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Notice2024-17603

Medicare Program; Transitional Coverage for Emerging Technologies

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Published

August 12, 2024

Effective

August 12, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final notice finalizes the process and procedures for the Transitional Coverage for Emerging Technologies (TCET) pathway and provides our responses to the public comments received.

Full Text

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[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65724-65754]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17603]

[[Page 65723]]

Vol. 89

Monday,

No. 155

August 12, 2024

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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Medicare Program; Transitional Coverage for Emerging Technologies;
Notice

Federal Register / Vol. 89 , No. 155 / Monday, August 12, 2024 /
Notices

[[Page 65724]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3421-FN]

Medicare Program; Transitional Coverage for Emerging Technologies

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).

ACTION: Final notice.

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SUMMARY: This final notice finalizes the process and procedures for the
Transitional Coverage for Emerging Technologies (TCET) pathway and
provides our responses to the public comments received.

DATES: This final notice is effective August 12, 2024.

FOR FURTHER INFORMATION CONTACT: Lori Ashby, (410) 786-6322.

SUPPLEMENTARY INFORMATION:

I. Background

This notice describes the method we will use to provide
transitional coverage for emerging technologies (TCET) through the
national coverage determination (NCD) process. The TCET pathway is
designed to deliver transparent, predictable, and expedited national
coverage for certain eligible Breakthrough Devices that are Food and
Drug Administration (FDA) market authorized. It builds upon CMS'
experience with the Parallel Review program and the Coverage with
Evidence Development (CED) pathway. Additionally, the TCET pathway
reflects the feedback received from interested parties, including
beneficiaries, patient groups, medical professionals and societies,
medical device manufacturers, other Federal partners, and others
involved in developing innovative medical devices. This feedback was
obtained from informal and formal meetings, the comments we received as
we conducted rulemaking for the Medicare Coverage of Innovative
Technology (MCIT) pathway (referenced later in this section), and
during the two listening sessions that were held following the repeal
of the January 14, 2021 MCIT/``Reasonable and Necessary (R&N)'' final
rule (86 FR 2987). Additionally, feedback was obtained from public
comments and one listening session following publication of the June
28, 2023, Federal Register notice (88 FR 41633) announcing the TCET
pathway. The TCET pathway described in this notice is intended to
balance multiple considerations when making coverage determinations:
(1) facilitating early, predictable, and safer beneficiary access to
new technologies; (2) reducing uncertainty about coverage by evaluating
early the potential benefits and harms of technologies with
manufacturers; and (3) encouraging evidence development if notable
evidence gaps exist for coverage purposes.
The Medicare program serves over 66.7 million beneficiaries \1\ and
is the largest single healthcare purchaser in the U.S. Currently,
approximately 51 percent of the total Medicare beneficiary population,
or 34 million Medicare beneficiaries, receive coverage through Medicare
fee-for-service (FFS). More than 1.1 billion Medicare FFS claims were
processed in fiscal year (FY) 2023, comprised of approximately 192
million Part A claims (such as inpatient care in hospitals, skilled
nursing facility care, hospice care, and home health care) and 950
million Part B claims (such as doctor and other health care services
and outpatient care, durable medical equipment, and some preventive
services), providing approximately $431.5 billion in Medicare FFS
benefits.\2\
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\1\ <a href="https://www.cms.gov/oact/tr/2024">https://www.cms.gov/oact/tr/2024</a>.
\2\ <a href="https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC">https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC</a>.
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Medicare Part A and Part B cover a wide range of items and services
but may not cover every item or service that a physician or healthcare
practitioner prescribes or orders. In general, for an item or service
to be covered under Medicare, it must meet the standard described in
section 1862(a)(1)(A) of the Social Security Act (the Act)--that is, it
must be reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body
member. CMS makes reasonable and necessary coverage decisions through
various pathways to facilitate expeditious beneficiary access to items
and services that meet the statutory standard for coverage.
We believe that new approaches could help make coverage decisions
on certain new items and services, such as medical devices, more
quickly and provide expedited access to new and innovative medical
technologies. On November 15, 2021 (86 FR 62944), CMS published a final
rule that repealed the MCIT rule before it was legally effective and,
thus, was never implemented.\3\ As promised in the repeal, CMS provided
additional opportunities to engage with the public. We have
incorporated that input, along with input gathered in MCIT rulemaking,
as we have developed the TCET pathway to make decisions on certain
emerging technologies at the national level.
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\3\ <a href="https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf">https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf</a>.
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We believe that the TCET pathway balances the needs of
beneficiaries, patient groups, medical professionals and societies,
medical device manufacturers, and others involved in developing
innovative medical devices.

A. Current Medicare Coverage Mechanisms

Items and services, including medical devices, are currently
covered under Part A or Part B in one of three ways, presented here for
context. The TCET pathway described in this notice will leverage the
existing NCD pathway, and CED in particular, to provide a streamlined
coverage pathway for emerging technologies. We note that the TCET
pathway does not alter the existing standards for these coverage
mechanisms.
1. Claim-by-Claim Adjudication
In the absence of an NCD or a local coverage determination (LCD),
Medicare Administrative Contractors (MACs) make coverage decisions
under section 1862(a)(1)(A) of the Act and may cover items and services
on a claim-by-claim basis if the MAC determines them to be reasonable
and necessary for individual patients. Though claims may be denied if
they are not determined to be reasonable and necessary, the claim-by-
claim adjudication pathway remains the fastest path to potential
coverage. The majority of all Medicare Parts A and B claims have
coverage determined through the claim-by-claim adjudication process.
2. Local Coverage Determinations (LCDs)
MACs develop LCDs under section 1862(a)(1)(A) that apply only
within their geographic jurisdictions (see sections 1862(l)(6)(B) and
1869(f)(2)(B) of the Act). LCDs govern only the issuing MAC's claims
adjudication and are not controlling authorities for qualified
independent contractors or administrative law judges in the claims
adjudication process.
The MACs follow specific guidance for developing LCDs for Medicare
coverage as outlined in the CMS Program Integrity Manual (PIM), Chapter
13. LCDs generally take 9 to 12 months to develop. MACs are expected to
finalize proposed LCDs within 365 days from opening, per Chapter
13.5.1-Local Coverage of the PIM.\4\ That

[[Page 65725]]

chapter will continue to be used in making determinations under section
1862(a)(1)(A) of the Act for items and services at the local level.
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\4\ CMS Program Integrity Manual, Chapter 13 Local Coverage
Determinations, available at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf</a>.
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3. National Coverage Determinations (NCDs)
The term ``national coverage determination'' is defined in section
1862(l)(6)(A) of the Act and means a determination by the Secretary of
the Department of Health and Human Services (the Secretary) with
respect to whether or not a particular item or service is covered
nationally under Title XVIII of the Act. In general, NCDs are national
policy statements published to identify the circumstances under which a
particular item or service will be considered covered (or not covered)
by Medicare. NCDs serve as generally applicable rules to ensure that
similar claims for items or services are covered in the same manner.
Often, an NCD is written in terms of defined clinical characteristics
that identify a population that may or may not receive Medicare
coverage for a particular item or service. Traditionally, CMS relies
heavily on health outcomes data to make NCDs.
Most NCDs have involved determinations under section 1862(a)(1)(A)
of the Act, but NCDs can be made based on other provisions of the Act,
such as section 1862(a)(1)(E) of the Act. Under section 1862(a)(1)(E)
of the Act, Medicare has provided coverage for certain promising
technologies with a limited evidence base on the condition that they
are furnished in the context of approved clinical studies or with the
collection of additional clinical data. CMS has used section
1862(a)(1)(E) of the Act to support the ``Coverage with Evidence
Development'' or ``CED'' policy since July 12, 2006, and the most
recent CED policy is described in the 2024 guidance document.\5\ In
general, CED enables providers and suppliers to perform high-quality
studies that we expect will produce evidence that may lead to positive
national coverage determinations under section 1862(a)(1)(A) of the
Act.
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\5\ The most recent CED guidance document is available at
<a href="https://www.cms.gov/medicare/coverage/evidence">https://www.cms.gov/medicare/coverage/evidence</a>.
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The Agency for Healthcare Research and Quality (AHRQ) reviews all
CED NCDs established under section 1862(a)(1)(E) of the Act. Consistent
with section 1142 of the Act, AHRQ collaborates with CMS to define
standards for the clinical research studies to address the CED
questions and support and endorse the general standards for CED studies
(<a href="https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development">https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development</a>).
NCDs also include a determination on whether the item or service
under consideration has a Medicare benefit category under Part A or
Part B,\6\ such as inpatient hospital services, physicians' services,
durable medical equipment, or others. All items and services coverable
by Medicare must fall within the scope of a statutory benefit category,
and many of these specific terms are defined under section 1861 of the
Act and in implementing regulations. While benefit category
determinations (BCDs) may often be completed within 3 months, in some
cases BCDs may take considerably longer. While CMS is working to align
the coverage and BCD review processes better, manufacturers should be
aware that, in some cases, benefit category reviews may not be
completed within the accelerated timeframes needed for the TCET
pathway. In addition, to be covered, the item or service must not be
excluded from coverage by statute or our regulations at 42 CFR part
411, subpart A. The NCD pathway, which has statutorily prescribed
timeframes, generally takes 9 to 12 months to complete from the opening
of the tracking sheet.\7\
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\6\ Note: Medicare does not develop NCDs for Part D.
\7\ Section 1862(l) of the Act.
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In addition to these coverage pathways, CMS has established a
Clinical Trial Policy (CTP) NCD 310.1. The CTP policy is applied when
Medicare covers routine care items and services (but generally not the
technology under investigation) in a clinical study that is supported
by certain Federal agencies. The CTP coverage policy was developed in
2000.\8\ We note that coverage under CED and the CTP may not occur
simultaneously.
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\8\ CMS, National Coverage Determination for Routine Costs in
Clinical Trials available at <a href="https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&fromdb=true">https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&fromdb=true</a>.
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Lastly, CMS has established the Parallel Review program. In the
September 17, 2010, Federal Register (75 FR 57045), FDA and CMS
announced their intention to initiate a Parallel Review pilot program
in an effort to increase the quality of patient health care by
facilitating earlier access to innovative medical technologies for
Medicare beneficiaries. In the October 24, 2016, Federal Register (81
FR 73113), FDA and CMS published a joint notice that announced and
described the processes for the fully implemented Program for Parallel
Review of Medical Devices.
Parallel Review is a mechanism for FDA and CMS to simultaneously
review the clinical data submitted by a manufacturer about a medical
device to help decrease the time between FDA's approval of an original
or supplemental premarket approval (PMA) application or granting of a
de novo classification request (De Novo request) and the subsequent CMS
proposed NCD. Parallel Review has two stages: (1) FDA and CMS meet with
the manufacturer to provide feedback on the proposed pivotal clinical
trial, and (2) FDA and CMS concurrently review (``in parallel'') the
clinical trial results submitted in the PMA application, or De Novo
request. FDA and CMS independently review the data to determine whether
it meets their respective Agency's standards and communicate with the
manufacturer during their respective reviews. This program relies upon
a technology having a comprehensive evidence base to support the
clinical analysis for the NCD.

B. Differences Between FDA and CMS Review

While FDA and CMS have a well-established history of collaboration
in the review of evidence for emerging medical technologies, FDA and
CMS must consider different legal authorities and apply different
statutory standards when making marketing authorization and coverage
decisions, respectively, for medical devices. Generally, FDA makes
marketing authorization decisions based on whether the relevant
statutory standard for safety and effectiveness is met, while CMS
generally makes NCDs based on whether an item or service is reasonable
and necessary for the diagnosis or treatment of an illness or injury
for individuals in the Medicare population. These two reviews are
separate and are conducted independently by the two agencies. The FDA
review of devices does not require a focus specifically on the Medicare
population.
Among other objectives, FDA conducts a premarket review of certain
devices to evaluate their safety and effectiveness and determine if
they meet the applicable standard to be marketed in the United States.
FDA approval or clearance alone does not entitle that technology to
Medicare coverage, given separate Medicare statutory coverage
requirements. While FDA reviews devices to ensure they meet applicable
safety and effectiveness standards, there is often limited evidence
regarding whether the device is clinically beneficial for Medicare
patients. Of

[[Page 65726]]

note, individuals representative of the Medicare population are often
excluded from the studies used to generate the evidence reviewed by
FDA. This is an important consideration for manufacturers and other
interested parties seeking the most appropriate coverage pathway under
Medicare. Where there is limited evidence on the health outcomes for
individuals in the Medicare population, there may be insufficient
evidence to support a full coverage national coverage determination
under section 1862(a)(1)(A) of the Act.
In general, as discussed, under section 1862(a)(1)(A) of the Act,
Congress required CMS to determine whether items and services are
reasonable and necessary to diagnose or treat an illness or injury or
to improve the functioning of a malformed body member for an individual
with Medicare. For CMS, the evidence base underlying FDA's decision to
approve or clear a device for particular indications for use has often
been crucial for determining Medicare coverage through the NCD process.
CMS looks to the evidence supporting FDA market authorization and the
device's approved or cleared indications for use for evidence
generalizable to the Medicare population, data on improvement in health
outcomes, and the durability of those outcomes. If there is no data on
those elements in the Medicare population, it is difficult for CMS to
make an evidence-based decision on whether the device is reasonable and
necessary for the Medicare population.
CMS considers whether the evidence shows that the item or service
will improve the health of Medicare patients recognizing that Medicare
beneficiaries are often older, have multiple comorbidities, and are
often underrepresented or not represented in many clinical studies.\9\
According to a recent study,<SUP>10 11</SUP> approximately 50 percent
of Medicare patients have two or more diseases. Clinical studies that
are conducted to gain FDA market authorization are not necessarily
required to include participants with similar demographics and
characteristics of the Medicare population. To demonstrate the safety
and effectiveness of a device as clearly as possible, many studies
impose stringent exclusion criteria that disqualify individuals with
characteristics that may make it harder to ascertain a device's
effects, such as comorbidities and concomitant treatment. Consequently,
a device's potential benefits and harms for older patients with more
comorbidities may not be well understood at the time of FDA market
authorization.
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\9\ Davide L Vetrano, MD, Katie Palmer, Ph.D., Alessandra
Marengoni, MD, Ph.D., Emanuele Marzetti, MD, Ph.D., Fabrizia
Lattanzio, MD, Ph.D., Regina Roller-Wirnsberger, MD, MME, Luz Lopez
Samaniego, Ph.D., Leocadio Rodr[iacute]guez-Ma[ntilde]as, MD, Ph.D.,
Roberto Bernabei, MD, Graziano Onder, MD, Ph.D., Frailty and
Multimorbidity: A Systematic Review and Meta-analysis, The Journals
of Gerontology: Series A, Volume 74, Issue 5, May 2019, Pages 659-
666, <a href="https://doi.org/10.1093/gerona/gly110">https://doi.org/10.1093/gerona/gly110</a>.
\10\ Tan, Y.Y., Papez, V., Chang, W.H., Mueller, S.H., Denaxas,
S., & Lai, A.G. (2022). Comparing clinical trial population
representativeness to real-world populations: an external validity
analysis encompassing 43 895 trials and 5 685 738 individuals across
989 unique drugs and 286 conditions in England. The Lancet Healthy
Longevity, 3(10), e674-e689.
\11\ Varma T, Mello M, Ross JS, et al Metrics, baseline scores,
and a tool to improve sponsor performance on clinical trial
diversity: retrospective cross sectional study BMJ Medicine
2023;2:e000395. doi: 10.1136/bmjmed-2022-000395.
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C. FDA Breakthrough Devices Program

Under the TCET coverage pathway, CMS will coordinate with FDA and
manufacturers of Breakthrough Devices as those devices move through the
FDA premarket review processes to ensure timely Medicare coverage
decisions following any FDA market authorization, as described in
detail later in this section. The FDA Breakthrough Devices Program is
an evolution of the Expedited Access Pathway Program and the Priority
Review Program. See section 515B of the FD&C Act, 21 U.S.C. 360e-3; see
also final guidance for industry entitled, ``Breakthrough Devices
Program.'' \12\
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\12\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program</a>.
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FDA's Breakthrough Devices Program is not for all new medical
devices; rather, it is only for those that FDA determines meet the
standards for Breakthrough Device designation. In accordance with
section 515B of the FD&C Act (21 U.S.C. 360e-3), the Breakthrough
Devices Program is for medical devices and device-led combination
products \13\ that meet two criteria. The first criterion is that the
device provides for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating human disease or conditions.
The second criterion is that the device must satisfy one of the
following elements: It represents a breakthrough technology; no
approved or cleared alternatives exist; it offers significant
advantages over existing approved or cleared alternatives, including
the potential, compared to existing approved alternatives, to reduce or
eliminate the need for hospitalization, improve patient quality of
life, facilitate patients' ability to manage their own care (such as
through self-directed personal assistance), or establish long-term
clinical efficiencies; or device availability is in the best interest
of patients (see 21 U.S.C. 360e-3(b)(2)). These criteria make
Breakthrough designated devices unique. Devices meeting these criteria
are also likely to be highly relevant to the needs of the Medicare
population who may not have other treatment options.
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\13\ Information on device-led combination products can be
accessed here: <a href="https://www.fda.gov/media/119958/download">https://www.fda.gov/media/119958/download</a>.
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FDA has explained in guidance that because decisions on requests
for Breakthrough designation will be made prior to marketing
authorization, FDA considers whether there is a ``reasonable
expectation that a device could provide for more effective treatment or
diagnosis relative to the current standard of care (SOC) in the U.S''
for purposes of the designation. This reasonable expectation can be
supported by sources including ``literature or preliminary data (bench,
animal, or clinical)''.\14\
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\14\ Food and Drug Administration, Breakthrough Devices Program
Guidance for Industry and Food and Drug Administration Staff,
available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program</a>.
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II. Summary of Proposed Provisions and CMS Responses to Public Comments
on the Proposed Notice

In the June 28, 2023, Federal Register (88 FR 41633), we published
a proposed notice to establish the TCET pathway. We received
approximately 150 timely pieces of correspondence in response to the
publication of the June 28, 2023, proposed notice. Commenters included
a broad range of interested parties, including physicians, professional
societies, manufacturers, manufacturer associations, venture capital
firms, health plans, and patient advocates. Some comments addressed
issues or expressed concerns that were beyond the scope of our
proposals in the proposed notice or were not relevant and will not be
summarized and included in our responses below. Revisions made to the
TCET pathway in response to specific comments are noted in the
applicable response to comments, and a listing of changes from proposed
to final is included in section III. of this final notice.
Additionally, clarifying edits have been made, as appropriate. The
following is a summary of the public comments that we received related
to the proposed notice, and our responses to the public comments.

