The New Era of Comparative Effectiveness: Will Public Health End up Left Behind?

Patient Protection and Affordable Care Act, Pub. L. No. 111–148, 124 Stat. 119 (2010) (hereinafter cited as PPACA).

Wachter B. , “Are We Mature Enough to Make Use of Comparative Effectiveness Research?” Wachter's World, available at <http://community.the-hospitalist.org/blogs/wachters_world/archive/2009/02/21/are-we-mature-enough-to-make-use-of-comparative-effectiveness-research.aspx> (last visited June 13, 2011).

Akhter M. N. Levinson R. A. , “Comparative Effectiveness Research and the Future Practice of Medicine,” Journal of the National Medical Association 101, no. 12 (2009): 1301–1302, at 1301.

Dentzer S. , “Comparative Effectiveness: Coherent Health Care at Last?” Health Affairs 29, no. 10 (2010): 1756.

Teutsch S. M. Fielding J. E. , “Applying Comparative Effectiveness Research to Public and Population Health Initiatives,” Health Affairs 30, no. 2 (2011): 349–355.

Saver R. , “Health Care Reform's Wild Card: The Uncertain Effectiveness of Comparative Effectiveness Research,” University of Pennsylvania Law Review 159 (forthcoming 2011)

Avorn J. Fischer M. , “‘Bench to Behavior’: Translating Comparative Effectiveness Research into Improved Clinical Practice,” Health Affairs 29, no. 10 (2010): 1891–1900.

Sox H. C. Greenfield S. , “Comparative Effectiveness Research: A Report from the Institute of Medicine,” Annals of Internal Medicine 151, no. 3 (2009): 203–205, at 204.

Federal Coordinating Council for Comparative Effectiveness Research, U.S. Department of Health and Human Services, Report to the President and the Congress (2009), at 17–21 (hereinafter cited as Federal CER Council).

See 21 C.F.R. § 312.21 (2010)

O'Connor A. B. , “Building Comparative Efficacy and Tolerability Into the FDA Approval Process,” JAMA 303, no. 10 (2010): 979–980.

Congressional Research Service, Comparative Clinical Effectiveness and Cost-Effectiveness Research: Background, History, and Overview (2007).

Id., at 5.

See Saver , supra note 6.

Institute of Medicine, Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care (Washington, D.C.: The National Academies Press, 2007): At 2 (hereinafter cited as IOM, Learning What Works Best).

See Federal CER Council, supra note 8, at 3

Congressional Budget Office, Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role (2007): At 12

Fisher E. S. , “Slowing the Growth of Health Care Costs – Lessons from Regional Variation,” New England Journal of Medicine 360, no. 9 (2009): 849–852.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provided about $15 million per year to AHRQ for research into outcomes and comparative clinical effectiveness of certain items and services. Pub. L. No. 108–173, § 1013(e), 117 Stat. 2066 (2003).

Institute of Medicine, Initial National Priorities for Comparative Effectiveness Research (Washington, D.C.: National Academies Press, 2009): At 43–51 (hereinafter cited as IOM, Initial National Priorities)

see Federal CER Council, supra note 8, at 12–13.

American Recovery and Reinvestment Act, Pub. L. No. 111–5, 123 Stat. 115 (2009).

Id. § 804.

Id. tit. VIII.

See IOM, Initial National Priorities, supra note 16.

See PPACA, supra note 1, §6301(a).

Id. § 6301(a).

Id. § 6301(e)

Nussbaum A. , “Obamacare's Cost Scalpel,” Business Week, April 5, 2010, at 64.

See Will G. F. , “Stimulus Math for the GOP,” Washington Post, January 29, 2009, at A19;

McCaughey B. , Ruin Your Health with the Obama Stimulus Plan, February 9, 2009, available at <http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aLzfDxfbwhzs>(last visited June 13, 2011);

Colliver V. , “Stimulus Prompts Talk of Health Care Rationing,” San Francisco Chronicle, February 12, 2009, at A12.

See PPACA, supra note 1, §6301(c).

Id. § 6301(c).

Id.

Id.

Id.

See Teutsch Fielding , supra note 5, at 350.

Perencevich E. N. Lautenbach E. , “Infection Prevention and Comparative Effectiveness Research,” JAMA 305, no. 14 (2011): 1482–1483, at 1482.

See Federal CER Council, supra note 8, at 3.

Gostin L. O. , “Restoring Health to Health Reform: Integrating Medicine and Public Health to Advance the Population's Wellbeing,” University of Pennsylvania Law Review 159 (forthcoming 2011).

