending through their practice patterns.");
35. Mark A. Hall, Institutional Control of Physician Behavior: Legal Barriers to Health Care Cost Containment, 137 U. PA. L. REV. 431, 434 (1988) (estimating that individual practitioners control seventy to ninety percent of health care expenditures).
36. See, e.g., Ana I. Balsa et al., Clinical Uncertainty and Healthcare Disparities, 29 AM. J.L. & MED. 203, 205 (2003) (noting that medical practice involves a great deal of physician discretion and "[n]either insurance contracts nor ethical and legal rules do a great deal to narrow the resulting clinical discretion");
37. Clark C. Havighurst, The Professional Paradigm of Medical Care: Obstacle to Decentralization, 30 JURIMETRICS J. 415, 425 (1990) ("[P]ayers are essentially locked into underwriting all care meeting professional standards.").
38. For example, a recent study published in Health Affairs indicates that patients have difficulty understanding what "quality guidelines" and "medical evidence" mean, and that they are dubious about evidence-based information to the extent that it precludes the ability of their physicians to provide individually tailored care. Kristin L. Carman et al., Evidence That Consumers Are Skeptical About Evidence-Based Health Care, 29 HEALTH AFF. 1400 (2010). The study suggests that, notwithstanding other credible sources of information, patients will likely continue to "rely heavily on their doctors for information, interpretation, and guidance on treatment options." Id. at 1403. The authors also concluded that patients' beliefs and attitudes "are often incompatible with evidence-based approaches" to medical care, such as CER. Id. at 1405. More generally, despite the theoretical appeal of the patient-as-consumer model, patients often perform poorly as consumers.
39. See, e.g., Mark A. Hall & Carl E. Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 MICH. L. REV. 643, 644-66 (2008);
40. Carl E. Schneider & Mark A. Hall, The Patient Life: Can Consumers Direct Health Care?, 35 AM. J.L. & MED. 7, 59-65 (2009).
41. See, e.g., Valerie Weber & Maulik S. Joshi, Effecting and Leading Change in Health Care Organizations, 26 J. QUALITY IMPROVEMENT 388, 388-92 (2000) (discussing the limited success of Total Quality Management (TQM) and Quality Improvement (QI) initiatives in hospitals in the 1990s because of lack of physician participation and, at times, physician resistance to changing practice patterns).
42. CONG. BUDGET OFFICE, PUB. NO. 3185, BUDGET OPTIONS VOLUME 1: HEALTH CARE 86-87 (2008);
43. see also Mark McClellan & Joshua Benner, Comparative Effectiveness Research: Will It Bend the Health Care Cost Curve and Improve Quality? (noting that critics object that CER "evidence may be outdated by the time it is available"), in ENGELBERG CTR. FOR HEALTH CARE REFORM, BROOKINGS INST., IMPLEMENTING COMPARATIVE EFFECTIVENESS RESEARCH: PRIORITIES, METHODS, AND IMPACT 7, 9 (2009) [hereinafter BROOKINGS INST.].
44. See, e.g., Lars Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 AM. J.L. & MED. 361, 394-400 (2002) (examining intricacies of postapproval drug regulation and how physicians deviate from approved uses);
45. Amy L. Wax, Technology Assessment and the Doctor-Patient Relationship, 82 VA. L. REV. 1641, 1648-49 (1996) (noting that practitioners base their assessments of cost-benefit tradeoffs for new technologies on "intuition, prejudice, anecdote, or unsubstantiated lore").
46. See, e.g., Mark A. Hall, The Defensive Effect of Medical Practice Policies in Malpractice Litigation, 54 LAW & CONTEMP. PROBS. 119, 127 (1991) ("[M]edical science⋯ thoroughly fails to conform to the legal ideal of an established standard of care. In most instances, no such definitive standard exists.");
47. William M. Sage, Managed Care's Crimea: Medical Necessity, Therapeutic Benefit, and the Goals of Administrative Process in Health Insurance, 53 DUKE L.J. 597, 636 (2003) ("Medical liability law reflects the paradox of wanting health insurers to be objective and consistent about coverage decisions when underlying medical practice is often neither.").
48. Compare MEDICARE PAYMENT ADVISORY COMM'N, REPORT TO THE CONGRESS: REFORMING THE DELIVERY SYSTEM 107-08 (2008), available at http://www.medpac.gov/ documents/jun08-entirereport.pdf ("Because [CER] information can benefit all users and is a public good, the Commission concluded a federal role is necessary to produce the information and make it publicly available."), with CANNON, supra note 21, at 1 (conceding that comparative effectiveness information has public-good characteristics but questioning whether it should receive governmental support).
49. See INST. OF MED. OF THE NAT'L ACADS., supra note 6, at 2-3;
50. David A. Hyman, Regulating Managed Care: What's Wrong with a Patient Bill of Rights, 73 S. CAL. L. REV. 221, 233-34 (2000).
51. See generally Kristin Madison, Regulating Health Care Quality in an Information Age, 40 U.C. DAVIS L. REV. 1577 (2007) (examining the information imperfections in health care markets and how better data can improve regulation);
52. William M. Sage, Regulating Through Information: Disclosure Laws and American Health Care, 99 COLUM. L. REV. 1701 (1999) (discussing how greater availability of information can promote competition, strengthen agency relationships, improve productive efficiency, ensure accountability, and foster democratic decisionmaking).
