[Federal Register Volume 91, Number 153 (Tuesday, August 11, 2026)]
[Notices]
[Pages 51710-51718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-16368]
[[Page 51710]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3487-NC]
Medicare Program; Regulatory Alignment for Predictable and
Immediate Device (RAPID) Coverage Pathway
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 CMS will use to provide accelerated Medicare
coverage through the Regulatory Alignment for Predictable and Immediate
Device (RAPID) coverage pathway for new innovative technologies. The
RAPID coverage pathway leverages existing processes to provide
expedited national Medicare coverage for eligible technologies. This
notice with comment period solicits public comment on the proposed
RAPID coverage pathway.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by October 13, 2026.
ADDRESSES: In commenting, refer to file code CMS-3487-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
regulation to https://www.regulations.gov/docket/CMS-2026-2674. 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-3487-NC, P.O. Box 8010,
Baltimore, MD 21244-8010.
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-3487-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
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.
I. Background
This notice with comment period describes the process we will use
to provide national coverage for eligible technologies under the
Regulatory Alignment for Predictable and Immediate Device (RAPID)
coverage pathway. The RAPID coverage pathway will provide accelerated
Medicare beneficiary access to certain eligible Class II and Class III
U.S. Food and Drug Administration (FDA) Breakthrough-designated
Devices. CMS will work with FDA to leverage current processes to
provide predictable and timely coverage for devices that demonstrate
positive clinical health outcomes for the Medicare population in the
premarket phase. For these devices, a proposed National Coverage
Determination (NCD) will be released on the same day as FDA market
authorization. The timing of the release of the proposed NCD will
coincide with both FDA market authorization and public availability of
the relevant FDA Decision Summary or Summary of Safety and
Effectiveness Data (SSED). A final NCD will be issued approximately 60
days later for Class II devices and 90 days later for Class III
devices.
The RAPID coverage pathway is designed to align with existing
programs and coverage frameworks. Specifically, the RAPID coverage
pathway leverages FDA's existing process to assess clinical outcomes
(direct measures of how a patient feels, functions or survives) in
proposed investigational device exemption (IDE) studies to facilitate a
more efficient and streamlined process for manufacturers seeking
Medicare coverage post-FDA market authorization.
In developing the RAPID coverage pathway, we reflected on the
feedback received from interested parties including beneficiaries,
advocacy organizations, medical professionals and societies, medical
device manufacturers, Federal partners, and others involved in
developing innovative medical devices. The RAPID coverage pathway
reflects feedback that CMS sought after the November 15, 2021 repeal of
the January 2021 Medicare Coverage of Innovative Technology (MCIT)
final rule (86 FR 62944).\1\ The RAPID coverage pathway also reflects
feedback gathered during the MCIT rulemaking process and during the
establishment of the Transitional Coverage for Emerging Technologies
(TCET) pathway on August 12, 2024 (89 FR 65724).\2\
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\1\ https://www.federalregister.gov/documents/2021/11/15/2021-24916/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and.
\2\ https://www.federalregister.gov/documents/2024/08/12/2024-17603/medicare-program-transitional-coverage-for-emerging-technologies.
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The Medicare program serves nearly 70 million beneficiaries and is
the largest single health care purchaser in the U.S. As of 2025,
approximately 51 percent of the total Medicare beneficiary population,
or 34 million Medicare beneficiaries, receive coverage through Original
Medicare.\3\ More than 1.1 billion Original Medicare 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 Original Medicare
benefits.\4\
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\3\ https://data.cms.gov/sites/default/files/2026-04/CMSFastFacts2026_508.pdf.
\4\ 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. To qualify for
Medicare coverage, an item or service generally must fall within a
Medicare benefit category and meet one of the standards specified in
section 1862(a)(1)(A) through (P) of the Social Security Act (Act). CMS
uses several coverage pathways, such as national coverage
determinations (NCDs), to determine whether these standards are met and
to facilitate timely beneficiary access to eligible items and services.
Many NCDs are made under section 1862(a)(1)(A) of
[[Page 51711]]
the Act, which states that an item covered under this standard must be
reasonable and necessary for the diagnosis or treatment of illness or
injury or to improve the functioning of a malformed body member.
Over the last several years, interested parties have expressed
support for coverage process improvements and an accelerated pathway
that is more flexible, transparent, predictable, and collaborative.
Additionally, we have heard concerns from interested parties that
medical device coverage lags behind that of drugs and biologics and
that devices are in need of an accelerated Medicare coverage pathway
like RAPID.
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.
We note that the RAPID coverage 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 on a claim-by-claim basis. The
MAC reviews the claim to determine if the item or service is reasonable
and necessary for the individual patient. 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)
In accordance with section 1869(f)(2)(B) of the Act, LCDs are MAC
determinations regarding whether or not a particular item or service is
covered on a contractor-wide basis in accordance with the ``reasonable
and necessary'' standard in section 1862(a)(1)(A) of the Act. LCDs
govern only the issuing MAC's claims adjudication and are not binding
controlling authorities for qualified independent contractors or
administrative law judges in the claims adjudication process.