See Teutsch Fielding , supra note 5, at 349.

Volpp K. G. Das A. , “Comparative Effectiveness – Thinking beyond Medication A Versus Medication B,” New England Journal of Medicine 361, no. 4 (2009): 331–333, at 331.

See also Hochman M. McCormick D. , “Characteristics of Published Comparative Effectiveness Studies of Medications,” JAMA 303, no. 10 (2010): 951–958.

See, e.g., 210 ILL. COMP. STAT. ANN. 83/5 (West 2011);

TENN. CODE ANN. § 68-11-269 (West 2011).

See Perencevich Lautenbach , supra note 31, at 1482.

See Givhan R. , “First Lady Michelle Obama: “Let's Move’ and Work on Childhood Obesity Problem,” Washington Post, February 10, 2010.

Kindig D. Mullahy J. , “Comparative Effectiveness – of What?: Evaluating Strategies to Improve Population Health,” JAMA 304, no. 8 (2010): 901–902.

See also Ness R. , “The Future of Epidemiology,” Academic Medicine 84, no. 11 (2009): 1631–1637, at 1634–1635 (“Scientists and physicians know remarkably little about the antecedents to childhood overweight and obesity…. Intervention studies…must be tested.”).

See “Influenza Vaccine Payment Allowances-Annual Update for 2010–2011 Season,” Medicare B Update: A Newsletter for MAC Jurisdiction 9 Providers, December, 2010, at 12, available at <http://medicare.fcso.com/publications_B/186385.pdf> (last visited June 13, 2011)

(guidance from a regional Medicare carrier to Medicare providers)

“Fluzone High-Dose Vaccine Covered Under Medicare Part B,” Drug Topics, July 20, 2010, available at <http://drugtopics.modernmedicine.com/drugtopics/Clinical+News/Fluzone-High-Dose-vaccine-covered-under-Medicare-P/Article/detail/679710> (last visited June 13, 2011).

Falsey A. R. , “Randomized, Double-Blind Controlled Phase 3 Trial Comparing the Immunogenicity of High-Dose and Standard-Dose Influenza Vaccine in Adults 65 Years of Age and Older,” Journal of Infectious Diseases 200, no. 2 (2009): 172–180.

Crawford G. B. , “Continued Debate on Comparative Effectiveness Research,” Health Affairs 29, no. 12 (2010): 2353.

Smith S. , “Comparative Effectiveness of Five Smoking Cessation Pharmacotherapies in Primary Care Clinics,” Archives of Internal Medicine 169, no. 22 (2009): 2148–2155.

Diabetes Prevention Program Research Group, “Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin,” New England Journal of Medicine 346, no. 6 (2002): 393–403.

An L. C. , “The Comparative Effectiveness of Clinic, Work-Site, Phone, and Web-Based Tobacco Treatment Programs,” Nicotine and Tobacco Research 12, no. 10 (2010): 989–996.

See Federal CER Council, supra note 8, at 10.

Symposium authors Sharona Hoffman and Andy Podgurski explore this interesting potential for CER in their intriguing discussion of how CER might be effectively used with electronic health records. They consider how integration of CER with electronic health records can enable, at the time of medical decision-making, more personalized comparisons of treatment effectiveness for different patient groups.

See Hoffman S. Podgurski A. , “Improving Health Care Outcomes through Personalized Comparisons of Treatment Effectiveness Based on Electronic Health Records,” Journal of Law, Medicine & Ethics 39, no. 3 (2011): 425–436.

See Gostin , supra note 33.

Gostin L. O. , Public Health Law: Power, Duty, Restraint, 2nd. ed. (Berkeley: University of California Press, 2008): At 493.

Id.

See PPACA, supra note 1, § 6301(a).

See Kindig Mullahy , supra note 39, at 901.

See PPACA, supra note 1, § 6301(a) (emphasis added).

Id.

Id. (emphasis added).

See Teutsch Fielding , supra note 5, at 353.

Thorpe J. H. , “Comparative Effectiveness Research and Health Reform: Implications for Public Health Policy and Practice,” Public Health Reports 125, no. 6 (2010): 909–912, at 910.

See Gostin , supra note 49, at 17.

See also Gostin L.O. , “Health of the People: The Highest Law?” Journal of Law, Medicine & Ethics 32, no. 3 (2004): 509–515, at 510 (“The field of public health would profit from a vibrant conception of ‘the common’ that sees public interests as more than the aggregation of individual interests.”).

