[Federal Register Volume 66, Number 21 (Wednesday, January 31, 2001)]
[Rules and Regulations]
[Pages 8365-8366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2763]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN 0720-AA57


Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS); Methodology for Coverage of Phase II and Phase III Clinical 
Trials Sponsored by the National Institutes of Health

AGENCY: Office of The Secretary; DoD.

ACTION: Final rule.

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SUMMARY: This 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.

EFFECTIVE DATE: March 2, 2001.

ADDRESSES: TRICARE Management Activity (TMA), Program Operations 
Directorate, Program Development, 5111 Leesburg Pike, Suite 810, Falls 
Church, VA 22041-3206.

FOR FURTHER INFORMATION CONTACT: Patricia Collins, Office of the 
Assistant Secretary of Defense (Health Affairs)/TRICARE Management 
Activity, telephone (703) 681-0039. Questions regarding payment of 
specific claims under CHAMPUS should be addressed to the appropriate 
regional TRICARE/CHAMPUS contractor.

SUPPLEMENTARY INFORMATION:

I. Overview of the Rule

Introduction and 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. The Department of Defense and the National Institutes of 
Health National Cancer Institute (NCI) established a partnership in 
1994 for the purpose of conducting a demonstration project that allowed 
patients with breast cancer to be considered for NCI-sponsored bone 
marrow transplant clinical trials. This program expanded in 1996 to 
include all cancers and NCI-Sponsored Phase II and III cancer treatment 
clinical trials. The partnership was further expanded as of June 21, 
1999 to include cancer prevention and treatment. Between January 1996 
and January 2000, approximately 270 beneficiaries have participated in 
NCI-approved clinical trials under the waiver. The Department of 
Defense hopes that this permanent benefit will heighten the awareness 
among our cancer patients that clinical trials are a promising 
treatment option and encourage them to consider this.

[[Page 8366]]

    Public Comments: The proposed rule was published in the Federal 
Register on May 31, 2000 (65 FR 34627). No public comments were 
received.
    Provisions of the Final Rule: The final rule is consistent with the 
proposed rule.

II. Regulatory Procedures

    Executive Order 12866 requires certain regulatory assessments for 
any significant regulatory action, defined as one which would result in 
an annual effect on the economy of $100 million or more, or have other 
substantial impacts.
    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.
    The 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, Health care, 
Health insurance, Military personnel.

PART 199--[AMENDED]

    1. The authority citation for Part 199 continues to read as 
follows:

    Authority: 5 U.S.C. 301; 10 U.S.C. Chapter 55.


    2. Section 199.4 is amended by adding new paragraph (e)(21) and 
revising paragraph (g)(15) introductory text to read as follows:


Sec. 199.4  Basic program benefits.

* * * * *
    (e) * * *
    (21) 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 specific clinical trials identified under 
paragraph (e)(2)(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)(20) of this section 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) CHAMPUS 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. CHAMPUS 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) CHAMPUS will not provide reimbursement for care rendered in the 
National Institutes of Health Clinical 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, OCHAMPUS, 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 199.4(e)(21) of this part.
* * * * *

    Dated: January 25, 2001.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 01-2763 Filed 1-30-01; 8:45 am]
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