Diagnostic Therapeutic and Interventional Cardiac Catheterization Procedures

Section 205 TITLE 77: PUBLIC HEALTH CHAPTER I: DEPARTMENT OF PUBLIC HEALTH SUBCHAPTER b: HEALTH CARE FACILITIES PART 205 AMBULATORY SURGICAL TREATMENT CENTER LICENSING REQUIREMENTS SECTION 205.135 DIAGNOSTIC THERAPEUTIC AND INTERVENTIONAL CARDIAC CATHETERIZATION PROCEDURES Section 205.135  Diagnostic Therapeutic and Interventional Cardiac Catheterization Procedures Diagnostic, therapeutic and interventional cardiac catheterization procedures included in the Center for Medicare and Medicaid Services' approved procedures list (see Section 205.115(a)(2)(C)) may be performed in an ambulatory surgical treatment center in accordance with the following requirements: a)         The procedure shall be approved by the facility's consulting committee in accordance with Section 205.130 of this Part. b)         The procedure shall meet the general exclusion criteria for invasive cardiac procedures in settings without cardiac surgery in Table 2 and Table 3 of the SCAI position statement on the performance of percutaneous coronary interventions in ambulatory surgical centers and Figure 1 in SCAI Expert Consensus Statement on Percutaneous Coronary Intervention Without On-Site Surgical Backup (see Section 205.115(a)(1)(E)). c)         The facility shall only perform cardiac catheterization procedures approved for reimbursement by the Centers for Medicare and Medicaid Services for ambulatory surgical centers, including: 1)         Percutaneous transluminal coronary angioplasty ("PTCA"); single major coronary artery or branch; 2)         PTCA; each additional branch of a major coronary artery; 3)         Percutaneous transcatheter placement of intracoronary stents with coronary angioplasty; single major coronary artery or branch; 4)         Percutaneous transcatheter placement of intracoronary stents with coronary angioplasty; each additional branch; 5)         Percutaneous transcatheter placement of drug-eluting intracoronary stents with coronary angioplasty; single major coronary artery or branch; and 6)         Percutaneous transcatheter placement of drug-eluting intracoronary stents with coronary angioplasty; each additional branch per the License for Use of Current Procedural Terminology (see Section 205.115(a)(2)(C)). d)         The facility shall have the following clinical staffing: 1)         A lab director who is board-certified or board-eligible in interventional cardiology, cardiology, internal medicine, pediatrics, vascular surgery , or radiology with subspecialty training in cardiology or cardiovascular radiology. 2)         Physicians who are board-certified or board-eligible in interventional cardiology, cardiology, internal medicine, pediatrics, or vascular surgery. 3)         If the facilities provide PCIs, physicians who perform PCI cardiac procedures in the catheterization lab must meet the following criteria, at a minimum: A)        Have completed at least 50 PCI sessions annually as the primary interventional cardiologist during the most recent 24-month period; B)        Have completed an interventional cardiology fellowship training program; C)        Be board certified or board eligible, or if seniority status and board ineligible then the provider must have unrestricted active current privileges in a cardiac specialty at a hospital in interventional cardiology; D)        Have performed a total of at least 250 PCI sessions as the primary interventional cardiologist, upon seeking practice privileges at the facility; and E)        Have a minimum of two years' experience at an attending level. e)         Accreditation 1)         Facilities shall obtain or maintain accreditation for the establishment of a cardiac catheterization category of service or when applying for a permit to modernize or to acquire new equipment for existing service. 2)         The cardiac catheterization laboratory shall be accredited by a nationally recognized accrediting organization (or become accredited once the service is operational).  Accreditation can be obtained from one of the following organizations: A)        Accreditation for Cardiovascular Excellence (Home | Accreditation for Cardiovascular Excellence specializes in Cath lab accreditation, Cath and PCI Accreditation, peer review (cvexcel.org); B)        American College of Cardiology (Accreditation); C)        Corazon (Accreditation | Corazon, Inc | Evaluate. Enhance. Excel.) (corazoninc.com); D)        Intersocietal Accreditation Commission (IAC Cardiovascular Catheterization Accreditation) (intersocietal.org); or E)        The Joint Commission (Comprehensive Cardiac Center (CCC) | The Joint Commission). f)         Quality Review and Emergency Transfer Preparedness 1)         Peer Review and Registry A)        Any facility proposing the establishment of a cardiac catheterization category of service, or the modernization of an existing cardiac catheterization unit, shall develop a protocol for adequate peer review of the service and its participation in a national registry. B)        Peer review teams will evaluate the quality of studies and related morbidity and mortality of patients and the technical aspects of providing the services such as film processing, equipment maintenance, etc. 2)         Emergency Transfers A)        Facilities shall have transfer arrangements and protocols in place with a hospital located within 30 minutes by ground travel that performs cardiac surgery to provide emergency surgery and ongoing care as required in Section 205.540(d).  The protocol shall include coordination of communication among the ambulatory facility, emergency medical services (EMS), and the receiving hospital. B)        Emergency mock transfer drills shall be conducted a minimum of two (2) times per year and shall include the EMS provider and the receiving hospital, as required under Section 205.510.