The MACs follow specific instructions and guidance for developing
LCDs for Medicare coverage as outlined in section 1862(l)(5)(D) of the
Act and in the CMS Program Integrity Manual (PIM), Chapter 13. MACs
usually finalize proposed LCDs no more than a year after publishing the
proposed LCD, per Chapter 13, Section 13.5.1 of the PIM.\5\
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\5\ 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 sections
1862(l)(6)(A) and 1869(f)(1)(B) of the Act and means a determination by
the Secretary of the Department of Health and Human Services (the
Secretary) as to whether or not a particular item or service is covered
nationally under Title XVIII of the Act. 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.
The NCD process, which has statutorily prescribed timeframes, generally
takes 9 to 12 months to complete.\6\
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\6\ Section 1869(f)(4) of the Act.
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In general, NCDs have involved determinations under section
1862(a)(1)(A) of the Act. However, NCDs can be made based on other
provisions of the Act such as section 1862(a)(1)(E) of the Act, which
is the statutory authority that supports the ``Coverage with Evidence
Development'' (CED) pathway. Under the CED pathway, Medicare provides
coverage for certain promising technologies that have limited
supporting evidence. This can occur if CMS determines coverage is
reasonable and necessary to carry out research conducted in
collaboration with the Agency for Healthcare Research and Quality
(AHRQ) pursuant to section 1142 of the Act.\7\ CMS has used section
1862(a)(1)(E) of the Act to support CED policy since July 12, 2006, and
the most recent CED policy is described in our August 7, 2024 guidance
document.\8\ In general, the CED pathway provides Medicare coverage
while providers and suppliers perform high-quality studies that are
expected to produce additional evidence that may lead to positive NCDs
under section 1862(a)(1)(A) of the Act.
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\7\ Section 1142 of the Act describes the authority of AHRQ to
conduct and support research on outcomes, effectiveness, and
appropriateness of services and procedures to identify the most
effective and appropriate means to prevent, diagnose, treat, and
manage disorders and other health conditions. That section includes
a requirement that the Secretary assure that AHRQ research
priorities under Section 1142 appropriately reflect the needs and
priorities of the Medicare program. See the August 2024 CED guidance
document: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development.
\8\ The 2024 guidance document is available at https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=38.
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Consistent with section 1142 of the Act, the Agency for Healthcare
Research and Quality (AHRQ) reviews all CED NCDs established under
section 1862(a)(1)(E) of the Act, and collaborates with CMS to define
general standards for clinical research studies that address the CED
questions and support and endorse the general standards for CED.
NCDs also include a determination regarding whether the item or
service is not excluded from coverage by statute or our regulations at
42 CFR part 411, subpart A and whether the item or service under
consideration fits within a Medicare benefit category under Part A or
Part B,\9\ such as inpatient hospital services, physician 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.
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\9\ Note: Medicare does not develop NCDs for Part D.
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In addition to these coverage pathways, CMS 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 to 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
[[Page 51712]]
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 the technology under review having a
quality evidence base to support the clinical analysis for the NCD.
Lastly, in the August 12, 2024, Federal Register (89 FR 65724), CMS
published a final procedural notice establishing the Transitional
Coverage for Emerging Technologies (TCET) pathway to achieve more
timely and predictable access to new medical technologies for Medicare
beneficiaries. The TCET pathway was designed to use current NCD and CED
processes to expedite Medicare coverage determinations of certain
Breakthrough Devices that are innovative technologies with limited or
developing evidence for Medicare coverage purposes. TCET is voluntary
and aims 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, the TCET pathway
includes an extensive evidence development framework that provides
manufacturers with opportunities for increased pre-market engagement
with CMS, and helps to coordinate benefit category determination,
coding, and payment reviews.
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 devices. Generally, FDA makes marketing
authorization decisions based on whether the relevant statutory
standard for safety and effectiveness is met, while CMS generally makes
coverage determinations 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 under section
1862(a)(1)(A) of the Act. These two reviews have historically been
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 market authorization alone does not entitle that technology to
Medicare coverage. While FDA reviews devices to ensure they meet
applicable safety and effectiveness standards, there may be varying
amounts of evidence regarding whether the device is clinically
beneficial for Medicare patients. Of note, individuals representative
of the Medicare population may not be sufficiently represented in
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. When
there is limited evidence as to the health outcomes for individuals in
the Medicare population, there may be insufficient evidence to support
a full coverage NCD under section 1862(a)(1)(A) of the Act.
In general, as discussed, under section 1862(a)(1)(A) of the Act,
Congress requires 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 reviews evidence as 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.
CMS considers whether the evidence shows that the item or service
will improve the health of Medicare beneficiaries, recognizing that
Medicare beneficiaries are often older and have multiple
comorbidities.\10\ Consequently, they are underrepresented or not
represented in many clinical studies. According to two recent
studies,11 12 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, studies may have exclusion criteria that
disqualify individuals with characteristics that may make it harder to
ascertain a device's effects on populations with multiple
comorbidities, such as Medicare beneficiaries. Consequently, a device's
potential benefits and harms for older beneficiaries with multiple
comorbidities may not be well understood at the time of FDA market
authorization.
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\10\ 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.
\11\ 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.
\12\ 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 RAPID coverage pathway, CMS will coordinate with FDA and
manufacturers of certain Class II and Class III Breakthrough Devices as
those devices move through the FDA premarket review processes to ensure
accelerated 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 Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360e-3; see
also final guidance for industry entitled, ``Breakthrough Devices
Program.'' \13\
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\13\ 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 \14\ that meet two criteria. The first criterion is that the
device provides for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating
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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.
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\14\ Information on device-led combination products can be
accessed at https://www.fda.gov/media/119958/download.
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FDA has explained in guidance that because decisions on requests
for Breakthrough designation will be made prior to marketing
authorization, FDA considers whether there is a ``reasonable
expectation that a device could provide for more effective treatment or
diagnosis relative to the current standard of care (SOC) in the U.S.''
for purposes of the designation. This reasonable expectation can be
supported by sources including ``literature or preliminary data (bench,
animal, or clinical)''.\15\
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\15\ 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.
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D. FDA Total Product Life Cycle Advisory Program (TAP)
FDA launched TAP to help spur more rapid development of high-
quality, safe, effective, and innovative medical devices that are
critical to public health. TAP's primary goal is to expedite patient
access to innovative medical devices by providing developers of such
devices early, frequent, and strategic communications with FDA via TAP
advisors and FDA review teams and by facilitating engagement with other
key parties. The relevant enrollment criteria for TAP requires that a
device has been granted a Breakthrough Device designation. In this
context, devices coming through the RAPID coverage pathway will be
facilitated by their FDA review team and TAP advisers.
E. Investigational Device Exemptions (IDEs)
An investigational device exemption (IDE) allows the
investigational device to be distributed and used in a clinical study
to collect safety and effectiveness data. Medicare may provide coverage
for certain items and services in FDA-approved IDE studies \16\ if
certain requirements are met (see section 1862(m) of the Act, and 42
CFR Subpart B). CMS introduced the centralized IDE process in 2015 to
permit coverage in Category A (Experimental) and Category B
(Nonexperimental/investigational) IDE studies that have been approved
by FDA. While coverage for Category A IDE studies is limited to routine
care items and services furnished in the study, CMS approval of a
Category B IDE study also allows premarket coverage for the Category B
device. CMS reviews each study to ensure the Medicare IDE coverage
criteria (42 CFR 405.212) have been satisfied, which includes the
assessment of Medicare health outcomes in the study. Additional
information on CMS' IDE process is available at https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies.
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\16\ Information on FDA's IDE process is available at https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.
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II. Provisions of the Notice With Comment Period
This notice with comment period proposes to establish the RAPID
coverage pathway, which, as described further in this notice,
establishes a voluntary, accelerated NCD process for certain Class II
FDA designated Breakthrough Devices enrolled in FDA's TAP and Class III
FDA designated Breakthrough Devices, regardless of whether they are
participating in TAP, that intend to engage in clinical studies under
an IDE that enrolls Medicare beneficiaries and studies clinical health
outcomes agreed upon by the FDA and CMS. We describe the procedures for
how interested parties and the public at large may engage with CMS to
facilitate the RAPID coverage pathway. The topics addressed in the
notice with comment period include the following: (1) RAPID coverage
pathway general principles; (2) appropriate candidates for the RAPID
coverage pathway; (3) procedures FDA and CMS intend to follow for the
RAPID coverage pathway; and (4) general roles and responsibilities of
the manufacturer, FDA, CMS, and AHRQ.
A. RAPID Coverage Pathway--An Opportunity To Accelerate Patient Access
to Beneficial Medical Products
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 Medicare coverage
purposes. CMS has received inquiries for coverage of new technologies
that are early in the product lifecycle, the point at which
manufacturers are beginning to develop clinical evidence supporting the
product's safety and effectiveness. In general, CMS relies heavily on
health outcomes data, especially as it relates to the Medicare
population, when determining whether to issue an NCD for a particular
item or service.
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.\17\ When there is limited evidence, CMS may not have
sufficient information to assess a device's potential benefits and
harms to make a NCD due to gaps in research about health outcomes
specific to the Medicare population.
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\17\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices.
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We recognize that many emerging technologies are likely to have
limited or developing bodies of clinical evidence that may not have
sufficiently 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.
We believe that the RAPID coverage pathway can address that gap by
providing manufacturers with information on the specific health
outcomes needed to support Medicare NCDs much earlier in the process.
A manufacturer seeking coverage for a device that meets the
eligibility requirements under the RAPID coverage pathway will need to
test, as part of an IDE study, whether the device improves health
outcomes for Medicare beneficiaries that FDA determines are appropriate
for the device and that CMS confirms would qualify as health outcomes
relevant to Medicare beneficiaries.
Though including an assessment of health outcomes for Medicare
beneficiaries in an IDE study is not always a requirement for FDA
market authorization, these are the assessments needed for CMS to
determine if the device is reasonable and necessary for the diagnosis
or treatment of illness and injury and if the device is therefore
eligible for coverage under Part A or Part B pursuant to section
1862(a)(1)(A) of the Act. Under the RAPID coverage
[[Page 51714]]
pathway, CMS and FDA will work together, along with manufacturers,
earlier in the technology development lifecycle so that evidence
generated for FDA review can also support Medicare coverage decisions.
By aligning regulatory and coverage expectations in advance, the RAPID
coverage pathway is designed to significantly reduce delays that have
historically occurred between FDA market authorization and Medicare
national coverage determinations. Under the RAPID coverage pathway, if
the results of the IDE study demonstrate an improvement in health
outcomes in the Medicare population, a proposed NCD will be issued on
the same day as FDA market authorization and finalized as early as 60
days later. Interested parties have communicated that a short delay (60
to 90 days) between FDA market authorization and a final NCD is
advantageous as it allows manufacturers to prepare for device
distribution into the marketplace.
B. RAPID Coverage Pathway General Principles
CMS is committed to ensuring Medicare beneficiaries have
accelerated access to new technologies that meet the statutory
requirements for coverage. Under the RAPID coverage pathway, if a
device under the pathway receives FDA marketing authorization and if
CMS and FDA determine there is sufficient clinical evidence
demonstrating the device meets the health outcomes for Medicare
beneficiaries identified by FDA and CMS, CMS will post a proposed NCD
on the day of FDA market authorization with the goal of finalizing the
NCD as soon as 60 days later for Class II devices and 90 days later for
Class III devices. To accomplish these accelerated timelines, the RAPID
coverage pathway leverages the existing IDE process and streamlines
aspects of the NCD process. The following principles are intended to
create a common understanding among manufacturers, FDA, and CMS about
the goals and parameters of the RAPID coverage pathway:
Participation in the RAPID coverage pathway is voluntary.
Devices eligible for the RAPID coverage pathway are
limited to certain Class II FDA designated Breakthrough Devices
enrolled in FDA's TAP and Class III FDA designated Breakthrough Devices
planning to submit a PMA application regardless of whether they are
participating in TAP. The device must also be at the IDE presubmission
stage and be the subject of an IDE study that enrolls Medicare
beneficiaries and studies clinical health outcomes that FDA and CMS
have agreed are appropriate to assess the health benefits to the
Medicare beneficiary population. Additional information regarding
appropriate candidates for the RAPID coverage pathway can be found in
section II.C., ``Appropriate Candidates'' of this notice with comment
period.
FDA and CMS will provide information to manufacturers on
appropriate clinical health outcomes applicable to Medicare
beneficiaries to include in the IDE protocol.
After completion of all applicable IDE studies, if the
clinical evidence demonstrates sufficient evidence that the device
meets the applicable health outcomes, CMS will issue a proposed NCD
upon FDA market authorization.
The improvement in health outcomes and the relative risk
of the device will determine if further evidence development (that is,
CED) will be part of the NCD. Lower risk devices are more likely to
have generated sufficient evidence at the time of FDA market
authorization to demonstrate they are reasonable and necessary under
1862(a)(1)(A) of the Act, while higher risk devices are more likely to
have remaining evidence gaps, need additional evidence generation and
qualify for coverage under 1862(a)(1)(E) of the Act. If CED is
expected, CMS will engage with FDA and manufacturers prior to FDA
market authorization to align potential CED requirements with any FDA-
required post-approval studies. (A more detailed description of this
engagement process can be found at II.D.3.d. of this notice with
comment period).
Manufacturers may withdraw from the RAPID coverage
pathway, up until CMS issues a proposed NCD, for various reasons. For
example, withdrawal may be appropriate if there is incomplete or
insufficient data. As another example, the manufacturer could decide
that pursuing coverage at the local level (LCD or claim by claim) may
be more advantageous. Additionally, FDA and CMS may make a
determination that the RAPID coverage pathway is not appropriate for a
specific manufacturer in instances where a manufacturer is not
providing the requested information needed to satisfy pathway
requirements or is found to be falsifying or omitting pertinent
information.
C. Appropriate Candidates
Only devices that meet all the following requirements are eligible
for entry into the RAPID coverage pathway:
Presumptive Class II FDA Breakthrough-designated Devices
participating in TAP planning to submit a De Novo request to FDA; \18\
or Class III FDA Breakthrough-designated Devices planning to submit a
PMA application regardless of whether they are participating in TAP;
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\18\ Includes 510(k) cleared devices where the primary predicate
was authorized via the De Novo classification pathway no earlier
than 18 months prior to acceptance into the RAPID coverage pathway.
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Devices in the IDE pre-submission stage, and the
manufacturer plans to conduct an IDE study that enrolls Medicare
beneficiaries and evaluates clinical outcomes that FDA determines are
appropriate for the device and that CMS confirms evidence showing that
the device achieves those outcomes in the Medicare beneficiary
population would demonstrate that the device improves health outcomes
for Medicare beneficiaries;
Based on the information available, there is no evidence
that immediately makes clear that the device will not fall under a
Medicare benefit category; \19\
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\19\ For more information on benefit category determinations,
see the CMS Guide for Medical Technology Companies and Other
Interested Parties at https://www.cms.gov/medicare/coding-billing/guide-medical-technology-companies-other-interested-parties.
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Not already the subject of a controlling Medicare NCD;
Separately payable devices that can, if approved, be
billed to Medicare; and
Not otherwise excluded from coverage through law or
regulation.\20\
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\20\ Information on coverage exclusions can be accessed at
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 in vitro
diagnostic (IVD) products, such as diagnostic laboratory tests. (See
also 21 CFR 809.3). IVDs, including diagnostic laboratory tests, are a
highly specific area of coverage policy development, and CMS has
historically delegated the review of many of these products to
specialized MACs. We believe that the majority of coverage
determinations for IVDs which have been granted Breakthrough Device
designation should continue to be determined by the MACs through
existing pathways. Therefore, IVD products will not be accepted into
the RAPID coverage pathway. In the rare case where manufacturers and
CMS agree that an NCD is appropriate for an IVD product, manufacturers
may submit an NCD request as outlined in 78 FR 48164.
Devices that are beyond the IDE presubmission stage (such as those
that are market authorized or already being studied under an IDE) are
not
[[Page 51715]]
appropriate for the RAPID coverage pathway. Under the RAPID coverage
pathway, CMS and FDA will leverage early coordination during IDE
presubmission and the existing IDE and NCD processes to provide
predictable and timely coverage upon FDA market authorization for
eligible devices that demonstrate positive clinical health outcomes in
the Medicare population during the premarket phase. Devices that are
FDA market authorized or those already the subject of an IDE are more
appropriate for an NCD outside the RAPID coverage pathway or coverage
at the local level through an LCD or claim by claim adjudication.
We solicit public comments on this approach. In addition, we are
also interested in feedback on whether we should establish a temporary
process under which devices that have progressed beyond the IDE
presubmission stage and are currently being studied under an IDE could
become eligible for the RAPID coverage pathway. As part of this
eligibility determination, CMS and FDA would assess whether ongoing IDE
studies evaluate the clinical health outcomes that FDA and CMS have
agreed are appropriate to assess the health benefits to the Medicare
beneficiary population or whether modifications to those studies would
be needed to support such assessment. The purpose of this process would
be to enable manufacturers of otherwise eligible devices that had
already initiated IDE studies, but that otherwise would have elected to
participate in the RAPID coverage pathway, to remain eligible for
participation. We solicit comment on whether such process should be
established, and if so, the appropriate duration of such process.
D. Procedures for the RAPID Coverage Pathway
The RAPID coverage pathway has three stages: (1) IDE Presubmission;
(2) Formal IDE Submission to FDA and CMS; and (3) Transition from IDE
to Coverage. (A graphic providing a high-level overview of the RAPID
coverage pathway can be found in II.D.3.f. of this notice with comment
period.)
1. IDE Presubmission
a. Entry Into the RAPID Coverage Pathway
The RAPID coverage pathway is voluntary. If interested in the RAPID
coverage pathway, manufacturers will express their interest in the
pathway (after receiving Breakthrough Device designation and being
accepted into TAP, as applicable) to FDA by sending an email to [email protected] in advance of an IDE presubmission. An FDA
TAP Advisor will provide the relevant information to manufacturers to
facilitate entry into the RAPID coverage pathway.
b. Consideration of Candidates
FDA will assess each candidate expressing interest in the RAPID
coverage pathway to determine if the device may be appropriate for the
pathway based on the criteria outlined in Section II.C. of this notice
with comment period. If a device is determined by FDA to meet initial
eligibility for the RAPID coverage pathway, FDA will share the relevant
information and consult CMS.
FDA will confirm with CMS that, based on the information available,
the information does not immediately make clear that the device will
not fall under a benefit category (further discussed in section
II.D.1.c. of this notice with comment period), that the device will not
be excluded from coverage by statute or our regulations at 42 CFR part
411, Subpart A, and that the device is not subject to a controlling
NCD.
FDA and CMS will communicate this determination to the
manufacturer, informing them of any potential exclusions that would
prevent them from pursuing the RAPID coverage pathway. If the
manufacturer wishes to continue, FDA will work with the manufacturer to
develop a clinical study synopsis for discussion at a RAPID kick-off
meeting, which will include FDA, the manufacturer, and CMS. During this
meeting, the manufacturer will walk through their study synopsis
explaining how they intend to address FDA and CMS regulatory
requirements. CMS and/or FDA may provide real-time comments to help the
manufacturer develop the complete IDE study protocol.
