I 

111TH CONGRESS 

2D SESSION H. R. 4568 

To direct the Secretary of Defense and the Secretary of Veterans Affairs 

to carry out a pilot program under which the Secretaries make payments 

for certain treatments of traumatic brain injury and post-traumatic stress 

disorder. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 2, 2010 

Mr. SESSIONS (for himself, Mr. PASCRELL, and Mr. PLATTS) introduced the 

following bill; which was referred to the Committee on Armed Services, 

and in addition to the Committee on Veterans’ Affairs, for a period to 

be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To direct the Secretary of Defense and the Secretary of 

Veterans Affairs to carry out a pilot program under 

which the Secretaries make payments for certain treatments of 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 ON PAYMENT FOR TREATMENT OF 

2 MEMBERS OF THE ARMED FORCES AND VET3 ERANS FOR TRAUMATIC BRAIN INJURY AND 

4 POST-TRAUMATIC STRESS DISORDER. 

5 (a) PAYMENT PROCESS.—The Secretary of Defense 

6 and the Secretary of Veterans Affairs shall carry out a 

7 five-year pilot program under which each such Secretary 

8 shall establish a process through which each Secretary 

9 shall provide payment for treatments (including diagnostic 

10 testing) of traumatic brain injury or post-traumatic stress 

11 disorder received by members of the Armed Forces and 

12 veterans in health care facilities other than military treat13 ment facilities or Department of Veterans Affairs medical 

14 facilities. Such process shall provide that payment be 

15 made directly to the health care facility furnishing the 

16 treatment. 

17 (b) CONDITIONS FOR PAYMENT.—The approval by a 

18 Secretary for payment for a treatment pursuant to sub19 section (a) shall be subject to the following conditions: 

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

21 must be approved or cleared by the Food and Drug 

22 Administration for any purpose. 

23 (2) The treatment or study protocol used in 

24 treating the member or veteran must have been ap25 proved by an institutional review board operating in 

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1 accordance with regulations issued by the Secretary 

2 of Health and Human Services. 

3 (3) The approved treatment or study protocol 

4 (including any patient disclosure requirements) must 

5 be used by the health care provider delivering the 

6 treatment. 

7 (4) The patient receiving the treatment or 

8 study protocol must demonstrate an improvement as 

9 a result of the treatment on one or more of the fol10 lowing: 

11 (A) Standardized independent pre-treat12 ment and post-treatment neuropsychological 

13 testing. 

14 (B) Accepted survey instruments. 

15 (C) Neurological imaging. 

16 (D) Clinical examination. 

17 (5) The patient receiving the treatment or 

18 study protocol must be receiving the treatment vol19 untarily. 

20 (c) ADDITIONAL RESTRICTIONS PROHIBITED.—Ex21 cept as provided in this subsection (b), no restriction or 

22 condition for reimbursement may be placed on any health 

23 care provider that is operating lawfully under the laws of 

24 the State in which the provider is located with respect to 

25 the receipt of payment under this Act. 

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1 (d) PAYMENT DEADLINE.—The Secretary of Defense 

2 and the Secretary of Veterans Affairs shall make a pay3 ment for a treatment or study protocol pursuant to sub4 section (a) not later than 30 days after a member of the 

5 Armed Forces or veteran (or health care provider on be6 half of such member or veteran) submits to the Secretary 

7 documentation regarding the treatment or study protocol. 

8 The Secretary of Defense and the Secretary of Veterans 

9 Affairs shall ensure that the documentation required 

10 under this subsection may not be an undue burden on the 

11 member of the Armed Forces or veteran or on the health 

12 care provider. 

13 (e) PAYMENT SOURCE.—Subsection (c)(1) of section 

14 1074 of title 10, United States Code, shall apply with re15 spect to the payment by the Secretary of Defense for 

16 treatment or study protocols pursuant to subsection (a) 

17 of traumatic brain injury and post-traumatic stress dis18 order received by members of the Armed Forces. 

19 (f) PAYMENT AMOUNT.—A payment under this Act 

20 shall be made at the equivalent Centers for Medicare and 

21 Medicaid Services reimbursement rate in effect for appro22 priate treatment codes for the State or territory in which 

23 the treatment or study protocol is received. If no such rate 

24 is in effect, payment shall be made at a fair market rate, 

25 as determined by the Secretary of Defense, in consultation 

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1 with the Secretary of Health and Human Services, with 

2 respect to a patient who is a member of the Armed Forces 

3 or the Secretary of Veterans Affairs with respect to a pa4 tient who is a veteran. 

5 (g) DATA COLLECTION AND AVAILABILITY.— 

6 (1) IN GENERAL.—The Secretary of Defense 

7 and the Secretary of Veterans Affairs shall jointly 

8 develop and maintain a database containing data 

9 from each patient case involving the use of a treat10 ment under this section. The Secretaries shall en11 sure that the database preserves confidentiality and 

12 be made available only— 

13 (A) for third-party payer examination; 

14 (B) to the appropriate congressional com15 mittees and employees of the Department of 

16 Defense, the Department of Veterans Affairs, 

17 the Department of Health and Human Services, 

18 and appropriate State agencies; and 

19 (C) to the primary investigator of the insti20 tutional review board that approved the treat21 ment or study protocol, in the case of data re22 lating to a patient case involving the use of 

23 such treatment or study protocol. 

