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, 76307-76311 [2016-26432]
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Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Rules and Regulations
Regulatory Flexibility Act, 5 U.S.C. 601,
et seq. Indian tribes are not considered
to be small entities for purposes of the
Regulatory Flexibility Act.
Small Business Regulatory Enforcement
Fairness Act
This rule is not a major rule under 5
U.S.C. 804(2), the Small Business
Regulatory Enforcement Fairness Act.
This rule will not result in an annual
effect on the economy of $100 million
per year or more. This rule will not
cause a major increase in costs or prices
for consumers, individual industries,
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agencies, or geographic regions and does
not have a significant adverse effects on
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productivity, innovation, or on the
ability of U.S.-based enterprises to
compete with foreign-based enterprises.
Unfunded Mandates Reform Act
The Commission, as an independent
regulatory agency, is exempt from
compliance with the Unfunded
Mandates Reform Act, 2 U.S.C. 1502(1);
2 U.S.C. 658(1).
In accordance with Executive Order
12630, the Commission determined the
rule does not have significant takings
implications. A takings implication
assessment is not required.
Civil Justice Reform Act
In accordance with Executive Order
12988, the Commission determined the
rule does not unduly burden the judicial
system and meets the requirements of
sections 3(a) and 3(b)(2) of the Executive
Order.
National Environmental Policy Act
The Commission determined this rule
does not constitute a major federal
action significantly affecting the quality
of the human environment and that a
detailed statement is not required
pursuant to the National Environmental
Policy Act of 1969, 42 U.S.C. 4321, et
seq.
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Paperwork Reduction Act
25 CFR Part 585
Administrative practice and
procedure, Gambling, Indians—lands,
Penalties.
For the reasons set forth in the
preamble, the NIGC amends 25 CFR
parts 517, 584, and 585 as follows:
PART 517—FREEDOM OF
INFORMATION ACT PROCEDURES
1. The authority citation for part 517
continues to read as follows:
25 CFR Part 517
Authority: 5 U.S.C. 552, as amended.
2. Revise the first sentence of § 517.2
to read as follows:
■
§ 517.2
13:32 Nov 01, 2016
Public reading room.
Requirements for making requests.
(a) How to make a FOIA request.
Requests for records made pursuant to
the FOIA must be in writing. Requests
should be sent to the National Indian
Gaming Commission, Attn: FOIA
Officer, C/O Department of Interior,
1849 C Street NW., Mailstop #1621,
Washington, DC 20240. * * *
*
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*
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■ 4. Revise the last sentence in
§ 517.8(b)(2) to read as follows:
§ 517.8
Appeals.
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(b) * * *
(2) * * * The appeal shall be
addressed to the National Indian
Gaming Commission, Attn: FOIA
Appeals Officer, C/O Department of
Interior, 1849 C Street NW., Mailstop
#1621, Washington, DC 20240.
*
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PART 584—APPEALS BEFORE A
PRESIDING OFFICIAL
5. The authority citation for part 584
continues to read as follows:
Authority: 25 U.S.C. 2706, 2710, 2711,
2712, 2713, 2715, 2717.
6. Revise the heading of part 584 to
read as set forth above.
■
7. The authority citation for part 585
continues to read as follows:
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DOD–2015–HA–0062]
Records that are required to be
maintained by the Commission shall be
available for public inspection and
copying at 90 K Street NE., Suite 200,
Washington, DC 20002. * * *
■ 3. Revise the first two sentences of
§ 517.4(a) to read as follows:
■
Freedom of information.
Dated: October 17, 2016.
Jonodev O. Chaudhuri,
Chairman.
Kathryn Isom-Clause,
Vice Chair.
E. Sequoyah Simermeyer,
Associate Commissioner.
■
PART 585—APPEALS TO THE
COMMISSION
List of Subjects
8. Revise the heading of part 585 to
read as set forth above.
■
■
The rule does not contain any
information collection requirements for
which Office of Management and
Budget approval under the Paperwork
Reduction Act (44 U.S.C. 3501–3520) is
required.
VerDate Sep<11>2014
Authority: 25 U.S.C. 2706, 2710, 2711,
2712, 2713, 2715, 2717.
25 CFR Part 584
Administrative practice and
procedure, Gambling.
§ 517.4
Takings
76307
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).