53. The Recovery Act gave $300 million in funding to the AHRQ for CER, an amount roughly equal to the agency's entire annual budget. Robert Steinbrook, Health Care and the American Recovery and Reinvestment Act, 360 NEW ENG. J. MED. 1057, 1058 (2009). Previous legislation only modestly supported CER - for example, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provided about $15 million per year in funding to AHRQ for research into outcomes and comparative clinical effectiveness of certain health care items and services. Pub. L. No. 108-173, § 1013(e), 117 Stat. 2066, 2438-41 (codified at 42 U.S.C. § 299b-7(e) (2006));
54. INST. OF MED. OF THE NAT'L ACADS., supra note 6, at 2;
55. GRETCHEN A. JACOBSON, CONG. RESEARCH SERV., RL34208, COMPARATIVE CLINICAL EFFECTIVENESS AND COST-EFFECTIVENESS RESEARCH: BACKGROUND, HISTORY, AND OVERVIEW 24 (2007).
56. See ELIZABETH DOCTEUR & ROBERT BERENSON, URBAN INST., HOW WILL COMPARATIVE EFFECTIVENESS RESEARCH AFFECT THE QUALITY OF HEALTH CARE?: TIMELY ANALYSIS OF IMMEDIATE HEALTH POLICY ISSUES 5-6 (2010).
57. Critics have called private CER studies conducted by drug and device manufacturers biased because the studies tend to favor the sponsors' products. Also, health plans and other payers that conduct CER often do not make their studies available to the public. See MEDICARE PAYMENT ADVISORY COMM'N, supra note 33, at 116-17. They are no doubt concerned that their competitors would free-ride on their efforts. More generally, private CER efforts have suffered from weak coordination and lack of consistent research methods.
58. Steven Pearson, From Better Evidence to Better Care: Using Comparative Effectiveness Research to Guide Practice and Policy, in BROOKINGS INST., supra note 29, at 58-59.
59. FEDERAL CER COUNCIL REPORT, supra note 7, at 12-13;
60. INST. OF MED. OF THE NAT'L ACADS., supra note 7, at 43-51; Pearson, supra note 38, at 58-59.
61. E.g., AM. MED. ASS'N, H.R. 1, THE "AMERICAN RECOVERY AND REINVESTMENT ACT OF 2009": EXPLANATION OF COMPARATIVE EFFECTIVENESS RESEARCH (CER) PROVISIONS, available at http://www.ama-assn.org/ama1/pub/upload/ mm/399/arra-cer-provisions.pdf; Sox & Greenfield, supra note 11, at 203.
62. Id. § 6301(e), 26 U.S.C.A. § 9511; see also AM. ASS'N OF MED. COLLS., SUMMARY OF PATIENT-CENTERED OUTCOMES RESEARCH PROVISIONS 11 (2010) (discussing funding for the PCOR trust fund);
63. COAL. FOR HEALTH SERVS. RESEARCH, HEALTH REFORM: WHAT IT MEANS FOR HEALTH SERVICES RESEARCH 3 (2010), available at http://www.chsr.org/CHSRReformSummary. pdf (estimating $500 million in funding per year by 2013);
64. Alex Nussbaum et al., Obamacare's Cost Scalpel, BUS. WK., Apr. 5, 2010, at 64, 64 (same).
65. "Evidence-based medicine" looks to the results of clinical trials and comprehensive data analysis involving large populations of patients to guide individual treatment decisions. It favors reliance on this type of information rather than physicians' tendencies to make treatment decisions based on anecdotal reports from peers, unsyste- matic observations from isolated clinical experiences, observations during medical-education training, and other less rigorous information sources. See Evidence-Based Med. Working Grp., Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine, 268 JAMA 2420, 2420-25 (1992).
66. See FEDERAL CER COUNCIL REPORT, supra note 7, at 17-21; JACOBSON, supra note 36, at 5.
67. See Common Questions About Clinical Trials, YALE CANCER CENTER, http://www.yalecancercenter.org/trials/questions.html (last visited Mar. 15, 2011) ("Enrolling participants with similar characteristics helps to ensure that the results of the trial will be due to what is under study and not other factors.").
68. Investigational new drugs typically undergo different phases of clinical-trial testing to satisfy FDA approval criteria. Phase I studies establish levels of tolerance to determine safe dosage levels. If deemed nontoxic, a drug passes into Phase II, where it is tested to demonstrate general efficacy and relative safety. Phase III studies involve expanded controlled and uncontrolled clinical trials and more comprehensive evaluations of general efficacy and safety. See 21 C.F.R. § 312.21 (2010) (explaining the phases of an FDA investigation). However, the FDA typically does not analyze how treatments compare to each other in terms of relative effectiveness. See Alec B. O'Connor, Building Comparative Efficacy and Tolerability into the FDA Approval Process, 303 JAMA 979, 979-80 (2010) (arguing that the FDA should consider comparative effectiveness research in its approval decisions so that new but inferior treatments do not replace established treatments);
69. see also Jordan Paradise et al., Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37 J.L. MED. & ETHICS 598, 601-02 (2009) (discussing criteria the FDA typically considers during its approval process for medical devices).
70. Bryan R. Luce et al., Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change, 151 ANNALS INTERNAL MED. 206, 208 (2009) (arguing that tightly controlled studies "do not reach their potential value for health care decision making").
71. For example, a recent comparative study of resuscitation treatments found that chest compression and breathing - the traditional resuscitation technique practiced for many years - was generally no more effective than chest compression alone. See Thomas D. Rea et al., CPR with Chest Compression Alone or with Rescue Breathing, 365 NEW ENG. J. MED. 423, 432 (2010). Also, chest compression alone had better outcomes in several patient subgroups. Both treatment interventions studied involved trained dispatchers assisting bystanders, who performed the procedures. Id.
72. Barbara J. Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era, 85 NOTRE DAME L. REV. 419, 488-89 (2010) (discussing postmarket study methodologies).
