BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 357
AUTHOR: Correa
AMENDED: April 4, 2013
HEARING DATE: April 17, 2013
CONSULTANT: Marchand
SUBJECT : Elective Percutaneous Coronary Intervention (PCI)
Pilot Program.
SUMMARY : Extends the January 1, 2014, sunset date for the
Elective Percutaneous Coronary Intervention Pilot Program (PCI
Pilot Program) to January 1, 2015, and requires the final report
by the PCI Pilot Program oversight committee to be completed by
July 31, 2013, rather than at the conclusion of the pilot
program.
Existing law:
1.Licenses and regulates general acute care hospitals by the
Department of Public Health (DPH), and in addition to the
basic services offered under that license, permits general
acute care hospitals to seek approval from DPH to offer
special services, including cardiac surgery and cardiac
catheterization laboratory services.
2.Requires DPH, for cardiac catheterization laboratory services,
to adopt standards and regulations that specify that only
diagnostic services, and which diagnostic services, may be
offered by an acute care hospital that is approved to provide
cardiac catheterization laboratory service but is not also
approved to provide cardiac surgery service.
3.Establishes the PCI Pilot Program to allow DPH to authorize up
to six general acute care hospitals that are licensed to
provide cardiac catheterization laboratory service in
California, and that meet specified requirements, to perform
scheduled, elective percutaneous transluminal coronary
angioplasty and stent placement for eligible patients without
onsite cardiac surgery.
4.Establishes an advisory oversight committee, comprised of one
interventionalist from each pilot hospital, an equal number of
cardiologists from nonpilot hospitals, and a representative
from DPH, to oversee, monitor, and make recommendations to DPH
Continued---
SB 357 | Page 2
concerning the PCI Pilot Program.
5.Requires the advisory oversight committee to submit at least
two reports to DPH during the pilot period, and to conduct a
final report at the conclusion of the pilot program, including
recommendations for the continuation or termination of the
pilot program.
6.Requires DPH to prepare and submit a report to the Legislature
on the results of the PCI Pilot Program no later than 90 days
after termination of the pilot program. Requires this report
to recommend whether elective PCI without onsite cardiac
surgery should be continued in California, and if so, under
what conditions.
7.Sunsets the provisions of law creating the PCI Pilot Program
on January 1, 2014.
This bill:
1.Extends the January 1, 2014, sunset date for the PCI Pilot
Program to January 1, 2015.
2.Requires the PCI Pilot Program advisory oversight committee to
conduct a final report by July 31, 2013, rather than at the
conclusion of the pilot program.
3.Requires the report that DPH is required to submit to the
Legislature to be completed within 90 days of receiving the
final report from the advisory oversight committee, rather
than 90 days after termination of the PCI Pilot Program, and
specifies that this report is to be on the initial results of
the pilot program.
4.Contains an urgency clause that will make this bill effective
upon enactment.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee
COMMENTS :
1.Author's statement. The intent of SB 891 (Correa), Chapter
295, Statutes of 2008, which created the PCI Pilot Program
allowing six acute care hospitals to provide cardiac
catheterization services without on-site surgery services, was
to have a report with the recommendations from the advisory
committee to be submitted to DPH prior to the end of the pilot
program, but there was a drafting error. The author states
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that this bill corrects the drafting error, allowing the pilot
hospitals to continue with the PCI Pilot Program while DPH
reviews the data from the advisory committee, and allows the
Legislature an opportunity to take action after reviewing the
report on the pilot project.
2.What is percutaneous transluminal coronary angioplasty?
According to Stanford Medical Center online health library,
percutaneous transluminal coronary angioplasty is performed to
open blocked coronary arteries cause by coronary artery
disease and to restore arterial blood flow to the heart tissue
without open-heart surgery. A special catheter with a tiny
balloon at its tip is inserted into the coronary artery to be
treated. The balloon is inflated once the catheter has been
placed into the narrowed area of the coronary artery. The
inflation of the balloon compresses the fatty tissue in the
artery and makes a larger opening inside the artery for
improved blood flow. Once the artery has been opened, a stent
is placed in the artery. A stent is a tiny, expandable metal
coil that is inserted into the newly-opened area of the artery
to help keep the artery from narrowing or closing again.
3.PCI Pilot Program background. According to the Senate Health
Committee analysis of SB 891 (Correa), Chapter 295, Statutes
of 2008, which created the PCI Pilot Program, legislation was
prompted by studies showing that elective PCI for low- to
medium-risk patients can be safely and effectively performed
at hospitals without cardiac surgery services if they meet
certain requirements. The current limitation on hospitals
performing interventional cardiac procedures, if they are not
also licensed to perform cardiac surgery, was enacted over 25
years ago. Since that time, there have been great
technological and methodological advances in interventional
cardiology that have significantly improved patient outcomes
and reduced incidents of emergency cardiac surgery. At the
time the PCI Pilot Program was enacted, hospitals in 28 states
were already performing elective PCI without on-site surgical
capability but with transfer arrangements to facilities that
do have such capability.
The six hospitals selected by DPH for the pilot program are:
Los Alamitos Medical Center; Sutter Roseville Medical Center;
Kaiser Permanente Walnut Creek Medical Center; Doctors Medical
Center-San Pablo; Clovis Community Medical Center; and St.
Rose Hospital in Hayward.
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The most recent update from the PCI Pilot Program Advisory
Oversight Committee, dated January 17, 2013, found no
significant outcome differences between the six hospitals in
the pilot program, and the control group of hospitals
performing these procedures with onsite cardiac surgery
services.
4.Prior legislation. SB 891 (Correa), Chapter 295, Statutes of
2008, enacted the PCI Pilot Program that this bill is seeking
to revise.
5.Support. The California Hospital Association (CHA) states in
support that the PCI Pilot Program expanded patients' access
to care, particularly benefitting underinsured and poor
patients who are often the least likely to undergo PCI due to
barriers accessing specialized cardiac services such as
geography, distance, culture, race, language, poverty and lack
of education. However, CHA states that there was a drafting
error in the original legislation that requires the program to
end prior to the Legislature making a determination whether or
not to extend the program. CHA states that there is very good
evidence at this time that the program should be extended, and
that interruption in the program would mean the patients
relying on the program could not receive the services.
The California Chapter of the American College of Cardiology
(ACC) also supports this bill, stating that the intent of the
prior legislation was to have a report with the
recommendations of the advisory committee be submitted to DPH
prior to the end of the pilot program, however there was a
drafting error. The ACC states that this bill addresses the
drafting error by enabling the pilot hospitals to continue
with the pilot program while DPH reviews the data from the
advisory committee and makes a recommendation to the
Legislature on whether the program should continue and if so
under what circumstances.
All six pilot hospitals also wrote in support, pointing to the
safe outcomes, and also pointing out that the increased volume
of patients has led to the hiring of additional staff, and
that returning to the previous process would be a disservice
to staff, patients and their families.
SUPPORT AND OPPOSITION :
Support: California Hospital Association
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California Chapter of the American College of
Cardiology
Clovis Community Medical Center
Doctors Medical Center
Kaiser Permanente Walnut Creek Medical Center
Los Alamitos Medical Center
Placer County Water Agency
St. Rose Hospital
Sutter Roseville Medical Center
Oppose: None received
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