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[Federal Register Volume 89, Number 238 (Wednesday, December 11, 2024)]
[Notices]
[Pages 99873-99874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29075]

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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.

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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 Sec.  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 Sec. Sec.  
488.4 and 488.5. The regulations at Sec.  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 CMS-approval 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 Sec.  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 
decision-making 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 Sec.  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

[[Page 99874]]

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]
BILLING CODE 4120-01-P
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