[[Page 65727]]

A. Overarching Comments Regarding CMS' Proposal To Establish the TCET
Pathway

CMS proposed that the TCET pathway use the NCD and CED processes to
expedite Medicare coverage of certain Breakthrough Devices. Our
proposal noted that the TCET pathway would be voluntary and stated that
the goal of the pathway is to reduce uncertainty about coverage options
through a pre-market evaluation of potential harms and benefits of
technologies while identifying any important evidence gaps.
Additionally, CMS' proposal for the TCET pathway provided an evidence
development framework to provide manufacturers with opportunities for
increased pre-market engagement with CMS and, to reduce manufacturer
burden, increased flexibility to address evidence gaps to support
Medicare coverage. In the proposed notice, CMS stated that we
anticipate accepting up to five TCET candidates annually.
1. General Concerns
Comment: Many commenters generally supported the TCET concept,
expressing that it could result in faster access to newly FDA market-
authorized technologies for Medicare beneficiaries. Commenters
appreciated that TCET will bring closer collaboration between FDA and
CMS. Those who were supportive also stated their belief that the
proposal would promote innovation, decrease uncertainty and delays in
coverage, and improve beneficiary access to cutting-edge treatments.
The majority of commenters expressed support for the TCET proposal in
principle, noting that it is a ``good first step,'' and provided
suggested modifications to improve the pathway.
Response: We appreciate the comments supporting the TCET proposal.
We also appreciate the suggestions provided by commenters to improve
the pathway. The modifications suggested by commenters and CMS'
responses to those suggestions are provided throughout this section.
Comment: Some commenters do not believe CMS' proposal goes far
enough and refer to it as ``flawed'' and a ``missed opportunity.''
Several commenters expressed concerns that the TCET pathway is limited
in scope in that it only applies to ``certain FDA-designated
Breakthrough Devices that fall within a Medicare benefit category.''
Some of these commenters expressed support for automatic, immediate
coverage upon FDA market authorization. A commenter expressing a
preference for immediate or near-immediate coverage referred to TCET as
a ``partial solution'' to providing timely access to innovative devices
as the pathway will be further limited by CMS resource constraints.
Response: We appreciate the public comments but do not agree that
the TCET proposal is flawed or was a missed opportunity to provide
better access to Breakthrough Devices for Medicare beneficiaries. We
also disagree that it is a ``partial solution.''
While the FDA reviews devices to ensure they meet applicable safety
and effectiveness standards, there is often limited evidence regarding
whether the device is clinically beneficial to Medicare patients at the
time of FDA market authorization. As such, we do not believe that it is
appropriate to grant all FDA market authorized Breakthrough Devices
automatic coverage solely based on their Breakthrough Designation.
Furthermore, when there is a lack of evidence specific to the Medicare
population, it makes it difficult for CMS to ensure that devices are
not posing additional risks in the Medicare population. Continuing to
develop evidence generalizable to the Medicare population is important
not only to payers, but is critical for patients, their caregivers, and
their treating clinicians to make the most informed decisions for their
treatment. We believe that it is important to require manufacturers
participating in any innovative coverage pathway, such as TCET, to
produce evidence that demonstrates the health benefit of the device and
the related services for patients with demographics similar to that of
the Medicare population.
Our proposal centered on Breakthrough Devices because we believe
this is the area with the most immediate need, particularly considering
the unique FDA criteria for Breakthrough designation status. We agree
with commenters about the importance of promoting innovation across all
items and services covered under Medicare. However, because we have
consistently heard from interested parties about the need for more
rapid coverage for Breakthrough Devices, we are focusing on
Breakthrough Devices in this final notice.
The TCET pathway will result in a more transparent, predictable,
and efficient Medicare coverage pathway that balances multiple
competing interests. Coverage under CED can expedite beneficiary access
to innovative technologies (and result in improved health outcomes) by
ensuring that systematic patient safeguards--including assurance that
the technology is provided to clinically appropriate patients--are in
place that reduce the risks inherent to new technologies, or to new
applications of older technologies. In the absence of CED, technologies
with limited evidence would likely not be covered. Further, TCET
represents a substantial transformation of how CMS conducts coverage
reviews and is responsive to extensive feedback from interested
parties. The pathway has broad support from the vast majority of
commenters and CMS views this as the best option to provide coverage
for emerging technologies for which the available evidence is
insufficient to support broad national coverage at the time of FDA
market authorization. As we gain experience with the TCET pathway, we
may consider expanding its application to other items and services.
Comment: A commenter questioned CMS' legal authority to use CED and
expressed opposition to CMS' use of it. This commenter noted past
communications from their organization, including some previously
shared with CMS, that ``have, among other things, questioned CMS's
reliance upon uncertain legal grounds for utilizing CED.'' One of the
examples provided by this commenter is the white paper, ``Fa[ccedil]ade
of Evidence: How Medicare's Coverage with Evidence Development Paradigm
Rations Care and Exacerbates Inequity'' \15\ which cites an Advisory
Opinion from the former General Counsel for HHS that ``support'' is
usually used to mean funding.
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\15\ Alliance for Aging Research, FA[Ccedil]ADE OF EVIDENCE: HOW
MEDICARE'S COVERAGE WITH EVIDENCE DEVELOPMENT PARADIGM RATIONS CARE
AND EXACERBATES INEQUITY (Feb. 13, 2023), available at <a href="https://www.agingresearch.org/wp-content/uploads/2023/02/Facade-of-Evidence-CED-2-13-2023.pdf">https://www.agingresearch.org/wp-content/uploads/2023/02/Facade-of-Evidence-CED-2-13-2023.pdf</a>.
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Response: We disagree with the commenter's assertion that CMS does
not have statutory authority for CED. Advisory Opinion 21-03 was issued
by the past administration on January 14, 2021. It has been removed
from the HHS website. Advisory opinions do not grant rights or impose
obligations and the opinions can be revised, modified, or eliminated as
necessary to reflect changing circumstances.
Congress has established an exception in section 1862(a)(1)(E) of
the Act that authorizes the Medicare program to pay for items and
services in the case of research conducted pursuant to section 1142 of
the Act, so long as the items or services are reasonable and necessary
to carry out the purposes of that section. Section 1142(a)(1)(A) of the
Act authorizes the Secretary, acting through the AHRQ Director, to
``conduct and

[[Page 65728]]

support research with respect to the outcomes, effectiveness, and
appropriateness of health care services and procedures in order to
identify the manner in which diseases, disorders, and other health
conditions can most effectively and appropriately be prevented,
diagnosed, treated, and managed clinically[.]'' In this subsection the
word ``support'' is not necessarily limited to financial backing.
``Support'' pursuant to this subsection may also take the form of an
appropriate AHRQ endorsement.
Under CED, AHRQ has endorsed and supported research for various
items and services that were of particular importance to the Medicare
population, but where the existing medical evidence was not sufficient
to permit coverage under section 1862(a)(1)(A) of the Act. AHRQ's
endorsement has occurred when AHRQ officials have used staff resources
to identify the general characteristics and attributes that are
necessary for any Medicare sponsored clinical trial. The general AHRQ
recommendations have been included in current and prior CED guidance
documents. AHRQ officials have also reviewed each NCD where CED has
been proposed or finalized, focusing on the specific methodological
approach that would be necessary for coverage in each specific CED NCD.
AHRQ's support has been documented and included in the record for each
CED NCD. AHRQ's expertise has been essential to support CED under
sections 1142 and 1862(a)(1)(E) of the Act.
Additionally, HHS has recognized that AHRQ's endorsement of
standards for qualifying clinical trials under section 1142 of the Act
can provide the statutory authority for Medicare coverage for items and
services under the Medicare program in circumstances outside of the CED
policy. The Medicare clinical trial policy, now established at section
310 of the Medicare National Coverage Determinations Manual, relies on
the same statutory authority and has been effective since September 19,
2000.
Subsequently, CMS, then known as the Health Care Financing
Administration, requested AHRQ convene a multi-agency Federal group to
develop readily verifiable criteria by which to identify trials that
meet an appropriate standard of quality. On October 20, 2000, AHRQ held
a public meeting to gather pertinent information and views that would
contribute to defining the qualifying criteria used to identify sound
clinical trials appropriate for Medicare coverage. The qualifying
criteria was developed under the authority to support health care
research in section1142 of the Act.
Comment: A commenter stated that TCET is not genuinely voluntary
and restricts access. This commenter asserts that ``CMS downplays the
reality that manufacturers who do not follow through with the TCET
pathway and subject themselves to CED requirements are virtually
excluded from Medicare coverage altogether without regard to the
implications for beneficiaries resulting from lack of access.''
Response: We disagree. Coverage under CED can expedite beneficiary
access to innovative technologies (and result in improved health
outcomes) while ensuring that systematic patient safeguards--including
assurance that the technology is provided to clinically appropriate
patients--are in place that reduce the risks inherent to new
technologies, or to new applications of older technologies. CMS may
cover certain items and services under the CED pathway that would
otherwise not satisfy the reasonable and necessary standard. In the
absence of CED, technologies with limited evidence could be noncovered.
Participation is voluntary for beneficiaries in CED studies. Receipt of
an item or service under a CED NCD is voluntary.
Comment: A commenter asserted that CMS' use of the NCD process, and
CED more specifically, to establish coverage under TCET interferes with
the practice of medicine. This commenter cited section 1801 of the Act
and stated that ``CMS' attempt to supervise or control healthcare
provider qualifications, healthcare settings, and recipients of
healthcare services violates the statute.''
Response: We acknowledge that under section 1801 of the Act Federal
officers and employees are not authorized to exercise any supervision
or control over the practice of medicine or the manner in which medical
services are provided, or over the selection, tenure, or compensation
of any officer or employee of any institution, agency, or person
providing health services; or to exercise any supervision or control
over the administration or operation of any such institution, agency,
or person. We disagree, however, with commenter's suggestion that NCDs,
CED, and the TCET proposal interfere in the practice of medicine.
As noted previously, the Medicare statute includes a number of
restrictions that limit payment for items and services under Part A and
Part B of Title XVIII. Medicare does not cover every item or service
just because it was recommended by a physician or healthcare
practitioner. Moreover, NCDs do not restrict the practice of medicine,
but do inform beneficiaries and practitioners in advance when
particular items and services will be covered (or not covered)
nationally under Title XVIII. NCDs are binding authorities for Medicare
contractors and adjudicators, but not medical practitioners (see 42 CFR
405.1060). NCDs ensure that similar claims are processed and paid in a
uniform manner. Physicians can still prescribe or order other services
that will not be paid by Medicare, and the beneficiary may agree to pay
for items or services that Medicare does not cover. CMS' role in making
NCDs is consistent with the agency's statutory authority.
Comment: A commenter questioned if obtaining an NCD without CED
would be possible under TCET.
Response: Yes, an NCD without CED is an option if there is
sufficient evidence to support Medicare coverage under section
1862(a)(1)(A) of the Act.
Comment: A commenter claimed that CMS' proposal for the TCET
pathway undermines FDA's Breakthrough Devices Program and postmarket
requirements.
Response: We do not agree that CMS is undermining FDA's
Breakthrough Devices Program and postmarket requirements. When we find
that the medical evidence is insufficient to permit Medicare payment
under section 1862(a)(1)(A) of the Act, we often consider whether an
item or service may still be clinically beneficial to patients within
the Medicare population. The limited coverage that we provide to those
beneficiaries that elect to participate in clinical studies through CED
does not interfere with FDA's role under that agency's separate
statutory authority. Further, there is opportunity under TCET to
leverage an FDA-required postmarket study, if any, to address specific
evidence gaps for Medicare beneficiaries.
Comment: Some commenters expressed that CMS should have issued the
proposal as a proposed rule rather than a notice to facilitate
meaningful changes and address key issues that hinder beneficiary
access.
Response: We do not agree that a proposed rule is required to
establish a procedural rule. The TCET pathway establishes procedures
for the effective and efficient operations of the agency designed to
expedite national coverage of Breakthrough Devices. The notice does not
establish or change a substantive legal standard but establishes a
process to identify specific evidence gaps and creates a framework to
fill those missing evidentiary gaps. Establishing TCET through a
proposed procedural notice enabled CMS to consider public comments but
also has

[[Page 65729]]

the advantage that the procedures may be modified as necessary as the
Agency, manufacturers, and the public gain experience using the
process. The procedural notice is important to explain how the public
and TCET sponsors can work with CMS with respect to coverage for
certain Breakthrough Devices and addresses key issues that may have
hindered beneficiary access in the past. The TCET pathway is intended
to balance multiple considerations when making coverage determinations:
(1) facilitating early, predictable, and safer beneficiary access to
new technologies; (2) reducing uncertainty about coverage by evaluating
early the potential benefits and harms of technologies with
manufacturers; and (3) encouraging evidence development if evidence
gaps exist. Further, the TCET pathway aims to coordinate benefit
category determination, coding, and payment reviews and to allow any
evidence gaps to be addressed through fit-for-purpose (FFP) studies.
The anticipated result of the new coverage pathway would be faster
access to technologies within a predictable coverage framework that
generates clinical evidence for the Medicare population.
Comment: Several commenters urged CMS to finalize the TCET pathway
quickly and commit to periodic refinements as needed as experience is
gained.
Response: We appreciate these comments. CMS has moved as quickly as
possible to review and respond to the 150 comments received on the
proposed notice and issue a final notice. We acknowledge that
refinements to the TCET pathway may be needed as CMS, manufacturers,
and other interested parties gain more experience.
2. TCET Timelines
Comment: Several commenters noted CMS' ambitious timelines for the
TCET pathway and questioned whether CMS' timelines are realistic. Some
of these commenters encouraged CMS to be forthcoming with realistic
timelines. A few commenters suggested that CMS provide coverage for
Breakthrough Devices sooner than the timeline proposed. Some commenters
requested that CMS provide more definitive timelines.
Response: We appreciate these comments. We agree that it is
important to provide reasonable and realistic timelines. In general, we
believe our timelines are reasonable and realistic based on our
experience and input from interested parties. While we understand that
some would like faster and more definitive timelines, we have also
heard that we should provide as much flexibility as possible, given
that all interested parties may experience unanticipated obstacles and
delays as they gain experience with TCET. We are making one specific
timeline update in the final notice to specify that we will consider
TCET nominations on a quarterly basis, rather than acting upon them
within 30 days of submission. This additional time provides a more
realistic timeframe for CMS to coordinate with the manufacturer and, as
appropriate, FDA on any outstanding issues and to begin internal
discussions within CMS regarding operational issues. It will also allow
CMS to prioritize between eligible devices and provide a fairer
opportunity for participation in the TCET pathway, regardless of the
anticipated timing of FDA's decision on market authorization.
Additional information regarding this change is detailed below in this
section under ``C. Nominations.''
Comment: Some commenters questioned whether CMS could adhere to the
timelines considering CMS' long-standing resource constraints. These
commenters cited the potential for delays. A few of these commenters
expressed that CMS should be held accountable for meeting all timelines
indicated in the notice.
Response: CMS expects to adhere to the timelines outlined in the
notice barring unexpected complications based on current resources, and
we expect that manufacturers will do the same or at least provide as
much notice as possible when complications are encountered. We have
built in flexibility for all parties to help ensure the success of the
new TCET pathway. We do not believe that imposing consequences on the
Agency or manufacturers for missed deadlines would be helpful. As we
gain more experience, we may modify aspects of the TCET pathway,
including timelines, in the future.
3. Limiting the TCET Pathway to Five Candidates Yearly
Comment: Many commenters expressed concerns with the potential
limit to five TCET candidates yearly. Some commenters contend that the
limitation is arbitrary and would like CMS to clarify how this number
was derived.
Response: We appreciate these comments. Based on our multiple
periodic assessments of Breakthrough Devices, we anticipate that we
will receive approximately eight nominations for the TCET pathway per
year. Most Breakthrough Devices are not appropriate for TCET because
they are not appropriate for Medicare beneficiaries (for example,
pediatric technologies not indicated for use in children with ESRD).
NCDs are limited to particular items or services but it is possible
that more than one device could fall under the same NCD because it
addresses the same indication. Based on current resources, we do not
anticipate being able to accept more than five candidates into the TCET
pathway per year. As we gain more experience with TCET, we will re-
evaluate and adjust if we can do so within our available resources.
Comment: A commenter stated that CMS does not have statutory
authority to limit the number of nominations. The commenter noted that
they are unaware of any other coverage, coding or payment mechanisms
that have instituted limits. The commenter also noted that MCIT had no
limitation to the number of technologies to be approved or considered.
Response: There is no statute that establishes a fixed limit on the
number of NCDs that CMS might issue per year; neither is there a
statute that requires CMS to issue an unlimited number of NCDs. The
anticipated number of TCET NCDs is based on current resources. As we
gain more experience with TCET, we will re-evaluate and adjust as
appropriate.
We note that MCIT was repealed before it became effective. As we
noted in the November 2021 final rule,\16\ MCIT had significant
limitations. For example, the MCIT pathway did not require evidence
development and did not include a mechanism to coordinate benefit
category, coding, and payment reviews. Additionally, MCIT did not
include beneficiary safeguards beyond limiting coverage to the FDA
approved or cleared indication(s) for use.
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\16\ <a href="https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf">https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf</a>.
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There are a number of ways in which TCET is different, and in fact
improves upon, MCIT. The TCET pathway is intended to balance multiple
considerations when making coverage determinations: (1) facilitating
early, predictable, and safer beneficiary access to new technologies;
(2) reducing uncertainty about coverage by evaluating early the
potential benefits and harms of technologies with manufacturers; and
(3) encouraging evidence development if notable evidence gaps exist for
coverage purposes. Further, the TCET pathway aims to coordinate benefit
category determination, coding, and payment reviews and to allow any
evidence gaps to be addressed through fit-for-purpose studies.

