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



[[Page 65723]]

Vol. 89

Monday,

No. 155

August 12, 2024

Part II





 Department of Health and Human Services





-----------------------------------------------------------------------





 Centers for Medicare & Medicaid Services





-----------------------------------------------------------------------





Medicare Program; Transitional Coverage for Emerging Technologies; 
Notice

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

[[Page 65724]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \1\ https://www.cms.gov/oact/tr/2024.
    \2\ https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \4\ CMS Program Integrity Manual, Chapter 13 Local Coverage 
Determinations, available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \5\ The most recent CED guidance document is available at 
https://www.cms.gov/medicare/coverage/evidence.
---------------------------------------------------------------------------

    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 
(https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development).
    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\
---------------------------------------------------------------------------

    \6\ Note: Medicare does not develop NCDs for Part D.
    \7\ Section 1862(l) of the Act.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \8\ CMS, National Coverage Determination for Routine Costs in 
Clinical Trials available at https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&fromdb=true.
---------------------------------------------------------------------------

    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,10 11 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.
---------------------------------------------------------------------------

    \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, https://doi.org/10.1093/gerona/gly110.
    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \12\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \13\ Information on device-led combination products can be 
accessed here: https://www.fda.gov/media/119958/download.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \14\ Food and Drug Administration, Breakthrough Devices Program 
Guidance for Industry and Food and Drug Administration Staff, 
available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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 https://www.agingresearch.org/wp-content/uploads/2023/02/Facade-of-Evidence-CED-2-13-2023.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \16\ https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf.
---------------------------------------------------------------------------

    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: https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties.
    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--
     Certain FDA-designated Breakthrough Devices;
     Determined to be within a Medicare benefit category;
     Not already the subject of an existing Medicare NCD; and
     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.
---------------------------------------------------------------------------

    \17\ https://www.palmettogba.com/moldx.
---------------------------------------------------------------------------

    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: https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#.
---------------------------------------------------------------------------

    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\ https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide.
---------------------------------------------------------------------------

    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 clinicaltrials.gov, 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.
---------------------------------------------------------------------------

    \20\ The clinical endpoints guidance can be accessed here upon 
release: https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1#.
---------------------------------------------------------------------------

    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: https://www.cms.gov/Medicare/Coverage/DeterminationProcess). 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\
---------------------------------------------------------------------------

    \22\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.
---------------------------------------------------------------------------

    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:
     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.
     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.
     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 
clinicaltrials.gov 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.
     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.
     Prioritizing Requests--We express our intent to release 
proposed prioritization factors for TCET nominations soon to provide 
greater transparency, consistency, and predictability.
     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 http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html.

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.
---------------------------------------------------------------------------

    \23\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \24\ https://www.cms.gov/medicare-coverage-database/reports/national-coverage-medicare-coverage-documents-report.aspx?docTypeId=1&status=all.
---------------------------------------------------------------------------

    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:
     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.
     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.
     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.
     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.
     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.
     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--
     FDA-designated Breakthrough Devices;
     Determined to be within a Medicare benefit category; \25\
---------------------------------------------------------------------------

    \25\ For more information on benefit category determinations see 
the CMS Guide for Medical Technology Companies and Other Interested 
Parties: https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties.
---------------------------------------------------------------------------

     Not already the subject of an existing Medicare NCD; and
     Not otherwise excluded from coverage through law or 
regulation.\26\
---------------------------------------------------------------------------

    \26\ Information on coverage exclusions can be accessed here: 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf.
---------------------------------------------------------------------------

    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 http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html. The following information will assist CMS 
in processing and responding to letters of intent:
     Name of the manufacturer and relevant contact information 
(name of contact person, address, email, and telephone number).
     Name of the product.
     Succinct description of the technology and the disease or 
condition the device is intended to diagnose or treat.
     Date of FDA Breakthrough Device Designation.
     Expected regulatory pathway (for example, PMA, De Novo, 
510(k)).
     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.
---------------------------------------------------------------------------

