Notice2022-26501
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee; Cancellation of the December 7, 2022 Virtual Meeting and Announcement of the February 13 and February 14, 2023 Virtual Meetings
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Published
December 6, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces the cancellation of the December 7, 2022 virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) ("Committee") that was published in the October 11, 2022 Federal Register. This notice also announces a virtual public meeting of the MEDCAC Committee on Monday, February 13 and Tuesday, February 14, 2023. National Coverage Determinations resulting in coverage with evidence development (CED) can expedite earlier Medicare beneficiary access to innovative technology while ensuring that systematic patient safeguards are in place to reduce the risks inherent to new technologies, or to new applications of older technologies. This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Full Text
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<title>Federal Register, Volume 87 Issue 233 (Tuesday, December 6, 2022)</title>
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[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74632-74634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3431-N2]
Medicare Program; Virtual Meeting of the Medicare Evidence
Development and Coverage Advisory Committee; Cancellation of the
December 7, 2022 Virtual Meeting and Announcement of the February 13
and February 14, 2023 Virtual Meetings
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Notice.
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SUMMARY: This notice announces the cancellation of the December 7, 2022
virtual public meeting of the Medicare Evidence Development & Coverage
Advisory Committee (MEDCAC) (``Committee'') that was published in the
October 11, 2022 Federal Register. This notice also announces a virtual
public meeting of the MEDCAC Committee on Monday, February 13 and
[[Page 74633]]
Tuesday, February 14, 2023. National Coverage Determinations resulting
in coverage with evidence development (CED) can expedite earlier
Medicare beneficiary access to innovative technology while ensuring
that systematic patient safeguards are in place to reduce the risks
inherent to new technologies, or to new applications of older
technologies. This meeting will examine the general requirements for
clinical studies submitted for CMS coverage requiring CED. The MEDCAC
will evaluate the CED criteria to assure that CED studies are evaluated
with consistent, feasible, transparent and methodologically rigorous
criteria and advise CMS on whether the criteria are appropriate to
ensure that CED-approved studies will produce reliable evidence that
CMS can rely on to help determine whether a particular item or service
is reasonable and necessary. This meeting is open to the public in
accordance with the Federal Advisory Committee Act.
DATES:
Meeting Date: The virtual meeting will be held on Monday, February
13 and Tuesday, February 14, 2023 from 10:00 a.m. until 3:00 p.m.,
Eastern Standard Time (EST).
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., Eastern Standard Time (EST), on Friday,
January 13, 2023. Once submitted, all comments are final.
Deadlines for Speaker Registration and Presentation Materials: The
deadline to register to be 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., EST, on Friday, January 13, 2023.
Speakers may register by phone or 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.
Submission of Presentations and 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#a7eac2c3e4e6e4d7d5c2d4c2c9d3c6d3cec8c9d4e7c4cad489cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="f4b99190b7b5b784869187919a8095809d9b9a87b4979987da9c9c87da939b82">[email protected]</span></a> section of this
notice by Friday, January 13, 2023.
Deadline for All Other Attendees Registration: Individuals who want
to join the meeting may register online at <a href="https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw">https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw</a> by 11:59 p.m. EST, on
Sunday, February 12, 2023.
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="http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">http://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.
Deadline for Submitting a Request for Special Accommodations:
Individuals viewing or listening to the meeting who 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., EST on Monday, January 23,
2023.
ADDRESSES: Due to the current COVID-19 public health emergency, the
Panel meeting will be held virtually and will not occur at the campus
of the Centers for Medicare & Medicaid Services (CMS), Central
Building, 7500 Security Boulevard, Baltimore, Maryland 21244.
FOR FURTHER INFORMATION CONTACT: Tara Hall, MEDCAC Coordinator, via
email at <a href="/cdn-cgi/l/email-protection#33675241521d7b525f5f73505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="b7e3d6c5d699ffd6dbdbf7d4dac499dfdfc499d0d8c1">[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="http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf">http://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="http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10">http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10</a>).
II. Meeting Topic and Format
This notice announces the February 13 and February 14, 2023,
virtual public meeting of the Committee. This meeting will examine the
requirements for clinical studies submitted for CMS coverage under
coverage with evidence development (CED). It has been 8 years since the
criteria for CED were last evaluated and revised. In that time, not
only have technologies become more complex, but there has been growing
appreciation and commitment to transparency in decision-making, to
making certain that study methodologies are ``fit to purpose'' as
determined by the topic, questions asked, health outcomes studied, and
to making certain that the populations studied are representative of
the diversity in the Medicare beneficiary population. For example, some
questions may be sufficiently answered through analysis of real-world
evidence including data from clinical registries, electronic health
records, and administrative claims. Any decision about whether an item
or service is reasonable and necessary must, minimally, be sensitive to
these commitments as well as to ensuring that study participants'
interests are respected and protected. The MEDCAC will evaluate the CED
criteria to assure that CED studies are evaluated with consistent,
feasible, transparent and methodologically rigorous criteria and advise
on whether the criteria are appropriate to ensure that CED-approved
studies will produce reliable evidence that CMS can rely on to help
determine whether a particular item or service is reasonable and
necessary.
Background information about this topic, including panel materials,
is available at <a href="http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&</a>. Electronic copies of all
the meeting materials will be on the CMS website no later than 2
business days before the meeting. We encourage the participation of
organizations, researchers and people with expertise or interest in the
thoughtful, efficient design and implementation of clinical studies
whose goals are to improve the health of people, especially Medicare
beneficiaries. This meeting is open to the public. The Committee will
hear oral presentations from the public. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than what can be reasonably accommodated
[[Page 74634]]
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 no later than 1 week from the speaker
registration deadline specified in the DATES section of this notice.
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="http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&">http://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. By the conclusion of
the second day, the panel members will vote and the Committee will make
its recommendation(s) to CMS.
III. Registration Instructions
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/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw">https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw</a> or by phone 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. chapter 35).
The Chief Medical Officer and Director of the Center for Clinical
Standards and Quality for the Centers for Medicare & Medicaid Services
(CMS), Lee A. Fleisher, having reviewed and approved this document,
authorizes Lynette Wilson, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: December 1, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-26501 Filed 12-5-22; 8:45 am]
BILLING CODE 4120-01-P
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