[[Page 65730]]

Comment: Commenters noted that the demand for TCET may outpace
available resources. Numerous commenters expressed that resources
should not hinder TCET and that all eligible devices should be accepted
into the pathway. Several commenters stated that the limitation would
constrain the pathway's potential and that TCET can be more impactful
if additional technologies can be accommodated. A few of these
commenters noted that CMS' limitation may create potential access
issues for beneficiaries and market disruption. A commenter suggested
CMS should consider how resources can be aligned to support a higher
number accepted into TCET and reevaluate the number annually. Another
commenter suggested that perhaps more devices can pursue TCET once
efficiencies can be realized. A commenter suggested that if CMS needs
to limit the number of technologies accepted into the pathway, CMS
should wait 2 years before creating a cap.
Response: We anticipate no more than five per year because that is
the largest number that we believe we can address within current
resources. As we gain more experience with TCET, we will re-evaluate
and adjust as appropriate based on available resources.
Comment: Numerous commenters expressed concerns with CMS' limited
resources within and beyond the TCET pathway. Some commenters
questioned how the NCD backlog would impact TCET. A commenter cautioned
that an excessive emphasis on coverage review for TCET devices could
delay consideration of important non-Breakthrough NCD requests.
Response: In addition to the TCET NCDs, we intend to continue
issuing our typical number of non-TCET NCDs. As we gain more experience
with TCET, we will re-evaluate and adjust our volumes as appropriate
within our available resources.
Comment: Some commenters expressed concerns that AHRQ's resources
are even more limited than CMS'. A commenter requested that AHRQ and
CMS resources be assessed to support the manufacturer feedback needed
for the Evidence Preview (EP) and Evidence Development Plan (EDP).
Response: A budget analysis for this activity is beyond the scope
of this notice.
Comment: Several commenters stated that CMS should clarify how
additional resources can expand the scope and breadth of the pathway.
Response: The proposal was based on current resources. As we gain
experience with the process, including any efficiencies that may emerge
over time, we will use that information to make adjustments as
appropriate.
Comment: A commenter stated that CMS needs sufficient resources to
ensure TCET is more utilized than Parallel Review has been to date.
Response: We continue to pursue the necessary resources to do our
work.
Comment: A commenter expressed appreciation for CMS' acknowledgment
of resource constraints and noted that TCET does not preclude coverage
of Breakthrough Devices through existing coverage mechanisms such as
claim-by-claim adjudication by MACs, LCDs, and the Parallel Review
Program.
Response: We appreciate this comment and acknowledge that existing
coverage mechanisms remain available for manufacturers of Breakthrough
Devices to pursue Medicare coverage.
4. Operational Issues
Comment: Numerous commenters expressed concerns that the proposed
procedural notice did not adequately address the operational issues
(e.g., coding and payment issues) that could inhibit the successful
implementation of the TCET pathway and would still need to be
addressed. Commenters indicated that the goals of TCET cannot be
achieved until these operational issues are resolved. Some commenters
requested that CMS provide more specifics on the coding and payment
processes. Numerous commenters cited the necessity of alignment among
coverage, coding, and payment. They requested that CMS provide more
specific information on how these processes will be coordinated under
TCET and include timelines. A commenter encouraged CMS to collaborate
internally to improve alignment among these processes.
Response: We appreciate these comments and agree that coordination
of coverage, coding, and payment processes supporting the TCET pathway
is important. We have established new internal collaborations to
improve coordination going forward. CMS recently released the CMS Guide
for Medical Technology Companies and Other Interested Parties website,
which provides interested parties, including, but not limited to,
medical device, pharmaceutical, and biotechnology companies, with
information about Medicare's processes for determining coding,
coverage, and payment as well as other key considerations. The Guide
will be updated to include information related to TCET in the near
future. This resource can be accessed here: <a href="https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties">https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties</a>.
Comment: Some commenters suggested that CMS begin discussions
regarding operational issues when a technology is accepted into TCET. A
commenter recommended that CMS offer a system readiness meeting within
45 days of acceptance that discusses coverage, BCD, coding, and payment
considerations to ensure overall alignment. A second system readiness
meeting could be scheduled following the EP meeting and the
manufacturer's decision to continue in the pathway. The timing for this
meeting can be flexible depending on factors such as EDP development
progress, FDA decision timing, and potential NCD opening date. The
recommended meeting could also be an opportunity to discuss the EDP.
Response: While we appreciate the suggestion to incorporate a
specific systems readiness meeting into the TCET process, we have not
added it as a formal step at this time . Instead, we believe that a
more informal approach will provide more flexibility and be less
burdensome for manufacturers since each technology and manufacturer may
have unique circumstances that could impact the timing of these
discussions. We continue to explore opportunities to better align
coverage, coding, and payment considerations for devices in the TCET
pathway.

B. Appropriate Candidates

CMS proposed to limit the TCET pathway to certain eligible FDA-
designated Breakthrough Devices, since we believe that this is the area
with the most immediate need. In our proposal, we stated that
appropriate candidates for the TCET pathway would include those devices
that are--
<bullet> Certain FDA-designated Breakthrough Devices;
<bullet> Determined to be within a Medicare benefit category;
<bullet> Not already the subject of an existing Medicare NCD; and
<bullet> Not otherwise excluded from coverage through law or
regulation.
CMS also indicated that the majority of coverage determinations for
diagnostic laboratory tests granted Breakthrough designation status
should continue to be determined by the MACs through existing pathways.
1. Scope of Pathway and FDA-Designated Breakthrough Devices
Comment: Commenters provided varied suggestions regarding which
technologies should be eligible for the TCET pathway. Some commenters
offering general support stated that the TCET pathway should be limited
to a subset of technologies, specifically, as

[[Page 65731]]

we proposed, to FDA-designated Breakthrough Devices. A few commenters
stated that TCET should be limited to Breakthrough Devices to ensure it
is unique from existing processes. Other commenters suggested that non-
Breakthrough Devices should be eligible for TCET or similar coverage
pathways because non-Breakthrough items and services also improve
patient health outcomes. These commenters pointed out that there may be
innovative technologies that they believe should be covered by Medicare
that choose not to use FDA's Breakthrough Devices Program or may be an
innovative technology that may not qualify for the designation. A few
commenters provided recommendations for CMS to consider if the TCET
pathway were to be expanded, including eligibility for FDA-designated
Regenerative Medicine Advanced Therapy products and FDA's Safer
Technologies for Medical Devices Program. They also recommended that
CMS align the TCET pathway with the Cancer Moonshot.
Response: We appreciate these comments and the suggestions for
expanding eligibility for the TCET pathway. Over the last several
years, we have heard concerns that there is more uncertainty
surrounding coverage of devices than for other items and services, such
as drugs and biologics. For this reason, our proposal centered on
Breakthrough Devices since we believed this was the area with the most
immediate need, particularly considering the unique FDA criteria for
Breakthrough designation status. We agree with commenters about the
importance of promoting innovation across all items and services
covered under Medicare. However, because we have consistently heard
from interested parties about the need for more rapid coverage for
Breakthrough Devices, we are focusing on Breakthrough Devices in this
final notice. As the TCET pathway develops and proves successful, we
may consider expanding its application to other items and services,
contingent on sufficient available resources.
Comment: Some commenters expressed that Breakthrough Devices have
very little evidence at the time of FDA market authorization to support
Medicare coverage. A commenter encouraged caution in allocating
Medicare resources for coverage of Breakthrough Devices under TCET,
considering what the commenter described as the relatively low
threshold of evidence required for Breakthrough Device designation. It
was also noted that if Breakthrough Device coverage is expanded,
coverage for other evidence-based and effective interventions could be
reduced. Several commenters noted potential safety concerns with
Breakthrough Devices. Multiple commenters recommended that CMS maintain
rigorous evidence development standards. Commenters stressed the need
to monitor the use and outcomes of these devices and build a mechanism
to trigger an NCD reconsideration if FDA withdraws approval or there
are postmarket safety concerns.
Response: We appreciate the comments. Please note that Medicare
coverage of Breakthrough-designated devices would only occur if the
device gains FDA marketing authorization. Breakthrough Devices are held
to the same safety and effectiveness standards to receive FDA market
authorization as other medical devices that do not have Breakthrough
Device designation; Breakthrough Device designation does not represent
a market authorization from FDA. Further, for CMS to provide coverage
for Breakthrough Devices, there must be sufficient evidence to conclude
that the evidence is promising, and that the device is potentially
important for the Medicare population even if the available evidence is
insufficient to satisfy the reasonable and necessary standard. Coverage
in these circumstances would be contingent on further evidence
generation under sections 1862(a)(1)(E) and 1142 of the Act. We believe
the TCET evidence generation framework will facilitate the development
of reliable evidence for patients and their physicians. It also
provides safeguards to ensure that Medicare beneficiaries are protected
and continue receiving high-quality care. Coverage under CED can
expedite earlier beneficiary access to innovative technology while
ensuring that systematic patient safeguards--including assurance that
the technology is provided to clinically appropriate patients--are in
place to reduce the potential risks associated with new technologies,
or to new applications of older technologies.
We agree that CMS should reconsider an NCD for Breakthrough Devices
if safety concerns arise. We noted in the proposed procedural notice
and reiterate in this final notice that CMS retains the right to
reconsider an NCD at any point in time. If an NCD is repealed, MACs
could deny coverage for particular devices. CMS may also issue a
national non-coverage NCD that would bar all coverage for the device.
2. Necessity of Falling Into an Existing Benefit Category
Comment: CMS proposed that a Breakthrough Device must fall into an
existing benefit category to be included under TCET. In general,
commenters supported this proposal. However, several commenters
recommended the inclusion of Breakthrough Devices that do not fall
within an existing benefit category, for example, many digital health
technologies. Several commenters requested CMS review and update
current benefit category definitions to reflect technological advances.
These commenters requested that CMS create new benefit categories or
make a determination that an item or service (for example, software or
other digital technologies) falls within a benefit category. Numerous
commenters noted that CMS' current approach to benefit category
determinations is limited and requested that CMS be more flexible in
its approach, including modifying existing benefit categories to
include these devices. A commenter requested that CMS provide clear
direction on how TCET can support AI and software technologies for
which no clear benefit category exists. A commenter suggested that CMS
ensure prescription digital therapeutics (PDTs) are eligible for TCET
even though there is no benefit category for them.
Response: CMS does not have authority to establish new Part B
benefit categories; benefit categories are statutory and established by
Congress. Consequently, some Breakthrough Devices will not fall within
a Medicare benefit category and cannot be covered or paid by Medicare.
3. Limitation for Devices Already the Subject of an Existing NCD
Comment: Many commenters requested that CMS eliminate the
limitation for devices already the subject of an existing Medicare NCD.
These commenters noted that there may be a situation where an NCD was
broadly written, and the new product was not specifically mentioned.
Commenters requested that CMS expand TCET eligibility criteria to
include technologies with an existing NCD that receive Breakthrough
designation from FDA for a novel indication that is non-covered under
an existing NCD or unrelated to the existing NCD. A commenter provided
an example of a device that received Breakthrough designation for what
the commenter described as very different indications with different
evidence and research needs.

[[Page 65732]]

Response: We appreciate these comments. However, we will maintain
the limitation. If devices are subject to an existing NCD, a
reconsideration of the NCD may be required to establish coverage.
4. Diagnostic Laboratory Tests
Comment: Numerous commenters disagreed with CMS' proposal that
coverage determinations for Breakthrough-designated diagnostic
laboratory tests should continue to be made by Medicare Administrative
Contractors under existing coverage mechanisms. Several commenters
claimed that diagnostic laboratory tests are subject to the same
coverage rules and regulations as other medical devices and are no more
specific than other areas of medicine. These commenters further
asserted that it may not be appropriate to defer coverage
determinations to the MACs for these tests. A few commenters noted CMS'
past precedent of issuing NCDs for diagnostic laboratory tests and
cited examples. Some commenters stated that not providing Medicare
coverage for some Breakthrough Devices, including diagnostics, under
TCET may limit the options that a physician can recommend for a
patient. A commenter claimed that the justifications CMS offers for its
general exclusion of diagnostic laboratory tests from eligibility for
the TCET coverage pathway do not adequately support exclusion from TCET
eligibility and may delay Medicare beneficiary access to innovative
tests. Some commenters requested that CMS permit diagnostic laboratory
tests to be eligible for TCET or provide a similar pathway.
Response: We appreciate these comments and acknowledge that the
Medicare coverage statute (section 1862(a)(1)(A) of the Act) applies to
clinical diagnostic laboratory tests just like other items and services
under Part A and Part B. While the TCET pathway is open to FDA
Breakthrough-designated devices, CMS expects the majority of coverage
determinations for Breakthrough-designated diagnostic laboratory tests
will continue to be made by Medicare Administrative Contractors. We
acknowledge there may be instances where manufacturers and CMS agree
that an NCD is appropriate for a diagnostic laboratory test. In those
instances where manufacturers believe that additional evidence
generation may be needed to satisfy the Medicare coverage standard, we
encourage manufacturers to contact CMS to discuss options for their
specific technology.
Comment: Some commenters who disagreed with CMS' proposal noted
that existing pathways, specifically the Molecular Diagnostic Services
(MolDx) Program,\17\ have limitations and cannot be viewed as an
alternative mechanism to TCET to accelerate Medicare coverage. These
commenters stated that MolDx is not a national program and that CMS'
proposal to leave the majority of coverage decisions for diagnostic
laboratory tests to the MACs through existing pathways would limit
access to care in regions that do not participate in the program. In
addition, some of these commenters noted that the MolDx program reviews
only nucleic-acid (DNA or RNA)-based tests performed by clinical
laboratories in 28 states within Palmetto's jurisdiction, so it is not
relevant to non-molecular tests nor clinical laboratories in states
located outside of the MolDx jurisdiction. Furthermore, a commenter
noted that MolDx reviews only tests with existing local coverage
determinations and is not authorized to impose CED requirements. A
commenter noted that the current coverage pathway for diagnostic
laboratory tests is fragmented and burdensome and results in unequal
Medicare beneficiary access, particularly when the tests are provided
by the manufacturers to laboratories nationwide.
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\17\ <a href="https://www.palmettogba.com/moldx">https://www.palmettogba.com/moldx</a>.
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Response: MolDx was not specifically mentioned in the proposed
notice when we stated that we have historically delegated review of
many diagnostic laboratory tests to specialized MACs and proposed that
coverage should continue to be determined by the MACs through existing
pathways.
Under MolDx, a program developed by the Palmetto MAC, the MAC
determines coverage for molecular diagnostic tests and other molecular
pathology services. Several other MACs have implemented the MolDx
program as part of their operations. In the MolDx program, the MACs
review all evidence that a manufacturer produces to determine whether
an item or service meets the reasonable and necessary standard.
We note that Congress in section 1834A(g)(2) of the Act
specifically granted the Secretary the authority to designate one or
more MACs to establish coverage policies for clinical diagnostic
laboratory tests and did not specify any exceptions for certain tests.
We acknowledge there may be instances where manufacturers and CMS
agree that an NCD is appropriate for a diagnostic laboratory test. In
those instances where manufacturers believe that additional evidence
generation may be needed to satisfy the Medicare coverage standard, we
encourage manufacturers to contact CMS to discuss options for their
specific technology.
Comment: Several commenters requested that CMS clarify whether the
TCET pathway excludes diagnostic laboratory tests and diagnostic tests
generally. They also noted that CMS did not expressly reference in
vitro diagnostic (IVD) products and seemingly omitted them from TCET.
Response: We appreciate these comments. The TCET pathway is limited
to Breakthrough Devices meeting the eligibility criteria outlined in
this notice. While we continue to believe that the majority of coverage
determinations for diagnostic laboratory tests granted Breakthrough
Designation should continue to be determined by the Medicare
Administrative Contractors through existing pathways, we acknowledge
there may be instances where manufacturers and CMS agree that an NCD is
appropriate for a diagnostic laboratory test. In those instances where
manufacturers believe that additional evidence generation may be needed
to satisfy the Medicare coverage standard, we encourage manufacturers
to contact CMS to discuss options for their specific technology.
In response to public comments seeking clarification regarding the
scope of the references to diagnostic laboratory tests in the proposed
notice, we have added language to clarify that we intend to refer to
IVDs, including diagnostic laboratory tests, in the discussion of
appropriate candidates. Other non-IVD diagnostic devices, such as
diagnostic imaging devices, may be considered for TCET.
Comment: A few commenters noted that the scope of CMS' proposed
exclusion of diagnostic laboratory tests in the TCET pathway is
unclear. These commenters stated that CMS did not articulate criteria
for determining which diagnostic laboratory tests would be eligible for
TCET. They requested that CMS clearly define TCET eligibility criteria
for certain diagnostic laboratory tests. A commenter stated that the
existing process likely remains appropriate for most laboratory tests
but requested that CMS confirm that it will consider nominations of
diagnostic laboratory tests and other diagnostic technologies when the
TCET pathway would ensure timely beneficiary access and support further
evidence generation. This commenter also encouraged CMS to consider how
collaboration with the specialized

[[Page 65733]]

MACs could provide the expertise and resources needed to develop a CED
NCD under the TCET pathway for a particular diagnostic technology.
Response: We appreciate these comments. We continue to believe that
that the majority of coverage determinations for IVD products,
including diagnostic laboratory tests, granted Breakthrough Designation
should continue to be determined by the Medicare Administrative
Contractors through existing pathways. We acknowledge there may be
instances where manufacturers and CMS agree that an NCD is appropriate
for an IVD product. In addition to TCET, if a manufacturer of a
Breakthrough-designated IVD product wishes to seek national coverage,
they may submit an NCD request as outlined in 78 FR 48164. Other, non-
IVD diagnostic devices may be considered for TCET, contingent on there
being an applicable benefit category.

