Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Refills of Maintenance Medications Through Military Treatment Facility Pharmacies or National Mail Order Pharmacy Program, 46796-46799 [2015-19196]
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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations
guidance information line at (202) 622–
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SUPPLEMENTARY INFORMATION:
Background
The temporary regulations (TD 9723)
that are the subject of this correction are
under section 432(e)(9) of the Internal
Revenue Code.
Need for Correction
As published, the temporary
regulations (TD 9723) contain errors that
may prove to be misleading and are in
need of clarification.
Correction of Publication
Accordingly, the temporary
regulations (TD 9723), that are subject to
FR Doc. 2015–14945, are corrected as
follows:
■ 1. On page 35207, in the preamble,
third column, third line, under
paragraph heading ‘‘Paperwork
Reduction Act,’’ the language
‘‘procedure pursuant to the’’ is corrected
to read ‘‘comment pursuant to the’’.
■ 2. On page 35210, in the preamble,
second column, ninth line, under
paragraph heading ‘‘Suspension
Applications,’’ the language ‘‘is eligible
for the suspensions and has’’ is
corrected to read ‘‘is eligible for the
suspension and has’’.
■ 3. On page 35215, in the preamble,
third column, third line, under
paragraph heading ‘‘Contact
Information,’’ the language ‘‘Department
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■
Martin V. Franks,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. 2015–19366 Filed 8–5–15; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD–2015–HA–0062]
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RIN 0720–AB64
Civilian Health and Medical Program of
the Uniformed Services (CHAMPUS)/
TRICARE: Refills of Maintenance
Medications Through Military
Treatment Facility Pharmacies or
National Mail Order Pharmacy Program
Office of the Secretary,
Department of Defense (DoD).
AGENCY:
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16:05 Aug 05, 2015
Jkt 235001
ACTION:
Interim final rule.
This interim final rule
implements Section 702 (c) of the Carl
Levin and Howard P. ‘‘Buck’’ McKeon
National Defense Authorization Act for
Fiscal Year 2015 which states that
beginning October 1, 2015, the
pharmacy benefits program shall require
eligible covered beneficiaries generally
to refill non-generic prescription
maintenance medications through
military treatment facility pharmacies or
the national mail-order pharmacy
program. Section 702(c) of the National
Defense Authorization Act for Fiscal
Year 2015 also terminates the TRICARE
For Life Pilot Program on September 30,
2015. The TRICARE For Life Pilot
Program described in Section 716 (f) of
the National Defense Authorization Act
for Fiscal Year 2013, was a pilot
program which began in March 2014
requiring TRICARE For Life
beneficiaries to refill non-generic
prescription maintenance medications
through military treatment facility
pharmacies or the national mail-order
pharmacy program. TRICARE for Life
beneficiaries are those enrolled in the
Medicare wraparound coverage option
of the TRICARE program. This interim
rule includes procedures to assist
beneficiaries in transferring covered
prescriptions to the mail order
pharmacy program. This regulation is
being issued as an interim final rule in
order to comply with the express
statutory intent that the program begin
October 1, 2015. Public comments,
however, are invited and will be
considered for possible revisions to this
rule for the second year of the program.
DATES: This rule is effective August 6,
2015. Written comments received at the
address indicated below by October 5,
2015 will be considered and addressed
in the final rule.
ADDRESSES: You may submit comments,
identified by docket number and/or
Regulatory Information Number (RIN)
number and title, by any of the
following methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Department of Defense, Office of
the Deputy Chief Management Officer,
Directorate for Oversight and
Compliance, Regulatory and Audit
Matters Office, 9010 Defense Pentagon,
Washington, DC 20301–9010.
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
SUMMARY:
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viewing on the Internet at https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
Dr.
George Jones, Chief, Pharmacy
Operations Division, Defense Health
Agency, telephone 703–681–2890.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
A. Executive Summary
1. Purpose
The legal authority for this rule is
Section 702 of the National Defense
Authorization Act for Fiscal Year 2015.
This interim final rule implements
Section 702 (c) of the Carl Levin and
Howard P. ‘‘Buck’’ McKeon National
Defense Authorization Act for Fiscal
Year 2015 which states that beginning
October 1, 2015, the pharmacy benefits
program shall require eligible covered
beneficiaries generally to refill nongeneric prescription maintenance
medications through military treatment
facility pharmacies or the national mailorder pharmacy program. Eligible
covered beneficiaries are defined in
sections 1072 (5) and 1086 of title 10,
United States Code.
