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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

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Office of The Secretary; DoD.

ACTION:

Final rule.

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.

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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.

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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.Start Printed 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).

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List of Subjects in 32 CFR Part 199

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PART 199—[AMENDED]

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

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

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

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Basic program benefits.
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(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 § 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.

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(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.

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Dated: January 25, 2001.

L.M. Bynum,

Alternate OSD Federal Register Liaison Officer, Department of Defense.

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[FR Doc. 01-2763 Filed 1-30-01; 8:45 am]

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