[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41633-41644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3421-NC]


Medicare Program; Transitional Coverage for Emerging Technologies

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

ACTION: Notice with comment period.

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SUMMARY: This notice with comment period provides information to the 
public on the process we will use to provide transitional coverage for 
emerging technologies (TCET) through the national coverage 
determination (NCD) process under the Social Security Act (the Act). It 
also solicits public comment on the proposed TCET pathway.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, by 5 p.m. on August 28, 2023.

ADDRESSES: In commenting, refer to file code CMS-3421-NC.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulatory document to https://www.regulations.gov. Follow the ``Submit 
a comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3421-NC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3421-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

[[Page 41634]]

I. Background

    This notice describes the process 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 the Centers 
for Medicare & Medicaid Services' (CMS') experience with the Parallel 
Review program and the Coverage with Evidence Development (CED) 
pathway. Additionally, the TCET pathway reflects the feedback received 
from multiple stakeholder groups, 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 Technologies (MCIT) 
pathway (referenced later in this section) as well as during the 
listening sessions that were held following the repeal of the MCIT/
Reasonable and Necessary (R&N) final rule (86 FR 62944, November 15, 
2021). The TCET pathway described in this notice is intended to balance 
multiple considerations when making coverage determinations: (1) 
facilitating early, predictable and safe beneficiary access to new 
technologies; (2) reducing uncertainty about coverage by evaluating 
early the potential benefits and harms of technologies with innovators; 
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.
    The Medicare program serves over 62 million beneficiaries and is 
the largest single health care purchaser in the U.S. Currently, 
approximately 60 percent of the total Medicare beneficiary population, 
or 36 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) 2021, comprised of approximately 221 
million Part A claims (such as inpatient care in hospitals, skilled 
nursing facility care, hospice care, and home health care) and 956 
million Part B claims (such as doctor and other health care services 
and outpatient care, durable medical equipment, and some preventive 
services), providing approximately $424 billion in Medicare FFS 
benefits.\1\
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    \1\ https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.
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    Medicare covers a wide range of items and services. In general, in 
order 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 in order to 
facilitate expeditious beneficiary access to items and services that 
meet the statutory standard for coverage. We recognize that new 
approaches are needed to make decisions on certain new items and 
services, such as medical devices, more quickly to provide expedited 
access to new and innovative medical technologies. On November 15, 2021 
(86 FR 62944), CMS published a final rule that repealed an earlier rule 
that never became legally effective and thus was not implemented.\2\ As 
promised in the repeal, CMS has conducted additional opportunities to 
engage with the public and stakeholders. We have incorporated that 
input, along with input gathered in MCIT rulemaking, into our plans to 
improve the Medicare coverage process when making decisions on certain 
emerging technologies at the national level.
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    \2\ https://www.govinfo.gov/content/pkg/FR-2021-11-15/pdf/2021-24916.pdf.
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    One of the issues identified in the prior rulemaking was that the 
agency did not adequately address how certain steps, which are 
necessary to implement national coverage determinations for a new item 
or service, would be accomplished in a timely manner. Specifically, 
under the Medicare program an item or service must fall within the 
parameters of a benefit category that is within the scope of Part A or 
Part B. Commenters have requested that CMS explain how benefit category 
determinations (BCDs) will be made in connection with emerging 
technology. CMS was also encouraged to align coding and payment 
processes to facilitate coverage and payment for new or emerging 
technologies.
    Over the last several years, stakeholders have expressed support 
for coverage process improvements and a new pathway that is more 
flexible, transparent, predictable, and collaborative. Additionally, 
stakeholders expressed that that they would like for CMS to develop a 
more agile, iterative evidence review process that considers real world 
evidence and fit-for-purpose evidence study designs. Further, we have 
heard concerns from stakeholders that device coverage lags further 
behind that of drugs and biologics and, devices are more in need of a 
program like TCET. In light of the unique FDA criteria for Breakthrough 
designation status (described later in this document), we are limiting 
the TCET pathway to certain eligible FDA-designated Breakthrough 
Devices, since we believe that this is the area with the most immediate 
need.
    We are committed to establishing an alternative coverage pathway 
that better 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 in Medicare 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 will 
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

