BILL ANALYSIS �
SB 906
Page 1
Date of Hearing: June 10, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 906 (Correa) - As Amended: June 4, 2014
SENATE VOTE : 36-0
SUBJECT : Elective Percutaneous Coronary Intervention Offsite
Program.
SUMMARY : Creates the Elective Percutaneous Coronary
Intervention (PCI) Offsite Program in the Department of Public
Health (DPH) to certify general acute care hospitals that are
licensed to provide cardiac catheterization laboratory services
in California, to perform scheduled, elective percutaneous
transluminal coronary angioplasty and stent placement for
eligible patients. Specifically, this bill :
1)Defines "Elective Percutaneous Coronary Intervention (elective
PCI)" to mean scheduled percutaneous transluminal coronary
angioplasty and stent placement, and not urgent or emergent
PCI.
2)Defines an "eligible hospital" as 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)Defines an "offsite" hospital as a hospital participating in
the PCI Offsite Program and requires eligible hospitals
wishing to participate in the PCI Offsite Program to obtain
certification from DPH and meet all of the following
requirements:
a) 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 (AHA), for
performance of PCI without onsite cardiac surgery;
b) 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
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banking;
c) Participate in, and provide timely submission of data
to, the American College of Cardiology-National
Cardiovascular Data Registry; and,
d) Confer rights to transfer the data submitted pursuant to
c) above to the Office of Statewide Health Planning and
Development (OSHPD).
4)Requires eligible hospitals to submit an application to DPH to
obtain certification to participate in the Elective PCI
Offsite Program which includes, but is not limited to, the
effective date for initiating elective PCI service, the
general service area, a description of the population to be
served, a description of backup emergency services, and the
qualifications of the general acute care hospital providing
emergency treatment.
5)Allows an eligible hospital that as of December 31, 2014 was
participating in the Elective PCI Pilot Program to continue to
perform elective PCI and requires that the hospital be
considered an offsite hospital provided it obtains
certification from DPH by January 1, 2016.
6)Requires OSHPD to use the data transferred to them to 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.
7)Allows DPH to establish an advisory oversight committee, to
revoke the certification of an offsite hospital if it fails to
meet the requirements of these provisions, to charge
participating hospitals a supplemental fee not to exceed the
reasonable cost of overseeing the program and to contract with
a professional entity with medical program knowledge to meet
the requirements of this bill.
EXISTING LAW :
1)Provides for the licensing and regulation of general acute
care hospitals by 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
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laboratory services.
2)Requires DPH to adopt standards and regulations for cardiac
catheterization laboratory services that specify that only the
diagnostic services, and which diagnostic services, may be
offered by an acute care hospital approved to provide cardiac
catheterization laboratory 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 services in
California, that meet specified requirements, to perform
scheduled, elective percutaneous transluminal coronary
angioplasty (PTCA) 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
concerning the PCI Pilot program.
5)Requires the AOC to submit at least two reports to DPH during
the pilot period, and to conduct a final report at the
conclusion of the PCI Pilot Program, including recommendations
for the continuation or termination of the PCI 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 PCI Pilot Program. Requires this
report to include, but not be limited to, an evaluation of the
PCI Pilot Program's cost, safety, and quality of care.
Requires the report also include a comparison of elective PCI
performed in connection with the PCI Pilot Program, and
elective PCI performed in hospitals with onsite cardiac
surgery services. Requires the report to further 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, 2015.
FISCAL EFFECT : According to the Senate Appropriations
Committee, one-time costs of about $110,000 for initial
licensing of hospitals by DPH (Licensing and Certification
Program Fund (LCPF)), minor ongoing costs to review compliance
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by participating hospitals (LCPF), and minor reporting costs by
OSHPD (California Health Data and Planning Fund).
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, until the
passage of SB 891 (Correa), Chapter 295, Statues of 2008, only
California hospitals licensed to provide cardiac surgery, such
as bypass surgery, were permitted to perform scheduled,
elective PCI treatment. SB 891 created the Elective PCI Pilot
Program, which allowed six California general acute care
hospitals that are licensed to provide cardiac catheterization
services, that have off-site cardiac surgery backup, and that
met the specified rigorous selection criteria, to perform
scheduled, elective PCI for low to medium risk patients. The
author argues that expanding access to quality healthcare and
addressing health disparities is important to improving
patients' quality of life and this bill is prompted by studies
showing that elective PCI for low to medium risk patients can
be safely and effectively performed in hospitals without
cardiac surgery services so long as they meet certain
requirements, including that they have in place stringent
patient selection criteria and a transfer agreement that
ensures transfer to a hospital with cardiac surgery services
within 60 minutes or less. Finally, the author argues that
the reports compiled by the oversight committee showing the
morbidity and mortality results of procedures from the pilot
hospitals from the past two plus years have been consistent
with the morbidity and mortality results from hospitals not
enrolled in the pilot program.
