Amended in Assembly June 4, 2014

Amended in Senate April 7, 2014

Senate Bill No. 906

Introduced by Senator Correa

January 21, 2014

An act to add Section 1256.01 to the Health and Safety Code, relating to health facilities.

LEGISLATIVE COUNSEL’S DIGEST

SB 906, as amended, Correa. Elective Percutaneous Coronary Intervention (PCI) Offsite Program.

Existing law establishes, until January 1, 2015, the Elective Percutaneous Coronary Intervention Pilot Program in the State Department of Public Health, which authorizes up to 6 eligible acute care hospitals that are licensed to provide cardiac catheterization laboratory service in California, and that meet prescribed, additional criteria, to perform scheduled, elective primary percutaneous coronary intervention (PCI), as defined, for eligible patients. Existing law establishes an advisory oversight committee to oversee, monitor, and make recommendations to the department concerning the pilot program. Existing law also imposes various reporting requirements on the advisory oversight committee and the department, including recommendations as to whether the pilot program should be continued or terminated and whether elective PCI without onsite cardiac surgery should be continued in California.

This bill would create the Elective Percutaneous Coronary Intervention Offsite Program in the State Department of Public Health to certify an unlimited number of general acute care hospitals that are licensed to provide begin insert urgent and emergent end insert cardiac catheterization laboratory service in California, and that meet prescribed, additional criteria, to perform scheduled, elective PCI. The bill would authorize a hospital that was participating in the Elective PCI Pilot Program as of December 31, 2014, to continue to perform elective PCI provided that the hospital obtains a certification under the bill’s provisions by January 1, 2016. The bill would require the Office of Statewide Health Planning and Development to annually develop and make available to the public a report regarding each participating hospital’s performance on mortality, stroke rate, and emergency coronary artery bypass graft rate and would authorize the department to form an advisory oversight committee for the purpose of analyzing those reports and recommending changes to the data to be included in the reports. The bill would also authorize the department to charge each participating hospital a supplemental licensing fee not to exceed the reasonable cost to the department of overseeing the program.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 1256.01 is added to the Health and Safety
Code, to read:

1256.01.  

(a) The Elective Percutaneous Coronary Intervention
(PCI) Offsite Program is hereby established in the department.
The purpose of the program is to allow the department to certify
general acute care hospitals that are licensed to provide begin insert urgent and
emergent end insert cardiac catheterization laboratory service in California,
and that meet the requirements of this section, to perform
scheduled, elective percutaneous transluminal coronary angioplasty
and stent placement for eligible patients.

(b) For purposes of this section, the following terms have the
following meanings:

(1) “Elective Percutaneous Coronary Intervention (elective
PCI)” means scheduled percutaneous transluminal coronary
angioplasty and stent placement. Elective PCI does not include
urgent or emergent PCI that is scheduled on an ad hoc basis.

(2) “Eligible hospital” means a general acute care hospital that
has a licensed cardiac catheterization laboratory and is in
substantial compliance with all applicable state and federal
licensing laws and regulations.

(3) “Interventionalist” means a licensed cardiologist who meets
the requirements for performing elective PCI at an offsite hospital.

(4) “Offsite hospital” means a hospital participating in the
Elective Percutaneous Coronary Intervention (PCI) Offsite Program
established by this section.

begin delete

(5) “Primary percutaneous coronary intervention (primary PCI)”
means percutaneous transluminal coronary angioplasty and stent
placement that is emergent in nature for acute myocardial infarction
and that is performed before administration of thrombolytic agents.

end delete

(c) To participate in the Elective PCI Offsite Program, an
eligible hospital shall obtain certification from the department and
shall meet all of the following requirements:

(1) Demonstrate that it complies with the recommendations of
the Society for Cardiovascular Angiography and Interventions
(SCAI), the American College of Cardiology Foundation, and the
American Heart Association, for performance of PCI without onsite
cardiac surgery, as those recommendations may evolve over time.

(2) Provide evidence showing the full support from hospital
administration in fulfilling the necessary institutional requirements,
including, but not limited to, appropriate support services such as
respiratory care and blood banking.

(3) Participate in, and provide timely submission of data to, the
American College of Cardiology-National Cardiovascular Data
Registry.

(4) Confer rights to transfer the data submitted pursuant to
paragraph (3) to the Office of Statewide Health Planning and
Development.

(d) An eligible hospital shall submit an application to the
department to obtain certification to participate in the Elective PCI
Offsite Program. The application shall include sufficient
information to demonstrate compliance with the standards set forth
in this section, and begin delete also end delete shall begin insert also end insert include the effective date for
initiating elective PCI service, the general service area, a
description of the population to be served, a description of the
services to be provided, a description of backup emergency
services, the availability of comprehensive care, and the
qualifications of the general acute care hospital providing the
emergency treatment. The department may require that additional
information be submitted with the application. Failure to begin delete include end delete
begin insert submit end insert any required criteria or additional information shall
disqualify the applicant from the application process and from
consideration for participation in the program.

(e) An eligible hospital that, as of December 31, 2014, was
participating in the Elective Percutaneous Coronary Intervention
Pilot Program established under Chapter 295 of the Statutes of
2008, as amended by Chapter 202 of the Statutes of 2013, may
continue to perform elective PCI and shall be considered an offsite
hospital provided that the hospital obtains a certification under
this section by January 1, 2016.

(f) The Office of Statewide Health Planning and Development
shall, using the data transferred pursuant to paragraph (4) of
subdivision (c), annually develop and make available to the public
a report regarding each offsite hospital’s performance on mortality,
stroke rate, and emergency coronary artery bypass graft rate.

(g) The department may establish an advisory oversight
committee composed of two interventionalists from offsite
hospitals, two interventionalists from general acute care hospitals
that are not offsite hospitals, and a representative of the department,
for the purpose of analyzing the report issued under subdivision
(f) and making recommendations for changing the data to be
included in future reports issued under subdivision (f).

(h) If at any time an offsite hospital fails to meet the criteria set
forth in this section for being an offsite hospital or fails to safeguard
patient safety, as determined by the department, the department
begin delete shall end delete begin insert may end insert revoke the certification issued to that offsite hospital
under this section. An offsite hospital whose certification is revoked
pursuant to this subdivision may request an appeal with the
department and is not precluded from reapplying for certification
under this section.

(i) The department may charge offsite hospitals a supplemental
licensing fee, the amount of which shall not exceed the reasonable
cost to the department of overseeing the program.

(j) The department may contract with a professional entity with
medical program knowledge to meet the requirements of this
section.