ACTION: Final rule.
AGENCY:
This 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. An interim
final rule is in effect. 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 rule
includes procedures to assist
beneficiaries in transferring covered
prescriptions to the mail order
pharmacy program.
SUMMARY:
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Effective Date: This rule is
effective January 6, 2017.
DATES:
Dr.
George Jones, Jr., Chief, Pharmacy
Operations Division, Defense Health
Agency, telephone 703–681–2890.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
A. Executive Summary
1. Purpose
This 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.
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2. Summary of the Major Provisions of
the 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 $81 million per year and
savings to beneficiaries of
approximately $20 million per year in
reduced copayments.
B. Background
In Fiscal Year 2014, 61 million
prescriptions were filled for TRICARE
beneficiaries through the TRICARE
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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 $10
copay for up to a 30 day in retail. The
savings is even greater for brand-name
prescriptions: $20 for up to 90 days in
mail versus $24 for up to 30 days in
retail, meaning that for a 90-day supply
the copayment comparison is $20 in
mail to $72 in retail. The non-formulary
copayment amount is $49 for up to 90
days in mail non-formulary drugs are
generally not available in retail.
C. Summary of the Final Rule
The final rule revises paragraph (r) to
32 CFR 199.21. This 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 non-generic
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
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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 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
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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.
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D. Summary of and Response to Public
Comments
The interim final rule was published
in the Federal Register (80 FR 46796)
August 6, 2015, for a 60-day comment
period. We received six comments on
the interim final rule; four comments
from individuals and two comments
from professional associations. We
appreciate these comments, which are
summarized here, along with DoD’s
response.
Comment: One comment expressed
concern regarding the possibilities of
delays in the mail causing the patient to
miss a day or more of their medication.
Response: The provisions of the
TRICARE pharmacy contract permit
beneficiaries to refill medications well
in advance of the refill due date to allow
for adequate shipping time.
Additionally, this final rule provides for
a case-by-case waiver to permit
prescription maintenance medication
refill at a retail pharmacy when
necessary due to personal need or
hardship, emergency, or special
circumstance.
Comment: One commenter objected to
the lack of clear communication from
ESI by stating that conflicting messages
are often given to a beneficiary who
calls with a question, i.e. your
medications has been shipped, your
medication has not been shipped, etc.
The same individual suggests that Prior
Approvals for brand name products
often get deleted from the system
requiring the beneficiary to repeat the
PA process.
Response: DoD acknowledges the
commenter’s concerns regarding
contractor communication and Prior
Approvals being deleted from the
system, both of which are contract
specific issues, and not part of the
regulatory language. It should be noted
that Prior Approvals may be time
limited depending on the medication.
DoD will consider the feedback for
incorporation into future contractor
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customer service performance
requirements.
Comment: One commenter inquired
why Active Duty personnel are not
required to participate in this
mandatory program which appears to be
targeting retirees. In addition, the
individual suggested a blanket waiver
be administered for retirees who live in
remote areas with very limited MTF
pharmacy access. A final concern asked
if MTF staffing has been increased to
accommodate the potential influx of
retirees.
Response: This final rule conforms
with the current statutory requirement
of Section 702 in the fiscal year (FY)
2015 National Defense Authorization
Act, requiring eligible covered
beneficiaries generally to refill nongeneric prescription maintenance
medications through military treatment
facility pharmacies or the national mail
order program. Eligible covered
beneficiaries are defined in Title 10,
Section 1072(5) and does not include
Active Duty service members. The
statute and the rule designate military
treatment facility (MTF) pharmacies or
the mail order pharmacy program as the
two options available to beneficiaries for
obtaining refills of non-generic
prescription maintenance medications.
For those beneficiaries who live in
remote areas with limited MTF access,
the mail order pharmacy program is an
ideal option saving both time and
copayment expenses. Our experience
and data from the TRICARE FOR LIFE
maintenance medication pilot showed
that there was sufficient capacity to
accommodate the change, both at mail
order and in the MTFs. Our data show
that the overall impact on the MTF
workload was very minimal, while
majority of the prescriptions went to
mail order. The movement of brand
maintenance medications from retail to
mail order actually saves beneficiaries
out-of-pocket expenses in the form of
reduced copays and up to a 90 day
supply for less than the 30 day copay at
retail. This provides a win-win scenario
for the beneficiary and the government.
