[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Rules and Regulations]
[Pages 62427-62430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24232]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

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


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: Final rule.

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SUMMARY: The Department of Defense (DoD) is publishing this final rule 
to remove the exclusion of drug maintenance programs and allow TRICARE 
coverage of the substitution of a therapeutic drug, with addictive 
potential, for a drug of addiction when medically necessary and 
appropriate as part of a comprehensive treatment plan for an individual 
with substance use dependence. The current regulation prohibits 
coverage of drug maintenance programs where one addictive substance is 
substituted for another. The final rule allows TRICARE to cover, as 
part of otherwise authorized treatment of substance use disorder, 
utilization of a specific category of psychoactive agent when medically 
necessary and appropriate. Removal of the exclusion is based on 
recognition of the accumulated medical evidence supporting the use of 
certain pharmacotherapies as one component in the continuum of opioid 
treatment services. Medication assisted treatment, to include drug 
maintenance involving substitution of a therapeutic drug with addiction 
potential, for a drug of addiction, is now generally accepted by 
qualified professionals to be reasonable and adequate as a component in 
the safe and effective treatment of substance use disorders treatment 
services, and thus appropriate for inclusion as a component in the 
TRICARE authorized substance use disorder treatment for beneficiaries.

DATES: Effective Date: This rule is effective November 21, 2013.

FOR FURTHER INFORMATION CONTACT: John Davison, Ph.D., TRICARE 
Management Activity, Office of the Chief Medical Officer, telephone 
(703) 681-0086.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Final Rule

1. Need for the Regulatory Action
    The original implementing regulations for the Civilian Health and 
Medical Program of the Uniformed Services (CHAMPUS), first issued in 
1977, excluded drug maintenance programs from coverage. The DoD, 
consistent with chapter 55 of title 10, United States Code and other 
third party payors, covered medical services and supplies which were 
medically or psychologically necessary to prevent, diagnose, or treat a 
mental or physical illness, injury or bodily malfunction. At that time, 
drug maintenance programs were not the standard of care and were

[[Page 62428]]

not generally accepted by qualified professionals to be medically 
necessary and appropriate for the diagnosis and treatment of an 
illness, injury, or mental disorder. The regulatory language has 
remained unchanged for over 35 years. This final rule changes TRICARE's 
coverage policy based on the acceptance of drug maintenance as an 
integral part of opioid treatment services, when medically necessary 
and as part of a comprehensive treatment plan for an individual with 
substance use disorder.
2. Legal Authority for the Regulatory Action
    This regulation is proposed under the authorities of 10 U.S.C. 
section 1073, which authorizes the Secretary of Defense to administer 
the medical and dental benefits provided in chapter 55 of title 10, 
United States Code. The Department is authorized to provide medically 
necessary and appropriate medical care for mental and physical 
illnesses, injuries and bodily malfunctions, including hospitalization, 
outpatient care and drugs under 10 U.S.C. 1077(a)(1)-(3). Although 
section 1077 defines benefits to be provided in the military treatment 
facilities (MTFs), these benefits are incorporated by reference for the 
benefits provided in the civilian health care sector to active duty 
family members and retirees and their dependents through section 1079 
and 1086 respectively.

B. Summary of the Major Provisions of the Final Rule

    In this rule, the proposed regulatory language eliminates the 
specific regulatory exclusion of drug maintenance programs found at 32 
CFR 199.4(e)(11)(ii). Further, this rule also revises both 32 CFR 
199.4(e)(4)(ii) and (e)(11) to affirmatively include substitution of a 
therapeutic drug with addictive potential, for a drug of addiction as a 
component in an otherwise authorized substance use disorder treatment 
benefit, when medically necessary and appropriate medical care for a 
beneficiary undergoing medically supervised treatment for a substance 
use disorder.

C. Costs and Benefits

    This rule is not anticipated to have a significant impact on 
TRICARE costs. All services and supplies authorized under the TRICARE 
Basic Program must be determined to be medically necessary in the 
treatment of an illness, injury or bodily malfunction before the care 
can be cost shared by TRICARE. For this reason, DoD anticipates that 
TRICARE will have a marginal increase in cost associated with the 
inclusion of drug maintenance programs within the TRICARE substance use 
disorder treatment benefit. The benefit of this rule is to improve 
substance use disorder treatment under TRICARE.

