Defense Health Agency Evaluation of Non-United States Food and Drug Administration; Approved Laboratory Developed Tests Demonstration Project, 34726-34729 [2014-14247]
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Secretary of the Army and based upon
the subject matters under consideration.
Subcommittee members, if not fulltime or permanent part-time Federal
employees, shall be appointed as
experts or consultants, pursuant to 5
U.S.C. 3109, to serve as special
government employee members. Those
individuals who are full-time or
permanent part-time Federal employees
will be appointed, pursuant to 41 CFR
102–3.130(a), to serve as RGE members.
With the exception of reimbursement
for official Task Force-related travel and
per diem, subcommittee members shall
serve without compensation.
All subcommittees operate under the
provisions of FACA, the Sunshine Act,
governing Federal statutes and
regulations, and established DoD
policies and procedures.
The Designated Federal Officer (DFO),
pursuant to DoD policy, shall be a fulltime or permanent part-time DoD
employee, and shall be appointed in
accordance with established DoD
policies and procedures.
In addition, the DFO is required to be
in attendance at all meetings of the Task
Force and any subcommittees, for the
entire duration of each and every
meeting; however, in the absence of the
DFO, a properly approved Alternate
DFO, duly appointed to the Task Force
according to established DoD policies
and procedures, shall attend the entire
duration of all meetings of the Task
Force or its subcommittees.
The DFO or the Alternate DFO, shall
call all meetings of the Task Force and
its subcommittees; prepare and approve
all meeting agendas; and adjourn any
meeting when the DFO, or the Alternate
DFO, determines adjournment to be in
the public interest or required by
governing regulations or DoD policies
and procedures.
Pursuant to 41 CFR 102–3.105(j) and
102–3.140, the public or interested
organizations may submit written
statements to Missouri River (North
Dakota) Task Force membership about
the Task Force’s mission and functions.
Written statements may be submitted at
any time or in response to the stated
agenda of planned meeting of Missouri
River (North Dakota) Task Force.
All written statements shall be
submitted to the DFO for the Missouri
River (North Dakota) Task Force, and
this individual will ensure that the
written statements are provided to the
membership for their consideration.
Contact information for the Missouri
River (North Dakota) Task Force DFO
can be obtained from the GSA’s FACA
Database—https://
www.facadatabase.gov/. The DFO,
pursuant to 41 CFR 102–3.150, will
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announce planned meetings of the
Missouri River (North Dakota) Task
Force. The DFO, at that time, may
provide additional guidance on the
submission of written statements that
are in response to the stated agenda for
the planned meeting in question.
Dated: June 12, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2014–14165 Filed 6–17–14; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
Defense Health Agency Evaluation of
Non-United States Food and Drug
Administration; Approved Laboratory
Developed Tests Demonstration
Project
Department of Defense.
Notice of Demonstration.
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.
DATES: This demonstration will be
effective July 18, 2014. This
demonstration will remain in effect for
three years.
ADDRESSES: Defense Health Agency,
Attn: Clinical Support Division, 7700
Arlington Blvd., Falls Church, VA
22040.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
ACTION:
Black, Clinical Support Division,
Defense Health Agency, Telephone
(703) 681–0068.
SUPPLEMENTARY INFORMATION:
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
SUMMARY:
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A. Background
1. LDTs
According to 32 CFR
199.4(g)(15)(i)(A), TRICARE may not
cost-share medical devices including
LDTs if the tests are non-FDA cleared or
approved; that is, they have not received
FDA medical device 510(k) clearance or
premarket approval. For purposes of
this demonstration, LDTs that are not
FDA cleared or approved will
hereinafter be referred to as non-FDA
approved for brevity purposes. Under
the current regulation cited above, LDTs
that have been identified as non-FDA
approved are summarily denied.
An LDT is an in vitro diagnostic (IVD)
that is designed, manufactured, and
used within a single laboratory. In the
past, these tests were relatively simple
tests used within a single laboratory,
usually at a local large hospital or
academic medical center, to diagnose
rare diseases or for other uses to meet
the needs of a local patient population.
The FDA has exercised enforcement
discretion in that the agency has
generally not enforced applicable
provisions under the Federal Food,
Drug, and Cosmetic Act (FFDCA) and its
regulations with respect to LDTs.
