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.