900 KAR 6:120. Certificate of Need pilot projects.

900 KAR 6:120. Certificate of Need pilot projects.

RELATES TO: KRS 216B.010-216B.130, 216B.330-216B.339, 216B.990

STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 216B.040(2)(a)1

NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.040(2)(a)1 requires the Cabinet for Health and Family Services to administer Kentucky's Certificate of Need Program and to promulgate administrative regulations as necessary for the program. This administrative regulation establishes the provisions for the pilot project for primary angioplasty in hospitals without on-site open heart surgery ("pilot program") established in the 2004-2006 State Health Plan for the certificate of need program.

Section 1. Definitions. (1) "Cabinet" is defined by KRS 216B.015(5).

(2) "Days" means calendar days, unless otherwise specified.

(3) "Improvement" means change or addition to the premises of an existing facility that enhances its ability to deliver the services that it is authorized to offer under its existing license or an approved certificate of need.

Section 2. Pilot Angioplasty Program. The provisions of this section shall apply to the pilot project for primary angioplasty in hospitals without on-site open heart surgery "pilot program" initially established in the 2004-2006 State Health Plan.

(1) Hospitals participating in the pilot program shall, within twenty-four (24) hours of the event or on the first business day following the event, report the following events to the Office of Health Policy by fax at (502) 564-0302 or by emailing the executive director:

(a) A death that occurs within twenty-four (24) hours of the cardiac catheterization procedure or hospital discharge. The report shall indicate if the death was a cardiac death or a noncardiac death.

1. A death shall be considered a cardiac death if the death was due to any of the following:

a. Acute myocardial infarction;

b. Cardiac perforation/pericardial tamponade;

c. Arrhythmia or conduction abnormality;

d. Cerebrovascular accident related to, or suspected of being related to, the cardiac catheterization procedure. An event shall be considered to be a cerebrovascular accident if there were acute neurological deficits recorded by clinical staff that persisted more than twenty-four (24) hours. The report shall note if these events occurred:

(i) During the index catheterization; or

(ii) During the index hospitalization;

e. Death due to complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery; or

f. Any death in which a cardiac cause could not be excluded.

2. A death shall be considered a noncardiac death if the death was not due to cardiac causes as described in subparagraph 1 of this paragraph;

(b) Emergency coronary artery bypass graft surgery (CABG) within twenty-four (24) hours of the procedure or hospital discharge. An event shall be considered to be an emergency if there is a sudden and often life-threatening mishap that arises in the course of, and as a result of, the performance of a cardiac catheterization or angioplasty procedure. It shall not include patients either transferred directly from the cardiac catheterization procedure room or taken within twenty-four (24) hours to the operating room for surgical correction of emergent or life threatening cardiac disease; or

(2) Hospitals participating in the pilot program shall report in writing within seven (7) days to the Office of Health Policy any of the following events:

(a) Cerebrovascular accident, which are acute neurological deficits recorded by clinical staff that persisted more than twenty-four (24) hours. The report shall note if these events occurred within thirty (30) days after the catheterization but were not clearly related to the procedure;

(b) Any intracranial bleed within thirty (30) days of the cardiac catheterization procedure;

(d) Vascular complications which occur within twenty-four (24) hours of the cardiac catheterization procedure or hospital discharge. These shall include:

1. Hematoma of more than four (4) centimeters;

2. Retroperitoneal Bleed;

3. False Aneurysm;

4. AV fistula;

5. Peripheral ischemic/nerve injury; or

6. Hemolysis and Hemolytic anemia.

(3) Hospitals participating in the pilot program shall:

(a) Establish a Joint Performance Improvement Committee (Joint PI Committee) with its collaborating tertiary hospital or with practicing interventional cardiologists. The membership of the Joint PI Committee shall, at a minimum, include each of the following disciplines from both the pilot program hospital and the collaborating tertiary hospital:

1. Physicians;

2. Nurses; and

3. Administrators;

(b) Convene the Joint PI Committee at least quarterly but sooner if twenty-five (25) patients have been treated to review the care provided to patients under the pilot program. This review process shall focus on patient outcomes and, at a minimum, include:

1. An assessment of the appropriateness of the selection of each patient entered into the pilot program;

2. All complications, any adverse outcomes, and for transfers, the number of patients requiring transfer and the reason for each transfer to a tertiary facility;

3. The technical quality of the catheterization and angioplasty procedures performed; and

4. The "door to cath lab time" and "door to treatment time";

(d) Develop a process for including the findings of the Joint PI Committee’s review in the pilot program hospital’s performance improvement program;

(e) Require the Joint PI Committee to make a quarterly recommendation to the Office of Health Policy whether the pilot program should continue; and

(f) Require all staff, including interventional cardiologists, nurses, and technicians, as well as representatives of the Emergency Department and Critical Care Unit staffs participating in the pilot program PI process, to attend a minimum of one (1) meeting of the Joint PI Committee per year.

(4) Performance of primary angioplasty at a hospital as measured by quality indicators including mortality, morbidity, and adverse reactions shall be comparable, on a risk adjusted basis, to the performance of existing angioplasty programs in Kentucky and with similar organizations nationally, according to the National Cardiovascular Data Registry.

