[Federal Register Volume 69, Number 153 (Tuesday, August 10, 2004)]
[Proposed Rules]
[Pages 48433-48434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18182]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN 0720-AA88


TRICARE Program; Rare Diseases Definition and Partial List of 
Examples of Unproven Drugs, Devices, Medical Treatments or Procedures

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed Rule.

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SUMMARY: This proposed rule revises the definition of rare diseases, 
clarifies case-by-case review of benefits for rare diseases, and 
removes the partial list of examples of unproven drugs, devices, 
medical treatments or procedures.

DATES: Written comments received at the address indicated below by 
October 12, 2004, will be accepted.

ADDRESSES: Because of staff and resource limitations, we cannot accept 
comments by facsimile (fax) transmission or e-mail. Mail written 
comments to the following address ONLY: TRICARE Management Activity, 
Medical Benefits and Reimbursement Systems, 16401 East Centretech 
Parkway, Aurora, CO 80011-9066. Please allow sufficient time for mailed 
comments to be timely received in the event of delivery delays.

FOR FURTHER INFORMATION CONTACT: Rene Morrell, Medical Benefits and 
Reimbursement Systems, TRICARE Management Activity, telephone (303) 
676-3618.

SUPPLEMENTARY INFORMATION: TRICARE supplements the availability of 
health care in military hospitals and clinics.

Rare Diseases

    On January 6, 1997, the Office of the Secretary of Defense 
published a final rule in the Federal Register (62 FR 627-631) 
clarifying the TRICARE exclusion of unproven drugs, devices, medical 
treatments and procedures and adding the TRICARE definition of rare 
diseases. This rule also added the provision for reviewing benefits for 
rare diseases on a case-by-case basis. Currently, TRICARE defines a 
rare disease as one which affects fewer than one in 200,000 Americans. 
The basis for this definition was not documented. Upon further review, 
we propose to revise our definition to be more in compliance with the 
definition of other Federal agencies and national organizations 
specializing in the identification of rare diseases. Our revised 
definition is based on the following:
    (1) For the purpose of designating drugs for rare diseases or 
conditions, the Food and Drug Administration defines the term rare 
disease, in part, as any disease or condition which affects less than 
200,000 persons in the United States (21 U.S.C. 360(bb)(a)(2)).
    2. Section 3 of the Rare Diseases Act of 2002, Public Law 107-28, 
defines a rare disease or condition as any disease or condition that 
affects less than 200,000 persons in the United States.
    3. The National Institutes of Health Office of Rare Diseases 
considers an orphan or rare disease or condition to have a prevalence 
of less than 200,000 affected individuals in the United States.
    4. The National Organization for Rare Disorders defines a rare or 
orphan disease as affecting fewer than 200,000 people in the United 
States.
    We also propose to clarify the provision for review of benefits for 
rare diseases on a case-by-case basis. We are not removing the 
provision for case-by-case review only clarifying that case-by-case 
review is not required for treatment that has already been established 
as safe and effective.

Partial List of Examples of Unproven Drugs, Devices, Medical Treatment 
or Procedures

    The current regulation and program policy exclude coverage of 
unproven drugs, devices, medical treatment or procedures. The current 
regulation and program policy provide a partial list of examples of 
unproven drugs, devices, medical treatment or procedures that are 
excluded from benefits. The intent of this partial list was to provide 
information on specific examples of emerging drugs, devices, medical 
treatment or procedures determined to be unproven by TRICARE based on 
review of current reliable evidence. Due to the rapid and extensive 
changes in medical technology it is not feasible to maintain this list 
in the regulation. Removal of the partial list of examples does not 
change the exclusion of unproven drugs, devices, medical treatment or 
procedures. Removal of the partial list of examples does not change the 
process TRICARE follows in determining for purposes of benefit coverage 
when a drug, device, medical treatment or procedure has moved from the 
status of unproven to proven medical effectiveness. Removal of the 
partial list of examples does not mean the drugs, devices, medical 
treatment or procedures cited in the partial list have now been 
determined to be proven. The intent of this revision is to ensure that 
benefit determinations are made based on current reliable evidence 
rather than relying on outdated regulatory provisions.

[[Page 48434]]

Regulatory Procedures

    Executive Order 12866 requires that a comprehensive regulatory 
impact analysis be performed on any economically significant regulatory 
action, defined as one that would result in an annual effect of $100 
million or more on the national economy or which would 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.
    This rule has been designated as significant and has been reviewed 
by the Office Management and Budget as required under the provisions of 
E.O. 12866 however, it would not have a significant impact on small 
entities. The changes set forth in the proposed rule are minor 
revisions to the existing regulation. In addition, this proposed rule 
does not impose new information collection requirements for purposes of 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).
    This is a proposed rule. Public comments are invited.

List of Subjects in 32 CFR Part 199

    Claims, Dental health, 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 199.2, paragraph (b) is proposed to be amended by 
revising the definition of ``Rare Diseases'' to read as follows:


Sec.  199.2  Definitions.

* * * * *
    (b) * * *
    Rare Diseases. TRICARE defines a rare disease as any disease or 
condition that affects less than 200,000 persons in the United States.
* * * * *
    3. Section 199.4 is proposed to be amended by revising paragraph 
(g)(15)(ii) and removing paragraph (g)(15)(iv) as follows:


Sec.  199.4  Basic program benefits.

* * * * *
    (g) * * *
    (15) * * *
    (ii) CHAMPUS benefits for rare diseases are reviewed on a case-by-
case basis by the Director, TRICARE Management Activity, or a designee. 
Case-by-case review is not required for drugs, devices, medical 
treatments and procedures that have already been established as safe 
and effective for treatment of rare diseases. In reviewing the case, 
the Director, or a designee, may consult with any or all of the 
following sources to determine if the proposed therapy is considered 
safe and effective.
* * * * *

    Dated: August 4, 2004.
L. M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 04-18182 Filed 8-9-04; 8:45 am]
BILLING CODE 5001-06-M