If the manufacturer continues to pursue the RAPID coverage pathway,
the manufacturer will submit a request for written feedback \21\ to FDA
for CMS and FDA to review the IDE study protocol.
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\21\ The request for written feedback would be via a TAP
Amendment or Sprint Discussion as applicable. Manufacturers are
encouraged to contact their TAP advisor for more information on the
applicable process and timelines.
---------------------------------------------------------------------------
During the review, FDA will consult with CMS to discuss the
protocol and any concerns. CMS will provide FDA with written feedback
regarding whether the health outcomes to be evaluated in the study are
sufficient to support an NCD, satisfy the CMS IDE criteria and any
other feedback CMS would require to be addressed. FDA will provide
feedback to the manufacturer via FDA's normal process that includes
written comments from FDA and CMS regarding any feedback relevant to
their respective statutory authorities. CMS and FDA will also provide
feedback regarding potential evidence gaps that manufacturers can
choose to address in their planned pivotal IDE study or can begin
planning to address in potential postmarket studies, including FDA
post-approval studies (if applicable).
The manufacturer must agree that information will be shared between
FDA and CMS. As noted in the Memorandum of Understanding \22\ between
FDA and CMS, the Agencies 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).
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\22\ https://www.fda.gov/about-fda/domestic-mous/mou-225-10-0010.
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c. Medicare Benefit Category Review
Prior to the RAPID kickoff meeting, CMS will initiate a preliminary
benefit category assessment if all other pathway criteria have been
met. Under this analysis, CMS will evaluate whether information exists
that immediately makes clear that the device will not fall under a
benefit category. If, based on the available information CMS has, it
does not appear that the device cannot fit within a Medicare benefit
category, the device may be accepted into the RAPID coverage pathway.
This is an interim step that is subject to change upon FDA's decision
regarding market authorization of the device. Participation in the
RAPID coverage pathway should not be viewed as a final benefit category
determination.
[[Page 51716]]
2. Formal IDE Submission to FDA and CMS
a. FDA Review
The manufacturer will submit the IDE application to FDA if
applicable. FDA will review the IDE application per the normal IDE
review process. FDA's IDE decision letter will inform the manufacturer
about any study design considerations (SDCs). In order to continue to
participate in the voluntary RAPID coverage pathway, the manufacturer
will be expected to satisfactorily address any SDCs necessary to enable
the study to support a future marketing application to FDA.
b. CMS Review
At the time FDA's IDE decision letter is issued to the
manufacturer, FDA will also share the decision letter, including the
SDCs, with CMS. CMS will communicate directly with the manufacturer
regarding the SDCs that must be addressed to continue participation in
the RAPID coverage pathway. This is a key step in the process that
provides an opportunity for the manufacturer to address CMS concerns
during the premarket phase. Once the manufacturer addresses any SDCs,
and FDA has approved a revised protocol if needed, manufacturers will
then submit their IDE protocol to CMS for approval using the existing
CMS IDE review process. If all CMS IDE requirements and RAPID
eligibility criteria have been met, CMS will provide the manufacturer
with an approval letter including the intent to issue a proposed NCD
concurrently with FDA market authorization. We note that approved IDE
studies are listed on the CMS website at https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved.
As stated in section II.I. of this notice with comment period, CMS
intends to indicate which approved IDEs are also RAPID participants. If
a manufacturer wishes to make any changes to the IDE study protocol
after CMS approval, these changes must be reviewed and agreed upon by
FDA and CMS to continue participation in the RAPID coverage pathway.
3. Transition From IDE to Coverage
a. IDE Completion and Manufacturer Next Steps
After completion of the IDE study, if the manufacturer continues to
want to participate in the RAPID coverage pathway, FDA will share the
IDE final report with CMS.
When the manufacturer submits the marketing submission to FDA, and
FDA accepts it for review, CMS will be notified and provided with the
clinical study report and any other relevant information needed for CMS
to confirm if the device has demonstrated an improvement in the
clinical outcomes that FDA has determined are appropriate for the
device and which CMS has confirmed is a qualifying health outcome for
purposes of Medicare coverage. At this time, if the manufacturer
decides to pursue national coverage through the RAPID coverage pathway,
the manufacturer will submit a formal NCD request cover letter
expressing the manufacturer's desire for CMS to open a RAPID NCD
analysis.
