[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2344 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 2344

  To direct the Secretary of Defense to carry out a pilot program for 
investigational treatment of members of the Armed Forces for traumatic 
            brain injury and post-traumatic stress disorder.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 12, 2013

 Mr. Sessions (for himself and Mr. Thompson of California) introduced 
   the following bill; which was referred to the Committee on Armed 
                                Services

_______________________________________________________________________

                                 A BILL


 
  To direct the Secretary of Defense to carry out a pilot program for 
investigational treatment of members of the Armed Forces for traumatic 
            brain injury and post-traumatic stress disorder.

    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 ``TBI Treatment Act''.

SEC. 2. PILOT PROGRAM FOR INVESTIGATIONAL TREATMENT OF MEMBERS OF THE 
              ARMED FORCES FOR TRAUMATIC BRAIN INJURY AND POST-
              TRAUMATIC STRESS DISORDER.

    (a) Process.--The Secretary of Defense shall carry out a five-year 
pilot program under which the Secretary shall establish a process 
through which the Secretary shall provide payment for investigational 
treatments (including diagnostic testing) of traumatic brain injury or 
post-traumatic stress disorder received by members of the Armed Forces 
in health care facilities other than military treatment facilities. 
Such process shall provide that payment be made directly to the health 
care facility furnishing the treatment.
    (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:
            (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.
            (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.
            (3) The patient receiving the treatment must demonstrate an 
        improvement under criteria approved by the Secretary, as a 
        result of the treatment on one or more of the following:
                    (A) Standardized independent pre-treatment and 
                post-treatment neuropsychological testing.
                    (B) Accepted survey instruments including, such 
                instruments that look at quality of life.
                    (C) Neurological imaging.
                    (D) Clinical examination.
            (4) The patient receiving the treatment must be receiving 
        the treatment voluntarily and based on informed consent.
            (5) 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.
    (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.
    (d) Authority.--The Secretary shall make payments under this 
section for treatments received by members of the Armed Forces using 
the authority in subsection (c)(1) of section 1074 of title 10, United 
States Code.
    (e) Amount.--A payment under this section shall be made at the 
equivalent Centers for Medicare and Medicaid Services reimbursement 
rate in effect for appropriate treatment codes for the State or 
territory in which the treatment is received. If no such rate is in 
effect, payment shall be made on a cost-reimbursement basis, as 
determined by the Secretary, in consultation with the Secretary of 
Health and Human Services.
    (f) Data Collection and Availability.--
            (1) In general.--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.
            (2) Publication of qualified institutional review board 
        studies.--The Secretary shall ensure that an Internet website 
        of the Department of Defense includes a list of all civilian 
        institutional review board studies that have received a payment 
        under this section.
    (g) Assistance for Members To Obtain Treatment.--
            (1) Assignment to temporary duty.--The Secretary of a 
        military department may assign a member of the Armed Forces 
        under the jurisdiction of the Secretary to temporary duty or 
        allow the member a permissive temporary duty in order to permit 
        the member to receive treatment for traumatic brain injury or 
        post-traumatic stress disorder, for which payments shall be 
        made under subsection (a), at a location beyond reasonable 
        commuting distance of the permanent duty station of the member.
            (2) Per diem.--A member who is away from the permanent 
        station of the member may be paid a per diem in lieu of 
        subsistence in an amount not more than the amount to which the 
        member would be entitled if the member were performing travel 
        in connection with a temporary duty assignment.
            (3) Gift rule waiver.--The Secretary of Defense may waive 
        any rule of the Department of Defense regarding ethics or the 
        receipt of gifts with respect to any assistance provided to a 
        member of the Armed Forces for travel or per diem expenses 
        incidental to receiving treatment under this section.
    (h) Memoranda of Understanding.--The Secretary shall enter into 
memoranda of understandings with civilian institutions for the purpose 
of providing members of the Armed Forces with treatment carried out by 
civilian health care practitioners under treatment--
            (1) approved by and under the oversight of civilian 
        institutional review boards; and
            (2) that would qualify for payment under this section.
    (i) Outreach.--The Secretary of Defense shall establish a process 
to notify members of the Armed Forces of the opportunity to receive 
treatment pursuant to this section.
    (j) 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.
    (k) Termination.--The authority to make a payment under this 
section shall terminate on the date that is five years after the date 
of the enactment of this Act.
    (l) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $10,000,000 for each fiscal year 
during which the Secretary is authorized to make payments under this 
section.
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