Sec. 801. Prohibition on certain uses of data obtained from comparative effectiveness research or from patient-centered outcomes research; accounting for personalized medicine and differences in patient treatment response

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Notwithstanding any other provision of law, the Secretary of Health and Human Services— shall not use data obtained from the conduct of comparative effectiveness research or patient-centered outcomes research, including such research that is conducted or supported using funds appropriated under the American Recovery and Reinvestment Act of 2009 ( Public Law 111–5 ), to deny coverage of an item or service under a Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))); and shall ensure that comparative effectiveness research and patient-centered outcomes research conducted or supported by the Federal Government accounts for factors contributing to differences in the treatment response and treatment preferences of patients, including patient-reported outcomes, genomics and personalized medicine, the unique needs of health disparity populations, and indirect patient benefits.

Nothing the Federal Coordinating Council for Comparative Effectiveness Research finds can be released in final form until after consultation with and approved by relevant physician specialty organizations. Nothing in this section shall be construed as affecting the authority of the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

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Pub. L. 111-5
42 USC 1320a–7b(f)

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Sec. 801

Prohibition on certain uses of data obtained from comparative effectiveness research or from patient-centered outcomes research; accounting for personalized medicine and differences in patient treatment response

Pub. L.Pub. L. 111-5

Cite42 USC 1320a–7b(f)

Cites 2Cited by 0 across 0 sources