2. Summary of the Major Provisions of
the Interim Final Rule
TRICARE beneficiaries are generally
required to obtain all prescription refills
for select non-generic maintenance
medications from the TRICARE mail
order program (where beneficiary
copayments are much lower than in
retail pharmacies) or military treatment
facilities (where there are no
copayments). Covered maintenance
medications are those prescribed for
chronic, long-term conditions that are
taken on a regular, recurring basis, but
do not include medications to treat
acute conditions. TRICARE will follow
best commercial practices, including
that beneficiaries will be notified of the
new rules and mechanisms to allow
them to receive adequate medication
during their transition to mail for their
refills. The statute and rule authorize a
waiver of the mail order requirement
based on patient needs and other
appropriate circumstances.
3. Costs and Benefits
The effect of the statutory
requirement, implemented by this rule,
is to shift a volume of prescriptions
from retail pharmacies to the mail order
pharmacy program. This will produce
savings to the Department of
approximately $88M per year and
savings to beneficiaries of
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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations
approximately $16.5 million per year in
reduced copayments.
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B. Background
In Fiscal Year 2014, 61 million
prescriptions were filled for TRICARE
beneficiaries through the TRICARE
retail pharmacy benefit at a net cost of
$5.1 billion to the government. On
average, the government pays 32% less
for brand name maintenance medication
prescriptions filled in the mail order
program or military treatment facility
pharmacies than through the retail
program. Not all prescriptions filled
through the retail program are
maintenance/chronic medications.
However, there is potential for
significant savings to the government by
shifting a portion of TRICARE
prescription refills to the mail order
program or military treatment facility
pharmacies. In addition, there will be
significant savings to TRICARE
beneficiaries who will receive up to a 90
day refill at no charge for generics in the
mail order program compared to $8
copay for up to a 30 day in retail. The
savings is even greater for brand-name
prescriptions: $16 for up to 90 days in
mail versus $20 for up to 30 days in
retail, meaning that for a 90-day supply
the copayment comparison is $16 in
mail to $60 in retail. The non-formulary
copayment comparison is $46 for up to
90 days in mail compared to $46 for up
to 30 days in retail.
C. Provisions of the Interim Final Rule
The interim final rule revises
paragraph (r) to 32 CFR 199.21.
Paragraph (r) establishes rules for the
new program of refills of maintenance
medications for TRICARE through the
mail order pharmacy program.
Paragraph (r)(1) requires that for covered
maintenance medications, TRICARE
beneficiaries are generally required to
obtain their prescription refills through
the national mail order pharmacy
program or through military treatment
facility pharmacies. TRICARE
beneficiaries are defined in sections
1072 (5) and 1086 of title 10, United
States Code, including those enrolled in
the Medicare wraparound coverage
option of the TRICARE program.
Paragraph (r)(2) provides that the
Director, Defense Health Agency will
establish, maintain, and periodically
revise and update a list of covered
maintenance medications, which will be
accessible through the TRICARE
Pharmacy Program Web site and by
telephone through the TRICARE
Pharmacy Program Service Center. Each
medication included on the list will be
a medication prescribed for a chronic,
long-term condition that is taken on a
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regular, recurring basis. It will be
clinically appropriate and cost effective
to dispense the medication from the
mail order pharmacy. It will be available
for an initial filling of a 30-day or less
supply through retail pharmacies, and
will be generally available at military
treatment facility pharmacies for initial
fill and refills. It will be available for
refill through the national mail-order
pharmacy.
Paragraph (r)(3) provides that a refill
is a subsequent filling of an original
prescription under the same
prescription number or other
authorization as the original
prescription, or a new original
prescription issued at or near the end
date of an earlier prescription for the
same medication for the same patient.
Paragraph (r)(4) provides that a waiver
of the general requirement to obtain
maintenance medication prescription
refills from the mail order pharmacy or
military treatment facility pharmacy
will be granted in several
circumstances. There is a blanket waiver
for prescription medications that are for
acute care needs. There is also a blanket
waiver for prescriptions covered by
other health insurance. There is a caseby-case waiver to permit prescription
maintenance medication refills at a
retail pharmacy when necessary due to
personal need or hardship, emergency,
or other special circumstance, for
example, for nursing home residents.
This waiver is obtained through an
administrative override request to the
TRICARE pharmacy benefits manager
under procedures established by the
Director, Defense Health Agency.
Paragraph (r)(5) establishes
procedures for the effective operation of
the program. The Department will
implement the program by utilizing best
commercial practices to the extent
practicable. An effective communication
plan that includes efforts to educate
beneficiaries in order to optimize
participation and satisfaction will be
implemented. Beneficiaries with active
prescriptions for a medication on the
maintenance medication list will be
notified that their medication is covered
under the program. Beneficiaries will be
advised that they may receive up to two
30 day fills at retail while they
transition their prescription to the mail
order program. The beneficiary will be
contacted after each of these two fills
reminding the beneficiary that the
prescription must be transferred to mail.
