Notice of Five-Year Extension of Defense Health Agency Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project, 44782-44784 [2023-14809]
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ddrumheller on DSK120RN23PROD with NOTICES1
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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
information technology; e.g., permitting
electronic submission of responses.
All comments must be submitted in
English, or if not, accompanied by an
English translation. Comments will be
posted as received to https://
www.cftc.gov. You should submit only
information that you wish to make
available publicly. If you wish the
Commission to consider information
that you believe is exempt from
disclosure under the Freedom of
Information Act, a petition for
confidential treatment of the exempt
information may be submitted according
to the procedures established in § 145.9
of the Commission’s regulations.1
The Commission reserves the right,
but shall have no obligation, to review,
pre-screen, filter, redact, refuse or
remove any or all of your submission
from https://www.cftc.gov that it may
deem to be inappropriate for
publication, such as obscene language.
All submissions that have been redacted
or removed that contain comments on
the merits of the ICR will be retained in
the public comment file and will be
considered as required under the
Administrative Procedure Act and other
applicable laws, and may be accessible
under the Freedom of Information Act.
Burden Statement: The Commission
is revising its burden estimate for OMB
control number 3038–0076 to account
for the amendments described above.
Specifically, the Commission believes
that the burden under this clearance
will increase because the 15 DCOs
subject to these requirements will be
required under § 39.24(b)(11) to create
and maintain minutes of each RMC
meeting, and under § 39.24(b)(12) to
document and provide to the RMC, at a
minimum, a summary of the topics
discussed and the main points raised
during each meeting of the RWG. The
Commission estimates a DCO will spend
an average of four hours creating
minutes of each RMC meeting and four
hours documenting a summary of the
topics discussed and the main points
raised during each meeting of the RWG,
which includes attending the meeting,
taking notes, and putting the notes into
the required format following the
meeting. The Commission estimates that
a DCO’s RMC and RWG will each need
to hold an average of six meetings per
year to satisfy the § 39.24(b)(11) and (12)
requirements that a DCO’s RMC and
RWG address all matters that could
materially affect the risk profile of the
DCO. Based upon the above, the
estimated hour burden for this
collection is calculated as follows:
1 17
CFR 145.9.
VerDate Sep<11>2014
17:24 Jul 12, 2023
Jkt 259001
Estimated number of respondents:
15.2
Estimated number of reports per
respondent: 18.
Average number of hours per report:
4.
Estimated gross annual reporting
burden: 1,080.
There are no capital costs or operating
and maintenance costs associated with
this collection.
(Authority: 44 U.S.C. 3501 et seq.)
Dated: July 3, 2023.
Christopher Kirkpatrick,
Secretary of the Commission.
[FR Doc. 2023–14358 Filed 7–12–23; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF DEFENSE
Department of the Army
Notice of Intent To Grant Exclusive
Patent License to TauMat, LLC; Silver
Spring, MD
Department of the Army, DoD.
Notice of intent.
AGENCY:
ACTION:
The Department of the Army
hereby gives notice of its intent to grant
to TauMat, LLC; a company having its
principal place of business at 10010
Portland Place, Silver Spring, MD
20901, an exclusive license.
DATES: Written objections must be filed
not later than 15 days following
publication of this announcement.
ADDRESSES: Send written objections to
U.S. Army Combat Capabilities
Development Command Army Research
Laboratory, Partnerships Support Office,
FCDD–RLB–SS/Wendy Leonard,
Building 4402, 6468 Integrity Ct.,
Aberdeen Proving Ground, MD 21005–
5425 or email to ORTA@arl.army.mil.
FOR FURTHER INFORMATION CONTACT:
Wendy Leonard, (410) 278–1646, EMail: wendy.a.leonard.civ@army.mil.
SUPPLEMENTARY INFORMATION: The
Department of the Army plans to grant
an exclusive license to TauMat, LLC in
the following fields of use related to:
SUMMARY:
• Cooling and thermal energy storage
associated with electronic and photonic
devices.
• Cooling and thermal energy storage
associated with battery/electrical storage
devices during charging and
discharging.
pertaining to the following;
—‘‘Solid-State Martensitic
Transformation Phase Change
Material Components for Thermal
Energy Storage and Transient Heat
Transfer Systems’’, ARL 19–02, US
Patent Application No. 16/910,652,
Filing Date: 06/24/2020, U.S.
Publication No. 2020/0407615A1,
Publication Date: 12/31/2020.
—‘‘Solid-State Thermal Energy Storage
Substrates and Methods for Same.’’,
ARL 22–04P, US Provisional Patent
Application No. 63/521,035, Filing
Date: 06/14/2023.
The prospective exclusive license
may be granted unless within fifteen
(15) days from the date of this published
notice, the U.S. Army Combat
Capabilities Development Command
Army Research Laboratory receives
written objections including evidence
and argument that establish that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i).
Competing applications completed and
received by the U.S. Army Combat
Capabilities Development Command
Army Research Laboratory within
fifteen (15) days from the date of this
published notice will also be treated as
objections to the grant of the
contemplated exclusive license.
Objections submitted in response to
this notice will not be made available to
the public for inspection and, to the
extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
James W. Satterwhite Jr.,
Army Federal Register Liaison Officer.
