[Federal Register: June 20, 2006 (Volume 71, Number 118)]
[Rules and Regulations]
[Page 35389-35391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn06-8]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket No. DoD-2006-HA-0143]
RIN 0720-0057
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS)/TRICARE; Coverage of Phase II and Phase III Clinical Trials
Sponsored by the National Institutes of Health National Cancer
Institute
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
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SUMMARY: The final rule allows the Department of Defense to waive
normal requirements so that covered beneficiaries can participate in
Phase II and Phase III clinical trials sponsored or approved by the
National Institutes of Health National Cancer Institute (NIH NCI). This
waiver authority is expected to promote beneficiary access to promising
new treatments and contribute to the development of such treatments.
DATES: This rule is effective July 20, 2006.
ADDRESSES: TRICARE Management Activity (TMA), Medical Benefits and
Reimbursement System, 16301 East Centretech Parkway, Aurora, CO 80011-
9066
FOR FURTHER INFORMATION CONTACT: Debra Hatzel, Medical Benefits and
Reimbursement Systems, TMA, telephone (303) 676-3572. Questions
regarding payment of specific claims under TRICARE should be addressed
to the appropriate TRICARE contractor.
SUPPLEMENTARY INFORMATION:
I. Background
This final rule implements Title 10, United States Code, section
1079(a)(13) which provides for a waiver of the general prohibition on
coverage of unproven medical treatments or procedures in connection
with clinical trials sponsored or approved by the National Institutes
of Health National Cancer Institute. This waiver is contingent upon the
Secretary of Defense's determination that a waiver will promote access
to promising new treatments and contribute to the development of such
treatments. Based on the improved beneficiary access to these trials,
and the contributions to the development of such treatments, it is in
the best interest of the Department and its beneficiaries to continue
to provide access through an authorized waiver as outlined in the
proposed rule.
Clinical trials are the major avenue for discovering, developing,
and evaluating new cancer therapies, and clinical trial participants
are among the first to receive new cancer prevention or treatment
methods before they are widely available. Many significant medical
discoveries in this field have occurred as a direct result of clinical
trial participation. For example, because of survival improvements seen
in an NCI-sponsored clinical trial, early initiation of hormonal
therapy has become the standard of care in node-positive prostrate
cancer patients. Even when they do not lead to new therapies, clinical
trials often answer important questions and help move research forward
so that others may prevent or survive this disease.
Cancer treatment trials may include testing new drugs, new
approaches to surgery or radiation therapy, new combinations of
treatments, or new methods such as gene therapy. Studies that involve
drugs or invasive procedures are categorized by phase. Phase I trials
evaluate new cancer drugs to determine what dose is safe, how a new
agent should be administered (by mouth, injected into a vein, or
injected into the muscle), and how frequently the treatment should be
given. After safety parameters have been established, Phase II trials
are conducted to assess the effectiveness of an agent or intervention
against a specific type of cancer. Phase III trials compare effective
treatments from Phase II studies to conventional cancer treatments.
Clinical trials offer high quality care for cancer prevention and
treatment, and no patient ever receives a placebo (substance with
active ingredients) when effective care exists.
The Department of Defense (DoD) and the National Cancer Institute
(NCI) established a partnership in 1994 to conduct a demonstration
project that allowed patients with breast cancer to participate in NCI-
sponsored bone marrow transplant clinical trials. This demonstration
project expanded in 1996 to include all cancers and NCI-sponsored Phase
II and III cancer treatment clinical trials. The DoD-NCI demonstration
partnership was further
[[Page 35390]]
expanded on June 21, 1999 to include clinical trials related to
prevention, screening and early detection of cancer. Because of the
inherent safety risks and unproven clinical benefits associated with
toxicology studies, Phase I clinical trials were not included in this
demonstration.
Between January 1996 and July 2004, approximately 350 TRICARE
beneficiaries have participated in NCI-approved clinical trials
conducted in doctors' offices, community hospitals and clinics, cancer
centers, other medical centers, and veterans' and military hospitals
across the United States. Healthcare costs for the DoD-NCI
demonstration have ranged from $5.8 million to $16 million per year,
and research has indicated that patient-care costs associated with
cancer clinical trials are only slightly higher than the costs
associated with treating similar patients outside of trials.
The Department of Defense hopes that his permanent benefit will
heighten the awareness among our cancer patients that clinical trials
are a promising treatment option and encourage them to consider Phase
II and Phase III clinical trial participation. Participation in
clinical trials related to prevention, screening, and early detection
of cancer will contribute to the growing base of medical knowledge in
these areas and may lead to more effective treatments in the future.
Phase I trials will continue to be excluded from coverage; also,
TRICARE will continue to deny coverage for any items or services that
are already covered under the investigational protocol. Only those
supplies and services that TRICARE otherwise would have covered during
the normal course of treatment (to include costs for screening tests to
determine clinical trial eligibility) will be eligible for cost-
sharing. This continues the coverage policy which was previously
established for the DoD-NCI cancer trials demonstration.