Most, if not all, of the clinical evidence needed to conduct the
RAPID NCD analysis would be included in the IDE final report and other
information FDA shares with CMS. However, CMS invites the manufacturer
to submit any additional materials along with the NCD request cover
letter they believe would support the RAPID NCD request, noting that
CMS must use publicly available information to inform the NCD. The
manufacturer may alternatively request that their device be withdrawn
from the RAPID coverage pathway, in which case CMS would not proceed
with the NCD analysis described in this section.
b. CMS NCD Analysis and Timing
The process for Medicare coverage under the RAPID coverage pathway
will generally follow the NCD statutory timeframes in section 1862(l)
of the Act. If a device continuing in the RAPID coverage pathway
submits an NCD request cover letter, receives FDA market authorization,
and has satisfactorily demonstrated improvement in a clinical outcome
that FDA has determined is appropriate for the device and that CMS has
confirmed would qualify as a health outcome, CMS will initiate the NCD
process by posting a tracking sheet and proposed NCD on the CMS website
on the same day as FDA market authorization.
We note the timing of the proposed NCD is contingent upon the
relevant FDA Decision Summary or SSED being made publicly available on
the day of FDA market authorization. CMS will include the link to the
relevant FDA Decision Summary or SSED on the NCD tracking sheet. RAPID
national coverage will be limited to the FDA authorized indication(s)
for use of the device. There will be a 30-day public comment period on
the proposed NCD. CMS' goal is to release the final NCD approximately
60 days after FDA market authorization for Class II devices and 90 days
after for Class III devices. More information on the NCD process is set
forth in the August 7, 2013, Federal Register notice (78 FR 48164)
(hereafter referred to as the August 2013 notice).
c. RAPID NCD Format
To provide accelerated Medicare coverage upon FDA market
authorization, RAPID NCDs may be more streamlined than conventional
NCDs. Because the RAPID coverage pathway leverages FDA's and CMS'
existing IDE processes to provide information on important clinical
outcomes much earlier in the process, and manufacturers will need to
satisfactorily show an improvement in a clinical outcome that FDA has
determined is appropriate for the device and CMS has confirmed would
qualify as a health outcome, we anticipate that RAPID NCDs may include
more concise evidence summaries than have typically been included in
conventional NCDs. New evidence to inform these NCDs will come from the
results of the pivotal IDE studies that FDA makes publicly available in
the Decision Summary for Class II devices or the SSED for Class III
devices.
d. Evidence Development for RAPID NCDs
Participation in the RAPID coverage pathway is voluntary, and we
believe that any new coverage pathway for emerging technologies should
facilitate evidence development when evidence gaps exist for coverage
purposes to ensure that Medicare beneficiaries have access to new
technologies that will improve health outcomes. If there is
insufficient evidence to support Medicare coverage under section
1862(a)(1)(A) of the Act, CMS may issue a proposed NCD under the CED
framework.
Manufacturers are strongly encouraged to remain engaged with their
FDA TAP advisor and CMS point of contact throughout their IDE study to
ensure that CMS can discuss any evidence gaps while the manufacturer is
designing any applicable FDA-required post-approval or other postmarket
study. We note that post-approval studies are not always required. CMS
will collaborate with FDA and manufacturers during the development of
these studies to ensure that CMS evidence development requirements pose
minimal burden and do not duplicate or conflict with any FDA postmarket
requirements for the device.
The RAPID coverage pathway will not alter the existing standards
for the NCD process or CED (for example, CMS' process for clinical
study protocol review and approval) and the established processes and
procedures for these coverage mechanisms will be
[[Page 51717]]
followed to provide coverage under the RAPID coverage pathway. Coverage
of services related to the NCD can begin once a CED study is approved.
For NCDs with CED requirements, approved CED studies will appear on
CMS' CED web page upon CMS approval.\23\
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\23\ https://www.cms.gov/medicare/coverage/evidence.
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e. Duration of Coverage Under the RAPID Coverage Pathway
RAPID NCDs will remain in effect until they are reconsidered (see
August 2013 notice). As it may pertain to RAPID NCDs issued under the
CED framework, we emphasize that CED NCDs are not meant to last
indefinitely. The 2024 CED guidance document states that coverage under
CED should 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. A CED cycle is considered completed when CMS
completes a reconsideration of the CED coverage decision and removes
the requirement for study participation as a condition of coverage. As
with any NCD, any member of the public may request to reopen the NCD
that requires CED.
f. RAPID Coverage Pathway Overview
The steps described in section II.D. of this notice with comment
period for the RAPID process and for obtaining a CMS coverage
determination are illustrated in Figure 1.
[GRAPHIC] [TIFF OMITTED] TN11AU26.058
E. Roles
CMS has outlined the general roles of each participant in the RAPID
coverage pathway.
1. Manufacturer
If interested in the RAPID coverage pathway, manufacturers need to
express their interest in the pathway (after receiving Breakthrough
Device designation and being accepted into TAP, as applicable) prior to
their IDE presubmission to FDA. The manufacturer will be expected to be
collaborative throughout the RAPID coverage pathway process, and comply
with all existing FDA and CMS requirements related to the IDE and NCD
processes, including any CED study requirements when applicable.