73. See, e.g., Martin Feldstein, Opinion, ObamaCare Is All About Rationing, WALL ST. J., Aug. 19, 2009, at A15 (arguing that "rationing health care is central" to President Obama's strategy to reduce health care costs); see also infra Section I.F.
74. See COST-EFFECTIVENESS IN HEALTH AND MEDICINE xviii (Marthe Gold et al. eds., 1996).
75. See, e.g., Adrian F. Hernandez et al., Clinical Effectiveness of Beta-Blockers in Heart Failure, 53 J. AM. C. CARDIOLOGY 184, 189 (2009) (studying the mortality rate in patients with heart failure who subsequently took beta-blockers).
76. Alvin I. Mushlin & Hassan Ghomrawi, Health Care Reform and the Need for Comparative-Effectiveness Research, 362 NEW ENG. J. MED. e6(1), e6(1) (2010), http://www.nejm.org/doi/full/10.1056/NEJMp0912651 ("[T]here are fears that patients will be denied effective care on the basis of CER's findings.").
77. AM. MED. ASS'N, supra note 40, at 2 (emphasis added). However, not all physician groups oppose integrating cost-effectiveness analysis with CER. The American College of Physicians has advocated that any national CER program should develop cost-effectiveness information as well. See Am. Coll. of Physicians, Information on Cost-Effectiveness: An Essential Product of a National Comparative Effectiveness Program, 148 ANNALS INTERNAL MED. 956, 956 (2008) (calling for government-sponsored CER and cost-effectiveness research).
78. Under the "Least Costly Alternative" (LCA) policy, Medicare allowed its contractors, when making local coverage determinations, to limit the amount paid for comparable treatment to the lower cost alternative and to not cover the excess payment for the more expensive intervention. For the most part, Medicare contractors applied these rules to reimbursement for certain drugs and devices. See MEDICARE PAYMENT ADVISORY COMM'N, REPORT TO THE CONGRESS: ALIGNING INCENTIVES IN MEDICARE 6-7 (2010) (discussing the LCA and functional equivalence policies behind Medicare's reference pricing strategy). However, the D.C. Circuit Court of Appeals struck down Medicare's attempts to use the LCA policy to limit reimbursement of DuoNeb, an inhalation drug used in treatment of chronic obstructive pulmonary disease.
79. See CMS Instructs Contractors to Rescind All LCA Provisions in Current LCDs, HEALTH POL'Y WKLY. (AmerisourceBergen Specialty Grp., Wash., D.C.), Apr. 30, 2010, https://www.iononline.com/app/Documents/Health%20Policy%20Weekly/2010/ April%2030,%202010.pdf.
80. See Medicare Program; Criteria and Procedures for Making Medical Services Coverage Decisions that Relate to Health Care Technology, 54 Fed. Reg. 4302, 4308-09 (proposed Jan. 30, 1989) (to be codified at 42 C.F.R. pts. 400, 405) (proposing cost-effectiveness as a criterion).
81. But see Medicare Program; Procedures for Making National Coverage Decisions, 64 Fed. Reg. 22,619, 22,620 (Apr. 27, 1999) (withdrawing proposed rule).
82. See generally Jacqueline Fox, Medicare Should, But Cannot, Consider Cost: Legal Impediments to a Sound Policy, 53 BUFF. L. REV. 577, 577-78 (2005) (arguing that Congress must require Medicare to consider cost-effectiveness).
83. Paul N. Van de Water notes, As the largest U.S. purchaser and regulator of health care, Medicare exerts a major influence on the rest of the health care system⋯. Its reimbursement and coverage policies have been widely adopted by private insurers and other public programs. For example, many private insurers follow Medicare's lead in approving coverage of new medical technologies. Paul N. Van de Water, Medicare Changes Can Complement Health Reform, CTR. ON BUDGET & POL'Y PRIORITIES, 3 (July 31, 2008), http://www.cbpp.org/cms/index.cfm?fa=view&id=563.
84. Robert A. Berenson, Implementing Health Care Reform - Why Medicare Matters, 363 NEW ENG. J. MED. 101, 102 (2010) ("The [Independent Medicare Advisory B]oard's role is carefully circumscribed⋯ [and] it is expressly prohibited from recommending increasing revenues; changing benefits, including patient cost sharing; or altering program eligibility.").
85. David A. Hyman, Follow the Money: Money Matters in Health Care, Just Like in Everything Else, 36 AM. J.L. & MED. 370, 381 (2010) (observing that the Board has limited authority to make fast-track recommendations about physician payments and questioning whether the Board will be able to make significant cost-cutting recommendations without creating a crippling political backlash);
86. Timothy Stoltzfus Jost, The Independent Payment Advisory Board, 363 NEW ENG. J. MED. 103, 104-05 (2010) (noting that the Board will most likely focus on cuts to Medicare Advantage plans in the early years, not significant changes in physician reimbursement, and also observing that "[m]any questions remain about how, and indeed whether, the [Board] will work").
87. Lisa Sanders, Medicine's Progress, One Setback at a Time, N.Y. TIMES, Mar. 16, 2003, at SM29;
88. see also Jerome Groopman & Pamela Hartzband, Op-Ed., Why "Quality" Care Is Dangerous, WALL ST. J., Apr. 8, 2009, at A13 (attributing a similar quotation to Dr. David Sackett, "a pioneer of [the] 'evidence-based medicine'" movement).
89. See, e.g., Barbara J. Evans, What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?, 61 FOOD & DRUG L.J. 753, 753-55 (2006) (outlining the regulatory issues raised by the genetic variability of drug response).