This final rule was previously published in the Federal Register on
January 31, 2001 (66 FR 8365-8366). The rule was withdrawn on February
7, 2001 (66 FR 9199) because it was determined that it should not have
been published in accordance with the Regulatory Review Plan. We are
reissuing this final rule with only minor changes (``CHAMPUS'' changed
to ``TRICARE'' where appropriate; minor changes to paragraph numbers to
reflect current regulations); however, we are repeating the entire
final rule here for the benefit of the public.
II. Public Comments
The proposed rule was published in the Federal Register on May 31,
2000 (65 FR 34627). No public comments were received. The final rule is
consistent with the proposed rule.
III. Regulatory Procedures
Executive Order (EO) 12866 requires that a comprehensive regulatory
impact analysis be performed on any economically significant regulatory
action, defined as one which would result in an annual effect of $100
million or more on the national economy or which would have other
substantial impacts. This is not a significant regulatory action under
EO 12866 and has been reviewed by the Office of Manpower and Budget.
The Regulatory Flexibility Act (RFA) requires that each Federal
agency prepare, and make available for public comment, a regulatory
flexibility analysis when the agency issues a regulation which would
have a significant impact on a substantial number of small entities. We
certify that this final rule will not significantly affect a
substantial number of small entities.
This final rule will not impose additional information collection
requirements on the public under the Paperwork Reduction Act of 1995
(44 U.S.C. chapter 55).
List of Subjects in 32 CFR Part 199
Administrative practice and procedure, Claims, Fraud, Healthcare,
Health insurance, Military personnel.
0
Accordingly, 32 CFR part 199 is amended as follows:
PART 199--[AMENDED]
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Section 199.4 is amended by adding new paragraph (e)(26) and
revising paragraph (g)(15) introductory text to read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(26) National Institutes of Health clinical trials. By law, the
general prohibition against CHAMPUS cost-sharing of unproven drugs,
devices, and medical treatments or procedures may be waived in
connection with clinical trials sponsored or approved by the National
Institutes of Health National Cancer Institute if it is determined that
such a waiver will promote access by covered beneficiaries to promising
new treatments and contribute to the development of such treatments. A
waiver shall only be exercised as authorized under this paragraph.
(i) Demonstration waiver. A waiver may be granted through a
demonstration project established in accordance with Sec. 199.1(o) of
this part.
(ii) Continuous waiver. (A) General. As a result of a demonstration
project under which a waiver has been granted in connection with a
National Institutes of Health National Cancer Institute clinical trial,
a determination may be made that it is in the best interest of the
government and CHAMPUS beneficiaries to end the demonstration and
continue to provide a waiver for CHAMPUS cost-sharing of the specific
clinical trial. Only those specified clinical trials identified under
paragraph (e)(26)(ii) of this section have been authorized a continuous
waiver under CHAMPUS.
(B) National Cancer Institute (NCI) sponsored cancer prevention,
screening, and early detection clinical trials. A continuous waiver
under paragraph (e)(26) of this regulation has been granted for CHAMPUS
cost-sharing for those CHAMPUS-eligible patients selected to
participate in NCI sponsored Phase II and Phase III studies for the
prevention and treatment of cancer.
(1) TRICARE will cost-share all medical care and testing required
to determine eligibility for an NCI-sponsored trial, including the
evaluation for eligibility at the institution conducting the NCI-
sponsored study. TRICARE will cost-share all medical care required as a
result of participation in NCI-sponsored studies. This includes
purchasing and administering all approved chemotherapy agents (except
for NCI-funded investigational drugs), all inpatient and outpatient
care, including diagnostic and laboratory services not otherwise
reimbursed under an NCI grant program if the following conditions are
met:
(i) The provider seeking treatment for a CHAMPUS-eligible patient
in an NCI approved protocol has obtained pre-authorization for the
proposed treatment before initial evaluation; and,
(ii) Such treatments are NCI sponsored Phase II or Phase III
protocols; and,
(iii) The patient continues to meet entry criteria for said
protocol; and,
(iv) The institutional and individual providers are CHAMPUS
authorized providers.
(2) TRICARE will not provide reimbursement for care rendered in the
National Institutes of Health Clinical
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Center or costs associated with non-treatment research activities
associated with the clinical trials.
(3) Cost-shares and deductibles applicable to CHAMPUS will also
apply under the NCI-sponsored clinical trials.
(4) The Director, TRICARE (or designee), shall issue procedures and
guidelines establishing NCI-sponsorship of clinical trials and the
administrative process by which individual patients apply for and
receive cost-sharing under NCI-sponsored cancer clinical trials.
(g) * * *
(15) Unproven drugs, devices, and medical treatments or procedures.
By law, CHAMPUS can only cost-share medically necessary supplies and
services. Any drug, device, or medical treatment or procedure, the
safety and efficacy of which have not been established, as described in
this paragraph (g)(15), is unproved and cannot be cost-shared by
CHAMPUS except as authorized under paragraph 199.4(e)(26) of this part.
* * * * *
Dated: June 9, 2006.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 06-5432 Filed 6-19-06; 8:45 am]
BILLING CODE 5001-06-M