[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 133 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                 S. 133

 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.


_______________________________________________________________________


                   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.

    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 2013'' or the ``PATIENTS Act of 2013''.

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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