[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Rules and Regulations]
[Pages 13236-13241]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03417]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DOD-2009-HA-0038]
RIN 0720-AB50


TRICARE: Smoking Cessation Program

AGENCY: Office of the Secretary, Department of Defense.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule implements Section 713 of the Duncan Hunter 
National Defense Authorization Act (NDAA) for Fiscal Year 2009. Section 
713 states the Secretary shall establish a smoking cessation program 
under the TRICARE program. The smoking cessation program under TRICARE 
shall, at a minimum, include the following: The availability, at no 
cost to the beneficiary, of pharmaceuticals used for smoking cessation, 
with the limitation on the availability of such pharmaceuticals to the 
mail-order pharmacy program under the TRICARE program; smoking 
cessation counseling; access to a toll-free quit line 24 hours a day, 7 
days a week; access to print and Internet web-based tobacco cessation 
material. Per the statute, Medicare-eligible beneficiaries are excluded 
from the TRICARE smoking cessation program.

DATES: Effective Date: This final rule is effective March 29, 2013.

FOR FURTHER INFORMATION CONTACT: Ms. Ginnean Quisenberry, Population 
Health, Medical Management, and Patient Centered Medical Home Division, 
Office of the Chief Medical Officer, TRICARE Management Activity, 
telephone (703) 681-6717.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose of the Final Rule

    The purpose of this final rule is to implement the provisions of 
the Duncan Hunter NDAA for FY 2009 (Pub. L. 110-417) that establishes a 
smoking cessation program under the TRICARE program. Establishment of 
the TRICARE smoking cessation program attempts to reduce the number of 
TRICARE beneficiaries who are nicotine dependent, thereby improving the 
health of the TRICARE beneficiary population and reducing Department of 
Defense costs, in particular those related to the adverse effects of 
smoking. The legal authority for the Final Rule is Section 713 of the 
Duncan Hunter NDAA FY09 (Pub. L. 110-417).

B. Summary of the Major Provisions of the Final Rule

    Section 713 of the Duncan Hunter NDAA for FY 2009 stipulates the 
following key features for inclusion in the TRICARE smoking cessation 
program:
    1. The availability, at no cost to the beneficiary, of 
pharmaceuticals used for smoking cessation, with a limitation on the 
availability of such pharmaceuticals to the national mail-order 
pharmacy program under the TRICARE program if appropriate.
    Smoking cessation medications will be covered by TRICARE through 
the Mail Order Pharmacy program, as well

[[Page 13237]]

as at Military Treatment Facilities at no cost, including no co-pay. 
The type of smoking cessation medications available, which may include 
over-the-counter medications, will be determined by the TRICARE 
Pharmacy and Therapeutics Committee based on clinical and cost 
effectiveness considerations.
    2. Counseling.
    In person smoking cessation counseling from a TRICARE authorized 
provider as detailed in the TRICARE Policy Manual for is a covered 
TRICARE benefit for those beneficiaries that are not eligible for 
Medicare.
    3. Access to a toll-free quit line that is available 24 hours a 
day, 7 days a week.
    Beneficiaries will have access to a toll-free smoking cessation 
quit line that will be available 24 hours a day, 7 days a week.
    4. Access to print and Internet web-based tobacco cessation 
material.
    TRICARE will provide access to both print and web-based tobacco 
cessation materials for any beneficiary who is interested in quitting 
using tobacco products.
    5. Chain of command involvement by officers in the chain of command 
of participants in the program who are on active duty.
    All of those in the chain of command are expected to provide their 
support to the program and to any member who wishes to quit smoking. 
There is no intent for any reporting requirements to the chain of 
command related to any member's participation.

C. Costs and Benefits of this Regulatory Action

    The cost for these changes is estimated to be 24 million dollars 
for a one year period. The benefits are that TRICARE will be in 
compliance with its statutory provisions and health of beneficiaries 
who quit smoking will be improved.