The 1976 Medical Device
Amendments modified the FFDCA to
provide for a comprehensive system for
the regulation of medical devices. The
term ‘‘device’’ is defined broadly in 21
U.S.C. 321(h) to include: ‘‘an
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instrument, apparatus, implement,
machine, contrivance, implant, in vitro
reagent, or other similar or related
article, including any component, part
or accessory, which is * * * intended
for use in the diagnosis of disease or
other conditions, or in the cure,
mitigation, treatment, or prevention of
disease.’’ Medical devices include IVDs.
FDA regulations in 21 CFR 809.3
define ‘‘in vitro diagnostic products’’ as:
‘‘those reagents, instruments, and
systems intended for use in diagnosis of
disease or other conditions, including a
determination of the state of health, in
order to cure, mitigate, treat, or prevent
disease or its sequelae. Such products
are intended for use in the collection,
preparation, and examination of
specimens taken from the human body.’’
As explained above, LDTs are a subset
of IVDs. The FDA has stated that
clinical laboratories that develop LDTs
are acting as manufacturers of medical
devices and are subject to FDA
jurisdiction under the FFDCA. As noted,
the FDA has chosen to exercise its
‘‘enforcement discretion’’ over many
LDTs and these tests are routinely sold
without FDA approval.
The Analyte Specific Reagents (ASRs)
rule was published in 1997 (21 CFR
864.4020), classifying most ASRs (ASRs
are considered to be the ‘‘active
ingredients’’ of tests) as Class I devices.
The intent was to ensure the quality of
the test components and to continue
enforcement discretion for LDTs.
During the 2000s, LDTs became more
complex at an increasingly fast pace. In
response, the FDA issued draft guidance
in 2007 relating to In Vitro Diagnostic
Multivariate Index Assays, a
particularly complex category of tests.
Final guidance has yet to be published.
In July 2010, the FDA held a public
meeting to discuss the agency’s
oversight of LDTs. In announcing the
public meeting, the FDA explained:
At the same time as LDTs are becoming
more complex, diagnostic tests are playing an
increasingly important role in clinical
decision making and disease management,
particularly in the context of personalized
medicine. However, LDTs that have not been
properly validated for their intended use put
patients at risk. Risks include missed
diagnosis, wrong diagnosis, and failure to
receive appropriate treatment. . . . [and]
some diagnostics critical for patient care may
not be developed in a manner that provides
a reasonable assurance of safety and
effectiveness.
(75 FR 34463–34464)
The FDA has continued its policy of
enforcement discretion over LDTs and
no new draft or final guidance on the
regulation of LDTs has been issued
since the enactment of the Food and
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Drug Administration Safety and
Innovation Act (FDASIA) on July 9,
2012.
Laboratories are assessed and
accredited under minimum quality
standards set by CMS under the Clinical
Laboratory Improvement Amendments
(CLIA) of 1988. CMS regulates
laboratories that use 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.
On December 27, 2011, the DoD
published a notice in the Federal
Register (76 FR 80905–80907),
announcing the TRICARE Evaluation of
Centers for Medicare and Medicaid
Services (CMS) Approved Laboratory
Developed Tests (LDTs) Demonstration
Project. LDTs for this demonstration
were limited to only those that had a
CMS national or local coverage
determination and significantly
informed clinical decision making for
surveillance, surgical interventions,
chemotherapy, or radiation therapy for
cancer. This three year demonstration
will continue until it expires or is
terminated via separate notice and LDTs
covered under the current
demonstration will continue to be
covered. The demonstration project was
based on interested laboratories
submitting their LDTs for consideration.
Limited participation from industry in
the demonstration served as a
constraining factor and did not provide
sufficient data for the DoD to make an
affirmative decision regarding the
feasibility of developing a cost-effective
and efficient method of reviewing nonFDA approved LDTs under TRICARE’s
requirements for safety and efficacy.
2. TRICARE Coverage of Cystic Fibrosis
Testing
In general, the TRICARE program has
been, and continues to be, a benefit
program based on medical necessity.
The current TRICARE maternity benefit
is limited to coverage of medically
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necessary services and supplies
associated with maternity care in
accordance with 32 CFR 199.4(e)(16).
Further, TRICARE covers genetic testing
that is medically necessary and
appropriate in the diagnosis and/or
treatment of a disease and when the
results of the test will influence the
medical management of the individual
or pregnancy. Routine genetic testing,
including carrier screening, that does
not influence a beneficiary’s medical
management is specifically excluded
from TRICARE coverage.