C. Nominations

CMS proposed that the appropriate timeframe for manufacturers to
submit TCET pathway nominations is approximately 12 months prior to the
anticipated FDA decision on a submission as determined by the
manufacturer. In the proposal, CMS stated that manufacturers of certain
FDA-designated Breakthrough Devices may self-nominate to participate in
the TCET pathway. The proposed notice outlined the information that
manufacturers should include in the self-nomination packet. CMS'
proposal explained how CMS intended to consider nominations, including
a meeting with the manufacturer to discuss the technology and a CMS-FDA
meeting to learn more information about the technology. The proposal
also noted that a technology may undergo a benefit category review as
part of the nomination review process.
Comment: Commenters generally agreed with our proposal that
nominations be submitted approximately 12 months before anticipated FDA
marketing authorization. Some noted that early engagement between CMS
and manufacturers before FDA authorization can inform and enable a more
efficient and effective evidence-generation strategy.
Response: We appreciate these supportive comments and agree that
early engagement between CMS and manufacturers is important.
Comment: Commenters encouraged CMS to be flexible with the
timeframe for submitting nominations and expressed various timeframes
for CMS to consider. A commenter suggested a 6-month timeframe is more
realistic for nominations to ensure manufacturers can provide CMS with
robust data. Other commenters encouraged CMS to provide an earlier
self-nomination timeframe. These commenters suggested that CMS build in
additional time ``to align trial design requirements'' and establish
BCD, coding, and payment amounts. Another commenter recommended that
nominations be accepted ``following FDA approval into the Breakthrough
Device status program'' to provide more time to obtain feedback to
inform EDP development. Several commenters suggested that CMS align
nomination timing to an FDA milestone.
Response: We appreciate these suggestions. We agree with commenters
that providing some flexibility in terms of nomination timeframes is
important. However, CMS believes that 12 months prior to anticipated
FDA market authorization is the appropriate timeframe that allows for
TCET procedural steps to be completed and for better coordination of
coding and payment. In this final notice we have modified the TCET
pathway procedures to include an opportunity for a manufacturer to
submit a non-binding letter of intent to nominate a potentially
eligible device approximately 18 to 24 months before the manufacturer
anticipates FDA marketing authorization. While formal nominations will
still be considered approximately 12 months prior to anticipated market
authorization, the submission of a non-binding letter of intent will
improve CMS' ability to track potential candidates, coordinate with
FDA, and make operational adjustments.
Comment: A commenter recommended that CMS build a meeting at ``the
pivotal trial milestone'' into the process, which the commenter stated
often occurs earlier than 12 months before FDA market authorization.
Response: While we are not incorporating a meeting into the process
at a milestone tied to initiation or completion of certain clinical
trials, meetings may occur between CMS and manufacturers in instances
where manufacturers have chosen to submit a non-binding letter of
intent approximately 18 to 24 months prior to FDA market authorization.
Comment: A commenter asserted that CMS' proposed nomination
timelines might be a significant burden on clinical teams building an
evidence strategy that satisfies both FDA and CMS and requested that
CMS consider ways to improve the nomination submission timelines to
minimize burden for manufacturers.
Response: We disagree. We believe our proposal for nominations to
be submitted approximately 12 months before anticipated FDA marketing
authorization is minimally burdensome and provides adequate flexibility
for manufacturers to: (1) provide supportive evidence for their
technology; (2) develop an EDP to address material evidence gaps for
CMS coverage; and (3) coordinate BCD, coding, and payment processes.
There is opportunity under TCET to leverage FDA-required postmarket
studies, if any, to address specific evidence gaps for Medicare
beneficiaries.
Comment: Some commenters provided feedback regarding specific
timeframes in the TCET nomination process. A few commenters supported
CMS' proposal to respond to nominations within 30 days. Another
commenter requested that CMS extend the nomination review period to 60
days rather than 30 to ensure rigorous evaluation and selection of the
most promising technologies for the TCET pathway.
Response: We appreciate these comments. We agree it is important to
provide timely feedback to manufacturers on whether their technology is
a suitable candidate for TCET. CMS is clarifying that suitable
candidates will be approved for the TCET pathway on a quarterly basis.
Consideration of TCET nominations on a quarterly basis will allow CMS
to prioritize the most promising devices, will facilitate TCET
implementation, and will establish a fair opportunity for eligible
devices to be considered, regardless of the timing of FDA market
authorization.
Comment: Many commenters recommended that CMS provide a lookback
period, meaning that Breakthrough Devices that are nearing an FDA
decision on market authorization (that is, less than 12 months) or
those recently achieving authorization would be eligible for the TCET
pathway. Several commenters recommended that a 3-year lookback period
would be appropriate.
Response: We disagree and did not include a lookback period in the
proposed notice. While we appreciate the substantial interest in the
TCET pathway, it is designed to expedite national coverage through
extensive premarket engagement. Developing an evidence development plan
(EDP) generally takes considerable time, and absent an adequate lead
time during the pre-market period, devices already available in the
market are more

[[Page 65734]]

appropriate for an NCD outside of the TCET pathway or for MAC
determinations under section 1862(a)(1)(A) of the Act.
Comment: A commenter requested that CMS provide specific nomination
guidance.
Response: We appreciate this comment. CMS will consider releasing
more specific nomination information in the future.
Comment: Some commenters requested that CMS provide additional
guidance on how it will treat nominations equitably when it receives
many more than anticipated and/or an irregular pattern of nominations.
For example, a commenter questioned how CMS would proceed when five
candidates have already been accepted for the year and additional
nominations come in. A commenter suggested that CMS define a set number
of application cycles per year to limit first-come-first-served
application bias.
Response: We appreciate these comments and acknowledge the
importance of providing more transparency to the public on how CMS will
prioritize TCET nominations. In this final notice, we are clarifying
that suitable candidates will be approved for the TCET pathway on a
quarterly basis. If a nomination is not accepted into the pathway in
one quarterly review cycle, it may be considered again in the following
quarterly review cycle. Manufacturers will not need to resubmit a
nomination for it to be considered in a subsequent quarter. Since TCET
is forward-looking and extensive pre-market engagement is essential,
nominations for Breakthrough devices anticipated to receive an FDA
decision on market authorization within 6 months may not be accepted
since CMS will be unable to reach a final NCD within the expedited
timeframes.
To provide greater transparency, consistency, and predictability we
intend to release proposed prioritization factors for TCET nominations
in the near future. We look forward to communicating additional details
on our planned approach in the near future and will provide an
opportunity for public comment.
Comment: A commenter requested that in instances where CMS declines
a nomination, it should provide a rationale and feedback mechanism for
the manufacturer. Another commenter stated that applicants should be
permitted to reapply.
Response: CMS will provide a justification and contact information
for additional information if we decline a nomination. CMS is
clarifying in this final notice that eligible nominations will be
considered for the TCET pathway on a quarterly basis. If not accepted
into the TCET pathway in one quarter, nominations may be considered
again in the subsequent quarter. Manufacturers will not need to
resubmit a nomination to be considered in a subsequent quarter.
However, since TCET is forward-looking and extensive pre-market
engagement is essential, nominations for Breakthrough Devices
anticipated to receive an FDA decision on market authorization within 6
months may not be accepted since CMS will be unable to reach a final
NCD within the expedited timeframes.
Comment: A commenter noted that it would be helpful if CMS could
create a TCET submission web page like the IDE Category A and B
submission web page and include instructions, application questions,
and a TCET checklist.
Response: We appreciate this comment. We intend to create several
web pages to support the TCET procedural pathway and provide important
process-related information to interested parties.
Comment: Several commenters requested that CMS streamline the TCET
nomination process by eliminating or combining some steps.
Response: We appreciate these comments. However, we believe all
steps of the TCET nomination process are important to successfully
implementing the pathway. However, as we gain experience with TCET, we
will consider revising the process as appropriate.
Comment: A commenter recommended that CMS permit manufacturers to
provide information on how their devices promote health equity.
Response: We welcome and strongly encourage any information
manufacturers wish to provide regarding how their devices promote
health equity.

D. Coordination With FDA

Comment: Many commenters expressed their support for enhanced FDA-
CMS collaboration to support the TCET pathway, and more specifically,
to foster alignment between FDA and CMS evidence development needs to
ensure CMS evidence development requirements are not duplicative or
contradictory with FDA requirements. Further, commenters stated that
FDA and CMS should provide early clarity about postmarket evidence
generation requirements to minimize provider and product developer
burden.
Response: We appreciate these comments. CMS and FDA have taken a
number of concrete steps to enhance alignment that will support the
TCET pathway. For example, CMS and FDA intend to collaborate in
identifying therapeutic areas where CMS clinical endpoint guidance
would be most impactful. Additionally, by CMS articulating material
evidence gaps for CMS coverage prior to FDA market authorization of
devices, manufacturers will be better positioned to efficiently satisfy
FDA and CMS requirements.
Comment: Some commenters would like additional information on how
and when CMS will collaborate with FDA specific to the TCET pathway.
Some commenters sought clarity as to whether manufacturers would be
permitted to participate in meetings between FDA and CMS. It was
suggested that CMS should provide a transcript to manufacturers if they
are not allowed to participate in the meetings with FDA. A few
commenters recommended that manufacturers be able to participate in the
first meeting with FDA and for subsequent meetings only when there are
specific questions that need to be addressed that the manufacturer is
better positioned to answer so as not to hold up timelines.
Response: We appreciate these comments. As we outlined in the
proposed notice and consistent with the FDA-CMS MOU, CMS may meet with
FDA when considering a TCET nomination submitted for CMS review so CMS
can learn more about the technology, including potential timing
considerations. Some of these meetings may be deliberative and not
appropriate for manufacturers or any other non-governmental parties to
participate. However, similar to meetings conducted for parallel
review, there may be occasions where it will be helpful to have CMS,
FDA, and manufacturers participate in a meeting, and CMS will consider
these requests on a case-by-case basis.

E. BCD Reviews

Comment: Commenters requested additional clarification regarding
the process and timeline for benefit category determination reviews.
These commenters note that the lack of an integrated, transparent,
expedited BCD process will limit TCET's impact. A commenter sought
additional information on how CMS will determine the devices that will
undergo a BCD review and whether there will be an appeal mechanism.
Response: We note that new products may fall within one or more
benefit categories or no benefit category at all. As stated in the
proposed notice, if CMS believes that the device, prior to a decision
on market authorization by

[[Page 65735]]

FDA, is likely to be payable through one or more benefit categories,
the device may be accepted into the TCET pathway. This is an interim
step that is subject to change upon FDA's decision regarding market
authorization of the device. Acceptance into TCET should not be viewed
as a final determination that a device fits within a benefit category.
When CMS issues the proposed NCD following approval or clearance of
the Breakthrough Device by FDA, the proposed NCD will include one or
more benefit categories to which CMS has determined the Breakthrough
Device falls. CMS will review and consider public comment on the
proposed NCD before reaching a final determination on the BCD(s).
Comment: A commenter recommended that CMS provide a benefit
category review for any FDA-designated Breakthrough Device earlier in
the process, possibly when FDA is meeting with manufacturers of these
devices regarding the design of their clinical trials to support FDA
marketing authorization.
Response: The BCD may rely on information generated during the
process to obtain FDA market authorization, making an earlier BCD
infeasible. Additionally, not all devices achieve marketing
authorization, so conducting a BCD review earlier would be inefficient
and potentially waste CMS resources.
Comment: A few commenters expressed that BCDs can be made quickly
and should not delay access. A commenter indicated that CMS should
commit to making BCD decisions no later than 30 days after the
nomination submission.
Response: CMS aims to make all BCD decisions expeditiously. CMS is
unable to commit to making all BCD decisions within 30 days of
nomination submission because the BCD may rely on information generated
during the process to obtain FDA market authorization making an earlier
BCD infeasible.
Comment: A commenter stated that when there is an issue in
determining the BCD, a meeting between CMS' Center for Medicare and the
manufacturer should be scheduled immediately.
Response: We appreciate these comments and agree that it is
important for CMS to provide timely communication to the manufacturer
when there are issues in determining the BCD.

F. Evidence Preview

CMS' proposal introduced the Evidence Preview (EP) concept, which
is a focused literature review that would provide early feedback on the
strengths and weaknesses of the available evidence, including any
evidence gaps, for a specific item or service. It is intended to inform
judgments by CMS and manufacturers about the best available coverage
options for an item or service and offers greater efficiency,
predictability and transparency to manufacturers and CMS on the state
of the evidence and any notable evidence gaps. In the proposed notice,
CMS expressed the intent for EPs to be supported by a contractor using
standardized evidence grading, risk of bias assessment, and
applicability assessment. CMS proposed that the EP would be made
publicly available on the CMS website when a tracking sheet is posted
announcing the opening of the NCD. Additionally, CMS proposed to share
the EP with the Medicare Administrative Contractors following a
manufacturer's decision to withdraw from the TCET pathway.
Comment: Some commenters requested that CMS provide more
transparency regarding the evidence review contractor. Specifically,
these commenters requested that CMS provide more information on the
processes used to select and monitor the evidence review contractor and
information regarding qualifications, safeguards, conflicts of
interest, and how the contractor will be evaluated. Some of these
commenters requested that CMS publish a list of contractors used for
conducting evidence reviews on its website.
Response: The Secretary has broad authority to contract out
functions under Title XVIII. CMS, in collaboration with AHRQ,
established rigorous review criteria that have undergone detailed
testing during the past year and are reflected in the 2024 CMS National
Coverage Analysis (NCA) Evidence Review guidance.\18\ The contractor's
role is to conduct a rapid systematic literature review and summarize
the evidence based on a modified Grading of Recommendations,
Assessment, Development, and Evaluations (GRADE) methodology. CMS and
the contractor have also begun recruiting and incorporating clinical
subject matter experts into the review process. All external subject
matter experts are carefully assessed for their expertise, screened for
conflicts of interest, and bound by non-disclosure agreements. The
contractor supports and accelerates CMS reviews, but CMS performs
extensive quality assurance on contracted reviews, contributes
substantial portions of the EP independently, and ultimately determines
policy. If an NCD is opened, an evidence summary will be included with
the tracking sheet for full public comment, including which contractor
completed the review.
---------------------------------------------------------------------------

\18\ CMS' guidance documents can be accessed here: <a href="https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#">https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#</a>.
---------------------------------------------------------------------------

Comment: Several commenters sought clarity on how the contractor
will perform evidence reviews under TCET, specifically the criteria
that the contractor will use to do the evidence preview. Some
commenters requested that CMS specify whether these standards are the
same or different from current processes. Commenters also asked that
CMS define the evidence grading system used and what kind of evidence
review conclusions are possible.
Response: We appreciate these comments. When nominating devices for
the TCET pathway, manufacturers should submit a comprehensive
bibliography of published studies for their device. For some devices,
studies will not yet be published in the peer-reviewed literature, and
CMS will instead review unpublished reports of clinical studies
intended to support the FDA marketing application provided by the
manufacturer. The contractor will supplement these materials with a
focused search of published peer-reviewed literature. The contractor
will use standardized tables to summarize the characteristics of each
study included in their focused literature review. These tables provide
information about each study's design, quality, interventions assessed,
target population, and outcomes assessed.
The methodological quality, or risk of bias, for randomized and
nonrandomized individual study designs will be assessed using a
components approach, considering each study for specific aspects of
design or conduct (such as allocation concealment for randomized
controlled trials (RCTs) or use of methods to address potential
confounding), as detailed in AHRQ's Methods Guide.\19\ Studies of
different designs are graded within the context of their respective
designs. Thus, RCTs are graded as good, fair, or poor, and
observational studies are separately graded as good, fair, or poor.
---------------------------------------------------------------------------

\19\ <a href="https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide">https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide</a>.
---------------------------------------------------------------------------

The contractor will also assess the applicability of the included
studies to

[[Page 65736]]

the Medicare population. Specifically, we plan to use the PICOTS
(population, intervention, comparator, outcomes, timing, and setting)
format to organize information relevant to applicability. The most
important issue concerning applicability is whether the outcomes are
different across studies that recruited diverse populations (for
example, age groups, exclusions for comorbidities) or used different
methods to implement the interventions of interest; that is, important
characteristics are those that affect baseline (control group) rates of
events, intervention group rates of events, or both.
Lastly, the contractor will identify and list any relevant
evidence-based guidelines, specialty society recommendations, consensus
statements, or appropriate use criteria that apply to the item or
service addressed by the Evidence Preview (EP). The reviewed evidence
is then qualitatively synthesized by the contractor. There are strict
non-disclosure agreements in place with the contractor to ensure the
protection of proprietary information.
Comment: Some commenters expressed concerns that CMS was ceding
decision-making to the evidence review contractor. These commenters
noted that the evidence review contractor should be prohibited from
making qualitative assessments of the literature and providing any
statements regarding medical necessity. Further, these commenters
stated that CMS should maintain ultimate decision-making responsibility
and CMS staff should be fully engaged to ensure that feedback among all
participants is transparent and timely.
Response: All decision-making resides with CMS. CMS does not
delegate the Secretary's authority to establish NCDs to a contractor.
The role of the evidence review contractor is to support the CMS review
team by summarizing the available evidence in a standardized format.
CMS staff specify the review requirements, supervise the contractor,
and conduct extensive quality assurance of all reviews. Additionally,
one of the benefits of utilizing an evidence review contractor is that
it will enhance CMS' ability to recruit specialized clinical expertise.
Lastly, CMS contributes substantial portions independently and
maintains ultimate decision-making responsibility. Any formal
determination regarding whether an item or service meets the reasonable
and necessary statutory standard will be made by CMS and completed
using the NCD process, which includes at least one public comment
period.
Comment: Some commenters stated that manufacturers should be able
to communicate directly with the evidence review contractor during the
development of the EP. Several commenters suggested that CMS establish
contact points to facilitate dialogue between the manufacturer and the
contractor responsible for conducting the EP. Some commenters
recommended that manufacturers should have an opportunity to provide
feedback on the literature search strategy, correct errors, and/or
discuss interpretations of data in the EP. Commenters encouraged CMS to
hold meetings before the EP to ensure appropriate search terms were
incorporated and to discuss results after the EP. A commenter stated
that CMS should allow manufacturers 30 days to return comments on the
EP.
Response: We disagree that manufacturers should be able to contact
the contractors that the government has engaged to summarize the
scientific evidence on its behalf. CMS notes that manufacturers must
submit a full bibliography of published studies with their TCET
nomination. Much of the EP is written directly by CMS staff, and
manufacturers have an opportunity to provide feedback on a draft of the
EP before it is finalized.
CMS will establish CMS-staff-level contact points to facilitate
timely communication with manufacturers, but CMS disagrees with having
manufacturers communicate directly with the evidence review contractor.
The contractor is performing work on CMS' behalf, and CMS needs to be
involved in all discussions. Manufacturers are encouraged to review and
provide feedback to CMS on the EP as soon as possible, ideally within
30 days. CMS believes it is important to provide flexibility especially
as manufacturers gain experience with the TCET pathway and is not
incorporating a specific timeframe in the final notice for
manufacturers to submit feedback on an EP.
Comment: A commenter noted that truly novel devices might have
completed only one study when applying for TCET, and ``in some cases,
the only published or presented data will be from the first in man or
preliminary FDA safety studies.'' The commenter expressed the position
that devices with minimal data should not be excluded from TCET, and
for devices with little published data, CMS should focus on ``FDA
pivotal trial results'' in the EP even if those results are not
published.
Response: The EP is a focused literature review summarizing the
strengths and weaknesses of the available clinical evidence supporting
a review request. The EP is not a national coverage analysis (NCA) and
is not a commitment to coverage. The EP is intended to inform decisions
about the best available coverage options for the nominated device.
Further, a broader range of studies may be included in a full national
coverage analysis (NCA) if one is opened. The EP reflects the best
available information at the time it is conducted, but multiple
elements of the EP may evolve during the review process.
When developing a literature search, we will carefully review the
bibliography that manufacturers provide in their nomination. CMS
recognizes that the most crucial study data from pivotal trial(s) may
not yet be published in the pre-market stage. If unpublished studies
are included in the review, the evidence review in the NCA, if one is
opened, will reflect the final labeling of the FDA market authorized
device and supplemental analyses and/or published, peer-reviewed report
of the clinical study.
Comment: Several commenters requested that CMS clarify that the EP
is a summary of the published peer-reviewed literature in the relevant
clinical space and an examination of the outcomes of interest to CMS,
associated endpoints, and clinically meaningful differences for the
target disease or condition. These commenters further noted that the EP
should not extend to include a gap analysis for the specific nominated
technology. Additionally, some commenters requested that the EP
explicitly state that it is not a coverage determination and should not
be interpreted as a reasonable and necessary determination. A commenter
noted that the EP, as currently constructed, will provide limited
insight into device performance. Some commenters requested that the EP
meeting between the manufacturer and CMS avoid bias toward additional
data collection, especially when a device has robust clinical evidence.
Response: The EP is a focused literature review that summarizes the
strengths and weaknesses of the available clinical evidence, including
any evidence gaps for CMS coverage for a specific item or service. It
offers greater efficiency, predictability, and transparency to
manufacturers and CMS on the state of the evidence and any notable
evidence gaps. It is intended to inform judgments by CMS and
manufacturers about the best available coverage options for an item or
service.

