[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: http://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 http://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