Comment: One commenter cited
anecdotal evidence in Alabama that
resulted in emergency room visits from
ingesting mail order prescriptions that
had been exposed to excessive heat. The
commenter expressed concerns about
proper temperature control of
medications shipped through the mail
and suggests the rule include a
requirement that all medications must
be kept within the FDA’s recommended
range of 59–86 degrees.
Response: The pharmacy contractor
reviews all medications dispensed
through the mail order pharmacy for
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unique shipping requirements, based on
information from the manufacturer. For
medications that are temperaturesensitive, special shipping procedures
are followed. The temperature-sensitive
medications are mailed via expedited
overnight shipping or 2nd day air, at no
cost to the beneficiary. Before certain
medications are delivered, a scheduling
call is made to the beneficiary to arrange
a delivery time and date.
Comment: A professional association
commented with a number of concerns:
beneficiaries should continue to have
choice, flexibility, and easy access to
prescription medications; unnecessary
waste resulting from auto-ship policies
and the suggestion to implement
policies to ensure mail order refills are
approved and needed; DoD should
conduct and publicize a beneficiary
satisfaction survey at the end of each
year; beneficiaries should be properly
informed about the options to seek a
waiver and clear instructions on how to
obtain one; DoD should develop and
make available a complete list of acute
care meds.
Response: This final rule conforms
with the current statutory requirement
of Section 702 in the FY 2015 NDAA
requiring eligible covered beneficiaries
generally to refill non-generic
prescription maintenance medications
through military treatment facility
pharmacies or the national mail order
program. DoD believes it is being
implemented successfully and without
adverse effects on beneficiaries. Nongeneric prescription maintenance
medications subject to the program are
listed at www.health.mil/selectdruglist.
DoD has determined it unnecessary to
have an additional list to specify acute
care medications that are not subject to
the program. DoD continues to monitor
beneficiary satisfaction of the TRICARE
pharmacy program.
Comment: A professional association
commented with the following
concerns: The rule should clearly
indicate that covered maintenance
medications include non-generic only;
beneficiaries should have to consent to
getting a refill rather than automatic
shipping; mandatory mail results in a
silo approach where the patient gets
prescriptions from multiple sources
resulting the lack of coordinated care;
community pharmacists are often the
sole source for medication and patient
education and can only judge the
patient’s understand by in-person
interactions; communications to
beneficiaries regarding waivers should
include complete information on how to
obtain a waiver.
Response: Section 199.21(r)(1) has
been amended to insert ‘‘non-generic’’
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prior to ‘‘covered medications’’.
Contractor requirements are not part of
the regulatory language. In order to
participate in the mail order auto-ship
program, beneficiaries must consent to
auto-ship enrollment but are not
required to do so. Beneficiaries enrolled
in the auto-ship program are notified
prior to medication shipment.
E. Regulatory Procedures
Executive Order 12866, ‘‘Regulatory
Planning and Review’’
Executive Order (E.O.) 12866 requires
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 final rule and based
on the resulting analysis, the Office of
Management and Budget has concluded
that this is an economically significant
regulatory action under the Executive
Order. The program rule will produce
savings to the Department of
approximately $81M per year and
savings to beneficiaries of
approximately $20 million per year in
reduced copayments. This rule results
in a shift of workload from retail
pharmacies to the mail order program.
This workload shift is estimated to
result in a net impact to retail pharmacy
margins nationwide of $15.6 million in
FY17 dollars. This rule has been
designated an economically significant
regulatory action under section 3(f) of
Executive Order 12866. Accordingly,
the rule has been reviewed by the Office
of Management and Budget (OMB).
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 final 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 final 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 final 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.
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 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 199.21 is amended by
revising paragraph (r) to read as follows:
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 final rule is not a major
rule under the Congressional Review
Act.
§ 199.21 TRICARE Pharmacy Benefits
Program.
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Section 202, Public Law 104–4,
‘‘Unfunded Mandates Reform Act’’
This 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
(adjusted for inflation) in any one year.
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(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 nongeneric 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.