II. Background

    The Duncan Hunter NDAA for FY 2009 (Pub. L. 110-417) provides 
authority for establishment of a smoking cessation program under the 
TRICARE program. Prior to enactment of Section 713 of the Duncan Hunter 
NDAA FY09 (Pub. L. 110-417), all supplies and services related to 
``stop smoking'' programs were excluded from TRICARE coverage per the 
regulation, 32 CFR 199.4(g)(65).
    Smoking is the number one cause of preventable illness and disease 
in the United States and yet, the prevalence of smoking among TRICARE 
beneficiaries exceeds that of the general population. According to the 
Centers for Disease Control and Prevention (CDC), adverse health 
effects from smoking account for an estimated 443,000 deaths in the 
United States each year.
    Smoking causes respiratory diseases such as emphysema, bronchitis, 
and chronic airway obstruction. It also causes several types of cancers 
including, but not limited to, esophageal, oral cavity, uterine, and 
lung cancer. In fact, the CDC estimates that 90 percent of lung cancer 
deaths in men and 80 percent in women are caused by smoking.
    Smoking also puts individuals at increased risk for several other 
types of diseases and adverse health outcomes such as coronary artery 
disease, chronic obstructive lung diseases, peripheral vascular 
disease, heart attack, and stroke. In addition, it increases the risk 
of infertility, preterm delivery, stillbirth, low birth weight, and 
sudden infant death syndrome.
    Smoking and its related adverse effects pose a significant 
challenge for many TRICARE beneficiaries. Establishment of the TRICARE 
smoking cessation program attempts to reduce the number of TRICARE 
beneficiaries who are nicotine dependent, thereby improving the health 
of the TRICARE beneficiary population and reducing Department of 
Defense costs, in particular those related to the adverse effects of 
smoking. For further information on TRICARE and the benefits provided 
under the TRICARE program, please visit www.tricare.mil.

III. Section 713 of the Duncan Hunter NDAA for FY 2009

    This final rule implements Section 713 of the Duncan Hunter NDAA 
for FY 2009. Section 713 stipulates the following key features for 
inclusion in the TRICARE smoking cessation program:
    (1) The availability, at no cost to the beneficiary, of 
pharmaceuticals used for smoking cessation, with a limitation on the 
availability of such pharmaceuticals to the national mail-order 
pharmacy program under the TRICARE program if appropriate.
    (2) Counseling.
    (3) Access to a toll-free quit line that is available 24 hours a 
day, 7 days a week.
    (4) Access to print and Internet web-based tobacco cessation 
material.
    (5) Chain of command involvement by officers in the chain of 
command of participants in the program who are on active duty.
    Additionally, Section 713 of NDAA FY 2009 stated the TRICARE 
smoking cessation program shall not be made available to Medicare-
eligible beneficiaries. The statutory language further stated that 
refunds of copayments paid by Medicare-eligible beneficiaries are 
available during fiscal year 2009, subject to the specific availability 
of appropriations for this purpose. However, this authority was not 
extended beyond FY 2009; consequently, no action is required by TRICARE 
regarding this provision.

IV. Final Rule

    This final rule establishes a smoking cessation program under the 
TRICARE program. The TRICARE smoking cessation program will be 
available to all TRICARE beneficiaries who reside in one of the 50 
United States or the District of Columbia who are not eligible for 
Medicare benefits authorized under Title XVIII of the Social Security 
Act. In general, the TRICARE smoking cessation program will not be 
available to TRICARE beneficiaries who reside overseas except that 
under authority of 32 CFR 199.17, active duty service members and 
active duty dependents residing overseas including the U.S. territories 
of Guam, Puerto Rico, and the Virgin Islands who are enrolled in 
TRICARE Prime at a military treatment facility may have access to those 
services that the ASD(HA) has determined may be reasonably provided 
overseas.
    It is the intent of the Department to provide access to smoking 
cessation pharmaceuticals and web based smoking cessation materials 
overseas where feasible. However, beneficiaries residing in certain 
areas overseas may not have easy access to the mail services, equipment 
or technology needed to receive these smoking cessation benefits and in 
those areas there is no requirement to make them available. For 
example, there is no intent by the Department to make the web based 
services available in areas where there are no web based carriers to 
provide such a service. Additionally, the laws and our treaties with 
various countries restrict the mailing of pharmaceuticals into the 
country. If such laws or treaties do not allow the delivery of the 
pharmaceuticals through the TRICARE Mail Order Pharmacy (TMOP), it is 
not the intent of the Secretary to provide the pharmaceutical benefit 
in those areas through this mechanism.
    At this time, it is not the intent of the Department to provide 
access to the toll free quit line overseas due to the technological 
barriers and cost involved in providing this service. In addition, it 
is not the intent of the Department at this time to make face-to-face 
smoking

