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Notice

TRICARE Over-the-Counter Drug Demonstration Project

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AGENCY:

Department of Defense.

ACTION:

Notice of a TRICARE over-the-counter drug demonstration project.

SUMMARY:

This notice is to advise interested parties of a demonstration project in which the Department of Defense will evaluate allowing selected over-the-counter (OTC) drugs to be included on the TRICARE uniform formulary. The Secretary will evaluate the costs/benefits and beneficiary satisfaction of providing OTC drugs under the pharmacy benefits program when the selected OTC drugs are determined to be clinically effective. The demonstration project will be available for beneficiaries within the United States, Puerto Rico, Virgin Islands, and Guam.

DATES:

Effective Date: This demonstration project is mandated by Section 705 of the John Warner National Defense Authorization Act for 2007, with an implementation deadline of May 1, 2007. Therefore, the Department of Defense is waiving the regulation (32 CFR 199.1(o)) requiring at least 30 days notice of a demonstration project prior to its effective date. Waiver of the notice period is deemed necessary to avoid delay in implementing program changes.

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FOR FURTHER INFORMATION CONTACT:

MAJ Travis Watson, TRICARE Management Activity, Pharmaceutical Operations Directorate, telephone (703) 681-2890.

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SUPPLEMENTARY INFORMATION:

A. Background

Section 705 of the John Warner National Defense Authorization Act for 2007 (hereafter Section 705) directed the Department of Defense to conduct a demonstration project to allow certain over-the-counter medications to be included on the uniform formulary under section 1074g of title 10, United States Code. Section 705 requires that OTC drugs provided under this demonstration project be made available through at least two of the following dispensing venues—military treatment facilities, TRICARE retail network pharmacies, or the TRICARE mail order pharmacy. The Department intends to initially offer the selected OTC drugs through the TRICARE mail order pharmacy and a limited number of designated military treatment facilities (no less than five per TRICARE region). Not all OTC drugs will be covered under this demonstration project. An OTC drug shall be made available to a beneficiary through the demonstration project if (a) the beneficiary has a prescription for a drug requiring a prescription; (b) the Pharmacy & Therapeutics Committee has determined Start Printed Page 33209the OTC drug to be cost-effective and therapeutically equivalent to the prescription drug; and (c) the OTC drug has been included on the uniform formulary.

Current law excludes cost sharing of OTC drugs (except insulin) under the Pharmacy Benefits Program. Section 705 requires the demonstration project to evaluate the clinical and cost effectiveness of OTC drugs as well as beneficiary satisfaction with the project. At the conclusion of not more than two years of the project, the Secretary will evaluate the hypotheses that substitution of selected OTC drugs under the TRICARE Pharmacy Benefits Program provides clinical and cost effectiveness along with beneficiary satisfaction, and submit a report to the Armed Services Committee of both the House and Senate that includes conclusions and recommendations for improving the provision of OTC drugs under the pharmacy benefits program and whether permanent legislative authority should be provided to cover OTC drugs under the pharmacy benefits program. Section 705 also authorizes the Department to continue the demonstration for up to one year after submitting the report if it is recommended that the Department should be granted permanent authority to provide OTCs.

B. Description of Demonstration Project

(1) Inclusion of certain over-the-counter drugs. The Department of Defense Pharmacy & Therapeutics (P&T) Committee must find that the OTC drug is cost-effective and therapeutically equivalent to a prescription drug within a selected therapeutic class. The P&T Committee will expeditiously begin relative clinical and cost-effective evaluations of OTC drugs in therapeutic classes that would meet the intent of this requirement. The P&T Committee will review OTC drugs throughout the course of the demonstration project. Some potential candidates include omeprazole, an anti-ulcer/heartburn agent; loratidine, a non-sedating antihistamine; topical antifungals; and niacin, a cholesterol lowering agent. The minutes of the DoD Pharmacy & Therapeutics Committee (http://www.tricare.mil/​pharmacy/​PT_​Cmte/​default.htm) will record the selection of OTC drugs which are part of this demonstration project.

