Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices 99873 

0938–1401); Frequency: On Occasion; 

Affected Public: Individuals, State, 

Local, or Tribal Governments, Private 

Sector; Number of Respondents: 

2,477,197; Total Annual Responses: 

85,148,199; Total Annual Hours: 

6,006,654. (For policy questions 

regarding this collection, contact Russell 

Tipps at 667–290–9640.) 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–29002 Filed 12–10–24; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3460–FN] 

Medicare and Medicaid Programs: 

Approval of Application by the DNV 

Healthcare USA, Inc. for Continued 

CMS-Approval of Its Critical Access 

Hospital Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice acknowledges the 

approval of an application by the DNV 

Healthcare USA, Inc., for continued 

recognition as a national accrediting 

organization for Critical Access 

Hospitals that wish to participate in the 

Medicare or Medicaid programs. 

FOR FURTHER INFORMATION CONTACT: 

Caecilia Andrews, (410) 786–2190. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a critical access hospital 

(CAH), provided that the facility meets 

certain requirements. Sections 

1820(c)(2)(B), 1820(e), and 1861(mm)(1) 

of the Social Security Act (the Act) 

establish distinct criteria for facilities 

seeking designation as a CAH. 

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. Our regulations 

at 42 CFR part 485, subpart F specify the 

conditions of participation (CoPs) that a 

CAH must meet to participate in the 

Medicare program, the scope of covered 

services, and the conditions for 

Medicare payment for CAHs. The 

regulations at § 485.647 specify that a 

CAH’s psychiatric or rehabilitation 

distinct part unit (DPU), if any, must 

meet the hospital requirements 

specified in subparts A, B, C, and D of 

part 482 in order for the CAH DPU to 

participate in the Medicare program. 

Prior to becoming a CAH, to enter into 

an agreement, a CAH must first be 

certified by a state survey agency as a 

hospital complying with the conditions 

of participation at 42 CFR part 482. It 

then can convert to a CAH by complying 

with the conditions or requirements at 

part 485, subpart F. Thereafter, the CAH 

is subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing state 

review. 

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 requirements are met or 

exceeded, we will deem those provider 

entities as having met such 

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 requirements. A national AO 

applying for approval of its 

accreditation program under 42 CFR 

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 requirements. 

Our regulations concerning the 

approval of AOs are at §§ 488.4 and 

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

require an AO to reapply for continued 

approval of its accreditation program 

every 6 years or sooner, as determined 

by CMS. This notice is to announce our 

continued approval of the DNV 

Healthcare USA, Inc.’s (DNV’s) CAH 

accreditation program for a period of 4 

years. 

II. Application Approval Process 

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

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On June 13, 2024, we published a 

proposed notice in the Federal Register 

(89 FR 50332), announcing DNV’s 

request for continued approval of its 

Medicare critical hospital accreditation 

program. In the proposed notice, we 

detailed our evaluation criteria. Under 

section 1865(a)(2) of the Act and in our 

regulations at § 488.5, we conducted a 

review of DNV’s Medicare CAH 

accreditation application in accordance 

with the criteria specified by our 

regulations, which include, but are not 

limited to the following: 

• An administrative review of DNV’s: 

(1) corporate policies; (2) financial and 

human resources available to 

accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and (5) survey review and decisionmaking process for accreditation. 

• A comparison of DNV’s 

accreditation to our current Medicare 

CAH conditions of participation (CoPs). 

• A documentation review of DNV’s 

survey process to: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and DNV’s ability to provide continuing 

surveyor training. 

++ Compare DNV’s processes to those 

of state survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ Evaluate DNV’s procedures for 

monitoring CAHs out of compliance 

with DNV’s program requirements. The 

monitoring procedures are used only 

when DNV identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the state survey 

agency monitors corrections as specified 

at § 488.7(d). 

++ Assess DNV’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ Establish DNV’s ability to provide 

CMS with electronic data and reports 

necessary for effective validation and 


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99874 Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices 

assessment of the organization’s survey 

process. 

++ Determine the adequacy of staff 

and other resources. 

++ Confirm DNV’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm DNV’s policies with 

respect to whether surveys are 

unannounced. 

++ Obtain DNV’s 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. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 

1865(a)(3)(A) of the Act, the June 13, 

2024 proposed notice also solicited 

public comments regarding whether 

DNV’s requirements met or exceeded 

the Medicare CoPs for CAHs. We did 

not receive any comments. 

