81 FR 76307 - 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
DEPARTMENT OF DEFENSE
Office of the Secretary Federal Register Volume 81, Issue 212 (November 2, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76307-76311 | |
| FR Document | 2016-26432 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Rules and Regulations] [Pages 76307-76311] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Rules and Regulations 76307
Regulatory Flexibility Act, 5 U.S.C. 601, 25 CFR Part 584 Authority: 25 U.S.C. 2706, 2710, 2711,
et seq. Indian tribes are not considered 2712, 2713, 2715, 2717.
Administrative practice and
to be small entities for purposes of the procedure, Gambling. ■ 8. Revise the heading of part 585 to
Regulatory Flexibility Act. read as set forth above.
25 CFR Part 585 Dated: October 17, 2016.
Small Business Regulatory Enforcement
Fairness Act Administrative practice and Jonodev O. Chaudhuri,
procedure, Gambling, Indians—lands, Chairman.
This rule is not a major rule under 5 Penalties. Kathryn Isom-Clause,
U.S.C. 804(2), the Small Business For the reasons set forth in the Vice Chair.
Regulatory Enforcement Fairness Act. preamble, the NIGC amends 25 CFR E. Sequoyah Simermeyer,
This rule will not result in an annual parts 517, 584, and 585 as follows:
Associate Commissioner.
effect on the economy of $100 million
PART 517—FREEDOM OF [FR Doc. 2016–26060 Filed 11–1–16; 8:45 am]
per year or more. This rule will not
cause a major increase in costs or prices INFORMATION ACT PROCEDURES BILLING CODE 7565–01–P
for consumers, individual industries, ■ 1. The authority citation for part 517
federal, state, or local government continues to read as follows:
agencies, or geographic regions and does DEPARTMENT OF DEFENSE
not have a significant adverse effects on Authority: 5 U.S.C. 552, as amended.
Office of the Secretary
competition, employment, investment, ■ 2. Revise the first sentence of § 517.2
productivity, innovation, or on the to read as follows: 32 CFR Part 199
ability of U.S.-based enterprises to
compete with foreign-based enterprises. § 517.2 Public reading room. [Docket ID: DOD–2015–HA–0062]
Records that are required to be
Unfunded Mandates Reform Act RIN 0720–AB64
maintained by the Commission shall be
available for public inspection and Civilian Health and Medical Program of
The Commission, as an independent
copying at 90 K Street NE., Suite 200, the Uniformed Services (CHAMPUS)/
regulatory agency, is exempt from Washington, DC 20002. * * *
compliance with the Unfunded TRICARE: Refills of Maintenance
■ 3. Revise the first two sentences of Medications Through Military
Mandates Reform Act, 2 U.S.C. 1502(1);
2 U.S.C. 658(1). § 517.4(a) to read as follows: Treatment Facility Pharmacies or
§ 517.4 Requirements for making requests. National Mail Order Pharmacy Program
Takings
(a) How to make a FOIA request. AGENCY: Office of the Secretary,
In accordance with Executive Order Requests for records made pursuant to Department of Defense (DoD).
12630, the Commission determined the the FOIA must be in writing. Requests ACTION: Final rule.
rule does not have significant takings should be sent to the National Indian
implications. A takings implication Gaming Commission, Attn: FOIA SUMMARY: This final rule implements
assessment is not required. Officer, C/O Department of Interior, section 702 (c) of the Carl Levin and
1849 C Street NW., Mailstop #1621, Howard P. ‘‘Buck’’ McKeon National
Civil Justice Reform Act Washington, DC 20240. * * * Defense Authorization Act for Fiscal
* * * * * Year 2015 which states that beginning
In accordance with Executive Order
October 1, 2015, the pharmacy benefits
12988, the Commission determined the ■ 4. Revise the last sentence in
program shall require eligible covered
rule does not unduly burden the judicial § 517.8(b)(2) to read as follows:
beneficiaries generally to refill non-
system and meets the requirements of
§ 517.8 Appeals. generic prescription maintenance
sections 3(a) and 3(b)(2) of the Executive
* * * * * medications through military treatment
Order.
