15 Miss. Code. R. 8-90-05-515.07

Current through December 10, 2024

Section 15-8-90-05-515.07 - Certificate of Need Criteria and Standards for the Establishment of Cardiac Ambulatory Surgical Facilities

The Mississippi State Department of Health will review applications for a Certificate of Need for the establishment of Cardiac Ambulatory Surgical Facilities (CASFs and JV-CASFs) 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.

Need Criterion 1: Minimum Procedures

An applicant proposing the establishment of a CASF shall demonstrate that the proposed service utilization will be a minimum of 300 cardiac catheterization procedures, diagnostic and therapeutic, per year, by the third year of operation. Applicants must certify they will submit volume data to demonstrate and verify the utilization of the service at a minimum of every three (3) years.

Need Criterion 2: Minimum Population

The applicant must document that the proposed Cardiac Catheterization/Open-Heart Surgery Planning Area (Map 5-2) has a population base of at least 60,000 within thirty (30) minutes travel time of the facility.

Need Criterion 3: Minimum Number of Procedure Rooms All CASFs shall establish and have available for service no fewer than two (2) procedure rooms used exclusively for cardiac catheterization and PCI services.

Need Criterion 4: Financial Feasibility

The applicant must provide documentation that the CASF will be economically viable within two (2) years of commencement of services.

Need Criterion 5: Letters of Support

The applicant must show support from the cardiologists who will be expected to utilize the CASF.

Need Criterion 6: 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. The applicant shall also certify that all cardiologists and providers who perform cardiac catheterization and/or PCI procedures in the CASF will maintain active medical staff and clinical privileges at an acute care hospital with which the facility has a formal emergency transfer agreement (as required by Need Criterion 8).

Need Criterion 7: Recording and Maintenance of Data

In addition to the certification in Need Criterion 1, applicants shall provide, as required under licensure standards, written assurance that they will record and maintain separate utilization data for diagnostic cardiac catheterization and PCI procedures (e.g., morbidity data, number of diagnostic cardiac catheterization and PCI 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 8: Service Specific

An applicant proposing the establishment of a CASF shall:

a. Document that open-heart surgery services will be available through a formal emergency transfer agreement to a hospital providing open heart surgery. Such transfer must be done at a minimum of less than 120 minutes to accomplish transfer from the onset of PCI complications to cardiopulmonary bypass. Transporting of the patient to the receiving hospital must include the capability to provide a ventricular support devise, such as an intra-aortic balloon pump (IABP), or an Impella.

b. Certify that the proposed primary operators performing PCI's have a life time experience of greater than 150 total PCIs with acceptable outcomes as primary operator after completing a cardiology fellowship. Successful completion of an Interventional Cardiology fellowship is considered adequate certification.

c. The CASF shall participate in and submit quality data to the appropriate cardiac catheterization registries.

d. Certify that the applicant will hold quarterly multi-disciplinary meetings to evaluate patient outcomes, review quality improvement data, and to identify and implement solutions for any operational issues.

e. Certify that the following guideline from the Society of Cardiovascular Angiography and Interventions (SCAI)-ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention or such sections' update(s), if applicable, at the time of filing the certificate of need application will be met:

i. Certify the applicant will have available in the catheterization lab the equipment in Section 4.1.1 entitled "Equipment" and that such will be routinely tested;

ii. Certify the availability of adequate staff in the catheterization lab as set forth in Section 4.1.2 entitled "Staffing" and that such staff will be certified on both basic life support and advanced cardiovascular life support;

iii. Certify that "time-out" procedures will be implemented as discussed in Section 4.1.3 entitled "'Time-Out' Procedures"; and

iv. Certify that the applicant will operate a quality improvement program and participate in a national PCI registry as discussed in Section 7.1 entitled "Quality Performance: Recommendations"

Need Criterion 9: Medicaid Participation

All CASFs shall participate in the Mississippi Medicaid program.

Need Criterion 10: Indigent/Charity Care

The applicant shall certify that the CASF will provide care to Medicaid patients. Also, the applicant shall certify that the CASF will provide indigent/charity care, including care to underinsured patients, of no less than five percent (5%) of the total volume of procedures performed at the CASF. Each approved facility shall report the total volume of indigent/charity care to the MSDH Office of Health Policy and Planning annually and shall publish their indigent/charity care policy to their facility website.

Need Criterion 11: Regulatory Approval

Before utilizing the equipment or providing the service, the applicant desiring to establish a CASF 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.

15 Miss. Code. R. 8-90-05-515.07

Adopted 2/20/2022

Amended 5/29/2023