Purpose: This procedure briefly describes the steps to establish a certified End-Stage Renal Disease facility in North Carolina. Federal requirements can be found in the Code of Federal Regulations at 42 CFR 405.2102-405.2180.
Please be aware that there may be variations in the process since individual projects may have special circumstances. The flow chart 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:
| Medical Facilities Planning Section | (919)855-3865 |
| Certificate of Need Section | (919) 855-3873 |
| Licensure; Acute and Home Care Branch | (919) 733-1610 |
Procedure Summary:
In order to establish an end-stage renal disease facility in North Carolina, an applicant must first consult 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:
| Step | Process followed |
|---|---|
| 1.0 | Consult the State Medical Facilities Plan: Medical Facilities Planning Section |
| 1.1 | Applicants can learn about the methodology for determining the need to establish a dialysis facility by consulting the State Medical Facilities Plan, which is published each calendar year. The Plan requires preparation of two “Semiannual Dialysis Reports” (one in March and the other in September). These semiannual reports specify the numbers of additional dialysis stations needed on a county-by-county basis. |
| 1.2 | 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. |
| 2.0 | Obtain a Certificate of Need: Certificate of Need Section |
| 2.1 | 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. |
| 2.2 | 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. |
| 2.3 | 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. |
| 2.4 | The CON Section decides to approve or disapprove an application within 150 days of the beginning of the review period. |
| 2.5 | 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. |
| 2.6 | After a certificate of need is issued, the applicant contacts the Acute and Home Care Branch about the requirements for the development of dialysis stations. |
| 3.0 | Obtain Certification: Acute and Home Care Branch |
| 3.1 | At least three months before operation, the facility contacts the Branch for an application packet. The applicant completes and returns all forms to the Branch. |
| 3.2 | The Branch forwards the Medicare Provider Enrollment Application to the fiscal intermediary to approve or disapprove. |
| 3.3 | The initial survey is scheduled within three weeks of the notice of the fiscal intermediary’s approval. |
| 3.4 | 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. |
| 3.5 | The Branch forwards all information to the Dallas Health Care Financing Administration (HCFA) Regional Office for approval. |
| 3.6 | The Regional Office assigns the provider number and notifies the fiscal intermediary. |
This page last updated on August 6, 2007.