90. See Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373, 447 (2002).
91. See Randall S. Stafford et al., New, But Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling, 361 NEW ENG. J. MED. 1230, 1232 (2009) ("In the absence of comparative data, drug and device labels should include a statement indicating that there is no evidence of the product's superiority to other products.").
92. The FDA device-approval process typically gathers safety and effectiveness information only for high-risk devices and produces very little data about relative effectiveness. See Hearing on Strategies to Increase Information on Comparative Clinical Effectiveness: Hearing Before the Subcomm. on Health of the H. Comm. on Ways & Means, 110th Cong. 57 (2007) (statement of Mark Miller, Executive Director, Medicare Payment Advisory Commission) (commenting that the FDA approval process does not generate comparative effectiveness evidence);
93. See Ronen Avraham, Clinical Practice Guidelines - The Warped Incentives in the US Healthcare System 32-36 (Univ. of Tex. Sch. of Law, Law & Econ. Research Paper Series, No. 181, 2010), available at http://ssrn.com/abstract= 1593133 (identifying flaws in the creation of practice guidelines).
94. See, e.g., Pierluigi Tricoci et al., Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines, 301 JAMA 831, 833-35 (2009) (finding that the American College of Cardiology and American Heart Association clinical practice guidelines show "consistent gaps in evidence about medical practices").
95. See Michael S. Lauer & Francis S. Collins, Using Science to Improve the Nation's Health System, 303 JAMA 2182, 2182 (2010) (noting that, "[t]o the surprise of many," drugs meant to treat cardiac arrhythmia led to increased rates of arrhythmic death).
96. See FEDERAL CER COUNCIL REPORT, supra note 7, at 10 ("When specific evidence is lacking, clinicians have to rely on their clinical experience⋯ [and] these decisions can result in less than optimal, and sometimes inappropriate, treatment choices."). When solid comparative effectiveness evidence is lacking, less reliable information is left to fill the void. "Unfortunately, the individual physician may be most impressed by observations made in his or her individual practice. This source of evidence is notoriously vulnerable to bias and error."
97. David M. Eddy, Variations in Physician Practice: The Role of Uncertainty, HEALTH AFF., May 1984, at 74, 81.
98. For example, in 2007, the New England Journal of Medicine published the "COURAGE" (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) study.
99. William E. Boden et al., Optimal Medical Therapy With or Without PCI for Stable Coronary Disease, 356 NEW ENG. J. MED. 1503 (2007). The research concluded that heart surgery using stents to unclog blocked arteries, a common procedure, often was not more effective than simply treating the cardiac patients with drugs alone or trying drug treatment first and moving to stents only if complications remained. Id. at 1509-11. Many expected the research's publication would lead to significantly decreased use of stents, but after a brief decline in use of the procedure, stent implants began to increase again.
100. See Keith J. Winstein, A Simple Health-Care Fix Fizzles Out, WALL ST. J., Feb. 11, 2010, at A1 (noting that stent implants "are now back at peak levels" and that such studies "have rarely altered medical practice"). Part of the resistance to change may be because physicians and hospitals receive more favorable reimbursement for performing stent implants than for initiating drug therapy alone. Also, a degree of path dependence makes physicians resistant to switching from previous practices.
101. Thom Wilder, Despite Doubts About CER's Impact, Studies Should Take Place, Researcher Says, 9 Med. Res. L. & Pol'y Rep. (BNA) No. 7, at 215-16 (Apr. 7, 2010).
102. See Jerry H. Gurwitz, Editorial, Serious Adverse Drug Effects - Seeing the Trees Through the Forest, 354 NEW ENG. J. MED. 1413, 1414 (2006).
103. See, e.g., Alan L. Hillman, Financial Incentives for Physicians in HMOs: Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743, 1746-47 (1987).
104. See, e.g., Arnold M. Epstein et al., The Effects of Physicians' Training and Personality on Test Ordering for Ambulatory Patients, 74 AM. J. PUB. HEALTH 1271, 1272 & tbl.1 (1984) (finding that physicians trained in medical schools with more academic focuses tended to order more tests than other physicians);
105. Sandra H. Johnson, Polluting Medical Judgment? False Assumptions in the Pursuit of False Claims Regarding Off-Label Prescribing, 9 MINN. J. L. SCI. & TECH. 61, 76-77 (2008) (observing that physicians' willingness to disregard evidence-based sources of information partly stems from their experiences as trainees in the hierarchical environment of residency training programs, "where the opinion of the attending physician is revered as authoritative" and, accordingly, crowds out other information sources).
106. Stephen B. Soumerai et al., Effect of Local Medical Opinion Leaders on Quality of Care for Acute Myocardial Infarction: A Randomized Controlled Trial, 279 JAMA 1358, 1362-63 (1998) ("[W]hen best practices are clearly defined⋯ local opinion leaders can accelerate adoption of effective treatments⋯.");
107. Jane M. Young et al., Role for Opinion Leaders in Promoting Evidence-Based Surgery, 138 ARCHIVES SURGERY 785, 789-91 (2003) (finding that most surgeons believe opinion leaders influence surgical practice).
108. See Ezekiel J. Emanuel & Victor R. Fuchs, The Perfect Storm of Overutilization, 299 JAMA 2789, 2790 (2008) ("Medical malpractice laws and the resultant defensive medicine also contribute to overutilization [of health care].").
109. See Alain Enthoven, What Medical Care Is and Isn't, in CLARK C. HAVIGHURST ET AL., HEALTH CARE LAW AND POLICY 135, 135-36 (2d ed. 1998)
110. (excerpting A. ENTHOVEN, HEALTH PLAN: THE ONLY PRACTICAL SOLUTION TO THE SOARING COSTS OF HEALTH CARE 1-9 (1980)).
