[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80905-80907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33066]
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DEPARTMENT OF DEFENSE
Office of the Secretary
TRICARE Evaluation of Centers for Medicare & Medicaid Services
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
Section 1092, Chapter 55, Title 10 of the United States Code (U.S.C.),
entitled TRICARE Evaluation of Centers for Medicare & Medicaid Services
Approved Laboratory Developed Tests Demonstration Project. The
demonstration project is intended to determine whether it is feasible
for the Department of Defense (DoD) to review Centers for Medicare and
Medicaid Services (CMS) approved laboratory developed tests (LDTs), not
yet examined by the United States Food and Drug Administration (FDA),
to determine if they meet TRICARE requirements for safety and
effectiveness according to the hierarchy of reliable evidence (32 CFR
199.2(b)) and allow those that do to be covered as a benefit under the
TRICARE Program. The LDTs for this demonstration would be limited to
only those that significantly inform clinical decision making for
surveillance, surgical interventions, chemotherapy, or radiation
therapy for cancer. The demonstration project will provide a valuation
of the potential improvement of the quality of healthcare services for
TRICARE beneficiaries who would not otherwise had access to these
tests. In addition, the demonstration project will evaluate the need to
modify 32 CFR 199.4(g)(15)(i)(A) to allow coverage for CMS approved
LDTs.
Interested LDT device manufacturers, or individual (single)
laboratories developing their own proprietary tests that have a CMS
National Coverage Determination (NCD) or Local Coverage Determination
(LCD) who desire the DoD to consider their tests for coverage under the
TRICARE Program, are encouraged to submit LDTs for consideration.
Submissions must include the LDT description and complete documentation
(including the CMS-assigned determination number) proving CMS National
Coverage Determination (NCD) or Local Coverage Determination (LCD).
Submissions will only be accepted for those LDTs which are CMS
approved, but have not received FDA clearance or approval LDTs will be
prioritized based on the combination of potential high utilization and
potential high clinical impact on TRICARE beneficiaries. If no
submission is received for a LDT and TMA is aware that a NCD or LCD
exists, TMA may elect to include the LDT in the prioritization process.
Relevant administrative data on number of diagnoses of specific
oncological diseases, procedures, treatments, and other requested data
and information will be used in the prioritization process. The
prioritized list will be sent to the Director, TMA for approval. The
approved list will then be reviewed in numerical order beginning with
the test listed as having the highest priority. Those selected for
review will be evaluated to determine whether they meet the TRICARE
hierarchy of reliable evidence for safety and effectiveness as
described in 32 CFR 199.4(g)(15). LDTs determined to meet TRICARE
criteria for safety and efficacy will be recommended to the Director,
TMA for approval for cost-sharing during the demonstration period.
DATES: This demonstration will be effective 30 days after publication
in the Federal Register. This demonstration will remain in effect for
three years.
ADDRESSES: TRICARE Management Activity (TMA), Office of the Chief
Medical Officer, Attn: HB&RM 5111 Leesburg Pike, Suite 810, Falls
Church, VA 22041-3206.
FOR FURTHER INFORMATION CONTACT: Timothy Stockdale, Office of the Chief
Medical Officer, TRICARE Management Activity, telephone (703) 681-0075.
SUPPLEMENTARY INFORMATION:
A. Background
According to 32 Code of Federal Regulation (CFR) 199.4(G)(15)(i)(a)
the TRICARE Management Activity (TMA) may not cost-share medical
devices including laboratory developed tests (LDTs) if the tests are
non-FDA approved, that is they have not received U.S. Food and Drug
Administration (FDA) marketing 510(k) clearance or premarket approval.
Under the current regulation cited above, LDT's that have been
identified as non-FDA approved are summarily denied. In contrast The
Centers for Medicare & Medicaid Services (CMS), which is not
constrained by any similar regulation, has a policy that provides a
mechanism for the review and payment of LDTs meeting the CMS standard
of reasonable and necessary meaning it is safe and effective, not
experimental or investigational, and appropriate.