(b) * * * facility pharmacies or the national mail-
National Environmental Policy Act (2) * * * The appeal shall be order pharmacy program. An interim
addressed to the National Indian final rule is in effect. Section 702(c) of
The Commission determined this rule Gaming Commission, Attn: FOIA the National Defense Authorization Act
does not constitute a major federal Appeals Officer, C/O Department of for Fiscal Year 2015 also terminates the
action significantly affecting the quality Interior, 1849 C Street NW., Mailstop TRICARE For Life Pilot Program on
of the human environment and that a #1621, Washington, DC 20240. September 30, 2015. The TRICARE For
detailed statement is not required Life Pilot Program described in section
* * * * *
pursuant to the National Environmental 716(f) of the National Defense
Policy Act of 1969, 42 U.S.C. 4321, et PART 584—APPEALS BEFORE A Authorization Act for Fiscal Year 2013,
seq. PRESIDING OFFICIAL was a pilot program which began in
Paperwork Reduction Act March 2014 requiring TRICARE For Life
■ 5. The authority citation for part 584 beneficiaries to refill non-generic
The rule does not contain any continues to read as follows: prescription maintenance medications
information collection requirements for Authority: 25 U.S.C. 2706, 2710, 2711, through military treatment facility
which Office of Management and 2712, 2713, 2715, 2717. pharmacies or the national mail-order
Budget approval under the Paperwork ■ 6. Revise the heading of part 584 to pharmacy program. TRICARE for Life
Reduction Act (44 U.S.C. 3501–3520) is beneficiaries are those enrolled in the
ehiers on DSK5VPTVN1PROD with RULES
read as set forth above.
required. Medicare wraparound coverage option
PART 585—APPEALS TO THE of the TRICARE program. This rule
List of Subjects includes procedures to assist
COMMISSION
25 CFR Part 517 beneficiaries in transferring covered
■ 7. The authority citation for part 585 prescriptions to the mail order
Freedom of information. continues to read as follows: pharmacy program.
VerDate Sep<11>2014 13:32 Nov 01, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\02NOR1.SGM 02NOR1](https://thefederalregister.org/doc/81_FR_76519/page/1.svg)
![76310 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Rules and Regulations
prior to ‘‘covered medications’’. Public Law 96–354, ‘‘Regulatory (2) Medications covered. The Director,
Contractor requirements are not part of Flexibility Act’’ (5 U.S.C. 601) DHA, will establish, maintain, and
the regulatory language. In order to The Regulatory Flexibility Act (RFA) periodically revise and update a list of
participate in the mail order auto-ship requires that each Federal agency non-generic covered maintenance
program, beneficiaries must consent to prepare and make available for public medications subject to the requirement
auto-ship enrollment but are not comment, a regulatory flexibility of paragraph (r)(1) of this section. The
required to do so. Beneficiaries enrolled analysis when the agency issues a current list will be accessible through
in the auto-ship program are notified regulation which would have a the TRICARE Pharmacy Program
prior to medication shipment. significant impact on a substantial Internet Web site and by telephone
number of small entities. This final rule through the TRICARE Pharmacy
E. Regulatory Procedures does not have a significant impact on a Program Service Center. Each
substantial number of small entities. medication included on the list will
Executive Order 12866, ‘‘Regulatory
meet the following requirements:
Planning and Review’’ Public Law 96–511, ‘‘Paperwork (i) It will be a medication prescribed
Reduction Act’’ (44 U.S.C. Chapter 35) for a chronic, long-term condition that
Executive Order (E.O.) 12866 requires
that a comprehensive regulatory impact This final rule contains no new is taken on a regular, recurring basis.
analysis be performed on any information collection requirements (ii) It will be clinically appropriate to
subject to the Paperwork Reduction Act dispense the medication from the mail
economically significant regulatory
(PRA) of 1995 (44 U.S.C. 3501–3511). order pharmacy.
action, defined primarily as one that (iii) It will be cost effective to
would result in an effect of $100 million Executive Order 13132, ‘‘Federalism’’ dispense the medication from the mail
or more in any one year. The DoD has order pharmacy.
This final rule does not have
examined the economic and policy federalism implications, as set forth in (iv) It will be available for an initial
implications of this final rule and based Executive Order 13132. This rule does filling of a 30-day or less supply through
on the resulting analysis, the Office of not have substantial direct effects on the retail pharmacies.
Management and Budget has concluded States; the relationship between the (v) It will be generally available at
that this is an economically significant National Government and the States; or military treatment facility pharmacies
regulatory action under the Executive the distribution of power and for initial fill and refills.
Order. The program rule will produce responsibilities among the various (vi) It will be available for refill
savings to the Department of levels of Government. through the national mail-order
approximately $81M per year and pharmacy program.
savings to beneficiaries of List of Subjects in 32 CFR Part 199 (3) Refills covered. For purposes of the
approximately $20 million per year in Administrative practice and program under paragraph (r)(1) of this
reduced copayments. This rule results procedure, Claims, Dental health, Fraud, section, a refill is:
in a shift of workload from retail Health care, Health insurance, (i) A subsequent filling of an original
pharmacies to the mail order program. Individuals with disabilities, Military prescription under the same
This workload shift is estimated to personnel. prescription number or other
result in a net impact to retail pharmacy Accordingly, 32 CFR part 199 is authorization as the original
margins nationwide of $15.6 million in amended as follows: prescription; or
(ii) A new original prescription issued
FY17 dollars. This rule has been
PART 199—[AMENDED] at or near the end date of an earlier
designated an economically significant
prescription for the same medication for
regulatory action under section 3(f) of ■ 1. The authority citation for part 199 the same patient.
