41040 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 

can be found in the collection’s 

supporting statement and associated 

materials (see ADDRESSES). 

Generic Information Collection 

1. Type of Information Collection 

Request: New collection: Title of 

Information Collection: Expressions of 

Interest in the Infant Well-Child Visit 

Affinity Group; Use: To improve the use 

and quality of well-child visits for 

Medicaid and CHIP beneficiaries ages 0 

to 12 months, CMS has launched the 

Infant Well-Child Visit Learning 

Collaborative Affinity Group. The 

affinity group will provide technical 

assistance to state Medicaid and CHIP 

agencies and their partners through 

group workshops and one-on-one 

meetings. Quality improvement (QI) 

advisors and subject matter experts will 

provide state teams with individualized 

guidance, including QI tools, to identify, 

implement, and test change ideas to 

improve infant well-child visits and 

then scale those changes that prove 

successful. 

Many infants do not receive the 

recommended number of infant wellchild visits. Reasons for missing visits 

include lack of transportation, work 

responsibilities, lack of childcare, and 

other social stressors. The COVID–19 

pandemic has exacerbated the number 

of missed well-child visits, with 21 

percent fewer (4.6 million) child 

screening services provided between 

March through October 2020, compared 

to the same period in 2019. Because 

Medicaid and CHIP cover nearly 40 

percent of all children, focusing on 

well-child visits is an opportunity for 

state Medicaid and CHIP programs to 

improve overall attendance and quality 

of infant well-child visits and to reduce 

disparities in well-infant care. When 

children receive the recommended 

number of high-quality visits, they are 

more likely to be up-to-date on 

immunizations, have developmental 

concerns recognized early, and are less 

likely to visit the emergency 

department. Form Number: CMS–10398 

(#72) (OMB control number: 0938– 

1148); Frequency: Once; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 20; Total 

Annual Hours: 140. (For policy 

questions regarding this collection 

contact Kristen Zycherman at 410–786– 

6974.) 

Dated: July 26, 2021. 

William N. Parham, III 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–16208 Filed 7–29–21; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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 MedCACpresentations@

cms.hhs.gov 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 

https://cms.zoomgov.com/webinar/ 

register/WN_

eJmuvv1UTImALOSXqhKmPQ 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 http://www.cms.gov/medicarecoverage-database/indexes/medcacmeetings-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., EDT on Friday, August 27, 2021. 


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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 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 

Tara.Hall@cms.hhs.gov 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-andGuidance/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-documentdetails.aspx?MCDId=10). 

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 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 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: 

http://www.cms.gov/medicare-coveragedatabase/indexes/medcac-meetingsindex.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 http://www.cms.gov/apps/ 

events/upcomingevents.

asp?strOrderBy=1&type=3 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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