I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘TBI Treatment Act’’. 

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1 SEC. 2. PILOT PROGRAM FOR INVESTIGATIONAL TREAT2 MENT OF MEMBERS OF THE ARMED FORCES 

3 FOR TRAUMATIC BRAIN INJURY AND POST4 TRAUMATIC STRESS DISORDER. 

5 (a) PROCESS.—The Secretary of Defense shall carry 

6 out a five-year pilot program under which the Secretary 

7 shall establish a process through which the Secretary shall 

8 provide payment for investigational treatments (including 

9 diagnostic testing) of traumatic brain injury or post-trau10 matic stress disorder received by members of the Armed 

11 Forces in health care facilities other than military treat12 ment facilities. Such process shall provide that payment 

13 be made directly to the health care facility furnishing the 

14 treatment. 

15 (b) CONDITIONS FOR APPROVAL.—The approval by 

16 the Secretary for payment for a treatment pursuant to 

17 subsection (a) shall be subject to the following conditions: 

18 (1) Any drug or device used in the treatment 

19 must be approved or cleared by the Food and Drug 

20 Administration for any purpose and its use must 

21 comply with rules of the Food and Drug Administra22 tion applicable to investigational new drugs or inves23 tigational devices. 

24 (2) The treatment must be approved by the 

25 Secretary following approval by an institutional re26 view board operating in accordance with regulations 

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1 issued by the Secretary of Health and Human Serv2 ices. 

3 (3) The patient receiving the treatment must 

4 demonstrate an improvement under criteria ap5 proved by the Secretary, as a result of the treatment 

6 on one or more of the following: 

7 (A) Standardized independent pre-treat8 ment and post-treatment neuropsychological 

9 testing. 

10 (B) Accepted survey instruments including, 

11 such instruments that look at quality of life. 

12 (C) Neurological imaging. 

13 (D) Clinical examination. 

14 (4) The patient receiving the treatment must be 

15 receiving the treatment voluntarily and based on in16 formed consent. 

17 (5) The patient receiving the treatment may not 

18 be a retired member of the Armed Forces who is en19 titled to benefits under part A, or eligible to enroll 

20 under part B, of title XVIII of the Social Security 

21 Act. 

22 (c) ADDITIONAL RESTRICTIONS AUTHORIZED.—The 

23 Secretary may establish additional restrictions or condi24 tions for reimbursement as the Secretary determines ap25 propriate to ensure the protection of human research submstockstill on DSK4VPTVN1PROD with BILLS

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1 jects, appropriate fiscal management, and the validity of 

2 the research results. 

3 (d) AUTHORITY.—The Secretary shall make pay4 ments under this section for treatments received by mem5 bers of the Armed Forces using the authority in subsection 

6 (c)(1) of section 1074 of title 10, United States Code. 

7 (e) AMOUNT.—A payment under this section shall be 

8 made at the equivalent Centers for Medicare and Medicaid 

9 Services reimbursement rate in effect for appropriate 

10 treatment codes for the State or territory in which the 

11 treatment is received. If no such rate is in effect, payment 

12 shall be made on a cost-reimbursement basis, as deter13 mined by the Secretary, in consultation with the Secretary 

14 of Health and Human Services. 

15 (f) DATA COLLECTION AND AVAILABILITY.— 

16 (1) IN GENERAL.—The Secretary shall develop 

17 and maintain a database containing data from each 

18 patient case involving the use of a treatment under 

19 this section. The Secretary shall ensure that the 

20 database preserves confidentiality and that any use 

21 of the database or disclosures of such data are lim22 ited to such use and disclosures permitted by law 

23 and applicable regulations. 

24 (2) PUBLICATION OF QUALIFIED INSTITU25 TIONAL REVIEW BOARD STUDIES.—The Secretary 

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1 shall ensure that an Internet website of the Depart2 ment of Defense includes a list of all civilian institu3 tional review board studies that have received a pay4 ment under this section. 

5 (g) ASSISTANCE FOR MEMBERS TO OBTAIN TREAT6 MENT.— 

7 (1) ASSIGNMENT TO TEMPORARY DUTY.—The 

8 Secretary of a military department may assign a 

9 member of the Armed Forces under the jurisdiction 

10 of the Secretary to temporary duty or allow the 

11 member a permissive temporary duty in order to 

12 permit the member to receive treatment for trau13 matic brain injury or post-traumatic stress disorder, 

14 for which payments shall be made under subsection 

15 (a), at a location beyond reasonable commuting dis16 tance of the permanent duty station of the member. 

17 (2) PER DIEM.—A member who is away from 

18 the permanent station of the member may be paid 

19 a per diem in lieu of subsistence in an amount not 

20 more than the amount to which the member would 

21 be entitled if the member were performing travel in 

22 connection with a temporary duty assignment. 

23 (3) GIFT RULE WAIVER.—The Secretary of De24 fense may waive any rule of the Department of De25 fense regarding ethics or the receipt of gifts with remstockstill on DSK4VPTVN1PROD with BILLS

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1 spect to any assistance provided to a member of the 

2 Armed Forces for travel or per diem expenses inci3 dental to receiving treatment under this section. 

4 (h) MEMORANDA OF UNDERSTANDING.—The Sec5 retary shall enter into memoranda of understandings with 

6 civilian institutions for the purpose of providing members 

7 of the Armed Forces with treatment carried out by civilian 

8 health care practitioners under treatment— 

9 (1) approved by and under the oversight of ci10 vilian institutional review boards; and 

11 (2) that would qualify for payment under this 

12 section. 

13 (i) OUTREACH.—The Secretary of Defense shall es14 tablish a process to notify members of the Armed Forces 

15 of the opportunity to receive treatment pursuant to this 

16 section. 

17 (j) REPORT TO CONGRESS.—Not later than 30 days 

18 after the last day of each fiscal year during which the Sec19 retary is authorized to make payments under this section, 

20 the Secretary shall submit to Congress an annual report 

21 on the implementation of this section and any available 

22 results on investigational treatment studies authorized 

23 under this section. 

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1 (k) TERMINATION.—The authority to make a pay2 ment under this section shall terminate on the date that 

3 is five years after the date of the enactment of this Act. 

4 (l) AUTHORIZATION OF APPROPRIATIONS.—There is 

5 authorized to be appropriated to carry out this section 

6 $10,000,000 for each fiscal year during which the Sec7 retary is authorized to make payments under this section. 

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