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Current US health policy and the future of person-centered care

Sandra Tanenbaum


Current US health policy is contested and consensual. This is not new to American healthcare, as the last 70 years have seen on the one hand conflict between those who would expand access to health services and those who would restrict it and, on the other, a popular pursuit of biomedical research and the interventions it spawns. During the last year, US health policy has repeated this dynamic, with multiple unsuccessful attempts to repeal the Affordable Care Act (ACA) as well as (near) unanimous passage of the 21st Century Cures Act. This paper reports on each half of the conflict-consensus dynamic and considers which, if any, aspects of these current US health policies might lead to more (or less) person-centered care. Attention will be drawn especially to access to healthcare under the ACA and the use of “real-world evidence” under the Cures Act. The former allows more Americans to receive more of the care they need. The latter challenges evidence-based medicine’s evidence hierarchy, where randomized controlled trials (RCTs) are considered superior to other ways of knowing, even for the care of individual persons. The paper describes the current discussion of what sorts of evidence are appropriate to a drug and device regulatory regime. It remarks on the claims to person-centeredness by proponents and opponents of both bills and on potential dilemmas posed when aspects of person-centeredness conflict.


Access to healthcare, Affordable Care Act (ACA), evidence-based medicine, healthcare policymaking, hierarchy of evidence, person-centered healthcare, precision medicine, randomized controlled trials, real world evidence, 21st Century Cures Act, value-base

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Garret, B. & Gangopadhyaya, A. (2016). Who Gained Health Insurance Coverage under the ACA, and Where Do They Live? Washington, D.C.: Urban Institute, December 2016. Available at: (Last accessed 23 Sept 2017).

U.S. Congressional Budget Office. (2016). Federal Subsidies for Health Insurance Coverage for People Under Age 65: 2016-2026. Washington, D.C.: CBO, March 2016. Available at: (Last accessed 23 Sept 2017).

Hartz, L. (1955). The Liberal Tradition in America.New York: Harcourt Brace.

Morone, J.A. (2003). Hellfire Nation: The Politics of Sin in American History. New Haven: Yale University Press.

National Center for Health Statistics. (2017). Health Insurance and Access to Care: Fact Sheet. February 2017. Available at: (Last accessed 3 October 2017).

Himmelstein, D.U., Thorne, D., Warren, E. & Woolhandler, S. (2009). Medical bankruptcy in the United States, 2007: results of a national study. American Journal of Medicine 122, 741-746.

Avorn, J. & Kesselheim, A.S. (2015). The 21st Century Cures Act - will it take us back in time? New England Journal of Medicine 372, 2473-2475.

Sarpatwari, A. & Kesselheim, A.S. (2015). The 21st Century Cures Act: opportunities and challenges. Clinical Pharmacology and Therapeutics 98, 575-577.

Associated Press. (2016). Sen. Warren blasts drug approval bill as “extortion.” New York Times 29 November 2016. Available at: (Last accessed 29 Nov 2016).

Zuckerman, D., Jury, N.J. & Silcox C.E. (2015). 21st Century Cures Act and similar policy efforts: at what cost? British Medical Journal 351, h6122.

n.a. (2017). Gottlieb: FDA to issue guidance on use of RWE to satisfy pre- and post-market requirements. Inside Health Policy, 21 Sept 2017. Available at: (Last accessed 21 Sept 2017).

n.a. Duke-Margolis says real-world evidence can include randomization, urges step-wise approach. Inside Health Policy, 21 Sept 2017. Available at: (Last accessed 21 Sept 2017).

Fox, D.M. (1986). Health Policies, Health Politics: The British and American Experience, 1911-1965. Princeton: Princeton University Press.

Rettig, R. (1977). Cancer Crusade: The Story of the National Cancer Act of 1971. Princeton: Princeton University Press.

Steinhauer, J. & Pear, R. (2016). Sweepting health measure, backed by Obama, passes Senate. New York Times, 7 Dec 2016. Available at: (Last accessed 8 Dec 2016).

NIH National Library of Medicine. What is precision medicine? Genetics Home Reference n.d. Available at: (Last accessed 27 Sept 2017).

Patient-Centered Outcomes Research Institute (PCORI). About our research. Available at: (Last accessed 3 Oct 2017).

Tunis, S.R., Stryer, D.B. & Clancy C.M. (2003). Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Journal of the American Medical Association 290, 1624-1632.

n.a. (2017). Gottlieb: FDA to set up patient affairs team to steer patient engagement efforts. Inside Health Policy, 13 Oct 2017. Available at: (Last accessed 16 Oct 2017).

Kaplan, S. (2016). Winners and losers of the 21st Century Cures Act. Stat, 5 Dec 2016. Available at: (Last accessed 29 Aug 2017).

Sullivan, P. (2017). CBO releases new score for Obamacare repeal bill. The Hill, 23 March 2017. Available at: (Last accessed 3 October 2017).

Greenberg, J. (2017). Paul Ryan wrong that most of the 22 million uninsured would be uninsured by choice. Politifact, 28 June 2017. Available at: (Last accessed 3 October 2017).

Pear, R., Ruiz, R.R. & Goodstein, L. (2017). Trump administration rolls back birth control mandate. New York Times, 7 Oct 2017. Available at: (Last accessed 7 Oct 2017).

Jost, T.S. & Pollack, H. (2015). Key Proposals to Strengthen the Affordable Care Act. The Century Foundation, 23 Nov 2015. Available at: (Last accessed 3 Oct 2017).



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