[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57623-57624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22833]


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DEPARTMENT OF DEFENSE

Office of the Secretary


TRICARE Over-the-Counter Drug Demonstration Project

AGENCY: Office of the Secretary, DoD.

ACTION: Notice of modification to the TRICARE Over-the-Counter Drug 
Demonstration Project.

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SUMMARY: This notice is to advise interested parties of a modification 
of the demonstration project in which the Department of Defense (DoD) 
evaluates allowing selected over-the-counter (OTC) drugs to be included 
on the TRICARE uniform formulary. The Department has been engaged in a 
demonstration project relating to Over the Counter (OTC) drugs since 
2009. This demonstration project has been evaluating the costs/benefits 
and beneficiary satisfaction of providing selected OTC drugs under the 
pharmacy benefits program when the selected OTC drugs are determined to 
be clinically effective and when recommended by the Pharmacy and 
Therapeutics Committed and approved by the Assistant Secretary of 
Defense (Health Affairs). Under the current demonstration, the eligible

[[Page 57624]]

drugs have been limited to those drugs for which the beneficiary has a 
prescription for a drug in the same class and for which a clinically 
effective OTC drug is also available. The current demonstration is 
scheduled to end in November 2014. In the National Defense 
Authorization Act for Fiscal Year 2013, Congress authorized the 
Department to provide Over the Counter (OTC) drugs to beneficiaries 
under regulations prescribed by the Secretary. Although the Department 
could now cease the demonstration and implement this new Congressional 
authority, it is now considering the viability of adding some drugs, 
such as the Plan B One-Step (levonorgestrel) which is an OTC product 
for all women of child-bearing potential that does not require a 
prescription. It was decided that the most efficient method of testing 
this new criteria was by modification to the current demonstration.

DATES: This demonstration project will continue through until November 
30, 2016 in order to provide adequate time to implement and evaluate 
the substantive changes allowing the DoD to provide drugs, such as the 
Plan B One-Step, that are in the class of drugs normally requiring a 
prescription but which the FDA has granted an exception to the 
prescription requirement.

FOR FURTHER INFORMATION CONTACT: Captain Nita Sood, TRICARE Management 
Activity, Pharmaceutical Operations Directorate, telephone (703) 681-
2890.

SUPPLEMENTARY INFORMATION:

Background

    Section 705 of the John Warner National Defense Authorization Act 
for 2007 directed the Secretary to conduct a demonstration project 
under 10 United States Code (U.S.C.) 1092 to allow certain over-the-
counter (OTC) medications to be included on the uniform formulary under 
10 U.S.C. 1074g. On June 15, 2007, the Department of Defense published 
a notice in the Federal Register (FR) (72 FR 33208-33210) implementing 
the demonstration project until the implementation of the combined 
TRICARE mail and retail contract (TPharm) which was on November 4, 
2009. In order to more thoroughly evaluate the clinical and cost 
effectiveness of OTC drugs as well as beneficiary satisfaction with the 
project, the Department published a notice in the FR (74 FR 66626-
66627) on December 16, 2009 that extended the demonstration project 
through November 4, 2012. The Department determined that continuation 
of the demonstration project for an additional 2 years was necessary to 
provide the Secretary with sufficient information to fully evaluate the 
project. The demonstration project continues to be authorized by 10 
U.S.C. 1092. Section 702 of the National Defense Authorization Act for 
Fiscal Year 2013 authorized the Department to provide OTC 
pharmaceuticals under terms prescribed by the Secretary. This 
authorization would allow the Department to implement its current 
demonstration under its current terms. These terms have been to 
authorize the provision of OTC drugs when the beneficiary had been 
receiving prescription drugs in the same class and a clinically 
effective OTC was available. These drugs were treated as generic 
prescription medications, except that the need for a prescription and/
or a copay were waived. The OTC drugs must have been recommended by the 
DoD Pharmacy and Therapeutics Committee and approved by the Assistant 
Secretary of Defense, (Health Affairs) prior to inclusion on the 
formulary. On June 20, 2013, the Food and Drug Administration (FDA) 
announced the use of Plan B One-Step (levonorgestrel) emergency 
contraceptive as an over-the-counter product ``for all women of child-
bearing potential without age or point-of-sale restrictions.'' 
Contraceptive drugs are a type of drug which normally would require a 
prescription prior to dispensing, however the FDA made an exception for 
this particular drug. The statute governing the Department's pharmacy 
program, 10 U.S.C. 1074g, requires the Department to make available to 
its beneficiaries all prescription drugs approved by the FDA. The 
current issue for the Department regarding this drug, and any drugs for 
which the FDA might issue similar exceptions and mandates, is to 
determine how best to implement this requirement in our regulations. 
The modifications to the current demonstration are designed to help the 
Department determine whether these drugs can be treated in the same 
manner as the other OTC drugs which moved from prescription to non-
prescription status.

Modification of the Demonstration Project

    (1) Inclusion of the Over-the-Counter Plan B One-Step Emergency 
Contraceptive (levonorgestrel).
    (2) OTC availability of Plan B One-Step Emergency Contraceptive 
(levonorgestrel) through the demonstration project will be at retail 
dispensing venue. Eligibility includes all active duty service women 
and female beneficiaries of child-bearing potential, without age 
restrictions. All military treatment facility (MTF) pharmacies carry 
OTC Plan B One-Step, and provide it to all active duty service women 
and female beneficiaries of child-bearing potential, without age 
restrictions, at no cost. The OTC Plan B One-Step Emergency 
Contraceptive (levonorgestrel) will not be available through the 
demonstration project at the TRICARE mail order program because it 
would be clinically inappropriate to take OTC Plan B One-Step Emergency 
Contraceptive (levonorgestrel) after 72 hours (3 days).
    (3) Eligible beneficiaries will not require a written prescription 
for Plan B One-Step Emergency Contraceptive (levonorgestrel). The 
beneficiary simply presents to the retail pharmacy and which will 
process the request identically to all other pharmacy claims.
    (4) Cost sharing requirements. The cost sharing will be zero copay.
    (5) Period of demonstration. The demonstration project will 
continue until November 30, 2016.

    Dated: September 16, 2013.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2013-22833 Filed 9-18-13; 8:45 am]
BILLING CODE 5001-06-P