Notice2023-14809
Notice of Five-Year Extension of Defense Health Agency Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project
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Published
July 13, 2023
Effective
July 19, 2023
Issuing agencies
Defense Department
Abstract
This notice is to advise interested parties of an additional five-year extension of the Defense Health Agency's (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project (hereinafter referred to as the "LDT demonstration"). The original notice was published on June 18, 2014. The LDT demonstration was effective July 18, 2014. It remained in effect for three years (July 18, 2017). A notice was published on June 20, 2017 extending the LDT demonstration for three years. The three-year extension was effective July 19, 2017, through July 18, 2020. A second notice extending the LDT demonstration for an additional three years was published on July 10, 2020. The three-year extension was effective July 19, 2020. It is scheduled to end July 18, 2023. As uncertainty remains regarding future regulatory oversight of LDTs, the LDT demonstration will now be extended for five additional years (July 18, 2028). Additionally, this notice announces the removal of preconception and prenatal carrier screening for Cystic Fibrosis (CF) from the LDT demonstration as these carrier screening tests have been added to the TRICARE Basic (i.e., medical) benefit as directed by the National Defense Authorization Act (NDAA) of 2022.
Full Text
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<title>Federal Register, Volume 88 Issue 133 (Thursday, July 13, 2023)</title>
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[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Pages 44782-44784]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14809]
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DEPARTMENT OF DEFENSE
Office of the Secretary
Notice of Five-Year Extension of Defense Health Agency Evaluation
of Non-United States Food and Drug Administration Approved Laboratory
Developed Tests Demonstration Project
AGENCY: Office of the Secretary, Department of Defense (DoD).
ACTION: Notice.
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[[Page 44783]]
SUMMARY: This notice is to advise interested parties of an additional
five-year extension of the Defense Health Agency's (DHA) Evaluation of
Non-United States Food and Drug Administration (FDA) Approved
Laboratory Developed Tests (LDTs) Demonstration Project (hereinafter
referred to as the ``LDT demonstration''). The original notice was
published on June 18, 2014. The LDT demonstration was effective July
18, 2014. It remained in effect for three years (July 18, 2017). A
notice was published on June 20, 2017 extending the LDT demonstration
for three years. The three-year extension was effective July 19, 2017,
through July 18, 2020. A second notice extending the LDT demonstration
for an additional three years was published on July 10, 2020. The
three-year extension was effective July 19, 2020. It is scheduled to
end July 18, 2023. As uncertainty remains regarding future regulatory
oversight of LDTs, the LDT demonstration will now be extended for five
additional years (July 18, 2028). Additionally, this notice announces
the removal of preconception and prenatal carrier screening for Cystic
Fibrosis (CF) from the LDT demonstration as these carrier screening
tests have been added to the TRICARE Basic (i.e., medical) benefit as
directed by the National Defense Authorization Act (NDAA) of 2022.
DATES: The extension of this demonstration will be effective July 19,
2023. It will continue through July 18, 2028.
FOR FURTHER INFORMATION CONTACT: LaChanda Black, Defense Health Agency,
(303) 676-3575, <a href="/cdn-cgi/l/email-protection#1874797b7079767c793675367a74797b73367b716e58707d79746c7036757174"><span class="__cf_email__" data-cfemail="7e121f1d161f101a1f5013501c121f1d15501d17083e161b1f120a1650131712">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: For additional information on the DHA LDT
demonstration, please see 79 FR 34726-34729, 82 FR 28052, and 85 FR
41574-41575. According to title 32, Code of Federal Regulations (CFR),
section 199.4(g)(15)(i)(A), TRICARE may not cost-share devices,
including LDTs, that have not received FDA required device 510(k)
clearance or premarket approval (referred to as ``non-FDA-approved''
hereafter). LDTs with FDA clearance or approval are available for cost-
sharing under the TRICARE Basic (i.e., medical) benefit as long as they
otherwise meet TRICARE criteria for coverage.
On June 18, 2014, a notice was published in the Federal Register
(79 FR 34726) announcing the start of the LDT demonstration initiated
by the DHA to review non-FDA-approved LDTs to determine if they meet
TRICARE's requirements for safety and effectiveness, and otherwise meet
TRICARE criteria for coverage. Under the LDT demonstration, DHA would
allow those LDTs that met such criteria to be covered as a benefit.
This demonstration also extended coverage for preconception and
prenatal CF carrier screening, when provided in accordance with the
most current American College of Obstetricians and Gynecologists (ACOG)
guidelines. The purpose of this demonstration is to improve the quality
of health care services for TRICARE beneficiaries.
Effective December 27, 2021, Section 702 of the National Defense
Authorization Act for Fiscal Year 2022 (NDAA FY 2022), codified at 10
U.S.C. 1079(a)(19), extended TRICARE Basic (i.e., medical) benefit
coverage for preconception and prenatal carrier screening tests for
Cystic Fibrosis, Spinal Muscular Atrophy, Fragile X Syndrome, Tay-Sachs
Disease, Hemoglobinopathies, and conditions linked with Ashkenazi
Jewish descent. As a result, preconception and prenatal carrier
screening for CF will be removed from the LDT demonstration as it is
now incorporated into the TRICARE Basic (i.e., medical) benefit.
Non-FDA-approved LDTs covered under the LDT demonstration are
available for cost-sharing for eligible TRICARE beneficiaries only when
performed by laboratories that are assessed and certified or accredited
under minimum quality standards set by the Centers for Medicare and
Medicaid Services (CMS) under the Clinical Laboratory Improvement
Amendments (CLIA) of 1988, i.e., CLIA certified. CMS regulates
laboratories that perform non-FDA-approved LDTs as well as FDA-
approved/cleared tests. Laboratories performing moderate or high
complexity tests are subject to specific regulatory standards governing
certification, personnel, proficiency testing, patient test management,
quality assurance, quality control, and inspections. CLIA certification
and biennial surveys evaluate whether the laboratory has verified or
established the analytical validity of the tests they offer, including
LDTs. Analytical validity refers to how well a test performs in the
laboratory; that is, how well the test measures the properties or
characteristics it is intended to measure. However, CLIA certification
does not assure a device is safe and effective for its intended use or
impose any type of post-market surveillance or adverse event reporting
requirements.
For the TRICARE Overseas Program (TOP), an exception to the
requirement for CLIA certification for overseas laboratories continues.
This is due to the majority of overseas laboratories not having CLIA
certification. As with the notice published at 85 FR 41574, this notice
restates that non-FDA-approved LDTs covered under the LDT demonstration
shall be available for cost-sharing for qualified TOP beneficiaries
when performed by either CLIA-certified laboratories or laboratories
that are assessed by the TOP contractor to be in accordance with the
host nation's credentialing/accreditation standards when those
standards for credentialing/accreditation are comparable to CLIA
standards.
LDTs provide an important health care capability for the TRICARE
Program. Nonetheless, LDTs are complex and do have some risks
associated with their use. For example, inaccurate tests may place
patients at otherwise avoidable risk. While laboratories that offer
LDTs are subject to the Federal Food, Drug, and Cosmetic Act (FFDCA),
the FDA has generally exercised enforcement discretion towards LDTs,
such that it has generally not enforced applicable provisions under the
FFDCA and FDA regulations with respect to LDTs. TRICARE's regulatory
requirement at 32 CFR 199.4(g)(15)(i)(A) requires LDTs covered in the
TRICARE Program to be FDA-approved or cleared, if required under FFDCA.
Further, as mentioned above, the FDA generally exercises enforcement
discretion for most LDTs, and most laboratories offering LDTs do not
submit their devices to the FDA for review. Therefore, most LDTs do not
satisfy the requirements at 32 CFR 199.4(g)(15), that the safety and
efficacy of these devices be established in order to permit cost-
sharing. As a result, TRICARE is unable to cost share for such LDTs.
However, in some instances, LDTs are important and necessary tests
and in many instances, there are no FDA-approved/cleared alternatives.
Therefore, the TRICARE Program has endeavored to evaluate LDTs through
its demonstration project initiated in 2014. Although ongoing for more
than eight years, additional work is necessary to ensure that the
TRICARE program conducts the appropriate evaluation of these tests
based on reliable evidence, and permit TRICARE cost-sharing of
medically necessary and appropriate LDTs that are found to otherwise
meet TRICARE criteria for coverage, including requirements for safety
and effectiveness.
While the DoD had hoped that another LDT demonstration extension
would not be required, uncertainty remains regarding future regulatory
oversight of LDTs. In the absence of any
[[Page 44784]]
change in the oversight of LDTs at this time, the DoD has determined
that continuation of the LDT demonstration for an additional five years
is necessary to provide TRICARE beneficiaries and their health care
providers with seamless access to safe and effective, medically
necessary tests, as determined by TRICARE, to support health care
decisions and treatment.
Health care costs projected for the LDT demonstration over the
five-year extension (Fiscal Year (FY) 2023-FY 2028) are $198.8 million
(M) and $2.1M in administrative costs for all contracts combined.
Because all managed care support contractors currently have systems in
place for the LDT demonstration, no additional start-up costs are
anticipated for this five-year extension.
During the next five 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 tests
that meet TRICARE requirements for safety and effectiveness. Based on
the results of the demonstration evaluation, and status of the
regulatory oversight of LDTs, a recommendation will be made on whether
to modify 32 CFR 199.4(g)(15) to permit TRICARE cost-sharing of non-FDA
approved LDTs that are found to meet TRICARE requirements for safety
and effectiveness. Our intent is for the LDT demonstration to conclude
at the end of this five-year extension. Should the FDA issue final
guidance on LDTs and/or enforce the requirement for clearance or
premarket approval for LDTs, the Director, DHA will modify or terminate
the LDT demonstration, as appropriate, and the DoD will ensure
compliance with applicable federal law and regulations.
The LDT demonstration continues to be authorized by 10 U.S.C. 1092.
Dated: July 7, 2023.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2023-14809 Filed 7-12-23; 8:45 am]
BILLING CODE 5001-06-P
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