[[Page 13238]]

cessation counseling available overseas through the local economy. 
However, in accordance with 32 CFR 199.17 should the ASD(HA) determine 
that it is technologically, economically, or otherwise feasible to 
provide additional benefits or it becomes impractical to continue the 
benefits and services overseas, the ASD(HA) may use this authority to 
add or modify any benefit or service. Notice of the use of this 
authority shall be published in the Federal Register.
    There will be no requirement for an eligible beneficiary to be 
diagnosed with a smoking related illness in order to access benefits 
under the TRICARE smoking cessation program. Benefits under this 
program will include, at no cost to the beneficiary, pharmaceuticals 
used for smoking cessation available through the TRICARE mail-order 
pharmacy program and at Military Treatment Facilities. The program will 
include smoking cessation counseling; access to a toll-free quit line 
24 hours a day, 7 days a week; and access to printed and Internet web-
based tobacco cessation material. Like other pharmaceuticals, smoking 
cessation pharmaceuticals may also be available at no cost to the 
beneficiary at an MTF; however, smoking cessation pharmaceuticals are 
not a covered benefit under the TRICARE Retail Pharmacy program.

V. Public Comments

    The proposed rule was published in the Federal Register (76 FR 
58199) dated September 20, 2011, for a 60-day public comment period. We 
received sixteen comments from different respondents on the proposed 
rule.
    All but one of the public comments was positive and supported the 
provisions of the proposed rule. Fifteen of the respondents approved of 
the new coverage of smoking cessation medications with no copay, 
however there were two comments questioning the limitation of 
availability to the Mail Order Pharmacy Program. There was concern that 
TRICARE had not explained the reasoning for this decision and some were 
concerned that this limitation would be a barrier to those seeking 
treatment. We appreciate the comments and acknowledge the concern. 
However, we do not believe that limiting availability of smoking 
cessation pharmaceuticals to the mail order pharmacy will be a barrier 
to seeking care by the majority of beneficiaries. Mail order is a more 
cost effective venue than retail pharmacy and this limitation is a way 
of controlling the cost of providing these pharmaceuticals at no cost 
to the beneficiary. We believe that providing these pharmaceuticals at 
no cost has a greater influence on a beneficiary's decision to seek 
care than the fact that the care is limited to a specific venue. We 
believe this to be a prudent, fair, and reasonable approach to 
providing the pharmaceutical component of the benefit.
    Additionally, one respondent, representing the National Community 
Pharmacists Association felt that since some retail pharmacists provide 
smoking cessation counseling, it would be more convenient for 
beneficiaries to be able to get their medications at the retail 
pharmacy where they might possibly be going for smoking cessation 
counseling, so that both activities could occur in one location. We 
appreciate the respondent's comment and the suggestion that would 
seemingly offer greater convenience to TRICARE beneficiaries; however, 
consistent with Center for Medicare and Medicaid Services (CMS), 
pharmacists are not recognized as authorized TRICARE independent 
providers. Although TRICARE currently recognizes pharmacies as 
providers for purposes of the pharmacy benefits program under 32 CFR 
199.21, which includes providing immunizations to our beneficiaries, 
the individual pharmacist is not recognized as an independent provider. 
Therefore, pharmacist counseling services are not currently a covered 