For cystic fibrosis (CF) testing in
particular, TRICARE covers CF testing
when performed as part of a newborn
screening panel as part of well-child
care. TRICARE will also cover
diagnostic genetic testing for CF when it
is performed on individuals to confirm
a clinical diagnosis that is already
suspected. TRICARE does not, however,
cover pre-conception CF carrier
screening for couples planning a
pregnancy, pre-implantation CF
screening of embryos, or prenatal CF
screening of pregnant women since the
results do not assist in the medical
management of the patient or
pregnancy. Awareness that a fetus is at
increased risk of having CF, in and of
itself, does not usually change the
management of labor, delivery, and the
neonatal period. Additionally, newborn
screening panels, which are performed
shortly after birth, include tests for a
number of conditions including CF, and
are a TRICARE covered benefit.
Notwithstanding current TRICARE
benefit limitations, the Department of
Defense is aware of the widespread
acceptance the American College of
Obstetricians and Gynecologists (ACOG)
guidelines of carrier screening for CF
have received. Carrier screening for CF
has been widely recognized and
commonly provided as part of routine
obstetric practice.
B. Demonstration Project Description
1. Review of LDTs
Consequently, the DoD will initiate a
new and expanded demonstration
project to test whether non-FDA
approved LDTs meet TRICARE’s
requirements for safety and
effectiveness in order to permit
TRICARE cost-sharing. The
demonstration project will be effective
30 days after publication in the Federal
Register and will continue for three
years from the effective date of this
demonstration. The new demonstration
project will evaluate the feasibility of
establishing a cost-effective and efficient
way to review an expanded pool of nonFDA approved LDTs. For example,
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LDTs evaluated under the new
demonstration are not limited to those
associated with cancer and do not
require a CMS national or local coverage
determination. Further, consideration of
specific gene testing as part of the
ongoing demonstration project,
discussed above, does not also prevent
consideration under the new
demonstration project.
Non-FDA approved LDTs will be
prioritized and reviewed for analytical
validity, clinical validity, and clinical
utility. LDT reviews will be based on
the TRICARE hierarchy of reliable
evidence, as defined below, to
determine whether the specific test is
proven safe and effective for TRICARE
cost-sharing purposes.
Reliable evidence is defined in 32
CFR 199.2(b) and includes: ‘‘(i) Wellcontrolled studies of clinically
meaningful endpoints, published in
refereed medical literature; (ii)
Published formal technology
assessments; (iii) The published reports
of national professional medical
associations; (iv) Published national
medical policy organization positions;
and (v) The published reports of
national expert opinion organizations.’’
The definition goes on to state, ‘‘The
hierarchy of reliable evidence of proven
medical effectiveness, established by (i)
through (v) of this paragraph, is the
order of the relative weight to be given
to any particular source. With respect to
clinical studies, only those reports and
articles containing scientifically valid
data and published in the refereed
medical and scientific literature shall be
considered as meeting the requirements
of reliable evidence. Specifically not
included in the meaning of reliable
evidence are reports, articles, or
statements by providers or groups of
providers containing only abstracts,
anecdotal evidence, or personal
professional opinions. Also not
included in the meaning of reliable
evidence is the fact that a provider or a
number of providers have elected to
adopt a drug, device, or medical
treatment or procedure as their personal
treatment or procedure of choice or
standard of practice.’’
There may also be non-FDA approved
LDTs reviewed under the new
demonstration project for use in the
diagnosis or medical management of a
rare disease. In accordance with 32 CFR
199.2(b), TRICARE defines a rare
disease as any disease or condition that
has a prevalence of less than 200,000
persons in the United States. Due to the
rare nature of the condition and lack of
clinical research, the hierarchy of
reliable evidence as described
previously may not be met. In
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accordance with 32 CFR 199.4(g)(15)(ii),
benefits for rare diseases are reviewed
on a case-by-case basis. In reviewing
proposed benefits for rare diseases
under the new demonstration,
consistent with TRICARE’s rare disease
policy, a proposed LDT for a rare
disease may be reviewed for analytical
validity, clinical validity, and clinical
utility from any or all of the following
sources to determine if the proposed
LDT for a rare disease is considered safe
and effective for TRICARE cost-sharing
purposes: (i) Trials published in
refereed medical literature; (ii) Formal
technology assessments; (iii) National
medical policy organization positions;
(iv) National professional associations;
and, (v) National expert opinion
organizations.
The DoD’s Laboratory Joint Working
Group (LJWG) will be responsible for
prioritizing and reviewing the non-FDA
approved LDTs for the new
demonstration. Representatives are
appointed by the Assistant Secretary of
Defense (Health Affairs) and are
comprised of government clinical and
policy professionals (DoD employees
and Active Duty Service Members).
