Effective January 1, 2015, SB 906 (Chapter 368, Statutes of 2014) permits an eligible hospital to apply to participate in the Elective PCI Program. GACHs that do not have on-site cardiac surgery but have an approved cardiac catheterization laboratory and are in substantial compliance with all applicable state and federal licensing laws and regulations are eligible to apply.

Any GACH seeking to participate in the elective PCI Program must submit a signed application (attached) to CDPH’s Centralized Applications Unit. The application must have sufficient information to demonstrate the ability to comply with all applicable standards and must include the effective initiation date for PCI services, the general service area, a description of population to be served, a description of services to be provided, a description of backup services, availability of comprehensive care, and qualifications of the eligible hospital. Failure to submit any required criteria or additionally requested information will disqualify the applicant.

The signed hard copy application (without attachments) must be submitted to:

Centralized Applications Unit
California Department of Public Health
Licensing & Certification Program
1615 Capitol Avenue, MS #3401,
P.O. Box 997377
Sacramento, CA 95899-7377

Hospitals must submit all application materials with attachments in electronic format to PCI@cdph.ca.gov.

Upon approval of the application and certification to participate in the program, a participating hospital must meet all of the following requirements:

• Demonstrate compliance with the recommendations of the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology Foundation (ACCF), and the American Heart Association (AHA) for performance of PCI without on-site cardiac surgery;
• Provide evidence showing full support from hospital administration in fulfilling the necessary institutional requirements;
• Participate in, and provide timely submission of data to the American College of Cardiology – National Cardiovascular Data Registry (ACC-NCDR);
• Confer rights to transfer the data submitted to ACC-NCDR to the Office of Statewide Health Planning and Development (OSHPD); and
• Satisfy any additional requirements the department deems necessary to protect patient safety or ensure quality of care.

An eligible GACH that was participating in the Elective PCI Pilot Program as of December 31, 2014 may continue to perform elective PCI as a certified hospital until January 1, 2016. After that date, pilot hospitals must obtain certification through the prescribed application process to continue to provide elective PCI.

CDPH will assess participating hospitals a supplemental licensing fee that will not exceed the reasonable cost of overseeing the program. CDPH will retroactively bill the fee, which will be based on the total cost to administer the program and will be divided by the total number of hospitals that are approved to participate in the program.

The most recent SCAI/ACCF/AHA recommendations for performance of PCI without on-site cardiac surgery can be accessed at the following link:

SCAI/ACC/AHA Expert Consensus Document: 2014 update on PCI

The department will host a seminar on the application and approval process Friday, May 29, 2015, from 1:00 pm to 5:00 pm, in the auditorium located at 1500 Capitol Ave, Sacramento, CA 95814.

The information in this AFL is a brief summary of the changes that SB 906 makes to the Health and Safety Code. Facilities are responsible for following all applicable laws. CDPH’s failure to expressly notify facilities of statutory or regulatory requirements does not relieve facilities of their responsibility for following all laws and regulations. Facilities should refer to the full text of all applicable sections of the Health and Safety Code.

If you have any questions about this AFL or the Elective PCI Program, please contact the Chief Medical Consultant at PCI@cdph.ca.gov.

Sincerely,

Original signed by Jean Iacino

Jean Iacino
Deputy Director

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