TRICARE Over-the-Counter Drug Demonstration Project, 57623-57624 [2013-22833]

Download as PDF Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices number and title 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 https:// www.regulations.gov as they are received without change, including any personal identifiers or contact information. To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Lt. Col. Judith Schulik, TRICARE Policy and Operations, TRICARE Management Activity, 5111 Leesburg Pike, Suite 810, Falls Church, VA 22041, telephone (703) 681–0039. SUPPLEMENTARY INFORMATION: Title; Associated Form; and OMB Number: Certification of noncontributory TriCare supplemental insurance plan; OMB Control Number 0720–0044. Needs and Uses: Section 707 of the John Warner National Defense Authorization Act for Fiscal Year 2007 added section 1097c to Title 10. Section 1097c prohibits employers from offering financial or other incentives to certain TRICARE-eligible employees to not enroll in an employer-offered group health plan. In other words, employers may no longer offer TRICARE supplemental insurance plans as part of an employee benefit package. Employers may, however, offer TRICARE supplemental insurance plans as part of an employee benefit package provided the plan is not paid for in whole or in part by the employer and is not endorsed by the employer. When such TRICARE supplemental plans are offered, the employer must properly document that they did not provide any payment for the benefit nor receive any direct or indirect consideration or compensation for offering the benefit; the employer’s only involvement is providing the administrative support. That certification will be provided upon request to the Department of Defense. Affected Public: Business or other for profit; Not-for-profit institutions. Annual Burden Hours: 250 hours. Number of Respondents: 1,500. Responses per Respondent: 1. Average Burden per Response: 10 minutes. Frequency: On Occasion. Respondents are employers who make available non-contributory TRICARE supplemental insurance plan to their employees. This new paperwork requirement is consistent with section 707 of the John Warner National tkelley on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 17:27 Sep 18, 2013 Jkt 229001 Defense Authorization Act for Fiscal Year 2007 which added Section 1097c to Title 10. Per Section 1097c, employers may no longer offer TRICARE supplemental insurance plans as part of an employee benefit package. They may offer TRICARE supplemental insurance plans, however, provided the plan is not paid for in whole or in part by the employer and is not endorsed by the employer. When such TRICARE supplemental plans are offered, the employer must properly document that they did not provide any payment for the benefit nor receive any direct or indirect consideration or compensation for offering the benefit; the employer’s only involvement is providing the administrative support. One certification must be completed per employer. It should be kept on file by the employer for as long as such plans are offered. The employer will provide the certification to the Department of Defense upon request. Dated: September 16, 2013. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR Doc. 2013–22807 Filed 9–18–13; 8:45 am] BILLING CODE 5001–06–P 57623 provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102–3.150. Pursuant to 5 U.S.C. 552b and 41 CFR 102–3.140 through 102–3.165, and the availability of space, this meeting is open to the public. The future agenda will include discussion on accreditation compliance, organizational management, strategic planning, resource management, and other matters of interest to the National Defense University. Limited space made available for observers will be allocated on a first come, first served basis. Pursuant to 41 CFR 102–3.105(j) and 102–3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, written statements to the committee may be submitted to the committee at any time or in response to a stated planned meeting agenda by FAX or email to the point of contact person listed in FOR FURTHER INFORMATION CONTACT. (Subject Line: Comment/Statement to the NDU BOV). Dated: September 16, 2013. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR Doc. 2013–22839 Filed 9–18–13; 8:45 a.m.] DEPARTMENT OF DEFENSE BILLING CODE 5001–06–P Office of the Secretary Notification of an Open Meeting of the National Defense University Board of Visitors (BOV) AGENCY: National Defense University, DoD. ACTION: Notice of open meeting. The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the National Defense University Board of Visitors (BOV) will take place. DATES: The meeting will be held on October 8, 2013, from 12:00 p.m. to 5:00 p.m. and will continue on October 9, 2013, from 9:00 a.m. to 12:00 p.m. ADDRESSES: The Board of Visitors meeting will be held at Lincoln Hall, Building 64, Room 1105, the National Defense University, 300 5th Avenue SW., Fort McNair, Washington, DC 20319–5066. FOR FURTHER INFORMATION CONTACT: The point of contact for this notice of open meeting is Ms. Joycelyn Stevens at (202) 685–0079, Fax (202) 685–3920 or StevensJ7@ndu.edu. SUMMARY: This meeting is being held under the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 DEPARTMENT OF DEFENSE Office of the Secretary TRICARE Over-the-Counter Drug Demonstration Project Office of the Secretary, DoD. Notice of modification to the TRICARE Over-the-Counter Drug Demonstration Project. AGENCY: ACTION: 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 SUMMARY: E:\FR\FM\19SEN1.SGM 19SEN1 57624 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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 OneStep, 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 VerDate Mar<15>2010 17:27 Sep 18, 2013 Jkt 229001 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 OneStep Emergency Contraceptive (levonorgestrel) through the demonstration project will be at retail PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF DEFENSE Department of the Army; Corps of Engineers Availability of a Draft Integrated Feasibility Report (Feasibility Study/ Environmental Impact Statement/ Environmental Impact Report), Los Angeles River Ecosystem Restoration Study, City of Los Angeles, Los Angeles County, CA Department of the Army, U.S. Army Corps of Engineers, DoD. ACTION: Notice of availability. AGENCY: The U.S. Army Corps of Engineers (Corps) in conjunction with the City of Los Angeles (City) announces the availability of a Draft Integrated Feasibility Report (IFR), which includes a Draft Feasibility Study (FS) and Environmental Impact Statement/ Environmental Impact Report (EIS/EIR) for the Los Angeles River Ecosystem Restoration Study, Los Angeles County, CA, for review and comment. The study evaluates alternatives for the purpose of restoring 11 miles of the Los Angeles River from approximately Griffith Park SUMMARY: E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57623-57624]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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
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