[[Page 65737]]

We disagree with commenters that an evidence preview should not be
specific to a particular technology. We believe it is important to
understand any material evidence gaps for CMS coverage for a particular
technology as early as possible so that manufacturers can develop a
plan to address them so that the device might be eligible for future
Medicare coverage under section 1862(a)(1)(A) of the Act.
Comment: A commenter suggested that CMS clarify circumstances where
they can convene a Medicare Evidence Development and Coverage Advisory
Committee (MEDCAC) or otherwise solicit broad public input to align on
evidence gaps in the evidence preview stage and explain how this might
affect evidence review timelines.
Response: We appreciate this comment. If a MEDCAC is needed to
clarify the appropriate clinical endpoints for a particular device, the
TCET review timeframes could be substantially delayed. The need for
MEDCACs during a TCET review may be mitigated by identifying potential
TCET candidates earlier in the review cycle than the timeframe we
proposed in the June 2023 notice. When CMS is aware that manufacturers
intend to pursue the TCET pathway for devices and appropriate clinical
endpoints are uncertain, we may preemptively conduct a clinical
endpoints review and may convene a MEDCAC. A CMS decision to initiate a
clinical endpoint review or a MEDCAC does not imply that a benefit
category exists for a particular device or make a commitment to make a
local or national coverage determination. We clarify in the final
notice how a MEDCAC may affect evidence review timelines and how
submitting a non-binding letter of intent can help alleviate potential
delays if a clinical endpoints review and/or MEDCAC is needed.
Comment: A commenter suggested that CMS reconsider the evidence
preview process, which they believe should also include other
considerations, such as shifts in the market, health equity, population
considerations, accessibility, usability, and other metrics.
Response: While we acknowledge those factors may be important, the
purpose of the evidence preview is to provide early feedback on the
strengths and weaknesses of the available clinical evidence, including
any evidence gaps, for a specific item or service. It is intended to
inform judgments by CMS and manufacturers about the best available
coverage options for an item or service. It offers greater efficiency,
predictability, and transparency to manufacturers and CMS by clarifying
the state of the evidence and any notable evidence gaps.
Comment: Many commenters disagreed with CMS' proposal to share the
Evidence Preview with the Medicare Administrative Contractors following
a manufacturer's decision to withdraw from the TCET pathway. These
commenters expressed concerns with how the MACs would use this
information, specifically that it would lead to de facto noncoverage
without going through the full national coverage process. While
commenters were generally opposed to CMS sharing this information, they
provided some recommendations. They suggested alternatives if CMS chose
to proceed, including obtaining manufacturer consent before sharing
with MACs, updating the Program Integrity Manual to describe the
appropriate use of EPs as MACs make coverage decisions, as well as
scaling back the evidence preview so it is not specific to a particular
technology.
Response: As we noted in the proposed notice, the EP represents a
substantial investment of public resources, and CMS wants to ensure we
use taxpayer dollars wisely. The EP includes a summary of the available
evidence for an FDA Breakthrough-designated device; manufacturers can
correct any errors and provide feedback before finalization. While CMS
believes the EP will be a fair reflection of the strength of the
available evidence to support Medicare coverage, CMS acknowledges that
manufacturers may withdraw from the TCET pathway for reasons unrelated
to the evidence. Based on the previous considerations and in response
to public comments, CMS will publish an evidence summary without the
evidence gap analysis if a manufacturer withdraws from the TCET
pathway. Similarly, only a summary of the evidence would be posted with
a tracking sheet if a national coverage analysis is opened. We believe
this approach offers transparency, makes judicious use of public
resources, and does not signal a specific conclusion about whether an
item or service satisfies the reasonable and necessary standard.
Comment: A few commenters supported CMS sharing the evidence
preview with the MACs. A commenter recommended that not only should the
MACs receive the EPs but that they should be shared with Medicare
Advantage Organizations as well. Another commenter suggested that these
EPs be shared publicly.
Response: We appreciate these comments. After considering all
public comments received on this issue, CMS has decided to publish an
evidence summary without the evidence gap analysis rather than sharing
the full EP with the MACs as we proposed.

G. Manufacturer Decision To Continue or Discontinue

CMS' proposal stated that upon finalization of the EP, the
manufacturer may decide to pursue national coverage under the TCET
pathway or to withdraw from the pathway. CMS proposed that if the
manufacturer decided to continue, the next step would include a
manufacturer's submission of a formal NCD letter expressing the
manufacturer's desire for CMS to open a TCET NCD analysis. We stated in
the proposal that most, if not all, of the information needed to begin
the TCET NCD would already be included in the TCET pathway nomination
and the EP, but we invited the manufacturer to submit any additional
materials the manufacturer believed would support the TCET NCD request.
Comment: A commenter stated that it is unclear whether the
manufacturer or CMS would initiate an NCD.
Response: If a manufacturer decides to continue pursuing coverage
under the TCET pathway upon finalization of the EP, the next step is
for the manufacturer to provide a formal NCD letter to CMS expressing
the manufacturer's desire for CMS to open an NCA. The manufacturer
would initiate the NCD request.
Comment: A commenter requested confirmation that CMS will not issue
a non-coverage NCD if a manufacturer withdraws from TCET.
Response: There could be rare instances where a non-coverage NCD
would be in the best interest of Medicare beneficiaries, such as when
the evidence points to potential serious beneficiary harm. CMS can
conduct a national coverage analysis at any time to swiftly act in
those circumstances.

H. Evidence Development Plans

CMS' proposal introduced the Evidence Development Plan (EDP)
concept. CMS proposed that EDPs would be developed by the manufacturer
to address any evidence gaps identified in the EP. In the proposal, CMS
indicated that EDPs may include fit-for-purpose (FFP) study designs,
including traditional clinical study designs and those that rely on
secondary use of real-world data, provided that those study designs
follow all applicable CMS guidance documents. CMS proposed that the
development of an EDP would include CMS-AHRQ collaboration to evaluate
the EDP to ensure that it meets

[[Page 65738]]

established standards of scientific integrity and relevance to the
Medicare population. Additionally, CMS proposed that the EDP process
will include CMS engagement with the manufacturer to provide feedback
and discuss any recommended refinements. The proposal stated that
elements of the EDP, specifically the non-proprietary information,
would be made publicly available on the CMS website when a proposed NCD
is posted.
Comment: Many commenters supported TCET's evidence development
framework, specifically CMS' inclusion of a more flexible approach that
allows for FFP studies. However, some commenters noted that CMS should
maintain rigorous evidence development standards. Commenters pointed
out that any evidence development framework should be patient-centered,
and high-quality evidence should be required to protect beneficiaries.
Response: We appreciate these comments and agree that including a
more flexible approach that allows for FFP studies is important. We
believe that the evidence development framework for TCET outlined in
this notice accomplishes that goal while also being patient-centered
and facilitating the generation of high-quality evidence to support
Medicare coverage. CMS expects to propose FFP study guidance in the
future, with a particular emphasis on study designs that make secondary
use of real-world data.
Comment: Commenters generally supported CMS' proposal regarding
evidence development plans. Some commenters encouraged CMS to work with
manufacturers to develop a reasonable, mutually agreed upon data
collection and review period in the EDP. A commenter suggested that CMS
consider structuring evidence development around achievement of
milestones rather than time. A commenter recommended that the EDP be
updated annually. The commenter recommended that CMS assign dedicated
staff to work collaboratively with the manufacturer when developing the
EDP. Some commenters cited that considerable time may be required to
develop and negotiate an EDP. Another commenter expressed that an NCD
should not be opened until an EDP is approved.
Response: We appreciate the supportive comments. For devices where
the evidence is promising but does not yet satisfy the reasonable and
necessary standard for Medicare coverage, the EDP intends to articulate
how material evidence gaps will be addressed during transitional
coverage so that the evidence may show that the device satisfies the
reasonable and necessary standard when a CED NCD is reconsidered.
Manufacturers often plan multiple studies for devices that are newly in
the market. For example, they may plan conventional clinical studies in
non-US markets, or conventional studies that test modifications to an
existing device. If generalizability to the Medicare population is an
important limitation of the existing evidence base, manufacturers may
submit an FFP study protocol that relies on secondary use of real-world
data as a component of their EDP. The EDP will describe the overall
portfolio of planned studies and identify the appropriate timing of a
future CED NCD reconsideration. We agree that providing enhanced
engagement and flexibility is important during EDP development, and we
are exploring ways that CMS can support manufacturers in efficiently
developing FFP protocols, but manufacturers are responsible for
developing their own EDPs. CMS agrees that a CMS and AHRQ-approved EDP
should be in place prior to opening an NCD. We note that prolonged
delays by manufacturers in drafting EDPs may substantially delay the
finalization of a CED NCD under the TCET pathway.
We are finalizing our proposal to have EDPs include a schedule of
updates and interim analyses along with a projected NCD reconsideration
window. CMS continues to believe that a core purpose of the EDP is to
anticipate the appropriate timing of reconsideration, but we recognize
that timelines may in some cases need to be revised. Particularly for
EDPs that propose longer CED timeframes, CMS agrees that they should
include plans for interim reporting to ensure adequate progress and
timely completion. Interim reports should also disclose any meaningful
changes to prespecified study protocols, which are essential to
transparency. These updates are in the interest of CMS, manufacturers,
and the public because they provide early feedback on the viability of
planned studies that use real-world data and offer early feedback on
real-world outcomes. Any changes to the anticipated NCD reconsideration
window will be reflected on the CED website.
Comment: Commenters encouraged CMS to be transparent and
recommended that as much of the EDP as possible be made publicly
available. Some commenters asked that CMS clarify what parts of the EDP
will be publicly posted. It was recommended that the technical
information regarding a device remain confidential. It was also
suggested that the status of CED studies under TCET be updated in a
publicly available manner.
Response: We appreciate these comments and agree that providing as
much transparency as possible for EDPs and the studies conducted as
part of them is important. To that end, a summary of the EDP, a linkage
to CMS-approved CED studies on <a href="http://clinicaltrials.gov">clinicaltrials.gov</a>, and the anticipated
CED NCD reconsideration window will be posted on the CMS website. We
also recognize that manufacturers want to preserve confidentiality
around their evidence-generation plans and product development
strategies. CMS is actively developing guidance on the level of detail
necessary to establish that a proposed study is FFP; while
manufacturers may be able to demonstrate that these elements establish
the scientific validity of a proposed study, it may not be necessary to
make all details public.
Comment: A commenter suggested that CMS clearly and rigorously
define what benchmarks will be considered ``clinically meaningful'' to
its beneficiary population. A commenter requested that CMS clarify the
meaning and significance of a post-market FFP study's potential to
``demonstrate[e] external validity'' concerning an EDP submission and
whether such potential is a criterion for the protocol.
Response: We generally look to the published literature when
assessing which clinical endpoints are important. In some instances,
there is limited published literature to address minimal clinically
important differences (MCIDs). Where appropriate clinical endpoints and
MCIDs are uncertain, CMS may refer a topic to the MEDCAC to help CMS
define evidence expectations through an open and transparent process.
We are also developing a series of Clinical Endpoint Guidance documents
to improve the predictability and transparency of our reviews.\20\ The
Knee Osteoarthritis Clinical Endpoint Guidance document is the first in
this series.
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\20\ The clinical endpoints guidance can be accessed here upon
release: <a href="https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#">https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#</a>.
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A concern about generalizability depends on whether a new
technology's effectiveness would reasonably be expected to vary between
the populations studied in clinical trials and Medicare recipients, who
are often older and have more comorbidities. If an Evidence Preview
identifies generalizability as a material evidence deficiency,
postmarket FFP studies may be used to confirm that expected

[[Page 65739]]

benefits and harms extend to the applicable Medicare population and the
context in which they receive care.
Comment: A commenter questioned how CMS will determine that an EDP
is ``sufficient'' and how that sufficiency standard is related to the
reasonable and necessary standard.
Response: The development of an EDP will include CMS-AHRQ
collaboration to evaluate the EDP to ensure that it meets established
standards of scientific integrity and relevance to the Medicare
population. As with all technologies seeking Medicare coverage, CMS
evaluates the available evidence when assessing whether an item/service
satisfies the reasonable and necessary standard for coverage through
the open and transparent NCD process.
Supportive clinical evidence that a device is reasonable and
necessary in the Medicare population, including evidence regarding the
device's safety and effectiveness for the Medicare population, is
crucial to approve coverage for a device under section 1862(a)(1)(A) of
the Act. Such evidence is used to determine whether a new technology
meets the appropriateness criteria of the longstanding Medicare Program
Integrity Manual Chapter 13 definition of reasonable and necessary.\21\
We believe it is important for manufacturers participating in TCET to
produce evidence demonstrating the health benefits of the device and
the related services for patients with demographics similar to that of
the relevant Medicare population.
---------------------------------------------------------------------------

\21\ CMS, Medicare Program Integrity Manual, Chapter 13, 13.5.4,
available at https://www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/pim83c13.pdf.
---------------------------------------------------------------------------

Comment: A commenter sought clarification on CMS' and AHRQ's
specific roles in reviewing the EDP and which Agency has ultimate
approval.
Response: As we noted in the proposed notice and this subsequent
notice, ``Since we anticipate that many of the NCDs conducted under the
TCET pathway will result in CED decisions, AHRQ will continue to review
all CED NCDs consistent with current practice. Additionally, AHRQ will
collaborate with CMS as appropriate, to evaluate the EP and EDP and
will have opportunities to offer feedback throughout the process that
will be shared with manufacturers. AHRQ will partner with CMS as the EP
and EDP are being developed, and approvals for these documents will be
a joint CMS-AHRQ decision.''
Comment: Several commenters expressed that manufacturers should be
required to ensure diversity in clinical trials across a wide range of
patient characteristics. A commenter stated that guidance from CMS is
necessary to assist manufacturers in clinical trial designs that
address access issues (specifically guidance on trial design for
diversity and equitable access). They noted that research has
demonstrated a lack of equitable representation in clinical trials.
Response: When reviewing evidence to assess whether items/services
are reasonable and necessary, CMS must have a basis to conclude that
the available evidence is generalizable to the intended Medicare
population(s). The NIH, FDA, and CMS have long stressed the broad
inclusion of diverse patient groups in clinical studies. Despite these
efforts, pre-market studies frequently lack adequate inclusion of
important patient subgroups, which limits their generalizability to the
intended Medicare population(s). CMS agrees that post-market FFP
studies may be necessary to address this common limitation of pre-
market RCTs. The final CED guidance clarifies that CED studies should
include specific patient groups that are essential to ensure the study
is representative of the Medicare population when there is good
clinical or scientific reason to expect that the results observed in
premarket studies might not be observed in older adults or
subpopulations identified by other clinical or demographic factors.
Comment: A commenter recommended that CMS should conduct regular
audits on EPs and EDPs.
Response: We appreciate this comment; however, it is beyond the
scope of this document.
Comment: A commenter recommended that CMS clarify that when the
available evidence is promising but is insufficient to satisfy the
reasonable and necessary standard for the Medicare population, CMS may
extend coverage under the TCET pathway conditioned on completion of an
FFP study that may convincingly address an evidence deficiency
identified in the EP. Additionally, some commenters recommended that
CMS acknowledge the dynamic nature of FFP studies and adopt
documentation best practices for study design and analysis changes to
ensure transparent study conduct and rigorous evidence development.
Response: We appreciate these comments and have clarified in the
final notice that EDPs must address material evidence deficiencies
identified in the EP. FFP studies addressing specific evidence
deficiencies identified in the EP may be proposed as part of a broader
EDP. CMS agrees that FFP studies, especially those that make secondary
use of real-world data, may require modifications to the pre-specified
protocol for various reasons. Thus, CMS agrees that EDPs should
incorporate interim reporting to ensure adequate progress and timely
completion. Interim reports should also disclose any meaningful changes
to prespecified study protocols, which are essential to transparency.
These updates are in the interest of CMS, manufacturers, and the public
because they provide early confirmation of the viability of planned
studies that use real-world data and early feedback on real-world
outcomes. CMS expects to publish detailed guidance on acceptable FFP
studies in the coming months.
Comment: A commenter noted that FFP evidence generation will likely
require new data sources and methods of data collection, which may be
particularly problematic for some Breakthrough Devices where the
primary benefit to Medicare beneficiaries may be improvements in a
patient-reported outcome (PRO). This commenter further stated that a
clear definition of acceptable alternative evidence-generation methods
and sources would be important since PROs are difficult to ascertain
from administrative claims data or electronic health records. The
commenter encouraged CMS to consider the balance between collecting
data on outcomes that are important to patients and caregivers and
minimizing the increased burden on providers, ideally by prioritizing
outcomes that address patient priorities and are easy to collect as a
part of routine care. This commenter suggested that a system that
allows CMS claims data to be linked with other data sources is
important for TCET to work effectively. The commenter suggested that
accessing and working with Medicare claims data is difficult and
burdensome. They recommended that CMS facilitate linkages to Medicare
claims to facilitate evidence generation under the TCET pathway.
Another commenter noted that CMS should ensure postmarket study designs
support efficient acquisition and linkage of data sources data so
studies can be efficiently completed.
Response: We appreciate these recommendations. We agree that
patient-reported outcomes are often unavailable from claims or
electronic health records (EHR) data sources. The real-world data
(RWD)/real world evidence (RWE) field is rapidly developing, and new
mechanisms for efficiently collecting supplemental data like PROs may
emerge. CMS agrees that

[[Page 65740]]

easier linkages between multiple data sources would simplify conduct of
studies using real-world data. While indirect matching strategies are
available, they may be cumbersome to implement.
CMS expects to publish detailed guidance on acceptable FFP studies
in the coming months. CMS is closely tracking developments in this
emerging field.

