15 Miss. Code. R. 8-90-05-515.04

Current through December 10, 2024

Section 15-8-90-05-515.04 - Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Therapeutic Cardiac Catheterization Equipment for the Performance of PCI Services in a Hospital Without On-Site Cardiac Surgery and/or the Offering Of PCI Services in a Hospital Without On-Site Cardiac Surgery

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 for the performance or offering of PCI services in a hospital without on-site cardiac surgery 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 for the performance of PCI services in a hospital without on-site cardiac surgery is reviewable if the equipment costs exceed $1,500,000. The offering of PCI services in a hospital without on-site cardiac surgery 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, regardless of the capital expenditure.

Need Criterion 1: Minimum Procedures

An applicant proposing the establishment of PCI services in a hospital without on-site cardiac surgery shall demonstrate that the proposed equipment/service utilization will be a minimum of 300 cardiac catheterizations, both diagnostic and PCI, with at least 100 being total PCIs, per year by its 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: Staffing Requirements

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 PCI procedures shall be onsite within thirty (30) minutes.

Need Criterion 4: 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 and PCI catheterization 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 5: Open-Heart Surgery

An applicant proposing the establishment of PCI services without on-site cardiac surgery 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 an intra-aortic balloon pump (IABP).

b. Programs must project and annually perform a minimum of 100 total PCIs per year to include at a minimum 12 primary PCIs per year by the end of the third year of operation. New programs should have three years to reach the absolute minimum volume, but after that, programs failing to reach this volume for two consecutive years should not remain open. MSDH has the discretion under a finding of rare or unique circumstances to grant an exception to the above based on a finding of need of access and quality of care by the program.

c. Certify that the proposed primary operators for the service 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.

d. New and Existing Programs must actively participate in the STEMI ("ST"-Segment Elevation Myocardial Infarction) Network, including, but not limited to, the submission of data to the STEMI databank.

e. At the present time, there is no justification for a PCI program without on-site surgery to perform only elective procedures or not provide availability to primary PCI 24 hours/365 days per year. The Mississippi State Department of Health has the discretion under a finding of rare or unique circumstances to grant exception to the above based on a finding of need of access and quality of care by the program.

f. Certify that the Applicant will provide educational programs to underserved patient populations (low income, racial and ethnic minorities, women, Medicaid eligible, and handicapped persons) with the goal of decreasing cardiac mortality rates in such populations.

g. Certify that the applicant will provide a reasonable amount of charity care.

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

i. 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 6: Applicants for PCI Services in a Hospital without On-Site Cardiac Surgery Capabilities Currently Providing Diagnostic Catheterization Services

In addition to Need Criteria 1-5, an applicant proposing the establishment of PCI services in a hospital without open heart surgery capabilities, who is already an existing provider of diagnostic catheterization services, shall demonstrate that its diagnostic cardiac catheterization unit has been utilized for a minimum of 300 procedures 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 or that its primary operators for the service have a life-time experience of greater than 250 total procedures (including both diagnostic catheterizations and PCIs) with acceptable outcomes after completing a cardiology fellowship. Successful completion of an Interventional Cardiology fellowship is considered adequate certification.

Need Criterion 7: 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.

15 Miss. Code. R. 8-90-05-515.04

Amended 12/1/2014

Amended 3/1/2016

Adopted 7/1/2018

Amended 12/9/2018

Amended 2/20/2022

Amended 5/29/2023