[[Page 41635]]

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 usually 
finalize proposed LCDs within 365 days from opening, per Chapter 
13.5.1--Local Coverage of the PIM.\3\ That chapter will continue to be 
used in making determinations under section 1862(a)(1)(A) of the Act 
for items and services at the local level.
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    \3\ CMS Program Integrity Manual, Chapter 13 Local Coverage 
Determinations, available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf.
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3. National Coverage Determinations (NCDs)
    The term ``national coverage determination'' is defined in section 
1862(l)(6)(A) of the Act and means a determination by the Secretary of 
the Department of Health and Human Services (the Secretary) with 
respect to whether or not a particular item or service is covered 
nationally under Title XVIII of the Act. In general, NCDs are national 
policy statements published to identify the circumstances under which a 
particular item or service will be considered covered (or not covered) 
by Medicare. NCDs serve as generally applicable rules to ensure that 
similar claims for items or services are covered in the same manner. 
Often an NCD is written in terms of defined clinical characteristics 
that identify a population that may or may not receive Medicare 
coverage for a particular item or service. Traditionally, CMS relies 
heavily on health outcomes data to make NCDs.
    Most NCDs have involved determinations under section 1862(a)(1)(A) 
of the Act, but NCDs can be made based on other provisions of the Act, 
such as section 1862(a)(1)(E) of the Act. Under section 1862(a)(1)(E) 
of the Act, Medicare has provided coverage for certain promising 
technologies with a limited evidence base on the condition that they 
are furnished in the context of approved clinical studies or with the 
collection of additional clinical data. CMS has used section 
1862(a)(1)(E) of the Act to support the ``Coverage with Evidence 
Development'' or ``CED'' policy since July 12, 2006, and the most 
recent CED policy is described in our November 20, 2014 guidance 
document.\4\ In general, CED enables providers and suppliers to perform 
high quality studies that we expect will produce evidence that may lead 
to positive national coverage determinations under section 
1862(a)(1)(A) of the Act.
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    \4\ The 2014 guidance document is available at https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=27.
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    The Agency for Healthcare Research and Quality (AHRQ) reviews all 
CED NCDs established under section 1862(a)(1)(E) of the Act. Consistent 
with section 1142 of the Act, AHRQ collaborates with CMS to define 
standards for the clinical research studies to address the CED 
questions and meet 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,\5\ 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. BCDs are made outside the Coverage 
and Analysis Group. While they may often be completed within 3 months, 
in some cases BCDs may take considerably longer. While CMS is working 
to better align the coverage and BCD review processes, manufacturers 
should be aware that in some cases benefit category reviews may not be 
completed within the accelerated timeframes needed for the TCET 
pathway. Moreover, in order 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.\6\
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    \5\ Note: Medicare does not develop NCDs for Part D.
    \6\ Section 1869(f)(4) of the Act.
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    In addition to these coverage pathways, CMS has established a 
Clinical Trial Policy (CTP) NCD 310.1. The CTP policy is applied when 
Medicare covers routine care items and services (but generally not the 
technology under investigation) in a clinical study that is supported 
by certain Federal agencies. The CTP coverage policy was developed in 
2000.\7\ We note that coverage under CED and the CTP may not occur at 
the same time. Additionally, this coverage policy has not generally 
been utilized by device manufacturers because they usually seek 
coverage of the device under investigation, which is not always 
available under the CTP.
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    \7\ 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.
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    Lastly, CMS has established the Parallel Review program. In the 
September 17, 2010 Federal Register (75 FR 57045), FDA and CMS 
announced their intention to initiate a Parallel Review pilot program 
in an effort to increase 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 in order 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 quality 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 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

