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 18 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 are being made to 11 of these proposed rules, nonsubstantive changes are being made to one proposed rule, and six rules are proposed for readoption as a repeal.
Substantive changes have been made to definitions to revise and update terms that apply to CON application performance standards for cardiac catheterization equipment, open-heart surgery services and heart-lung bypass machines, linear accelerators, magnetic resonance imaging scanners, positron emission tomography scanners and intermediate care facilities for individuals with intellectual disabilities.
Substantive changes have been made to these proposed rules to revise, condense, clarify, and remove unnecessary text in the Certificate of Need applicant performance standards criteria for acquiring fixed, shared fixed, or mobile cardiac catheterization equipment, a fixed or mobile MRI (magnetic resonance imaging) scanner, a fixed or mobile PET (positron emission tomography), and a linear accelerator pursuant to a need determination in the State Medical Facilities Plan in effect as of the first day of the review period. The performance projections for proposed MRI scanner acquisition applicants has been lowered. Substantive changes have been made to revise, condense, clarify, and remove unnecessary text in the performance standards criteria for developing a new open-heart surgery service and acquiring a heart-lung bypass machine.
The six rules proposed for readoption as a repeal are no longer necessary because the Certificate of Need applicant performance standards are obsolete for CT (computed tomography) scanners, substance use disorder (chemical dependency treatment) beds, and psychiatric beds.
In addition, non-substantive and technical changes were made to the proposed rules. Non substantive changes include updating to ICF/IID terminology and removing references to State Medical Facilities Plan adjusted need determinations no longer relevant.
- Notification of proposed readoption of rules
- Proposed Effective Date: January 1, 2022
- Public Comment Period: July 15, 2021 – September 13, 2021 Comments may be submitted by:
- Email: [email protected]
- Mail: Nadine Pfeiffer, Division of Health Service Regulation, 809 Ruggles Drive, 2701 Mail Service Center, Raleigh, NC 27699-2701
- Date: August 31, 2021
- Time: 10:00 a.m.
- By: Webex. Participants may log in 15 minutes prior to the start of the meeting.
- To join the meeting by audio only or by audio and video:
- Copy this link and enter it in your browser (preferably Google Chrome):https://ncgov.webex.com/ncgov/j.php?MTID=m885e5129d76a92c903b34aebf84a0a84
- Meeting password (case sensitive): rules
- Your name and email address may be needed to be entered to register for the event
- Access code: 161 511 9699
- To join the meeting by telephone audio only:
- Meeting password (case sensitive): rules
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The fiscal note was approved by:
- OSBM on June 17, 2021
- N.C. DHHS/Director, DHSR on June 22, 2021
- Rule Fiscal Note
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Federal Certification required by GS 150B-19.1(g)
- Not applicable for these rules
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The notice of text as approved by the N.C. DHHS/Director, DHSR on June 22, 2021:
- 10A NCAC 14C .1601
- 10A NCAC 14C .1603
- 10A NCAC 14C .1701
- 10A NCAC 14C .1703
- 10A NCAC 14C .1901
- 10A NCAC 14C .1903
- 10A NCAC 14C .2301
- 10A NCAC 14C .2303
- 10A NCAC 14C .2401
- 10A NCAC 14C .2403
- 10A NCAC 14C .2501
- 10A NCAC 14C .2503
- 10A NCAC 14C .2601
- 10A NCAC 14C .2603
- 10A NCAC 14C .2701
- 10A NCAC 14C .2703
- 10A NCAC 14C .3701
- 10A NCAC 14C .3703
- Public Comments
- Technical Changes
- 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.
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These rules were approved by the Rules Review Commission on December 16, 2021:
- 10A NCAC 14C .1601
- 10A NCAC 14C .1603
- 10A NCAC 14C .1701
- 10A NCAC 14C .1901
- 10A NCAC 14C .1903
- 10A NCAC 14C .2301
- 10A NCAC 14C .2303
- 10A NCAC 14C .2401
- 10A NCAC 14C .2403
- 10A NCAC 14C .2501
- 10A NCAC 14C .2503
- 10A NCAC 14C .2601
- 10A NCAC 14C .2603
- 10A NCAC 14C .2701
- 10A NCAC 14C .2703
- 10A NCAC 14C .3701
- 10A NCAC 14C .3703
- The effective date of these rules is January 1, 2022
- This rule was approved by the Rules Review Commission on January 20, 2022:
- The effective date of this rule is February 1, 2022
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Public Hearing: