[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41574-41575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14951]


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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: Office of the Secretary, Department of Defense (DoD).

ACTION: Notice of demonstration project extension.

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SUMMARY: This notice is to advise interested parties of an additional 
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. The notice extending the demonstration project for three years 
was published on June 20, 2017.

DATES: This extension is applicable July 19, 2020.

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

FOR FURTHER INFORMATION CONTACT: Valerie Palmer, Defense Health Agency, 
303-676-3557, [email protected]; Jim Black, Defense Health 
Agency, 303-676-3487, [email protected].

SUPPLEMENTARY INFORMATION: For additional information on the DHA 
Evaluation of Non-United States FDA Approved LDTs Demonstration Project 
(hereinafter referred to as the ``LDT demonstration''), please see 79 
FR 34726-34729 and 82 FR 28052. According to Title 32, Code of Federal 
Regulations (CFR), Part 199.4, paragraph (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. LDTs with FDA 
approval are available for cost-sharing under the TRICARE Basic Program 
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, and allow those that do to be covered as 
a benefit under the demonstration. This demonstration also extends 
coverage for preconception and prenatal cystic fibrosis (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.
    Currently, non-FDA approved LDTs covered under the LDT 
demonstration are available for cost-sharing for qualified TRICARE 
beneficiaries only when performed by laboratories that are assessed and 
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 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 periodic inspections evaluate whether the laboratory has determined 
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. CLIA certification does not, 
however, assure a device is safe and effective for its intended use, or 
impose any type of postmarket surveillance or adverse event reporting 
requirements.
    The TRICARE Overseas Program (TOP) is the DoD's program for the 
delivery of health care support services overseas (all locations 
outside of the 50 United States (U.S.) and the District of Columbia). 
TOP provides health care coverage for all overseas beneficiaries, 
including Active Duty Service Members (ADSMs), eligible Reserve 
Component (RC) personnel, Active Duty Family Members (ADFMs) (including 
family members of eligible RC personnel), retired military and their 
respective family members, and transitional survivors. This coverage 
applies regardless of where the services are received. The delivery of 
health care services overseas represents a unique situation that cannot 
be effectively addressed by applying all of the standards that apply in 
the 50 U.S. and the District of Columbia. TOP blends many of the 
features of the TRICARE program in the U.S. while allowing for 
significant cultural differences unique to health care practices and 
services in

[[Page 41575]]

overseas locations. Cultural differences may apply to things like 
location of care (provider comes to the patient's home), the manner in 
which care is provided (services commonly done by a provider class in 
the U.S. may be performed by a provider assistant or physician 
overseas, depending on the country), or the manner in which claims are 
submitted to TRICARE. In some situations, TRICARE may authorize 
coverage for a specific service or supply under the TOP, even though 
the service or supply would normally be excluded from coverage by 
TRICARE. Such situations are expected to be rare and are noted in the 
TRICARE Policy Manual. The TRICARE manuals may be accessed online at 
https://manuals.health.mil/.
    The current TOP contractor has noted a unique situation that only 
occurs overseas. Because the majority of overseas laboratories are not 
CLIA certified, samples for genetic testing under the LDT demonstration 
from TOP beneficiaries must be shipped back to the U.S. for processing 
at CLIA certified laboratories which can be detrimental to the 
beneficiary's health care. Cold chain shipment may create a sample that 
becomes unviable. If a new sample is needed from the beneficiary, this 
means they may not obtain their test results for some time, impacting 
their diagnosis and/or treatment. Alternatively, individuals are given 
travel orders to return to the U.S. for the test, an unnecessary and 
disruptive requirement. As a result, we are providing an exception to 
the requirement for CLIA certification for overseas laboratories. This 
notice provides 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. LDTs are complex and do have some risks associated with their 
use, such as inaccurate tests placing patients at otherwise avoidable 
risk. While laboratories that offer LDTs are subject to the Federal 
Food, Drug, and Cosmetic Act (FDCA), the FDA has generally exercised 
enforcement discretion towards these tests, which includes not 
enforcing applicable provisions under the FDCA and FDA regulations. The 
FDA's enforcement discretion stance leaves the TRICARE Program in a 
difficult position because the requirement at 32 CFR 199.4(g)(15)(i)(A) 
requires LDTs covered in the TRICARE program to be FDA approved. As a 
result of the FDA's enforcement discretion, many LDTs do not receive 
FDA approval. LDTs are important and necessary tests and in many 
instances there are no FDA-approved alternatives. Therefore, the 
TRICARE program has endeavored to evaluate LDTs through its 
demonstration project initiated in 2014. Although ongoing for six 
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 LDTs that are found to 
otherwise meet TRICARE requirements for safety and effectiveness. The 
DoD has determined that continuation of the demonstration project for 
an additional three years is necessary 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. Based on the results of the demonstration 
evaluation, a recommendation will be made on whether to modify 32 CFR 
199.4(g)(15)(i)(A) to remove the restriction for non-FDA approved LDTs 
and permit TRICARE cost-sharing of LDTs that are found to otherwise 
meet TRICARE requirements for safety and effectiveness. The DoD will 
also conduct a cost benefit analysis of providing CF carrier screening 
in accordance with ACOG guidelines to the TRICARE beneficiary 
population for purposes of determining whether to permanently establish 
coverage. Our intent is for the demonstration to conclude at the end of 
this three year extension and additional extensions will not need to be 
pursued.
    The LDT demonstration continues to be authorized by 10 U.S.C. 1092.

    Dated: July 7, 2020.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2020-14951 Filed 7-9-20; 8:45 am]
BILLING CODE 5001-06-P