[[Page 41636]]

injury for individuals in the Medicare population.
    These two reviews are separate and are conducted independently by 
the two agencies. At CMS, we respect the findings of our FDA colleagues 
and appreciate the expertise they bring to the premarket review process 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA 
review of devices does not focus specifically on the Medicare 
population.
    Among other objectives, FDA conducts 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. 
An FDA-regulated product must receive marketing authorization \8\ 
(unless exempt from FDA premarket review) for at least one indication 
to be eligible for consideration of Medicare coverage (except in 
specific circumstances). However, FDA approval or clearance alone does 
not entitle that technology to Medicare coverage, given 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 specifically because of the lack of evidence 
concerning individuals in the Medicare population. This is an important 
consideration for manufacturers and other interested parties who are 
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 
fully favorable Medicare national coverage determination under section 
1862(a)(1)(A) of the Act. In these instances, it is difficult to make a 
prospective national reasonable and necessary determination as to 
whether Medicare should cover the device with evidence development or 
should limit the NCD to coverage for only individuals with certain 
conditions or procedures performed by certain practitioners or health 
care facilities with expertise necessary to safely treat the individual 
with the new technology.
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    \8\ Additional information on FDA marketing authorization, 
specifically device approvals, denials and clearances can be 
accessed here: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances.
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    In general, as discussed, under the Medicare statute (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 durability of 
those outcomes. If there are no data on those elements in the Medicare 
population, it is difficult for CMS to make an evidence-based decision 
whether the device is reasonable and necessary for the Medicare 
population.
    Because Medicare beneficiaries are often older, with multiple 
comorbidities, and are often underrepresented or not represented in 
many clinical studies, CMS considers whether the evidence shows that 
the item or service will improve the health of Medicare patients.\9\ 
According to a recent study,10 11 approximately 50 percent 
of Medicare patients have two or more diseases. Clinical studies that 
are conducted in order to gain FDA market authorization are not 
necessarily required to include participants with similar demographics 
and characteristics of the Medicare population. A potential reason 
there may not be a strong evidence base specific to the Medicare 
population could include the desire by device manufacturers to 
demonstrate the safety and effectiveness of a device as clearly as 
possible. To achieve this aim, many studies impose stringent exclusion 
criteria that disqualify individuals with certain characteristics, such 
as comorbidities and concomitant treatment, that might make the effect 
of the investigational device more difficult to determine. 
Consequently, the potential benefits and harms of a device for older 
patients with more comorbidities may not be well understood at the time 
of FDA market authorization.
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    \9\ Davide L Vetrano, MD, Katie Palmer, Ph.D., Alessandra 
Marengoni, MD, Ph.D., Emanuele Marzetti, MD, Ph.D., Fabrizia 
Lattanzio, MD, Ph.D., Regina Roller-Wirnsberger, MD, MME, Luz Lopez 
Samaniego, Ph.D., Leocadio Rodr[iacute]guez-Ma[ntilde]as, MD, Ph.D., 
Roberto Bernabei, MD, Graziano Onder, MD, Ph.D., Frailty and 
Multimorbidity: A Systematic Review and Meta-analysis, The Journals 
of Gerontology: Series A, Volume 74, Issue 5, May 2019, Pages 659-
666, 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.
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C. FDA Breakthrough Devices Program

    Under the TCET coverage pathway, CMS will coordinate with FDA and 
manufacturers of Breakthrough Devices as those devices move through the 
FDA premarket review processes to ensure timely Medicare coverage 
decisions following any FDA market authorization, as described in 
detail later in this section. The Breakthrough Devices Program is an 
evolution of the Expedited Access Pathway Program and the Priority 
Review Program. See section 515B of the FD&C Act, 21 U.S.C. 360e-3; see 
also final guidance for industry entitled, ``Breakthrough Devices 
Program.'' \12\
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    \12\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
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    FDA's Breakthrough Devices Program is not for all new medical 
devices; rather, it is only for those that FDA determines meet the 
standards for Breakthrough Device designation. In accordance with 
section 515B of the FD&C Act (21 U.S.C. 360e-3), the Breakthrough 
Devices Program is for medical devices and device-led combination 
products \13\ that meet two criteria. The first criterion is that the 
device provides for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating human disease or conditions. 
The second criterion is that the device must satisfy one of the 
following elements: It represents a breakthrough technology; no 
approved or cleared alternatives exist; it offers significant 
advantages over existing approved or cleared alternatives, including 
the potential, compared to existing approved alternatives, to reduce or 
eliminate the need for hospitalization, improve patient quality of 
life, facilitate patients' ability to manage their own care (such as 
through self-directed personal assistance), or establish long-term 
clinical efficiencies; or device availability is in the best interest 
of patients (for more information see 21 U.S.C. 360e-3(b)(2)). These 
criteria make Breakthrough designated devices unique. Devices meeting 
these criteria

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are also likely to be highly relevant to the needs of the Medicare 
population, if the item or service falls within a Medicare benefit 
category.
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    \13\ Information on device-led combination products can be 
accessed here: https://www.fda.gov/media/119958/download.
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II. Provisions of the Notice With Comment Period

    This notice proposes to create the TCET pathway. Since the TCET 
pathway relies on our existing authorities, we believe that 
establishing TCET through a procedural notice rather than rulemaking 
has the advantages that it is faster to implement and can be more 
easily modified as we gain experience with the approach. We also 
describe the procedures for how stakeholders and the public at large 
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 pursue our efforts to work with various sectors of 
the scientific and medical community to develop and publish guidance 
documents on our website that describe our approach when analyzing 
scientific and clinical evidence to develop an NCD. In response to 
stakeholder feedback, our proposed CED and Evidence Review guidance 
documents propose to incorporate robust fit-for-purpose evidence 
development where manufacturers may use fit-for-purpose studies to 
close any evidence gaps. Fit-for-purpose studies are those where the 
study design, analysis plan, and study data can credibly answer the 
research question. Additionally, CMS intends to 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 which will be available on the CMS coverage website which can 
be accessed at https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html.

A. TCET Pathway--An Opportunity To Accelerate Patient Access to 
Beneficial 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, it is rare that there is 
sufficient clinical evidence to support broad national coverage at this 
point.
    In general, CMS relies heavily on health outcomes data, including 
but not limited to health outcomes data as it relates to the Medicare 
population, before 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 lifestyle regarding health outcomes (for example, 
mortality, disease progression, 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. 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.
    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 includes attention to the 
intended users' racial and ethnic backgrounds, sex and gender, age, 
disabilities, important comorbidities, and depends on data being 
available on these characteristics 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 appropriate for 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 access to 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.
    CMS has issued a total of 26 NCDs requiring CEDs over the last two 
decades to provide Medicare beneficiary access to promising items and 
services that could not otherwise be covered under section 
1862(a)(1)(A) of the Act. CMS has approved 109 CED studies and five 
national registries to facilitate evidence development for these CED 
NCDs. Forty-two of these studies have generated evidence across 14 
topics covered under CED. Three CED NCD topics have had the CED 
requirement removed following an NCD reconsideration and have received 
national coverage.
    With respect to evidence generation, the TCET pathway would build 
upon

