S.Amdt. 2301

1. Adds SEC. 713. PILOT PROGRAM ON INVESTIGATIONAL TREATMENT OF MEMBERS OF THE ARMED FORCES FOR TRAUMATIC BRAIN INJURY AND POST-TRAUMATIC STRESS DISORDER at the end of subtitle B of title VII

   Adds a section

   In S. 1197 · Placed on Calendar Senate

   (B) allow medical providers of the Department of Defense and the Department of Veterans Affairs to access such records in the course of providing care to members of the Armed Forces and veterans.

   Inserted: SEC. 713. PILOT PROGRAM ON INVESTIGATIONAL TREATMENT OF MEMBERS OF THE ARMED FORCES FOR TRAUMATIC BRAIN INJURY AND POST-TRAUMATIC STRESS DISORDER.

   Inserted: (a) Pilot Program Authorized.--The Secretary of Defense may carry out a 3-year pilot program under which the Secretary shall establish a process for randomized placebo-controlled clinical trials of investigational treatments (including diagnostic testing) of Traumatic Brain Injury (TBI) or Post-Traumatic Stress Disorder (PTSD) received by members of the Armed Forces in health care facilities other than military treatment facilities.

   Inserted: (b) Conditions for Approval.--The approval by the Secretary for payment for a treatment pursuant to subsection (a) shall be subject to the following conditions:

   Inserted: (1) Any drug or device used in the treatment must be approved or cleared by the Food and Drug Administration for any purpose and its use must comply with rules of the Food and Drug Administration applicable to investigational new drugs or investigational devices.

   Inserted: (2) The treatment must be approved by the Secretary following approval by an institutional review board operating in accordance with regulations issued by the Secretary of Health and Human Services.

   Inserted: (3) The patient receiving the treatment may not be a retired member of the Armed Forces who is entitled to benefits under part A, or eligible to enroll under part B, of title XVIII of the Social Security Act.

   Inserted: (c) Additional Restrictions Authorized.--The Secretary may establish additional restrictions or conditions for reimbursement as the Secretary determines appropriate to ensure the protection of human research subjects, appropriate fiscal management, and the validity of the research results.

   Inserted: (d) Data Collection and Availability.--The Secretary shall develop and maintain a database containing data from each patient case involving the use of a treatment under this section. The Secretary shall ensure that the database preserves confidentiality and that any use of the database or disclosures of such data are limited to such use and disclosures permitted by law and applicable regulations.

   Inserted: (e) Report to Congress.--Not later than 30 days after the last day of each fiscal year during which the Secretary is authorized to make payments under this section, the Secretary shall submit to Congress an annual report on the implementation of this section and any available results on investigational treatment studies authorized under this section.

   Original wording

   At the end of subtitle B of title VII, add the following:

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As printed