15 Miss. Code. R. 8-90-05-513.02.01 - Policy Statement Regarding Certificate of Need Applications for the Acquisition or Otherwise Control of a Positron Emission Tomography (PET) Scanner and Related Equipment including Cardiac only PET Scanner

1. CON Review Requirements: Applicants proposing the acquisition or otherwise control of a PET scanner shall obtain a CON to do so if the capital expenditure for the scanner and related equipment exceeds $1,500,000.

2. Indigent/Charity Care: An applicant shall be required to provide a "reasonable amount" of indigent/charity care as described in Chapter 1 of this Plan.

3. Service Areas: The state as a whole shall serve as a single service area in determining the need for a PET scanner. In the case of Cardiac only PET Scanner, the service area will be the General Hospital Service Areas.

4. Equipment to Population Ratio: The need for a PET scanner is estimated to be one scanner per 300,000 population. MSDH will consider out-of-state population in determining need only when the applicant submits adequate documentation acceptable to MSDH, such as valid patient origin studies. In the case of Cardiac only PET Scanner, this policy will not apply.

5. Access to Supplies: Applicants must have direct access to appropriate radio-pharmaceuticals.

6. Services and Medical Specialties Required: The proposed PET units must function as a component of a comprehensive inpatient or outpatient diagnostic service. The proposed PET unit must have the following modalities (and capabilities) on-site or through contractual arrangements:

a. Computed tomography - (whole body)

b. Magnetic resonance imaging - (brain and whole body)

c. Nuclear medicine - (cardiac, SPECT)

d. Conventional radiography

e. The following medical specialties during operations hours:

i. Cardiology

ii. Neurology

iii. Neurosurgery

iv. Oncology

v. Psychiatry

vi. Radiology

7. Hours of Operation: PET facilities should have adequate scheduled hours to avoid an excessive backlog of cases.

8. CON Approval Preference: MSDH may approve applicants proposing to enter ventures utilizing mobile and/or shared equipment.

9. CON Requirements: The criteria and standards contained herein pertain to both fixed and/or mobile PET scanner equipment.

10. CON Exemption: Nothing contained in these CON criteria and standards shall preclude the University of Mississippi School of Medicine from acquiring and operating a PET scanner and a Cardiac only PET Scanner, provided the acquisition and use of such equipment is justified by the School's teaching and/or research mission and complies with the teaching exception as outlined in section 102.02 of this Plan. However, the requirements listed under the section regarding the granting of "appropriate scope of privileges for access to the scanner to any qualified physician" must be met. MSDH shall not consider utilization of equipment/services at any hospital owned and operated by the state or its agencies when reviewing CON applications.

11. Addition to a Health Care Facility: An equipment vendor who proposes to add a health care facility to an existing or proposed route must notify MSDH by submitting a determination of reviewability for any proposed changes from those presented in the CON application prior to such change, i.e., additional health care facilities or route deviations.

12. Equipment Registration: The applicant must provide the Department with the registration/serial number of the CON-approved PET scanner.

13. Certification: If a mobile PET scanner, the applicant must certify that only the single authorized piece of equipment and related equipment vendor described in the CON application will be utilized for the PET service by the authorized facility/facilities.

14. Conversion from mobile to fixed service: The conversion from a mobile PET service site to a fixed PET service site will not be considered the establishment of a new service and will not require CON review under Section 513.02.03; provided, however, that the facility submit an application for a determination of non-reviewability prior to converting the service.

15. 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 Policy Statement number 4 (Equipment to Population Ratio).

Notes

15 Miss. Code. R. 8-90-05-513.02.01

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