The Florida Senate BILL ANALYSIS AND FISCAL IMPACT STATEMENT (This document is based on the provisions contained in the legislation as of the latest date listed below.) Prepared By: The Professional Staff of the Committee on Health Policy BILL: CS/SB 1612 INTRODUCER: Health Policy Committee and Senator Brodeur SUBJECT: Adult Cardiovascular Care Standards DATE: February 7, 2024 ANALYST STAFF DIRECTOR REFERENCE ACTION 1. Looke Brown HP Fav/CS 2. AHS 3. RC Please see Section IX. for Additional Information: COMMITTEE SUBSTITUTE - Substantial Changes I. Summary: CS/SB 1612 amends s. 395.1055, F.S., to amend requirements in that section related to the Agency for Health Care Administration’s (AHCA) rules governing adult cardiovascular services (ACS) to specify that Level I services include rotational or other atherectomy devices, electrophysiology, and treatment of chronic total occlusions. II. Present Situation: Adult Cardiovascular Services Section 395.1055(18), F.S., establishes requirements that the AHCA must adopt in rule governing the provision of ACS. The section divides ACS into two levels, Level I and Level II, with Level I ACS providers authorized to provide adult percutaneous cardiac intervention (PCI) without cardiac surgery and with Level II providers being authorized to perform PCI with cardiac surgery. REVISED: BILL: CS/SB 1612 Page 2 Percutaneous Coronary Intervention Percutaneous coronary intervention (PCI), also commonly known as coronary angioplasty or angioplasty, is a nonsurgical technique for treating obstructive coronary artery disease, including unstable angina, acute myocardial infarction, and multi-vessel coronary artery disease. 1 PCI uses a catheter to insert a small structure called a stent to reopen blood vessels in the heart that have been narrowed by plaque build-up, a condition known as atherosclerosis. Using a special type of X-ray called fluoroscopy, the catheter is threaded through blood vessels into the heart where the coronary artery has narrowed. When the tip is in place, a balloon tip covered with a stent is inflated. The balloon tip compresses the plaque and expands the stent. Once the plaque is compressed and the stent is in place, the balloon is deflated and withdrawn. The stent stays in the artery, holding it open. 2 Rotational Atherectomy Rotational atherectomy (RA) is an atheroablative technology that enables percutaneous coronary intervention for complex, calcified coronary lesions. RA works on the principle of ‘differential cutting’ and preferentially ablates hard, inelastic, calcified plaque. The objective of RA use has evolved from plaque debulking to plaque modification to enable balloon angioplasty and optimal stent expansion. 3 Electrophysiological Study An electrophysiological study (EP study) is a test used to evaluate the heart's electrical system and to check for abnormal heart rhythms. Natural electrical impulses coordinate contractions of the different parts of the heart. This helps keep blood flowing the way it should. This movement of the heart creates the heartbeat, or heart rhythm. During an EP study, a doctor inserts small, thin wire electrodes into a vein in the groin (or neck, in some cases). He or she will then thread the wire electrodes through the vein and into the heart. To do this, he or she uses a special type of X-ray called fluoroscopy. Once in the heart, the electrodes measures the heart’s electrical signals. Electrical signals are also sent through the electrodes to stimulate the heart tissue to try to cause the abnormal heart rhythm. This is done so that it can be evaluated and its cause can be found. It may also be done to help evaluate how well a medicine is working. 4 Chronic Total Occlusion A Chronic total occlusion (CTO) is a complete or nearly complete blockage of one or more coronary arteries. The blockage, typically present for at least three months, is caused by a 1 Medscape: Percutaneous cardiac intervention, available at http://emedicine.medscape.com/article/161446-overview, (last visited Feb. 2, 2024). 2 Heart and Stroke Foundation, available at https://www.heartandstroke.ca/heart/treatments/surgery-and-other- procedures/percutaneous-coronary-intervention, (last visited Feb. 2, 2024). 3 Gupta T, Weinreich M, Greenberg M, Colombo A, Latib A. Rotational Atherectomy: A Contemporary Appraisal. Interv Cardiol. 2019 Nov 18;14(3):182-189. doi: 10.15420/icr.2019.17.R1. PMID: 31867066; PMCID: PMC6918488. 4 What is an electrophysiological study? Johns Hopkins Medicine, available at https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/electrophysiological- studies#:~:text=An%20electrophysiological%20study%20(EP%20study,flowing%20the%20way%20it%20should., (last visited Feb. 2, 2024). BILL: CS/SB 1612 Page 3 buildup of plaque within a coronary artery. When this happens, blood flow to the heart is compromised. CTO is a common heart disorder in patients with coronary artery disease. Between 20 and 25 percent of patients with coronary artery disease also have a chronically blocked artery. 5 III. Effect of Proposed Changes: CS/SB 1612 amends s. 395.1055, F.S., to specify that Level I ACS includes PCI with rotational or other atherectomy devices, electrophysiology, and treatment of chronic total occlusions. The bill provides an effective date of July 1, 2024. IV. Constitutional Issues: A. Municipality/County Mandates Restrictions: None. B. Public Records/Open Meetings Issues: None. C. Trust Funds Restrictions: None. D. State Tax or Fee Increases: None. E. Other Constitutional Issues: None. V. Fiscal Impact Statement: A. Tax/Fee Issues: None. B. Private Sector Impact: None. C. Government Sector Impact: None. 5 Chronic Total Occlusion (CTO), University of Michigan Health, available at https://www.uofmhealth.org/conditions- treatments/chronic-total-occlusion-cto, (last visited Feb. 2, 2024). BILL: CS/SB 1612 Page 4 VI. Technical Deficiencies: None. VII. Related Issues: None. VIII. Statutes Affected: This bill substantially amends section 395.1055 of the Florida Statutes. IX. Additional Information: A. Committee Substitute – Statement of Substantial Changes: (Summarizing differences between the Committee Substitute and the prior version of the bill.) CS by Health Policy on February 6, 2024: The committee substitute eliminates all provisions of the bill other than the provision specifying rotational or other atherectomy devices, electrophysiology, and treatment of chronic total occlusions to services that may be provided by Level I ACS providers. B. Amendments: None. This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.