    \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 
(https://www.fda.gov/media/158308/download).
---------------------------------------------------------------------------

    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 http://www.cms.gov/Medicare/Coverage/InfoExchange/contactus.html. CMS will acknowledge receipt of nominations by email. 
The following information will assist CMS in processing and responding 
to nominations:
     Name of the manufacturer and relevant contact information 
(name of contact person, address, email, and telephone number).
     Name of the product.
     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
     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)
     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
     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
     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 (https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center) and the CMS 
Guide for Medical Technology Companies and Other Interested Parties 
(https://www.cms.gov/cms-guide-medical-tech-companies-other-parties), 
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 information, such as the information that 
would be protected from public disclosure pursuant to Exemption 6 or 
7(c) of the FOIA; or (3) information that is otherwise protected from 
public disclosure by Federal statutes and their implementing 
regulations (for example, the Trade Secrets Act (18 U.S.C. 1905), the 
Privacy Act (5 U.S.C. 552a), the Freedom of Information Act (5 U.S.C. 
552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
and the Health Insurance Portability and Accountability Act (HIPAA), 
Pub. L. 104-191).
---------------------------------------------------------------------------

    \28\ https://www.fda.gov/about-fda/domestic-mous/mou-225-10-0010.
---------------------------------------------------------------------------

f. Benefit Category Review
    Following discussions with FDA, CMS may initiate a benefit category 
review if all other pathway criteria have been met. Emerging devices 
may fit within a Medicare benefit category, but that does not mean all 
medical devices will fall within a benefit category. If CMS believes 
that the device, before a decision on market authorization by 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. However, if 
it appears that a device, before a decision on market authorization by 
FDA, will not fall under an existing benefit category, the TCET 
nomination will be denied, and the rationale will be discussed in the 
denial letter. CMS will likely not assess every submitted application 
for a benefit category review, as the TCET pathway is limited in size 
per the discussion in section I.G. of this Addendum.
g. Manufacturer Notification
    As noted previously, upon completion of CMS' review of the 
nomination, including the initial meeting with the manufacturer, 
discussions with FDA, and benefit category determination, CMS will 
notify the manufacturer by email whether the product has been accepted 
into the TCET pathway. In instances where CMS does not accept a 
nomination, CMS will offer a virtual meeting with the manufacturer to 
answer any questions and discuss other potential coverage pathways.
h. Evidence Preview (EP)
    Following acceptance into the TCET pathway, CMS will initiate an 
Evidence Preview, which is a systematic literature review that would 
provide early feedback on the strengths and weaknesses of the publicly 
available evidence for a specific item or service. The EP will be a 
focused, but not necessarily exhaustive, review that will help CMS to 
identify any material evidence shortfalls. We believe the review 
conducted for the Evidence Preview will offer greater predictability 
and transparency to manufacturers and CMS on the state of the evidence 
and any notable evidence gaps for coverage purposes. It is intended to 
efficiently inform judgments by CMS and manufacturers about the best 
available coverage options for an item or service. CMS intends for the 
EP to be supported by a contractor using 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 rapid 
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, independently contributes substantial portions of the EP, and 
ultimately determines appropriate coverage policy. To initiate an EP, 
CMS will request written permission from the manufacturer to share any 
confidential commercial information (CCI) included in the nomination 
submission with the contractor. CMS anticipates that the EP will take 
approximately 12 weeks to complete once the review is initiated, 
following acknowledgment of an accepted nomination in the TCET pathway. 
More time may be needed to complete the review in the event the product 
is novel, has conflicting evidence, or other unanticipated issues 
arise.
i. Evidence Preview Meeting
    CMS will share the EP with the manufacturer via email and will 
offer a meeting to discuss it. The EP will have been previously shared 
with AHRQ and may also be shared with FDA to obtain their feedback, as 
relevant. Representatives from those Agencies may participate in the EP 
meeting at their discretion. Manufacturers will have an opportunity to 
propose corrections to any errors, contribute supplemental materials, 
and raise any important concerns with the EP before it is finalized.
    CMS will review the manufacturer feedback on the EP and work with 
our contractor to revise the draft, as appropriate, prior to 
finalization. Upon finalizing the EP, manufacturers may request a 
meeting to discuss the strengths and weaknesses of the evidence and 
discuss the available coverage pathways (examples include an NCD, which 
could include CED, or seeking coverage decisions made by a MAC). These 
meetings to discuss the EP may be conducted virtually or in person and 
will be scheduled for 60 minutes. 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.

