15 Miss. Code. R. 8-90-05-513.02.03

Current through December 10, 2024

Section 15-8-90-05-513.02.03 - Certificate of Need Criteria and Standards for Offering of Fixed or Mobile Positron Emission Tomography (PET) Services including Cardiac only PET Scanner

The offering of fixed or mobile 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.

Need Criterion 1: Minimum Procedures

The entity desiring to offer PET services must document that the equipment shall perform a minimum of 1,000 clinical procedures per year and must show the methodology used for the projection.

Need Criterion 2: PET Equipment Utilized by Multiple Providers

It is recognized that a particular PET unit may be utilized by more than one provider of PET services, some of which may be located outside of Mississippi. In such cases all existing or proposed providers of PET services utilizing the same PET unit must jointly meet the required service volume of 1,000 procedures annually. If the PET unit in question is presently utilized by other providers of PET services, the actual number of procedures performed by them during the most recent 12-month period may be used.

Need Criterion 3: Quality Control and Environmental Requirements

An applicant proposing to provide new or expanded PET services must include written assurances in the application that the service will be offered in a physical environment that conforms to federal standards, manufacturer's specifications, and licensing agencies' requirements. The following areas are to be addressed:

a. Quality control and assurance of radiopharmaceutical production of generator or cyclotron-produced agents;

b. Quality control and assurance of PET tomograph and associated instrumentation;

c. Radiation protection and shielding; and

d. Radioactive emissions to the environment.

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: Provision of On-Site Medical Cyclotron

The applicant shall document provision of an on-site medical cyclotron for radionuclide production and a chemistry unit for labeling radiopharmaceuticals; or an on-site rubidium-82 generator; or access to a supply of cyclotron-produced radiopharmaceuticals from an off-site medical cyclotron and a radiopharmaceutical production facility within a two-hour air transport radius.

Need Criterion 6: Staffing Requirements

Applicants for PET shall document that the necessary qualified staff are available to operate the proposed unit. The applicant shall document the PET training and experience of the staff. The following minimum staff shall be available to the PET unit:

a. If operating a fixed PET unit, one or more nuclear medicine imaging physician(s) available to the PET unit on a full-time basis (e.g., radiologist, nuclear cardiologist) who have been licensed by the state for the handling of medical radionuclides and whose primary responsibility for at least a one-year period prior to submission of the CON application has been in acquisition and interpretation of tomographic images. This individual shall have knowledge of PET through training, experience, or documented postgraduate education. The individual shall also have training with a functional PET facility.

b. If operating a cyclotron on site, a qualified PET radiochemist or radiopharmacist personnel, available to the facility during PET service hours, with at least one year of training and experience in the synthesis of short-lived positron emitting radiopharmaceuticals. The individual(s) shall have experience in the testing of chemical, radiochemical, and radionuclidic purity of PET radiopharmaceutical syntheses.

c. Qualified engineering and physics personnel, available to the facility during PET service hours, with training and experience in the operation and maintenance of the PET equipment. Engineering personnel are not required on-site for mobile PET units.

d. Qualified radiation safety personnel, available to the facility at all times, with training and experience in the handling of short-lived positron emitting nuclides. If a medical cyclotron is operated on-site, personnel with expertise in radiopharmacy, radiochemistry, and medical physics would also be required.

e. Certified nuclear medicine technologists with expertise in computed tomographic nuclear medicine imaging procedures, at a staff level consistent with the proposed center's expected PET service volume.

f. Other appropriate personnel shall be available during PET service hours which may include certified nuclear medicine technologists, computer programmers, nurses, and radio-chemistry technicians.

Need Criterion 7: Management of Medical Emergencies

The applicant shall demonstrate how medical emergencies within the PET unit will be managed in conformity with accepted medical practice.

Need Criterion 8: Accommodating Referred Patients

The applicant shall affirm that, in addition to accepting patients from participating institutions, facilities performing clinical PET procedures shall accept appropriate referrals from other local providers. These patients shall be accommodated to the extent possible by extending the hours of service and by prioritizing patients according to standards of need and appropriateness rather than source of referral.

Need Criterion 9: Medical Necessity

The applicant shall affirm that protocols will be established to assure that all clinical PET procedures performed are medically necessary and cannot be performed as well by other, less expensive, established modalities.

Need Criterion 10: Notification of Procedures Offered

Applicants will be required to maintain current listings of appropriate PET procedures for use by referring physicians.

Need Criterion 11: Data Requirements

The applicant shall provide assurances that the following data regarding the PET service will be kept and made available to MSDH upon request:

a. Total number of procedures performed; total number of inpatient procedures (indicate type of procedure);

b. Total number of outpatient procedures (indicate type of procedure);

c. Average charge per specific procedure;

d. Hours of operation of the PET unit;

e. Days of operation per year; and

f. Total revenue and expense for the PET unit for the year.

Need Criterion 12: CON Approval/Exemption for PET Equipment

Before the specified service can be provided, the applicant desiring to offer the PET service shall provide written evidence that the specified PET equipment provider has 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. 8-90-05-513.02.03

Amended 12/1/2014

Amended 3/1/2016

Adopted 7/1/2018

Amended 12/9/2018

Amended 2/20/2022

Amended 5/29/2023