Reliable evidence reviews may also be
performed by a third party with the
appropriate expertise and
recommendations provided to the
LJWG.
The LJWG will prioritize the LDTs
based on their potential high utilization
and high clinical utility within the
TRICARE population based on existing
direct and purchased care data. LDTs
used for non-covered conditions or tests
related to unproven treatments will not
be eligible for coverage and thus will
not be reviewed under the new
demonstration or recommended by the
LJWG. Selected LDTs will be evaluated
using the hierarchy of reliable evidence
or rare disease policy as outlined above.
By majority vote, the LJWG will
recommend approval or disapproval to
the Director, DHA, or designee.
Approved LDTs will be available for
cost-sharing under the new
demonstration.
2. LDT Coverage Decisions Under the
New Demonstration
Non-FDA approved LDTs determined
to meet TRICARE’s requirements for
safety and effectiveness according to the
hierarchy of reliable evidence or rare
disease policy, and otherwise meet
TRICARE criteria for coverage, will be
recommended to the Director, DHA, or
designee, for decision for approval for
cost-sharing during the new
demonstration period. The effective date
for coverage of specific LDTs approved
under the new demonstration project
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will be the later of: (1) January 1, 2013;
or (2) the date on which there is
sufficient reliable evidence to determine
that the specific LDT is proven safe and
effective for TRICARE cost-sharing
purposes. LDTs that have been
approved by the Director, DHA, or
designee, under the new demonstration,
as well as LDTs that have been
evaluated under the new demonstration
and found to lack sufficient reliable
evidence of safety and efficacy and thus
remain excluded from coverage, will be
appropriately documented in the
TRICARE Operations Manual (TOM)
following existing processes. Additional
information on payment methodologies
will be included in the operational
procedures for the new demonstration
and will be published in the TOM found
at https://manuals.tricare.osd.mil/.
Decisions regarding which LDTs are
reviewed under the new demonstration,
including the priority of review, are not
appealable. Additionally, in order to
dedicate maximum resources to the
review of LDTs under the new
demonstration, no formal appeal rights
will be extended for tests that are
reviewed under the new demonstration
and found to lack sufficient reliable
evidence of safety and efficacy. Should
the new demonstration project be
deemed successful and permanent
regulatory authority enacted, appeal
rights will be available as provided in
32 CFR 199.10.
3. Coverage of CF Carrier Screening
Under the Demonstration
This new demonstration project will
also extend coverage for prenatal and
preconception CF carrier screening,
when provided in accordance with the
ACOG guidelines. This demonstration
project will allow DoD to establish
whether there is a benefit to offering
such testing for purposes of determining
whether to permanently establish
coverage as part of the family planning
genetic testing benefit at 32 CFR
199.4(e)(3)(ii), the maternity benefit at
32 CFR 199.4(e)(16), or otherwise as a
special benefit. By extending coverage
for CF carrier screening in accordance
with ACOG guidelines under this
demonstration project DoD will be able
to gather the necessary data to evaluate
whether there is a benefit to offering
such screening, including evaluating the
impact on follow-on care that a patient
is given based on testing results and any
other identified benefits of the testing.
The Director, DHA (or designee) shall
issue guidelines for collection of data
involving individual cases of CF carrier
screening covered under this
demonstration as necessary for
evaluation of the benefits resulting from
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such screening. This demonstration
project will extend coverage for this
testing from January 1, 2013 through the
end of the demonstration in order to
obtain sufficient data to be able to
conduct a cost benefit analysis of
providing this screening for our
beneficiary population.
Dated: June 13, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
D. Implementation
DEPARTMENT OF EDUCATION
The new demonstration is effective 30
days after publication in the Federal
Register and will continue for a period
of three years from the date of the
original demonstration unless
terminated earlier by the Director, DHA.
LDTs approved by the Director, DHA, or
designee, during the new demonstration
period will become available for costsharing for qualified TRICARE
beneficiaries during the demonstration
period when performed by CLIA
certified laboratories. 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 demonstration, as appropriate, and
the DoD will ensure compliance with
applicable federal law and regulations.
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E. Evaluation
An annual evaluation of the new
demonstration will be conducted to
determine how many TRICARE
approved LDTs were provided to
beneficiaries across all TRICARE
Regions. The evaluation will also
include a review of the LDT
examination and recommendation
process to assess feasibility, resource
requirements, and cost-effectiveness of
DHA establishing an internal safety and
efficacy review process for these devices
for TRICARE cost-sharing purposes.