See IOM, supra note 16, at 34–36 and table 2.1 (providing a comprehensive list of varying definitions of CER adopted by public and private entities in recent years).

Id., at 13 (emphasis added).

See Thorpe , supra note 57, at 909.

See Kindig and Mullahy, supra note 39, at 902.

See IOM Initial National Priorities, supra note 16.

For example, the IOM Report's first quartile of high priority CER topics includes a recommendation to study the comparative effectiveness of various screening, prophylaxis, and treatment interventions in eradicating MRSA in communities, institutions, and hospitals.

Id., at 107.

Kaats G. R. , “Comparative Effectiveness Research (CER): Opportunities and Challenges for the Nutritional Industry,” Journal of the American College of Nutrition 28, no. 3 (2009): 234–237.

U.S. Government Accountability Office, GAO Announces Appointments to New Patient-Centered Outcomes Research Institute Board of Governors, Press Release, September 23, 2010, available at <http://www.gao.gov/press/pcori2010sep23.html> (hereinafter cited as GAO Press Release) (last visited June 13, 2011).

The initial chair of the PCOR Institute's Board of Governors, UCLA Medical School Dean Eugene Washington, earlier in his career worked for the Centers for Disease Control and Prevention in the U.S. Public Health Service and a few other members of the initial governing board have public health training to some degree. But most members of the initial board do not have extensive public health backgrounds.

See id.

The statute requires that members on the governing board include physicians and other health care provider representatives. It also requires that the provider members include a surgeon, nurse, integrative health care practitioner, and hospital representative. PPACA further provides that the governing board should collectively have expertise in clinical health sciences research, including, among other topics, epidemiology. But the statute does not otherwise specify how many board members must have epidemiology expertise. It also does not otherwise require that board members have extensive specialty training in public health (or in any other area for that matter) or come from particular public health practice backgrounds.

See PPACA, supra note 1, § 6301(a).

See Fieldstein M. , “ObamaCare Is All About Rationing,” Wall Street Journal, August 19, 2009, at A15.

See PPACA, supra note 1, § 6301(a).

See Gostin , supra note 33.

Luce B. R. , “Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change,” Annals of Internal Medicine 151, no. 3 (2009): 206–209.

Id.

Sullivan P. Goldmann D. , “The Promise of Comparative Effectiveness Research,” JAMA 305, no. 4 (2011): 400–401.

See Perencevich and Lautenbach, supra note 31, at 1482–1483

Tunis S. R. , “Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy,” JAMA 290, no. 12 (2003): 1624–1632.

Rich E. C. , “The Policy Debate over Public Investment in Comparative Effectiveness Research,” Journal of General Internal Medicine 24, no. 6 (2009): 752–757.

See Kaats , supra note 65, at 236.

See Perencevich and Lautenbach, supra note 31, at 1482.

See Teutsch and Fielding, supra note 5, at 351.

See Gostin , supra note 33;

Teutsch and Fielding, supra note 5, at 352.

See Teutsch and Fielding, supra note 5, at 351.

See PPACA, supra note 1, § 6301(c).

See Teutsch and Fielding, supra note 5, at 353.

The House reform bill also would have established an independent CER Commission to oversee the activities of the CER program within the AHRQ. Affordable Health Care for America Act, H.R. 3962, 111th Cong. § 1401 (2009).

See PPACA, supra note 1, § 6301(a).

See GAO Press Release, supra note 66.

See, e.g., Lobel O. , “The Renew Deal: The Fall of Regulation and the Rise of Governance in Contemporary Legal Thought,” Minnesota Law Review 89 (2004): 342–470;

Hunter N. D. , “‘Public-Private’ Health Law: Multiple Directions in Public Health,” Journal of Health Care Law and Policy 10, no. 1 (2007): 89–119.

Selker H. P. Wood A. J. J. , “Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform,” New England Journal of Medicine 361, no. 27 (2009): 2595–2597, at 2596.

Rothstein M. A. , “Rethinking the Meaning of Public Health,” Journal of Law, Medicine & Ethics 30, no. 2 (2002): 144–149.

See Gostin , supra note 49, at 8–9.

See Gostin , supra note 33.

Patel K. , “Health Reform's Tortuous Route to the Patient-Centered Outcomes Research Institute,” Health Affairs 29, no. 10 (2010): 1777–1782, at 1781.

See Gostin , supra note 33.

