TRICARE; Smoking Cessation Program Under TRICARE, 58199-58202 [2011-23764]
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Federal Register / Vol. 76, No. 182 / Tuesday, September 20, 2011 / Proposed Rules
Unfunded Mandates Reform Act of
1995
This rule will not result in the
expenditure by State, local and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
in any one year, and it will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This rule is not a major rule as
defined by § 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996. This rule will not result in an
annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects in 28 CFR Part 570
Prisoners.
Thomas R. Kane,
Acting Director, Bureau of Prisons.
Under rulemaking authority vested in
the Attorney General in 5 U.S.C. 301; 28
U.S.C. 509, 510 and delegated to the
Director, Bureau of Prisons, we propose
to revise 28 CFR part 570 as set forth
below.
Subchapter D—Community Programs and
Release
PART 570—COMMUNITY PROGRAMS
1. Revise the authority citation for 28
CFR part 570 to read as follows:
Authority: 5 U.S.C. 301; 18 U.S.C. 751,
3621, 3622, 3624, 4001, 4042, 4081, 4082
(Repealed in part as to offenses committed on
or after November 1, 1987), 4161–4166,
5006–5024 (Repealed October 12, 1984, as to
offenses committed after that date), 5039; 28
U.S.C. 509, 510.
2. In part 570, subpart B is revised to
read as follows:
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Subpart B—Pre-Release Community
Confinement
Sec.
570.20
570.21
570.22
Purpose.
Time-frames.
Designation.
§ 570.20
to pre-release community confinement
or home detention.
(a) Community confinement is
defined as residence in a community
treatment center, halfway house,
restitution center, mental health facility,
alcohol or drug rehabilitation center, or
other community correctional facility
(including residential re-entry centers);
and participation in gainful
employment, employment search
efforts, community service, vocational
training, treatment, educational
programs, or similar facility-approved
programs during non-residential hours.
(b) Home detention is defined as a
program of confinement and
supervision that restricts the defendant
to his place of residence continuously,
except for authorized absences, enforced
by appropriate means of surveillance by
the probation office or other monitoring
authority.
§ 570.21
Time-frames.
(a) Community confinement. Inmates
may be designated to community
confinement as a condition of prerelease custody and programming
during the final months of the inmate’s
term of imprisonment, not to exceed
twelve months.
(b) Home detention. Inmates may be
designated to home detention as a
condition of pre-release custody and
programming during the final months of
the inmate’s term of imprisonment, not
to exceed the shorter of ten percent of
the inmate’s term of imprisonment or
six months.
(c) Exceeding time-frames. These
time-frames may be exceeded when
separate statutory authority allows
greater periods of community
confinement as a condition of prerelease custody.
§ 570.22
Designation.
Inmates will be considered for prerelease community confinement in a
manner consistent with 18 U.S.C.
Section 3621(b), determined on an
individual basis, and of sufficient
duration to provide the greatest
likelihood of successful reintegration
into the community, within the timeframes set forth in this part.
Purpose.
[FR Doc. 2011–23684 Filed 9–19–11; 8:45 am]
BILLING CODE 4410–05–P
The purpose of this subpart is to
provide the procedures of the Bureau of
Prisons (Bureau) for designating inmates
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58199
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
Office of the Secretary,
Department of Defense.
ACTION: Proposed rule.
AGENCY:
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: https://
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 https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT:
Barbara (Bobbie) Matthews, Medical
SUMMARY:
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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 https://
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
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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 webbased 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
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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 mailorder 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.
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Federal Register / Vol. 76, No. 182 / Tuesday, September 20, 2011 / Proposed Rules
This proposed rule is not a significant
regulatory action.
PART 199—[AMENDED]
1. The authority citation for Part 199
continues to read as follows:
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.
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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:
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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:
§ 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 tollfree quit line for non-medical assistance;
and, access to print and Internet Webbased 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
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58201
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-thecounter (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 TRICAREauthorized 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 faceto-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 nonmedical 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
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suggested actions and motivational
counseling to enhance the chances of a
successful quit attempt. When
appropriate, quit line counselors will
refer beneficiaries to a TRICAREauthorized 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 preauthorization. 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.
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(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:
§ 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 copayment 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
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to smoking cessation pharmaceuticals
through either an MTF or the TMOP
program where available.
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*
*
*
*
(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
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD–2011–HA–0035]
RIN 0720–AB49
TRICARE; TRICARE Sanction
Authority for Third-Party Billing Agents
Office of the Secretary,
Department of Defense.
ACTION: Proposed rule.
AGENCY:
The rule proposes to provide
the Director, TRICARE Management
Activity (TMA), or designee, with the
authority to sanction third-party billing
agents by invoking the administrative
remedy of exclusion or suspension from
the TRICARE program. Such sanctions
SUMMARY:
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]]>Agencies
[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]
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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: https://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 https://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 https://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
