[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77615-77617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3429-FN]


Medicare and Medicaid Programs: Application From the Center for 
Improvement in Healthcare Quality for Continued Approval of Its 
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 (CIHQ) for continued recognition as a 
national accrediting organization for hospitals that wish to 
participate in the Medicare or Medicaid programs.

DATES: The decision announced in this notice is applicable January 1, 
2023 through January 1, 2028.

FOR FURTHER INFORMATION CONTACT: 
Erin Imhoff, (410) 786-2337.
Caecilia Blondiaux, (410) 786-2190.

SUPPLEMENTARY INFORMATION: 

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 
statutory authority for the Secretary of the Department of Health and 
Human Services (Secretary) to set 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 of participation 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 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 set forth at Sec. Sec.  488.4, 488.5 
and 488.5(e)(2)(i). The regulations at Sec.  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.

[[Page 77616]]

    Center for Improvement in Healthcare Quality (CIHQ)'s current term 
of approval for their hospital accreditation program expires July 26, 
2023. As discussed in the proposed notice (87 FR 43525), CIHQ submitted 
its application for renewal earlier than expected and therefore CMS 
will adjust their future term of approval accordingly.

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 July 21, 2022, we published a proposed notice in the Federal 
Register (87 FR 43525), announcing CIHQ's request for continued 
approval of its Medicare hospital accreditation program. In that 
proposed notice, we detailed our evaluation criteria. Under section 
1865(a)(2) of the Act and in our regulations at Sec. Sec.  488.5 and 
488.8(h), we conducted a review of CIHQ's Medicare hospital 
accreditation application in accordance with the criteria specified by 
our regulations, which include, but are not limited to the following:
     An 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 CIHQ facility surveyors; (4) ability to investigate 
and respond appropriately to complaints against accredited CIHQ 
facilities; and (5) survey review and decision-making process for 
accreditation.
     A review of CIHQ's survey processes to confirm that a 
provider or supplier, under CIHQ's hospital deeming accreditation 
program, meets or exceeds the Medicare program requirements.
     A documentation review of CIHQ's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and CIHQ's ability to provide continuing surveyor 
training.
    ++ Compare CIHQ's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against CIHQ accredited 
hospitals.
    ++ Evaluate CIHQ's procedures for monitoring accredited hospitals 
it has found to be out of compliance with its program requirements.
    ++ Assess CIHQ's ability to report deficiencies to the surveyed 
hospitals and respond to the hospitals plan of correction in a timely 
manner.
    ++ Determine the adequacy of CIHQ's staff and other resources.
    ++ Confirm CIHQ's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm CIHQ's policies with respect to surveys being 
unannounced.
    ++ Confirm CIHQ's 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.
    ++ 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 July 21, 
2022 proposed notice also solicited public comments regarding whether 
CIHQ's requirements met or exceeded the Medicare conditions of 
participation for hospitals. We received approximately 19 timely public 
comments from hospitals and individuals, and another that was out of 
scope of the proposed rule.
    Comment: Most commenters expressed support for CIHQ and their 
hospital accreditation program and encouraged CMS to approve them for 
continued recognition as a national AO for hospitals.
    Response: We appreciate the support from those hospitals who have 
experience with CIHQ's Medicare hospital accreditation program and 
agree that CIHQ should be approved for continued recognition as a 
national AO for hospitals that wish to participate in the Medicare or 
Medicaid programs.
    Comment: A commenter expressed concern about hospital accreditation 
programs overall and the responsibility of CMS to oversee the process. 
The comment was not specific to CIHQ.
    Response: We appreciate this comment and the concern for patient 
safety and quality of care. We continue to prioritize patient safety 
and our responsibility for oversight of AOs. As described in section 
III. Provisions of the Proposed Notice of this notice, CMS takes 
various steps when considering whether to approve or not approve a 
national AO. Each AO wishing to be recognized by Medicare as a national 
AO must go through a rigorous process for CMS approval. We remain 
steadfast in our commitment to keeping the public informed of our 
evaluation process for AOs seeking approval from CMS.
    Comment: A commenter expressed concern for paying out of pocket for 
chronic diseases.
    Response: We thank the commenter for expressing concern, but this 
comment is outside the scope of the notice.
    Final Decision: After consideration of the public comments 
received, we are finalizing our decision to approve CIHQ's application 
for continued recognition as a national AO for hospitals that wish to 
participate in the Medicare or Medicaid programs.

