15 Miss. Code. R. 8-90-05-513.01.03

Current through December 10, 2024
Section 15-8-90-05-513.01.03 - Certificate of Need Criteria and Standards for Invasive Digital Angiography (DA) in a Freestanding Facility

Need Criterion 1: Staffing Requirements

a. The applicant for invasive DA services shall demonstrate that proper protocols for screening and medical specialty backup are in place before services are rendered by personnel other than those with specialized training. The protocols shall include, but are not limited to, having prior arrangements for consultation/backup from a vascular surgeon, cardiologist, radiologist or nephrologist credentialed and accredited for interventional peripheral vascular procedures.
b. Identify physicians in the group and state which physicians(s) will perform intravascular interventions using DA. Certify that:
i. Each physician will maintain medical staff privileges at a full service hospital; or
ii. At least one member of the physician group has staff privileges at a full service hospital and will be available at the facility or on call within a 30-minute travel time of the full service hospital during the hours of operation of the facility.

Need Criterion 2: Types of Procedures

a. Procedures in a freestanding facility are generally non-emergent nor life threatening in nature and require a patient stay of less than 24 consecutive hours. The procedures shall not be of a type that:
i. Generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin;
ii. Require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; or
iii. Involve major blood vessels.
1. Major blood vessels are defined as the group of critical arteries and veins including the aorta, coronary arteries, pulmonary arteries, superior and inferior vena cava, pulmonary veins, carotid arteries, and any intra-cerebral artery or vein.
b. Percutaneous endovascular interventions of the peripheral vessels not excluded in a.iii.1. above are permitted to be performed in a freestanding facility. These procedures are defined as procedures performed without open direct visualization of the target vessel, requiring only needle puncture of an artery or vein followed by insertion of catheters, wires, or similar devices which are then advanced through the blood vessels using imaging guidance. Once the catheter reaches the intended location, various maneuvers to address the diseased area may be performed which include, but are not limited to, injection of contrast for imaging, ultrasound of the vessel, treatment of vessels with angioplasty, artherectomy, covered or uncovered stenting, intentional occlusion of vessels or organs (embolization), and delivering of medications, radiation, or other energy such as laser, radiofrequency, or cryo.

Need Criterion 3: Transfer Agreement

The applicant must certify that the proposed facility will have a formal transfer agreement with a full service hospital to provide services which are required beyond the scope of the freestanding facility's programs.

Need Criterion 4: CON Exemption

Before utilizing or providing the equipment or service, the applicant desiring to provide the digital angiography equipment or invasive DA services shall have CON approval or written evidence that the equipment or service is exempt from CON approval as determined by MSDH through a determination of reviewability.

15 Miss. Code. R. 8-90-05-513.01.03

Amended 12/1/2014
Amended 3/1/2016
Adopted 7/1/2018
Amended 12/9/2018
Amended 2/20/2022
Amended 5/29/2023