II. Discussion of the Final Rule

    The practice of medicine is constantly evolving, including in the 
area of substance use disorder treatment. At the implementation of the 
original CHAMPUS regulation, the Department of Defense, consistent with 
other third party payors, provided coverage based on what was generally 
accepted by qualified professionals to be reasonable and adequate in 
the treatment of substance use disorders. Based on current medical 
evidence, this exclusion of medication assisted treatment of substance 
use dependence utilizing a specific category of psychoactive agent is 
outdated and fails to recognize that the current standard of practice 
supports the medical necessity and appropriate medical care of certain 
drug maintenance programs as one component of the continuum of opioid 
treatment services that are medically or psychologically necessary for 
the effective treatment of substance dependence.
    The Institute of Medicine (IOM) of the National Academies of 
Science completed a report in September 2012, entitled ``Substance Use 
Disorders in the U.S. Armed Forces,'' http://www.iom.edu/Reports/2012/Substance-Use-Disorders-in-the-US-Armed-Forces.aspx. The IOM found that 
the standards of care for substance use disorders are changing to 
reflect the inclusion of research-based pharmacological therapies. This 
final rule to permit the use of evidence-based pharmacological 
therapies is consistent with the recommendations of the IOM as well as 
the 2007 National Quality Forum's National Voluntary Consensus 
Standards for the Treatment of Substance Use Conditions. TRICARE 
currently limits pharmaceutical therapy to acute detoxification but 
does not cover medications like buprenorphine and naloxone when used 
for either prolonged ambulatory detoxification (greater than 30 days) 
or maintenance therapy. Evidence-based modalities of care in the 
treatment of substance use disorders include the use of agonist and 
antagonist medications that help to reduce cravings, maintain 
functioning and support long-term recovery. This type of 
pharmacological therapy has been described by a number of different 
terms including ``drug maintenance programs,'' ``substitution 
therapy,'' ``medication assisted treatment,'' ``prolonged 
detoxification,'' ``prolonged withdrawal management,'' ``short-term 
maintenance,'' ``long term maintenance,'' and ``pharmacological 
therapy.''
    Documented increases in the prescription of opioid pain medications 
throughout the United States have resulted in subsequent increases in 
opioid dependence and abuse in both the civilian and military 
populations. Service members are returning home from the wars in Iraq 
and Afghanistan with severe and painful injuries that require opioid 
pain management using medications that have the potential for 
addiction. The advances in battlefield injury protection and medicine 
have drastically reduced the number of battlefield deaths and have 
returned some of 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 some of our 
Service members using those medicines at risk for opioid dependence. 
Many of the medical conditions that prevail in a heavily deployed force 
have also led to frequent prescriptions for controlled substances, 
which are high risk for addiction or misuse. Additionally, for our 
broader beneficiary population, the unintended consequence of 
compassionate pain management includes an escalation in the use of 
prescription opioid analgesics for medical purposes which can result in 
dependency and other adverse effects. This reality makes it ever more 
important to ensure that all medically or psychologically necessary and 
appropriate medical care for substance use disorder are available to 
our TRICARE beneficiaries; consistent with the authority to provide 
treatment for mental or physical illness.

III. Public Comments

    The proposed rule was published in the Federal Register (76 FR 
81899-80901) on December 29, 2011, for a 60 day public comment period. 
We received comments from 35 respondents. A large majority of 
commenters, 33 of 35 in total, expressed support for the rule change. 
Two comments opposed the rule change. We thank those who provided 
comments. Specific matters raised by commenters and the Department's 
responses are summarized below.
    Comment: Two commenters who expressed strong support for the rule 
objected to use of the term ``addictive drugs.'' One respondent was 
concerned that the terminology conveys stigma. Another objected to 
categorizing substitution medications like buprenorphine as addictive 
drugs