111. See generally Michael Hochman & Danny McCormick, Characteristics of Published Comparative Effectiveness Studies of Medications, 303 JAMA 951 (2010).
112. Publication bias describes the greater likelihood that studies showing a significant positive result will receive publication opportunities (or are published at all) than equally well-conducted studies that report a negative result. This can lead to a discounting of costs and risks and an overrating of published treatments. See generally Lakshmi Sridharan & Philip Greenland, Editorial, Editorial Policies and Publication Bias: The Importance of Negative Studies, 169 ARCHIVES INTERNAL MED. 1022 (2009).
113. As Mark Miller, Executive Director of MedPAC, explained, "we expected to see a lot more drug-drug, device-device, medical treatment versus surgical" comparisons as recommended research priorities. Mark Miller, Remarks at the Public Meeting of the Medicare Payment Advisory Commission 107 (Sept. 17, 2009) [hereinafter Remarks at MedPAC Meeting], available at http://www.medpac.gov/transcripts/0909MedPAC.pdf. MedPAC Commissioner Dr. Thomas Dean expressed his surprise "at how vague or kind of non-focused some of the [IOM's priority] recommendations were," as well as his disappointment with the lack of specifics. Thomas Dean, Remarks at MedPAC Meeting, supra, at 109. He further opined, "At least from a clinical point of view, that's what we would need to make clinical decisions. From a policy point of view, maybe some of the other broader things." Id.
114. See ROBERT J. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH 211 (2d ed. 1986) ("[T]he RCT is the gold standard⋯.");
115. Noah, supra note 112, at 381 (listing RCTs as the preferred study model when health professionals are "faced with a clinical problem"). In an RCT, subjects are randomly assigned to receive one of several clinical interventions. The possible interventions include the standard of comparison or control. The control may be the leading customary treatment, a placebo, or no treatment at all. Study Design, DUKE UNIV. MED. CTR. ONLINE, http://www.mclibrary.duke.edu/subject/ebm/studies.html (last visited Mar. 15, 2011).
116. See generally Analysis of Comparative Effectiveness, RAND HEALTH COMPARE, http://www.randcompare.org/analysis-of-options/analysis-of-comparative- effectiveness (last visited Mar. 15, 2011).
117. The goal of making CER pragmatic and quickly responsive to clinicians may conflict at times with the concurrent goal of generating hard scientific data. See Eugene C. Rich, The Policy Debate over Public Investment in Comparative Effectiveness Research, 24 J. GEN. INTERNAL MED. 752, 752-53 (2009).
118. Nancy Berlinger & Anne Lederman Flamm, Define "Effective": The Curious Case of Chronic Cancer, HASTINGS CTR. REP., Nov.-Dec. 2009, at 17, 18.
119. Research Should Be Patient-Focused, Comparative Effectiveness Council Told, 3 Life Sci. L. & Indus. Rep. (BNA) 657 (2009).
120. See generally A. Laurie Shroyer et al., On-Pump Versus Off-Pump Coronary-Artery Bypass Surgery, 361 NEW ENG. J. MED. 1827 (2009).
121. Gina Kolata, Older Bypass Method Is Best, A Study Shows, N.Y. TIMES, Nov. 5, 2009, at A20.
122. See Eric David Peterson, Innovation and Comparative-Effectiveness Research in Cardiac Surgery, 361 NEW ENG. J. MED. 1897 (2009).
123. See, e.g., John D. Puskas et al., Letter to the Editor, On-Pump Versus Off-Pump CABG, 362 NEW ENG. J. MED. 851, 851 (2010) ("It is illogical to conduct a randomized trial comparing patient outcomes with alternative surgical techniques among surgical operators who have grossly asymmetric experience and expertise with the two procedures being compared. This is the 'fatal flaw' of the ROOBY trial."). On-pump surgeons in the trial were somewhat more likely to have been residents instead of attending physicians. See Shroyer et al., supra note 165, at 1836. Also, the off-pump surgeons might have lacked sufficient experience with that procedure to represent its advantages fairly, while the level of expertise of the cardiac anesthesiologist, another relevant factor in surgical success, was not reported. See Peterson, supra note 173, at 1898.
124. See Leonard A. Zwelling, Op-Ed., "Comparative Effectiveness" Research is Always Behind the Curve, WALL ST. J., Mar. 16, 2010, at A23 (arguing that CER cannot keep pace with advances in medicine as it relies on "old data" in a misguided attempt to standardize therapy and reduce costs).
125. See Susan Gilbert, The Nesting-Egg Problem: Why Comparative Effectiveness Research Is Trickier Than It Looks, HASTINGS CTR. REP., Nov.-Dec. 2009, at 11, 11-12 (discussing the tendency of CER to "open[] the door to new questions" rather than to give "definitive answers").
126. Under Medicare's RBRVS fee schedule, physicians receive higher payments for services that are considered to require greater skill and time to perform. At bottom, it remains a fee-for-service system, with physicians generally paid based on the reimbursable services that they provide, not on the quality of the outcome. See 42 U.S.C. § 1395w-4 (setting out the rules of payment for physicians' services); Thomas L. Greaney, Economic Regulation of Physicians: A Behavioral Economics Perspective, 53 ST. LOUIS U. L.J. 1189, 1201-02 (2009) (characterizing RBRVS ratemaking as "a politicized⋯ process" that results in fees that "have sent distorted economic signals to the market").
127. This effect is due to the fact that the RBRVS fee schedule, and the fee-for-service payment system generally, are ordinarily insensitive to the quality of the treatment outcome. For example, "[s]ervices that contribute greatly to high-quality care that are labor- or time-intensive and rely less on technical resources, such as patient education in self-management of chronic conditions and care coordination, tend to be undervalued and are not adequately reflected in current payment arrangements." INST OF MED. OF THE NAT'L ACADS., REWARDING PROVIDER PERFORMANCE 4 (2007).
