TRICARE: Smoking Cessation Program, 13236-13241 [2013-03417]
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approved by the ALJ if the case is before
the ALJ, or by the ARB if the ARB has
accepted the case for review. A copy of
the settlement will be filed with the ALJ
or the ARB, as the case may be.
(e) Any settlement approved by the
Assistant Secretary, the ALJ, or the ARB
will constitute the final order of the
Secretary and may be enforced in
United States district court pursuant to
§ 1984.113.
§ 1984.112
Judicial review.
(a) Within 60 days after the issuance
of a final order under §§ 1984.109 and
1984.110, any person adversely affected
or aggrieved by the order may file a
petition for review of the order in the
United States Court of Appeals for the
circuit in which the violation allegedly
occurred or the circuit in which the
complainant resided on the date of the
violation.
(b) A final order is not subject to
judicial review in any criminal or other
civil proceeding.
(c) If a timely petition for review is
filed, the record of a case, including the
record of proceedings before the ALJ,
will be transmitted by the ARB or the
ALJ, as the case may be, to the
appropriate court pursuant to the
Federal Rules of Appellate Procedure
and the local rules of such court.
§ 1984.113
Judicial enforcement.
Whenever any person has failed to
comply with a preliminary order of
reinstatement, or a final order, including
one approving a settlement agreement,
issued under section 18C of the FLSA,
the Secretary or a person on whose
behalf the order was issued may file a
civil action seeking enforcement of the
order in the United States district court
for the district in which the violation
was found to have occurred. The
Secretary also may file a civil action
seeking enforcement of the order in the
United States district court for the
District of Columbia.
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§ 1984.114 District court jurisdiction of
retaliation complaints.
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§ 1984.115
of rules.
Special circumstances; waiver
In special circumstances not
contemplated by the provisions of these
rules, or for good cause shown, the ALJ
or the ARB on review may, upon
application, after three- days notice to
all parties, waive any rule or issue such
orders that justice or the administration
of section 18C of the FLSA requires.
[FR Doc. 2013–04329 Filed 2–22–13; 11:15 am]
BILLING CODE 4510–26–P
DEPARTMENT OF DEFENSE
Office of the Secretary
(a) The complainant may bring an
action at law or equity for de novo
review in the appropriate district court
of the United States, which will have
jurisdiction over such an action without
regard to the amount in controversy,
either:
(1) Within 90 days after receiving a
written determination under
§ 1984.105(a) provided that there has
been no final decision of the Secretary;
or
(2) If there has been no final decision
of the Secretary within 210 days of the
filing of the complaint.
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(3) At the request of either party, the
action shall be tried by the court with
a jury.
(b) A proceeding under paragraph (a)
of this section shall be governed by the
same legal burdens of proof specified in
section 1984.109. The court shall have
jurisdiction to grant all relief necessary
to make the employee whole, including
injunctive relief and compensatory
damages, including:
(1) Reinstatement with the same
seniority status that the employee
would have had, but for the discharge
or discrimination;
(2) The amount of back pay, with
interest; and
(3) Compensation for any special
damages sustained as a result of the
discharge or discrimination, including
litigation costs, expert witness fees, and
reasonable attorney fees.
(c) Within seven days after filing a
complaint in federal court, a
complainant must file with the
Assistant Secretary, the ALJ, or the ARB,
depending on where the proceeding is
pending, a copy of the file-stamped
complaint. A copy of the complaint also
must be served on the OSHA official
who issued the findings and/or
preliminary order, the Assistant
Secretary, and the Associate Solicitor,
Division of Fair Labor Standards, U.S.
Department of Labor.
32 CFR Part 199
[DOD–2009–HA–0038]
RIN 0720–AB50
TRICARE: Smoking Cessation
Program
Office of the Secretary,
Department of Defense.
ACTION: Final rule.
AGENCY:
SUMMARY: This final rule implements
Section 713 of the Duncan Hunter
National Defense Authorization Act
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(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, Medicareeligible 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
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as at Military Treatment Facilities at no
cost, including no co-pay. The type of
smoking cessation medications
available, which may include over-thecounter 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 webbased 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.
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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.
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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 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
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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
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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
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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
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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
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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
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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.
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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,
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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]
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)
introductory text.
■ b. Adding new paragraph (d)(3)(vi)(C).
■ c. Adding new paragraph (e)(30).
■ d. Revising paragraph (g)(39).
■ e. Removing and reserving paragraph
(g)(65).
The revisions and additions read as
follows:
■
■
§ 199.4
Basic program benefits.
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*
*
*
*
*
(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
VerDate Mar<15>2010
15:05 Feb 26, 2013
Jkt 229001
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
for Medicare benefits authorized under
Title XVIII of the Social Security Act. In
addition, pursuant to § 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
§ 199.21. Smoking cessation
pharmaceutical agents, including FDAapproved 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 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)(30)(iii) of this section. A
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
TRICARE-authorized provider listed in
§ 199.6 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
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) * * *
(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
E:\FR\FM\27FER1.SGM
27FER1
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations
or mental health counselor in the
treatment of a mental disorder as
specifically provided in paragraph
(c)(3)(ix) of this section and in § 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]
*
*
*
*
*
■ 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:
erowe on DSK2VPTVN1PROD with RULES
§ 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 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 § 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 § 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
VerDate Mar<15>2010
15:05 Feb 26, 2013
Jkt 229001
§ 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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2012–1065]
RIN 1625–AA09
Drawbridge Operation Regulation;
Sabine River, Near Ruliff, LA
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is removing
the existing drawbridge operation
regulation for the Kansas City Southern
(KCS) Railroad drawbridge across
Sabine River, mile 36.2, between
Newton County, TX and Calcasieu
Parish, LA. The drawbridge was
converted to a fixed bridge in 2012 and
the operating regulation is no longer
applicable or necessary.
DATES: This rule is effective February
27, 2013.
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
13241
Documents mentioned in
this preamble are part of docket USCG–
2012–1065. To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type the docket
number in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Mr. Jim Wetherington, Bridge
Administration Branch, Coast Guard;
telephone 504–671–2128, email
james.r.wetherington@uscg.mil. If you
have questions on viewing the docket,
call Barbara Hairston, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
A. Regulatory History and Information
The Coast Guard is issuing this final
rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because the
Kansas City Southern Railroad Bridge
over the Sabine River, mile 36.2, that
once required draw operations in 33
CFR 117.493(b), was converted to a
fixed bridge in 2012. Therefore, the
regulation is no longer applicable and
shall be removed from publication. It is
unnecessary to publish an NPRM
because this regulatory action does not
purport to place any restrictions on
mariners but rather removes a
restriction that has no further use or
value.
Under 5 U.S.C. 553(d)(1), a rule that
relieves a restriction is not required to
provide the 30 day notice period before
its effective date. This rule removes the
Kansas City Southern (KCS) Railroad
Bridge over the Sabine River, mile 36.2,
draw operation requirements under 33
CFR 117. 493(b), thus removing a
regulatory restriction on the public.
E:\FR\FM\27FER1.SGM
27FER1
Agencies
[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