Requests for a third fill at retail will be
blocked and the beneficiary advised to
call the pharmacy benefits manager
(PBM) for assistance. The PBM will
provide a toll free number to assist
beneficiaries in transferring their
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46797
prescriptions from retail to the mail
order program. With the beneficiary’s
permission, the PBM will contact the
physician or other health care provider
who prescribed the medication to assist
in transferring the prescription to the
mail order program. In any case in
which a beneficiary is required to obtain
a maintenance medication prescription
refill from the national mail-order
pharmacy program and attempts instead
to refill such medications at a retail
pharmacy, the PBM will also maintain
the toll free number to assist the
beneficiary. This assistance may include
information on how to request a waiver
or in taking any other appropriate action
to meet the beneficiary’s needs and to
implement the program. The PBM will
ensure that a pharmacist is available at
all times through the toll-free telephone
number to answer beneficiary questions
or provide other appropriate assistance.
Paragraph (r)(6) provides that the
program will remain in effect
indefinitely with any adjustments or
modifications required by law.
D. Regulatory Procedures
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
Executive Orders (EOs) 12866 and
13563 require that a comprehensive
regulatory impact analysis be performed
on any economically significant
regulatory action, defined primarily as
one that would result in an effect of
$100 million or more in any one year.
The DoD has examined the economic
and policy implications of this interim
rule and has concluded that this is not
an economically significant regulatory
action under the Executive Order. The
program rule will produce savings to the
Department of approximately $88M per
year and savings to beneficiaries of
approximately $16.5 million per year in
reduced copayments. This rule has been
designated a ‘‘significant regulatory
action,’’ although not economically
significant, under section 3(f) of
Executive Order 12866. Accordingly,
the rule has been reviewed by the Office
of Management and Budget (OMB).
Congressional Review Act, 5 U.S.C. 801,
et seq.
Under the Congressional Review Act,
a major rule may not take effect until at
least 60 days after submission to
Congress of a report regarding the rule.
A major rule is one that would have an
annual effect on the economy of $100
million or more or have certain other
impacts. This interim rule is not a major
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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations
rule under the Congressional Review
Act.
Section 202, Pub. L. 104–4, ‘‘Unfunded
Mandates Reform Act’’
This rule does not contain a Federal
mandate that may result in the
expenditure by State, local and tribunal
governments, in aggregate, or by the
private sector, of $100 million or more
(adjusted for inflation) in any one year.
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601)
The Regulatory Flexibility Act (RFA)
requires that each Federal agency
prepare and make available for public
comment, a regulatory flexibility
analysis when the agency issues a
regulation which would have a
significant impact on a substantial
number of small entities. This interim
rule does not have a significant impact
on a substantial number of small
entities.
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
This interim rule contains no new
information collection requirements
subject to the Paperwork Reduction Act
(PRA) of 1995 (44 U.S.C. 3501–3511).
Executive Order 13132, ‘‘Federalism’’
This interim rule does not have
federalism implications, as set forth in
Executive Order 13132. This rule does
not have substantial direct effects on the
States; the relationship between the
National Government and the States; or
the distribution of power and
responsibilities among the various
levels of Government.
Public Comments Invited
This rule is being issued as an interim
final rule based on the statutory
requirement of an October 1, 2015 start
date. DoD invites public comments on
all provisions of the rule. They will be
considered for possible revisions to the
program for the second and subsequent
years of operation.
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List of Subjects in 32 CFR Part 199
Administrative practice and
procedure, Claims, Dental health, Fraud,
Health care, Health insurance,
Individuals with disabilities, Military
personnel.
Accordingly, 32 CFR part 199 will 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.
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16:05 Aug 05, 2015
Jkt 235001
2. Section 199.21 is amended by
revising paragraph (r), to read as
follows:
■
§ 199.21 TRICARE Pharmacy Benefits
Program.
*
*
*
*
*
(r) Refills of maintenance medications
for eligible covered beneficiaries
through the mail order pharmacy
program—(1) In general. Consistent
with section 702 of the National Defense
Authorization Act for Fiscal Year 2015,
this paragraph requires that for covered
maintenance medications, beneficiaries
are generally required to obtain their
prescription through the national mailorder pharmacy program or through
military treatment facility pharmacies.
For purposes of this paragraph, eligible
covered beneficiaries are those defined
under sections 1072 and 1086 of title 10,
United States Code.
(2) Medications covered. The Director,
DHA, will establish, maintain, and
periodically revise and update a list of
covered maintenance medications
subject to the requirement of paragraph
(r)(1) of this section. The current list
will be accessible through the TRICARE
Pharmacy Program Internet Web site
and by telephone through the TRICARE
Pharmacy Program Service Center. Each
medication included on the list will
meet the following requirements:
(i) It will be a medication prescribed
for a chronic, long-term condition that
is taken on a regular, recurring basis.
