1.This Act may be cited as the TBI
Treatment Act
.
2.Pilot program on
payment for treatment of members of the Armed Forces and veterans for traumatic
brain injury and post-traumatic stress disorder
(a)The Secretary of
Defense and the Secretary of Veterans Affairs shall carry out a five-year pilot
program under which each such Secretary shall establish a process through which
each Secretary shall provide payment for treatments (including diagnostic
testing) of traumatic brain injury or post-traumatic stress disorder received
by members of the Armed Forces and veterans in health care facilities other
than military treatment facilities or Department of Veterans Affairs medical
facilities. Such process shall provide that payment be made directly to the
health care facility furnishing the treatment.
(b)The approval by a
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.
(2)The treatment or study protocol used in
treating the member or veteran must have been approved by an institutional
review board operating in accordance with regulations issued by the Secretary
of Health and Human Services.
(3)The approved treatment or study protocol
(including any patient disclosure requirements) must be used by the health care
provider delivering the treatment.
(4)The patient receiving the treatment or
study protocol must demonstrate an improvement 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.
(C)Neurological
imaging.
(D)Clinical
examination.
(5)The patient
receiving the treatment or study protocol must be receiving the treatment
voluntarily.
(c)Additional
restrictions prohibitedExcept as provided in this subsection (b),
no restriction or condition for reimbursement may be placed on any health care
provider that is operating lawfully under the laws of the State in which the
provider is located with respect to the receipt of payment under this
Act.
(d)The Secretary of
Defense and the Secretary of Veterans Affairs shall make a payment for a
treatment or study protocol pursuant to subsection (a) not later than 30 days
after a member of the Armed Forces or veteran (or health care provider on
behalf of such member or veteran) submits to the Secretary documentation
regarding the treatment or study protocol. The Secretary of Defense and the
Secretary of Veterans Affairs shall ensure that the documentation required
under this subsection may not be an undue burden on the member of the Armed
Forces or veteran or on the health care provider.
(e)Subsection (c)(1) of
section 1074 of title 10, United States Code, shall apply with respect to the
payment by the Secretary of Defense for treatment or study protocols pursuant
to subsection (a) of traumatic brain injury and post-traumatic stress disorder
received by members of the Armed Forces.
(f)A payment under this Act 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
or study protocol is received. If no such rate is in effect, payment shall be
made at a fair market rate, as determined by the Secretary of Defense, in
consultation with the Secretary of Health and Human Services, with respect to a
patient who is a member of the Armed Forces or the Secretary of Veterans
Affairs with respect to a patient who is a veteran.
(g)Data collection
and availability
(1)The Secretary of
Defense and the Secretary of Veterans Affairs shall jointly develop and
maintain a database containing data from each patient case involving the use of
a treatment under this section. The Secretaries shall ensure that the database
preserves confidentiality and be made available only—
(A)for third-party
payer examination;
(B)to the appropriate
congressional committees and employees of the Department of Defense, the
Department of Veterans Affairs, the Department of Health and Human Services,
and appropriate State agencies; and
(C)to the primary investigator of the
institutional review board that approved the treatment or study protocol, in
the case of data relating to a patient case involving the use of such treatment
or study protocol.
(2)Enrollment in
Institutional Review Board StudyIn the case of a patient enrolled in a
registered institutional review board study, results may be publically
distributable in accordance with the regulations prescribed pursuant to the
Health Insurance Portability and Accountability Act of 1996 (Public Law
104–191) and other regulations and practices in effect as of the date of the
enactment of this Act.
(3)Qualified
institutional review boardsThe Secretary of Defense and the
Secretary of Veterans Affairs shall each ensure that the Internet website of
their respective departments includes a list of all civilian institutional
review board studies that have received a payment under this Act.
(h)Assistance for
members To obtain treatment
(1)Assignment to
temporary dutyThe 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 or
study protocol 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 member’s permanent duty station.
(2)A member who is away from the member’s permanent station 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)Notwithstanding any
rule of any department or agency with respect to ethics or the receipt of
gifts, any assistance provided to a member of the Armed Forces with a
service-connected injury or disability for travel, meals, or entertainment
incidental to receiving treatment or study protocol under this Act, or for the
provision of such treatment or study protocol, shall not be subject to or
covered by any such rule.
(i)No retaliation may
be made against any member of the Armed Forces or veteran who receives
treatment or study protocol as part of registered institutional review board
study carried out by a civilian health care practitioner.
(j)Treatment of
university and nationally accredited institutional review
boardsFor purposes of this Act, a university-affiliated or
nationally accredited institutional review board shall be treated in the same
manner as a Government institutional review board.
(k)Memoranda of
understandingThe Secretary of Defense and the Secretary of
Veterans Affairs shall seek to expeditiously enter into memoranda of
understandings with civilian institutional review boards described in
subsection (j) for the purpose of providing for members of the Armed Forces and
veterans to receive treatment carried out by civilian health care practitioners
under a treatment or study protocol approved by and under the oversight of
civilian institutional review boards that would qualify for payment under this
Act.
(l)
(1)The Secretary of Veterans Affairs shall notify each
veteran with a service-connected injury or disability of the opportunity to
receive treatment or study protocol pursuant to this Act.
(2)Outreach to
members of the Armed ForcesThe Secretary of Defense shall notify each
member of the Armed Forces with a service-connected injury or disability of the
opportunity to receive treatment or study protocol pursuant to this Act.
(m)Not later than 30 days after the last day of each fiscal
year during which the Secretary of Defense and the Secretary of Veterans
Affairs are authorized to make payments under this Act, the Secretaries shall
jointly submit to Congress an annual report on the implementation of this Act.
Such report shall include each of the following for that fiscal year:
(1)The number of
individuals for whom the Secretary has provided payments under this Act.
(2)The condition for
which each such individual receives treatment for which payment is provided
under this Act and the success rate of each such treatment.
(3)Treatment methods
that are used by entities receiving payment provided under this Act and the
respective rate of success of each such method.
(4)The
recommendations of the Secretaries with respect to the integration of treatment
methods for which payment is provided under this Act into facilities of the
Department of Defense and Department of Veterans Affairs.
(n)The
authority to make a payment under this Act shall terminate on the date that is
five years after the date of the enactment of this Act.
(o)Authorization of
appropriationsThere is authorized to be appropriated to carry
out this Act $10,000,000 for each fiscal year during which the Secretary of
Veterans Affairs and the Secretary of Defense are authorized to make payments
under this Act.