benefit under TRICARE and pharmacists cannot be reimbursed for this 
service. Therefore, beneficiaries who obtain smoking cessation products 
in a retail pharmacy may not receive counseling from the pharmacist as 
a covered benefit. In addition, as mentioned above, providing these 
products in the retail venue would significantly increase the cost of 
this program. The respondents were also concerned that if medications 
for smoking cessation are mailed to a patient's home, they will not 
have the opportunity to ask questions of a pharmacist before taking 
them. Unlike the majority of retail pharmacies, the mail order pharmacy 
program provides access to pharmacists 24/7 via a toll free number. 
Consistent with most pharmacy services, the mail order program provides 
complete written information including instructions for use, side 
effects, adverse effects, doses, warnings, and telephone numbers for 
questions.
    Five respondents expressed concern that these new benefits were 
only available CONUS and not OCONUS. One respondent suggested a change 
to the language that deals with OCONUS availability. The commentor 
would prefer that it say that TRICARE is required to make the smoking 
cessation program available overseas unless the ASD(HA) determines it 
is not possible to provide the program in specific overseas locations 
or situations, instead of stating that the benefits are not available 
overseas unless the Assistant Secretary of Defense for Health Affairs 
[ASD(HA)] determines they can be reasonably provided. We appreciate the 
respondent's comments and acknowledge the respondent's suggestion, 
however during the implementation of this benefit the ability to 
provide the benefit overseas was extensively explored. The Department 
found significant barriers and elected not to implement at this time. 
The language gives the Assistant Secretary the ability to expand the 
benefit as technology and other innovations make the delivery of these 
benefits feasible. Additionally the current federal regulations 
relating to the implementation of TRICARE overseas states that the 
program is not implemented overseas without affirmative action by the 
Department, thus the language used is consistent with our current 
regulatory framework.
    One person commented that the smoking cessation program should 
include provisions to assist with tobacco cessation as well. We 
appreciate the comment; however, the language in section 713 of the 
NDAA 2009 limits us to providing a smoking cessation program with one 
exception. That exception allows the Department to provide printed and 
Internet web-based tobacco cessation materials.
    One respondent was concerned that the language in the summary 
statement that says that there is a ``limitation on the availability of 
such pharmaceuticals to the mail-order pharmacy'' will cause the 
beneficiaries to believe that they cannot get these medications at the 
MTF pharmacies. We appreciate the respondent's comment and concern, and 
would like to assure the respondent that this was unintentional. To 
correct this and assure clarity, the language in Section III, the 
Summary, concerning the availability of smoking cessation 
pharmaceuticals has been revised to include a reference to the 
availability of pharmaceuticals at the MTFs. The language in the 
regulation itself reflects the correct availability of these 
pharmaceutical agents.
    The statement in the proposed rule that says, ``the Secretary of 
Defense shall provide for involvement by officers in the chain of 
command of participants in the program who are on active duty'' caused 
concern for one responder. This commentor took this statement to mean 
that those active duty members who took advantage of the program would

[[Page 13239]]