128. The term "new governance" is intentionally used broadly here to cover different, if somewhat overlapping, schools of thought that favor breaking away from both traditional public regulation and complete deregulation. The various theories have numerous labels, including "new governance," "reflexive law," "responsible regulation," "outsourcing regulation," and "public/private." These approaches share an interest in participatory governance structures, tapping the expertise and capacity of private interests and nongovernmental actors, and horizontal rather than vertical oversight. The new governance paradigm also views regulatory power as diffused among and arising from networks of public and private actors operating together through negotiated relationships. See generally IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE (1992);
129. Jody Freeman, The Private Role in Public Governance, 75 N.Y.U. L. REV. 543 (2000) (recognizing the pervasive presence of private actors in governance);
130. Nan D. Hunter, "Public-Private" Health Law: Multiple Directions in Public Health, 10 J. HEALTH CARE L. & POL'Y 89 (2007) (exploring the development of new governance perspectives in health care law);
131. Orly Lobel, The Renew Deal: The Fall of Regulation and the Rise of Governance in Contemporary Legal Thought, 89 MINN. L. REV. 342 (2004) (summarizing theoretical insights of new governance scholars).
132. See John M. Conley & Cynthia A. Williams, Engage, Embed, and Embellish: Theory Versus Practice in the Corporate Social Responsibility Movement, 31 J. CORP. L. 1, 32-35 (2005) (summarizing critiques of new governance theories).
133. See id. at 35; Gráinne de Búrca, New Governance and Experimentalism: An Introduction, 2010 WIS. L. REV. 227, 236-37 (discussing a critique of the new governance model's ability to predict and respond to human tendencies).
134. Louise G. Trubek, New Governance Practices in US Health Care, in LAW AND NEW GOVERNANCE IN THE EU AND THE US 245, 249 (Gráinne de Búrca & Joanne Scott eds., 2006).
135. Harry P. Selker & Alastair J.J. Wood, Industry Influence on Comparative-Effectiveness Research Funded Through Health Care Reform, 361 NEW ENG. J. MED. 2595, 2596 (2009).
136. See, e.g., Josephine Johnston, Conflict of Interest in Biomedical Research (reporting the close relationship between biomedical research institutions and for-profit businesses), in FROM BIRTH TO DEATH AND BENCH TO CLINIC: THE HASTINGS CENTER BIOETHICS BRIEFING BOOK 31, 32-33 (Mary Crowley ed., 2008);
137. Gardiner Harris & Benedict Carey, Researchers Fail to Reveal Full Drug Pay, N.Y. TIMES, June 8, 2008, at A1 ("Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.");
138. Rick Weiss, "Serious Misconduct" by NIH Expert Found, WASH. POST, June 14, 2006, at A6 (reporting that a researcher traded valuable tissue specimens for money because of "lax oversight").
139. Since the Recovery Act's initial heavy funding for CER, "[a] major goal" of PIPC has been to "give industry a seat at the table" in deciding what CER studies to conduct. Alicia Mundy, Drug Makers Fight Stimulus Provision, WALL ST. J., Feb. 10, 2009, at A4;
140. see also Howard Brody, Now It's Time to Start Clearing the Land Mines.CER, HOOKED: ETHICS, MED., AND PHARMA (Mar. 23, 2010, 4:59 PM), http://brodyhooked.blogspot.com/2010/03/now-its-time-to-start-clearing-land. html ("PIPC has been waging a stealth campaign, superficially applauding CER while trying hard behind the scenes to be sure that CER never gets to grow any teeth."). PIPC indeed publicly applauded the eventual CER provisions in the final health care reform law.
141. See Press Release, P'ship to Improve Patient Care, PIPC Applauds New
142. Jonathan D. Salant & Aliza Marcus, Drugmakers Boost Lobbying To Police Drug Comparisons, BLOOMBERG (Apr. 17, 2010, 16:49 EDT), http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aHjr0BP1zvgo.
143. ELIOT FREIDSON, PROFESSION OF MEDICINE: A STUDY OF THE SOCIOLOGY OF APPLIED KNOWLEDGE 23-33, 137-57, 359-82 (Robert Bierstedt ed., 4th prtg. 1972).
144. See Barry R. Furrow, Incentivizing Medical Practice: What (If Anything) Happens to Professionalism?, 1 WIDENER L. SYMP. J. 1, 5-6 (1996) (noting tensions between independent medical professionals and health care bureaucracies); Hall, supra note 25, at 451 (describing "clinical autonomy" as the medical profession's "most sensitive nerve");
145. Edward A. Pont, The Culture of Physician Autonomy: 1900 to the Present, 9 CAMBRIDGE Q. HEALTHCARE ETHICS 98, 100 (2000) (discussing the history of physician reactions to government "encroachment[]").
146. see also Jacqueline Kosecoff et al., Effects of the National Institutes of Health Consensus Development Program on Physician Practice, 258 JAMA 2708, 2713 (1987) (noting the difficulty of convincing physicians to follow National Institutes of Health recommendations).
147. See James L. Reinertsen, Zen and the Art of Physician Autonomy Maintenance, 138 ANNALS INTERNAL MED. 992, 993-94 (2003) (detailing common arguments that physicians use to defy evidence-based guidelines and protocols). For example, the TQM initiatives introduced in medical centers in the 1990s largely floundered, due in part to clinical autonomy concerns. See Weber & Joshi, supra note 28, at 389-92. A more recent example concerns health care institutions' attempts to impose antibiotic-control policies. Although initiated for valid public-health reasons, the control programs have generated resistance because of physicians' desire to control their own work.