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CMS and AHRQ's ongoing collaboration on the CED NCD process. We 
anticipate that many of the 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 resources allow on evidence development activities 
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. CMS and AHRQ have made iterative 
refinements to the CED coverage pathway over time, and while we believe 
CED has reduced barriers to innovation and expanded beneficiary access 
to new technologies and therapies, our experience over the last several 
years indicates that further improvements can be made to the CED 
process. We believe that certain coverage decisions--in particular, 
those involving innovative devices--would benefit from a more 
systematic framework for CED that establishes a more predictable and 
transparent approach for the public when facilitating evidence 
development.
    Working in conjunction with AHRQ, our goal is to improve CED so 
that it fulfills its potential as a mechanism that simultaneously 
reduces barriers for innovation and enables CMS to make better informed 
decisions on coverage for medical devices that improve health outcomes 
for Medicare beneficiaries. CMS believes that public input should 
inform this effort, and we will continue to provide numerous 
opportunities for stakeholders to engage with us as we convene future 
Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) 
meetings and update specific aspects of the CED paradigm.
    For example, CMS has been actively collaborating with AHRQ on 
potential revisions to the general criteria for CED studies, originally 
described in 2014, to ensure the criteria are up to date and continue 
to maintain rigorous evidentiary standards. In November 2022, in order 
to better inform the CED process, AHRQ released a final report on ``The 
Analysis of Requirements for Coverage with Evidence Development 
(CED).'' \14\ The AHRQ report was first released in draft form in 
September 2022 and the public had an opportunity to provide comment on 
the draft report. The AHRQ report served as the basis for discussion at 
the February 13-14, 2023 MEDCAC meeting. CMS convened the MEDCAC to 
examine the general requirements for clinical studies submitted for CMS 
coverage under CED. The MEDCAC panel consisted of a variety of experts 
on the topic and included an industry representative and patient 
advocate. MEDCAC guest panel members included representatives from FDA, 
AHRQ, and National Institutes of Health (NIH). Specifically, the MEDCAC 
evaluated the CED criteria to assure that studies informing CED are 
assessed using consistent, feasible, transparent and methodologically 
rigorous criteria. The MEDCAC advised CMS on whether the criteria are 
appropriate to ensure that studies approved to inform CED decisions 
will produce informative evidence that CMS can rely on when making 
future reasonable and necessary determinations.\15\ AHRQ and CMS 
collaboratively evaluated the information discussed at the MEDCAC 
meeting as well as the MEDCAC panel scores and are considering 
corresponding refinements to the proposed new criteria. CMS is 
proposing updated criteria in a proposed CED guidance document and the 
public will have an opportunity to provide comment on that document. 
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.
---------------------------------------------------------------------------

    \14\ https://effectivehealthcare.ahrq.gov/products/coverage-evidence-development/research-report.
    \15\ Additional information on the MEDCAC can be found at 
https://www.cms.gov/medicare-coverage-database/view/medcac-meeting.aspx?medcacid=79&year=all&sortBy=meetingdate&bc=15.
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    More specifically, coverage under a CED NCD can expedite earlier 
beneficiary access for individuals who volunteer to participate in the 
clinical studies of 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 of new technologies, or to new applications of 
older technologies. CMS' current CED guidance document contains 
specific criteria that details patient protections under CED. As we 
note earlier, we are proposing updated criteria that reflects the 
feedback received on the November 2022 AHRQ report and February 2023 
MEDCAC in a proposed CED guidance document. Because the TCET pathway 
described in this document would utilize the existing CED NCD process, 
all of these safeguards would apply if finalized.
    Stakeholder input 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 stakeholder engagement would also 
be available in TCET.

B. TCET General Principles

    CMS is committed to ensuring Medicare beneficiaries have access to 
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 off of 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. 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. Others are not indicated for use in a 
population that includes Medicare beneficiaries (for example, those 
devices that are targeted toward a pediatric population).
     CMS may conduct an early evidence review (Evidence 
Preview, more details in section II.D.1.g. of this notice with comment 
period) before FDA decides on marketing authorization for the device 
and discuss with the manufacturer the best available coverage

[[Page 41639]]

pathways depending on the strength of the evidence.
     Prior to FDA marketing authorization, CMS may initiate 
discussions with manufacturers to 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 post-market 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. If a manufacturer does not wish the 
information that would be revealed by the posting of the NCD tracking 
sheet to become public, it should withdraw from the TCET pathway prior 
to this point. CMS requests that a manufacturer who wishes to withdraw 
from the TCET pathway notify CMS by email at [email protected].

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; \16\
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    \16\ For more information on benefit category determinations see 
the CMS Innovator's Guide to Navigating Medicare (https://www.cms.gov/medicare/coverage/councilontechinnov/downloads/innovators-guide-master-7-23-15.pdf). Please note that an updated 
version of the Innovators' Guide is forthcoming. The updated guide 
will reflect a new name, the CMS Guide for Medical Technology 
Companies and Other Interested Parties, which can be found here upon 
release (the URL we have requested for this is: https://www.cms.gov/cms-guide-medical-tech-companies-other-parties).
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     Not already the subject of an existing Medicare NCD; and
     Not otherwise excluded from coverage through law or 
regulation.\17\
---------------------------------------------------------------------------