[[Page 65751]]

    There will be no publicly posted tracking sheet for manufacturers 
who withdraw from the TCET pathway after the completion of an EP. While 
CMS believes the EP will be a fair reflection of the strength of 
evidence available at that time to support Medicare coverage, CMS 
acknowledges that manufacturers may withdraw from the TCET pathway for 
reasons unrelated to the strength of evidence. Since the development of 
an EP review represents a substantial investment of public resources in 
a thorough evidence review for pre-market devices, CMS will publicly 
post a summary of the evidence. This summary will not include an 
evidence gap assessment.
j. Manufacturer's Decision To Continue or Discontinue With the TCET 
Pathway
    Upon finalization of the EP, the manufacturer may decide to pursue 
national coverage under the TCET pathway or to withdraw from the 
pathway. If the manufacturer decides to continue, the next step will 
include submitting a formal NCD request cover letter expressing the 
manufacturer's desire for CMS to open a TCET NCD analysis. Most, if not 
all, of the information needed to begin the TCET NCD would be included 
in the initial TCET pathway nomination and the EP. However, CMS invites 
the manufacturer to submit any additional materials the manufacturer 
believes would support the TCET NCD request.
k. Evidence Development Plan (EDP)
    If CMS and/or AHRQ identifies evidence gaps during the EP, the 
manufacturer should also submit an evidence development plan (EDP) to 
CMS that sufficiently addresses the evidence gaps identified in the EP. 
The EDP should be submitted to CMS simultaneously with the formal NCD 
request cover letter. The EDP 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. Additional 
information can be found here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Medicare-Coverage-Guidance-Documents-.
    An FFP study is one where the study design, analysis plan, and 
study data are appropriate for the question the study aims to answer. 
FFP study designs, which include traditional clinical study designs as 
well as those that rely on secondary use of real-world data, align 
sample size, duration, study type, analytic methods, etc., based on the 
utilization and risk profile of the item or service. We believe that 
permitting FFP study designs will be less burdensome for manufacturers 
and address the public's concerns that CED should be time-limited to 
facilitate the timely generation of evidence that can inform patient 
and clinician decision making and lead to predictable Medicare 
coverage.
    Postmarket FFP study proposals, particularly those that rely on 
real world data, have the potential to generate evidence that 
complements tightly controlled premarket traditional clinical trials by 
demonstrating external validity. Nonetheless, manufacturers should be 
aware that these studies require considerable planning in data 
validation, linkage, and transformation; specification of the study 
protocol and documentation of any changes; data analysis; and 
reporting. The study design, patient inclusion criteria, primary and 
secondary endpoints, treatment setting, analytic approaches, timing of 
outcome assessment, and data sources should be fully pre-specified in 
the submitted protocol. CMS notes that though FFP studies that use 
real-world data may be less burdensome in terms of data collection, 
they may take more time to complete due to lags in the availability of 