148. See Richard S. Saver, In Tepid Defense of Population Health: Physicians and Antibiotic Resistance, 34 AM. J.L. & MED., 431, 478-79 (2008).
149. See Marc A. Rodwin, The Politics of Evidence-Based Medicine, 26 J. HEALTH POL. POL'Y & L. 439, 440-41 (2001) (discussing shifts in power from physicians to other decisionmakers).
150. See, e.g., Muriel R. Gillick, The Technological Imperative and the Battle for the Hearts of America, 50 PERSP. BIOLOGY & MED. 276, 276 (2007) (discussing, as an example of the technological imperative, physicians' uncritical adoption of the left ventricular assist device for treatment of advanced heart failure).
151. See Arnold J. Rosoff, Policy Challenges in Modern Health Care, 26 J. LEGAL MED. 523, 525 (2005) (book review) ("[M]any of the core policy challenges facing health care today involve the interaction between individual health and public health and the inevitable tradeoffs that arise in trying to optimize health at both levels.").
152. See LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 10-11 (2d ed. 2008).
153. See, e.g., Janet S. St. Lawrence et al., STD Screening, Testing, Case Reporting, and Clinical Partner Notification Practices: A National Survey of US Physicians, 92 AM. J. PUB. HEALTH 1784, 1787 (2002) (finding low physician compliance with laws that require reporting of sexually transmitted diseases, an activity critical to population health surveillance efforts).
154. See, e.g., Donald A. Redelmeier & Amos Tversky, Discrepancy Between Medical Decisions for Individual Patients and for Groups, 322 NEW ENG. J. MED. 1162, 1163-64 (1990).
155. William Sage refers to these duties to individual patients as "relational duties," which contrast with the physician's "regulatory duties" to advance larger societal goals for the health care system. William M. Sage, Relational Duties, Regulatory Duties, and the Widening Gap Between Individual Health Law and Collective Health Policy, 96 GEO. L.J. 497, 500-01 (2008).
156. Jerome Groopman, Health Care: Who Knows "Best"?, N.Y. REV. BOOKS, Feb. 11, 2010, at 12, 13.
157. See Pauline W. Chen, A Tool to Strengthen the Doctor-Patient Relationship, HASTINGS CENTER REP., Nov.-Dec. 2009, at 15, 16-17.
158. Alan M. Garber & Sean R. Tunis, Does Comparative-Effectiveness Research Threaten Personalized Medicine?, 360 NEW ENG. J. MED. 1925, 1925 (2009).
159. See Andrew Pollack, Patient's DNA May Be Signal to Tailor Drugs, N.Y. TIMES, Dec. 30, 2008, at A1, A16 (describing problems with nonpersonalized medicine);
160. Susan Gilbert, Behind the Curtain of Personalized Medicine: The Havasupai Tribe Settlement, BIOETHICS FORUM (June 14, 2010, 1:50 PM), http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4705&blogid= 140 (discussing the need for continued improvement in personalized medicine techniques like genetic tests).
161. See Fay Rozovsky, A Risk Manager's Tour of the ARRA, AM. SOC'Y HEALTHCARE RISK MGMT. 5 (May 2009), http://www.ashrm.org/ashrm/education/development/ monographs/Mono-ARRA.pdf.
162. See, e.g., David A. Hyman, Commentary, Medical Malpractice and the Tort System: What Do We Know and What (If Anything) Should We Do About It?, 80 TEX. L. REV. 1639, 1641-45 (2002) (reporting that instead of fault, the best predictor of the size of a tort award is the severity of disability);
163. David M. Studdert et al., Claims, Errors, and Compensation Payments in Medical Malpractice Litigation, 354 NEW ENG. J. MED. 2024, 2025, 2029-31 (2006) (analyzing the costs involved with malpractice suits).
164. See Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 TEX. L. REV. 1595, 1623 (2002) ("[T]he deterrent effect occurs primarily at the institutional level. Individual providers will always lack strong tort incentives to improve care because most are sued so infrequently.").
165. See Joan Sokolovsky, Remarks at MedPAC Meeting, supra note 145, at 103.
166. But see Philip G. Peters, Jr., The Role of the Jury in Modern Malpractice Law, 87 IOWA L. REV. 909, 913-917 (2002) (arguing that state courts have been retreating from the traditional rule that custom defines the medical standard of care and replacing it with a reasonable physician standard).
167. See Daniel Merenstein, Winners and Losers, 291 JAMA 15 (2004).
168. See, e.g., Darshak Sanghavi, Do We Have a Winner?: How to Reform the Broken Medical Malpractice System, SLATE, Nov. 9, 2009, http://www.slate.com/id/ 2235027.
169. See Mark A. Hall et al., Letter to the Editor, 291 JAMA 1697 (2004) (questioning the general applicability of the Merenstein case because the jury may have found against the residency program for other reasons than the adoption of evidence-based practice).
170. See, e.g., Ann G. Lawthers et al., Physicians' Perceptions of the Risk of Being Sued, 17 J. HEALTH POL. POL'Y & L. 463, 463 (1992) (finding that physicians' perception of the risk of facing a malpractice suit was three times the actual risk);
171. Am. Roentgen Ray Soc'y, Radiologists Overestimate Their Overall Risk of Malpractice Lawsuits in Breast Imaging, SCI. DAILY, Feb. 2, 2009, http://www.sciencedaily.com/releases/2009/02/090202175100.htm (reporting that radiologists perceived a thirty-five percent risk of being sued in the next five years despite the actual risk being ten percent).
