22894 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–08216 Filed 4–15–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3424–PN] 

Medicare and Medicaid Programs: 

Application From Det Norske Veritas 

for Continued Approval of Its Hospital 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: This notice acknowledges the 

receipt of an application from Det 

Norske Veritas for continued 

recognition as a national accrediting 

organization for hospitals that wish to 

participate in the Medicare or Medicaid 

programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on May 18, 2022. 

ADDRESSES: In commenting, please refer 

to file code CMS–3424–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3424–PN, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3424–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: Joy 

Webb, (410) 786–1667. Lillian William, 

(410) 786–8636. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospital provided 

certain requirements are met. Section 

1861(e) of the Social Security Act (the 

Act), establishes distinct criteria for 

facilities seeking designation as a 

hospital. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are at 42 CFR part 488. The 

regulations at 42 CFR part 482 specify 

the minimum conditions that a hospital 

must meet to participate in the Medicare 

program. 

Generally, to enter into an agreement, 

a hospital must first be certified by a 

state survey agency (SA) as complying 

with the conditions or requirements set 

forth in part 482 of our regulations. 

Thereafter, the hospital is subject to 

regular surveys by a SA to determine 

whether it continues to meet these 

requirements. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by a Centers for 

Medicare & Medicaid Services (CMS) 

approved national accrediting 

organization (AO) that all applicable 

Medicare conditions are met or 

exceeded, we will deem those provider 

entities as having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. 

If an AO is recognized by the 

Secretary of the Department of Health 

and Human Services (the Secretary) as 

having standards for accreditation that 

meet or exceed Medicare requirements, 

any provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national AO 

applying for approval of its 

accreditation program under part 488, 

subpart A, must provide CMS with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of AOs are set forth at §§ 488.4 and 

488.5. The regulations at § 488.5(e)(2)(i) 

require AOs to reapply for continued 

approval of its accreditation program 

every 6 years or sooner as determined 

by CMS. 

Det Norske Veritas’ current term of 

approval for their hospital accreditation 

program expires September 26, 2022. 

II. Approval of Deeming Organization 

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

regulations at § 488.5 require that our 

findings concerning review and 

approval of a national AO’s 

requirements consider, among other 

factors, the applying AO’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of Det Norske 

Veritas’ request for continued approval 

of its hospital accreditation program. 

This notice also solicits public comment 

on whether Det Norske Veritas’ 

requirements meet or exceed the 

Medicare conditions of participation 

(CoPs) for hospitals. 

III. Evaluation of Deeming Authority 

Request 

Det Norske Veritas submitted all the 

necessary materials to enable us to make 

a determination concerning its request 


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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 


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