Notice2023-10824
Medicare and Medicaid Programs: Application From the Center for Improvement in Healthcare Quality for Initial 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
May 22, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces our decision to approve the Center for Improvement in Healthcare Quality for initial 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 88 Issue 98 (Monday, May 22, 2023)</title>
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[Federal Register Volume 88, Number 98 (Monday, May 22, 2023)]
[Notices]
[Pages 32770-32772]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10824]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3435-FN]
Medicare and Medicaid Programs: Application From the Center for
Improvement in Healthcare Quality for Initial 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 announces our decision to approve the Center for
Improvement in Healthcare Quality for initial recognition as a national
accrediting organization for critical access hospitals that wish to
participate in the Medicare or Medicaid programs.
[[Page 32771]]
DATES: The decision announced in this notice is applicable June 1, 2023
to June 1, 2027.
FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786-2190.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a critical access hospital (CAH) provided certain
requirements are met. Sections 1820(c)(2)(B), 1820(e) and 1861(mm)(1)
of the Social Security Act (the Act) establishes 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. The 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 42 CFR
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 and selected provisions of 42
CFR part 412 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 or requirements at part 482, then can convert to a
CAH by complying with the conditions or requirements at part 485,
subpart F. 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 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
initial approval of the Center for Improvement in Healthcare Quality's
(CIHQ's) CAH accreditation program. CIHQ's CAH deeming authority will
be reviewed for continued approval in accordance with the regulations
at Sec. Sec. 488.4 and 488.5 after this initial term of approval.
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 December 7, 2022, we published a proposed notice in the Federal
Register (87 FR 75049), announcing CIHQ's request for initial approval
of its Medicare critical hospital accreditation program. In the
December 2022 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 CIHQ's Medicare CAH accreditation
application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
<bullet> A virtual administrative review of CIHQ'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 CIHQ's accreditation to our current
Medicare CAH CoPs.
<bullet> A documentation review of CIHQ's survey process to:
++ Determine the composition of the survey team, surveyor
qualifications, and CIHQ's ability to provide continuing surveyor
training.
++ Compare CIHQ'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 CIHQ's procedures for monitoring CAH out of compliance
with CIHQ's program requirements. The monitoring procedures are used
only when CIHQ identifies noncompliance. If noncompliance is identified
through validation reviews, the state survey agency monitors
corrections as specified at Sec. 488.7(d).
++ Assess CIHQ's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ Establish CIHQ's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of staff and other resources.
++ Confirm CIHQ's ability to provide adequate funding for
performing required surveys.
++ Confirm CIHQ's policies with respect to whether surveys are
announced or unannounced.
++ Obtain CIHQ'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 December
7, 2022 proposed notice also solicited public comments regarding
whether CIHQ's requirements met or exceeded the Medicare CoPs for CAHs.
We received one comment, which was out of the scope of the proposed
notice.
[[Page 32772]]
V. Provisions of the Final Notice
A. Differences Between CIHQ's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared CIHQ'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 CIHQ'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, CIHQ'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 485.604(a)(2), to clarify the requirements for clinical
nurse specialists' education, including a master's or doctoral level
degree in a defined clinical area of nursing from an accredited
educational institution.
++ Section 485.616(c)(4)(iv), to specify the requirement of an
internal review of a distant-site physician's or practitioner's
performance under privileges at the CAH whose patients are receiving
the telemedicine services from the physician or practitioner.
++ Section 485.623(b)(1), to ensure that all essential mechanical,
electrical and patient care equipment is maintained in safe operating
condition.
++ Section 485.623(c)(1)(i), to align CIHQ's comparable standards
with the Life Safety Code (LSC) (National Fire Protection Association
(NFPA) 101 and Tentative Interim Amendments (TIAs): TIA 12-1, TIA 12-2,
TIA 12-3, and TIA 12-4).
++ Section 485.627(a), to include additional clarification or
specific language on ``determining, implementing and monitoring
policies governing the CAH's total operation''.
++ Section 485.635(b)(3), to include reference to state law within
its standard for radiology services.
++ Section 485.638(a)(4)(iv), to specify the qualifications of who
may make entries into the medical record, which must be dated, and
signed by the individual who made the entry.
++ Section 485.639(a), to further expand on the qualifications on
the practitioners who are allowed to perform surgery for CAH patients,
in accordance with its approved policies and procedures, and with state
scope of practice laws.
In addition to the standards review, CMS also reviewed CIHQ'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, CIHQ 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 CIHQ's surveyor guide to ensure a comprehensive
review of environmental safety and life safety requirements are
performed.
<bullet> Clarifying CIHQ's policies to align with the SOM Appendix
A-Hospitals, Survey Protocol, Task 3, Survey Locations, and Appendix W-
CAHs Entrance Activities, to include that all hospital departments and
services at the primary hospital campus and remote locations, satellite
locations, inpatient care locations, out-patient surgery locations,
complex out-patient care locations, and a select sample of each type of
other services provided at additional provider based locations,
including contracted patient care activities or patient services will
be surveyed. These facility types may have occupancy classifications
other than healthcare or ambulatory occupancies, as determined by the
LSC.
<bullet> Updating CIHQ's position summaries and description to
include that the LSC surveyor's responsibilities is comprised of an
assessment of both the LSC and Health Care Facilities Code.
B. Term of Approval
Based on our review and observations described in sections III and
V of this notice, we approve CIHQ as a national AO for CAHs that
request participation in the Medicare program. The decision announced
in this notice is effective June 1, 2023 through June 1, 2027 (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 Evell J. Barco Holland, who is the Federal
Register Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: May 17, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-10824 Filed 5-19-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on May 22, 2023.
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