administrative claims needed for the analysis. When writing EDPs, 
manufacturers should propose clinically meaningful benchmarks for each 
study outcome and provide supporting evidence. FFP studies addressing 
specific evidence deficiencies identified in the EP may be proposed as 
part of a broader EDP.
    Manufacturers should incorporate a continued access study into 
their EDP to maintain market access between the completion of the 
primary EDP, the refresh of the evidence review, and the finalization 
of a decision regarding post-TCET coverage. 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.
l. EDP Submission Timing
    Because of the tight timeframes needed to effectuate CMS' goal of 
finalizing a TCET NCD within 6 months after FDA market authorization, 
manufacturers are strongly encouraged to begin developing a rigorous 
proposed EDP as soon as possible after receiving the finalized EP. To 
meet the goal of having a finalized EDP within approximately 90 
business days after FDA market authorization, the manufacturer is 
encouraged to submit an EDP to CMS as soon as possible after FDA market 
authorization.
m. EDP Meeting and Finalization of the EDP
    Once CMS receives the EDP from the manufacturer, CMS will have 30 
business days to review the proposed EDP and provide written feedback 
to the manufacturer. During this time, CMS will collaborate with AHRQ 
to evaluate the EDP to ensure that it addresses the material evidence 
gaps identified in the EP and meets established standards of scientific 
integrity and relevance to the Medicare population. CMS will 
incorporate AHRQ's feedback on the EDP and will email the consolidated 
feedback to the manufacturer. Soon after providing written feedback, 
CMS will schedule a meeting with the manufacturer, which may also 
include AHRQ, to discuss any recommended refinements and address any 
questions.
    In the EDP meetings, the manufacturer should be prepared to 
demonstrate: (1) a compelling rationale for its evidence development 
plan; (2) the study design, analysis plan, and data for any CED studies 
are all fit for purpose; and (3) any CED studies sufficiently addresses 
threats to internal validity. The EDP should include clear enrollment, 
follow-up, study completion dates for included studies, and the timing 
and content of scheduled updates to CMS on study progress. For FFP 
studies with expected completion timeframes longer than 5 years, 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. Manufacturers should present and justify their study 
outcomes and performance benchmarks.
    Following the EDP meeting, the manufacturer and CMS will have 
another 60 business days to make any adjustments to the EDP. We 
recognize that, in some instances, manufacturers may require additional 
time to develop and refine their EDP. In these instances, CMS may 
provide additional time to manufacturers, but we note that delays in 
submitting and revising an EDP may substantially impact the overall 
timeline for providing coverage under the TCET pathway. Elements of the 
CMS and AHRQ approved EDPs, specifically the non-proprietary 
information, will be made publicly available on the CMS website upon 
posting of the proposed TCET NCD. In addition, the anticipated CED NCD 
reconsideration window will also be posted. The forthcoming FFP 
guidance will provide information on the level of detail necessary to 
establish

