Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22895 

for continued approval of its hospital 

accreditation program. This application 

was determined to be complete on 

February 28, 2022. Under section 

1865(a)(2) of the Act and our regulations 

at § 488.5 (Application and reapplication procedures for national 

accrediting organizations), our review 

and evaluation of Det Norske Veritas 

will be conducted in accordance with, 

but not necessarily limited to, the 

following factors: 

• The equivalency of Det Norske 

Veritas’ standards for hospitals as 

compared with CMS’ hospital CoPs. 

• Det Norske Veritas’ survey process 

to determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of Det Norske 

Veritas’ processes to those of state 

agencies, including survey frequency, 

and the ability to investigate and 

respond appropriately to complaints 

against accredited facilities. 

++ Det Norske Veritas’ processes and 

procedures for monitoring a hospital 

found out of compliance with Det 

Norske Veritas’ program requirements. 

These monitoring procedures are used 

only when Det Norske Veritas identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the SA monitors 

corrections as specified at § 488.9. 

++ Det Norske Veritas’ capacity to 

report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

++ Det Norske Veritas’ capacity to 

provide CMS with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ The adequacy of Det Norske 

Veritas’ staff and other resources, and its 

financial viability. 

++ Det Norske Veritas’ capacity to 

adequately fund required surveys. 

++ Det Norske Veritas’ policies with 

respect to whether surveys are 

announced or unannounced, to assure 

that surveys are unannounced. 

++ Det Norske Veritas’ policies and 

procedures to avoid conflicts of interest, 

including the appearance of conflicts of 

interest, involving individuals who 

conduct surveys or participate in 

accreditation decisions. 

++ Det Norske Veritas’ agreement to 

provide CMS with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require (including 

corrective action plans). 

IV. Collection of Information 

Requirements 

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). 

V. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, 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: April 13, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–08251 Filed 4–15–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1777–N] 

Medicare Program; Meeting 

Announcement for the Medicare 

Advisory Panel on Clinical Diagnostic 

Laboratory Tests 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

public meeting dates for the Medicare 

Advisory Panel on Clinical Diagnostic 

Laboratory Tests (the Panel) on Monday, 

July 18, 2022 and Tuesday, July 19, 

2022. The purpose of the Panel is to 

advise the Secretary of the Department 

of Health and Human Services and the 

Administrator of the Centers for 

Medicare & Medicaid Services on issues 

related to clinical diagnostic laboratory 

tests. 

DATES: 

Meeting Dates: The virtual meeting of 

the Panel is scheduled for Monday, July 

18, 2022 from 9:00 a.m. to 5:00 p.m., 

Eastern Daylight Time (E.D.T.) and 

Tuesday, July 19, 2022, from 9:00 a.m. 

to 5:00 p.m., E.D.T. The Panel is also 

expected to virtually participate in the 

Clinical Laboratory Fee Schedule 

(CLFS) Annual Public Meeting for 

Calendar Year (CY) 2023 on June 23, 

2022 in order to gather information and 

ask questions to presenters. Notice of 

the CLFS Annual Public Meeting for CY 

2023 is published elsewhere in this 

issue of the Federal Register. 

Deadline Date for Registration: All 

stand-by speakers for the Panel meeting 

must register electronically to our CDLT 

Panel dedicated email box, CDLTPanel@

cms.hhs.gov by June 27, 2022. 

Registration is not required for nonspeakers. The public may view this 

meeting via webinar, or listen-only via 

teleconference. 

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 approximately 2 weeks prior to 

the meeting at https://www.cms.gov/ 

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelonClinical

DiagnosticLaboratoryTests.html. A 

preliminary agenda is described in 

section II of this notice. 

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– 

1850. 