See generally Elhauge E. , ed., The Fragmentation of U.S. Health Care: Causes and Solutions (New York: Oxford University Press, 2010).

Glasgow R. E. , “If Diabetes Is a Public Health Problem, Why Not Treat It as One? A Population-Based Approach to Chronic Illness,” Annals of Behavioral Medicine 21, no. 2 (1999): 159–170.

See Gostin , supra note 33.

Hemenway D. , “Why We Don't Spend Enough on Public Health,” New England Journal of Medicine 362, no. 18 (2010): 1657–1658, at 1657.

Schulman D. I. , “Public Health Legal Services: A New Vision,” Georgetown Journal on Poverty Law and Policy 15, no. 3 (2008): 729–779;

see Gostin , supra note 33.

See Saver R. , “In Tepid Defense of Population Health: Physicians and Antibiotic Resistance,” American Journal of Law and Medicine 34, no. 4 (2008): 431–491, at 454–461;

Sage W. M. , “Relational Duties, Regulatory Duties, and the Widening Gap between Individual Health Law and Collective Health Policy,” Georgetown Law Journal 96, no. 2 (2008): 497–522.

Rodwin M. A. , “The Politics of Evidence-Based Medicine,” Journal of Health Politics, Policy, and Law 26, no. 2 (2001): 439–446.

See Saver , supra note 6.

Id.

Indeed, according to the Federal CER Council, “The purpose of [CER] is to provide information that helps clinicians and patients choose which option best fits an individual patient's needs and preferences.”

See Federal CER Council Report, supra note 8, at 3.

See Teutsch and Fielding, supra note 5, at 350.

Indeed, Mark Miller, Executive Director of the Medicare Payment Advisory Commission, expressed his disappointment with the IOM's initial priority list because as part of the CER program's research agenda “we expected to see a lot more drug-drug, device-device medical treatment versus surgical” comparisons than some of the broader health systems questions recommended by the IOM.

Miller M. , Remarks at the Public Meeting of the Medicare Payment Advisory Commission 107 (September 17, 2009), available at <http://www.medpac.gov/transcripts/0909MedPAC.pdf> (last visited June 13, 2011) (hereinafter cited as MedPAC Meeting Remarks).

42 U.S.C. § 1395y(a)(1)(A)-(B) (2006).

See Pearson S. , “From Better Evidence to Better Care: Using Comparative Effectiveness Research to Guide Practice and Policy,” in Brookings Institution, Implementing Comparative Effectiveness Research: Priorities, Methods, and Impact (Washington, D.C.: Engelberg Center for Health Care Reform at Brookings, 2009): At 55–77.

See supra notes 25 to 29 and accompanying text.

See PPACA, supra note 1, §§ 6301(a) and (b).

Id. § 3023.

Id. § 3021(a).

See Saver , supra note 6.

See Sokolovsky J. , MedPAC Meeting Remarks, supra note 104, at 103.

Merenstein D. , “Winners and Losers,” JAMA 291, no. 1 (2004): 15–16.

Pont E. A. , “The Culture of Physician Autonomy: 1900 to the Present,” Cambridge Quarterly Healthcare Ethics 9, no. 1 (2000): 98–113.

See generally Freidson E. , Profession of Medicine: A Study of the Sociology of Applied Knowledge (Chicago: University of Chicago Press, 1972).

Reinertsen See J. L. , “Zen and the Art of Physician Autonomy Maintenance,” Annals of Internal Medicine 138, no. 12 (2003): 992–995.

Sokolovsky J. , MedPAC Meeting Remarks, supra note 104, at 100–101.

Mushlin A. I. Ghomrawi H. , “Health Care Reform and the Need for Comparative-Effectiveness Research,” New England Journal of Medicine 362 (2010): E6(1)-e(6)(3), at e(6) (1), available at <http://www.nejm.org/doi/full/10.1056/NEJMp0912651> (last visited June 23, 2011).

See Saver , supra note 98

St. Lawrence J. S. , “STD Screening, Testing, Case Reporting, and Clinical and Partner Notification Practices: A National Survey of U.S. Physicians,” American Journal of Public Health 92, no. 11 (2002): 1784–1788.

Carman K. L. , “Evidence That Consumers Are Skeptical about Evidence-Based Health Care,” Health Affairs 29, no. 7 (2010): 1400–1406.

Kravitz R. , “Beyond Gatekeeping: Enlisting Patients as Agents for Quality and Cost-Containment,” Journal of General Internal Medicine 23, no. 10 (2008): 1722–1723.