I 113th CONGRESS 1st Session H. R. 2344 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.

1. Short title This Act may be cited as the TBI Treatment Act . 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.