Notice2025-06834
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 21, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) ("Committee") will be held on Wednesday, June 25, 2025.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 75 (Monday, April 21, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Pages 16689-16691]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06834]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3470-N]
Medicare Program; Virtual Meeting of the Medicare Evidence
Development and Coverage Advisory Committee
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a virtual public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC)
(``Committee'') will be held on Wednesday, June 25, 2025.
DATES:
Meeting Date: The virtual meeting will be held on Wednesday, June
25, 2025, from 10:00 a.m. until 4:00 p.m., Eastern Daylight Time (EDT).
Deadline for Submission of Written Comments: Written comments must
be received at the email address specified in the ADDRESSES section of
this notice by 5:00 p.m., EDT, on Wednesday, May 21, 2025. Once
submitted, all comments are final.
Deadlines for Speaker Registration and Presentation Materials: The
deadline to register as a speaker and to submit PowerPoint presentation
materials and writings that will be used in support of an oral
presentation, is 5:00 p.m., EDT on Wednesday, May 21, 2025. Speakers
may register via email by contacting the person listed in the FOR
FURTHER INFORMATION CONTACT section of this notice. Presentation
materials must be received at the email address specified in the
ADDRESSES section of this notice.
Deadline for All Other Attendees Registration: Individuals who want
to join the meeting may register online at: <a href="https://cms.zoomgov.com/meeting/register/vJIsfuiuqTooHSfrDZdYHzCLsztgUqyaxvo">https://cms.zoomgov.com/meeting/register/vJIsfuiuqTooHSfrDZdYHzCLsztgUqyaxvo</a> until 10:00 a.m.,
EDT on Wednesday, June 25, 2025.
Deadline for Submitting a Request for Special Accommodations:
Individuals viewing or listening to the meeting who
[[Page 16690]]
are hearing or visually impaired and have special requirements, or a
condition that requires special assistance, should send an email to the
MEDCAC Coordinator as specified in the FOR FURTHER INFORMATION CONTACT
section of this notice no later than 5:00 p.m., EDT on Wednesday, May
21, 2025.
ADDRESSES: To allow for broader public participation in the meeting,
the Panel meeting will be held virtually.
Submission of Presentations and Written Comments: Presentation
materials and written comments that will be presented at the meeting
must be submitted via email to <a href="/cdn-cgi/l/email-protection#e9a48c8daaa8aa999b8c9a8c879d889d8086879aa98a849ac781819ac78e869f"><span class="__cf_email__" data-cfemail="d19cb4b5929092a1a3b4a2b4bfa5b0a5b8bebfa291b2bca2ffb9b9a2ffb6bea7">[email protected]</span></a>. All
comments, presentations and articles/background materials will be
posted on the MEDCAC website.
Webinar and Teleconference Meeting Information: Teleconference
dial-in instructions, and related webinar details will be posted on the
meeting agenda, which will be available on the CMS website <a href="https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&</a>. Participants in the MEDCAC meeting will
require the following: a computer, laptop or smartphone where the Zoom
application needs to be downloaded; a strong Wi-Fi or an internet
connection and access to use Chrome or Firefox web browser and a webcam
if the meeting participant is scheduled to speak or make a presentation
during the meeting.
FOR FURTHER INFORMATION CONTACT: Tara Hall, MEDCAC Coordinator, via
email at <a href="/cdn-cgi/l/email-protection#422f27262123211d3027252b31363023362b2d2c02212f316c2a2a316c252d34"><span class="__cf_email__" data-cfemail="78151d1c1b191b270a1d1f110b0c0a190c111716381b150b5610100b561f170e">[email protected]</span></a> or by phone 410-786-4347.
SUPPLEMENTARY INFORMATION:
I. Background
MEDCAC, formerly known as the Medicare Coverage Advisory Committee
(MCAC), is advisory in nature, with all final coverage decisions
resting with CMS. MEDCAC is used to supplement CMS' internal expertise.
Accordingly, the advice rendered by the MEDCAC is most useful when it
results from a process of full scientific inquiry and thoughtful
discussion, in an open forum, with careful framing of recommendations
and clear identification of the basis of those recommendations. MEDCAC
members are valued for their background, education, and expertise in a
wide variety of scientific, clinical, and other related fields. (For
more information on MEDCAC, see the MEDCAC Charter (<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf</a>) and the CMS Guidance Document, Factors CMS Considers
in Referring Topics to the MEDCAC <a href="https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10">https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10</a>).
