[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Rules and Regulations]
[Pages 35389-35391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5432]


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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