24 (2) ENROLLMENT IN INSTITUTIONAL REVIEW

25 BOARD STUDY.—In the case of a patient enrolled in 

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1 a registered institutional review board study, results 

2 may be publically distributable in accordance with 

3 the regulations prescribed pursuant to the Health 

4 Insurance Portability and Accountability Act of 

5 1996 (Public Law 104–191) and other regulations 

6 and practices in effect as of the date of the enact7 ment of this Act. 

8 (3) QUALIFIED INSTITUTIONAL REVIEW

9 BOARDS.—The Secretary of Defense and the Sec10 retary of Veterans Affairs shall each ensure that the 

11 Internet website of their respective departments in12 cludes a list of all civilian institutional review board 

13 studies that have received a payment under this Act. 

14 (h) ASSISTANCE FOR MEMBERS TO OBTAIN TREAT15 MENT.— 

16 (1) ASSIGNMENT TO TEMPORARY DUTY.—The 

17 Secretary of a military department may assign a 

18 member of the Armed Forces under the jurisdiction 

19 of the Secretary to temporary duty or allow the 

20 member a permissive temporary duty in order to 

21 permit the member to receive treatment or study 

22 protocol for traumatic brain injury or post-traumatic 

23 stress disorder, for which payments shall be made 

24 under subsection (a), at a location beyond reasonmstockstill on DSKH9S0YB1PROD with BILLS

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1 able commuting distance of the member’s permanent 

2 duty station. 

3 (2) PAYMENT OF PER DIEM.—A member who is 

4 away from the member’s permanent station may be 

5 paid a per diem in lieu of subsistence in an amount 

6 not more than the amount to which the member 

7 would be entitled if the member were performing 

8 travel in connection with a temporary duty assign9 ment. 

10 (3) GIFT RULE WAIVER.—Notwithstanding any 

11 rule of any department or agency with respect to 

12 ethics or the receipt of gifts, any assistance provided 

13 to a member of the Armed Forces with a service14 connected injury or disability for travel, meals, or 

15 entertainment incidental to receiving treatment or 

16 study protocol under this Act, or for the provision 

17 of such treatment or study protocol, shall not be 

18 subject to or covered by any such rule. 

19 (i) RETALIATION PROHIBITED.—No retaliation may 

20 be made against any member of the Armed Forces or vet21 eran who receives treatment or study protocol as part of 

22 registered institutional review board study carried out by 

23 a civilian health care practitioner. 

24 (j) TREATMENT OF UNIVERSITY AND NATIONALLY

25 ACCREDITED INSTITUTIONAL REVIEW BOARDS.—For 

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1 purposes of this Act, a university-affiliated or nationally 

2 accredited institutional review board shall be treated in the 

3 same manner as a Government institutional review board. 

4 (k) MEMORANDA OF UNDERSTANDING.—The Sec5 retary of Defense and the Secretary of Veterans Affairs 

6 shall seek to expeditiously enter into memoranda of under7 standings with civilian institutional review boards de8 scribed in subsection (j) for the purpose of providing for 

9 members of the Armed Forces and veterans to receive 

10 treatment carried out by civilian health care practitioners 

11 under a treatment or study protocol approved by and 

12 under the oversight of civilian institutional review boards 

13 that would qualify for payment under this Act. 

14 (l) OUTREACH REQUIRED.— 

15 (1) OUTREACH TO VETERANS.—The Secretary 

16 of Veterans Affairs shall notify each veteran with a 

17 service-connected injury or disability of the oppor18 tunity to receive treatment or study protocol pursu19 ant to this Act. 

20 (2) OUTREACH TO MEMBERS OF THE ARMED

21 FORCES.—The Secretary of Defense shall notify 

22 each member of the Armed Forces with a service23 connected injury or disability of the opportunity to 

24 receive treatment or study protocol pursuant to this 

25 Act. 

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1 (m) REPORT TO CONGRESS.—Not later than 30 days 

2 after the last day of each fiscal year during which the Sec3 retary of Defense and the Secretary of Veterans Affairs 

4 are authorized to make payments under this Act, the Sec5 retaries shall jointly submit to Congress an annual report 

6 on the implementation of this Act. Such report shall in7 clude each of the following for that fiscal year: 

8 (1) The number of individuals for whom the 

9 Secretary has provided payments under this Act. 

10 (2) The condition for which each such indi11 vidual receives treatment for which payment is pro12 vided under this Act and the success rate of each 

13 such treatment. 

14 (3) Treatment methods that are used by enti15 ties receiving payment provided under this Act and 

16 the respective rate of success of each such method. 

17 (4) The recommendations of the Secretaries 

18 with respect to the integration of treatment methods 

19 for which payment is provided under this Act into 

20 facilities of the Department of Defense and Depart21 ment of Veterans Affairs. 

22 (n) TERMINATION.—The authority to make a pay23 ment under this Act shall terminate on the date that is 

24 five years after the date of the enactment of this Act. 

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1 (o) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated to carry out this Act 

3 $10,000,000 for each fiscal year during which the Sec4 retary of Veterans Affairs and the Secretary of Defense 

5 are authorized to make payments under this Act. 

Æ 

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