FOR FURTHER INFORMATION CONTACT: 

Rasheeda Arthur, Ph.D., (410) 786–3434, 

email, CDLTPanel@cms.hhs.gov. Press 

inquiries are handled through the CMS 

Press Office at (202) 690–6145. For 

additional information on the Panel, we 

refer readers to the CMS website at 

https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonClinicalDiagnosticLaboratory

Tests.html. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Medicare Advisory Panel on 

Clinical Diagnostic Laboratory Tests (the 

Panel) is authorized by section 

1834A(f)(1) of the Social Security Act 

(the Act) (42 U.S.C. 1395m–1), as 

established by section 216(a) of the 

Protecting Access to Medicare Act of 

2014 (PAMA) (Pub. L. 113–93), enacted 

on April 1, 2014. The Panel is subject 


khammond on DSKJM1Z7X2PROD with NOTICES
22896 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

to the Federal Advisory Committee Act 

(FACA), as amended (5 U.S.C. appendix 

2), which sets forth standards for the 

formation and use of advisory panels. 

Section 1834A(f)(1) of the Act directs 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) to consult with an expert 

outside advisory panel established by 

the Secretary, composed of an 

appropriate selection of individuals 

with expertise in issues related to 

clinical diagnostic laboratory tests, 

which may include the development, 

validation, performance, and 

application of such tests. Such 

individuals may include molecular 

pathologists, researchers, and 

individuals with expertise in laboratory 

science or health economics. 

The Panel will provide input and 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

on the following: 

• The establishment of payment rates 

under section 1834A of the Act for new 

clinical diagnostic laboratory tests, 

including whether to use 

‘‘crosswalking’’ or ‘‘gapfilling’’ 

processes to determine payment for a 

specific new test. 

• The factors used in determining 

coverage and payment processes for 

new clinical diagnostic laboratory tests. 

• Other aspects of the new payment 

system under section 1834A of the Act. 

A notice announcing the 

establishment of the Panel and soliciting 

nominations for members was 

published in the October 27, 2014 

Federal Register (79 FR 63919 through 

63920). In the August 7, 2015 Federal 

Register (80 FR 47491), we announced 

membership appointments to the Panel 

along with the first public meeting date 

for the Panel, which was held on August 

26, 2015. Subsequent meetings of the 

Panel and membership appointments 

were also announced in the Federal 

Register. 

II. Agenda 

The Agenda for the July 18 and July 

19, 2022 Panel meeting will provide for 

discussion and comment on the 

following topics as designated in the 

Panel’s charter: 

• Calendar Year (CY) 2023 Clinical 

Laboratory Fee Schedule (CLFS) new 

and reconsidered test codes, which will 

be posted on the CMS website at https:// 

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ClinicalLabFee

Sched/Laboratory_Public_

Meetings.html. 

• Other CY 2023 CLFS issues 

designated in the Panel’s charter and 

further described on our Agenda. 

A detailed Agenda will be posted 

approximately 2 weeks before the 

meeting, on the CMS website at https:// 

www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonClinicalDiagnosticLaboratory

Tests.html. The Panel will make 

recommendations to the Secretary and 

the Administrator of CMS regarding 

crosswalking and gapfilling for new and 

reconsidered laboratory tests discussed 

during the CLFS Annual Public Meeting 

for CY 2023. The Panel will also provide 

input on other CY 2023 CLFS issues that 

are designated in the Panel’s charter and 

specified on the meeting agenda. 

III. Meeting Participation 

This meeting is open to the public. 

Stand-by speakers may participate in 

the meeting via teleconference and 

webinar. A stand-by speaker is an 

individual who will speak on behalf of 

a company or organization if the Panel 

has any questions during the meeting 

about technical information described 

in the public comments or presentation 

previously submitted or presented by 

the organization or company at the 

recent Clinical Laboratory Fee Schedule 

(CLFS) Annual Public Meeting for 

Calendar Year (CY) 2023 on June 23, 

2022. The public may also view or 

listen-only to the meeting via 

teleconference and webinar. 