[[Page 65752]]

that a proposed study is fit for purpose; while manufacturers should 
demonstrate all these elements to establish the scientific validity of 
a proposed study, not all details need to be public.
    In instances where the manufacturer's EDP is insufficient to meet 
CMS' and AHRQ's established standards and cannot be approved, CMS may 
exercise its option to withdraw acceptance into the TCET pathway as 
noted in section I.B. of this Addendum. We anticipate this will be a 
rare occurrence as CMS will make every effort to provide flexibility 
and information to manufacturers to facilitate the development of EDPs.
2. Coverage Under the TCET Pathway
    CMS follows applicable statutory requirements when developing 
coverage policy at the national level, which includes an open and 
transparent process. Though some elements of coverage review can be 
accelerated, gathering and reviewing meaningful public comment takes 
time. When CMS undertakes an NCD, we draw upon our analysis of the 
available evidence to identify the specific beneficiaries and 
conditions of coverage that are appropriate for the item or service. 
CMS also strongly considers information from patient advocacy 
organizations, specialty society guidance, expert consensus and 
recommendations for beneficiary selection, provider training and 
certification requirements, and facility requirements.
a. CMS NCD Review and Timing
    If a device that is accepted into the TCET pathway receives FDA 
market 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). The manufacturer may also withdraw from the TCET 
pathway at this stage in the process, in which case CMS would not 
proceed with the NCD review described in this section. As previously 
noted, the goal is to have a finalized EDP no later than 90 business 
days after FDA market authorization.
    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 an evidence 
summary from 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. Our goal is to release the 
proposed and final NCD before the statutory deadline that applies to 
all NCDs. More information on the NCD process is outlined in the August 
7, 2013 Federal Register notice (78 FR 48164).
b. Request for Specific Input on the Evidence Base and Conditions of 
Coverage
    Since the evidence base for these emerging technologies will likely 
be incomplete and practice standards not yet established, we believe 
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.
    Upon opening an NCD analysis, CMS strongly encourages these 
organizations to provide specific feedback on the state of the evidence 
and their suggested approaches to best practices for the emerging 
technologies under review. While CMS prefers 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. 
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. These 
organizations are encouraged to notify CMS when recommendations have 
been posted. All 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.
c. Coverage of Similar Devices
    FDA market-authorized Breakthrough Devices are often followed by 
similar devices that other manufacturers develop. We believe that it is 
important to let physicians and their patients make decisions about the 
best available treatment, depending upon each patient's situation. 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. 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.
    In these instances, CMS will follow the existing NCD process 
detailed in section 1862(l) of the Act.
d. Duration of Coverage Under the TCET Pathway
    The duration of transitional coverage through the TCET pathway will 
be tied to the CMS- and AHRQ-approved EDP. CMS expects that TCET CED 
studies will be listed on the clinicaltrials.gov website, and a summary 
of the EDPs as well as the anticipated CED NCD reconsideration window 
will be posted on the CMS website so the public can stay informed 
throughout the process. 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. Given the short timeframes in the TCET 
pathway, an unpublished publication draft that a journal has accepted 
may also be acceptable. CMS will consider the minimum period of 
transitional coverage necessary to address the evidence gaps identified 
in the EP. In general, we anticipate this transitional coverage period 
may last for 5 or more years as evidence is generated to address 
evidence gaps. However, CMS retains the right to reconsider an NCD at 
any point in time.
3. Transition to Post-TCET Coverage
    TCET provides time-limited coverage for devices with the potential 
to deliver improved outcomes to the Medicare population but do not yet 
meet the reasonable and necessary standard for coverage under section 
1862(a)(1)(A) of the Act. Consequently, TCET coverage is conditioned on 
further evidence development as agreed in a CMS- and AHRQ-approved EDP.
a. Updated Evidence Review
    CMS intends to initiate an updated evidence review within 6 
calendar months of the review date specified in the EDP. CMS intends to 
engage a third-party contractor to conduct a systematic literature 
review using detailed requirements that CMS developed in collaboration 
with AHRQ. The

[[Page 65753]]

contractor will then perform a qualitative evidence synthesis and 
compare those findings against the benchmarks for each outcome 
specified in the original NCD. After conducting quality assurance on 
the contractor review, CMS will assess whether the evidence is 
sufficient to reach the reasonable and necessary standard. CMS will 
also review applicable practice guidelines and consensus statements and 
consider whether the conditions of coverage remain appropriate. CMS 
will collaborate with AHRQ and FDA as appropriate as the updated 
Evidence Review is conducted and will share the updated review with 
them.
b. NCD Reconsideration
    Based upon the updated evidence review and consideration of any 
applicable practice guidelines, CMS, when appropriate, will open an NCD 
reconsideration by posting a proposed decision that proposes 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) permitting local MAC 
discretion under section 1862(a)(1)(A) of the Act. Neither an FDA 
market authorization nor a CMS approval of an Evidence Development Plan 
guarantees a favorable coverage decision. Standard NCD processes and 
timelines will continue to apply, and following a 30-day public comment 
period, CMS will have 60 days to finalize the NCD reconsideration.
    The steps previously described for the TCET process and for 
obtaining a CMS coverage determination are illustrated in the diagram:
[GRAPHIC] [TIFF OMITTED] TN12AU24.000