[[Page 62429]]

because once a patient is stabilized on these medications, the patient 
no long meets DSM-IV criteria for substance dependence.
    Response: We appreciate the comments and are mindful that terms 
conveying stigma create barriers to care. The exact language used in 
the proposed rule was derived from the existing regulatory language 
prohibiting coverage ``when one addictive drug is substituted for 
another.'' We have carefully considered terminology as a result of 
these comments and conclude it would be appropriate to replace 
``addictive drugs'' in 32 CFR 199.4(e)(11) with ``the substitution of a 
therapeutic drug with addictive potential for a drug of addiction'' as 
a more neutral term that accurately describes substitution medications. 
To clarify the comment about DSM-IV diagnostic criteria for substance 
dependence, six treatment specifiers addressing the treatment recovery 
process are listed under the ``Substance Dependence'' section in the 
DSM-IV, including ``On Agonist Therapy.'' This specifier accurately 
describes the status of one whose substance use disorder is in a state 
of remission while on the agent during a specific phase of treatment 
recovery.
    Comment: Eight respondents who support the rule emphasized that 
substitution medications should only be used within the context of a 
comprehensive addiction treatment program.
    Response: We agree that the substitution of a therapeutic drug with 
addiction potential for a drug of addiction, when medically or 
psychologically necessary and appropriate medical care, should not be 
used in isolation but rather utilized as one component of a 
comprehensive treatment plan for an individual with a substance use 
disorder. To clarify this point, we have added language in the amended 
provision at 32 CFR 199.4(e)(11) specifically limiting coverage to 
otherwise authorized substance use disorder treatment under 32 CFR 
199.4(e)(4)(ii).
    We also recognize that treatment must meet the specific patient's 
medical needs and is not necessarily amenable to a one-size-fits-all 
approach. Medication assisted treatment will not be medically necessary 
or appropriate in all cases. To clarify this, paragraph 32 CFR 
199.4(e)(4)(ii) has been revised specifically to include, as a TRICARE 
covered service, the substitution of a therapeutic drug with addictive 
potential, for a drug addiction when medically or psychologically 
necessary and appropriate medical care for a beneficiary undergoing 
medically supervised treatment for a substance use disorder.
    Several of the comments also made reference to approval for office-
based practitioners as well. To the extent any of these comments were 
intended to seek to expand TRICARE authorized providers for substance 
use disorder inpatient and outpatient care, these comments fall outside 
the scope of the provisions of the proposed rule. We appreciate the 
comments and will take them into consideration in developing future 
rulemaking.
    Comment: One commenter requests that TRICARE not impose treatment 
limits on the duration of opioid treatment.
    Response: We concur that treatment limits should be guided by the 
patient's clinical condition and treatment needs. Studies have shown 
that good outcomes from substance abuse treatment are unequivocally 
contingent on adequate length of treatment. Although the current 
substance use disorder benefits contain treatment limitations, see 
specifically 32 CFR 199.4(e)(4)(ii), the existing regulation at 32 CFR 
199.4(e)(4)(v) allows for waiver of limits based on individual 
treatment needs. This type of provision helps to ensure TRICARE 
beneficiaries have access to medically or psychologically necessary and 
appropriate medical care for substance use disorders. We appreciate 
this comment and will also take it into consideration in developing any 
future rulemaking regarding TRICARE substance use disorder treatment.
    Comment: Two commenters request that TRICARE not impose high 
deductibles and co-payments on individual visits to decrease the 
likelihood that high costs become a barrier to care.
    Response: We concur that access to care is important for 
beneficiaries seeking opioid addiction treatment. In general, TRICARE 
provides beneficiaries with a robust health care benefit with limited 
out-of-pocket costs. TRICARE deductibles and cost shares are set by 
Congress in statute. Beneficiaries are further protected by statutorily 
imposed catastrophic caps that limit the maximum out-of-pocket amounts 
beneficiaries will have to pay each fiscal year, with a few exceptions. 
The cap applies to annual deductibles, pharmacy copayments, TRICARE 
Prime enrollment fees and all other copayments or cost shares 
beneficiaries pay for TRICARE-covered services. Active duty family 
members and beneficiaries enrolled in TRICARE Reserve Select have a 
$1,000 per family, per fiscal year catastrophic cap. The catastrophic 
cap for other beneficiaries is $3,000 per family, per fiscal year.
    Comment: One of two respondents who objected to the proposed rule 
change, indicated that opioid maintenance treatment on a long term 
basis has not been proven to improve function or reduce mortality or 
relapse in opioid addicted individuals and that research is based on 
short term studies. The respondent also expressed concern that the 
provision of medication assisted treatment is actually enabling 
substance abuse.
    Response: We do not agree. Standards of care and best practices in 
the prevention, diagnosis, treatment, and management of substance use 
disorders have changed considerably over the course of the past decade 
to reflect developments in the evidence base. The use of evidence-based 
practices in substance use dependence care is integral to ensuring that 
individuals receive medically necessary and appropriate medical care 
that is effective, high-quality care. The September 2012, IOM report 
discusses in greater detail the evidence base, including randomized 
controlled trials, that support the use of pharmacotherapies in 
substance use dependence treatment.
    Comment: The second objector asks why tax dollars should go to help 
those who made a decision to partake in illegal activity.
    Response: By law, TRICARE beneficiaries are entitled to medically 
or psychologically necessary and appropriate medical care in the 
treatment of mental or physical illness unless otherwise excluded by 
law and regulation.