172. As of 2008, Medicare covers approximately fifteen percent of United States residents. Ctrs. for Medicare & Medicaid Servs., Data Compendium, 2009 Edition, CENTERS FOR MEDICARE & MEDICAID SERVS., tbl.VII.4 (Dec. 2009), http://www.cms.gov/DataCompendium/15-2009-Data-Compendium.asp. Twenty-three percent of total national health care spending is for the Medicare program.
173. HENRY J. KAISER FAMILY FOUND., MEDICARE SPENDING AND FINANCING: FACT SHEET 1 (2010), available at http://www.kff.org/medicare/upload/7305-05.pdf.
174. See generally CTRS. FOR MEDICARE & MEDICAID SERVS., NATIONAL COVERAGE DETERMINATIONS WITH DATA COLLECTION AS A CONDITION OF COVERAGE: COVERAGE WITH EVIDENCE DEVELOPMENT (2006), available at https://www.cms.gov/medicare-coverage- database/details/medicare-coverage-document-details.aspx?MCDId=8. Conditioning payment on study participation is a particular form of CED known as "Coverage With Study Participation." Id. The CED process is, however, not without its critics.
175. See, e.g., Lars Noah, Coerced Participation in Clinical Trials: Conscripting Human Research Subjects, 62 ADMIN. L. REV. 329, 366 (2010) (concluding the Centers for Medicare and Medicaid Services' practices are "heavy-handed" and contravene federal regulations).
176. MedPAC Cites Challenges to Wide Use of Coverage with Evidence Development, 8 Med. Res. L. & Pol'y Rep. (BNA) No. 22, at 767 (Nov. 18, 2009).
177. See Peter J. Neumann et al., Medicare's National Coverage Decisions for Technologies, 1999-2007, 27 HEALTH AFF. 1620, 1623 (2008) ("CMS used its CED policy in seven decisions through 2007⋯.").
178. For the criteria for Medicare coverage, see supra notes 185-87 and accompanying text. For complaints about the limitations of CED, see Mindy Yochelson, "Coverage with Evidence Development" Falling Short, Former CMS Official Says, 9 Med. Res. L. & Pol'y Rep. (BNA) No. 6, at 174 (Mar. 17, 2010).
179. Cf. David Orentlicher, Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research, HASTINGS CTR. REP., Sept.-Oct. 2005, at 20, 20-22 (noting the need for better comparative effectiveness information and suggesting that physicians should be able to condition continued care on their patients' willingness to participate in comparative-efficacy trials).
180. Michelle M. Mello, Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. PA. L. REV. 645, 682-83 (2001).
181. See, e.g., MARK A. HALL, MAKING MEDICAL SPENDING DECISIONS: THE LAW, ETHICS, AND ECONOMICS OF RATIONING MECHANISMS 171 (1997) ("[T]here is no dispute about whether financial incentives will work⋯.");
182. cf. MARC A. RODWIN, MEDICINE, MONEY & MORALS: PHYSICIANS' CONFLICTS OF INTEREST 97-105 (1993) (discussing the possible dangers of using financial incentives to increase or decrease services);
183. Fred J. Hellinger, The Impact of Financial Incentives on Physician Behavior in Managed Care Plans: A Review of the Evidence, 53 MED. CARE RES. & REV. 294, 311 (1996) ("[F]inancial incentives are a key element in explaining the success of managed care plans in reducing the utilization of health services.").
184. See, e.g., David Orentlicher, Paying Physicians More to Do Less: Financial Incentives to Limit Care, 30 U. RICH. L. REV. 155, 174-77 (1996) (observing that the alternative of caps on specific services would restrict physicians' ability to tailor care to the needs of a given patient).
185. See generally Roberto Grilli et al., Practice Guidelines Developed by Specialty Societies: The Need for a Critical Appraisal, 355 LANCET, Jan. 8, 2000, at 103, 104-05 (evaluating existing guidelines and finding many of them lacking).
186. See Stephen R. Latham, Regulation of Managed Care Incentive Payments to Physicians, 22 AM. J.L. & MED. 399, 408 (1996) ("[W]e have good reason to hope that financial incentives will help move providers to pool their information and eliminate some⋯ overcare.").
187. Michelle M. Mello & Troyen A. Brennan, The Role of Medical Liability Reform in Federal Health Care Reform, 361 NEW ENG. J. MED. 1, 3 (2009).
188. See Stephen B. Soumerai & Jerry Avorn, Principles of Educational Outreach ("Academic Detailing") To Improve Clinical Decision Making, 263 JAMA 549 (1990).
189. See PEW PRESCRIPTION PROJECT, FACT SHEET - ACADEMIC DETAILING: EVIDENCE-BASED PRESCRIBING INFORMATION 1 (2009), available at http://www.prescriptionproject.org/tools/fact-sheets/files/0007.pdf ("[T]he approach resembles the marketing approach of drug companies, but instead⋯ present[s] balanced, evidence-based information about common prescribing choices without a sales agenda.").
190. Michael Allen et al., Family Physicians' Perceptions of Academic Detailing: A Quantitative and Qualitative Study, 7 BMC MED. EDUC., no. 36 (2007), http://www.biomedcentral.com/1472-6920/7/36 (discussing the features of academic detailing that physicians find most educational);
191. James Ducharme, Clinical Guidelines and Policies: Can They Improve Emergency Department Pain Management?, 33 J.L. MED. & ETHICS 783, 787 (2005) (concluding that outreach methods are the "most effective, albeit costly, method" of modifying physician behavior).
192. See Bronwyn Mixter, Congressional Leaders Praise AHRQ for Funding "Academic Detailing" Program, 9 Med. Res. L. & Pol'y Rep. (BNA) No. 8, at 249 (Apr. 21, 2010).