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(2) Medications covered. The Director,
DHA, will establish, maintain, and
periodically revise and update a list of
non-generic 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
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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 result in 100% patient cost shares
and will be blocked from any TRICARE
payments 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 paragraph (r) of this
section 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 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: October 28, 2016.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2016–26432 Filed 11–1–16; 8:45 am]
BILLING CODE 5001–06–P
VerDate Sep<11>2014
13:32 Nov 01, 2016
Jkt 241001
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–HQ–ES–2016–0109;
4500030113]
RIN 1018–BB82
Endangered and Threatened Wildlife
and Plants; Adding Ten Species and
Updating Five Species on the List of
Endangered and Threatened Wildlife
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), in
accordance with the Endangered
Species Act of 1973, as amended (Act),
are amending the List of Endangered
and Threatened Wildlife (List) by
adding: three foreign coral species
(Cantharellus noumeae, Siderastrea
glynni, and Tubastraea floreana), dusky
sea snake (Aipysurus fuscus), Banggai
cardinalfish (Pterapogon kauderni), the
Tanzanian distinct population segment
(DPS) of African coelacanth (Latimeria
chalumnae), Nassau grouper
(Epinephelus striatus), and three
angelshark species (Squatina aculeata,
S. oculata, and S. squatina). We are also
updating the entries for Puget SoundGeorgia Basin canary rockfish (Sebastes
pinniger), Puget Sound-Georgia Basin
yelloweye rockfish (Sebastes
ruberrimus), lower Columbia River coho
salmon (Oncorhynchus kisutch), and the
Puget Sound steelhead (Oncorhynchus
mykiss) to reflect the designation of
critical habitat, and we are updating the
entry for the North Atlantic right whale
(Eubalaena glacialis) to reflect an
applicable rule citation. These
amendments are based on previously
published determinations by the
National Marine Fisheries Service
(NMFS) of the National Oceanic and
Atmospheric Administration,
Department of Commerce, which has
jurisdiction for these species.
DATES: This rule is effective November
2, 2016. Applicability date: The three
coral and dusky sea snake listings were
applicable as of November 6, 2015. The
Banggai cardinalfish listing was
applicable as of February 19, 2016. The
Tanzanian DPS of African coelacanth
listing was applicable as of April 28,
2016. The Nassau grouper listing was
applicable as of July 29, 2016. The three
angelshark listings were applicable as of
August 31, 2016. The critical habitat
designations for the Puget SoundGeorgia Basin canary rockfish (Sebastes
SUMMARY:
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
76311
pinniger) and Puget Sound-Georgia
Basin yelloweye rockfish (Sebastes
ruberrimus) were applicable as of
February 11, 2015. The critical habitat
designations for the lower Columbia
River coho salmon (Oncorhynchus
kisutch) and the Puget Sound steelhead
(Oncorhynchus mykiss) were applicable
as of March 25, 2016. The applicable
rule citation for the North Atlantic right
whale (Eubalaena glacialis) was
applicable as of December 6, 2013.
FOR FURTHER INFORMATION CONTACT:
Sarah Quamme, Chief, Unified Listing
Team, U.S. Fish and Wildlife Service,
MS–ES, 5275 Leesburg Pike, Falls
Church, VA 22041–3803; 703–358–
1796.
SUPPLEMENTARY INFORMATION:
Background
In accordance with the Act (16 U.S.C.
1531 et seq.) and Reorganization Plan
No. 4 of 1970 (35 FR 15627; October 6,
1970), NMFS has jurisdiction over the
marine and anadromous taxa specified
in this rule. Under section 4(a)(1) of the
Act, NMFS must decide whether a
species under its jurisdiction should be
classified as endangered or threatened.
Under section 4(a)(3)(A)(i) of the Act,
NMFS must designate any habitat of
endangered or threatened species which
is then considered to be critical habitat.
NMFS makes these determinations and
critical habitat designations via its
rulemaking process. Under section
4(a)(2) of the Act, we, the Service, are
then responsible for publishing final
rules to amend the List in title 50 of the
Code of Federal Regulations (CFR) at 50
CFR 17.11(h).
On December 16, 2014, NMFS
published a proposed rule (79 FR
74953) to list the dusky sea snake
(Aipysurus fuscus) and three foreign
corals (Cantharellus noumeae,
Siderastrea glynni, and Tubastraea
floreana) as endangered species, and the
Banggai cardinalfish (Pterapogon
kauderni) as a threatened species.