(ii) It will be clinically appropriate to
dispense the medication from the mail
order pharmacy.
(iii) It will be cost effective to
dispense the medication from the mail
order pharmacy.
(iv) It will be available for an initial
filling of a 30-day or less supply through
retail pharmacies.
(v) It will be generally available at
military treatment facility pharmacies
for initial fill and refills.
(vi) It will be available for refill
through the national mail-order
pharmacy program.
(3) Refills covered. For purposes of the
program under paragraph (r)(1) of this
section, a refill is:
(i) A subsequent filling of an original
prescription under the same
prescription number or other
authorization as the original
prescription; or
(ii) A new original prescription issued
at or near the end date of an earlier
prescription for the same medication for
the same patient.
(4) Waiver of requirement. A waiver of
the general requirement to obtain
maintenance medication prescription
refills from the mail order pharmacy or
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military treatment facility pharmacy
will be granted in the following
circumstances:
(i) There is a blanket waiver for
prescription medications that are for
acute care needs.
(ii) There is a blanket waiver for
prescriptions covered by other health
insurance.
(iii) There is a case-by-case waiver to
permit prescription maintenance
medication refills at a retail pharmacy
when necessary due to personal need or
hardship, emergency, or other special
circumstance. This waiver is obtained
through an administrative override
request to the TRICARE pharmacy
benefits manager under procedures
established by the Director, DHA.
(5) Procedures. Under the program
established by paragraph (r)(1) of this
section, the Director, DHA will establish
procedures for the effective operation of
the program. Among these procedures
are the following:
(i) The Department will implement
the program by utilizing best
commercial practices to the extent
practicable.
(ii) An effective communication plan
that includes efforts to educate
beneficiaries in order to optimize
participation and satisfaction will be
implemented.
(iii) Beneficiaries with active retail
prescriptions for a medication on the
maintenance medication list will be
notified that their medication is
included under the program.
Beneficiaries will be advised that they
may receive two 30 day fill at retail
while they transition their prescription
to the mail order program.
(iv) Requests for a third fill at retail
will be blocked and the beneficiary
advised to call the pharmacy benefits
manager (PBM) for assistance.
(v) The PBM will provide a toll free
number to assist beneficiaries in
transferring their prescriptions from
retail to the mail order program. With
the beneficiary’s permission, the PBM
will contact the physician or other
health care provider who prescribed the
medication to assist in transferring the
prescription to the mail order program.
(vi) In any case in which a beneficiary
required under this paragraph (r) to
obtain a maintenance medication
prescription refill from national mail
order pharmacy program and attempts
instead to refill such medications at a
retail pharmacy, the PBM will also
maintain the toll free number to assist
the beneficiary. This assistance may
include information on how to request
a waiver, consistent with paragraph
(r)(4)(iii) of this section, or in taking any
other appropriate action to meet the
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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations
beneficiary’s needs and to implement
the program.
(vii) The PBM will ensure that a
pharmacist is available at all times
through the toll-free telephone number
to answer beneficiary questions or
provide other appropriate assistance.
(6) This program will remain in effect
indefinitely with any adjustments or
modifications required by law.
Dated: July 31, 2015.
Patricia L. Toppings,
OSD Federal Register Liaison Officer,
Department of Defense.
[FR Doc. 2015–19196 Filed 8–5–15; 8:45 am]
BILLING CODE 5001–06–P
Program Authority: 29 U.S.C. 773(b).
DEPARTMENT OF EDUCATION
34 CFR Chapter III
[Docket ID ED–2015–OSERS–0061]
Final Priority and Definitions;
Demonstration and Training Program:
Career Pathways for Individuals With
Disabilities
Office of Special Education and
Rehabilitative Services, Department of
Education.
ACTION: Final priority and definitions.
AGENCY:
[CFDA Number: 84.235N.]
The Assistant Secretary for
Special Education and Rehabilitative
Services announces a priority designed
to demonstrate promising practices in
the use of career pathways to improve
employment outcomes for individuals
with disabilities. Specifically, this
priority will establish model
demonstration projects that engage State
vocational rehabilitation (VR) agencies
in partnerships with other entities to
develop and use career pathways to
help individuals with disabilities
eligible for VR services, including youth
with disabilities, acquire necessary
marketable skills and recognized
postsecondary credentials. The
Assistant Secretary may use this priority
for competitions in fiscal year (FY) 2015
and later years.
DATES: This priority and these
definitions are effective September 8,
2015.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Felipe Lulli, U.S. Department of
Education, 400 Maryland Avenue SW.,
Room 5042, Potomac Center Plaza
(PCP), Washington, DC 20202–2800.
Telephone: (202) 245–7425 or by email:
felipe.lulli@ed.gov.
