06-5489. TRICARE Program; Routine Care Not Directly Related to Study, Grant or Research Program

AGENCY:

Office of the Secretary, DoD.

ACTION:

Proposed rule.

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:

René Morrell, Medical Benefits and Reimbursement Systems, TRICARE Management Activity, telephone [phone].

SUPPLEMENTARY INFORMATION:

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

§ 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.