```

[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Proposed Rules]
[Pages 58199-58202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23764]

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

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[Docket ID: DOD-2011-HA-0038]
RIN 0720-AB50

TRICARE; Smoking Cessation Program Under TRICARE

AGENCY: Office of the Secretary, Department of Defense.

ACTION: Proposed rule.

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

SUMMARY: This proposed rule implements Section 713 of the Duncan Hunter 
National Defense Authorization Act (NDAA) for Fiscal Year 2009 (FY 
2009), Public Law 110-417. 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; and 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: Written comments received at the address indicated below by 
November 21, 2011 will be accepted.

ADDRESSES: You may submit comments, identified by docket number or 
Regulatory Information Number (RIN) and title, by any of the following 
methods:
    Federal Rulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    Mail: Federal Docket Management System Office, 4800 Mark Center 
Drive, 2nd Floor, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
    Instructions: All submissions received must include the agency name 
and docket number or RIN for this Federal Register document. The 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
Internet at http://www.regulations.gov as they are received without 
change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: Barbara (Bobbie) Matthews, Medical

[[Page 58200]]

Benefits and Reimbursement Branch, TRICARE Management Activity, 
telephone (303) 676-3558.

SUPPLEMENTARY INFORMATION:

I. 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 Code of Federal Regulations (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 more than two million TRICARE beneficiaries. 
Establishment of the TRICARE smoking cessation program attempts to 
reduce the number of TRICARE beneficiaries who are nicotine dependant, 
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 http://www.tricare.mil.

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

    This proposed 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.

III. Provisions of Proposed Rule

    This proposed 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 of this part, 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 cessation counseling available overseas through the local 
economy. However, in accordance with 32 CFR 199.17 of this part 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. 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, with a limitation on the availability of 
such pharmaceuticals to the national 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; and access to print and 
internet web-based tobacco cessation materials.

IV. 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.

[[Page 58201]]

This proposed 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 proposed rule will not have a significant impact on a substantial 
number of small entities. Therefore, this proposed rule is not subject 
to the requirements of the RFA.

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

    This rule does not contain a ``collection of information'' 
requirement, and will not impose additional information collection 
requirements on the public under Pub. L. 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 proposed rule does not contain a Federal mandate 
that may result in the expenditure by State, local and tribal 
governments, in aggregate, or by the private sector, of $100 million or 
more in any one year, and thus this proposed rule is not subject to 
this requirement.

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, or 
on the distribution of power and responsibilities among the various 
levels of government. This proposed 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 proposed to be amended as follows:

PART 199--[AMENDED]

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

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

    2. Section 199.4 is amended by:
    a. Revising paragraph (d)(3)(vi).
    b. Adding new paragraph (d)(3)(vi)(C).
    c. Adding new paragraph (e)(28).
    d. Revising paragraph (g)(39).
    e. Removing and reserving paragraph (g)(65).
    The revisions and additions read as follows:

Sec.  199.4  TRICARE--Basic Program Benefits.

* * * * *
    (d) Other benefits.
* * * * *
    (3) Other covered services or supplies.
* * * * *
    (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.
    (A) * * *
    (B) * * *
    (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)(28) of this section.
* * * * *
    (e) Special benefit information.
* * * * *
    (28) 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 section 199.17 of this Part, 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. The use of this authority, 
not otherwise mentioned below, 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 section 199.21 of this 
Part. 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 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)(28)(iii) of this section. A TRICARE-
authorized provider listed in section 199.6 of this Part 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

[[Page 58202]]

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) Exclusions and limitations.
* * * * *
    (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 or mental health counselor in the treatment of a mental 
disorder as specifically provided in paragraph (c)(3)(ix) of this 
section and in section 199.6 of this Part.
    (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)(28) 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]
* * * * *
    3. Section 199.21 is amended by:
    a. Revising paragraph (a)(2);
    b. Revising paragraph (h)(2)(i);
    c. Adding a new paragraph (h)(2)(iii); and
    d. Adding a new (i)(2)(v)(D).
    The additions and revisions read as follows:

Sec.  199.21  TRICARE--Pharmacy Benefits Program.

    (a) General.
    (1) * * *
    (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 section 199.4(e)(28) of this 
Part 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 section 199.4(e)(28) of this Part, 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 section 199.17 of this part 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) Obtaining pharmacy services under the retail network pharmacy 
benefits program.
    (1) * * *
    (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.
    (ii) * * *
    (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) Cost-sharing requirements under the pharmacy benefits program.
    (1) * * *
    (2) * * *
    (v) For pharmaceutical agents obtained under the TMOP program there 
is a:
    (A) * * *
    (B) * * *
    (C) * * *
    (D) $0.00 co-payment for smoking cessation pharmaceutical agents 
covered under the smoking cessation program.
* * * * *

    Dated: August 24, 2011.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-23764 Filed 9-19-11; 8:45 am]
BILLING CODE 5001-06-P
```