I. CMS NCD Review and Timing

CMS proposed that if a device that is accepted into the TCET
pathway receives FDA marketing authorization, CMS will initiate the NCD
process by posting a tracking sheet following FDA market authorization
(that is, the date the device receives PMA approval; 510(k) clearance;
or the granting of a De Novo request) pending a CMS and AHRQ-approved
Evidence Development Plan (in cases where there are evidence gaps as
identified in the Evidence Preview). In the proposal CMS stated that
the goal is to have a finalized EDP no later than 90 business days
after FDA market authorization.
CMS' proposal stated that the process for Medicare coverage under
the TCET pathway would follow the NCD statutory timeframes in section
1862(l) of the Act. CMS would start the process by posting a tracking
sheet and elements of the finalized Evidence Preview, specifically the
non-proprietary information, which would initiate a 30-day public
comment period. Following further CMS review and analysis of public
comments, CMS would issue a proposed TCET NCD and EDP within 6 months
of opening the NCD. There would be a 30-day public comment period on
the proposed TCET NCD and EDP, and a final TCET NCD would be due within
90 days of the release of the proposed TCET NCD.
Comment: Some commenters requested that the proposed decision memo
for an initial TCET NCD should be posted at the same time as a tracking
sheet, similar to what has previously been done for Parallel Review
NCDs. These commenters note that this would help streamline the process
since there would be only one 30-day public comment period.
Response: While we appreciate the suggestions to streamline the
TCET process by providing for only one public comment period, we
believe posting a tracking sheet with a proposed NCD is operationally
impractical for CMS and provides insufficient opportunity for public
feedback on the coverage conditions that optimize patient outcomes. The
evidence base for emerging technologies is often incomplete, and
practice guidelines are not yet established, so we believe input from
interested parties is critical to ensure that Medicare is providing
appropriate coverage for new, innovative technologies that balance
access with beneficiary safeguards.
Comment: Several commenters noted inconsistencies in the proposed
TCET process timeline. They noted CMS' stated goal of finalizing an NCD
within 6 months of FDA marketing authorization and pointed out that we
also state that there would be a tracking sheet posted with a 30-day
comment with a proposed NCD posted 6 months after that (~7 months) and
a final NCD statutorily due a few months later. Another commenter noted
that the Timeline Diagram has a stakeholder meeting and evidence
preview meeting listed, but the stakeholder meeting is not described in
the notice.
Response: We appreciate the feedback. CMS notes that if material
evidence deficiencies for Medicare coverage are identified in an
evidence preview, manufacturers must have an approved evidence
development plan before CMS will initiate a national coverage analysis.
Delays in drafting an approvable evidence development plan may make it
impossible to achieve coverage within 6 months of FDA authorization.
Nonetheless, the final notice clarifies that the initial 30-day comment
period is concurrent with the national coverage analysis, and CMS aims
to shorten the NCD review by initiating our evidence review in the
premarket period. We have removed the ``stakeholder meeting'' from the
Timeline Diagram in the final notice since it is synonymous with the
evidence preview meeting in the notice.

J. Input From Interested Parties

CMS stated in its proposal that feedback from the relevant
specialty societies and patient advocacy organizations, in particular,
their expert input and recommended conditions of coverage (with special
attention to appropriate beneficiary safeguards), is especially
important for technologies covered through the TCET pathway. In the
proposal, CMS strongly encourages these organizations to provide
specific feedback on the state of the evidence and their recommended
best practices for the emerging technologies under review upon opening
a national coverage analysis. We noted that while we prefer to have
this information during the initial public comment period upon opening
the NCD, we realize that, in many cases, it may take longer for these
organizations to provide their collective perspectives to CMS since
these technologies will have only recently received FDA market
authorization. Further, we stated that since CMS may consider any
information provided in the public domain while undertaking an NCD, CMS
encourages these organizations to publicly post any additional
feedback, including relevant practice guidelines, within 90 days of
CMS' opening of the NCD. We specified that information considered by
CMS to develop the proposed TCET NCD will become part of the NCD record
and will be reflected in the bibliography as is typical for NCDs.
Comment: Numerous commenters agreed that engagement with all
interested parties, particularly specialty societies, is important.
Some commenters encouraged CMS to maintain close relationships with
specialty societies and engage them as soon as an NCD is open. A few
commenters suggested that CMS be flexible regarding the timeframe for
developing consensus documents, as these documents may take an extended
time to develop. Several commenters recommended that CMS be transparent
when specialty society feedback is received outside a public comment
period and suggested that CMS acknowledge receipt of the information
and notify the manufacturer, post the information on the CMS website,
and provide an opportunity for manufacturer feedback. Another commenter
requested that CMS have a vetting process to ensure these sources of
information are legitimate. It was noted that more formal public
engagement mechanisms, like those used by FDA, are needed. A commenter
suggested that CMS establish a Network of Experts like FDA's Center for
Devices and Radiological Health (CDRH) and Center for Drug Evaluation
and Research (CDER).
Response: We agree that engagement with specialty societies is
important, and we intend to maintain our collaborative relationships
with them to facilitate timely coverage and provide appropriate
beneficiary access to promising new technologies. We believe that TCET
includes adequate flexibility for specialty societies to provide
important input. As is current practice, information sources that
inform an NCD are documented in the decision memo and the bibliography
of the proposed and final NCD. CMS carefully evaluates evidence and
public comment when proposing and finalizing NCDs. While establishing
more formal public engagement mechanisms is beyond the scope of this
notice, we appreciate the suggestions commenters offered.

[[Page 65741]]

Comment: Several commenters requested that CMS establish a formal
and robust patient engagement process. A few commenters stated that
patients and patient organizations should be consulted regarding how
CED affects access, outcomes, and caregiver experiences. They also
stated that patient groups should be consulted to discuss study
protocols and clinical endpoints. A commenter stated that CMS should
agree to timely meetings with all interested parties.
Response: We routinely meet with interested parties about coverage
requests for new technologies and reconsiderations of NCDs for existing
technologies. CMS also regularly attends public meetings to discuss new
technologies and to gather input from multiple perspectives.
Furthermore, most NCDs allow two opportunities for public comment: when
a national coverage analysis is initiated and when an NCD is proposed.
Therefore, we believe the current process allows the public to express
their views. CMS notes that additional public engagement requirements
will increase coverage review costs and slow the initiation and
completion of NCDs. CMS also solicits patient input on clinical
endpoints that are relevant for coverage decisions and their minimally
clinically meaningful differences through the Clinical Endpoints
Guidance series.

J. Coverage of Similar Devices

In our proposal we noted that FDA market-authorized Breakthrough
Devices are often followed by similar devices that other manufacturers
develop. Additionally, we expressed that we believe it is important to
let physicians and their patients make decisions about the best
available treatment depending upon the patient's individual situation.
We proposed that to be eligible for coverage under a TCET NCD, similar
devices would be subject to the same coverage conditions, including a
requirement to propose an EDP. CMS sought public comment on whether
similar devices to the Breakthrough Device should be addressed under a
separate NCD or should be subject to the same coverage conditions as
the Breakthrough Device, including a requirement to propose an EDP.
Comment: Commenters generally supported CMS' proposal to cover
similar devices under NCDs. Some commenters noted that NCDs have
generally covered a particular class of technologies and supported a
similar approach in the TCET pathway.
Response: We appreciate these comments. NCDs are limited to
particular items or services, but some NCDs apply to products for the
same indication. In these instances, CMS will follow the existing NCD
process detailed in section 1862(l) of the Act. We recognize that some
differences may exist for technologies in a class that may result in a
distinct benefit/risk profile, and each will be evaluated on its own
merit.
Comment: A few commenters disagreed with CMS' proposal, citing
concerns that covering similar devices undercuts the voluntary nature
of TCET. These commenters stated that Breakthrough Devices are unique
and should be individually addressed.
Response: We appreciate the commenter's concern. We believe that it
is important for the TCET pathway to foster innovation and not limit
access to competitive devices. In some cases, providing coverage using
a class approach may be appropriate and could avoid delays in access
that would occur if a separate NCD were required to ensure coverage and
would also provide more treatment options for patients and their
physicians. We recognize that some differences may exist for
technologies in a class that may result in a distinct benefit/risk
profile, and each will be evaluated on its own merit.
Comment: Several commenters requested that CMS define ``similar
devices.'' For example, a commenter suggested that CMS define similar
devices as either: (1) those with the same or similar intended use as
the initial product; or (2) devices with the same FDA product code. A
commenter noted that it may be unclear whether two devices are in ``the
same category.''
Response: To preserve flexibility for manufacturers and CMS, we
have not defined ``similar devices'' in the final notice. If the
similarity of two or more devices is uncertain, CMS will consult with
FDA and the manufacturer(s), as appropriate, when determining whether a
device could be considered individually or as part of a class of
similar devices for coverage purposes.
Comment: Some commenters requested that CMS clarify how coverage
for similar devices will be handled under TCET. Commenters expressed
mixed opinions and offered various suggestions as to how CMS could
provide coverage under TCET for follow-on devices. Many commenters
indicated that follow-on devices should be subject to the same coverage
conditions and evidence standards and should be required to develop a
comparable EDP to the original device. Several commenters recommended
that CMS set clear expectations for evidence development for second and
third devices to market. Some commenters encouraged CMS to be flexible
in its approach to providing coverage for similar devices under TCET. A
commenter suggested that CMS should require one EDP for all devices in
the class. A commenter recommended that CMS require the same nomination
and evidence preview processes for follow-on devices as for the first
device to ensure that sponsors and CMS are aware of the available
evidence. Another commenter suggested that CMS should require follow-on
device manufacturers to submit an EDP but noted that existing endpoint
guidance and the available data standards and infrastructure may reduce
the cost of CED studies for follow-on devices with similar evidentiary
questions.
Response: We appreciate these comments and agree with commenters
that providing flexibility regarding coverage for follow-on devices is
important. We do not believe that a one-size-fits-all approach to
evidence development is appropriate since evidence gaps are specific to
each device, and therefore, the evidence development needed to meet the
reasonable and necessary standard may differ. In some cases, second and
third follow-on devices may have fewer or different material evidence
deficiencies. We recognize that each technology in a class may have
differences that result in a distinct benefit/risk profile, and each
will be evaluated on its own merit.
Comment: Some commenters recommended that the first device to
market should have privileged status, such as a 1-year coverage
exclusivity period. These commenters suggested that CMS should balance
rewarding the first-to-market device with granting coverage to follow-
on devices.
Response: We do not believe that a coverage exclusivity period for
the first-to-market device is necessary and note that it would
considerably complicate TCET implementation. Further, we believe that
granting privileged status to the first-to-market device could impede
Medicare beneficiary access to the best available device for their
circumstances.
Comment: A commenter requested clarification on whether NCD
reconsiderations would be delayed if two devices have EDPs with
different timelines. Another commenter suggested that when a positive
NCD is issued at the conclusion of a TCET NCD, CMS and the manufacturer
of the follow-on device should discuss whether the agreed-upon evidence
development should continue. Another commenter noted that a post-TCET
NCD should apply to follow-on devices.

[[Page 65742]]

Response: We appreciate these comments. We believe it is important
to provide flexibility so that a post-TCET NCD can apply to follow-on
devices under appropriate circumstances. We do not anticipate a
situation where we would delay an NCD reconsideration when two devices
have EDPs with different timelines. Some studies in an EDP may continue
beyond the pre-specified NCD reconsideration date. In this case, CMS
strongly encourages manufacturers to complete these studies even if
further evidence development is voluntary. CMS will engage with
manufacturers when these situations are encountered to ensure the least
burdensome approach is utilized while ensuring adequate evidence is
collected to support Medicare coverage.
Comment: Several commenters requested that CMS clarify whether the
follow-on devices would be required to have FDA Breakthrough
designation to seek coverage under a TCET NCD. Some commenters
expressed that follow-on devices should be required to have
Breakthrough designation to receive coverage under TCET.
Response: We appreciate these comments. We believe that it is
important for the TCET pathway to foster innovation and not limit
access to competitive devices. To apply for the TCET pathway, the
device must have FDA Breakthrough designation. All NCDs, whether
through the TCET pathway or other, must follow the statutory process
detailed in section 1862(l) of the Act which includes a public comment
period.
Comment: Many commenters supported coverage of similar devices but
recommended that follow-on devices not count against the annual cap of
devices accepted into the TCET pathway.
Response: The final notice clarifies that follow-on devices will
not count against the limit on TCET reviews.
Comment: A commenter questioned how CMS would address a situation
where one device covered under the NCD has a safety concern, and other
devices are covered under that NCD.
Response: CMS action would depend on the specific situation. CMS
could reconsider a TCET NCD if safety concerns arise. We noted in the
proposed procedural notice and reiterate in this final notice that CMS
retains the right to reconsider an NCD at any point in time. Any
reconsideration undertaken by CMS would be informed by the relevant
evidentiary and safety information available at the time.
Comment: A commenter recommended that CMS solicit further feedback
regarding coverage of similar devices under TCET and reassess after a
year.
Response: CMS may reassess our approach as we gain more experience
with the TCET pathway.

K. Duration of Coverage

CMS proposed that the duration of transitional coverage through the
TCET pathway would be time-limited and be tied to the CMS- and AHRQ-
approved Evidence Development Plan (EDP). The proposal stated that the
review date specified in the EDP will provide 1 additional year after
study completion to allow manufacturers to complete their analysis
draft one or more reports and submit them for peer-reviewed
publication. In the proposed notice, we stated that we anticipate the
transitional coverage period would last for 3 to 5 years as evidence is
generated to address evidence gaps identified in the Evidence Preview.
Comment: Many commenters supported CMS' proposal for time-limited
coverage under TCET with the coverage period specified in the EDP. Some
commenters suggested a 3- to 5-year timeframe may not be sufficient as
it may take longer for some studies to be completed and published, and
encouraged CMS to be flexible, especially if a manufacturer acted in
good faith or extenuating circumstances occurred. They noted that 3 to
5 years may be insufficient to gather all the necessary data and to
ensure safety. A commenter encouraged CMS to remain flexible since
cancer studies often use 5-year outcomes. Some commenters stated that
CMS should establish a series of touch points where CMS and
manufacturer can discuss progress and adjust the EDP as needed.
Response: We appreciate the supportive comments. CMS agrees that
the duration of transitional coverage should be tied to an EDP that
sufficiently addresses the material evidence gaps identified in the EP,
and we will work with manufacturers to define an appropriate NCD
reconsideration window. Particularly where longer periods of
transitional coverage are anticipated, CMS agrees that EDPs should
incorporate interim reporting to ensure adequate progress, public
transparency, and timely completion. These updates are in the interest
of CMS, manufacturers, and the public because they provide early
confirmation of the viability of planned studies that use real-world
data and early feedback on real-world outcomes. As noted in the
proposed and final notice, we will be flexible when working with
manufacturers if unavoidable delays occur.
Comment: Commenters offered support for sufficient time and
flexibility to ensure seamless coverage following the TCET coverage
period. Many commenters encouraged CMS to stipulate there would be no
gap in coverage upon study completion and the time to reconsider the
NCD. Others requested clarification on the timeline for using
``continued access'' to better ensure clarity for manufacturers
participating in TCET. Some commenters suggested that CMS allow less
burdensome alternatives (for example, literature review, claims data
analysis) for data collection for the continued access study.
Response: We appreciate these comments. The inclusion of a
continued access study in the EDP is intended to provide seamless
coverage. As we noted in the proposed notice and are finalizing in this
notice, ``Manufacturers should conceive a continued access study that
maintains market access between the period when the primary EDP is
complete, the evidence review is refreshed, and a decision regarding
post-TCET coverage is finalized. The continued access study may rely on
a claims analysis, focusing on device utilization, geographic
variations in care, and access disparities for traditionally
underserved populations.''
Comment: A commenter requested clarification regarding the purpose
and requirements of the continued access study.
Response: Under CED NCDs, coverage is granted for items and
services provided within a clinical study. Evidence development
requirements remain in place until an NCD reconsideration that removes
them is finalized. Continued access studies maintain market access
during the period beginning when the last patient is enrolled in a CED
study until an NCD reconsideration that removes CED requirements is
finalized. A discussion of requirements for continued access studies
are beyond the scope of this document.
Comment: A commenter expressed that data collection should continue
until an NCD reconsideration is conducted.
Response: An NCD with CED requirements remains in place until an
NCD reconsideration without CED requirements is finalized. CMS has
published details of the NCD process at 78 FR 48164.
Comment: A commenter suggested that CMS consider including in the
original TCET NCD, when appropriate, automatic termination of CED
evidence

[[Page 65743]]

collection requirements and conversion of the policy to a regular NCD
in situations where all endpoints are met, and there are no serious
adverse events or other significant problems during the CED study.
Response: We appreciate the suggestion, but an NCD with CED
requirements remains in place until an NCD reconsideration is
finalized. We are unable to include an automatic termination provision
in the original TCET NCD. CMS has published details of the NCD process
at 78 FR 48164.
Comment: Some commenters expressed that if a study has met the
endpoints, a change in coverage status should proceed without delay,
and peer-reviewed publication should not be required.
Response: We disagree with the commenter regarding peer-reviewed
publication. CMS believes that rigorous and publicly available evidence
is necessary to inform beneficiaries, the clinical community, and the
public about the benefits and harms of available treatment options. CMS
generally considers peer-reviewed evidence of higher quality and
evidentiary value than study results that are not peer-reviewed.
Published studies are also necessary for devices to be included in
evidence-based guidelines, which feature heavily in CMS' assessment of
accepted standards of medical practice. Therefore, it is essential that
evidence is published in the peer-reviewed clinical literature, and CMS
applies rigorous methodologic standards in evidence review supporting
local or national coverage analyses. CMS may sometimes review pre-
publication evidence to accelerate our reviews. Nonetheless, the
national coverage analysis process is open and transparent, and the
evidence considered must be in the public domain. To judge whether CMS'
analysis is appropriate, the public must also have access to the
information that CMS relied on to conduct its evidence review. The 2024
CED guidance document states, ``If peer-reviewed publication is not
possible, results may also be published in an online publicly
accessible registry dedicated to the dissemination of clinical trial
information such as ClinicalTrials.gov, or in journals willing to
publish in abbreviated format (for example, for studies with incomplete
results).''
Comment: A commenter suggested that CMS ensure that studies are
published in well-respected journals. This commenter also recommended
naming specific examples to ensure scientific rigor.
Response: We appreciate these comments, but CMS does not believe it
would be appropriate to name specific examples. As previously
described, it is in the manufacturer's best interest to have their
studies published in peer-reviewed journals.