These results of the evaluation will
provide an evaluation of the potential
improvement of the quality of
healthcare 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 Department of
Defense 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.
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[FR Doc. 2014–14247 Filed 6–17–14; 8:45 am]
BILLING CODE 5001–06–P
[Docket No.: ED–2014–ICCD–0090]
Agency Information Collection
Activities; Comment Request; Report
of Infants and Toddlers Receiving
Early Intervention Services and of
Program Settings Where Services Are
Provided in Accordance With Part C
Office of Special Education and
Rehabilitative Services (OSERS),
Department of Education (ED)
ACTION: Notice
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 3501 et seq.), ED is
proposing an extension of an existing
information collection.
DATES: Interested persons are invited to
submit comments on or before August
18, 2014.
ADDRESSES: Comments submitted in
response to this notice should be
submitted electronically through the
Federal eRulemaking Portal at https://
www.regulations.gov by selecting
Docket ID number ED–2014–ICCD–0090
or via postal mail, commercial delivery,
or hand delivery. If the regulations.gov
site is not available to the public for any
reason, ED will temporarily accept
comments at ICDocketMgr@ed.gov.
Please note that comments submitted by
fax or email and those submitted after
the comment period will not be
accepted; ED will ONLY accept
comments during the comment period
in this mailbox when the
regulations.gov site is not available.
Written requests for information or
comments submitted by postal mail or
delivery should be addressed to the
Director of the Information Collection
Clearance Division, U.S. Department of
Education, 400 Maryland Avenue SW.,
LBJ, Mailstop L–OM–2–2E319, Room
2E105, Washington, DC 20202.
FOR FURTHER INFORMATION CONTACT: For
specific questions related to collection
activities, please contact Meredith
Miceli, 202–245–6028.
SUPPLEMENTARY INFORMATION: The
Department of Education (ED), in
accordance with the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3506(c)(2)(A)), provides the general
public and Federal agencies with an
opportunity to comment on proposed,
SUMMARY:
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34729
revised, and continuing collections of
information. This helps the Department
assess the impact of its information
collection requirements and minimize
the public’s reporting burden. It also
helps the public understand the
Department’s information collection
requirements and provide the requested
data in the desired format. ED is
soliciting comments on the proposed
information collection request (ICR) that
is described below. The Department of
Education 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
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: Report of Infants
and Toddlers Receiving Early
Intervention Services and of Program
Settings Where Services are Provided in
Accordance with Part C.
OMB Control Number: 1820–0557.
Type of Review: Revision of a
currently approved collection.
Respondents/Affected Public: State,
Local, or Tribal Governments.
Total Estimated Number of Annual
Responses: 56.
Total Estimated Number of Annual
Burden Hours: 6,697.
Abstract: This data collection
provides instructions and forms
necessary for States to report the
number of children receiving early
intervention services under Part C of
Individuals with Disabilities Education
Act (IDEA), the settings in which these
children are provided services, and the
reasons by which these children exit
Part C of IDEA. The form satisfies
reporting requirements and is used by
OSEP to monitor State agencies and for
Congressional reporting.
Dated: June 13, 2014.
Stephanie Valentine,
Acting Director, Information Collection
Clearance Division, Privacy, Information and
Records Management Services, Office of
Management.
[FR Doc. 2014–14262 Filed 6–17–14; 8:45 am]
BILLING CODE 4000–01–P
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Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34726-34729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14247]
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DEPARTMENT OF DEFENSE
Office of the Secretary
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 Demonstration.
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SUMMARY: 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.
DATES: This demonstration will be effective July 18, 2014. This
demonstration will remain in effect for three years.
ADDRESSES: Defense Health Agency, Attn: Clinical Support Division, 7700
Arlington Blvd., Falls Church, VA 22040.
FOR FURTHER INFORMATION CONTACT: Jim Black, Clinical Support Division,
Defense Health Agency, Telephone (703) 681-0068.
SUPPLEMENTARY INFORMATION:
A. Background
1. LDTs
According to 32 CFR 199.4(g)(15)(i)(A), TRICARE may not cost-share
medical devices including LDTs if the tests are non-FDA cleared or
approved; that is, they have not received FDA medical device 510(k)
clearance or premarket approval. For purposes of this demonstration,
LDTs that are not FDA cleared or approved will hereinafter be referred
to as non-FDA approved for brevity purposes. Under the current
regulation cited above, LDTs that have been identified as non-FDA
approved are summarily denied.