2. CMS
CMS will collaborate with FDA to identify eligible candidates for
the RAPID coverage pathway and will provide timely feedback to
manufacturers to ensure that the clinical outcomes (direct measures of
how a patient feels, functions, or survives) that FDA has agreed are
appropriate for the device would qualify as health outcomes for CMS.
The requirement to evaluate whether the device improves such health
outcomes must be included in the IDE protocol to facilitate Medicare
coverage following FDA market authorization. Additionally, CMS will
work with manufacturers to leverage FDA-required postmarket studies, if
any, to address specific evidence gaps for Medicare beneficiaries.
Throughout all stages of the RAPID coverage pathway, CMS will maintain
open communication channels with FDA, AHRQ, and manufacturers and
fulfill all statutory and regulatory obligations concerning the IDE and
NCD processes.
3. FDA
FDA will assess each candidate expressing interest in the RAPID
coverage pathway to determine if the device is appropriate for the
pathway. FDA will keep open lines of communication with CMS regarding
the Breakthrough Devices seeking to participate in the RAPID coverage
pathway and will provide relevant information and expertise during the
premarket phase to facilitate timely
[[Page 51718]]
Medicare coverage upon FDA market authorization. Participation in the
RAPID coverage 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
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/evidence). Since we
anticipate that a subset of NCDs conducted under the RAPID coverage
pathway could result in CED decisions, AHRQ will continue to review all
CED NCDs consistent with current practice.
F. RAPID Coverage Pathway and Parallel Review
While the RAPID coverage 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 RAPID 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. RAPID Coverage Pathway and TCET
The TCET pathway will be paused for new candidates upon publication
of this notice with comment period as CMS focuses on the successful
implementation of the RAPID coverage pathway. Upon the announcement of
the RAPID coverage pathway on April 23, 2026, FDA and CMS began
engaging with manufacturers of devices potentially eligible for the
RAPID coverage pathway so these manufacturers can be positioned to
benefit from the efficiencies that RAPID is intended to provide. For
manufacturers who are past the point of initiating their IDE study and
believe there is sufficient evidence to support national coverage of
their device, we recommend that they contact CMS to discuss available
coverage mechanisms, including a potential NCD request submission as
outlined in 78 FR 48164. CMS will apply lessons learned across coverage
pathways to strengthen and improve Medicare coverage processes over
time.
H. RAPID Coverage Pathway Prioritization
Due to CMS' commitment to issue proposed NCDs for devices in the
RAPID coverage pathway on the same day as FDA market authorization, CMS
proposes to prioritize the opening of RAPID NCDs over non-RAPID NCDs
from the NCD Wait List if we are unable to address the total volume of
NCDs within our available resources at any given time.
When we consider opening or reconsidering non-RAPID NCDs, we will
continue to apply the circumstances described in the August 2013 notice
as we prioritize topics. The circumstances described in the August 2013
notice are relevant to how we prioritize internally generated and
externally requested NCDs. We consider when, practitioners, patients,
or other members of the public have raised significant questions about
the health outcomes attributable to the use of the items or services
for the Medicare beneficiary population; new evidence or reasonable
reinterpretation of previously available evidence indicates that a
national coverage review may be warranted; local coverage policies on a
particular item or service may vary in language or implementation; the
health technology represents a substantial clinical advance and is
likely to result in a significant improvement in patient health
outcomes or positive impact on the Medicare program; rapid diffusion of
an item or service is anticipated, if the evidence may inadequately
address questions regarding impact on the Medicare population, target
subgroup populations, practitioner or facility qualifications, etc., or
on beneficiary health outcomes; or any combination thereto.
Also, given that we currently have topics on the NCD Wait List, we
reiterate from the August 2013 notice that ``[i]n the event that 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.''
I. RAPID Coverage Pathway Transparency
We believe it is important to provide maximum transparency
regarding the devices accepted into the RAPID coverage pathway. CMS
proposes to make the identity of specific manufacturers and devices in
the RAPID coverage pathway publicly available. Examples of where this
information could be made publicly available include the respective
device's listing on the CMS Approved IDE Studies web page and the NCD
Dashboard.\24\
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\24\ The NCD Dashboard can be found here: https://www.cms.gov/files/document/ncddashboard.pdf.
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III. Collection of Information Requirements
This notice with comment period refers to previously approved
collections of information. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Applicable
collections of information include: (1) Medicare Coverage of Items and
Services in FDA Investigational Device Exemption Clinical Studies (OMB
0938-1250); (2) Medicare Program Revised Procedures for Making National
Coverage Determinations (OMB 0938-0776); (3) Medicare Coverage of Items
and Services for Coverage with Evidence Development (CMS-OMB 0938-
1387); and (4) Q-Submissions and Early Payor Feedback Request Programs
and Medical Device Development Tools (FDA-OMB 0910-0756).
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 preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Mehmet Oz, Administrator of the Centers for Medicare & Medicaid
Services, approved this document on August 7, 2026.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-16368 Filed 8-7-26; 4:15 pm]
BILLING CODE 4169-69-P