Mississippi Administrative Code
Title 15 - Mississippi Department of Health
Part 8 - Office of Health Policy and Planning
Subpart 90 - Planning and Resource Development
Chapter 05 - Acute Care Facilities and Services Overview
Section 15-8-90-05-513 - Certificate of Need Criteria and Standards for Diagnostic and Therapeutic Imaging Services
Section 15-8-90-05-513.02 - Positron Emission Tomography (PET) Equipment and Services
Section 15-8-90-05-513.02.02 - Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of a Positron Emission Tomography (PET) Scanner and Related Equipment including Cardiac only PET Scanner
Current through September 24, 2024
MSDH will review applications for a Certificate of Need for the acquisition or otherwise control of a PET scanner and related equipment under the applicable statutory requirements of Sections 41-7-173, 41-7-191, and 41-7-193, Mississippi Code 1972, as amended. MSDH will also review applications for Certificate of Need according to the general review criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures, and plans of MSDH; and the specific criteria and standards listed below.
The acquisition or otherwise control of a PET scanner and related equipment is reviewable if the equipment cost is in excess of $1,500,000, or if the equipment is relocated. The offering of PET services is reviewable if the proposed provider has not provided those services on a regular basis within the period of twelve (12) months prior to the time such services would be offered, regardless of the capital expenditure.
Need Criterion 1: Minimum Procedures/Population
a. The entity desiring to acquire or to otherwise control the PET scanner must project a minimum of 1,000 clinical procedures per year and must show the methodology used for the projection.
b. The applicant shall document a minimum population of 300,000 per PET scanner unit. The Division of Health Planning and Resource Development population projections shall be used. In the case of Cardiac only PET Scanner, this Criterion will not apply.
Need Criterion 2: Business Registration
The entity desiring to acquire or otherwise control the PET equipment must be a registered entity authorized to do business in Mississippi.
Need Criterion 3: Approval of Additional PET Equipment
MSDH will approve additional PET equipment in a service area with existing equipment only when it is demonstrated that the existing PET equipment in that service area is performing an average of 1,500 clinical procedures per PET unit per year (six clinical procedures per day x 250 working days per year). For purposes of this Criterion, PET and Cardiac only PET are to be evaluated separately.
Need Criterion 4: Division of Radiological Health Approval
The application shall affirm that the applicant shall receive approval from the Division of Radiological Health for the proposed site, plans, and equipment before service begins.
Need Criterion 5: Data Requirements
The applicant shall provide assurances that the following data regarding the PET equipment will be kept and made available to MSDH upon request:
a. Total number of procedures performed;
b. Total number of inpatient procedures (indicate type of procedure);
c. Total number of outpatient procedures (indicate type of procedure);
d. Average charge per specific procedure;
e. Hours of operation of the PET unit;
f. Days of operation per year; and
g. Total revenue and expense for the PET unit for the year.
Need Criterion 6: Fixed/Minimum Value Contracts
The applicant shall provide a copy of the proposed contract and document that if the equipment is to be rented, leased, or otherwise used by other qualified providers on a contractual basis, no fixed/minimum volume contracts will be permitted.
Need Criterion 7: CON Approval/Exemption for PET Equipment
Before the specified equipment can be utilized, the applicant desiring to provide the PET equipment shall have CON approval or written evidence that the equipment is exempt from CON approval as determined by MSDH. Each specified piece of equipment must be exempt from or have CON approval.
Need Criterion 8: Applicants with an Accredited Cancer Center
Applicants seeking to acquire and operate a fixed PET scanner as part of a Cancer Center accredited by the Commission on Cancer, a program of the American College of Surgeons, shall be exempt from the requirements set forth in Need Criterion 1b (Minimum Procedures/Populations) and Need Criterion 3 (Approval of Additional PET Equipment).