Executive Order 12866. Accordingly, continues to read as follows: (4) Waiver of requirement. A waiver of
the rule has been reviewed by the Office the general requirement to obtain
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
of Management and Budget (OMB). 55. maintenance medication prescription
Congressional Review Act, 5 U.S.C. 801, ■ 2. Section 199.21 is amended by refills from the mail order pharmacy or
et seq. revising paragraph (r) to read as follows: military treatment facility pharmacy
will be granted in the following
Under the Congressional Review Act, § 199.21 TRICARE Pharmacy Benefits circumstances:
a major rule may not take effect until at Program. (i) There is a blanket waiver for
least 60 days after submission to * * * * * prescription medications that are for
Congress of a report regarding the rule. (r) Refills of maintenance medications acute care needs.
A major rule is one that would have an for eligible covered beneficiaries (ii) There is a blanket waiver for
annual effect on the economy of $100 through the mail order pharmacy prescriptions covered by other health
million or more or have certain other program—(1) In general Consistent with insurance.
section 702 of the National Defense (iii) There is a case-by-case waiver to
impacts. This final rule is not a major
Authorization Act for Fiscal Year 2015, permit prescription maintenance
rule under the Congressional Review
this paragraph requires that for non- medication refills at a retail pharmacy
Act.
generic covered maintenance when necessary due to personal need or
Section 202, Public Law 104–4, medications, beneficiaries are generally hardship, emergency, or other special
‘‘Unfunded Mandates Reform Act’’ required to obtain their prescription circumstance. This waiver is obtained
through the national mail-order through an administrative override
ehiers on DSK5VPTVN1PROD with RULES
This rule does not contain a Federal pharmacy program or through military request to the TRICARE pharmacy
mandate that may result in the treatment facility pharmacies. For benefits manager under procedures
expenditure by State, local and tribal purposes of this paragraph, eligible established by the Director, DHA.
governments, in aggregate, or by the covered beneficiaries are those defined (5) Procedures. Under the program
private sector, of $100 million or more under sections 1072 and 1086 of title 10, established by paragraph (r)(1) of this
(adjusted for inflation) in any one year. United States Code. section, the Director, DHA will establish
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![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Rules and Regulations 76311
procedures for the effective operation of DEPARTMENT OF THE INTERIOR pinniger) and Puget Sound-Georgia
the program. Among these procedures Basin yelloweye rockfish (Sebastes
are the following: Fish and Wildlife Service ruberrimus) were applicable as of
(i) The Department will implement February 11, 2015. The critical habitat
the program by utilizing best 50 CFR Part 17 designations for the lower Columbia
commercial practices to the extent [Docket No. FWS–HQ–ES–2016–0109; River coho salmon (Oncorhynchus
practicable. 4500030113] kisutch) and the Puget Sound steelhead
(ii) An effective communication plan (Oncorhynchus mykiss) were applicable
RIN 1018–BB82 as of March 25, 2016. The applicable
that includes efforts to educate
beneficiaries in order to optimize rule citation for the North Atlantic right
Endangered and Threatened Wildlife
participation and satisfaction will be whale (Eubalaena glacialis) was
and Plants; Adding Ten Species and
implemented. applicable as of December 6, 2013.
Updating Five Species on the List of
Endangered and Threatened Wildlife FOR FURTHER INFORMATION CONTACT:
(iii) Beneficiaries with active retail
prescriptions for a medication on the Sarah Quamme, Chief, Unified Listing
AGENCY: Fish and Wildlife Service, Team, U.S. Fish and Wildlife Service,
maintenance medication list will be
Interior. MS–ES, 5275 Leesburg Pike, Falls
notified that their medication is
included under the program. ACTION: Final rule. Church, VA 22041–3803; 703–358–
Beneficiaries will be advised that they 1796.
SUMMARY: We, the U.S. Fish and
may receive two 30 day fill at retail SUPPLEMENTARY INFORMATION:
Wildlife Service (Service), in
while they transition their prescription Background
accordance with the Endangered
to the mail order program.
Species Act of 1973, as amended (Act), In accordance with the Act (16 U.S.C.
