Notice2022-22067
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee-December 7, 2022
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
October 11, 2022
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, December 7, 2022. 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
<html>
<head>
<title>Federal Register, Volume 87 Issue 195 (Tuesday, October 11, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61331-61333]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3431-N]
Medicare Program; Virtual Meeting of the Medicare Evidence
Development and Coverage Advisory Committee--December 7, 2022
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (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, December 7, 2022. 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
[[Page 61332]]
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 Wednesday,
December 7, 2022 from 10:00 a.m. until 5:00 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 Monday,
November 7, 2022. 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 Monday, November 7, 2022.
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#5518303116141625273026303b2134213c3a3b26153638267b3d3d267b323a23"><span class="__cf_email__" data-cfemail="e0ad8584a3a1a390928593858e948194898f8e93a0838d93ce888893ce878f96">[email protected]</span></a> section of this
notice by Monday November 7, 2022.
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
Tuesday, December 6, 2022.
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, November 14,
2022.
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#f8ac998a99d6b0999494b89b958bd690908bd69f978e"><span class="__cf_email__" data-cfemail="20744152410e68414c4c60434d530e4848530e474f56">[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 Wednesday, December 7, 2022, virtual
public meeting of the Committee. This meeting will examine the
requirements for clinical studies submitted for CMS coverage under CED.
It has been nearly 8 years since the criteria for CED were last
evaluated and codified. 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 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.
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 for approximately 45 minutes.
Time allotted for each presentation may be limited. 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
[[Page 61333]]
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. At the conclusion of
the day, the 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: October 5, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-22067 Filed 10-7-22; 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 October 11, 2022.
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.