Medicare and Medicaid Programs: Application From DNV Healthcare, Inc. for Initial CMS-Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <DEPDOC>[CMS-3474-PN]</DEPDOC> <SUBJECT>Medicare and Medicaid Programs: Application From DNV Healthcare, Inc. for Initial CMS-Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), HHS. <HD SOURCE="HED">ACTION:</HD> Notice with request for comment. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This notice acknowledges the receipt of an application from DNV Healthcare Inc. for initial recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses discussed later in this section, no later than 5 p.m. on May 28, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, refer to file code CMS-3474-PN. Due to staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov</E> . Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3474-PN, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3474-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Joy Webb, (410) 786-1667, or Danielle Adams, (410) 786-8818. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received at <E T="03">http://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. The Centers for Medicare & Medicaid Services (CMS) will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. <HD SOURCE="HD1">I. Background</HD> Ambulatory Surgical Centers (ASCs) are distinct entities that operate exclusively for the purpose of furnishing outpatient surgical services to patients. Under the Medicare program, eligible beneficiaries may receive covered services from an ASC provided certain requirements are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) establishes distinct criteria for a facility seeking designation as an ASC. 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 416 specify the conditions that an ASC must meet to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for ASCs. Generally, to enter into an agreement, an ASC must first be certified by a state survey agency (SA) as complying with the conditions or requirements set forth in part 416 of our Medicare regulations. Thereafter, the ASC is subject to regular surveys by an 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 conditions are met or exceeded, we may deem that 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 of the Department of Health and Human Services 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. The 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 §§ 488.4 and 488.5. This is DNV Healthcare, Inc.'s (DNV's) initial application and does not have a current term of approval for its ASC program. <HD SOURCE="HD1">II. Approval of Deeming Organization</HD> Section 1865(a)(2) of the Act and our 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 found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation. Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. The purpose of this proposed notice is to inform the public of DNV's request for initial CMS-approval of its ASC accreditation program. This notice also solicits public comment on whether DNV's requirements meet or exceed the Medicare conditions for coverage (CfCs) for ASCs. <HD SOURCE="HD1">III. Evaluation of Deeming Authority Request</HD> DNV submitted all the necessary materials to enable us to make a determination concerning its request for initial CMS-approval of its ASC accreditation program. This application was determined to be complete on March 21, 2025. Under section 1865(a)(2) of the Act and § 488.5, our review and evaluation of DNV will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of DNV's standards for ASCs as compared with Medicare's CfCs for ASCs. • DNV's survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ++ The comparability of DNV's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ++ DNV's processes and procedures for monitoring an ASC found out of compliance with DNV's program requirements. These monitoring procedures are used only when DNV identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c)(1). ++ DNV's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. ++ DNV's capacity to provide CMS with electronic data and reports necessary for the effective validation and assessment of the organization's survey process. ++ The adequacy of DNV's staff and other resources, and its financial viability. ++ DNV's capacity to adequately fund required surveys. ++ DNV's policies with respect to whether surveys are announced or unannounced, to ensure that surveys are 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. ++ 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 CMS may require (including corrective action plans). <HD SOURCE="HD1">IV. Collection of Information Requirements</HD> 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 <E T="03">et seq.</E> ). <HD SOURCE="HD1">V. Response to Public Comments</HD> Because of the large number of public comments, we normally receive on <E T="04">Federal Register</E> documents, we are not able to acknowledge or respond to them individually. We wil ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 11k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━