Florida Senate - 2016                                    SB 1518
       By Senator Grimsley
       21-01207-16                                           20161518__
    1                        A bill to be entitled                      
    2         An act relating to adult cardiovascular services;
    3         amending s. 408.0361, F.S.; expanding rulemaking
    4         criteria for the Agency for Health Care Administration
    5         for licensure of hospitals performing percutaneous
    6         coronary intervention; deleting provisions relating to
    7         newly licensed hospitals seeking a specified program
    8         status; repealing s. 408.036(3)(m) and (n), F.S.,
    9         relating to exemptions for certificate of need
   10         projects subject to review relating to adult open
   11         heart services in a hospital and percutaneous coronary
   12         intervention; providing an effective date.
   14  Be It Enacted by the Legislature of the State of Florida:
   16         Section 1. Section 408.0361, Florida Statutes, is amended
   17  to read:
   18         408.0361 Cardiovascular services and burn unit licensure.—
   19         (1) Each provider of diagnostic cardiac catheterization
   20  services shall comply with rules adopted by the agency that
   21  establish licensure standards governing the operation of adult
   22  inpatient diagnostic cardiac catheterization programs. The rules
   23  shall ensure that such programs:
   24         (a) Comply with the most recent guidelines of the American
   25  College of Cardiology and American Heart Association Guidelines
   26  for Cardiac Catheterization and Cardiac Catheterization
   27  Laboratories.
   28         (b) Perform only adult inpatient diagnostic cardiac
   29  catheterization services and will not provide therapeutic
   30  cardiac catheterization or any other cardiology services.
   31         (c) Maintain sufficient appropriate equipment and health
   32  care personnel to ensure quality and safety.
   33         (d) Maintain appropriate times of operation and protocols
   34  to ensure availability and appropriate referrals in the event of
   35  emergencies.
   36         (e) Demonstrate a plan to provide services to Medicaid and
   37  charity care patients.
   38         (2) Each provider of adult cardiovascular services or
   39  operator of a burn unit shall comply with rules adopted by the
   40  agency that establish licensure standards that govern the
   41  provision of adult cardiovascular services or the operation of a
   42  burn unit. Such rules shall consider, at a minimum, staffing,
   43  equipment, physical plant, operating protocols, the provision of
   44  services to Medicaid and charity care patients, accreditation,
   45  licensure period and fees, and enforcement of minimum standards.
   46  The certificate-of-need rules for adult cardiovascular services
   47  and burn units in effect on June 30, 2004, are authorized
   48  pursuant to this subsection and shall remain in effect and shall
   49  be enforceable by the agency until the licensure rules are
   50  adopted. Existing providers and any provider with a notice of
   51  intent to grant a certificate of need or a final order of the
   52  agency granting a certificate of need for adult cardiovascular
   53  services or burn units shall be considered grandfathered and
   54  receive a license for their programs effective on the effective
   55  date of this act. The grandfathered licensure shall be for at
   56  least 3 years or until July 1, 2008, whichever is longer, but
   57  shall be required to meet licensure standards applicable to
   58  existing programs for every subsequent licensure period.
   59         (3) In establishing rules for adult cardiovascular
   60  services, the agency shall include provisions that allow for:
   61         (a) Establishment of two hospital program licensure levels:
   62  a Level I program authorizing the performance of adult
   63  percutaneous cardiac intervention without onsite cardiac surgery
   64  and a Level II program authorizing the performance of
   65  percutaneous cardiac intervention with onsite cardiac surgery.
   66         (b) For a hospital seeking a Level I program, demonstration
   67  that, for the most recent 12-month period as reported to the
   68  agency, it has provided a minimum of 300 adult inpatient and
   69  outpatient diagnostic cardiac catheterizations or, for the most
   70  recent 12-month period, has discharged or transferred at least
   71  300 inpatients with the principal diagnosis of ischemic heart
   72  disease and that it has a formalized, written transfer agreement
   73  with a hospital that has a Level II program, including written
   74  transport protocols to ensure safe and efficient transfer of a
   75  patient within 60 minutes. However, a hospital located more than
   76  100 road miles from the closest Level II adult cardiovascular
   77  services program does not need to meet the 60-minute transfer
   78  time protocol if the hospital demonstrates that it has a
   79  formalized, written transfer agreement with a hospital that has
   80  a Level II program. The agreement must include written transport
   81  protocols to ensure the safe and efficient transfer of a
   82  patient, taking into consideration the patient’s clinical and
   83  physical characteristics, road and weather conditions, and
   84  viability of ground and air ambulance service to transfer the
   85  patient. At a minimum, the rules must require the following:
   86         1. Cardiologists must be experienced interventionalists who
   87  have performed a minimum of 50 interventions annually, averaged
   88  over 2 years, that were performed in institutions performing
   89  more than 200 total intervention procedures annually and more
   90  than 36 primary intervention procedures annually.
   91         2. The hospital must provide a minimum of 36 primary
   92  interventions annually in order to continue to provide the
   93  service.
   94         3. The hospital must offer sufficient physician, nursing,
   95  and laboratory staff to provide the services 24 hours a day, 7
   96  days a week.