An LDT is a test developed by a single clinical laboratory that
provides testing to the public but does not sell the lab kit to other
labs. In the past, these tests were relatively simple tests used to
diagnose or monitor diseases and other conditions within a single
laboratory usually at a local large hospital or academic medical
center. As a result the FDA has utilized enforcement discretion (where
the FDA does not enforce some or all applicable laws and regulations on
certain categories of products) of LDTs and has taken no action to
remove them from the marketplace.
The 1976 Device Amendments modified the Federal Food, Drug, and
Cosmetic Act (FFDCA) to provide for the regulation of medical devices.
These medical devices are defined broadly in section 201(h) of 21
U.S.C. 321 to include: ``an instrument, apparatus, implement, machine,
continuance,
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implant, in vitro reagent, or similar or related articles, including
any component, part or accessory which is * * * intended for use in the
diagnosis or disease or other conditions, or in the cure, mitigation,
treatment or prevention of disease.'' Medical devices include
laboratory tests also known as in vitro diagnostics (IVDs).
The FDA authority over IVDs, which includes LDTs, is defined in 21
CFR 809.33 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.'' 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 Analytic Specific Reagents rule was published in 1997 (21 CFR
864.4020) where FDA regulates the primary active reagents of laboratory
developed tests rather than the LDTs themselves. The intent was to
ensure the quality of the test components and to continue enforcement
discretion for LDTs.
During the 2000's LDTs were developed and becoming more complex at
an increasingly fast pace. In response FDA issued draft guidance
relating to In Vitro Diagnostic Multivariate Index Assays, a
particularly complex category of tests in 2007. A final rule has yet to
be published. Recently in July 2011, the FDA released draft guidance on
In Vitro Companion Diagnostic Devices which are devices that provide
information that is essential for the safe and effective use of a
corresponding therapeutic agent.
Laboratories are assessed and accredited under 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 ensure the analytical validity of laboratory
tests, 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.
In contrast to TMA, CMS regulations do not have a specific
requirement that devices be FDA approved. As a result CMS policy
provides a mechanism for the review and payment of non-FDA approved
LDTs (Section 522 of the Benefits Improvement and Protection Act). Non-
FDA approved LDTs which meet CMS's standards are approved through its
National Coverage Determination (NCD) or Local Coverage Determination
(LCD) process. Once a LDT receives a LCD, it is considered a nationwide
Medicare covered benefit.
B. Demonstration Project Description
A demonstration project will be initiated by the TMA to test
whether CMS approved LDTs which have not received FDA medical device
510(k) clearance or premarket approval (therefore considered non-FDA
approved) are safe and effective for cost-sharing for TRICARE
beneficiaries. The LDTs for this demonstration would be limited to only
those that significantly inform clinical decision-making for
surveillance, surgical intervention, chemotherapy, or radiation therapy
for cancer. 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 the original demonstration. The
demonstration project will establish a process for TRICARE to evaluate
the subset of non-FDA approved LDTs currently covered by a CMS NCD or
LCD.
Upon publication of this Federal Register notification, TMA will
solicit submissions from LDT device manufacturers and individual
(single) laboratories which develop their own proprietary laboratory
developed tests requests for DoD coverage of their LDTs. LDTs with
current FDA 510(k) clearance or premarket approval will not be
considered for this demonstration project; but will continue to be
considered for coverage under the current routine coverage
determination process of the TRICARE Program. Submissions must include
evidence of CMS LCD or NCD approval and a statement from the
manufacturer or laboratory attesting that the LDT has not received FDA
medical device clearance or approval for marketing. CLIA certification
is also required and a copy of the certificate should be included. If a
submission is not received for an eligible LDT, TMA may elect to add
the LDT to the list for consideration; but a manufacturer should not
assume that their product will be considered without a submission.
Submissions will be accepted for 90 calendar days from the date of
publication of the demonstration project in the Federal Register.
All submissions will be reviewed by the Department of Defense (DoD)
Laboratory Joint Working Group (LJWG), appointed by the Director, TMA.
