Mississippi Administrative Code › Title 15 - Mississippi Department of Health › Part 8 - Office of Health Policy and Planning › Subpart 90 - Planning and Resource Development › Chapter 05 - Acute Care Facilities and Services Overview › Section 15-8-90-05-515 - Certificate of Need Criteria and Standards for Cardiac Catheterization Services and Open-Heart Surgery Services › Section 15-8-90-05-515.05 - Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Therapeutic Cardiac Catheterization Equipment and/or the Offering Of Therapeutic Cardiac Catheterization Services

Current through June 25, 2024
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.