[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61331-61333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22067]


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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.

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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, 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

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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 [email protected] 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 https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw 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 http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. 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 [email protected] 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 (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and 
the CMS Guidance Document, Factors CMS Considers in Referring Topics to 
the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10).

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 http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. 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

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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 http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. 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 https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw 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