[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Proposed Rules]
[Pages 35402-35403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5489]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DoD-OS-2006-0054]
RIN 0720-AA98 (previously 0720-AA94)


TRICARE Program; Routine Care Not Directly Related to Study, 
Grant or Research Program

AGENCY: Office of the Secretary, DoD.

ACTION:  Proposed rule.

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SUMMARY: This proposed rule amends the exclusion of services and 
supplies provided as part of or under a research study, grant or 
research program to add coverage for routine patient care that would 
have been necessary in the absence of the study as well as care of 
complications that result from participation in the trial.

DATES: Written comments received at the address indicated below by 
August 21, 2006 will be accepted.

ADDRESSES: You may submit comments, identified by docket number and or 
RIN number and title, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, Washington, DC 20301-1160.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
Federal Register document. The general policy for comments and other 
submissions from members of the public is to make these submissions 
available for public viewing on the Internet at http://regulations.gov 
as they are received without change, including any personal identifiers 
or contact information.

FOR FURTHER INFORMATION CONTACT: Ren[eacute] 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.

[[Page 35403]]

This proposed rule revises the exclusion of services and supplies 
provided as part of or under a research study, grant or research 
program to allow coverage of routine care not directly associated with 
the research study or grant.

Research Study, Grant or Research Program

    By law, under 10 U.S.C. 1079(a)(13), TRICARE may cost share only 
medically or psychologically necessary services or supplies. The 
regulation and program policies currently exclude cost-sharing of 
services and supplies provided as part of or under a research study, 
grant or research program, because the medical efficacy and safety of 
such services and supplies, and as such, the medical necessity, has not 
yet been established. For people with serious or life-threatening 
diseases, curative treatment is often not available. A clinical trial 
or research study offers the potential to provide curative treatment. 
By participating in a clinical trial, people with serious or life-
threatening diseases may benefit from curative treatment. This change 
will assist eligible TRICARE beneficiaries who participate in clinical 
trials by providing coverage for medically necessary routine care not 
directly associated with the treatment under investigation and 
providing coverage for complications arising from participation in 
clinical trials.
    This exclusion removal applies only to clinical trials that are 
Phase II, Phase III, or Phase IV patient research studies approved by 
centers or cooperative groups that are funded by the National 
Institutes of Health (NIH), the Food and Drug Administration (FDA), the 
Centers for Disease Control (CDC), the Agency for Health Care Research 
and Quality (AHRQ), or the Department of Veterans Affairs (VA).
    In general, there are two types of costs associated with a clinical 
trial--routine medically necessary patient care costs and research 
costs. Routine patient care costs can include (but are not limited to) 
doctor office visits, hospital stays, clinical laboratory tests (e.g., 
blood tests, CT scans, bone scans) and X-rays. These are the type of 
costs that will be covered by TRICARE. Research costs are divided into 
treatment costs and administrative costs. Treatment costs include test 
performed purely for research purposes, additional research physician 
and nurse time, and the additional cost of the experimental therapy or 
treatment itself. Administrative costs include the costs associated 
with recruiting patients, data collection and management, and 
statistical analysis of results. These types of administrative costs 
are almost always paid for by the clinical trial sponsor. All types of 
research costs will continue to be excluded from TRICARE coverage. This 
change will make coverage for medically necessary services not directly 
associated with the treatment under investigation consistent with both 
the statute and medically necessary services and supplies authorized as 
an exception to the TRICARE exclusion for unproven medical treatments 
and procedures under the regulation. Under 32 CFR 199.4(g)(15), 
unproven drugs, devices, and medical treatments or procedures are 
excluded. However, coverage is authorized under paragraph (g)(15)(iii) 
of this section when treatment is not related to the unproven drug, 
device or medical treatment or procedure, e.g., medically necessary in 
the absence of the unproven treatment. Treatment is also authorized 
which is necessary follow-up to the unproven drug, device or medical 
treatment or procedure but which might have been necessary in the 
absence of the unproven treatment. This change is also consistent with 
the coverage of Medicare and private insurance carriers.

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 is neither a significant regulatory action under Executive 
Order 12886, nor would it have a significant impact on small entities. 
The changes set forth in the proposed rule are minor revisions to the 
existing regulation and affect only a small portion of the population 
who participate in research studies or grants. In addition, the 
proposed rule does not impose new information collection requirements 
for purposes of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3511).

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--TRICARE PROGRAM; ROUTINE CARE NOT DIRECTLY RELATED TO 
STUDY, GRANT OR RESEARCH PROGRAM.

    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 
(g)(14)(i) and by reserving paragraph (g)(14)(ii) to read as follows:


Sec.  199.4  Basic program benefits.

* * * * *
    (g) * * *
    (14) * * *
    (i) Care excluded. This exclusion from benefits includes the 
investigational item or treatment itself, services and supplies 
customarily provided by the research sponsors free of charge for any 
enrollee in the trial, services and supplies provided solely to satisfy 
data collection and analysis and that are not used in the direct 
clinical management of the patient, and services and supplies provided 
to determine eligibility to participate in the study or research 
program. However, TRICARE may cover routine care not directly 
associated with the study or grant provided the research study or 
program is a Phase II, Phase III, or Phase IV patient research study 
approved by centers or cooperative groups that are funded by the 
National Institutes of Health (NIH), the Food and Drug Administration 
(FDA), the Centers for Disease Control (CDC), the Agency for Health 
Care Research and quality (AHRQ), or the Department of Veterans 
Affairs. Under those circumstances, TRICARE coverage is authorized for:
    (A) Treatment that is not directly associated with the study or 
grant, e.g., medically necessary in the absence of the study or grant.
    (B) Services and supplies that are medically necessary for the 
diagnosis or treatment of complications arising from participation in 
the research study or program.
    (ii) [Reserved]
* * * * *

    Dated: June 13, 2006.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 06-5489 Filed 6-19-06; 8:45 am]
BILLING CODE 5001-06-M