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.
- Notification of proposed readoption of rules
- Notification of proposed readoption of rules – revised August 11, 2020
- Proposed Effective Date: January 1, 2021
- Public Comment Period: July 15, 2020 – September 14, 2020
Comments may be submitted by:- Email: DHSR.RulesCoordinator@dhhs.nc.gov
- Mail: Nadine Pfeiffer, Division of Health Service Regulation, 809 Ruggles Drive, 2701 Mail Service Center, Raleigh, NC 27699-2701
- Public Hearing:
- Date: August 25, 2020
- Time: 10:00 a.m.
- By: WebEx using one of the following methods
- Copy this link and enter it in your browser (preferably Google Chrome):https://ncgov.webex.com/ncgov/j.php?MTID=m885e5129d76a92c903b34aebf84a0a84
- When prompted, enter the meeting password: rules (case sensitive).
- You may also need to enter your name and email address to register for the event.
- This option allows you a choice to join the meeting by audio only or by audio and video.
- Join by telephone by calling 415-655-0003; Access code: 161 813 4838
- This option allows you to join the meeting by audio only.
- Copy this link and enter it in your browser (preferably Google Chrome):https://ncgov.webex.com/ncgov/j.php?MTID=m885e5129d76a92c903b34aebf84a0a84
- The fiscal note was approved by:
- OSBM on April 24, 2020
- N.C. DHHS/Director, DHSR on June 22, 2020
- Fiscal note
- Federal Certification required by GS 150B-19.1(g)
- Not applicable for these rules
- The notice of text as approved by the N.C. DHHS/Director, DHSR on June 22, 2020:
- Public Comments
- Proposed changes to rules published in N.C. Register
- Technical Changes
- These rules were approved by the Rules Review Commission on December 17, 2020:
- Procedure for subjecting a proposed rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2)
from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1)
. The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission.
- The effective date of these rules is January 1, 2021.
Denotes link to site outside of N.C. DHHS.