An LDT is an in vitro diagnostic (IVD) that is designed,
manufactured, and used within a single laboratory. In the past, these
tests were relatively simple tests used within a single laboratory,
usually at a local large hospital or academic medical center, to
diagnose rare diseases or for other uses to meet the needs of a local
patient population. The FDA has exercised enforcement discretion in
that the agency has generally not enforced applicable provisions under
the Federal Food, Drug, and Cosmetic Act (FFDCA) and its regulations
with respect to LDTs.
The 1976 Medical Device Amendments modified the FFDCA to provide
for a comprehensive system for the regulation of medical devices. The
term ``device'' is defined broadly in 21 U.S.C. 321(h) to include: ``an
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instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part or accessory, which is * * * intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease.'' Medical devices include IVDs.
FDA regulations in 21 CFR 809.3 define ``in vitro diagnostic
products'' as: ``those reagents, instruments, and systems intended for
use in diagnosis of disease or other conditions, including a
determination of the state of health, in order to cure, mitigate,
treat, or prevent disease or its sequelae. Such products are intended
for use in the collection, preparation, and examination of specimens
taken from the human body.'' As explained above, LDTs are a subset of
IVDs. The FDA has stated that clinical laboratories that develop LDTs
are acting as manufacturers of medical devices and are subject to FDA
jurisdiction under the FFDCA. As noted, the FDA has chosen to exercise
its ``enforcement discretion'' over many LDTs and these tests are
routinely sold without FDA approval.
The Analyte Specific Reagents (ASRs) rule was published in 1997 (21
CFR 864.4020), classifying most ASRs (ASRs are considered to be the
``active ingredients'' of tests) as Class I devices. The intent was to
ensure the quality of the test components and to continue enforcement
discretion for LDTs.
During the 2000s, LDTs became more complex at an increasingly fast
pace. In response, the FDA issued draft guidance in 2007 relating to In
Vitro Diagnostic Multivariate Index Assays, a particularly complex
category of tests. Final guidance has yet to be published. In July
2010, the FDA held a public meeting to discuss the agency's oversight
of LDTs. In announcing the public meeting, the FDA explained:
At the same time as LDTs are becoming more complex, diagnostic
tests are playing an increasingly important role in clinical
decision making and disease management, particularly in the context
of personalized medicine. However, LDTs that have not been properly
validated for their intended use put patients at risk. Risks include
missed diagnosis, wrong diagnosis, and failure to receive
appropriate treatment. . . . [and] some diagnostics critical for
patient care may not be developed in a manner that provides a
reasonable assurance of safety and effectiveness.
(75 FR 34463-34464)
The FDA has continued its policy of enforcement discretion over LDTs
and no new draft or final guidance on the regulation of LDTs has been
issued since the enactment of the Food and Drug Administration Safety
and Innovation Act (FDASIA) on July 9, 2012.
Laboratories are assessed and accredited under minimum quality
standards set by CMS under the Clinical Laboratory Improvement
Amendments (CLIA) of 1988. CMS regulates laboratories that use 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.
On December 27, 2011, the DoD published a notice in the Federal
Register (76 FR 80905-80907), announcing the TRICARE Evaluation of
Centers for Medicare and Medicaid Services (CMS) Approved Laboratory
Developed Tests (LDTs) Demonstration Project. LDTs for this
demonstration were limited to only those that had a CMS national or
local coverage determination and significantly informed clinical
decision making for surveillance, surgical interventions, chemotherapy,
or radiation therapy for cancer. This three year demonstration will
continue until it expires or is terminated via separate notice and LDTs
covered under the current demonstration will continue to be covered.
The demonstration project was based on interested laboratories
submitting their LDTs for consideration. Limited participation from
industry in the demonstration served as a constraining factor and did
not provide sufficient data for the DoD to make an affirmative decision
regarding the feasibility of developing a cost-effective and efficient
method of reviewing non-FDA approved LDTs under TRICARE's requirements
for safety and efficacy.
2. TRICARE Coverage of Cystic Fibrosis Testing
In general, the TRICARE program has been, and continues to be, a
benefit program based on medical necessity. The current TRICARE
maternity benefit is limited to coverage of medically necessary
services and supplies associated with maternity care in accordance with
32 CFR 199.4(e)(16). Further, TRICARE covers genetic testing that is
medically necessary and appropriate in the diagnosis and/or treatment
of a disease and when the results of the test will influence the
medical management of the individual or pregnancy. Routine genetic
testing, including carrier screening, that does not influence a
beneficiary's medical management is specifically excluded from TRICARE
coverage.