(a) If the outcomes are worse at a pilot hospital, that facility shall file and implement a plan of correction with the Office of Health Policy.

(b) If the facility’s results do not improve after one (1) quarter of implementing a plan of correction, the Office of Health Policy may terminate the facility’s participation in the pilot program.

(5) Hospitals participating in the pilot program shall:

(a) Continue to make available the cardiac catheterization service twenty-four (24) hours per day and seven (7) days per week;

(b) Develop policies and procedures that will assure that all interventional cardiologists performing primary angioplasty procedures at the pilot program hospital maintain an appropriate level of proficiency as a member of the team performing primary angioplasty at the pilot program hospital. The policies and procedures shall detail the process the physician director will utilize to assure the establishment, maintenance, and monitoring of the proficiency of each interventional cardiologist;

(c) Maintain a collaborative association and a current, valid collaboration agreement with a tertiary hospital including Joint PI and staff education programs; and

(d) Perform a minimum of thirty-six (36) primary angioplasty procedures per year. At least thirty (30) of these angioplasty procedures shall be primary angioplasty procedures, excluding patients that have "rescue angioplasty" procedures performed.

(6) The time frame for measuring compliance with procedural utilization requirements shall begin six (6) months after the date of the physician director’s notification to the Office of Health Policy that all training requirements have been fulfilled. Within twelve (12) months from the start date, the hospital shall have performed eighteen (18) primary angioplasty procedures or shall receive a warning that approval to participate in the pilot program may be withdrawn.

(7) Within the following six (6) months, a total of eighteen (18) months from the date of the department’s letter of approval, the hospital shall have performed at least another eighteen (18) procedures for a total of thirty-six (36) primary angioplasty procedures, or the program may be discontinued at that site.

(8) Each site shall continue to perform at least eighteen (18) primary angioplasty procedures per six (6) months and a total of thirty-six (36) primary angioplasty procedures per year, or the program may be discontinued at that site.

(9) All physicians performing percutaneous coronary intervention (PCI) at a pilot program hospital shall:

(a) Continue to perform no fewer than 100 cardiac catheterization diagnostic and therapeutic procedures per year. At least seventy-five (75) procedures shall be angioplasty procedures unless the procedures are being performed at a facility at which more than 400 angioplasty procedures are being performed per year; and

(b) Maintain credentials at a hospital at which that operator performs elective angioplasty procedures.

(10)(a) All staff that are hired after the completion of the initial training at the pilot program hospital shall complete a training program that mirrors the initial training program. The relevant collaborating tertiary and pilot program hospitals shall develop this training program.

(b) Training of all staff including all interventional cardiologists, nurses, and technicians, shall be performed on the intra-aortic balloon pump annually.

(c) All staff involved in providing PCI, including the interventional cardiologists, nurses and technicians, shall have a current Advanced Cardiac Life Support (ACLS) certification.

(d) Inservice programs shall be based upon need identified through staff evaluations and the quality assurance process.

(11) The Office of Health Policy may discontinue the pilot program at a participant hospital at any time after reviewing the following:

(a) Quarterly reports made by the American College of Cardiology - National Cardiovascular Data Registry (ACC-NCDR);

(b) Records obtained through an audit;

(d) Reports on serious adverse events.

(12) Upon notification to the hospital by the Office of Health Policy, the hospital shall terminate the pilot program and cease to perform primary angioplasty procedures.

(13) In order to assist the Office of Health Policy in evaluating the pilot program, the performance of pilot hospitals, and the formulation of recommendations for continuing or modifying the project, the Office of Health Policy may collaborate with university based researchers to:

(a) Evaluate and compare performance data of pilot hospitals with existing Kentucky angioplasty programs; and

(b) Conduct an evaluation of the short-and long-term outcomes of patients undergoing primary angioplasty at pilot hospitals with those patients transferred to hospitals with open heart surgical backup.

(14) The Office of Health Policy shall review reports from the collaborating university based researchers as well as quarterly reports made by the ACC-NCDR, records obtained through audit, peer review reports, and reports of serious adverse events in order to develop recommendations for continuing, discontinuing, or modifying the pilot program. If the project is continued, these recommendations shall include establishing criteria for determining need to expand angioplasty services to additional hospitals without on-site surgical backup, qualifications of those hospitals, and ongoing requirements for a hospital’s continued provision of this service.

(15) The Office of Health Policy may convene all hospitals participating in the pilot program on a regular basis for the purpose of discussing and assessing the status of the implementation of the pilot program.

(16) Three (3) years from the start date of the pilot program, the Office of Health Policy shall publish a report on the program that shall:

(a) Indicate whether it is in the best interest of the Commonwealth to eliminate the requirement for open heart surgery for hospitals to perform therapeutic cardiac catheterization; and

(b) Include the requirements for patient selection, procedural volume, and staffing that hospitals shall continue to meet if the Office of Health Policy finds that this service may be provided by hospitals in the absence of on-site open heart surgery. (36 Ky.R. 257; Am. 818; eff. 10-21-09.)