have to report on their progress to their supervisor, which they felt 
would be very intimidating for those trying to quit, especially if they 
were having difficulties. We appreciate the comment, and want to 
clarify that the intent is not to have supervising officers be directly 
involved in individual active duty service members quit attempts, but 
to have them provide their support to the program. That is, it is the 
intent of the Department for all parts of the chain of command to 
support any member who wishes to quit smoking. There is no intent for 
any reporting requirements by a member to his or her command or for any 
member within the chain of command to report to their superiors 
relating to any member's participation in a smoking cessation program.
    There were several comments related to the number of quit attempts 
available to participants in the program. One respondent did not think 
that a beneficiary should get more than three attempts total. The 
commenter was opposed to having three possible attempts per year and 
felt it would be a waste of TRICARE resources to continue to pay for 
additional attempts for someone who was not successful within a year of 
trying. We acknowledge the respondent's comments and appreciate the 
concerns. TRICARE is dedicated to the appropriate and judicious use of 
taxpayers' money and the decision to allow more than three quit 
attempts in total was the result of extensive research concerning 
smoking cessation. This research revealed that, on average, it takes 
smokers seven attempts to quit. Allowing more than three total attempts 
will give TRICARE beneficiaries who want to quit smoking the best 
opportunity to do so. This will result in a healthier beneficiary 
population; and as this population becomes healthier and more 
individuals choose to quit, TRICARE health care costs associated with 
treating diseases that are either caused by or exacerbated by smoking 
will be reduced.
    Another respondent had the opposite view, believing that since 
``tobacco dependence is a chronic disease that often requires repeated 
intervention and multiple attempts to quit'', patients should not be 
limited in their attempts and should have access to tobacco cessation 
services throughout the year. We acknowledge and respect this 
respondent's point of view; however, believe it would be fiscally 
irresponsible not to impose a limit on quit attempts. Furthermore, 
while our research revealed that the average person requires multiple 
attempts at quitting before they are successful, our research did not 
support a conclusion that allowing unlimited quit attempts results in 
improved success rates.
    This respondent also requested that the DoD Pharmacy and 
Therapeutics Committee, when deciding which specific smoking cessation 
medications TRICARE will cover, will choose to include all FDA-approved 
tobacco cessation medications. We appreciate this respondent's comment 
and suggestion. The Pharmacy and Therapeutics Committee has a mandate 
to review and recommend drugs based on their clinical and cost 
effectiveness. After this formal process, these recommendations will 
then go to the TMA Director, who will make the final decision. At this 
point, we do not know which of the smoking cessation medications will, 
or will not be on the formulary.
    Another comment requested that TRICARE providers be made aware of 
the available cessation benefits and be trained in smoking cessation 
counseling. We appreciate the respondent's comments and suggestions and 
want to assure this respondent that once the final rule is published 
and this becomes a TRICARE benefit, information concerning it will be 
well publicized. This publicity will include information for TRICARE 
providers and our beneficiaries. Information concerning this new 
benefit will also be available on the TRICARE Web site 
(www.TRICARE.mil), which is accessible to beneficiaries, providers and 
the general public. In addition, the Managed Care Support Contractors 
are required to disseminate information to providers affected by 
implementation of new TRICARE benefits.
    Another comment recommended an expansion of the TRICARE smoking 
cessation program to include a reduction of tobacco advertising in 
military literature and increasing the cost of tobacco products on 
military bases. We appreciate this respondent's comment and 
suggestions; however, the authority to take the actions suggested is 
beyond the scope of the requirements of the law that TRICARE was tasked 
to implement.
    Unrelated to the Proposed Rule on Smoking Cessation, one comment 
was received from a retiree who was upset that he might be forced to 
pay more for TRICARE Prime as a part of DoD cutbacks. We appreciate 
this respondent's comments; however, we cannot address these here as 
they are outside the scope of the law that implements the TRICARE 
smoking cessation benefits.

VI. Regulatory Procedures

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

    Section 801 of title 5, United States Code, and Executive Orders 
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. This 
final rule is not a significant regulatory action.

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 final rule will not have a significant impact on a substantial 
number of small entities. Therefore, this final 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).

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

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

Executive Order 13132, ``Federalism''

    Executive Order 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,

[[Page 13240]]

or on the distribution of power and responsibilities among the various 
levels of government. This final rule does not have federalism 
implications, as set forth in Executive Order 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:
0
a. Revising paragraph (d)(3)(vi) introductory text.
0
b. Adding new paragraph (d)(3)(vi)(C).
0
c. Adding new paragraph (e)(30).
0
d. Revising paragraph (g)(39).
0
e. Removing and reserving paragraph (g)(65).
    The revisions and additions read as follows:


Sec.  199.4  Basic program benefits.

