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 June 25, 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).