15 Miss. Code. R. 8-90-05-515.05
The Mississippi State Department of Health will review applications for a Certificate of Need for the acquisition or otherwise control of therapeutic cardiac catheterization equipment and/or the offering of therapeutic cardiac catheterization services 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 criteria listed in the Mississippi Certificate of Need Review Manual; all adopted rules, procedures and plans of the Mississippi State Department of Health; and the specific criteria and standards listed below.
The acquisition or otherwise control of therapeutic cardiac catheterization equipment is reviewable if the equipment costs exceed $1,500,000. The offering of therapeutic cardiac catheterization 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:
An applicant proposing the establishment of therapeutic cardiac catheterization services shall demonstrate that the proposed equipment/service utilization will be a minimum of 450 cardiac catheterizations, both diagnostic and therapeutic, of which at least 100 should be PCIs, per year by its third year of operation.
Need Criterion 2: Staffing Standards
The applicant shall document that it has, or can obtain, the ability to administer the proposed services, provide sufficiently trained and experienced professional staff, and evaluate the performance of the programs.
Need Criterion 3: Staff Residency
The applicant shall certify that medical staff performing therapeutic cardiac catheterization procedures shall be onsite within thirty (30) minutes.
Need Criterion 4: Recording and Maintenance of Data
Applicants shall provide, as required under licensure standards, written assurance that they will record and maintain separate utilization data for diagnostic and therapeutic cardiac catheterization procedures (e.g., morbidity data, number of diagnostic and therapeutic cardiac catheterization procedures performed and mortality data, all reported by race, sex and payor status) and make that data available to the Mississippi State Department of Health annually.
Need Criterion 5: Open-Heart Surgery
An applicant proposing the establishment of therapeutic cardiac catheterization services shall document that open-heart surgery services are available or will be available on-site where the proposed therapeutic cardiac catheterization services are to be offered before such procedures are performed.
Need Criterion 6: Regulatory Approval
Before utilizing or providing the equipment or service, the applicant desiring to provide the cardiac catheterization equipment or service shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by the Mississippi State Department of Health. Each specified piece of equipment must be exempt from or have CON approval.
Need Criterion 7: Applicants for Therapeutic Cardiac Catheterization Currently Providing Diagnostic Catheterization Services or PCI Services in a Hospital without On-Site Cardiac Surgery
In additional to Need Criteria 1-6, an applicant proposing the establishment of therapeutic cardiac catheterization services, who is already an existing provider of diagnostic catheterization services and/or PCI services in a hospital without on-site cardiac surgery, shall demonstrate that it has provided a minimum of 300 procedures (including both diagnostic catheterizations and PCIs) per year for the two most recent years as reflected in the data supplied to and/or verified by the Mississippi State Department of Health.
15 Miss. Code. R. 8-90-05-515.05