V. Provisions of the Final Notice 

A. Differences Between DNV’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements 

We compared DNV’s CAH 

requirements and survey process with 

the Medicare CoPs and survey process 

as outlined in the State Operations 

Manual (SOM). Our review and 

evaluation of DNV’s CAH application 

were conducted as described in section 

III. of this notice and has yielded the 

following areas where, as of the date of 

this notice, DNV’s has completed 

revising its standards and certification 

processes in order to: 

• Meet the standard’s requirements of 

all of the following regulations: 

++ Section 485.614, to incorporate 

language ensuring promotion and 

protection of each patient’s rights. 

++ Section 485.614(b)(4), to 

incorporate language ensuring the 

patient’s family member or 

representative of their choice and their 

own physician are notified promptly of 

their admission to the hospital. 

++ Section 485.614(d)(2), to 

incorporate language that the patient 

has the right to access their medical 

records, including current medical 

records, upon an oral or written request, 

in the form and format requested by the 

individual, if it is readily producible in 

such form and format. 

++ Section 485.618(d)(1)(ii)(A), to 

add the definition of a CAH that is 

located in an area designated as a 

frontier area. 

++ Section 485.625(d), to specify that 

the CAH must review and update its 

emergency preparedness training 

program at least every two years. 

++ Section 485.625(d)(1), to include 

language that training must include: 

prompt reporting and extinguishing of 

fires; protection and, where necessary, 

evacuation, of patients, personnel, and 

guests; fire prevention; and cooperation 

with firefighting and disaster 

authorities, to all new and existing staff, 

individuals providing services under 

arrangement, and volunteers, consistent 

with their expected roles. 

++ Section 485.625(d)(1)(iv), to 

specify that staff must be able to 

demonstrate knowledge of their role 

during an emergency. 

++ Section 485.627(b), to include the 

requirement for addresses within the 

disclosure. 

++ Section 485.631(a)(3), to clarify 

that staff is sufficient to provide the 

services essential to the operation of the 

CAH. 

++ Section 485.638(b)(2), to provide 

additional language that there must be 

written policies and procedures that 

govern the use and removal of records 

from the CAH and the conditions for the 

release of information. 

++ Section 485.639(c), to revise the 

language from ‘‘directing’’ to 

‘‘administering’’ anesthesia. 

++ Section 485.639(c)(2), to clarify 

the requirement surrounding a Certified 

Registered Nurse Anesthetist 

supervision requirements under the 

operating practitioner when 

administering anesthesia. 

++ Section 485.640, to include that 

the CAH’s infection prevention and 

control and antibiotic stewardship 

program is an active facility-wide 

program. 

++ Section 485.645(d)(5), to 

encompass the notation of 

comprehensive assessment of a 

resident’s needs, strengths, goals, life 

history and preferences. 

++ Section 485.645(d)(8), to state 

‘‘assisted nutrition and hydration.’’ 

In addition to the standards review, 

we also reviewed DNV’s comparable 

survey processes, which were 

conducted as described in section III. of 

this notice, and yielded the following 

areas where, as of the date of this notice, 

DNV has completed revising its survey 

processes, in order to demonstrate that 

it uses survey processes that are 

comparable to state survey agency 

processes by: 

• Revising DNV’s complaint policy to 

reflect that any withdrawals from 

accreditation and deemed status, 

whether voluntary or involuntary, must 

be reported within three business days. 

• Revising DNV’s internal policies to 

ensure all surveyors are qualified. 

• Providing training and education to 

surveyors to ensure records are 

reviewed and reported consistently on 

DNV’s survey report. 

• Developing a process to verify 

levels of deficiency citations for the 

physical environment and Life Safety 

Codes citations to ensure facilities are 

appropriately cited based on the 

potential for harm. 

• Ensuring citations are closely 

aligned or cross-walked from DNV’s 

standard to the Medicare condition(s). 

• Developing process or policy to 

ensure swing beds are reviewed, when 

applicable, and providing education to 

surveyors to adequately annotate swing 

bed reviews in DNV’s surveyor notes. 

• Providing additional education to 

surveyors related to observations of care 

and patient interviews. 

• Providing additional clarifications 

on the survey process for medical record 

reviews comparable to those in the 

SOM, Appendix W. 

B. Term of Approval 

Based on our review and observations 

described in section III. and section V. 

of this notice, we approve DNV as a 

national AO for CAHs that request 

participation in the Medicare program. 

The decision announced in this final 

notice is effective December 23, 2024 

through December 23, 2028 (4 years). 

VI. 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 Vanessa Garcia, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Vanessa Garcia, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2024–29075 Filed 12–10–24; 8:45 am] 

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