   97         4. Nursing and technical staff must have demonstrated
   98  experience in handling acutely ill patients requiring
   99  intervention based on the staff members’ previous experience in
  100  dedicated interventional laboratories or surgical centers. In
  101  order for experience acquired at a dedicated interventional
  102  laboratory at a hospital without an approved adult open-heart
  103  surgery program to qualify, the cardiac interventional
  104  laboratory must have, throughout the training period:
  105         a.Had an annual volume of 200 or more percutaneous
  106  coronary intervention procedures;
  107         b.Achieved a demonstrated success rate of 95 percent or
  108  greater for percutaneous coronary intervention procedures;
  109         c.Experienced a complication rate of less than 5 percent
  110  for percutaneous coronary intervention procedures;
  111         d.Experienced required emergent coronary artery bypass
  112  grafting on less than 2 percent of the patients undergoing a
  113  percutaneous coronary intervention procedure; and
  114         e.Performed diverse cardiac procedures, including, but not
  115  limited to, balloon angioplasty and stenting, rotational
  116  atherectomy, cutting balloon atheroma remodeling, and procedures
  117  relating to left ventricular support capability.
  118         5. Cardiac care nursing staff must be adept in hemodynamic
  119  monitoring, operation of temporary pacemakers, intra-aortic
  120  balloon pump management, management of indwelling arterial and
  121  venous sheaths, and identifying potential complications.
  122         6. Hospitals implementing the service must first undertake
  123  a training program of 3 to 6 months’ duration, which includes
  124  establishing standards and testing logistics, creating quality
  125  assessment and error management practices, and formalizing
  126  patient-selection criteria.
  127         7. The applicant must certify that the hospital will use at
  128  all times the patient-selection criteria for the performance of
  129  primary angioplasty at hospitals without adult open-heart
  130  surgery programs issued by the American College of Cardiology
  131  and the American Heart Association.
  132         8. The hospital must agree to submit a quarterly report to
  133  the agency detailing patient characteristics, treatment, and
  134  outcomes for all patients receiving emergency percutaneous
  135  coronary interventions pursuant to this paragraph. This report
  136  must be submitted within 15 days after the close of each
  137  calendar quarter.
  138         (c) For a hospital seeking a Level II program,
  139  demonstration that, for the most recent 12-month period as
  140  reported to the agency, it has performed a minimum of 1,100
  141  adult inpatient and outpatient cardiac catheterizations, of
  142  which at least 400 must be therapeutic catheterizations, or, for
  143  the most recent 12-month period, has discharged at least 800
  144  patients with the principal diagnosis of ischemic heart disease.
  145         (d) Compliance with the most recent guidelines of the
  146  American College of Cardiology and American Heart Association
  147  guidelines for staffing, physician training and experience,
  148  operating procedures, equipment, physical plant, and patient
  149  selection criteria to ensure patient quality and safety.
  150         (e) Establishment of appropriate hours of operation and
  151  protocols to ensure availability and timely referral in the
  152  event of emergencies.
  153         (f) Demonstration of a plan to provide services to Medicaid
  154  and charity care patients.
  155         (4) In order to ensure continuity of available services,
  156  the holder of a certificate of need for a newly licensed
  157  hospital that meets the requirements of this subsection may
  158  apply for and shall be granted Level I program status regardless
  159  of whether rules relating to Level I programs have been adopted.
  160  To qualify for a Level I program under this subsection, a
  161  hospital seeking a Level I program must be a newly licensed
  162  hospital established pursuant to a certificate of need in a
  163  physical location previously licensed and operated as a
  164  hospital, the former hospital must have provided a minimum of
  165  300 adult inpatient and outpatient diagnostic cardiac
  166  catheterizations for the most recent 12-month period as reported
  167  to the agency, and the newly licensed hospital must have a
  168  formalized, written transfer agreement with a hospital that has
  169  a Level II program, including written transport protocols to
  170  ensure safe and efficient transfer of a patient within 60
  171  minutes. A hospital meeting the requirements of this subsection
  172  may apply for certification of Level I program status before
  173  taking possession of the physical location of the former
  174  hospital, and the effective date of Level I program status shall
  175  be concurrent with the effective date of the newly issued
  176  hospital license.
  177         (4)(5)(a) The agency shall establish a technical advisory
  178  panel to develop procedures and standards for measuring outcomes
  179  of adult cardiovascular services. Members of the panel shall
  180  include representatives of the Florida Hospital Association, the
  181  Florida Society of Thoracic and Cardiovascular Surgeons, the
  182  Florida Chapter of the American College of Cardiology, and the
  183  Florida Chapter of the American Heart Association and others
  184  with experience in statistics and outcome measurement. Based on
  185  recommendations from the panel, the agency shall develop and
  186  adopt rules for the adult cardiovascular services that include
  187  at least the following:
  188         1. A risk adjustment procedure that accounts for the
  189  variations in severity and case mix found in hospitals in this
  190  state.
  191         2. Outcome standards specifying expected levels of
  192  performance in Level I and Level II adult cardiovascular
  193  services. Such standards may include, but shall not be limited
  194  to, in-hospital mortality, infection rates, nonfatal myocardial
  195  infarctions, length of stay, postoperative bleeds, and returns
  196  to surgery.
  197         3. Specific steps to be taken by the agency and licensed
  198  hospitals that do not meet the outcome standards within
  199  specified time periods, including time periods for detailed case
  200  reviews and development and implementation of corrective action
  201  plans.
  202         (b) Hospitals licensed for Level I or Level II adult
  203  cardiovascular services shall participate in clinical outcome
  204  reporting systems operated by the American College of Cardiology
  205  and the Society for Thoracic Surgeons.
  206         Section 2. Paragraphs (m) and (n) of subsection (3) of
  207  section 408.036, Florida Statutes, are repealed.
  208         Section 3. This act shall take effect July 1, 2016.