Certificate of Need Rules

Pursuant to GS 150B-21.3A, Periodic Review and Expiration of Existing Rules, all rules are reviewed at least every 10 years, or they shall expire. As a result of the periodic review of Subchapter 10A NCAC 14C, Certificate of Need Regulations, these 10 proposed rules for readoption were part of the 39 rules determined as “Necessary With Substantive Public Interest,” requiring readoption. With input from stakeholders, substantive changes have been made to these proposed rules. Definitions revise listed terms that apply throughout this Subchapter in the filing of Certificate of Need (CON) applications with the agency, and terms that apply to CON application performance standards for dialysis services and new gastrointestinal endoscopy rooms. References to the annual State Medical Facilities Plan are updated in the proposed rules.

The proposed rules clearly define the circumstances that a non-expedited review may be extended for a CON application and add the requirement for applicant notification when the review period has been extended. The replacement equipment exemption requirements are clarified with terms defined and criteria listed for when replacement equipment would not be comparable. The performance standards are revised in proposed rule 10A NCAC 14C .2103 to be in compliance with the annual State Medical Facilities Plan for applicants proposing to increase operating rooms. The proposed rules revise performance standards criteria for establishing a new dialysis facility for in-center services and increasing the number of in-center dialysis stations. Rule 10A NCAC 14C .2203 was amended with temporary procedures Eff. February 1, 2020 and published in 34:16 NCR 2/17/20. Criteria was added to the performance standards for new facilities for home hemodialysis or peritoneal dialysis services and increasing the number of home hemodialysis or peritoneal dialysis facility stations.