NMFS solicited public comments on the
proposed rule through February 17,
2015. On October 7, 2015, NMFS
published a final rule (80 FR 60560) to
list the dusky sea snake and the three
foreign coral species as endangered
species. On January 20, 2016, NMFS
published a final rule (81 FR 3023) to
list the Banggai cardinalfish as a
threatened species.
The listing of the dusky sea snake and
three foreign coral species was
applicable as of November 6, 2015. The
listing of the Banggai cardinalfish was
applicable as of February 19, 2016. In
the final rules for these species (dusky
sea snake and three corals: 80 FR 60560;
E:\FR\FM\02NOR1.SGM
02NOR1
]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Rules and Regulations]
[Pages 76307-76311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26432]
=======================================================================
-----------------------------------------------------------------------
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: This 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. An interim final rule is in effect. 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 rule includes procedures to assist beneficiaries
in transferring covered prescriptions to the mail order pharmacy
program.
[[Page 76308]]
DATES: Effective Date: This rule is effective January 6, 2017.
FOR FURTHER INFORMATION CONTACT: Dr. George Jones, Jr., Chief, Pharmacy
Operations Division, Defense Health Agency, telephone 703-681-2890.
SUPPLEMENTARY INFORMATION:
A. Executive Summary
1. Purpose
This 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 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 $81 million per year and savings to
beneficiaries of approximately $20 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 $10 copay for up to a 30 day in retail. The savings
is even greater for brand-name prescriptions: $20 for up to 90 days in
mail versus $24 for up to 30 days in retail, meaning that for a 90-day
supply the copayment comparison is $20 in mail to $72 in retail. The
non-formulary copayment amount is $49 for up to 90 days in mail non-
formulary drugs are generally not available in retail.
C. Summary of the Final Rule
The final rule revises paragraph (r) to 32 CFR 199.21. This
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 non-generic
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 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
[[Page 76309]]
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. Summary of and Response to Public Comments
The interim final rule was published in the Federal Register (80 FR
46796) August 6, 2015, for a 60-day comment period. We received six
comments on the interim final rule; four comments from individuals and
two comments from professional associations. We appreciate these
comments, which are summarized here, along with DoD's response.
Comment: One comment expressed concern regarding the possibilities
of delays in the mail causing the patient to miss a day or more of
their medication.
Response: The provisions of the TRICARE pharmacy contract permit
beneficiaries to refill medications well in advance of the refill due
date to allow for adequate shipping time. Additionally, this final rule
provides for a case-by-case waiver to permit prescription maintenance
medication refill at a retail pharmacy when necessary due to personal
need or hardship, emergency, or special circumstance.
Comment: One commenter objected to the lack of clear communication
from ESI by stating that conflicting messages are often given to a
beneficiary who calls with a question, i.e. your medications has been
shipped, your medication has not been shipped, etc. The same individual
suggests that Prior Approvals for brand name products often get deleted
from the system requiring the beneficiary to repeat the PA process.
Response: DoD acknowledges the commenter's concerns regarding
contractor communication and Prior Approvals being deleted from the
system, both of which are contract specific issues, and not part of the
regulatory language. It should be noted that Prior Approvals may be
time limited depending on the medication. DoD will consider the
feedback for incorporation into future contractor customer service
performance requirements.
Comment: One commenter inquired why Active Duty personnel are not
required to participate in this mandatory program which appears to be
targeting retirees. In addition, the individual suggested a blanket
waiver be administered for retirees who live in remote areas with very
limited MTF pharmacy access. A final concern asked if MTF staffing has
been increased to accommodate the potential influx of retirees.
Response: This final rule conforms with the current statutory
requirement of Section 702 in the fiscal year (FY) 2015 National
Defense Authorization Act, requiring eligible covered beneficiaries
generally to refill non-generic prescription maintenance medications
through military treatment facility pharmacies or the national mail
order program. Eligible covered beneficiaries are defined in Title 10,
Section 1072(5) and does not include Active Duty service members. The
statute and the rule designate military treatment facility (MTF)
pharmacies or the mail order pharmacy program as the two options
available to beneficiaries for obtaining refills of non-generic
prescription maintenance medications. For those beneficiaries who live
in remote areas with limited MTF access, the mail order pharmacy
program is an ideal option saving both time and copayment expenses. Our
experience and data from the TRICARE FOR LIFE maintenance medication
pilot showed that there was sufficient capacity to accommodate the
change, both at mail order and in the MTFs. Our data show that the
overall impact on the MTF workload was very minimal, while majority of
the prescriptions went to mail order. The movement of brand maintenance
medications from retail to mail order actually saves beneficiaries out-
of-pocket expenses in the form of reduced copays and up to a 90 day
supply for less than the 30 day copay at retail. This provides a win-
win scenario for the beneficiary and the government.