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 hospital accreditation requirements and survey 
process with the Medicare conditions of participation of part 482, and 
the survey and certification process requirements of parts 488 and 489. 
Our review and evaluation of CIHQ's renewal application, which were 
conducted as described in section III. of this final notice, yielded 
the following areas where, as of the date of this notice, CIHQ has 
completed revising its standards and certification processes in order 
to--
     Meet the requirements of all of the following Medicare 
regulations:
    ++ Section 482.41(a)(1), to include the appropriate Life Safety 
Code (LSC) references that address hospitals classified as new 
occupancies.
    ++ Section 482.41(b)(1)(i), to include the appropriate National 
Fire Protection Agency (NFPA) 101 requirements for hospitals classified 
as Business Occupancies.
    ++ Section 482.41(d)(4), to include compliance with the 2008 
American Society of Heating, Refrigerating and Air-Conditioning 
Engineers (ASHRAE) Standard 170--Ventilation of Health Care Facilities, 
in accordance with 2012

[[Page 77617]]

NFPA requirements and to ensure sterile supply and medical equipment 
manufacturer instructions for use (IFUs) are considered before 
hospitals reduce relative humidity levels.
    ++ Section 488.5(a)(3), to correct formatting and technical errors 
in the crosswalk as requested by CMS.
    In addition to the standards review, CMS reviewed CIHQ's comparable 
survey processes, which was conducted as described in section III. of 
this notice, and also reviewed corporate policies, which yielded the 
following areas where, as of the date of this notice, CIHQ has 
completed revising its survey processes to demonstrate that it uses 
survey processes that are comparable to state survey agency processes 
by:
    ++ Revising Facility & Life Safety worksheets for surveyors to 
explain that the worksheet does not include all 2012 LSC & Health Care 
Facilities Code requirements in accordance with survey comparability at 
Sec.  488.5(a)(4)(ii).
    ++ Providing additional training to surveyors related to the number 
of medical records that should be reviewed during the survey of larger 
hospitals in accordance with survey comparability at Sec.  
488.5(a)(4)(ii).
    ++ Improving the level of detail in survey documentation in 
accordance with survey comparability at Sec.  488.5(a)(4)(ii).
    ++ Providing CMS with the job description required for CIHQ's LSC 
Consultants in accordance with the description of education and 
experience requirements surveyors must meet at Sec.  488.5(a)(7).
    ++ Revising complaint procedures to ensure the survey investigation 
process is clearly documented in accordance with the organizations 
complaint procedures at Sec.  488.5(a)(12).

B. Term of Approval

    Based on our review and observations described in section III. and 
section V. of this notice, we approve CIHQ as a national accreditation 
organization for hospitals that request participation in the Medicare 
program. The decision announced in this notice is effective January 1, 
2023 through January 1, 2028 (5 years). Due to the timing of the start 
of the fiscal year and associated travel restrictions, CMS was unable 
to conduct a hospital survey observation of CIHQ surveyors in 
accordance with 42 CFR 488.8(h), which is one component of the 
comparability evaluation. Therefore, we are providing CIHQ with a 
reduced term of approval. In accordance with 42 CFR 488.5(e)(2)(i), CMS 
may not give a term of the approval that exceeds 6 years.
    Based on our discussions with CIHQ and the information provided in 
its application, we are confident that CIHQ will continue to ensure 
that its deemed hospitals will continue to meet or exceed Medicare 
standards. Additionally, CIHQ has applied for critical access hospital 
deeming authority and as part of that application we will complete a 
survey observation. Critical access hospitals have similar CoPs and 
survey process to hospitals and therefore we are confident in a 5-year 
approval term for this application.

VI. Collection of Information and Regulatory Impact Statement

    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 Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: December 14, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-27465 Filed 12-16-22; 8:45 am]
BILLING CODE 4120-01-P