2)BACKGROUND . PCI encompasses a variety of procedures used to
treat patients with diseased arteries of the heart such as,
chest pain caused by a build-up of fats, cholesterol, and
other substances from the blood (referred to as plaque) that
can reduce blood flow to a near trickle, or a heart attack
caused by a large blood clot that completely blocks the
artery. The American Heart Association reports that PCI is
typically performed by PTCA, or threading a catheter - a
slender balloon-tipped tube - from the artery in the groin to
a trouble spot in an artery of the heart. The balloon is then
inflated, compressing the plaque and dilating the narrowed
coronary artery so that blood can flow more easily. This is
also accompanied by inserting an expandable metal stent, a
wire mesh tube used to prop open arteries after PTCA. For
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patients suffering from a heart attack, science shows that
patients benefit from the restoration of blood flow to the
heart muscle within 90 minutes of the patient's arrival at the
hospital. PCI done under emergency circumstances is referred
to as "primary" PCI. Other PCI procedures, such as those done
to unblock an artery before a heart attack occurs, are
referred to as "elective" PCI.
A 2005 joint report of the American College of Cardiology, AHA,
and SCAI provides guidelines for the management of patients
undergoing PCI. The report recommends that elective PCI be
performed in facilities that have an experienced
cardiovascular surgical team available onsite as emergency
back-up for all elective PCI procedures. However, the report
acknowledges that several centers, which do not have onsite
cardiac surgery services have reported satisfactory results
with elective PCI based on careful case selection and
well-defined arrangements for immediate transfer to a surgical
program. The report notes that a small but real fraction of
patients undergoing elective PCI will experience a life
threatening complication that could be managed with immediate
onsite availability of cardiac surgical support but cannot be
managed effectively by urgent transfer. The report ultimately
classifies elective PCI without onsite back-up cardiac surgery
services as a Class III recommendation reserved for conditions
for which there is evidence and/or general agreement that the
procedure or treatment is not useful and/or effective and in
some cases may be harmful.
In early 2007, SCAI, one of the three groups that issued the
2005 guidelines, issued a consensus document on best practices
for PCI without onsite back-up cardiac surgery services.
According to this document, elective PCI without onsite
back-up cardiac surgery is being performed with acceptable
outcomes in many states and its use is growing. The consensus
document recommends standards for elective PCI, and SB 891
requires eligible hospitals to be in compliance with those
standards in order to participate in the PCI Pilot Program.
The SCAI consensus document also notes that guidelines in
other countries do not distinguish between facilities with and
without onsite back-up cardiac surgery.
The six hospitals selected by DPH for the PCI Pilot Program
were: Los Alamitos Medical Center; Sutter Roseville Medical
Center; Kaiser Permanente Walnut Creek Medical Center; Doctors
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Medical Center-San Pablo; Clovis Community Medical Center;
and, St. Rose Hospital in Hayward. All six hospitals have
maintained their eligibility to participate throughout the
entire program.
According to the November 19, 2013 final report from the PCI
Pilot oversight committee, the PCI Pilot hospitals
demonstrated similar safety and efficacy results for elective
and non-elective PCIs when compared to 116 hospitals with
onsite surgery. Pursuant to SB 357 (Correa) DPH was required
to submit a report to the Legislature recommending whether
elective PCI without onsite cardiac surgery should be
continued in California, and if so, under what conditions.
According to DPH their report to the Legislature is not
completed yet.
3)SUPPORT . The California Chapter of the American College of
Cardiology supports this bill writing that the recently
completed pilot program shows no difference in morbidity and
mortality in elective PCI procedures without on-site cardiac
surgery and these results are consistent with many other
studies.
The California Hospital Association states this bill will expand
access to care, especially for the uninsured and underinsured,
which are less likely to undergo PCI due to barriers in
accessing specialized cardiac services, such as geography,
distance, culture, race, language, and poverty.
4)RELATED LEGISLATION . SB 830 (Galgiani) would have required
OSHPD to include heart valve repair and replacement surgeries
in their annual risk adjusted outcome reports for coronary
artery bypass graft surgeries, and to annually publish a new
risk-adjusted outcome report for all PCIs and transcatheter
valve procedures performed in California. SB 830 was held in
the Senate Appropriations Committee.
5)PREVIOUS LEGISLATION .
a) SB 357 (Correa), Chapter 202, Statues of 2013, extends
the January 1, 2014 sunset date for the PCI Pilot Program
to January 1, 2015, and required the final report by the
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oversight committee to be completed by November 30, 2013,
rather than at the conclusion of the pilot program.
b) SB 891 creates the PCI Pilot Program.
REGISTERED SUPPORT / OPPOSITION :
Support
California Chapter of the American College of Cardiology
California Hospital Association
Tenet
Opposition
None on file.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097