If you use a telecommunications
device for the deaf (TDD) or a text
telephone (TTY), call the Federal Relay
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16:05 Aug 05, 2015
Jkt 235001
Service (FRS), toll free, at 1–800–877–
8339.
SUPPLEMENTARY INFORMATION:
Purpose of Program: The purpose of
the Demonstration and Training
Program is to provide competitive grants
to, or enter into contracts with, eligible
entities to expand and improve
rehabilitation and other services
authorized under the Rehabilitation Act
of 1973, as amended (Rehabilitation
Act), or to further the purposes and
policies in sections 2(b) and 2(c) of the
Rehabilitation Act by supporting
activities that increase the provision,
extent, availability, and scope, as well
as improve the quality of rehabilitation
services under the Rehabilitation Act.
Applicable Program Regulations: 34
CFR part 373.
We published a notice of proposed
priority and definitions for this
competition in the Federal Register on
May 15, 2015 (80 FR 27874). That notice
contained background information and
our reasons for proposing the particular
priority and definitions. There are
differences between the proposed
priority and the final priority which are
explained in the Analysis of Comments
and Changes section of this notice.
Public Comment: In response to our
invitation in the notice of proposed
priority and definitions, two parties
submitted comments relevant to this
priority.
Generally, we do not address
technical and other minor changes.
Analysis of the Comments and
Changes: An analysis of the comments
and of any changes in the priority and
definitions since publication of the
notice of proposed priority follows.
Comment: One commenter inquired
whether there were any Federal
requirements for the legal or
programmatic structure of an eligible
consortium. We also identified a second
issue implicit in the commenter’s
question, namely, when it is appropriate
for VR agencies to apply as a group.
Discussion: We agree that the
reference to ‘‘a consortium of State VR
agencies’’ in the Eligible Applicants
section of the proposed priority requires
further definition. The Education
Department General Administrative
Regulations (EDGAR) at 34 CFR 75.127–
129 authorize eligible entities to apply
as a group. According to EDGAR, groups
may take various forms, including
consortia, provided that the constituent
members are eligible entities and that
the eligible applicants formally bind
themselves to all the application
statements and assurances, describe the
activities they plan to conduct, and
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46799
assume responsibility for compliance
with all relevant Federal requirements.
Accordingly, the final priority
incorporates references to these
requirements in the Eligibility and
Application Requirements sections.
We also agree that further clarification
is needed regarding the circumstances
in which application by a group would
be appropriate. Thus, we have added a
requirement that groups must serve a
defined metropolitan area or distinct
population that exists across State lines.
Changes: In the Eligible Applicants
section, we updated the final priority to
use the broader term ‘‘group’’ instead of
‘‘consortium.’’ With regard to the
circumstances for group applications,
we have updated the Eligible Applicants
section of the final priority to specify
that State VR agencies may apply as a
group if they serve individuals in a
distinct geographic area shared by two
or more adjacent States (e.g.,
metropolitan areas, targeted
occupational clusters or related
industries whose employment base
extends beyond a single adjacent State).
Also, in the Application
Requirements paragraph (c)(3), we
added a new requirement that State VR
agencies applying as a group identify
their shared geographic area and
describe how they will coordinate their
project activities within that area. In
paragraph (e) of the Application
Requirements section, we stipulate that
applications by groups must include a
copy of the members’ signed agreement
designating the agency authorized to
sign the application on behalf of the
group; binding each agency to every
statement, assurance and obligation in
the application; and detailing the
agencies’ assigned project roles and
responsibilities.
Comment: One commenter stated that
the project requirements in the
proposed priority would not ensure that
grantees provide individuals with the
kind of career development support
they need for success in a career
pathway. The commenter described the
comprehensive career development
process in terms of three distinct
elements: the individual’s selfexploration of career-related skills,
interests, and values; exploration of
potential occupations and career goals
aligned with the individual’s skills,
interests, and values; and career
planning and management to achieve
the individual’s chosen employment
and personal goals. The commenter
stated that career planning and
management may involve careerspecific skills, job search skills, and soft
skills involving communication,
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]]>Agencies
[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Rules and Regulations]
[Pages 46796-46799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19196]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD-2015-HA-0062]
RIN 0720-AB64
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS)/TRICARE: Refills of Maintenance Medications Through Military
Treatment Facility Pharmacies or National Mail Order Pharmacy Program
AGENCY: Office of the Secretary, Department of Defense (DoD).
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: This interim final rule implements Section 702 (c) of the Carl
Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act
for Fiscal Year 2015 which states that beginning October 1, 2015, the
pharmacy benefits program shall require eligible covered beneficiaries
generally to refill non-generic prescription maintenance medications
through military treatment facility pharmacies or the national mail-
order pharmacy program. Section 702(c) of the National Defense
Authorization Act for Fiscal Year 2015 also terminates the TRICARE For
Life Pilot Program on September 30, 2015. The TRICARE For Life Pilot
Program described in Section 716 (f) of the National Defense
Authorization Act for Fiscal Year 2013, was a pilot program which began
in March 2014 requiring TRICARE For Life beneficiaries to refill non-
generic prescription maintenance medications through military treatment
facility pharmacies or the national mail-order pharmacy program.