* * * * *
    (d) * * *
    (3) * * *
    (vi) Drugs and medicines. Drugs and medicines that by United States 
law require a prescription are also referred to as ``legend drugs.'' 
Legend drugs are covered when prescribed by a physician or other 
authorized individual professional provider acting within the scope of 
the provider's license and ordered or prescribed in connection with an 
otherwise covered condition or treatment, and not otherwise excluded by 
TRICARE. This includes Rh immune globulin.
* * * * *
    (C) Over-the-counter (OTC) drugs (drugs that by United States law 
do not require a prescription), in general, are not covered. However, 
insulin is covered for a known diabetic even in states that do not 
require a prescription for its purchase. In addition, OTC drugs used 
for smoking cessation are covered when all requirements under the 
TRICARE smoking cessation program are met as provided in paragraph 
(e)(30) of this section.
* * * * *
    (e) * * *
    (30) Smoking cessation program. The TRICARE smoking cessation 
program is a behavioral modification program to assist eligible 
beneficiaries who desire to quit smoking. The program consists of a 
pharmaceutical benefit; smoking cessation counseling; access to a toll-
free quit line for non-medical assistance; and, access to print and 
internet web-based tobacco cessation materials.
    (i) Availability. The TRICARE smoking cessation program is 
available to all TRICARE beneficiaries who reside in one of the 50 
United States or the District of Columbia who are not eligible for 
Medicare benefits authorized under Title XVIII of the Social Security 
Act. In addition, pursuant to Sec.  199.17, if authorized by the 
Assistant Secretary of Defense (Health Affairs), the TRICARE smoking 
cessation program may be implemented in whole or in part in areas 
outside the 50 states and the District of Columbia for active duty 
members and their dependents who are enrolled in TRICARE Prime 
(overseas Prime beneficiaries). In such cases, the Assistant Secretary 
of Defense (Health Affairs) may also authorize modifications to the 
TRICARE smoking cessation program rules and procedures as may be 
appropriate to the overseas area involved. Notice of the use of this 
authority, not otherwise mentioned in this paragraph (e)(30), shall be 
published in the Federal Register.
    (ii) Benefits. There is no requirement for an eligible beneficiary 
to be diagnosed with a smoking related illness to access benefits under 
this program. The specific benefits available under the TRICARE smoking 
cessation program are:
    (A) Pharmaceutical agents. Products available under this program 
are identified through the DoD Pharmacy and Therapeutics Committee, 
consistent with the DoD Uniform Formulary in Sec.  199.21. Smoking 
cessation pharmaceutical agents, including FDA-approved over-the-
counter (OTC) pharmaceutical agents, are available through the TRICARE 
Mail Order Pharmacy (TMOP) or the MTF at no cost to the beneficiary. 
Smoking cessation pharmaceuticals through the TRICARE program will not 
be available at any retail pharmacies. A prescription from a TRICARE-
authorized provider is required to obtain any pharmaceutical agent used 
for smoking cessation, including OTC agents. For overseas Prime 
beneficiaries, pharmaceutical agents may be provided either in the MTF 
or through the TMOP where such facility or service is available.
    (B) Face-to-face smoking cessation counseling. Both individual and 
group smoking cessation counseling are covered. The number and mix of 
face-to-face counseling sessions covered under this program shall be 
determined by the Director, TMA; however, shall not exceed the limits 
established in paragraph (e)(30)(iii) of this section. A TRICARE-
authorized provider listed in Sec.  199.6 must render all counseling 
sessions.
    (C) Toll-free quit line. Access to a non-medical toll-free quit 
line 7 days a week, 24 hours a day will be available. The quit line 
will be staffed with smoking cessation counselors trained to assess a 
beneficiary's readiness to quit, identify barriers to quitting, and 
provide specific suggested actions and motivational counseling to 
enhance the chances of a successful quit attempt. When appropriate, 
quit line counselors will refer beneficiaries to a TRICARE-authorized 
provider for medical intervention. The quit line may, at the discretion 
of the Director, TMA, include the opportunity for the beneficiary to 
request individual follow-up contact initiated by quit line personnel; 
however, the beneficiary is not required to participate in the quit 
line initiated follow-up. Printed educational materials on the effects 
of tobacco use will be provided to the beneficiary upon request. This 
benefit may be made available to overseas Prime beneficiaries should 
the ASD(HA) exercise his authority to do so and provide appropriate 
notice in the Federal Register.
    (D) Web-based resources. Downloadable educational materials on the 
effects of tobacco use will be available through the internet or other 
electronic media. This service may be made available to overseas Prime 
beneficiaries in all locations where web based resources are available. 
There shall be no requirement to create web based resources in any 
geographic area in order to make this service available.
    (iii) Limitations of smoking cessation program. Eligible 
beneficiaries are entitled to two quit attempts per year (consecutive 
12 month period). A third quit attempt may be covered per year with 
physician justification and pre-authorization. A quit attempt is 
defined as up to eighteen face-to-face counseling sessions over a 120 
consecutive day period and/or 120 days of pharmacologic intervention 
for the purpose of smoking cessation. Counseling and pharmacological 
treatment periods that overlap by at least 60-days are considered a 
single quit attempt.
* * * * *
    (g) * * *
    (39) Counseling. Educational, vocational, and nutritional 
counseling and counseling for socioeconomic purposes, stress 
management, and/or lifestyle modification purposes, except that the 
following are not excluded:
    (i) Services provided by a certified marriage and family therapist, 
pastoral