Regulatory Procedures

Executive Order 12866, ``Regulatory Planning and Review'' and EO 13563, 
``Improving Regulation and Regulatory Review''

    Section 801 of title 5, United States Code, and Executive Orders 
(EOs) 12866 and 13563 require certain regulatory assessments and 
procedures for any major rule or 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. It 
has been certified that this rule is not an economically significant 
rule, but it has been designated a significant regulatory action.

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

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

[[Page 62430]]

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 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 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 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 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 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 amended as follows:

PART 199--[AMENDED]

0
1. The authority citation for Part 199 continues to read as follows:

    Authority:  5 U.S.C. 301; 10 U.S.C. chapter 55.


0
2. Section 199.4 is amended by revising paragraphs (e)(4)(ii) 
introductory text and (e)(11) introductory text, and removing and 
reserving paragraph (e)(11)(ii), to read as follows:


Sec.  199.4  Basic program benefits.

* * * * *
    (e) * * *
    (4) * * *
    (ii) Authorized substance use disorder treatment. Only those 
services provided by TRICARE-authorized institutional providers are 
covered. Such a provider must be either an authorized hospital, or an 
organized substance use disorder treatment program in an authorized 
free-standing or hospital-based substance use disorder rehabilitation 
facility. Covered services consist of any or all of the services listed 
below, including the substitution of a therapeutic drug, with addictive 
potential, for a drug addiction when medically or psychologically 
necessary and appropriate medical care for a beneficiary undergoing 
medically supervised treatment for a substance use disorder. A 
qualified mental health provider (physicians, clinical psychologists, 
clinical social workers, psychiatric nurse specialists) (see paragraph 
(c)(3)(ix) of this section) shall prescribe the particular level of 
treatment. Each TRICARE beneficiary is entitled to three substance use 
disorder treatment benefit periods in his or her lifetime, unless this 
limit is waived pursuant to paragraph (e)(4)(v) of this section. (A 
benefit period begins with the first date of covered treatment and ends 
365 days later, regardless of the total services actually used within 
the benefit period. Unused benefits cannot be carried over to 
subsequent benefit periods. Emergency and inpatient hospital services 
(as described in paragraph (e)(4)(i) of this section) do not constitute 
substance abuse treatment for purposes of establishing the beginning of 
a benefit period.)
* * * * *
    (11) Drug abuse. Under the Basic Program, benefits may be extended 
for medically necessary prescription drugs required in the treatment of 
an illness or injury or in connection with maternity care (refer to 
paragraph (d) of this section). However, TRICARE 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 the substitution of a therapeutic drug with 
addictive potential for a drug of addiction, prescribed to 
beneficiaries undergoing medically supervised treatment for a substance 
use disorder as authorized under paragraph (e)(4)(ii) of this section 
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: September 26, 2013.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2013-24232 Filed 10-21-13; 8:45 am]
BILLING CODE 5001-06-P