    \17\ Information on coverage exclusions can be accessed here: 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf.
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    In section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(h)(1), the definition of device includes diagnostic 
laboratory tests. Diagnostic lab tests are a highly specific area of 
coverage policy development, and CMS has historically delegated review 
of many of these tests to specialized MACs. We believe that the 
majority of coverage determinations for diagnostic tests granted 
Breakthrough Designation should continue to be determined by the MAC 
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. Nominations for the TCET Pathway
    The appropriate timeframe for manufacturers to submit TCET pathway 
nominations to CMS is approximately 12 months prior to anticipated FDA 
decision on a submission as determined by the manufacturer. 
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.\18\ CMS encourages manufacturers not to delay 
submitting nominations to facilitate alignment among CMS benefit 
category determination, and coverage, coding and payment 
considerations.
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    \18\ 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).
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    The manufacturer may submit a nomination for the TCET pathway by 
sending an email to [email protected], which indicates their interest in 
the pathway. 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 the product.
     Succinct description of the technology and disease or 
condition the device is intended to diagnose or treat.
     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 Designation and the PMA application, De Novo request or 
premarket notification (510(k)) submission, if available, is preferred.
     A comprehensive list of peer-reviewed, English-language 
publications that support the nominated Breakthrough Device as 
applicable/available.
     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 to facilitate benefit category and coding 
determinations.
    Two good sources of information to facilitate the development of 
nomination submissions are the CMS Coverage website at https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center and the CMS 
Innovators' Guide to Navigating Medicare at https://www.cms.gov/medicare/coverage/councilontechinnov/downloads/innovators-guide-master-7-23-15.pdf, which provides information that may facilitate durable 
medical equipment, prosthetics, orthotics, and supplies (DMEPOS) BCDs, 
along with coverage, coding and payment processes, and considerations. 
We note that an updated version of the Innovators' Guide is 
forthcoming. The updated guide will reflect a new name, the CMS Guide 
for Medical Technology Companies and Other Interested Parties, which 
can be found at the URL we have requested for this upon release: 
https://www.cms.gov/cms-guide-medical-tech-companies-other-parties.
     A statement describing how the medical device addresses 
the health needs of the Medicare population.
     A brief statement explaining why the device is an 
appropriate candidate for the TCET pathway as described under the 
section II.C. of this document (``B. Appropriate Candidates'').
    CMS will contact the manufacturer by email to confirm that a 
submitted nomination appears to be complete and is under review by CMS. 
This email will include the date that CMS initiated the review of the 
complete nomination. If

[[Page 41640]]

the nomination is not complete, CMS will contact the manufacturer for 
more information.
b. CMS Consideration
    CMS may contact the manufacturer to request supplemental 
information to ensure a timely review of the nomination. CMS commits to 
making at least a preliminary decision to provisionally accept or 
decline a nomination within 30 business days following the date noted 
in CMS' email to manufacturer as described previously and will 
communicate this information to the manufacturer by email. The process 
for determining whether or not the technology falls within a benefit 
category may take longer and, in those instances, CMS will send a 
subsequent email to the manufacturer communicating a final decision on 
the nomination when the benefit category review is completed.
c. 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.
d. 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 \19\ 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), 
Public Law 104-191).
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    \19\ https://www.fda.gov/about-fda/domestic-mous/mou-225-10-0010.
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e. 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 that 
all medical devices will fall within a benefit category. If CMS 
believes that the device, prior to a decision on its approval or 
clearance by FDA, is likely to be coverable 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 
approval or clearance of the device by FDA. 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, prior to a 
decision on its approval or clearance by FDA, will not fall under an 
existing benefit category, the TCET nomination will be denied and this 
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 its size per the discussion that follows 
in section II.G. of this document.
f. 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 is an appropriate 
candidate for the TCET pathway at this time. 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.
g. Evidence Preview
    Following CMS' determination that the product is an appropriate 
candidate, 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 Evidence Preview 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 efficiency, 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 inform judgments 
by CMS and manufacturers about the best available existing coverage 
options for an item or service. CMS intends for the Evidence Preview to 
be conducted by a contractor using standardized evidence grading, risk 
of bias assessment, and applicability assessment according to a 
protocol initially developed in collaboration with AHRQ in 2020. In 
order to initiate an Evidence, Preview, 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 Evidence Preview will take 
approximately 12 weeks to complete once the review is initiated, 
following acknowledgement 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.
h. Evidence Preview Meeting
    CMS will share the Evidence Preview with the manufacturer via email 
and will offer a meeting to discuss it. The Evidence Preview 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 Evidence Preview meeting. Manufacturers will 
have an opportunity to propose corrections to any errors and raise any 
important concerns with the Evidence Preview.
    CMS will review the manufacturer feedback on the Evidence Preview 
and work with our contractor to revise the draft, as appropriate, prior 
to finalization. Upon finalizing the