II. Meeting Topic and Format
This notice announces the Wednesday, June 25, 2025, virtual public
meeting of the Committee. The MEDCAC panel will examine which clinical
endpoints in studies of devices to manage tremor in Parkinson's disease
and essential tremor should be of interest to CMS. Given the increased
emphasis on new and innovative medical products for difficult-to-manage
conditions, some studies of new medical technologies have focused on
short-term data with greater reliance on intermediate outcomes and
surrogate endpoints. Furthermore, studies of new devices are often not
representative of the Medicare beneficiary population in terms of
demographics, comorbidity prevalence or care setting. As a result,
there are more frequent evidence gaps with respect to the health
outcomes that are clinically meaningful for CMS beneficiaries in
assessments of medical technologies. The MEDCAC panel will consider a
review of the relevant clinical research and professional guidance
literature, along with expert commentary. By voting on specific
questions, and by their discussions, MEDCAC panel members will advise
CMS about the ideal clinical endpoints in research studies of devices
to manage tremor in Parkinson's disease and essential tremor, as well
as appropriate measurement instruments and follow-up durations, to help
to provide clarity and transparency of National Coverage Analyses
(NCAs). This meeting is open to the public in accordance with the
Federal Advisory Committee Act (5 U.S.C. app. 2, section 10(a)).
Background information about this topic, including panel materials,
is available at <a href="https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&</a>. Electronic copies of all
the meeting materials, to include public comments and presentations,
will be on the CMS website approximately 15 days before the meeting. We
encourage the participation of organizations with expertise in the
appraisal of the state of evidence for the use of device to manage
tremor in Parkinson's disease and essential tremor. This meeting is
open to the public. The Committee will hear oral presentations from the
public for approximately 45 minutes. Time allotted for each
presentation may be limited, based on the number of speakers. If the
number of registrants requesting to speak is greater than what can be
reasonably accommodated during the scheduled open public hearing
session, we may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 4, 2025.
Your comments must focus on issues specific to the list of topics that
we have proposed to the Committee. The list of research topics to be
discussed at the meeting will be available on the following website
prior to the meeting: <a href="https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">https://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&</a>. We require that
you declare at the meeting whether you have any financial involvement
with manufacturers (or their competitors) of any items or services
being discussed. Speakers presenting at the MEDCAC meeting must include
a full disclosure slide as their second slide in their presentation for
financial interests (for example, type of financial association--
consultant, research support, advisory board, and an indication of
level, such as minor association < $10,000 or major association >
$10,000) as well as intellectual conflicts of interest (for example,
involvement in a federal or nonfederal advisory committee that has
discussed the issue) that may pertain in any way to the subject of this
meeting. If you are representing an organization, we require that you
also disclose conflict of interest information for that organization.
If you do not have a PowerPoint presentation, you will need to present
the full disclosure information requested previously at the beginning
of your statement to the Committee.
The Committee will deliberate openly on the topics under
consideration. Interested persons may observe the deliberations, but
the Committee will not hear further comments during this time except at
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address
issues specific to the topics under consideration. At the conclusion of
the day, the members will vote, and the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
[[Page 16691]]
CMS' Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. You may register online at <a href="https://cms.zoomgov.com/meeting/register/vJIsfuiuqTooHSfrDZdYHzCLsztgUqyaxvo">https://cms.zoomgov.com/meeting/register/vJIsfuiuqTooHSfrDZdYHzCLsztgUqyaxvo</a> or by email by
contacting the person listed in the FOR FURTHER INFORMATION CONTACT
section of this notice by the deadline listed in the DATES section of
this notice. Please provide your full name (as it appears on your
state-issued driver's license), address, organization, telephone
number(s), and email address. You will receive a registration
confirmation with instructions for your participation at the virtual
public meeting.
IV. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 35).
The Chief Medical Officer and Acting Director of the Center for
Clinical Standards and Quality for the Centers for Medicare & Medicaid
Services (CMS), Dora Hughes, having reviewed and approved this
document, authorizes Chyana Woodyard, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-06834 Filed 4-18-25; 8:45 am]
BILLING CODE 4120-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 21, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.