United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2014_register
executive
2014-06-18
article
Defense Health Agency Evaluation of Non-United States Food and Drug Administration; Approved Laboratory Developed Tests Demonstration Project
Notices
D09002ee1bdc4139f
D09002ee1bdc41413
United States
Department of Defense
originator
org
United States Government Agency or Subagency
United States
Office of the Secretary
originator
org
United States Government Agency or Subagency
This notice is to advise interested parties of a Military Health System (MHS) demonstration project under the authority of Title 10, United States Code, Section 1092, entitled Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The demonstration project is intended to further evaluate whether it is feasible for the Department of Defense (DoD) to review LDTs not yet examined by the FDA to determine if they meet TRICARE's requirements for safety and effectiveness according to the hierarchy of reliable evidence (32 CFR 199.4(g)(15)(i)(C) and 32 CFR 199.2(b)), or TRICARE's rare disease policy (32 CFR 199.4(g)(15)(ii)) in the case of LDTs used in the diagnosis or medical management of a rare disease (32 CFR 199.2(b)), and allow those that do to be covered as a benefit under the TRICARE Program. The demonstration project will evaluate feasible alternatives to support modifications to 32 CFR 199.4(g)(15)(i)(A) to allow coverage for non-FDA approved LDTs that otherwise meet the TRICARE requirements for safety and effectiveness. The Department currently has an ongoing demonstration project to test this same provision for LDTs with a Center for Medicare and Medicaid Services (CMS) national or local coverage determination that were submitted by laboratories for consideration for coverage under TRICARE. However, this new demonstration is being conducted in order to be able to evaluate the feasibility of establishing a cost-effective and efficient way to review an expanded pool of non-FDA approved LDTs prioritized based on their potential high utilization and clinical utility within the TRICARE population. This new demonstration project will also extend coverage for prenatal and preconception cystic fibrosis carrier screening, when provided in accordance with the American College of Obstetricians and Gynecologists guidelines in order to allow DoD to establish whether there is a benefit to offering such testing to TRICARE beneficiaries.
79 FR 34726
https://www.govinfo.gov/app/details/FR-2014-06-18/2014-14247
2014-14247
fr18jn14-37
5001-06-P
https://www.govinfo.gov/app/details/FR-2014-06-18/2014-14247
https://www.govinfo.gov/content/pkg/FR-2014-06-18/html/2014-14247.htm
https://www.govinfo.gov/content/pkg/FR-2014-06-18/pdf/2014-14247.pdf
4 p.
34726
34729
79 FR 34726
Defense Health Agency Evaluation of Non-United States Food and Drug Administration; Approved Laboratory Developed Tests Demonstration Project; Federal Register Vol. 79, Issue
NOTICE
2014-14247
DEPARTMENT OF DEFENSE
Office of the Secretary
2014-07-18
5001-06-P
2014-14247
Notice of Demonstration.
This notice is to advise interested parties of a Military Health System (MHS) demonstration project under the authority of Title 10, United States Code, Section 1092, entitled Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The demonstration project is intended to further evaluate whether it is feasible for the Department of Defense (DoD) to review LDTs not yet examined by the FDA to determine if they meet TRICARE's requirements for safety and effectiveness according to the hierarchy of reliable evidence (32 CFR 199.4(g)(15)(i)(C) and 32 CFR 199.2(b)), or TRICARE's rare disease policy (32 CFR 199.4(g)(15)(ii)) in the case of LDTs used in the diagnosis or medical management of a rare disease (32 CFR 199.2(b)), and allow those that do to be covered as a benefit under the TRICARE Program. The demonstration project will evaluate feasible alternatives to support modifications to 32 CFR 199.4(g)(15)(i)(A) to allow coverage for non-FDA approved LDTs that otherwise meet the TRICARE requirements for safety and effectiveness. The Department currently has an ongoing demonstration project to test this same provision for LDTs with a Center for Medicare and Medicaid Services (CMS) national or local coverage determination that were submitted by laboratories for consideration for coverage under TRICARE. However, this new demonstration is being conducted in order to be able to evaluate the feasibility of establishing a cost-effective and efficient way to review an expanded pool of non-FDA approved LDTs prioritized based on their potential high utilization and clinical utility within the TRICARE population. This new demonstration project will also extend coverage for prenatal and preconception cystic fibrosis carrier screening, when provided in accordance with the American College of Obstetricians and Gynecologists guidelines in order to allow DoD to establish whether there is a benefit to offering such testing to TRICARE beneficiaries.
This demonstration will be effective July 18, 2014. This demonstration will remain in effect for three years.
Jim Black, Clinical Support Division, Defense Health Agency, Telephone (703) 681-0068.
Demonstration Project:
Defense Health Agency Evaluation of Non-U.S. Food and Drug Administration Approved Laboratory Developed Tests
,
http://manuals.tricare.osd.mil/
Federal Register
Vol. 79, no. 117
Office of the Federal Register, National Archives and Records Administration
2014-06-18
continuing
daily
deposited
born digital
419 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-06-18
P0b002ee1895840d1
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr18jn14
https://www.govinfo.gov/app/details/FR-2014-06-18
https://www.govinfo.gov/content/pkg/FR-2014-06-18/pdf/FR-2014-06-18.pdf
https://www.govinfo.gov/content/pkg/FR-2014-06-18/xml/FR-2014-06-18.xml
fdlp
34621
35031
DGPO
2014-06-18
2023-04-29
FR-2014-06-18
machine generated
eng
FR
FR-2014-06-18
79
117