Application: DNV Healthcare USA Inc. for Continued Approval of Its Psychiatric Hospital Accreditation Program

Medicare and Medicaid Programs: Application by DNV Healthcare USA Inc. for Continued CMS Approval of Its Psychiatric Hospital Accreditation Program

Dates

This notice is applicable on July 30, 2024 through July 30, 2028.

Supplementary Information

I. Background

Under the Medicare program, eligible beneficiaries may receive covered services from a psychiatric hospital provided certain requirements established by the Secretary of the Department of Health and Human Services (the Secretary) are met. Section 1861(f) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a psychiatric hospital under Medicare. Regulations concerning provider agreements and supplier approval 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 subpart E specify the minimum conditions that a psychiatric hospital must meet to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for psychiatric hospitals.

Generally, to enter into a provider agreement with the Medicare program, a psychiatric hospital must first be certified by a State Survey Agency as complying with the conditions or requirements set forth in part 482 subpart E of CMS regulations. Thereafter, the psychiatric hospital is subject to regular surveys by a State Survey Agency to determine whether it continues to meet the Medicare requirements. There is an alternative, however, 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 an approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may treat the provider entity as having met those conditions, that is, we may "deem" the provider entity as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.

If an AO is recognized by 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 may be deemed to meet the Medicare conditions. 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 conditions. Our regulations concerning the approval of AOs are set forth at § 488.5. The regulations at § 488.5(e)(2)(i) require the AO to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS.

II. Application Approval Process

Section 1865(a)(2) of the Act and CMS regulations at § 488.5 require that our findings concerning review and approval of an AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities that were not in compliance with the conditions or requirements; and their ability to provide CMS with the necessary data for validation.

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 CMS 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, CMS 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, CMS must publish a notice in the Federal Register approving or denying the application.

III. Provisions of the Proposed Notice

In the February 6, 2024 Federal Register (89 FR 8203), we published a proposed notice announcing DNV's request for approval of its Medicare psychiatric 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 § 488.5, we conducted a review of DNV's Medicare psychiatric hospital accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:

• An onsite 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 psychiatric hospital surveyors; (4) ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals; and (5) survey review and decision-making process for accreditation.
• The comparison of DNV's Medicare psychiatric hospital accreditation program standards to our current Medicare hospitals Conditions of Participation (CoPs) and psychiatric hospital special CoPs.
• A documentation review of DNV's psychiatric hospital survey process to do the following:

++ Determine the composition of the survey team, surveyor qualifications, and DNV's ability to provide continuing surveyor training.

++ Compare DNV's processes to those we require of State Survey Agencies, including periodic re-survey and the ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals.

++ Evaluate DNV's procedures for monitoring psychiatric hospitals it has found to be out of compliance with DNV's program requirements. (This pertains only to monitoring procedures when DNV identifies non-compliance. If noncompliance is identified by a State Survey Agency through a validation survey, the State Survey Agency monitors corrections as specified at § 488.9(c)(1)).

++ Assess DNV's ability to report deficiencies to the surveyed hospital and respond to the psychiatric hospital'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 assessment of the organization's survey process.

++ Determine the adequacy of DNV's staff and other resources.

++ Confirm DNV's ability to provide adequate funding for performing required surveys.

++ Confirm DNV's policies with respect to surveys being unannounced.

++ DNV'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 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.

++ As authorized under 488.8(h), CMS reserves the right to conduct onsite observations of accrediting organization operations at any time as part of the ongoing review and continuing oversight of an AO's performance.

In accordance with section 1865(a)(3)(A) of the Act, the February 6, 2024, proposed notice also solicited public comments regarding whether DNV's requirements met or exceeded the Medicare CoPs for psychiatric hospitals. No comments were received in response to our proposed notice.

IV. 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 psychiatric hospital accreditation program requirements and survey process with the Medicare CoPs at 42 CFR part 482 subpart E, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of DNV's psychiatric hospital 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, DNV has completed revising its standards and certification processes in order to meet the requirements at:

• Section 482.41(c)(2), to address the requirements regarding the Health Care Facilities Code waiver allowance.
• Section 488.5(4)(ii), to address the requirements to include the requirement for Life Safety Specialist to have training or experience in the Health Care Facilities Code.

B. Term of Approval

Based on our review and observations described in section III of this final notice, we have determined that DNV's psychiatric hospital accreditation program requirements meet or exceed our requirements, and its survey processes are also comparable. Therefore, we approve DNV as a national accreditation organization for psychiatric hospitals that request participation in the Medicare program, effective July 30, 2024 through July 30, 2028.

V. 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 .