TRICARE; Removal of the Prohibition To Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries, 62427-62430 [2013-24232]
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations
PBGC has determined that this action
is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive
Order 12866.
Because no general notice of proposed
rulemaking is required for this
amendment, the Regulatory Flexibility
Act of 1980 does not apply. See 5 U.S.C.
601(2).
Authority: 29 U.S.C. 1302, 1322, 1322b,
1341(c)(3)(D), and 1344.
List of Subjects in 29 CFR Part 4022
Employee benefit plans, Pension
insurance, Pensions, Reporting and
recordkeeping requirements.
In consideration of the foregoing, 29
CFR part 4022 is amended as follows:
2. In appendix B to part 4022, Rate Set
241, as set forth below, is added to the
table.
■
Appendix B to Part 4022—Lump Sum
Interest Rates for PBGC Payments
PART 4022—BENEFITS PAYABLE IN
TERMINATED SINGLE-EMPLOYER
PLANS
*
*
*
*
*
1. The authority citation for part 4022
continues to read as follows:
■
For plans with a valuation
date
Rate set
On or after
*
Before
*
241
12–1–13
3. In appendix C to part 4022, Rate Set
241, as set forth below, is added to the
table.
■
For plans with a valuation
date
On or after
*
Before
*
[FR Doc. 2013–24592 Filed 10–21–13; 8:45 am]
BILLING CODE 7709–02–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DOD–2011–HA–0085]
RIN–0720–AB54
emcdonald on DSK67QTVN1PROD with RULES
TRICARE; Removal of the Prohibition
To Use Addictive Drugs in the
Maintenance Treatment of Substance
Dependence in TRICARE Beneficiaries
Office of the Secretary,
Department of Defense.
ACTION: Final rule.
AGENCY:
The Department of Defense
(DoD) is publishing this final rule to
remove the exclusion of drug
maintenance programs and allow
SUMMARY:
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Deferred annuities
(percent)
Immediate
annuity rate
(percent)
12–1–13
Issued in Washington, DC, on this 9th day
of October 2013.
Judith Starr,
General Counsel, Pension Benefit Guaranty
Corporation.
i3
Appendix C to Part 4022—Lump Sum
Interest Rates for Private-Sector
Payments
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11–1–13
i2
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4.00
1.75
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241
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annuity rate
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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
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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
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations
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.
emcdonald on DSK67QTVN1PROD with RULES
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
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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,’’ https://
www.iom.edu/Reports/2012/SubstanceUse-Disorders-in-the-US-ArmedForces.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
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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 longterm 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
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations
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
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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
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62429
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,’’
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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).
emcdonald on DSK67QTVN1PROD with RULES
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]
1. The authority citation for Part 199
continues to read as follows:
■
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
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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:
■
§ 199.4
Basic program benefits.
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(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 freestanding 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.)
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(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
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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.
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(ii) [Reserved]
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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
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 236
[DOD–2009–OS–0183]
RIN 0790–AI60
Department of Defense (DoD)—
Defense Industrial Base (DIB)
Voluntary Cyber Security and
Information Assurance (CS/IA)
Activities
Office of the DoD Chief
Information Officer, DoD.
ACTION: Final rule.
AGENCY:
This final rule responds to
public comments regarding the
establishment of the DIB CS/IA
program, a voluntary cyber security
information sharing program between
DoD and eligible DIB companies. The
program enhances and supplements DIB
participants’ capabilities to safeguard
DoD information that resides on, or
transits, DIB unclassified information
systems.
SUMMARY:
Effective Date: This rule is
effective November 21, 2013.
DATES:
Mr.
Dan Prieto at 703–571–5911, or the DIB
Cyber Security and Information
Assurance Program Office: (703) 604–
3167, toll free (855) 363–4227, email
osd.ncr.dod-cio.mbx.dib-cs-ia-programregistration@mail.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Executive Summary
This final rule responds to public
comments regarding the establishment
of the DIB CS/IA program, a voluntary
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]]>Agencies
[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.
-----------------------------------------------------------------------
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,'' https://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
