Medicare and Medicaid Programs: Center for Healthcare Quality Improvement Application for Initial CMS Approval of its Critical Care Hospital Accreditation Program (2023)

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Centers for Medicare and Medicaid Services (CMS), HHS.

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This notice announces our decision to approve the Center for Healthcare Quality Improvement for initial recognition as a national accrediting organization for critical access hospitals wishing to participate in the Medicare or Medicaid programs.

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The decision published in this notice is applicable from June 1, 2023 to June 1, 2027.

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Cecilia Blondiaux, (410) 786–2190.

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I. Background

Under Medicare, eligible beneficiaries can receive covered services at a critical access hospital (CAH) as long as certain requirements are met. Sections 1820(c)(2)(B), 1820(e) and 1861(mm)(1) of the Social Security Act (Act) establish various criteria for establishments seeking CAH designation. The regulations relating to contracts with service providers can be consulted at42 CFR of 489and those related to tasks related to the inspection and certification of installations are in42 CFR of 488. regulations on42 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 Medicare payment terms for CAHs. regulations on42 CFR 485.647state that the special psychiatric or rehabilitation unit (DPU) of the CAH, if any, must meet the hospital requirements set forth in subparts A, B, C, and D of part 482 and selected provisions42 CFR of 412for the HUH DPU to participate in the Medicare program.

Before becoming a CAH, in order to enter into a contract, a CAH must first be certified by a state regulatory agency as a hospital meeting the conditions or requirements of Part 482 and can then convert to a CAH meeting the conditions or requirements of Part 482. 485, subpart F. The CAH is subject to regular review by the state's oversight agency to determine whether it continues to meet these requirements. However, there is an alternative to government agency surveys. Certification by a nationally recognized accreditation program can replace an ongoing state audit.

Section 1865(a)(1) of the Act provides that if a service provider demonstrates through accreditation by a national accrediting organization (AO) approved by the Centers for Medicare and Medicaid Services (CMS) that all applicable requirements ​Medicare requirements have been met or exceeded, we will assume that providers meet those requirements. AO accreditation is voluntary and not required for participation in Medicare.

If the Secretary of the Department of Health and Human Services (Secretary) recognizes that the AO has credentialing standards that meet or exceed Medicare requirements, any provider accredited by an approved program of a national accrediting body will be deemed to meet the requirements of the Medicare. 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 accredited providers to meet requirements that are at least as stringent as Medicare requirements.

Our regulations regarding the approval of AOs are in §§ 488.4 and 488.5. The regulations in § 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 the CMS. This notice is to announce our initial approval of the Center for Healthcare Quality Improvement (CIHQ) CAH accreditation program. CIHQ's CAH review authority will be reviewed for further approval in accordance with the regulations in §§ 488.4 and 488.5 after this initial approval period.

II. Application approval process

Section 1865(a)(3)(A) of the Act provides a statutory timeline to ensure that our review of requests for approval of accreditation programs by CMS is conducted in a timely manner. The law gives us 210 days from the date we receive a completed application, with all the necessary documentation to make a decision, to complete our research activities and application process. Within 60 days of receiving a completed application, we must post a notice on theFederal Registerthat identifies the national accreditation body making the application, describes the application, and provides a public comment period of at least 30 days. At the end of the 210 day period, we must post a notice in theFederal Registerapprove or reject the request.

III. Provisions of the proposed notice

On December 7, 2022, we posted a proposed notice onFederal Register(87 FR 75049), announcing CIHQ's solicitation for initial approval of its Medicare Critical Hospitals Accreditation Program. In the December 2022 notification proposal, we detailed our evaluation criteria. Pursuant to section 1865(a)(2) of the Act and our regulations at § 488.5, we conducted a review of the CIHQ application for Medicare CAH accreditation in accordance with the criteria set forth in our regulations, which include, but are not limited to , the next::

• A virtual administrative overview of CIHQ: (1) corporate policies; (2) financial and human resources available for the implementation of the proposed research; (3) procedures for training, monitoring and evaluating their supervisors; (4) ability to properly investigate and respond to complaints against accredited facilities; and (5) the review and decision-making process for accreditation.
• Comparison of CIHQ accreditation with our current Medicare CAH CoPs.
• Document review of the CIHQ research process for:

++ Determine the composition of the monitoring team, the qualifications of the surveyors, and the ability of CIHQ to provide ongoing training to surveyors.

++ Compare CIHQ procedures with those of national oversight agencies, including frequency of investigations and ability to adequately investigate and respond to complaints against accredited facilities.

