113 S133 IS: Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2013 U.S. Senate 2013-01-24 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II 113th CONGRESS 1st Session S. 133 IN THE SENATE OF THE UNITED STATES January 24 (legislative day, January 3), 2013 Mr. Roberts (for himself, Mr. Coburn, Mr. Barrasso, Mr. Portman, Mr. Crapo, Mr. Inhofe, and Mr. Vitter) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny or delay coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in personalized medicine and differences in patient treatment response.

1.

Short title

This Act may be cited as the Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2013 or the PATIENTS Act of 2013.

2.

Prohibition on Certain Uses of Data Obtained from Comparative Effectiveness Research; Accounting for Personalized Medicine and Differences in Patient Treatment Response

(a)

In general

Notwithstanding any other provision of law, the Secretary of Health and Human Services— (1)shall not use data obtained from the conduct of comparative effectiveness 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) or authorized or appropriated under the Patient Protection and Affordable Care Act (Public Law 111–148), to deny or delay 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 (2)shall ensure that comparative effectiveness 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. (b)

Rule of construction

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.