Amended in Assembly August 18, 2014

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) begin delete Offsite end delete 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 begin delete Offsite end delete Program in the State Department of Public Health to certify an unlimited number of general acute care hospitals that are licensed to provide urgent and emergent 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 begin delete provided that the hospital obtains end delete begin insert , but would require the hospital to obtain end insert 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) begin delete Offsite end delete 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 urgent and
emergent 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:

begin insert

(1) “Certified hospital” means an eligible hospital that is
certified by the department to participate in the Elective
Percutaneous Coronary Intervention (PCI) Program established
by this section.

end insert begin delete

(1)

end delete

begin insert (2) end insert  “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.

begin delete

(2)

end delete

begin insert (3) end insert  “Eligible hospital” means a general acute care hospital that
has begin delete a licensed end delete begin insert an approved end insert cardiac catheterization laboratory begin insert , does
not have onsite cardiac surgery, end insert and is in substantial compliance
with all applicable state and federal licensing laws and regulations.

begin delete

(3)

end delete

begin insert (4) end insert  “Interventionalist” means a licensed cardiologist who meets
the requirements for performing elective begin delete PCI at an offsite hospital. end delete
begin insert PCI. end insert

begin delete

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

end delete

(c) To participate in the Elective PCI begin delete Offsite end delete 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.

begin insert

(5) Any additional requirements the department deems necessary
to protect patient safety or ensure quality of care.

end insert

(d) An eligible hospital shall submit an application to the
department begin insert pursuant to Section 1265 end insert to obtain certification to
participate in the Elective PCI begin delete Offsite end delete Program. The application
shall include sufficient information to demonstrate compliance
with the standards set forth in this section, and shall also 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 begin delete general acute care hospital providing the
emergency treatment end delete begin insert eligible hospital end insert . The department may require
that additional information be submitted with the application.
Failure to submit any required criteria or additional information
shall disqualify the applicant from the application process and
from consideration for participation in the program. begin insert The department
may deny an Elective PCI Program applicant pursuant to Article
2 (commencing with Section 1265). end insert

(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 begin delete an offsite end delete
begin insert a certified end insert hospital begin delete provided that the end delete begin insert until January 1, 2016. On
and after January 1, 2016, a hospital described in this subdivision
shall not be considered a certified hospital unless the end insert hospital
begin delete obtains end delete begin insert has obtained end insert a certification under this section begin delete by January
1, 2016 end delete .

(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 begin delete offsite end delete begin insert certified end insert 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 begin delete offsite end delete begin insert certified end insert
hospitals, two interventionalists from general acute care hospitals
that are not begin delete offsite end delete begin insert certified end insert 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 begin delete an offsite end delete begin insert a certified end insert hospital fails to meet the
criteria set forth in this section for being begin delete an offsite end delete begin insert a certified end insert
hospital or fails to safeguard patient safety, as determined by the
department, the department may begin insert suspend or end insert revoke begin insert , pursuant to
Section 70309 of Title 22 of the California Code of Regulations, end insert
the certification issued to that begin delete offsite end delete hospital under this section.
begin delete An offsite end delete begin insert A end insert 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 begin delete offsite end delete begin insert certified end insert 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.