TRICARE for Life beneficiaries are those enrolled in the Medicare
wraparound coverage option of the TRICARE program. This interim rule
includes procedures to assist beneficiaries in transferring covered
prescriptions to the mail order pharmacy program. This regulation is
being issued as an interim final rule in order to comply with the
express statutory intent that the program begin October 1, 2015. Public
comments, however, are invited and will be considered for possible
revisions to this rule for the second year of the program.
DATES: This rule is effective August 6, 2015. Written comments received
at the address indicated below by October 5, 2015 will be considered
and addressed in the final rule.
ADDRESSES: You may submit comments, identified by docket number and/or
Regulatory Information Number (RIN) number and title, by any of the
following methods:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Department of Defense, Office of the Deputy Chief Management
Officer, Directorate for Oversight and Compliance, Regulatory and Audit
Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.
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: Dr. George Jones, Chief, Pharmacy
Operations Division, Defense Health Agency, telephone 703-681-2890.
SUPPLEMENTARY INFORMATION:
A. Executive Summary
1. Purpose
The legal authority for this rule is Section 702 of the National
Defense Authorization Act for Fiscal Year 2015.
This interim final rule implements Section 702 (c) of the Carl
Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act
for Fiscal Year 2015 which states that beginning October 1, 2015, the
pharmacy benefits program shall require eligible covered beneficiaries
generally to refill non-generic prescription maintenance medications
through military treatment facility pharmacies or the national mail-
order pharmacy program. Eligible covered beneficiaries are defined in
sections 1072 (5) and 1086 of title 10, United States Code.
2. Summary of the Major Provisions of the Interim Final Rule
TRICARE beneficiaries are generally required to obtain all
prescription refills for select non-generic maintenance medications
from the TRICARE mail order program (where beneficiary copayments are
much lower than in retail pharmacies) or military treatment facilities
(where there are no copayments). Covered maintenance medications are
those prescribed for chronic, long-term conditions that are taken on a
regular, recurring basis, but do not include medications to treat acute
conditions. TRICARE will follow best commercial practices, including
that beneficiaries will be notified of the new rules and mechanisms to
allow them to receive adequate medication during their transition to
mail for their refills. The statute and rule authorize a waiver of the
mail order requirement based on patient needs and other appropriate
circumstances.
3. Costs and Benefits
The effect of the statutory requirement, implemented by this rule,
is to shift a volume of prescriptions from retail pharmacies to the
mail order pharmacy program. This will produce savings to the
Department of approximately $88M per year and savings to beneficiaries
of
[[Page 46797]]
approximately $16.5 million per year in reduced copayments.
B. Background
In Fiscal Year 2014, 61 million prescriptions were filled for
TRICARE beneficiaries through the TRICARE retail pharmacy benefit at a
net cost of $5.1 billion to the government. On average, the government
pays 32% less for brand name maintenance medication prescriptions
filled in the mail order program or military treatment facility
pharmacies than through the retail program. Not all prescriptions
filled through the retail program are maintenance/chronic medications.
However, there is potential for significant savings to the government
by shifting a portion of TRICARE prescription refills to the mail order
program or military treatment facility pharmacies. In addition, there
will be significant savings to TRICARE beneficiaries who will receive
up to a 90 day refill at no charge for generics in the mail order
program compared to $8 copay for up to a 30 day in retail. The savings
is even greater for brand-name prescriptions: $16 for up to 90 days in
mail versus $20 for up to 30 days in retail, meaning that for a 90-day
supply the copayment comparison is $16 in mail to $60 in retail. The
non-formulary copayment comparison is $46 for up to 90 days in mail
compared to $46 for up to 30 days in retail.
C. Provisions of the Interim Final Rule
The interim final rule revises paragraph (r) to 32 CFR 199.21.
Paragraph (r) establishes rules for the new program of refills of
maintenance medications for TRICARE through the mail order pharmacy
program. Paragraph (r)(1) requires that for covered maintenance
medications, TRICARE beneficiaries are generally required to obtain
their prescription refills through the national mail order pharmacy
program or through military treatment facility pharmacies. TRICARE
beneficiaries are defined in sections 1072 (5) and 1086 of title 10,
United States Code, including those enrolled in the Medicare wraparound
coverage option of the TRICARE program.
