82 FR 28052 - Notice of Three-Year Extension of Defense Health Agency Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project

DEPARTMENT OF DEFENSE
Office of the Secretary

Federal Register Volume 82, Issue 117 (June 20, 2017)

This notice is to advise interested parties of a three-year extension of a demonstration project entitled Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The original notice was published on June 18, 2014 (79 FR 34726-34729).

[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Page 28052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12840]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF DEFENSE

Office of the Secretary


Notice of Three-Year Extension of Defense Health Agency 
Evaluation of Non-United States Food and Drug Administration Approved 
Laboratory Developed Tests Demonstration Project

AGENCY: Department of Defense.

ACTION: Notice of three-year extension of Defense Health Agency 
Evaluation of Non-United States Food and Drug Administration Approved 
Laboratory Developed Tests Demonstration Project.

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

SUMMARY: This notice is to advise interested parties of a three-year 
extension of a demonstration project entitled Defense Health Agency 
(DHA) Evaluation of Non-United States Food and Drug Administration 
(FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. 
The original notice was published on June 18, 2014 (79 FR 34726-34729).

DATES: Effective July 19, 2017.

ADDRESSES: Defense Health Agency (DHA), Attn: Clinical Support 
Division, 16401 East Centretech Parkway, Aurora, CO 80011-9066.

FOR FURTHER INFORMATION CONTACT: Jim Black, Clinical Support Division, 
Defense Health Agency, Telephone (303) 676-3487.

SUPPLEMENTARY INFORMATION: For additional information on the DHA 
Evaluation of Non-United States FDA Approved LDTs Demonstration 
Project, please see 79 FR 34726-34729. According to 32 CFR 
199.4(g)(15)(i)(A), TRICARE may not cost-share medical devices, 
including LDTs, that have not received FDA medical device 510(k) 
clearance or premarket approval.
    The purpose of this demonstration is to improve the quality of 
health care services for TRICARE beneficiaries. Under this 
demonstration, the Department of Defense reviews non-FDA approved LDTs 
to determine if they meet TRICARE's requirements for safety and 
effectiveness, and allows those that do to be covered as a benefit 
under the demonstration. This demonstration also extends coverage for 
prenatal and preconception cystic fibrosis (CF) carrier screening, when 
provided in accordance with the American College of Obstetricians and 
Gynecologists guidelines.
    The Department has determined that continuation of the 
demonstration project for an additional three years is necessary to 
provide the Secretary with sufficient information to fully evaluate the 
project while continuing to provide TRICARE beneficiaries and their 
health care providers with seamless access to safe and effective, 
medically necessary tests to support health care decisions and 
treatment. During the next three years, the DHA will continue to 
evaluate the LDT examination and recommendation process to assess 
feasibility, resource requirements, and the cost-effectiveness of 
establishing an internal safety and efficacy review process to permit 
TRICARE cost-sharing for an ever-expanding pool of non-FDA approved 
LDTs, including tests for cancer risk, diagnosis and treatment, blood 
and clotting disorders, a variety of genetic diseases and syndromes, 
and neurological conditions. The results of the evaluation will provide 
an assessment of the potential improvement of the quality of health 
care services for beneficiaries who would not otherwise have access to 
these safe and effective tests and to support future regulatory 
revisions which will enhance the flexibility of the Military Health 
System in responding to emerging technologies. The demonstration 
project continues to be authorized by 10 U.S.C. 1092.

    Dated: June 15, 2017.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2017-12840 Filed 6-19-17; 8:45 am]
BILLING CODE 5001-06-P