(2) OTC drug availability through the demonstration project. There are two categories of beneficiaries who are eligible candidates for the demonstration: (1) Those who have a current prescription filled for a drug in the therapeutic class; and (2) those who have a new prescription for a prescription item that has an approved OTC drug equivalent, as defined by the program. For beneficiaries who have a currently filled prescription, the Pharmacy Data Transaction Service (PDTS) will be used to review a patient's medication history to verify whether they have received a therapeutically equivalent prescription drug that corresponds to the OTC drug covered under the demonstration project. For beneficiaries who have a new prescription, the process used to verify eligibility will depend upon the dispensing venue the beneficiary chooses to use. Not all OTC drugs eligible for dispensing through this project will be available at all dispensing venues. The Pharmacy Program Office will communicate OTC drug availability through the use of the TRICARE Web site (http://www.tricare.mil/​pharmacy), public affairs outreach, and through the representative military beneficiary organizations.

(3) Dispensing venues and project scope. This demonstration project is required to be conducted through at least two of the three points of service for dispensing prescriptions. Standard utilization management processes will be applied to the demonstration project consistent with current practices at TMOP, military treatment facilities, and the TRICARE Retail Pharmacy network.

i. TRICARE Mail Order Pharmacy. The demonstration project will be initiated in the TRICARE mail order pharmacy. When a beneficiary receives a prescription product from TMOP, which has an OTC drug available for dispensing under this demonstration, the beneficiary will have their prescription filled, and additionally, they will receive a letter informing them about the demonstration and how to participate. The letter will consist of demonstration information and a pre-printed prescription for the OTC drug. In order to participate in the demonstration, the beneficiary must take the pre-printed prescription to their provider for signature. The beneficiary can send the signed, pre-printed prescription or a new prescription from the provider to TMOP for filling in place of the legend prescription. A provider's signature is required on either. Providers may send a prescription to the TMOP via facsimile or mail. When the prescription for the OTC is received by TMOP, all remaining refills (if any) will be filled with the OTC instead of the original prescription drug. The contractor shall accept either the signed pre-printed prescription or a new prescription from the provider.

ii. Military treatment facilities. The Pharmacy Program Office in conjunction with the DoD P&T Committee will search for opportunities to find cost-effective OTC drugs that meet the intent of the program design. Many therapeutic drugs in drug classes with an equivalent OTC are more costly than the generic drug that can be obtained by the MTF with federal pricing. The number of military treatment facilities that will participate in the demonstration project will be consistent in scope with the requirements in Section 705, which allows the Department to conduct the demonstration throughout the entire pharmacy benefits program, or at a limited number of sites. If a limited number of sites are selected, the number may not be less than five in each TRICARE region. The Pharmacy Program Office will communicate OTC drug availability through the use of the TRICARE Web site (http://www.tricare.mil/​pharmacy), public affairs outreach, and through the representative military beneficiary organizations. Notice of an opportunity to participate in the demonstration will be given to the beneficiary at the selected MTF by either the physician writing the prescription or by the MTF pharmacy dispensing the drug.

iii. TRICARE retail pharmacy network. Upon the completion of contract changes and operational considerations, the demonstration project will be conducted within selected pharmacies of the TRICARE retail pharmacy network. The number and location of retail pharmacies that will participate in the demonstration project will be consistent in scope with the requirements in Section 705, which allows the Department to conduct the demonstration throughout the entire pharmacy benefits program, or at a limited number of sites. If a limited number of sites are selected, the number may not be less than five in each TRICARE region. The Pharmacy Program Office will communicate OTC drug availability through the use of the TRICARE Web site (http://www.tricare.mil/​pharmacy), public affairs outreach, and through the representative military beneficiary organizations. Notice of an opportunity to participate in the demonstration will be given to the beneficiary at the selected retail network pharmacy by the pharmacy dispensing the drug through an electronic message sent to the pharmacist through the Pharmacy Data Transaction Service.

(4) Cost sharing requirements. Beneficiaries will not be charged a cost Start Printed Page 33210share for OTC drugs received under this demonstration project.

(5) Period of demonstration. This demonstration project will begin no later than May 1, 2007 in TMOP, and phased in at MTFs and/or retail pharmacies during the first year and the demonstration will last until the implementation of the combined TRICARE mail and retail contract (TPharm) which is approximately two years from the start date of the demonstration project.

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Dated: June 11, 2007.

L.M. Bynum,

Alternate OSD Federal Register Liaison Officer, DoD.

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[FR Doc. E7-11558 Filed 6-14-07; 8:45 am]

BILLING CODE 5001-06-P