Source: https://www.federalregister.gov/documents/2018/08/07/2018-16871/medicare-and-medicaid-programs-national-dialysis-accreditation-commission-ndac-for-approval-of-its
Timestamp: 2018-08-18 18:56:44
Document Index: 581409633

Matched Legal Cases: ['art 489', 'art 488', 'art 494', 'art 494', 'art 488', '§\u2009488', '§\u2009488', '§\u2009488']

Federal Register :: Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation Program
Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation Program
A Notice by the Centers for Medicare & Medicaid Services on 08/07/2018
83 FR 38697
38697-38699 (3 pages)
CMS-3366-PN
https://www.federalregister.gov/d/2018-16871 https://www.federalregister.gov/d/2018-16871
This PDF is the current document as it appeared on Public Inspection on 08/06/2018 at 08:45 am.
This proposed notice acknowledges the receipt of an application from the National Dialysis Accreditation Commission (NDAC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities that wish to participate in the Medicare or Medicaid programs.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 6, 2018.
In commenting, refer to file code CMS-3366-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3366-PN, P.O. Box 8010, Baltimore, MD 21244-8010.
3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3366-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Tara Lemons, (410) 786-3030, Monda Shaver, (410) 786-3410, or Marie Vasbinder, (410) 786-8665.
End Further Info End Preamble Start Supplemental Information Start Printed Page 38698
Under the Medicare program, eligible beneficiaries may receive covered services from an end-stage renal disease (ESRD) facility provided the facility meets the requirements established by the Secretary of the Department of Health and Human Services (Secretary). Section 1881(b) of the Social Security Act (the Act) establishes distinct requirements for facilities seeking designation as an ESRD facility under Medicare. Regulations concerning provider agreements and supplier approval are at 42 CFR part 489 and those pertaining to activities relating to the survey, certification, and enforcement procedures of suppliers which include ESRD facilities are at 42 CFR part 488. The regulations at 42 CFR part 494 subparts A through D implement section 1881(b) of the Act, which specify the conditions that an ESRD facility must meet in order to participate in the Medicare program and the conditions for Medicare payment for ESRD facilities.
Generally, to enter into a Medicare agreement, an ESRD facility must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 494 subparts A through D of our Medicare regulations. Thereafter, the ESRD facility is subject to regular surveys by a State survey agency 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 those provider entities as having met the requirements. Section 1865(a)(1) of the Act had historically prohibited dialysis facilities from participating in Medicare via a CMS-approved accreditation program; however, section 50403 of the Bipartisan Budget Act of 2018 amended section 1865(a) of the Act to include renal dialysis facilities as provider entities allowed to participate in Medicare through a CMS-approved accreditation program. 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. An 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 purpose of this proposed notice is to inform the public of National Dialysis Accreditation Commission's (NDAC) request for CMS-approval of its ESRD facility accreditation program. This notice also solicits public comment on whether NDAC's requirements meet or exceed the Medicare conditions for coverage (CfCs) for ESRD facilities.
This is the first application from a national accreditation body seeking approval of an accreditation program for ESRD facilities.
NDAC submitted all the necessary materials to enable us to make a determination concerning its request for CMS-approval of its ESRD facility accreditation program. This application was determined to be complete on June 8, 2018. Under section 1865(a)(2) of the Act and our regulations at § 488.5, our review and evaluation of NDAC will be conducted in accordance with, but not necessarily limited to, the following factors:
The equivalency of NDAC's standards for ESRD facilities as compared with Medicare's CfCs for ESRD facilities.
NDAC's survey process to determine the following:
++ The comparability of NDAC's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ NDAC's processes and procedures for monitoring an ESRD facility found out of compliance with NDAC's program requirements. These monitoring procedures are used only when NDAC 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).
++ NDAC's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ NDAC's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of NDAC's staff and other resources, and its financial viability.
++ NDAC's capacity to adequately fund required surveys.
++ NDAC's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ NDAC'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).Start Printed Page 38699
[FR Doc. 2018-16871 Filed 8-6-18; 8:45 am]