For cystic fibrosis (CF) testing in particular, TRICARE covers CF
testing when performed as part of a newborn screening panel as part of
well-child care. TRICARE will also cover diagnostic genetic testing for
CF when it is performed on individuals to confirm a clinical diagnosis
that is already suspected. TRICARE does not, however, cover pre-
conception CF carrier screening for couples planning a pregnancy, pre-
implantation CF screening of embryos, or prenatal CF screening of
pregnant women since the results do not assist in the medical
management of the patient or pregnancy. Awareness that a fetus is at
increased risk of having CF, in and of itself, does not usually change
the management of labor, delivery, and the neonatal period.
Additionally, newborn screening panels, which are performed shortly
after birth, include tests for a number of conditions including CF, and
are a TRICARE covered benefit.
Notwithstanding current TRICARE benefit limitations, the Department
of Defense is aware of the widespread acceptance the American College
of Obstetricians and Gynecologists (ACOG) guidelines of carrier
screening for CF have received. Carrier screening for CF has been
widely recognized and commonly provided as part of routine obstetric
practice.
B. Demonstration Project Description
1. Review of LDTs
Consequently, the DoD will initiate a new and expanded
demonstration project to test whether non-FDA approved LDTs meet
TRICARE's requirements for safety and effectiveness in order to permit
TRICARE cost-sharing. The demonstration project will be effective 30
days after publication in the Federal Register and will continue for
three years from the effective date of this demonstration. The new
demonstration project will evaluate the feasibility of establishing a
cost-effective and efficient way to review an expanded pool of non-FDA
approved LDTs. For example,
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LDTs evaluated under the new demonstration are not limited to those
associated with cancer and do not require a CMS national or local
coverage determination. Further, consideration of specific gene testing
as part of the ongoing demonstration project, discussed above, does not
also prevent consideration under the new demonstration project.
Non-FDA approved LDTs will be prioritized and reviewed for
analytical validity, clinical validity, and clinical utility. LDT
reviews will be based on the TRICARE hierarchy of reliable evidence, as
defined below, to determine whether the specific test is proven safe
and effective for TRICARE cost-sharing purposes.
Reliable evidence is defined in 32 CFR 199.2(b) and includes: ``(i)
Well-controlled studies of clinically meaningful endpoints, published
in refereed medical literature; (ii) Published formal technology
assessments; (iii) The published reports of national professional
medical associations; (iv) Published national medical policy
organization positions; and (v) The published reports of national
expert opinion organizations.'' The definition goes on to state, ``The
hierarchy of reliable evidence of proven medical effectiveness,
established by (i) through (v) of this paragraph, is the order of the
relative weight to be given to any particular source. With respect to
clinical studies, only those reports and articles containing
scientifically valid data and published in the refereed medical and
scientific literature shall be considered as meeting the requirements
of reliable evidence. Specifically not included in the meaning of
reliable evidence are reports, articles, or statements by providers or
groups of providers containing only abstracts, anecdotal evidence, or
personal professional opinions. Also not included in the meaning of
reliable evidence is the fact that a provider or a number of providers
have elected to adopt a drug, device, or medical treatment or procedure
as their personal treatment or procedure of choice or standard of
practice.''
There may also be non-FDA approved LDTs reviewed under the new
demonstration project for use in the diagnosis or medical management of
a rare disease. In accordance with 32 CFR 199.2(b), TRICARE defines a
rare disease as any disease or condition that has a prevalence of less
than 200,000 persons in the United States. Due to the rare nature of
the condition and lack of clinical research, the hierarchy of reliable
evidence as described previously may not be met. In accordance with 32
CFR 199.4(g)(15)(ii), benefits for rare diseases are reviewed on a
case-by-case basis. In reviewing proposed benefits for rare diseases
under the new demonstration, consistent with TRICARE's rare disease
policy, a proposed LDT for a rare disease may be reviewed for
analytical validity, clinical validity, and clinical utility from any
or all of the following sources to determine if the proposed LDT for a
rare disease is considered safe and effective for TRICARE cost-sharing
purposes: (i) Trials published in refereed medical literature; (ii)
Formal technology assessments; (iii) National medical policy
organization positions; (iv) National professional associations; and,
(v) National expert opinion organizations.
The DoD's Laboratory Joint Working Group (LJWG) will be responsible
for prioritizing and reviewing the non-FDA approved LDTs for the new
demonstration. Representatives are appointed by the Assistant Secretary
of Defense (Health Affairs) and are comprised of government clinical
and policy professionals (DoD employees and Active Duty Service
Members). Reliable evidence reviews may also be performed by a third
party with the appropriate expertise and recommendations provided to
the LJWG.
