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Notice2021-16314

Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee-September 22, 2021

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Published
July 30, 2021

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, September 22, 2021. The MEDCAC panel will examine relevant health outcomes in studies for cerebrovascular disease treatment with a particular focus on new technologies of interest to CMS. Given the increased emphasis on new and innovative medical products for treating diseases that have few proven therapies, studies on certain medical technologies have focused on intermediate and surrogate outcomes rather than longer-term data. As a result, there are more frequent evidence gaps with respect to the clinically meaningful health outcomes for CMS beneficiaries, and these gaps impact our assessments of medical technologies. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of cerebrovascular disease treatment technologies, 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.

Full Text

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<title>Federal Register, Volume 86 Issue 144 (Friday, July 30, 2021)</title>
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[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41040-41041]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3410-N]


Medicare Program; Virtual Meeting of the Medicare Evidence 
Development and Coverage Advisory Committee--September 22, 2021

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

ACTION: Notice.

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SUMMARY: This notice announces a virtual public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MEDCAC) 
(``Committee'') will be held on Wednesday, September 22, 2021. The 
MEDCAC panel will examine relevant health outcomes in studies for 
cerebrovascular disease treatment with a particular focus on new 
technologies of interest to CMS. Given the increased emphasis on new 
and innovative medical products for treating diseases that have few 
proven therapies, studies on certain medical technologies have focused 
on intermediate and surrogate outcomes rather than longer-term data. As 
a result, there are more frequent evidence gaps with respect to the 
clinically meaningful health outcomes for CMS beneficiaries, and these 
gaps impact our assessments of medical technologies. The MEDCAC panel 
will examine the growing challenges associated with the decreased level 
of evidence of certain new and innovative technologies. By voting on 
specific questions, and by their discussions, MEDCAC panel members will 
advise CMS about the ideal health outcomes in research studies of 
cerebrovascular disease treatment technologies, 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.

DATES: 
    Meeting Date: The virtual meeting will be held on Wednesday, 
September 22, 2021 from 8:00 a.m. until 4:30 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., Eastern Daylight Time (EDT), on Monday, 
August 23, 2021. 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., EDT, on Monday, August 23, 2021. 
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#e7aa8283a4a6a49795829482899386938e888994a7848a94c98f8f94c9808891"><span class="__cf_email__" data-cfemail="6c2109082f2d2f1c1e091f0902180d180503021f2c0f011f4204041f420b031a">[email&#160;protected]</span></a> section of this 
notice by Monday, August 23, 2021.
    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_eJmuvv1UTImALOSXqhKmPQ">https://cms.zoomgov.com/webinar/register/WN_eJmuvv1UTImALOSXqhKmPQ</a> 4:30 p.m. EDT, on Wednesday, 
September 22, 2021.
    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., EDT on Friday, August 27, 2021.

[[Page 41041]]


ADDRESSES: Due to the current COVID-19 public health emergency, the 
Panel meeting will be held virtually.

FOR FURTHER INFORMATION CONTACT: Tara Hall, MEDCAC Coordinator, via 
email at <a href="/cdn-cgi/l/email-protection#01556073602f49606d6d41626c722f6969722f666e77"><span class="__cf_email__" data-cfemail="ffab9e8d9ed1b79e9393bf9c928cd197978cd1989089">[email&#160;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, September 22, 2021, virtual 
public meeting of the Committee. The MEDCAC panel will examine relevant 
health outcomes in studies for cerebrovascular disease treatment with a 
particular focus on new technologies of interest to CMS. Given the 
increased emphasis on new and innovative medical products for treating 
diseases that have few proven therapies, studies on certain medical 
technologies have focused on intermediate and surrogate outcomes rather 
than longer-term data. As a result, there are more frequent evidence 
gaps with respect to the clinically meaningful health outcomes for CMS 
beneficiaries, and these gaps impact our assessments of medical 
technologies. The MEDCAC panel will examine the growing challenges 
associated with the decreased level of evidence of certain new and 
innovative technologies. By voting on specific questions, and by their 
discussions, MEDCAC panel members will advise CMS about the ideal 
health outcomes in research studies of cerebrovascular disease 
treatment technologies, appropriate measurement instruments and follow-
up durations to help to provide clarity and transparency of National 
Coverage Analyses (NCAs).
    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 with expertise in the appraisal of the state of evidence 
for the use of services and technologies to diagnose and treat patients 
with cerebrovascular disease. 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 request to speak 
by August 30, 2021. 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="http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3">http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3</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: July 27, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-16314 Filed 7-29-21; 8:45 am]
BILLING CODE 4120-01-P


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