[Federal Register: June 20, 2006 (Volume 71, Number 118)]
[Proposed Rules]
[Page 35402-35403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn06-16]
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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