The LJWG team will be comprised of government clinical and policy
professionals (DoD employees or active duty service members) to
include; medical specialists, clinical laboratory medicine specialists,
and medical benefits specialists. The LJWG will prioritize the list of
LDTs based on the potential high utilization and potential high
clinical impact on TRICARE beneficiaries. Administrative information
from DoD clinical information systems relating to number of diagnoses
of specific oncological diseases, procedures, treatments, and other
requested data and information will be used in the prioritization
process. LDTs used for non-covered conditions or tests related to
unproven treatments will not be eligible for coverage and thus will not
be recommended by the LJWG.
The prioritized list will be submitted to the Director, TMA for
approval of the test as well as its priority placement on the list.
Once an approved list has been obtained, a health care technology
assessment and review for analytical validity, clinical validity, and
clinical utility will be conducted. All health care technology
assessments will be based on the TRICARE hierarchy of reliable
evidence, as defined below, for criteria for safety and efficacy. CLIA
certification will meet the requirement of analytical validity.
Clinical validity and clinical utility are defined in the Agency of
Healthcare Research and Quality (AHRQ) report titled, ``Quality,
Regulation and Clinical Utility of Laboratory-developed Molecular
Tests, Project ID: LABC0707. In this report clinical validity is
defined as: ``test characteristics (sensitivity, specificity,
predictive values, and likelihood ratios) in other words, the accuracy
with which a test predicts the presence or absence of a clinical
condition or predisposition. Clinical utility is defined as: ``whether
the results of the test can be used to pursue effective treatment or
provide other concrete clinical benefit,'' that is the usefulness of
the test and the value of the information to medical practice. These
standards will be used in determining if an LDT meets the requirements
for clinical validity and clinical utility.
The LJWG will conduct a review of the LDT using the evidence which
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meets the hierarchy of reliable evidence as well as the evidence
outlined above which meet the requirements for analytical validity, and
clinical validity and utility. The definition of reliable evidence
which will be used by the LJWG is defined in 32 CFR 199.2(b) and
includes: ``(i) Well-controlled trials of clinically meaningful
endpoints, published in refereed medical literature, (ii) Published
formal technology assessments, (iii) Published reports of national
medical policy organization positions, (iv) Published national
professional associations, and (v) Published reports of national expert
opinion organizations.'' 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. By majority vote the LJWG
would recommend approval or disapproval to the Director, TMA. Approved
LDTs would be available for cost-sharing with TRICARE beneficiaries.
C. Final Coverage Decisions
LDTs (evaluated under the demonstration project) determined by the
JLWG to meet the TRICARE hierarchy of evidence for safety and
effectiveness will be recommended to the Director, TMA for decision for
acceptance for cost-sharing during the demonstration period. LDTs
approved by the Director, TMA for cost-sharing will follow existing
processes for inclusion as a TRICARE benefit. Additional information on
payment methodologies will be included in the operational procedures
for this Demonstration and will be published in the TRICARE Operations
Manual found at http://manuals.tricare.osd.mil/.
D. Implementation
The 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, TMA. LDTs approved by the Director, TMA during the
demonstration period will become available for cost-sharing for
qualified TRICARE beneficiaries during the demonstration period. Should
the FDA issue final guidance on and or enforcement of the requirement
for prior marketing approval, the Director TMA will terminate the
demonstration and the DoD will ensure compliance with applicable
federal law and regulations.
E. Evaluation
An evaluation will be conducted during the third year of the
demonstration period 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 review and recommendation
process. These results of the evaluation will provide a valuation of
the potential improvement of the quality of healthcare services for
beneficiaries who would not otherwise had access to these safe and
effective tests. Based on the utilization results, a decision will be
made to modify 32 CFR 199.4(g)(15)(i)(A) to remove the restriction for
non-FDA approved devices and allow TRICARE cost-sharing of CMS approved
LDTs determined to meet the TRICARE criteria for safety and
effectiveness.
Dated: December 21, 2011.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-33066 Filed 12-23-11; 8:45 am]
BILLING CODE 5001-06-P