[Federal Register Volume 65, Number 105 (Wednesday, May 31, 2000)]
[Proposed Rules]
[Pages 34627-34628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13520]


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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 NIH-Sponsored Clinical Trials

AGENCY: Office of the Secretary, DoD.

ACTION:  Proposed rule.

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SUMMARY: This proposed rule modifies the general prohibition against 
CHAMPUS cost-sharing of unproven drugs, devices, and medical treatments 
or procedures by adding a provision allowing a waiver of the 
prohibition in connection with clinical trials sponsored or approved by 
the National Institutes of Health, 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.

 DATES: Public comments must be received by July 31, 2000.

ADDRESSES: TRICARE Management Activity (TMA), Program Development 
Branch, Aurora, CO 80045-6900.

FOR FURTHER INFORMATION CONTACT: Kathleen Larkin, Office of the 
Assistant Secretary of Defense (Health Affairs)/TRICARE Management 
Activity, telephone (703) 681-3628.

SUPPLEMENTARY INFORMATION:  

I. Proposed Changes

Introduction and Background

    On January 24, 1996, the Department provided notice in the Federal 
Register (61 FR 1899) of an expansion of an existing demonstration to 
provide coverage for all cancer treatment clinical trials under 
approved National Cancer Institute (NCI) clinical trials. The 
demonstration's purpose was to improve beneficiary access to promising 
new therapies, assist in meeting the National Cancer Institute's 
clinical trial

[[Page 34628]]

goals, and arrival at conclusions regarding the safety and efficacy of 
emerging therapies in the treatment of cancer. The demonstration was 
further expanded on June 21, 1999 (64 FR 109) to include cancer 
prevention clinical trials. 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.
    This proposed 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 if the Secretary of Defense so determines that a waiver will 
promote access to promising new treatments and contributes to the 
development of such treatments.

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 proposed rule will not impose additional information collection 
requirements on the public under the Paperwork Reduction Act of 1995 
(44 U.S.C. Chapter 55).
    Public comments are invited. All comments will be carefully 
considered. A discussion of the major issues received by public 
comments will be included with the issuance of the permanent final 
rule, anticipated approximately 60 days after the end of the comment 
period.

List of Subjects in 32 CFR Part 199

    Claims, Fraud, Health care, Health insurance, Individuals with 
disabilities, Military personnel.
    Accordingly, 32 CFR part 199 is proposed to be amended as follows:

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 proposed to be 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 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).
    (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 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 wiaver 
for CHAMPUS cost-sharing of the specific clinical trial. Only those 
specific clinical trials identified under paragraph (e)(21)(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)(21) of this section has been granted for CHAMPUS 
cost-sharing for those CHAMPUS-eligible patients selected to 
participated 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 preauthorization 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 Sec. 199.4(e)(20) of this part.
* * * * *

    Dated: May 24, 2000.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 00-13520 Filed 5-30-00; 8:45 am]
BILLING CODE 5001-10-M