The LJWG will prioritize the LDTs based on their potential high
utilization and high clinical utility within the TRICARE population
based on existing direct and purchased care data. LDTs used for non-
covered conditions or tests related to unproven treatments will not be
eligible for coverage and thus will not be reviewed under the new
demonstration or recommended by the LJWG. Selected LDTs will be
evaluated using the hierarchy of reliable evidence or rare disease
policy as outlined above. By majority vote, the LJWG will recommend
approval or disapproval to the Director, DHA, or designee. Approved
LDTs will be available for cost-sharing under the new demonstration.
2. LDT Coverage Decisions Under the New Demonstration
Non-FDA approved LDTs determined to meet TRICARE's requirements for
safety and effectiveness according to the hierarchy of reliable
evidence or rare disease policy, and otherwise meet TRICARE criteria
for coverage, will be recommended to the Director, DHA, or designee,
for decision for approval for cost-sharing during the new demonstration
period. The effective date for coverage of specific LDTs approved under
the new demonstration project will be the later of: (1) January 1,
2013; or (2) the date on which there is sufficient reliable evidence to
determine that the specific LDT is proven safe and effective for
TRICARE cost-sharing purposes. LDTs that have been approved by the
Director, DHA, or designee, under the new demonstration, as well as
LDTs that have been evaluated under the new demonstration and found to
lack sufficient reliable evidence of safety and efficacy and thus
remain excluded from coverage, will be appropriately documented in the
TRICARE Operations Manual (TOM) following existing processes.
Additional information on payment methodologies will be included in the
operational procedures for the new demonstration and will be published
in the TOM found at https://manuals.tricare.osd.mil/.
Decisions regarding which LDTs are reviewed under the new
demonstration, including the priority of review, are not appealable.
Additionally, in order to dedicate maximum resources to the review of
LDTs under the new demonstration, no formal appeal rights will be
extended for tests that are reviewed under the new demonstration and
found to lack sufficient reliable evidence of safety and efficacy.
Should the new demonstration project be deemed successful and permanent
regulatory authority enacted, appeal rights will be available as
provided in 32 CFR 199.10.
3. Coverage of CF Carrier Screening Under the Demonstration
This new demonstration project will also extend coverage for
prenatal and preconception CF carrier screening, when provided in
accordance with the ACOG guidelines. This demonstration project will
allow DoD to establish whether there is a benefit to offering such
testing for purposes of determining whether to permanently establish
coverage as part of the family planning genetic testing benefit at 32
CFR 199.4(e)(3)(ii), the maternity benefit at 32 CFR 199.4(e)(16), or
otherwise as a special benefit. By extending coverage for CF carrier
screening in accordance with ACOG guidelines under this demonstration
project DoD will be able to gather the necessary data to evaluate
whether there is a benefit to offering such screening, including
evaluating the impact on follow-on care that a patient is given based
on testing results and any other identified benefits of the testing.
The Director, DHA (or designee) shall issue guidelines for collection
of data involving individual cases of CF carrier screening covered
under this demonstration as necessary for evaluation of the benefits
resulting from
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such screening. This demonstration project will extend coverage for
this testing from January 1, 2013 through the end of the demonstration
in order to obtain sufficient data to be able to conduct a cost benefit
analysis of providing this screening for our beneficiary population.
D. Implementation
The new demonstration is effective 30 days after publication in the
Federal Register and will continue for a period of three years from the
date of the original demonstration unless terminated earlier by the
Director, DHA. LDTs approved by the Director, DHA, or designee, during
the new demonstration period will become available for cost-sharing for
qualified TRICARE beneficiaries during the demonstration period when
performed by CLIA certified laboratories. 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 demonstration, as appropriate, and the DoD will ensure compliance
with applicable federal law and regulations.
E. Evaluation
An annual evaluation of the new demonstration will be conducted to
determine how many TRICARE approved LDTs were provided to beneficiaries
across all TRICARE Regions. The evaluation will also include a review
of the LDT examination and recommendation process to assess
feasibility, resource requirements, and cost-effectiveness of DHA
establishing an internal safety and efficacy review process for these
devices for TRICARE cost-sharing purposes. These results of the
evaluation will provide an evaluation of the potential improvement of
the quality of healthcare 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 Department of Defense 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.
Dated: June 13, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2014-14247 Filed 6-17-14; 8:45 am]
BILLING CODE 5001-06-P