Notice2024-29075
Medicare and Medicaid Programs: Approval of Application by the DNV Healthcare USA, Inc. for Continued CMS-Approval of Its Critical Access Hospital Accreditation Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 11, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 238 (Wednesday, December 11, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> 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.
<bullet> A comparison of DNV's accreditation to our current
Medicare CAH conditions of participation (CoPs).
<bullet> 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:
<bullet> 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:
<bullet> 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.
<bullet> Revising DNV's internal policies to ensure all surveyors
are qualified.
<bullet> Providing training and education to surveyors to ensure
records are reviewed and reported consistently on DNV's survey report.
<bullet> 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.
<bullet> Ensuring citations are closely aligned or cross-walked
from DNV's standard to the Medicare condition(s).
<bullet> 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.
<bullet> Providing additional education to surveyors related to
observations of care and patient interviews.
<bullet> 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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</html>Indexed from Federal Register on December 11, 2024.
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