Florida Senate - 2024 SB 1612 By Senator Brodeur 10-01555-24 20241612__ 1 A bill to be entitled 2 An act relating to adult cardiovascular care 3 standards; amending s. 395.1055, F.S.; deleting the 4 requirement for the Agency for Health Care 5 Administration to adopt certain rules for adult 6 inpatient diagnostic cardiac catheterization programs; 7 revising standards for rules relating to adult 8 cardiovascular services; requiring the agency to 9 update its rules as often as necessary to remain 10 consistent with new standards and guidelines published 11 by certain entities; providing an effective date. 12 13 Be It Enacted by the Legislature of the State of Florida: 14 15 Section 1.Subsections (16), (18), and (19) of section 16 395.1055, Florida Statutes, are amended to read: 17 395.1055Rules and enforcement. 18 (16)Each provider of diagnostic cardiac catheterization 19 services shall comply with rules adopted by the agency which 20 establish licensure standards governing the operation of adult 21 inpatient diagnostic cardiac catheterization programs. The rules 22 must ensure that such programs: 23 (a)Comply with the most recent guidelines of the American 24 College of Cardiology and American Heart Association Guidelines 25 for Cardiac Catheterization and Cardiac Catheterization 26 Laboratories. 27 (b)Perform only adult inpatient diagnostic cardiac 28 catheterization services and will not provide therapeutic 29 cardiac catheterization or any other cardiology services. 30 (c)Maintain sufficient appropriate equipment and health 31 care personnel to ensure quality and safety. 32 (d)Maintain appropriate times of operation and protocols 33 to ensure availability and appropriate referrals in the event of 34 emergencies. 35 (e)Demonstrate a plan to provide services to Medicaid and 36 charity care patients. 37 (18)In establishing rules for adult cardiovascular 38 services, the agency shall include provisions that provide allow 39 for all of the following: 40 (a)The establishment of two hospital program licensure 41 levels, a Level I program that authorizes the performance of 42 adult percutaneous cardiac intervention without onsite cardiac 43 surgery, including rotational or other atherectomy devices, 44 electrophysiology, and treatment of chronic total occlusions, 45 and a Level II program that authorizes the performance of 46 percutaneous cardiac intervention with onsite cardiac surgery. 47 (b)1.For A hospital seeking a Level I program must have a, 48 demonstration that, for the most recent 12-month period as 49 reported to the agency, the hospital has provided a minimum of 50 300 adult inpatient and outpatient diagnostic cardiac 51 catheterizations or, for the most recent 12-month period, has 52 discharged or transferred at least 300 patients with the 53 principal diagnosis of ischemic heart disease and that it has a 54 formalized, written transfer agreement with a hospital that has 55 a Level II program, including written transport protocols to 56 ensure safe and efficient transfer of a patient within 60 57 minutes. 58 2.a.A hospital located more than 100 road miles from the 59 closest Level II adult cardiovascular services program is not 60 required to meet the diagnostic cardiac catheterization volume 61 and ischemic heart disease diagnosis volume requirements in 62 subparagraph 1. if the hospital demonstrates that it has, for 63 the most recent 12-month period as reported to the agency, 64 provided a minimum of 100 adult inpatient and outpatient 65 diagnostic cardiac catheterizations or that, for the most recent 66 12-month period, it has discharged or transferred at least 300 67 patients with the principal diagnosis of ischemic heart disease. 68 2.b.A hospital located more than 100 road miles from the 69 closest Level II adult cardiovascular services program must have 70 a does not need to meet the 60-minute transfer time protocol 71 requirement in subparagraph 1. if the hospital demonstrates that 72 it has a formalized, written transfer agreement with a hospital 73 that has a Level II program which includes. The agreement must 74 include written transport protocols to ensure the safe and 75 efficient transfer of a patient, taking into consideration the 76 patients clinical and physical characteristics, road and 77 weather conditions, and viability of ground and air ambulance 78 service to transfer the patient. 79 3.At a minimum, the rules for adult cardiovascular 80 services must require nursing and technical staff to have 81 demonstrated experience in handling acutely ill patients 82 requiring intervention, based on the staff members previous 83 experience in dedicated cardiac interventional laboratories or 84 surgical centers. If a staff members previous experience is in 85 a dedicated cardiac interventional laboratory at a hospital that 86 does not have an approved adult open heart surgery program, the 87 staff members previous experience qualifies only if, at the 88 time the staff member acquired his or her experience, the 89 dedicated cardiac interventional laboratory: 90 a.Had an annual volume of 500 or more percutaneous cardiac 91 intervention procedures. 92 b.Achieved a demonstrated success rate of 95 percent or 93 greater for percutaneous cardiac intervention procedures. 94 c.Experienced a complication rate of less than 5 percent 95 for percutaneous cardiac intervention procedures. 96 d.Performed diverse cardiac procedures, including, but not 97 limited to, balloon angioplasty and stenting, rotational 98 atherectomy, cutting balloon atheroma remodeling, and procedures 99 relating to left ventricular support capability. 100 (c)For a hospital seeking a Level II program, 101 demonstration that, for the most recent 12-month period as 102 reported to the agency, the hospital has performed a minimum of 103 1,100 adult inpatient and outpatient cardiac catheterizations, 104 of which at least 400 must be therapeutic catheterizations, or, 105 for the most recent 12-month period, has discharged at least 800 106 patients with the principal diagnosis of ischemic heart disease. 107 (d)Compliance with the most recent guidelines of the 108 American College of Cardiology, and the American Heart 109 Association, and the Society for Cardiac Angiography and 110 Intervention guidelines for staffing, physician training and 111 experience, operating procedures, equipment, physical plant, and 112 patient selection criteria, to ensure patient quality and 113 safety. 114 (e)The establishment of appropriate hours of operation and 115 protocols to ensure availability and timely referral in the 116 event of emergencies. 117 (f)The demonstration of a plan to provide services to 118 Medicaid and charity care patients. 119 (g)For a hospital licensed for adult diagnostic cardiac 120 catheterization that provides Level I or Level II adult 121 cardiovascular services, demonstration that the hospital is 122 participating in the American College of Cardiologys National 123 Cardiovascular Data Registry or the American Heart Associations 124 Get with the GuidelinesCoronary Artery Disease registry and 125 documentation of an ongoing quality improvement plan ensuring 126 that the licensed cardiac program meets or exceeds national 127 quality and outcome benchmarks reported by the registry in which 128 the hospital participates. A hospital licensed for Level II 129 adult cardiovascular services must also participate in the 130 clinical outcome reporting systems operated by the Society for 131 Thoracic Surgeons. 132 (19)The agency may adopt rules to administer the 133 requirements of part II of chapter 408 and shall update agency 134 rules as often as necessary to remain consistent with new 135 standards and guidelines published by federal health agencies 136 and nationally recognized medical organizations. 137 Section 2.This act shall take effect July 1, 2024.