++ Evaluate CIHQ procedures to monitor CAH non-compliance with CIHQ program requirements. Monitoring procedures are only used when non-compliance is identified by CIHQ. If nonconformity is determined by the validity review, the state oversight agency oversees corrections as specified in § 488.7(d).

++ Assess CIHQ's ability to report deficiencies to surveyed facilities and respond to a facility repair plan in a timely manner.

++ Establish CIHQ's ability to provide the CMS with the electronic data and reports needed to effectively validate and evaluate the organization's research process.

++ Determine suitability of staff and other resources.

++ Confirm CIHQ's ability to secure adequate funding to carry out the necessary research.

++ Please confirm CIHQ policies on whether or not the survey is advertised.

++ Obtain CIHQ's consent to provide CMS with a copy of the most recent credentialing survey, along with any other survey-related information we may request, including corrective action plans.

4. Analysis and responses to public comments on the proposed public notice

Pursuant to section 1865(a)(3)(A) of the Act, the proposed December 7, 2022 notice also requested public comment on whether the CIHQ requirements met or exceeded the Medicare CoPs for CAHs. We received a comment, which was outside the scope of the proposed notice.Top of printed page 32772

V. Final Notice Provisions

A. Differences between CIHQ credentialing standards and requirements and Medicare testing requirements and requirements

We compared the CIHQ CAH requirements and search process to the Medicare CoPs and search process as described in the State Operations Manual (SOM). Our review and assessment of the CIHQ CAH application was conducted as described in Section III of this notice and provided the following areas where, as of the date of this notice, CIHQ has completed a review of its standards and certification process to—

• Meet the standard requirements of all of the following regulations:

++ Section 485.604(a)(2), to clarify requirements for specialized education in clinical nursing, including master's or doctoral degrees in a defined area of ​​clinical nursing from an accredited educational institution.

++ Section 485.616(c)(4)(iv), to specify the requirement to internally review the work of a telephysician or practitioner under privilege at a CAH whose patients receive 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 harmonize CIHQ's comparable standards with the Life Safety Code (LSC) (National Fire Protection Association (NFPA) 101 and Interim Amendments (TIA): TIA 12– 1, TIA 12–2, TIA 12–3, and TIA 12–4).

++ Section 485.627(a), to include additional clarification or specific language regarding "determining, implementing, and monitoring policies governing the general operation of the CAH".

++ Section 485.635(b)(3), which includes a reference to state law within the standards for radiology services.

++ Section 485.638(a)(4)(iv), to specify the qualifications of persons who may enter information into the health record, which must be dated and signed by the person who entered it.

++ Section 485.639(a), to further expand the qualifications of professionals authorized to perform surgery for patients with CAH in accordance with approved policies and procedures and state scope of practice laws.

In addition to reviewing the standards, CMS also reviewed CIHQ's comparable research processes, which were conducted as described in Section III of this notice, and provided the following areas where, as of the date of this notice, CIHQ had completed a review of its research processes in order to demonstrate that it uses research processes comparable to those of state research agencies:

• Review of CIHQ supervisors' guide to ensure a comprehensive environmental and life safety review is conducted.
• Clarification of CIHQ policies to align with Appendix A-Hospital of SOM, Research Protocol, Task 3, Research Sites and Entry Activities of Appendix W–CAH, to include all hospital departments and services on the primary hospital campus and remote sites, satellite sites, inpatients will be examined care sites, ambulatory surgery sites, complex ambulatory care sites, and a selected sample of each type of other service provided at additional provider-based locations, including contracted customer care activities. patient or patient services. These types of facilities may have occupancy classifications other than medical or ambulatory occupancy, as determined by the LSC.
• Updated CIHQ job descriptions and summaries to include that LSC supervisors' responsibilities consist of reviewing the LSC and the Health Facilities Code.

B. Term of approval

Based on our review and observations described in sections III and V of this notice, we are approving CIHQ as a national AO for CAHs seeking participation in the Medicare program. The decision published in this notice will be in effect from June 1, 2023 to June 1, 2027 (4 years).

YOU. Information collection requests

This document does not impose information collection requirements, ie reporting requirements, record keeping or third party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Bureaucracy Reduction Act 1995 (44 U.S.C. 3501 i seq.).

The Administrator of the Centers for Medicare and Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Evell J. Barco Holland, who is the representative of the Federal Register, to electronically sign this document for publication in theFederal Register.

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