L. Transition to Post-TCET Coverage

CMS proposed to conduct an updated evidence review within 6
calendar months of the review date specified in the EDP. Additionally,
as part of this process, CMS would review applicable practice
guidelines and consensus statements and consider whether the conditions
of coverage remain appropriate. CMS proposed that based upon this
assessment, when appropriate, CMS would open an NCD reconsideration by
posting a proposed decision that includes one of the following
outcomes: (1) an NCD without evidence development requirements; (2) an
NCD with continued evidence development requirements; (3) a non-
coverage NCD; or (4) Medicare Administrative Contractor (MAC)
discretion.
Comment: Commenters generally supported CMS' proposal to conduct an
updated evidence review and an NCD reconsideration to facilitate the
transition to post-TCET coverage.
Response: We appreciate these comments.
Comment: A few commenters stated that 6 months may not be enough
time to complete the updated evidence review, and one of these
commenters recommended 12 months. As in other TCET phases, some
commenters suggested that CMS maintain flexibility.
Response: We agree with commenters that flexibility is important in
the NCD reconsideration phase of the TCET pathway. Projected timeframes
for the completion of real-world studies are estimated, and defining a
precise date for a future NCD reconsideration is impossible. In this
final notice, CMS clarifies that we intend to initiate an updated
evidence review within 6 calendar months of the date specified in the
EDP.
Comment: Additionally, several commenters requested that CMS
clarify the manufacturer's role in the updated evidence review process
and allow manufacturers to have a dialogue with the evidence review
contractor to provide feedback on the evidence review findings.
Response: We disagree that manufacturers should be able to contact
the contractors that the government has engaged to conduct an unbiased
and neutral review of the scientific evidence. CMS has established
rigorous review criteria that were developed in collaboration with
AHRQ, have undergone detailed testing during the past year, and are
reflected in the CMS NCA Evidence Review guidance. The contractor's
role is to conduct a systematic literature review and summarize the
evidence based on a modified GRADE methodology. The contractor supports
and accelerates CMS reviews, but CMS performs extensive quality
assurance on contracted reviews, contributes substantial portions of
the NCA independently, and ultimately determines policy. Further, we
believe there are ample opportunities for manufacturers to provide
feedback throughout the process.
Comment: A commenter recommended that CMS look for opportunities to
streamline the reconsideration process to preserve resources so that
more technologies can be considered under the TCET pathway. This
commenter suggested that CMS could eliminate the initial 30-day comment
period for the NCD reconsideration and post a proposed decision along
with the tracking sheet.
Response: We appreciate this comment and note that we stated in the
proposed notice and reiterate in this final notice that we would open a
TCET NCD reconsideration with a proposed NCD.
Comment: A commenter encouraged CMS to remain transparent and
consider comments from interested parties on the reconsidered NCDs.
Response: We agree and will consider comments from interested
parties during the NCD reconsideration process.

M. TCET and Parallel Review

In the proposed notice, CMS noted that other potential expedited
coverage mechanisms, such as Parallel Review, remain available. CMS
stated in the proposal that eligibility for the Parallel Review program
is broader than for the TCET pathway and could facilitate expedited CMS
review of non-Breakthrough Devices. Further, CMS' proposal expressed
CMS' intent to work with FDA to consider updates to the Parallel Review
program and other initiatives to align procedures, as appropriate.
Comment: Several commenters stated that Parallel Review has yielded
few results and noted many features of TCET have wide overlap with the
Parallel Review Program. A commenter recommended that more technologies
be accepted into the Parallel Review Program. Another commenter
supported expanding the Parallel Review Program

[[Page 65744]]

to accommodate devices that are ineligible for TCET.
Response: We appreciate these comments and will consider them as we
move forward in conjunction with FDA to consider updates to the
Parallel Review Program.
Comment: A commenter requested that CMS clarify whether
technologies already accepted into parallel review are eligible for
TCET.
Response: Technologies accepted into the Parallel Review Program
may be considered for TCET if they align with the criteria for the TCET
pathway.

N. Prioritizing Requests

CMS proposed to respond to TCET nominations within 30 days.
Additionally, CMS' proposal indicated our intent to accept up to five
candidates into the pathway annually. (We note that our responses to
comments received regarding TCET timeframes, as well as the annual
number of candidates accepted into the TCET pathway, are addressed in
section II.A.3. of the notice.) CMS stated in the proposed notice that
we intend to prioritize innovative medical devices that, as determined
by CMS, have the potential to benefit the greatest number of
individuals with Medicare.
Comment: Several commenters recommended that CMS establish and make
public the prioritization factors used to triage TCET nominations when
there are many candidates at a given time.
Response: We appreciate these comments and acknowledge the
importance of clarifying how we will prioritize TCET nominations. To
provide greater transparency, consistency, and predictability, we
intend to release proposed prioritization factors for TCET nominations
in the near future. We look forward to public comment on our proposed
approach.
Comment: Some commenters disagreed with CMS' intention of
prioritizing TCET candidates based on the overall impact on the
Medicare population. These commenters noted that prioritizing based on
overall impact will not address issues with underserved populations
with limited or no treatment options. Commenters suggested that CMS
should consider using the following factors when prioritizing NCD
requests: making significant improvements to patients' lives;
underserved populations; augmenting population health management
practices; advancing the Quadruple Aim; potentially lifesaving;
utilizing a more novel approach than current options, serving an unmet
need, having a significant impact on patients and caregivers,
addressing orphan diseases, and contributing to advancing health
equity, access and improved health outcomes. Additionally, commenters
requested that CMS provide consideration for special patient
populations, including the needs of people with disabilities under age
65. A commenter suggested that CMS consider implementing well-
established measures of healthcare benefits (for example, Quality-
Adjusted Life Years (QALYs) and Disability-Adjusted Life Years (DALYs))
alongside measures that account for innovative benefits not
traditionally derived from current standards-of-care (for example,
procedure efficiency, treatment invasiveness, and Patient-Reported
Outcome Metrics (PROMs)). Several commenters stated that CMS should not
prioritize those technologies with the largest evidence bases.
Response: We appreciate these suggestions and will consider them
when we propose TCET prioritization factors in the future. In the
meantime, we will prioritize TCET candidates based upon the language
from the August 7, 2013, Federal Register notice (78 FR 48164) stating
that in the event we have a large volume of NCD requests for
simultaneous review, we prioritize these requests based on the
magnitude of the potential impact on the Medicare program and its
beneficiaries and staffing resources. We note that section 1182(e) of
the Act prohibits the Secretary from using QALYs or similar measures to
determine coverage, reimbursement, or incentive programs under
Medicare.

O. TCET Transparency

Comment: Several commenters requested that CMS be transparent
regarding devices in the TCET pathway. Suggestions for more
transparency included publicly posting information such as the number
of devices in the TCET pathway, the date of nomination, the date of
acceptance, and the date the NCD process is initiated. A commenter also
recommended that information regarding TCET NCDs be included in the
annual Report to Congress on NCDs.
Response: We appreciate these comments and recognize the importance
of transparency regarding the TCET pathway. In response to public
comments, we agree that including the number of devices in the TCET
pathway, the date of nomination, the date of acceptance, and the date
the NCD process is initiated would be helpful and we will incorporate
this information into future iterations of the NCD Dashboard (available
here: <a href="https://www.cms.gov/Medicare/Coverage/DeterminationProcess">https://www.cms.gov/Medicare/Coverage/DeterminationProcess</a>). We
intend to update the NCD Dashboard every quarter. Since we will use the
NCD process to provide coverage under the TCET pathway, TCET NCDs will
be reflected in the annual Report to Congress.

P. Miscellaneous Comments

Comment: Several commenters suggested that CMS create a similar but
separate pathway for technologies that meet the reasonable and
necessary standard, but with limited context on real-world use in the
Medicare population. This suggested pathway would offer temporary
transitional national coverage and would not rely on the CED statutory
authority; instead, these technologies could be covered under section
1862(a)(1)(A) of the Act. These commenters noted that this ``limited
context'' pathway would accelerate beneficiary access to these
technologies and promote the collection and assessment of real-world
evidence to support the development of a long-term national coverage
policy.
Response: These comments are outside the scope of the TCET notice.
However, we will consider them in the future as we consider providing
additional coverage pathways. In general, CED is not required for items
and services that meet the reasonable and necessary standard. CED is an
important option when the evidence is promising but does not yet
satisfy the reasonable and necessary standard. CED relies primarily on
the statutory exception in section 1862(a)(1)(E) of the Act, which
effectively permits Medicare payment in the case of research conducted
pursuant to section 1142 of the Act for items and services that are
reasonable and necessary to carry out that section.
In some cases, the available evidence may satisfy the reasonable
and necessary standard only within a narrow context and be appropriate
for coverage on an individual claim determination basis. However, broad
local or national coverage requires evidence generalizable to the
intended Medicare beneficiary population.
Comment: A commenter requested that Medicare Advantage plans should
be required to cover TCET technologies without prior authorization.
Response: This comment is out of scope as we are unable to impose
new requirements on Medicare Advantage plans in this notice.
Comment: Some commenters requested that CMS build a CMS Office of
the Actuary (OACT) determination into whether a Breakthrough Device in
the TCET pathway triggers the

[[Page 65745]]

significant cost threshold as soon as possible after an NCD.
Response: We do not believe building an OACT significant cost
threshold determination into the TCET pathway is necessary. Significant
cost threshold determinations for TCET NCDs will be handled consistent
with the existing process we use for all NCDs.
Comment: A commenter recommended that CMS explain how the Clinical
Endpoints Guidance documents will interact with and facilitate the TCET
pathway and clarify whether CMS will prioritize TCET candidates in
disease areas for which Clinical Guidance Documents have already been
developed. This commenter also noted that through the FFP and Clinical
Endpoints guidance documents, CMS can provide recommendations on the
type of data collection best suited for given therapeutic areas,
including guidance on data sources and data infrastructures. This
commenter further stated that CMS could support better evidence
development infrastructure by aligning TCET activities with its overall
strategy to advance the use of interoperable electronic health data.
Response: We appreciate these comments. We intend to develop
clinical endpoint guidance documents in therapeutic areas with a great
deal of active research and development or in areas with considerable
uncertainty about appropriate outcomes. The decision to develop a
Clinical Endpoints Guidance (CEG) document is unrelated to our
evaluation of a specific TCET nomination, and we may develop CEGs
unrelated to the TCET pathway. Publication of a CEG does not imply that
CMS intends to open an NCD. The RWD/RWE field is rapidly evolving, and
CMS is closely tracking developments. CMS appreciates the suggestions
for improving CEG documents by incorporating recommendations for data
sources and infrastructures. CMS expects to publish detailed guidance
on acceptable FFP studies in the coming months.
Comment: Commenters generally supported CMS collaboration with
other HHS Agencies and encouraged further collaboration with FDA, NIH,
and ARPA-H.
Response: We appreciate these comments. CMS intends to continue its
collaboration with our fellow HHS sister agencies.
Comment: A commenter requested that CMS clarify the following
sentence from the proposed notice: ``We note that many Breakthrough
Devices are currently coverable without the TCET pathway because they
are not separately payable (that is, the device may be furnished under
a bundled payment, such as payment for a hospital stay) or they are
addressed by an existing NCD.'' The commenter stated that it seems a
device always used in the inpatient hospital setting would never need a
coverage determination at the national or local level since it is part
of a bundled payment. The commenter requested confirmation of the
assumption that CMS would cover new devices for existing inpatient-only
procedures, such as transcatheter aortic valve replacement since it
would eliminate the need for many devices paid as part of a bundled
payment to request coverage through the TCET pathway.
Response: We acknowledge this sentence has caused unintended
confusion. It was not intended to communicate a universal statement
regarding Medicare coverage. We have deleted the sentence from the
final notice.
Comment: A commenter expressed concerns about accelerating the
integration of 510(k) devices into practice since, as the commenter
stated, 510(k) devices must prove ``substantial equivalence'' to a
device that is already on the market and are not designed to
demonstrate ``safety and effectiveness'' like the ``Pre-Market
Authorization'' process. This commenter requested clarification on how
an EDP would address devices without clinical evidence before
clearance.
Response: In general, for an item or service to be covered under
Medicare, it must meet the standard described in section 1862(a)(1)(A)
of the Act--that is, it must be reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member. In contrast, CED relies
primarily on the statutory exception in section 1862(a)(1)(E) of the
Act, which effectively permits Medicare payment when that bar has not
yet been met, in order to support research conducted pursuant to
section 1142 of the Act for items and services that are reasonable and
necessary to carry out that section. CED is an important option when
the evidence is promising but does not yet satisfy the reasonable and
necessary standard under 1862(a)(1)(A).
In general, clinical evidence relevant to the Medicare population
is necessary to achieve a favorable Medicare coverage decision. We
anticipate that most TCET nominations will be for Breakthrough Devices
where robust Medicare beneficiary protections and evidence generation
are important to achieving optimal health outcomes. Additionally, CMS
anticipates that most devices considered for the TCET pathway will be
devices reviewed under a De Novo request or PMA submission. However, we
note that devices subject to the 510(k) clearance pathway may qualify
for Breakthrough designation (see 21 U.S.C. 360e-3(c)). Although the
510(k) review standard is substantial equivalence of a new device to a
legally marketed device, the principles of safety and effectiveness
underlie the substantial equivalence determination in every 510(k)
review.\22\
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\22\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k</a>.
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Comment: A commenter requested clarification as to who would be
responsible for maintaining the integrity of an evidence development
plan, particularly for FFP designs using real-world data. This
commenter also questioned if CMS would consider a support mechanism if
registries were required.
Response: It is the manufacturer's responsibility to maintain the
integrity of an EDP. In approving EDPs, CMS, in collaboration with
AHRQ, has agreed that the proposed studies are likely to substantially
address material evidence gaps identified in the EP if faithfully
executed. CMS' 2024 CED guidance document states that changes to
approved study protocols must be justified and publicly reported. It
also states that sponsors/investigators commit to making study data
publicly available by sharing data, methods, analytic code, and
analytical output with CMS or with a CMS-approved third party. The
ultimate value of approved CED studies will be assessed when CED
studies are completed, and the results are known.
CMS intends to issue FFP study guidance soon. We believe the
guidance will clarify CMS' expectations for FFP studies, particularly
those that rely on the secondary use of real-world data.
A discussion of CMS payment for data submission into registries is
beyond the scope of this document.
Comment: A commenter requested that CMS clarify how upcoming pilots
will relate to the TCET pathway and timing.
Response: We are currently testing aspects of the TCET process,
specifically, the EP and EDP concepts within the existing NCD review
process. More information will be provided as these NCDs are opened. We
cannot provide information on the timing for opening any of these
pilots.
Final Decision: After review of the public comments received, we
are

[[Page 65746]]

finalizing the TCET pathway with the modifications and clarifications
noted previously in our responses to public comments. The following
section lists our changes between the proposed and final notice.

III. Provisions of the Final Notice

The final notice incorporates many of the provisions of the
proposed notice and revises some of the provisions as proposed in
response to issues raised by commenters. Based on CMS' analysis of the
topics raised during the public comment period, CMS made several
changes between the proposed notice and final notice, specifically the
following:
<bullet> Nominations:
++ We incorporate an opportunity for manufacturers to submit a non-
binding letter of intent to nominate a potentially eligible device
approximately 18 to 24 months before they anticipate FDA market
authorization.
++ We clarify that when CMS is aware that manufacturers will likely
pursue the TCET pathway for devices where appropriate clinical
endpoints are uncertain, we may preemptively conduct a clinical
endpoints review and may convene a MEDCAC. We note that submission of a
non-binding letter of intent may avoid delays in TCET reviews.
++ We have revised the timeframe for reviewing TCET nominations. We
will review nominations on a quarterly basis.
++ CMS clarifies that nominations for devices that are already FDA
market authorized or those anticipated to receive an FDA decision on
market authorization within 6 months of nomination will not be accepted
for TCET because TCET relies on extensive pre-market engagement to
expedite coverage reviews. CMS notes that if the timelines for this
pre-market engagement are shortened, it is unlikely that an NCD will be
finalized within 6 months of FDA market authorization. We note that
pursuing an NCD outside of TCET or MAC discretion is also available.
<bullet> Evidence Preview (EP):
++ We clarify that the evidence review contractor's role is to
support the CAG staff by conducting a rapid systematic literature
review and summarizing the evidence based on a modified GRADE
methodology. We further clarify that the contractor's role is to
support and accelerate CMS reviews, but we will perform extensive
quality assurance on contracted reviews, independently complete
substantial portions of the EP, and determine coverage policy.
++ We state that if an NCD is opened, an evidence summary,
including a disclosure of which contractor completed the review, will
be posted with the tracking sheet on the CMS website for public
comment.
++ We have changed our position on sharing the full EP with the
MACs if a manufacturer withdraws from the TCET pathway. While we
believe that an EP will be a fair reflection of the strength of
evidence available at that time to support Medicare coverage, we
acknowledge that manufacturers may withdraw from the TCET pathway for
reasons unrelated to the strength of evidence. Nonetheless, EPs
represent a substantial investment of public resources, and we will
publicly post an evidence summary for devices that are withdrawn from
the TCET pathway without an evidence gap assessment.
<bullet> Evidence Development Plans (EDPs):
++ We state that EDPs should incorporate interim reporting to
ensure adequate progress and timely completion. Interim reports should
also disclose any meaningful changes to prespecified study protocols,
which are essential to transparency.
++ We note that the forthcoming FFP guidance will provide
information on study designs and analysis methods that are FFP. We
expect TCET CED studies to be registered and listed on the
<a href="http://clinicaltrials.gov">clinicaltrials.gov</a> website. Additionally, we specify that a summary of
the EDPs and the anticipated CED NCD reconsideration window will be
posted on the CMS website so the public can stay informed throughout
the process.
<bullet> Coverage of Similar Devices:
++ We clarify that NCDs are limited to particular items or
services, but note that some NCDs apply to products for the same
indication. In these instances, we will follow the existing NCD process
detailed in section 1862(l) of the Act. We recognize that some
differences may exist for technologies in a class that may result in a
distinct benefit/risk profile, and each will be evaluated on its own
merit.
++ We clarify that any follow-on devices in the TCET pathway will
not count toward CMS' annual limit.
<bullet> Prioritizing Requests--We express our intent to release
proposed prioritization factors for TCET nominations soon to provide
greater transparency, consistency, and predictability.
<bullet> TCET Transparency--We indicate that information on TCET
devices will be added to the NCD Dashboard, including the number of
devices in the TCET pathway, the date of nomination, the date of
acceptance, and the date the NCD process was initiated.
All other provisions are being finalized as proposed. The Addendum
that follows provides the updated process and procedures for the TCET
pathway that reflect the changes made in response to public comments.

IV. Collection of Information Requirements

Based on our initial assessment of Breakthrough Devices applying
the characteristics we list in section I.C. of the Addendum to this
notice regarding appropriate candidates for the TCET pathway, we
anticipate receiving approximately eight nominations for the TCET
pathway per year. Based on current resources, we do not anticipate the
TCET pathway will accept more than five candidates per year. Since we
estimate fewer than 10 respondents, the information collection
requirements are exempt in accordance with the implementing regulations
of the PRA at 5 CFR 1320.3(c). As we gain experience with the TCET
pathway, we will provide an updated analysis if we receive a higher
number of respondents than anticipated.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on August 2, 2024.

Xavier Becerra,
Secretary, Department of Health and Human Services.

I. Addendum--Process and Procedures for the TCET Pathway

We describe in this Addendum the process and procedures for how
interested parties and the public may engage with CMS to facilitate the
TCET pathway. The topics addressed in the notice include the following:
(1) TCET general principles; (2) appropriate candidates for the TCET
pathway; (3) procedures for the TCET pathway; and (4) general roles.
We continue to work with various sectors of the scientific and
medical communities to develop and publish guidance documents on our
website that describe our approach when analyzing scientific and
clinical evidence when developing NCDs. In response to feedback from
interested parties, the 2024 CED and Evidence Review guidance documents
incorporate recommendations for when FFP studies may be used to close
material evidence gaps. FFP studies are those where the study design,
analysis plan, and study data can credibly answer the research
question. Additionally, CMS intends to

[[Page 65747]]

publish a series of guidance documents that review health outcomes and
their clinically meaningful differences within priority therapeutic
areas. The public will have an opportunity to provide comments on these
guidance documents available on the CMS coverage website. The website
may be accessed at <a href="http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html">http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html</a>.

A. TCET Pathway--An Opportunity To Accelerate Patient Access to
Promising Medical Products While Generating Evidence

Since CMS started covering technology in the context of clinical
studies almost two decades ago, the timing of evidence development and
the stages of the technology development lifecycle have evolved. Over
the past few years, innovative technologies have come on the market
earlier in the technology development lifecycle and reached the market
with limited or developing evidence for coverage purposes. CMS has
received inquiries for coverage of new technologies that are early in
the product lifecycle, which means the clinical evidence is just
starting to accumulate. For new technologies, there is often
insufficient clinical evidence to support broad national coverage at
this point.
In general, CMS relies heavily on health outcomes data, especially
as it relates to the Medicare population when proposing an NCD. Early
in the product lifecycle, there is usually evidence about whether the
product is safe and may produce the intended result: for example, a
laboratory measurement, radiographic image, physical sign, or other
measure that is believed to predict clinical benefit but is not itself
a measure of clinical benefit. However, there is often little evidence
in the early stages of the product lifecycle regarding health outcomes
(for example, mortality, disease progression, or impact on a patient's
quality of life). When premarket, pivotal clinical study data is
collected to support an application to FDA for market authorization, it
provides clinical evidence for a defined population enrolled in the
study.
If there is health outcome evidence for a new technology, it may
not be generalizable to the Medicare population if Medicare
beneficiaries are insufficiently represented in pivotal clinical
studies.\23\ Medicare beneficiaries have been historically
underrepresented in pivotal studies due to age, access, multiple
comorbidities, and concurrent treatments. When there is little or
limited evidence, CMS may not have enough information to make a
favorable NCD due to gaps in research about health outcomes, including
potential safety risks to the Medicare population.
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\23\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices</a>.
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While CMS has attempted to streamline the NCD process with the
Parallel Review program, we recognize that most emerging technologies
are likely to have limited or developing bodies of clinical evidence
that may not have included the Medicare population (that is,
individuals over age 65, people with disabilities, and those with end-
stage renal disease). Many Medicare beneficiaries have comorbid medical
conditions, and those factors may have limited their participation in
certain clinical trials. Additionally, we recognize the importance that
applicable clinical trials reflect the demographic and clinical
diversity among the Medicare beneficiaries who are the intended users
of the intervention. At a minimum, this requires the availability of
data on, and attention to, the intended users' racial and ethnic
backgrounds, sex and gender, age, disabilities, important
comorbidities, and relevant social determinants of health. We believe
that the TCET pathway can support manufacturers that are interested in
working with CMS to generate additional evidence that is applicable to
Medicare beneficiaries and that may demonstrate improved health
outcomes in the Medicare population to support more expeditious
national Medicare coverage. While we believe that leveraging the
statutorily established NCD process will allow us to responsibly cover
new, innovative technologies with limited or developing evidence, it is
important that we provide an evidence generation framework that, when
appropriate, not only develops reliable evidence for patients and their
physicians but also provides safeguards to ensure that Medicare
beneficiaries are protected and continue to receive high-quality care.
Specifically, CED has been used to support evidence development for
certain innovative technologies that are likely to show benefit for the
Medicare population when the available evidence is not sufficient to
demonstrate that the technologies are reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member under section 1862(a)(1)(A) of
the Act. In instances where there is limited evidence, CED may be an
option for Medicare beneficiaries seeking earlier coverage for
promising technologies. CED has been a pathway whereby, after a CMS and
AHRQ review, Medicare covers items and services on the condition that
they are furnished in the context of approved clinical studies or with
the collection of additional clinical data. Participation in a CED
trial is voluntary, but beneficiaries are protected by separate
regulations, including those at 45 CFR part 46 related to the
protection of human research subjects.
With respect to evidence generation, the TCET pathway will build
upon CMS and AHRQ's ongoing collaboration on the CED NCD process. We
anticipate that many NCDs conducted under the TCET pathway will result
in CED decisions, and AHRQ will continue to review all CED NCDs
consistent with current practice. Additionally, AHRQ will collaborate
with CMS as appropriate on evidence development activities, such as the
EP and EDP, conducted to support Medicare coverage under the TCET
pathway and will have opportunities to offer feedback throughout the
process that will be shared with manufacturers. Approvals related to
evidence development will be a joint CMS-AHRQ decision.
With respect to beneficiary safeguards, the NCD process allows for
coverage with appropriate safeguards for Medicare beneficiaries,
including coverage criteria based on evidence regarding eligibility,
frequency, provider experience, site of service, or availability of
supporting services. Specifically, CMS develops clinician and
institutional requirements after careful review of expert physicians'
specialty society guidelines and clinical study results. These
guidelines and recommendations are often part of NCDs. Unless these
coverage criteria are established within coverage determinations,
devices could be provided by unqualified individuals, offered at
inappropriate facilities, and utilized by patients who may be unlikely
to benefit or likely to experience adverse effects.
Coverage under a CED NCD can expedite earlier beneficiary access
for individuals who volunteer to participate in the clinical studies of
innovative technologies while ensuring that systematic patient
safeguards, including assurance that the technology is provided to
clinically appropriate patients, are in place to reduce the potential
risks of new technologies, or to new applications of older
technologies. CMS' 2024 CED guidance document includes specific patient
protections

[[Page 65748]]

under CED.\24\ Because the TCET pathway described in this document
would utilize the existing CED NCD process, all these safeguards would
apply.
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\24\ <a href="https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1&status=all">https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1&status=all</a>.
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Input from interested parties is important to CMS, and we are
particularly interested in engagement with patient advocacy
organizations and medical specialty societies as they have valuable
expertise and first-hand experience in the field that will help CMS
develop Medicare coverage policies. Because the TCET pathway would
utilize the current NCD process, these opportunities for engagement
with interested parties are also available in TCET.

B. TCET General Principles

CMS is committed to ensuring Medicare beneficiaries have access to
promising emerging, technologies. CMS' goal is to finalize an NCD for
technologies accepted into and continuing in the TCET pathway, within 6
months after FDA market authorization. The TCET pathway builds on prior
initiatives, including CED. The TCET pathway will meet the following
principles:
<bullet> Medicare coverage under the TCET pathway is limited to
certain Breakthrough Devices that receive market authorization for one
or more indications for use covered by the Breakthrough Device
designation when used according to those indications for use.
Manufacturers of FDA-designated Breakthrough Devices that fall within a
Medicare benefit category may self-nominate to participate in the TCET
pathway on a voluntary basis.
<bullet> CMS may conduct an early evidence review (Evidence
Preview, more details can be found in section. I.D.1.h. of this
Addendum) before FDA decides on marketing authorization for the device
and discuss with the manufacturer the best available coverage pathways
depending on the strength of the evidence.
<bullet> Prior to FDA marketing authorization, CMS and
manufacturers may discuss any evidence gaps for coverage purposes and
the types of studies that may need to be completed to address the gaps,
which could include the manufacturer developing an evidence development
plan and confirming that there are appropriate safeguards for Medicare
beneficiaries.
<bullet> If CMS determines that further evidence development (that
is, CED) is the best coverage pathway, CMS will work with the
manufacturers to reduce the burden on manufacturers, clinicians, and
patients while maintaining rigorous evidence requirements. CMS will
work to ensure we are not requiring duplicative or conflicting evidence
development with any FDA postmarket requirements for the device.
<bullet> CMS does not believe that an NCD that requires CED as a
condition of coverage should last indefinitely, including under the
TCET pathway. If the evidence supports a favorable coverage decision
under CED, coverage will be time-limited to facilitate the timely
generation of sufficient evidence to inform patient and clinician
decision making and to support a Medicare coverage determination under
section 1862(a)(1)(A) of the Act.
<bullet> Manufacturers and CMS have the option to withdraw from the
pathway up until CMS opens the NCD by posting a tracking sheet. CMS
will not publicly disclose participation of a manufacturer in the TCET
pathway prior to CMS' posting of an NCD tracking sheet unless the
manufacturer consents or has already made this information public or
disclosure is required by law. CMS requests that a manufacturer who
wishes to withdraw from the TCET pathway notify CMS by email.

C. Appropriate Candidates

Appropriate candidates for the TCET pathway would include those
devices that are--
<bullet> FDA-designated Breakthrough Devices;
<bullet> Determined to be within a Medicare benefit category; \25\
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\25\ For more information on benefit category determinations see
the CMS Guide for Medical Technology Companies and Other Interested
Parties: <a href="https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties">https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties</a>.
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<bullet> Not already the subject of an existing Medicare NCD; and
<bullet> Not otherwise excluded from coverage through law or
regulation.\26\
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\26\ Information on coverage exclusions can be accessed here:
<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf</a>.
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In section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)(1)), the definition of device includes IVD products,
such as diagnostic laboratory tests. See 21 CFR 809.3. IVDs, including
diagnostic laboratory tests, are a highly specific area of coverage
policy development, and CMS has historically delegated review of many
of these products to specialized MACs. We believe that the majority of
coverage determinations for IVDs granted Breakthrough designation
should continue to be determined by the MACs through existing pathways.

D. Procedures for the TCET Pathway

The TCET pathway has three stages: (1) premarket; (2) coverage
under the TCET pathway; and (3) transition to post-TCET coverage.
1. Premarket
a. Non-Binding Letter of Intent for the TCET Pathway
Manufacturers may submit a non-binding letter of intent to nominate
a potentially eligible device for the TCET pathway approximately 18 to
24 months before anticipated FDA marketing authorization as determined
by the manufacturer.
The letter of intent to nominate a device for the TCET pathway may
be submitted electronically via the Coverage Center Website using the
``Contact Us'' link at <a href="http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html">http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html</a>. The following information will assist CMS
in processing and responding to letters of intent:
<bullet> Name of the manufacturer and relevant contact information
(name of contact person, address, email, and telephone number).
<bullet> Name of the product.
<bullet> Succinct description of the technology and the disease or
condition the device is intended to diagnose or treat.
<bullet> Date of FDA Breakthrough Device Designation.
<bullet> Expected regulatory pathway (for example, PMA, De Novo,
510(k)).
<bullet> Expected completion date for pivotal clinical study.
CMS will email the manufacturer to confirm that a submitted letter
of intent has been received by CMS.
b. Nominations for the TCET Pathway
The appropriate timeframe for manufacturers to submit nominations
to CMS is approximately 12 months prior to when the manufacturer
anticipates an FDA decision on a submission. Manufacturers are
generally aware of when they intend to submit their application, and
the FDA has agreed to review time goals as part of its device user fee
program.\27\ CMS encourages manufacturers not to delay submitting
nominations to facilitate alignment among CMS benefit category
determination, and coverage, coding,

[[Page 65749]]

and payment considerations. Additionally, when CMS is aware that
manufacturers will likely pursue the TCET pathway for devices where
appropriate clinical endpoints are uncertain, we may preemptively
conduct a clinical endpoints review and may convene a MEDCAC at a later
date. In these instances, there may be a delay of several months due to
the logistics involved in conducting these activities so the submission
of a non-binding letter of intent may avoid potential delays.
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\27\ For more information on the specific review time goals that
apply to different types of device premarket submissions, see MDUFA
Performance Goals and Procedures, Fiscal Years 2023 Through 2027
(<a href="https://www.fda.gov/media/158308/download">https://www.fda.gov/media/158308/download</a>).
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Under the TCET pathway, CMS will conduct extensive work in the pre-
market period to shorten coverage review timeframes after devices are
FDA market-authorized. Since TCET is forward-looking and extensive pre-
market engagement is essential, CMS will not accept nominations for
already FDA market authorized devices or those anticipated to receive
an FDA decision market authorization within 6 months of nomination. CMS
may be unable to reach a final NCD within the expedited timeframes for
TCET nominations submitted or accepted less than 12 months before
anticipated FDA market authorization. We note that the option to pursue
an NCD or LCD outside of the TCET pathway is available for these
technologies.
The manufacturer may submit a nomination for the TCET pathway
electronically via the Coverage Center website using the ``Contact Us''
link at <a href="http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html">http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html</a>. CMS will acknowledge receipt of nominations by email.
The following information will assist CMS in processing and responding
to nominations:
<bullet> Name of the manufacturer and relevant contact information
(name of contact person, address, email, and telephone number).
<bullet> Name of the product.
<bullet> Succinct description of the technology and disease or
condition the device is intended to diagnose or treat.
++ Description of the product, including components (for example,
single-use catheter, power source, charger system, etc.)
++ Description of the use context (for example, inpatient, ASC,
outpatient clinic, home)
++ Description of the disease or condition that the product is
intended to treat or diagnose and mechanism of action for the product
<bullet> State of development of the technology (that is, in pre-
clinical testing, in clinical trials, currently undergoing premarket
review by FDA). The submission of a copy of FDA's letter granting
Breakthrough Device Designation and the PMA application, De Novo
request or premarket notification (510(k)) submission, if available, is
preferred.
++ Date of FDA Breakthrough Device Designation
++ Expected regulatory pathway (for example, PMA, De Novo, 510(k))
++ Current development status (for example, pre-clinical testing,
in clinical trials, under FDA premarket review, post-market)
<bullet> A brief statement explaining why the device is an
appropriate candidate for the TCET pathway as described under section
I.C. of this Addendum (``C. Appropriate Candidates'').
++ Rationale for Breakthrough Designation
++ Unmet need the product addresses
<bullet> A statement describing how the medical device addresses
the health needs of the Medicare population.
++ Description of the condition with respect to the full US
population (for example, incidence, prevalence, significance)
++ Description of the applicable Medicare population(s) (for
example, estimated population size, other considerations specific to
the Medicare beneficiary population)
++ Description of the magnitude of the expected benefit from the
product
<bullet> A statement that the medical device is not excluded by
statute from Part A or Part B Medicare coverage or both, and a list of
Part A or Part B or both Medicare benefit categories, as applicable,
into which the manufacturer believes the medical device falls.
Additionally, manufacturers are encouraged to provide additional
specific information to help facilitate benefit category
determinations.
++ Product not excluded from Medicare coverage by statute
++ Most likely benefit categories (for example, inpatient,
physician services, DME, etc.)
++ A comprehensive list of peer-reviewed, English-language
publications that are relevant to the nominated Breakthrough Device as
applicable/available.
++ Relevant background literature (for example, important
publications CMS should review for context).
++ Relevant unpublished clinical studies regarding the safety/
efficacy of the product, with the expected publication date for each.
++ Relevant published clinical studies regarding the safety/
efficacy of the product.
Two good sources of information to facilitate the development of
nomination submissions are the CMS Coverage website (<a href="https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center">https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center</a>) and the CMS
Guide for Medical Technology Companies and Other Interested Parties
(<a href="https://www.cms.gov/cms-guide-medical-tech-companies-other-parties">https://www.cms.gov/cms-guide-medical-tech-companies-other-parties</a>),
which provide information that may facilitate durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS) BCDs, along
with coverage, coding and payment processes and considerations.
CMS will email the manufacturer to confirm that a submitted
nomination appears to be complete and is under review. This email will
include the date that CMS initiated the review of the complete
nomination. CMS will contact the manufacturer for more information if
the nomination is incomplete.
c. CMS Nomination Cycles and Consideration of Nominations
CMS will accept suitable TCET candidates quarterly. If a suitable
nomination is not selected in the first review, it will be
automatically considered in the subsequent quarter. Manufacturers will
not need to resubmit to be considered in a subsequent quarter. Since
TCET is forward-looking and extensive pre-market engagement is
essential, nominations for Breakthrough Devices anticipated to receive
an FDA decision on market authorization within 6 months may not be
accepted since CMS will be unable to reach a final NCD within the
expedited timeframes. It is possible that a nominated device that is
not accepted in a first review may be accepted during a subsequent
review even though FDA's decision on market authorization is
anticipated within 6 months. If this occurs, CMS will work with the
manufacturer to expedite the review as practically achievable.
CMS may contact the manufacturer to request supplemental
information to ensure a timely review of the nomination. Once CMS
decides to provisionally accept or decline a nomination, CMS will
communicate their decision to the manufacturer by email with their
designated point of contacts. Acceptance into TCET should not be viewed
as a final determination that a device fits within a benefit category.
When CMS issues the proposed NCD for a Breakthrough Device that has
received FDA marketing authorization, the proposed NCD will include one
or more benefit categories to which CMS has determined the Breakthrough
Device falls. CMS will review and consider public comment on the
proposed NCD before reaching a final determination on the BCD(s).

[[Page 65750]]

d. Intake Meeting
Following the submission of a complete TCET nomination, CMS will
offer an initial meeting with the manufacturer to review the nomination
within 20 business days of receipt of a complete nomination. In this
initial meeting, the manufacturer is expected to describe the device,
its intended application, place of service, a high-level summary of the
evidence supporting its use, and the anticipated timeframe for FDA
review. CMS will answer any questions about the TCET process. CMS
intends for these meetings to be held remotely to reduce travel burden
on manufacturers and expeditiously meet these timeframes. These
meetings will have a duration of 30 minutes. If a manufacturer declines
to meet or if there is difficulty finding a mutually convenient time
for the meeting, then CMS action on the nomination may be delayed.
e. Coordination With FDA
After CMS initiates review of a complete, formal nomination,
representatives from CMS will meet with their counterparts at FDA to
learn more information about the technology in the nomination to the
extent the Agencies have not already done so. These discussions may
help CMS gain a better understanding of the device and potential FDA
review timing.
As noted in the Memorandum of Understanding \28\ between FDA and
CMS, FDA and CMS recognize that the following types of information
transmitted between them in any medium and from any source must be
protected from unauthorized disclosure: (1) trade secret and other
confidential commercial information that would be protected from public
disclosure pursuant to Exemption 4 of the Freedom of Information Act
(FOIA); (2) personal privacy informatio

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.