IV. Registration Instructions for StandBy Speakers 

Beginning Monday, May 2, 2022 and 

ending Monday, June 27, 2022 at 5:00 

p.m. E.D.T., registration to serve as a 

stand-by speaker may be completed by 

sending an email to the following 

resource box CDLTPanel@cms.hhs.gov. 

The subject of the email should state 

‘‘Stand-by Speaker Registration for 

CDLT Panel Meeting.’’ In the email, all 

of the following information must be 

submitted when registering: 

• Stand-by Speaker name. 

• Organization or company name. 

• Email addresses that will be used 

by the speaker to connect to the virtual 

meeting. 

• New or Reconsidered Code(s) for 

which the company or organization you 

are representing submitted a comment 

or presentation. 

Registration details may not be 

revised once they are submitted. If 

registration details require changes, a 

new registration entry must be 

submitted by the date specified in the 

DATES section of this notice. Also, 

registration information must reflect 

individual-level content and not reflect 

an organization entry. In addition, each 

individual may only register one person 

at a time. That is, one individual may 

not register multiple individuals at the 

same time. 

After registering, a confirmation email 

will be sent upon receipt of the 

registration. The email will provide 

information to the speaker in 

preparation for the meeting. Registration 

is only required for stand-by speakers 

and must be submitted by the deadline 

specified in the DATES section of this 

notice. We note that registration is not 

required for participants who plan to 

view the Panel meeting via webinar or 

listen via teleconference. 

V. Panel Recommendations and 

Discussions 

The Panel’s recommendations will be 

posted approximately 2 weeks after the 

meeting on the CMS website at https:// 

www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonClinicalDiagnosticLaboratory

Tests.html. 

VI. 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 resource box 

(CDLTPanel@cms.hhs.gov). The 

deadline for submitting this request is 

listed in the DATES section of this notice. 

VII. Copies of the Charter 

The Secretary’s Charter for the 

Medicare Advisory Panel on Clinical 

Diagnostic Laboratory Tests is available 

on the CMS website at http://cms.gov/ 

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelonClinical

DiagnosticLaboratoryTests.html or a 

copy of the charter may be obtained by 

submitting a request to the contact listed 

in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

VIII. Collection of Information 

Requirements 

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. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22897 

purposes of publication in the Federal 

Register. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–08253 Filed 4–15–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10440] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice; correction. 

SUMMARY: On April 6, 2022, CMS 

published a notice in the Federal 

Register that sought comment on a 

collection of information concerning 

CMS–10440 (OMB control number 

0938–1191) entitled ‘‘Data Collection to 

Support Eligibility Determinations for 

Insurance Affordability Programs and 

Enrollment through Health Insurance 

Marketplaces, Medicaid and Children’s 

Health Insurance Program Agencies.’’ In 

one other instance the title was correct 

and in another the title was incorrect. 

This document corrects the incorrect 

occurrence. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham, III, (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the April 6, 2022, issue of the 

Federal Register (87 FR 19957), we 

published a Paperwork Reduction Act 

notice requesting a 60-day public 

comment period for the information 

collection request identified under 

CMS–10440, OMB control number 

0938–1191, and titled ‘‘Data Collection 

to Support Eligibility Determinations for 

Insurance Affordability Programs and 

Enrollment through Health Insurance 

Marketplaces, Medicaid and Children’s 

Health Insurance Program Agencies.’’ 

II. Explanation of Error 

In the April 6, 2022, notice, the title 

associated with the information 

collection request identified under 

CMS–10440 is correctly listed on page 

19957, in the second column, in the 

third paragraph under ‘‘Contents.’’ 

However, the title on page 19958 in the 

first column, in the second paragraph, 

beginning on line 11, the ‘‘Title of 

Information Collection:’’ incorrectly 

reads, ‘‘Medicare Coverage of Items and 

Services in FDA Investigational Device 

Exemption Clinical Studies—Revision 

of Medicare Coverage.’’ This notice 

corrects the ‘‘Title of Information 

Collection.’’ All of the other information 

contained in the April 6, 2022, notice is 

correct. The related public comment 

period remains in effect and ends June 

6, 2022. 

