Certify an End-Stage Renal Disease Facility

Purpose: This procedure briefly describes the steps to establish a certified end-stage renal disease facility in North Carolina. The federal requirements can be found in the Code of Federal Regulations at 42 CFR 405.2102-405.2180 (PDF, 1.63 MB).

Because individual projects may have special circumstances, there may be variations in the process that are not covered in these setps. The outline is intended to be a general guide to aid the applicant in completing the overall project.

Contacts: For questions regarding any part of the process, please contact the appropriate sections of the N.C. Division of Health Service Regulation:

Acute and Home Care Licensure and Certification Section 919-855-4620
Certificate of Need Section 919-855-3873
Medical Facilities Planning Section 919-855-3865

Procedure Summary:
In order to establish an end-stage renal disease facility in North Carolina, an applicant must first review the State Medical Facilities Plan and the most recent Semiannual Dialysis Report. Applicants must obtain a certificate of need, and then apply for Medicare/Medicaid certification.

Procedures:

  1. Review the State Medical Facilities Plan: Medical Facilities Planning Section
    1. Applicants can learn about the methodology for determining the need to establish a dialysis facility by reviewing the State Medical Facilities Plan, which is published each calendar year. The Plan requires preparation of two "Semiannual Dialysis Reports". These semiannual reports specify the numbers of additional dialysis stations needed on a county-by-county basis.
    2. Applicants can also find the Certificate of Need Section review schedules and deadline for submittal of applications to establish a dialysis facility in the Semiannual Dialysis Reports. No one may develop a dialysis facility without first obtaining a certificate of need.
  2. Obtain a Certificate of Need: Certificate of Need Section
    1. The applicant submits an application for the proposed dialysis facility to the Certificate of Need Section (CON) for review and approval according to the schedule outlined in the State Medical Facilities Plan and Semiannual Dialysis Reports. If the applicant is leasing the facility, both the prospective owner/lessor and the lessee of the facility must submit a joint application.
    2. The CON Section advertises a written public comment period. Within 30 days of the beginning of the review period, written comments may be filed by any person regarding the proposals under review, although an applicant may not comment on its own proposal.
    3. The CON Section may conduct a public hearing within 30 to 50 days from the beginning of the review period, at which time the applicant is given the opportunity to respond to written comments submitted to the CON Section and inquiries made at the hearing.
    4. The CON Section decides to approve or disapprove an application within 150 days of the beginning of the review period.
    5. The CON Section issues a certificate of need 35 days after the date of approval if a petition for a contested case hearing is not filed.
    6. After a certificate of need is issued, the applicant contacts the Acute and Home Care Licensure and Certification Section about the requirements for the development of dialysis stations.
  3. Obtain Certification: Acute and Home Care Licensure and Certification Section
    1. At least three months before operation, the facility contacts the section for an application packet. The applicant completes and returns all forms to the section.
    2. The section forwards the Medicare Provider Enrollment Application to the fiscal intermediary to approve or disapprove.
    3. The initial survey is scheduled within three weeks of the notice of the fiscal intermediary’s approval.
    4. If a facility has deficiencies during the initial survey, the effective date of certification will be the latest date that an acceptable Plan of Correction is signed by the facility.
    5. The section forwards all information to the Dallas Centers for Medicare & Medicaid Services (CMS) Regional Office for approval.
    6. The regional office assigns the CMS Certification Number (CCN) and notifies the fiscal intermediary.