Paragraph (r)(2) provides that the Director, Defense Health Agency
will establish, maintain, and periodically revise and update a list of
covered maintenance medications, which will be accessible through the
TRICARE Pharmacy Program Web site and by telephone through the TRICARE
Pharmacy Program Service Center. Each medication included on the list
will be a medication prescribed for a chronic, long-term condition that
is taken on a regular, recurring basis. It will be clinically
appropriate and cost effective to dispense the medication from the mail
order pharmacy. It will be available for an initial filling of a 30-day
or less supply through retail pharmacies, and will be generally
available at military treatment facility pharmacies for initial fill
and refills. It will be available for refill through the national mail-
order pharmacy.
Paragraph (r)(3) provides that a refill is a subsequent filling of
an original prescription under the same prescription number or other
authorization as the original prescription, or a new original
prescription issued at or near the end date of an earlier prescription
for the same medication for the same patient.
Paragraph (r)(4) provides that a waiver of the general requirement
to obtain maintenance medication prescription refills from the mail
order pharmacy or military treatment facility pharmacy will be granted
in several circumstances. There is a blanket waiver for prescription
medications that are for acute care needs. There is also a blanket
waiver for prescriptions covered by other health insurance. There is a
case-by-case waiver to permit prescription maintenance medication
refills at a retail pharmacy when necessary due to personal need or
hardship, emergency, or other special circumstance, for example, for
nursing home residents. This waiver is obtained through an
administrative override request to the TRICARE pharmacy benefits
manager under procedures established by the Director, Defense Health
Agency.
Paragraph (r)(5) establishes procedures for the effective operation
of the program. The Department will implement the program by utilizing
best commercial practices to the extent practicable. An effective
communication plan that includes efforts to educate beneficiaries in
order to optimize participation and satisfaction will be implemented.
Beneficiaries with active prescriptions for a medication on the
maintenance medication list will be notified that their medication is
covered under the program. Beneficiaries will be advised that they may
receive up to two 30 day fills at retail while they transition their
prescription to the mail order program. The beneficiary will be
contacted after each of these two fills reminding the beneficiary that
the prescription must be transferred to mail. Requests for a third fill
at retail will be blocked and the beneficiary advised to call the
pharmacy benefits manager (PBM) for assistance. The PBM will provide a
toll free number to assist beneficiaries in transferring their
prescriptions from retail to the mail order program. With the
beneficiary's permission, the PBM will contact the physician or other
health care provider who prescribed the medication to assist in
transferring the prescription to the mail order program. In any case in
which a beneficiary is required to obtain a maintenance medication
prescription refill from the national mail-order pharmacy program and
attempts instead to refill such medications at a retail pharmacy, the
PBM will also maintain the toll free number to assist the beneficiary.
This assistance may include information on how to request a waiver or
in taking any other appropriate action to meet the beneficiary's needs
and to implement the program. The PBM will ensure that a pharmacist is
available at all times through the toll-free telephone number to answer
beneficiary questions or provide other appropriate assistance.
Paragraph (r)(6) provides that the program will remain in effect
indefinitely with any adjustments or modifications required by law.
D. Regulatory Procedures
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
Executive Orders (EOs) 12866 and 13563 require that a comprehensive
regulatory impact analysis be performed on any economically significant
regulatory action, defined primarily as one that would result in an
effect of $100 million or more in any one year. The DoD has examined
the economic and policy implications of this interim rule and has
concluded that this is not an economically significant regulatory
action under the Executive Order. The program rule will produce savings
to the Department of approximately $88M per year and savings to
beneficiaries of approximately $16.5 million per year in reduced
copayments. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget (OMB).
Congressional Review Act, 5 U.S.C. 801, et seq.
Under the Congressional Review Act, a major rule may not take
effect until at least 60 days after submission to Congress of a report
regarding the rule. A major rule is one that would have an annual
effect on the economy of $100 million or more or have certain other
impacts. This interim rule is not a major
[[Page 46798]]
rule under the Congressional Review Act.
Section 202, Pub. L. 104-4, ``Unfunded Mandates Reform Act''
This rule does not contain a Federal mandate that may result in the
expenditure by State, local and tribunal governments, in aggregate, or
by the private sector, of $100 million or more (adjusted for inflation)
in any one year.
Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)
The Regulatory Flexibility Act (RFA) requires that each Federal
agency prepare and make available for public comment, a regulatory
flexibility analysis when the agency issues a regulation which would
have a significant impact on a substantial number of small entities.
This interim rule does not have a significant impact on a substantial
number of small entities.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
This interim rule contains no new information collection
requirements subject to the Paperwork Reduction Act (PRA) of 1995 (44
U.S.C. 3501-3511).
Executive Order 13132, ``Federalism''
This interim rule does not have federalism implications, as set
forth in Executive Order 13132. This rule does not have substantial
direct effects on the States; the relationship between the National
Government and the States; or the distribution of power and
responsibilities among the various levels of Government.