Comment: One commenter cited anecdotal evidence in Alabama that
resulted in emergency room visits from ingesting mail order
prescriptions that had been exposed to excessive heat. The commenter
expressed concerns about proper temperature control of medications
shipped through the mail and suggests the rule include a requirement
that all medications must be kept within the FDA's recommended range of
59-86 degrees.
Response: The pharmacy contractor reviews all medications dispensed
through the mail order pharmacy for unique shipping requirements, based
on information from the manufacturer. For medications that are
temperature-sensitive, special shipping procedures are followed. The
temperature-sensitive medications are mailed via expedited overnight
shipping or 2nd day air, at no cost to the beneficiary. Before certain
medications are delivered, a scheduling call is made to the beneficiary
to arrange a delivery time and date.
Comment: A professional association commented with a number of
concerns: beneficiaries should continue to have choice, flexibility,
and easy access to prescription medications; unnecessary waste
resulting from auto-ship policies and the suggestion to implement
policies to ensure mail order refills are approved and needed; DoD
should conduct and publicize a beneficiary satisfaction survey at the
end of each year; beneficiaries should be properly informed about the
options to seek a waiver and clear instructions on how to obtain one;
DoD should develop and make available a complete list of acute care
meds.
Response: This final rule conforms with the current statutory
requirement of Section 702 in the FY 2015 NDAA requiring eligible
covered beneficiaries generally to refill non-generic prescription
maintenance medications through military treatment facility pharmacies
or the national mail order program. DoD believes it is being
implemented successfully and without adverse effects on beneficiaries.
Non-generic prescription maintenance medications subject to the program
are listed at www.health.mil/selectdruglist. DoD has determined it
unnecessary to have an additional list to specify acute care
medications that are not subject to the program. DoD continues to
monitor beneficiary satisfaction of the TRICARE pharmacy program.
Comment: A professional association commented with the following
concerns: The rule should clearly indicate that covered maintenance
medications include non-generic only; beneficiaries should have to
consent to getting a refill rather than automatic shipping; mandatory
mail results in a silo approach where the patient gets prescriptions
from multiple sources resulting the lack of coordinated care; community
pharmacists are often the sole source for medication and patient
education and can only judge the patient's understand by in-person
interactions; communications to beneficiaries regarding waivers should
include complete information on how to obtain a waiver.
Response: Section 199.21(r)(1) has been amended to insert ``non-
generic''
[[Page 76310]]
prior to ``covered medications''. Contractor requirements are not part
of the regulatory language. In order to participate in the mail order
auto-ship program, beneficiaries must consent to auto-ship enrollment
but are not required to do so. Beneficiaries enrolled in the auto-ship
program are notified prior to medication shipment.
E. Regulatory Procedures
Executive Order 12866, ``Regulatory Planning and Review''
Executive Order (E.O.) 12866 requires 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 final rule and based on
the resulting analysis, the Office of Management and Budget has
concluded that this is an economically significant regulatory action
under the Executive Order. The program rule will produce savings to the
Department of approximately $81M per year and savings to beneficiaries
of approximately $20 million per year in reduced copayments. This rule
results in a shift of workload from retail pharmacies to the mail order
program. This workload shift is estimated to result in a net impact to
retail pharmacy margins nationwide of $15.6 million in FY17 dollars.
This rule has been designated an economically significant regulatory
action 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 final rule is not a major rule under the Congressional
Review Act.
Section 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
This 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 (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 final 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 final 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 final 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.
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 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 199.21 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 non-generic
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 non-generic
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
[[Page 76311]]
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 result in 100%
patient cost shares and will be blocked from any TRICARE payments 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 paragraph
(r) of this section 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 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: October 28, 2016.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2016-26432 Filed 11-1-16; 8:45 am]
BILLING CODE 5001-06-P