[[Page 13241]]

or mental health counselor in the treatment of a mental disorder as 
specifically provided in paragraph (c)(3)(ix) of this section and in 
Sec.  199.6.
    (ii) Diabetes self-management training (DSMT) as specifically 
provided in paragraph (d)(3)(ix) of this section.
    (iii) Smoking cessation counseling and education as specifically 
provided in paragraph (e)(30) of this section.
    (iv) Services provided by alcoholism rehabilitation counselors only 
when rendered in a CHAMPUS-authorized treatment setting and only when 
the cost of those services is included in the facility's CHAMPUS-
determined allowable cost rate.
* * * * *
    (65) [Reserved]
* * * * *

0
3. Section 199.21 is amended by:
0
a. Revising paragraph (a)(2);
0
b. Revising paragraph (h)(2)(i);
0
c. Adding a new paragraph (h)(2)(iii); and
0
d. Adding a new (i)(2)(v)(D).
    The additions and revisions read as follows:


Sec.  199.21  Pharmacy benefits program.

    (a) * * *
    (2) Pharmacy benefits program. (i) Applicability. The pharmacy 
benefits program, which includes the uniform formulary and its 
associated tiered co-payment structure, is applicable to all of the 
uniformed services. Geographically, except as specifically provided in 
paragraph (a)(2)(ii) of this section, this program is applicable to all 
50 states and the District of Columbia, Guam, Puerto Rico, and the 
Virgin Islands. In addition, if authorized by the Assistant Secretary 
of Defense (Health Affairs) (ASD(HA)), the TRICARE pharmacy benefits 
program may be implemented in areas outside the 50 states and the 
District of Columbia, Guam, Puerto Rico, and the Virgin Islands. In 
such case, the ASD (HA) may also authorize modifications to the 
pharmacy benefits program rules and procedures as may be appropriate to 
the area involved.
    (ii) Applicability exception. The pharmaceutical benefit under the 
TRICARE smoking cessation program under Sec.  199.4(e)(30) is available 
to TRICARE beneficiaries who are not entitled to Medicare benefits 
authorized under Title XVIII of the Social Security Act. Except as 
noted in Sec.  199.4(e)(30), the smoking cessation program, including 
the pharmaceutical benefit, is not applicable or available to 
beneficiaries who reside overseas, including the U. S. territories of 
Guam, Puerto Rico, and the Virgin Islands, except that under the 
authority of Sec.  199.17 active duty service members and active duty 
dependents enrolled in TRICARE Prime residing overseas, including the 
U. S. territories of Guam, Puerto Rico, and the Virgin Islands, shall 
have access to smoking cessation pharmaceuticals through either an MTF 
or the TMOP program where available.
* * * * *
    (h) * * *
    (2) Availability of formulary pharmaceutical agents. (i) General. 
Subject to paragraphs (h)(2)(ii) and (h)(2)(iii) of this section, 
formulary pharmaceutical agents are available under the Pharmacy 
Benefits Program from all points of service identified in paragraph 
(h)(1) of this section.
* * * * *
    (iii) Pharmaceutical agents prescribed for smoking cessation are 
not available for coverage when obtained through a retail pharmacy. 
This includes network and non-network retail pharmacies.
* * * * *
    (i) * * *
    (2) * * *
    (v) * * *
    (D) $0.00 co-payment for smoking cessation pharmaceutical agents 
covered under the smoking cessation program.
* * * * *

    Dated: February 1, 2013.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2013-03417 Filed 2-26-13; 8:45 am]
BILLING CODE 5001-06-P