1. Short title
This Act may be cited as the “Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2015” or the “PATIENTS Act of 2015”.
Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2015
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.
2. Prohibition on Certain Uses of Data Obtained from Comparative Effectiveness Research; Accounting for Personalized Medicine and Differences in Patient Treatment Response
In general— 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, 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
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.
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.