[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Proposed Rules]
[Pages 81899-81901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33106]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[DOD-2011-HA-0085]
RIN 0720-AB54

32 CFR Part 199


TRICARE; Removal of the Prohibition to Use Addictive Drugs in the 
Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries

AGENCY: Office of the Secretary, Department of Defense.

ACTION: Proposed rule.

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SUMMARY: This rule proposes revisions to remove the exclusion of drug 
abuse maintenance programs and allow as part of a comprehensive 
treatment plan for an individual with substance dependence, the 
substitution of a therapeutic drug with addictive potential for a drug 
of addiction (e.g. the

[[Page 81900]]

substitution of methadone for heroin). The current regulation prohibits 
drug maintenance programs where one addictive substance is substituted 
for another. However, this prohibition of maintenance treatment of 
substance dependence utilizing a specific category of psychoactive 
agent is outdated and fails to recognize the accumulated medical 
evidence supporting certain maintenance programs as one component of 
the continuum of care necessary for the effective treatment of 
substance dependence. Current medical evidence shows that this is 
medically or psychologically necessary and integral to the safe and 
effective treatment of drug abuse as is generally required for all 
treatment benefits for inclusion in the TRICARE benefit.

DATES: Written comments received at the address indicated below by 
February 27, 2012 will be accepted.

ADDRESSES: You may submit comments, identified by docket number and or 
Regulatory Information Number (RIN) number and title, by either of the 
following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, OSD Mailroom 3C843, Washington, DC 20301-1160.
    Instructions: All submissions received must include the agency name 
and docket number or 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://www.regulations.gov as they are received without 
change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: CAPT Robert DeMartino, TRICARE 
Management Activity, Office of the Chief Medical Officer, telephone 
(703) 681-0070.

SUPPLEMENTARY INFORMATION:
    Contingency operations involving DoD personnel are now in their 
tenth year. The advances in battlefield injury protection and medicine 
have drastically reduced the number of battlefield deaths and have 
returned our Service members home, injured, but prepared to recover. 
For many, pain related to injuries must be treated for many months and 
such long-term use of pain medications has put our Service members 
using those medicines at risk for dependence. This reality makes it 
ever more important to ensure that all safe and effective treatments 
for substance dependence are available to our Service members.
    The current TRICARE regulation prohibits drug maintenance programs 
where a therapeutic drug with addictive potential is substituted for a 
drug of addiction. However, medicine is constantly evolving including 
in the area of drug addiction treatments. In the past, there was not 
sufficient reliable evidence as that term is used in the TRICARE 
regulations at 32 CFR 199.4(g)(15), to establish that the substitution 
of one addictive drug for another was an effective part of a drug 
treatment program.
    The changes proposed to the CFR will remove the specific 
prohibition on coverage of drug maintenance programs when one addictive 
drug is substituted for another, thereby allowing treatment regimens 
involving the substitution of one addictive drug for another when it is 
a medical necessity and appropriate for an individual beneficiary.

Regulatory Procedures

Executive Order 12866 and Executive Order 13563

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated a ``significant regulatory 
action'' although not economically significant, under section 3(f) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget.

Public Law 104-4, Section 202, ``Unfunded Mandates Reform Act''

    Section 202 of Public Law 104-4, ``Unfunded Mandates Reform Act,'' 
requires that an analysis be performed to determine whether any federal 
mandate may result in the expenditure by State, local and tribal 
governments, in the aggregate, or by the private sector of $100 million 
in any one year. It has been certified that this proposed rule does not 
contain a Federal mandate that may result in the expenditure by State, 
local and tribal governments, in aggregate, or by the private sector, 
of $100 million or more in any one year, and thus this proposed rule is 
not subject to this requirement.

Public Law 96-354, ``Regulatory Flexibility Act'' (RFA) (5 U.S.C. 601)

    Public Law 96-354, ``Regulatory Flexibility Act'' (RFA) (5 U.S.C. 
601), requires that each Federal agency prepare a regulatory 
flexibility analysis when the agency issues a regulation which would 
have a significant impact on a substantial number of small entities. 
This proposed rule is not an economically significant regulatory 
action, and it has been certified that it will not have a significant 
impact on a substantial number of small entities. Therefore, this 
proposed rule is not subject to the requirements of the RFA.

Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)

    This rule does not contain a ``collection of information'' 
requirement, and will not impose additional information collection 
requirements on the public under Public Law 96-511, ``Paperwork 
Reduction Act'' (44 U.S.C. chapter 35).

Executive Order 13132, ``Federalism''

    E.O. 13132, ``Federalism,'' requires that an impact analysis be 
performed to determine whether the rule has federalism implications 
that would have substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. It has been certified that this proposed rule does not have 
federalism implications, as set forth in E.O. 13132.

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 199.4 is amended by revising paragraph (e)(11) 
introductory text, and removing and reserving paragraph (e)(11)(ii), to 
read as follows:


Sec.  199.4  Basic program benefits. * * *

* * * * *
    (e) * * *
    (11) Drug abuse. Under the Basic Program, benefits may be extended 
for medically necessary prescription drugs

[[Page 81901]]

required in the treatment of an illness or injury or in connection with 
maternity care (refer to paragraph (d) of this section). However, 
CHAMPUS benefits cannot be authorized to support or maintain an 
existing or potential drug abuse situation whether or not the drugs 
(under other circumstances) are eligible for benefit consideration and 
whether or not obtained by legal means. Drugs, including addictive 
drugs, prescribed to beneficiaries undergoing medically supervised 
treatment for a substance use disorder are not considered to be in 
support of, or to maintain, an existing or potential drug abuse 
situation and are allowed. The Director, TRICARE Management Activity 
may prescribe appropriate policies to implement this prescription drug 
benefit for those undergoing medically supervised treatment for a 
substance use disorder.
* * * * *
    (ii) [Reserved]
* * * * *

    Dated: December 21, 2011.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-33106 Filed 12-28-11; 8:45 am]
BILLING CODE 5001-06-P