15 Miss. Code. R. 8-90-05-512.01.03

Current through December 10, 2024
Section 15-8-90-05-512.01.03 - Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of MRI Equipment

Need Criterion 1: Minimum Procedures/Population

The entity desiring to acquire or otherwise control the MRI equipment shall demonstrate a minimum of 2,700 procedures per year by the end of the second year of operation; provided, however, that MRI equipment exclusively servicing rural hospitals (those located outside U.S. Census Bureau Metropolitan Statistical Areas with 75 or less beds) shall be required to demonstrate a minimum of 1,700 procedures per year by the end of the second year of operation. This criterion includes both fixed and mobile MRI equipment. The applicant must show the methodology used for the projections.

a. Applicants for non-hospital based MRI facilities may submit affidavits from referring physicians. MRI procedures projected in affidavits shall be based on actual MRI procedures referred during the year.
b. The applicant shall document a reasonable population base to document that a minimum of 2,700 procedures will be performed per proposed MRI unit (or 1,700 procedures per year for a mobile MRI route exclusively serving rural hospitals).
c. The applicant shall demonstrate that all existing units within its defined service area have performed an average of 1,700 procedures for the most recent 12-month period.

It is recognized that an applicant desiring to acquire or otherwise control an MRI unit may make or propose to make the MRI unit available to more than one provider of MRI services, some of which may be located outside of Mississippi. In such cases all existing or proposed users of the MRI unit must jointly meet the required service volume of 2,700 (or 1,700 for mobile MRI route exclusively serving rural hospitals) procedures annually. If the MRI unit in question is presently utilized by other providers of MRI services, the actual number of procedures performed by them during the most recent twelve (12) month period and/or documented projections of physician referrals may be used.

Need Criterion 2: Equipment Requirements

In order to receive CON approval to acquire or otherwise control MRI equipment, the applicant shall provide a copy of the proposed contract and document the following:

a. that the equipment is FDA approved;
b. that only qualified personnel will be allowed to operate the equipment; and
c. 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 3: Data Requirements

Applicants shall provide written assurance that they will record and maintain, at a minimum, the following information and make it available to MSDH:

a. All facilities which have access to the equipment;
b. Utilization by each facility served by the equipment, e.g., days of operation, number of procedures, and number of repeat procedures;
c. Financial data, e.g., copy of contracts, fee schedule, and cost per scan; and
d. Demographic and patient origin data for each facility.

In addition, if required by the Department, the above referenced information and other data pertaining to the use of MRI equipment will be made available to the MSDH within fifteen (15) business days of request. The required information may also be requested for entities outside of Mississippi that use the MRI equipment in question.

Need Criterion 4: Business Registration

The entity desiring to acquire or otherwise control the MRI equipment must be a registered entity authorized to do business in Mississippi.

Need Criterion 5: CON Approval/Exemption for MRI Equipment

Before the specified equipment can be utilized, the applicant desiring to provide the MRI equipment shall have CON approval or written evidence that the equipment is exempt from CON approval, as determined by MSDH through a determination of reviewability. Each specified piece of equipment must be exempt from or have CON approval.

15 Miss. Code. R. 8-90-05-512.01.03

Amended 12/1/2014
Amended 3/1/2016
Adopted 7/1/2018
Amended 12/9/2018
Amended 2/20/2022
Amended 5/29/2023