E. Roles

    CMS has outlined the general roles of each participant in the TCET 
pathway.
1. Manufacturer
    The manufacturer may voluntarily choose to email a non-binding 
letter of intent to CMS to express intent to nominate a device for the 
TCET pathway. The manufacturer initiates formal consideration for TCET 
by voluntarily submitting a complete nomination as outlined previously 
under ``1. b. Nominations for the TCET Pathway,'' of section I.D. of 
this Addendum titled ``Procedures for the TCET Pathway.'' In the 
interest of expediting CMS decision making, the manufacturer should be 
prepared to quickly and completely respond to all issues and requests 
for information raised by the CMS reviewers. If CMS does not receive 
information from manufacturers in a timely fashion, CMS review 
timelines will be lengthened, potentially significantly. Manufacturers 
are encouraged to submit any materials they plan to present during 
meetings with CMS at least 7 days in advance of the scheduled meeting. 
Manufacturers should be prepared with the resources and skills to 
successfully develop, conduct, and complete the studies included in the 
EDP.
2. CMS
    CMS will provide a secure and confidential nomination and review 
process as outlined previously in section I.D. of this Addendum. CMS 
will initiate review of nominations for the TCET pathway by retrieving 
applications from the secure mailbox and communicating with FDA 
regarding Breakthrough Devices seeking coverage under the TCET pathway. 
CMS will also oversee the work of the contractor conducting evidence 
reviews and will perform extensive quality assurance on contracted 
reviews, independently contribute substantial portions of the EP, and 
ultimately determine appropriate coverage policy. Along with AHRQ, CMS 
will review and make decisions regarding EDPs. Throughout all stages of 
the TCET pathway, CMS intends to maintain open communication channels 
with FDA, AHRQ, and the relevant manufacturer and fulfill its statutory 
obligations concerning the NCD process.
3. FDA
    FDA will keep open lines of communication with CMS on Breakthrough 
Devices seeking coverage under the TCET pathway as resources permit. 
Participation in the TCET pathway does not change the review standards 
for FDA market authorization of a device, which are separate and

[[Page 65754]]

distinct from the standards governing a CMS NCD.
4. AHRQ
    Currently, 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 clinical research studies 
to address the CED questions and meet the general standards for CED 
studies (https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development). Since we anticipate that many NCDs conducted under the 
TCET pathway will result in CED decisions, AHRQ will continue to review 
all CED NCDs to ensure they are 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 Evidence Preview and EDP are being 
developed, and approvals for these documents will be a joint CMS-AHRQ 
decision.

F. TCET and Parallel Review

    While the TCET pathway will be limited to Breakthrough Devices, 
other potential expedited coverage mechanisms, such as Parallel Review, 
remain available. Eligibility for the Parallel Review program is 
broader than for the TCET pathway and could facilitate expedited CMS 
review of non-Breakthrough Devices. To achieve greater efficiency and 
to simplify the coverage process generally, CMS intends to work with 
FDA to consider updates to the Parallel Review program and other 
initiatives to align procedures, as appropriate.

G. Prioritizing Requests

    CMS intends to review TCET pathway nominations on a quarterly 
basis. CMS anticipates accepting up to five TCET candidates annually 
based on current resources. Any follow-on devices in the TCET pathway 
will not count toward CMS' annual limit. To provide greater 
transparency, consistency, and predictability, we intend to release 
proposed prioritization factors in the near future. The public will 
have an opportunity to provide comment on CMS' proposed prioritization 
factors. In the interim, CMS intends to prioritize innovative medical 
devices that, as determined by CMS, have the potential to benefit the 
greatest number of individuals with Medicare.

H. TCET Transparency

    While CMS will not divulge the identity of specific manufacturers 
or devices in the TCET pathway prior to the opening of an NCD, we 
believe it is important to provide transparency regarding the devices 
accepted into the pathway. Specifically, CMS will include 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 into future iterations of the NCD Dashboard. We intend to 
update the NCD Dashboard quarterly.

[FR Doc. 2024-17603 Filed 8-7-24; 4:15 pm]
BILLING CODE 4120-01-P