(iv) Requests for a third fill at retail are amending the List of Endangered
will result in 100% patient cost shares 1531 et seq.) and Reorganization Plan
and Threatened Wildlife (List) by No. 4 of 1970 (35 FR 15627; October 6,
and will be blocked from any TRICARE adding: three foreign coral species
payments and the beneficiary advised to 1970), NMFS has jurisdiction over the
(Cantharellus noumeae, Siderastrea marine and anadromous taxa specified
call the pharmacy benefits manager glynni, and Tubastraea floreana), dusky
(PBM) for assistance. in this rule. Under section 4(a)(1) of the
sea snake (Aipysurus fuscus), Banggai Act, NMFS must decide whether a
(v) The PBM will provide a toll free cardinalfish (Pterapogon kauderni), the species under its jurisdiction should be
number to assist beneficiaries in Tanzanian distinct population segment classified as endangered or threatened.
transferring their prescriptions from (DPS) of African coelacanth (Latimeria Under section 4(a)(3)(A)(i) of the Act,
retail to the mail order program. With chalumnae), Nassau grouper NMFS must designate any habitat of
the beneficiary’s permission, the PBM (Epinephelus striatus), and three endangered or threatened species which
will contact the physician or other angelshark species (Squatina aculeata, is then considered to be critical habitat.
health care provider who prescribed the S. oculata, and S. squatina). We are also NMFS makes these determinations and
medication to assist in transferring the updating the entries for Puget Sound- critical habitat designations via its
prescription to the mail order program. Georgia Basin canary rockfish (Sebastes rulemaking process. Under section
(vi) In any case in which a beneficiary pinniger), Puget Sound-Georgia Basin 4(a)(2) of the Act, we, the Service, are
required under paragraph (r) of this yelloweye rockfish (Sebastes then responsible for publishing final
section to obtain a maintenance ruberrimus), lower Columbia River coho rules to amend the List in title 50 of the
medication prescription refill from salmon (Oncorhynchus kisutch), and the Code of Federal Regulations (CFR) at 50
national mail order pharmacy program Puget Sound steelhead (Oncorhynchus CFR 17.11(h).
and attempts instead to refill such mykiss) to reflect the designation of On December 16, 2014, NMFS
medications at a retail pharmacy, the critical habitat, and we are updating the published a proposed rule (79 FR
PBM will also maintain the toll free entry for the North Atlantic right whale 74953) to list the dusky sea snake
number to assist the beneficiary. This (Eubalaena glacialis) to reflect an (Aipysurus fuscus) and three foreign
assistance may include information on applicable rule citation. These corals (Cantharellus noumeae,
how to request a waiver, consistent with amendments are based on previously Siderastrea glynni, and Tubastraea
paragraph (r)(4)(iii) of this section, or in published determinations by the floreana) as endangered species, and the
taking any other appropriate action to National Marine Fisheries Service Banggai cardinalfish (Pterapogon
meet the beneficiary’s needs and to (NMFS) of the National Oceanic and kauderni) as a threatened species.
implement the program. Atmospheric Administration, NMFS solicited public comments on the
(vii) The PBM will ensure that a Department of Commerce, which has proposed rule through February 17,
pharmacist is available at all times jurisdiction for these species. 2015. On October 7, 2015, NMFS
through the toll-free telephone number DATES: This rule is effective November published a final rule (80 FR 60560) to
to answer beneficiary questions or 2, 2016. Applicability date: The three list the dusky sea snake and the three
provide other appropriate assistance. coral and dusky sea snake listings were foreign coral species as endangered
(6) This program will remain in effect applicable as of November 6, 2015. The species. On January 20, 2016, NMFS
indefinitely with any adjustments or Banggai cardinalfish listing was published a final rule (81 FR 3023) to
modifications required by law. applicable as of February 19, 2016. The list the Banggai cardinalfish as a
* * * * * Tanzanian DPS of African coelacanth threatened species.
listing was applicable as of April 28, The listing of the dusky sea snake and
ehiers on DSK5VPTVN1PROD with RULES
Dated: October 28, 2016. 2016. The Nassau grouper listing was three foreign coral species was
Aaron Siegel, applicable as of July 29, 2016. The three applicable as of November 6, 2015. The
Alternate OSD Federal Register Liaison angelshark listings were applicable as of listing of the Banggai cardinalfish was
Officer, Department of Defense. August 31, 2016. The critical habitat applicable as of February 19, 2016. In
[FR Doc. 2016–26432 Filed 11–1–16; 8:45 am] designations for the Puget Sound- the final rules for these species (dusky
BILLING CODE 5001–06–P Georgia Basin canary rockfish (Sebastes sea snake and three corals: 80 FR 60560;
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Document Created: 2016-11-02 01:40:48
Document Modified: 2016-11-02 01:40:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Contact | Dr. George Jones, Jr., Chief, Pharmacy Operations Division, Defense Health Agency, telephone 703-681-2890. | |
| FR Citation | 81 FR 76307 | |
| RIN Number | 0720-AB64 | |
| CFR Associated | Administrative Practice and Procedure; Claims; Dental Health; Fraud; Health Care; Health Insurance; Individuals with Disabilities and Military Personnel |
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