[[Page 41641]]

Evidence Preview, 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 Evidence Preview may be conducted virtually or in person and will 
be scheduled for 60 minutes.
    For those manufacturers who withdraw from the TCET pathway 
following the completion of an Evidence Preview, there will be no 
publicly posted tracking sheet and no public notification that an 
Evidence Preview was completed. However, we believe it is in the best 
interests of patients and the Medicare program to share the Evidence 
Preview with the MACs to aid them in their decision making since the 
development of an Evidence Preview represents a substantial investment 
of public resources in a thorough evidence review for pre-market 
devices. We solicit public comment on this approach.
i. Manufacturer's Decision to Continue or Discontinue With the TCET 
Pathway
    Upon finalization of the Evidence Preview, the manufacturer may 
decide to pursue national coverage under the TCET pathway or to 
discontinue with the pathway. If the manufacturer decides 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. Most, if not all, of the information needed to begin the TCET 
NCD would be included in the initial TCET pathway nomination, however, 
CMS invites the manufacturer to submit any additional materials the 
manufacturer believes would support the TCET NCD request.
j. Evidence Development Plan (EDP)
    If evidence gaps are identified by CMS and/or AHRQ during the 
Evidence Preview, the manufacturer should also submit an evidence 
development plan (EDP) to CMS that sufficiently addresses the evidence 
gaps identified in the Evidence Preview. The EDP should be submitted to 
CMS at the same time as the formal NCD request cover letter. The EDP 
may include traditional clinical study designs or fit-for-purpose study 
designs or both, including 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-.
    Over the last several years, and most recently during the two 
stakeholder listening sessions we held on February 17, and March 31, 
2022, we heard from stakeholders that they would like for CMS to 
utilize a more agile, iterative evidence review process that considers 
fit-for-purpose (FFP) study designs, including those that make 
secondary use of real-world data. 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 scale sample size, 
duration, and study type, etc., based off of the utilization and risk 
profile of the item or service. We are partnering with AHRQ to consider 
how to incorporate greater flexibility into the CED paradigm by 
allowing FFP evidence study designs that meet rigorous CMS evidence 
requirements. Any updates will be communicated in guidance documents 
and potential rulemaking as applicable and will include an opportunity 
for public comment. We believe that FFP study designs will be less 
burdensome for manufacturers. We also believe that by incorporating FFP 
study designs, we will address one of 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; 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. When writing 
EDPs, manufacturers should propose clinically meaningful benchmarks for 
each study outcome and provide supporting evidence.
    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, with a focus on device utilization, geographic 
variations in care, and access disparities for traditionally 
underserved populations.
k. EDP Submission Timing
    Because of the tight timeframes that are 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 Evidence Preview. To meet the goal of having a finalized 
EDP 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.
l. EDP Meeting and Finalization of the EDP
    Once CMS receives the EDP from the manufacturer, it will share the 
document with AHRQ. 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 meets established standards of scientific integrity and 
relevance to the Medicare population. CMS will incorporate AHRQ's 
feedback on the EDP and will share the consolidated feedback with the 
manufacturer by email. 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 are all fit for 
purpose; and (3) the study sufficiently addresses threats to internal 
validity. The EDP should include clear enrollment, follow-up, study 
completion dates, and the timing and content of scheduled updates to 
CMS on study progress. 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 from the date of the EDP meeting 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