III. Correction of Error 

In the Federal Register of April 6, 

2022, in FR Doc. 2022–07314, on page 

19958, in the first column, in the second 

paragraph, under ‘‘Title of Information 

Collection;’’ in lines 11–15, correct 

‘‘Medicare Coverage of Items and 

Services in FDA Investigational Device 

Exemption Clinical Studies—Revision 

of Medicare Coverage’’ to read, ‘‘Data 

Collection to Support Eligibility 

Determinations for Insurance 

Affordability Programs and Enrollment 

through Health Insurance Marketplaces, 

Medicaid and Children’s Health 

Insurance Program Agencies;’’. 

Dated: April 12, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–08221 Filed 4–15–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1775–N] 

Medicare Program; Public Meeting on 

June 23, 2022 Regarding New and 

Reconsidered Clinical Diagnostic 

Laboratory Test Codes for the Clinical 

Laboratory Fee Schedule for Calendar 

Year 2023 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting to receive comments and 

recommendations (including data on 

which recommendations are based) on 

the appropriate basis for establishing 

payment amounts for new or 

substantially revised Healthcare 

Common Procedure Coding System 

codes being considered for Medicare 

payment under the Clinical Laboratory 

Fee Schedule (CLFS) for calendar year 

(CY) 2023. This meeting also provides a 

forum for those who submitted certain 

reconsideration requests regarding final 

determinations made last year on new 

test codes and for the public to provide 

comment on the requests. 

DATES: 

CLFS Annual Public Meeting Date: 

The virtual meeting is scheduled for 

Thursday, June 23, 2022 from 9:00 a.m. 

to 5:00 p.m., E.D.T. 

Deadline for Submission of 

Presentations and Written Comments: 

All presenters for the CLFS Annual 

Public Meeting must register and submit 

their presentations electronically to our 

CLFS dedicated email box, CLFS_

Annual_Public_Meeting@cms.hhs.gov, 

by June 2, 2022 at 5:00 p.m., E.D.T. All 

written comments (non-presenter 

comments) must also be submitted 

electronically to our CLFS dedicated 

email box, CLFS_Annual_Public_

Meeting@cms.hhs.gov, by June 2, 2022, 

at 5:00 p.m., E.D.T. Any presentations or 

written comments received after that 

date and time will not be included in 

the meeting and will not be reviewed. 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

received no later than June 2, 2022 at 

5:00 p.m. E.D.T. 

Publication of Proposed 

Determinations: We intend to publish 

our proposed determinations for new 

test codes and our proposed 

determinations for reconsidered codes 

(as described later in section II 

‘‘Format’’ of this notice) for CY 2023 by 

early September 2022. 

Deadline for Submission of Written 

Comments Related to Proposed 

Determinations: Comments in response 

to the proposed determinations for new 

and reconsidered codes will be due by 

early October 2022. 

ADDRESSES: Due to the current COVID– 

19 public health emergency, the CLFS 

Annual Public 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 21244–1850. 

Where to Submit Written Comments: 

Interested parties should submit all 

written comments on presentations and 

proposed determinations electronically 

to our CLFS dedicated email box, CLFS_

Annual_Public_Meeting@cms.hhs.gov 

(the specific date for the publication of 

these determinations and the deadline 

for submitting comments regarding 

these determinations will be published 

on the CMS website). 

FOR FURTHER INFORMATION CONTACT: 

Rasheeda Arthur, Ph.D., (410) 786–3434. 

Submit all inquiries to the CLFS 

dedicated email box, CLFS_Annual_

Public_Meeting@cms.hhs.gov with the 


khammond on DSKJM1Z7X2PROD with NOTICES