Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations 62427 

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). 

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: 

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE-EMPLOYER 

PLANS 

■ 1. The authority citation for part 4022 

continues to read as follows: 

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344. 

■ 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 

* * * * * 

Rate set 

For plans with a valuation 

date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

241 11–1–13 12–1–13 1.75 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, Rate Set 

241, as set forth below, is added to the 

table. 

Appendix C to Part 4022—Lump Sum 

Interest Rates for Private-Sector 

Payments 

* * * * * 

Rate set 

For plans with a valuation 

date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

241 11–1–13 12–1–13 1.75 4.00 4.00 4.00 7 8 

Issued in Washington, DC, on this 9th day 

of October 2013. 

Judith Starr, 

General Counsel, Pension Benefit Guaranty 

Corporation. 

[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 

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 


emcdonald on DSK67QTVN1PROD with RULES
62428 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. 

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/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 

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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations 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,’’ 


emcdonald on DSK67QTVN1PROD with RULES
62430 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Rules and Regulations 

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] 

■ 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 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. 

* * * * * 

(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.) 

* * * * * 

(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 

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 

AGENCY: Office of the DoD Chief 

Information Officer, DoD. 

ACTION: Final rule. 

SUMMARY: 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. 

DATES: Effective Date: This rule is 

effective November 21, 2013. 

FOR FURTHER INFORMATION CONTACT: 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:

Executive Summary 

This final rule responds to public 

comments regarding the establishment 

of the DIB CS/IA program, a voluntary 


emcdonald on DSK67QTVN1PROD with RULES