[[Page 41642]]

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 instances where the manufacturer's EDP is 
insufficient to meet CMS' and AHRQ's established standards and is 
therefore not able to be approved, CMS may exercise its option to 
withdraw participation from the TCET pathway as noted in II.B. of this 
document. 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 the statutory requirements, which includes an open and 
transparent process, when developing coverage policy at the national 
level. 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 
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). The manufacturer may also request that their device 
be withdrawn 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 elements of the 
finalized Evidence Preview, specifically the non-proprietary 
information, which would initiate the start of 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 in advance of the statutory deadline that 
applies to all NCDs. More information on the NCD process is set forth 
in the August 7, 2013 Federal Register notice (78 FR 48164).
b. Request for Specific Stakeholder 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 the opening of 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 that is in the public 
domain while undertaking an NCD, CMS encourages these organizations to 
publicly post on their website 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 the patient's individual 
situation. Rather than extending privileged coverage status only to the 
first device that achieves FDA market authorization, we are seeking 
comments on whether coverage of similar devices using CED would 
establish a level playing field and avoid delays in access that would 
occur if a separate NCD were required to ensure coverage. To be 
eligible for coverage under a TCET NCD, similar devices will be subject 
to the same coverage conditions, including a requirement to propose an 
EDP. Elements of the approved EDPs for similar devices, specifically 
the non-proprietary information, will be posted on the CMS website. In 
some cases, studies under the 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 seeks public comments on its approach for 
providing coverage for similar devices under the TCET pathway.
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. The review date specified in 
the EDP will provide one 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. In general, we anticipate 
this transitional coverage period would last for a period of 3 to 5 
years as evidence is generated to address evidence gaps identified in 
the Evidence Preview. 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 conduct an updated evidence review within 6 calendar 
months of the review date specified in

[[Page 41643]]

the EDP. To conduct the review, 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 
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 which 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 to make a decision 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 follows with 
the applicable estimated timelines for obtaining a CMS coverage 
determination are illustrated in the diagram:
[GRAPHIC] [TIFF OMITTED] TN27JN23.013

E. Roles

    CMS has outlined the general roles of each participant in the TCET 
pathway.
1. Manufacturer
    The manufacturer initiates consideration for TCET by voluntarily 
submitting a complete nomination as outlined previously under ``1. 
Nomination,'' of section II.D of this document entitled ``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 II.C. of this document. 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. 
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 
distinct from the standards governing a CMS NCD.
4. AHRQ
    Currently, AHRQ reviews all CED NCDs established under section

[[Page 41644]]

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 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 resources allow to evaluate the 
Evidence Preview and EDP and will have opportunities to offer feedback 
throughout the process that will be shared with manufacturers. AHRQ 
will be a 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 and respond within 
30 days after receipt of the email. At present, CMS anticipates 
accepting up to five TCET candidates annually due to CMS resource 
constraints. CMS intends to prioritize innovative medical devices that, 
as determined by CMS, have the potential to benefit the greatest number 
of individuals with Medicare.

III. Collection of Information Requirements

    Based on our initial assessment of Breakthrough Devices applying 
the characteristics we list in II.C. of this notice with comment period 
regarding appropriate candidates for the TCET pathway, we anticipate 
that we will receive approximately eight nominations for the TCET 
pathway per year. Due to current CMS resource constraints, 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 Paperwork Reduction Act (PRA) at 5 CFR 1320.3(c). As 
we gain experience with the TCET pathway, if we receive a higher number 
of respondents than anticipated, we will provide an updated analysis.

IV. Response to Comments

    Because of the large number of public comments, we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this notice, 
and, when we proceed with a subsequent document, we will respond to the 
comments in that document.

    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on June 20, 2023.

    Dated: June 21, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-13544 Filed 6-22-23; 4:15 pm]
BILLING CODE 4120-01-P