[FR Doc. 2023–14890 Filed 7–12–23; 8:45 am]
BILLING CODE 5001–03–P
DEPARTMENT OF DEFENSE
Commission notes that while new
§ 39.24(d) provides that a DCO may satisfy the
requirements of paragraphs (b)(11), (b)(12),
(c)(1)(iv), and (c)(3) by having rules that permit it
to clear only fully collateralized positions, such
DCOs are included in the total estimated number
of respondents because these DCOs would still be
required to develop and disclose governance
arrangements required by the other provisions of
§ 39.24. The Commission’s estimate is therefore
conservative to the extent that these DCOs are not
required to prepare and maintain minutes of each
RMC meeting, and document and provide to the
RMC, at a minimum, a summary of the topics
discussed and the main points raised during each
meeting of the RWG.
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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
Office of the Secretary,
Department of Defense (DoD).
ACTION: Notice.
AGENCY:
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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
This notice is to advise
interested parties of an additional fiveyear extension of the Defense Health
Agency’s (DHA) Evaluation of NonUnited 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,
lachanda.m.black.civ@health.mil.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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17:24 Jul 12, 2023
Jkt 259001
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
PO 00000
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Fmt 4703
Sfmt 4703
44783
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 FDAapproved 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 FDAapproved/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
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Federal Register / Vol. 88, No. 133 / Thursday, July 13, 2023 / Notices
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 everexpanding 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 costsharing 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.
VerDate Sep<11>2014
17:24 Jul 12, 2023
Jkt 259001
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
DEPARTMENT OF EDUCATION
[Docket No.: ED–2023–SCC–0059]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget for Review
and Approval; Comment Request;
Request for Title IV Reimbursement or
Heightened Cash Monitoring 2 (HCM2)
Federal Student Aid (FSA),
Department of Education (ED).
ACTION: Notice.
AGENCY:
In accordance with the
Paperwork Reduction Act (PRA) of
1995, the Department is proposing an
extension without change of a currently
approved information collection request
(ICR).
DATES: Interested persons are invited to
submit comments on or before August
14, 2023.
ADDRESSES: Written comments and
recommendations for proposed
information collection requests should
be submitted within 30 days of
publication of this notice. Click on this
link www.reginfo.gov/public/do/
PRAMain to access the site. Find this
information collection request (ICR) by
selecting ‘‘Department of Education’’
under ‘‘Currently Under Review,’’ then
check the ‘‘Only Show ICR for Public
Comment’’ checkbox. Reginfo.gov
provides two links to view documents
related to this information collection
request. Information collection forms
and instructions may be found by
clicking on the ‘‘View Information
Collection (IC) List’’ link. Supporting
statements and other supporting
documentation may be found by
clicking on the ‘‘View Supporting
Statement and Other Documents’’ link.
FOR FURTHER INFORMATION CONTACT: For
specific questions related to collection
activities, please contact Beth
Grebeldinger, 202–377–4018.
SUPPLEMENTARY INFORMATION: The
Department is especially interested in
public comment addressing the
following issues: (1) is this collection
necessary to the proper functions of the
Department; (2) will this information be
processed and used in a timely manner;
(3) is the estimate of burden accurate;
(4) how might the Department enhance
the quality, utility, and clarity of the
information to be collected; and (5) how
SUMMARY:
PO 00000
Frm 00010
Fmt 4703
Sfmt 4703
might the Department minimize the
burden of this collection on the
respondents, including through the use
of information technology. Please note
that written comments received in
response to this notice will be
considered public records.
Title of Collection: Request for Title
IV Reimbursement or Heightened Cash
Monitoring 2 (HCM2).
OMB Control Number: 1845–0089.
Type of Review: An extension without
change of a currently approved ICR.
Respondents/Affected Public: Private
Sector; State, Local, and Tribal
Governments.
Total Estimated Number of Annual
Responses: 564.
Total Estimated Number of Annual
Burden Hours: 564.
Abstract: 34 CFR part 668—Student
Assistance General Provisions, Subpart
K—Cash Management (§ 668.162)
establishes the rules and procedures for
a participating institution to request,
maintain, disburse, and manage the
Title IV (TIV) program funds.
Institutions must complete and submit a
Form 270 to request TIV program funds
while participating under the
Reimbursement and Heightened Cash
Monitoring payment methods as
explained in § 668.162(c) and (d). We
are requesting an extension of the
currently approved information
collection. There have been no changes
to the information requested or the form
since its prior approval in September
2020.
Dated: July 10, 2023.
Kun Mullan,
PRA Coordinator, Strategic Collections and
Clearance, Governance and Strategy Division,
Office of Chief Data Officer, Office of
Planning, Evaluation and Policy
Development.
[FR Doc. 2023–14885 Filed 7–12–23; 8:45 am]
BILLING CODE 4000–01–P
DEPARTMENT OF EDUCATION
Tests Determined To Be Suitable for
Use in the National Reporting System
for Adult Education
Office of Career, Technical, and
Adult Education, Department of
Education.
ACTION: Notice.
AGENCY:
The Secretary announces
tests, test forms, and delivery formats
that the Secretary determines to be
suitable for use in the National
Reporting System for Adult Education
(NRS). This notice relates to the
approved information collections under
OMB control numbers 1830–0027 and
1830–0567.
SUMMARY:
E:\FR\FM\13JYN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Pages 44782-44784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14809]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
[[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, [email protected].
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