Public Comments Invited
This rule is being issued as an interim final rule based on the
statutory requirement of an October 1, 2015 start date. DoD invites
public comments on all provisions of the rule. They will be considered
for possible revisions to the program for the second and subsequent
years of operation.
List of Subjects in 32 CFR Part 199
Administrative practice and procedure, Claims, Dental health,
Fraud, Health care, Health insurance, Individuals with disabilities,
Military personnel.
Accordingly, 32 CFR part 199 will be 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 199.21 is amended by revising paragraph (r), to read as
follows:
Sec. 199.21 TRICARE Pharmacy Benefits Program.
* * * * *
(r) Refills of maintenance medications for eligible covered
beneficiaries through the mail order pharmacy program--(1) In general.
Consistent with section 702 of the National Defense Authorization Act
for Fiscal Year 2015, this paragraph requires that for covered
maintenance medications, beneficiaries are generally required to obtain
their prescription through the national mail-order pharmacy program or
through military treatment facility pharmacies. For purposes of this
paragraph, eligible covered beneficiaries are those defined under
sections 1072 and 1086 of title 10, United States Code.
(2) Medications covered. The Director, DHA, will establish,
maintain, and periodically revise and update a list of covered
maintenance medications subject to the requirement of paragraph (r)(1)
of this section. The current list will be accessible through the
TRICARE Pharmacy Program Internet Web site and by telephone through the
TRICARE Pharmacy Program Service Center. Each medication included on
the list will meet the following requirements:
(i) It will be a medication prescribed for a chronic, long-term
condition that is taken on a regular, recurring basis.
(ii) It will be clinically appropriate to dispense the medication
from the mail order pharmacy.
(iii) It will be cost effective to dispense the medication from the
mail order pharmacy.
(iv) It will be available for an initial filling of a 30-day or
less supply through retail pharmacies.
(v) It will be generally available at military treatment facility
pharmacies for initial fill and refills.
(vi) It will be available for refill through the national mail-
order pharmacy program.
(3) Refills covered. For purposes of the program under paragraph
(r)(1) of this section, a refill is:
(i) A subsequent filling of an original prescription under the same
prescription number or other authorization as the original
prescription; or
(ii) A new original prescription issued at or near the end date of
an earlier prescription for the same medication for the same patient.
(4) Waiver of requirement. A waiver of the general requirement to
obtain maintenance medication prescription refills from the mail order
pharmacy or military treatment facility pharmacy will be granted in the
following circumstances:
(i) There is a blanket waiver for prescription medications that are
for acute care needs.
(ii) There is a blanket waiver for prescriptions covered by other
health insurance.
(iii) There is a case-by-case waiver to permit prescription
maintenance medication refills at a retail pharmacy when necessary due
to personal need or hardship, emergency, or other special circumstance.
This waiver is obtained through an administrative override request to
the TRICARE pharmacy benefits manager under procedures established by
the Director, DHA.
(5) Procedures. Under the program established by paragraph (r)(1)
of this section, the Director, DHA will establish procedures for the
effective operation of the program. Among these procedures are the
following:
(i) The Department will implement the program by utilizing best
commercial practices to the extent practicable.
(ii) An effective communication plan that includes efforts to
educate beneficiaries in order to optimize participation and
satisfaction will be implemented.
(iii) Beneficiaries with active retail prescriptions for a
medication on the maintenance medication list will be notified that
their medication is included under the program. Beneficiaries will be
advised that they may receive two 30 day fill at retail while they
transition their prescription to the mail order program.
(iv) Requests for a third fill at retail will be blocked and the
beneficiary advised to call the pharmacy benefits manager (PBM) for
assistance.
(v) The PBM will provide a toll free number to assist beneficiaries
in transferring their prescriptions from retail to the mail order
program. With the beneficiary's permission, the PBM will contact the
physician or other health care provider who prescribed the medication
to assist in transferring the prescription to the mail order program.
(vi) In any case in which a beneficiary required under this
paragraph (r) to obtain a maintenance medication prescription refill
from national mail order pharmacy program and attempts instead to
refill such medications at a retail pharmacy, the PBM will also
maintain the toll free number to assist the beneficiary. This
assistance may include information on how to request a waiver,
consistent with paragraph (r)(4)(iii) of this section, or in taking any
other appropriate action to meet the
[[Page 46799]]
beneficiary's needs and to implement the program.
(vii) The PBM will ensure that a pharmacist is available at all
times through the toll-free telephone number to answer beneficiary
questions or provide other appropriate assistance.
(6) This program will remain in effect indefinitely with any
adjustments or modifications required by law.
Dated: July 31, 2015.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2015-19196 Filed 8-5-15; 8:45 am]
BILLING CODE 5001-06-P
