[Congressional Record Volume 157, Number 43 (Tuesday, March 29, 2011)]
[Senate]
[Page S1935]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KYL (for himself, Mr. McConnell, Mr. Barrasso, Mr. Coburn, 
        Mr. Crapo, and Mr. Roberts):
  S. 660. 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; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. KYL. Mr. President, I ask unanimous consent that the text of the 
bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 660

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Preserving Access to 
     Targeted, Individualized, and Effective New Treatments and 
     Services (PATIENTS) Act of 2011'' or the ``PATIENTS Act of 
     2011''.

     SEC. 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.
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