BILL ANALYSIS �
SB 357
Page 1
Date of Hearing: June 4, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 357 (Correa) - As Amended: April 4, 2013
SENATE VOTE : 35-0
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 PCI Pilot
Program. Contains an urgency clause in order to become
effective immediately upon enactment. Specifically, 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
(AOC) to conduct a final report by July 31, 2013, rather than
at the conclusion of the PCI Pilot Program.
3)Requires the report that the Department of Public Health (DPH)
is required to submit to the Legislature to be completed
within 90 days of receiving the final report from the AOC,
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 PCI Pilot Program.
EXISTING LAW :
1)Licenses and regulates 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 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
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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 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)Delineates extensive qualification criteria for pilot
hospitals wishing to participate in the pilot, including, but
not limited to:
a) Having the capacity to perform at least 200 primary and
elective PCI procedures annually;
b) Permits only interventionists who meet strict criteria
including but not limited to: having lifetime experience
of at least 500 total PCI procedures as primary operator,
and have complication rates and outcomes equivalent or
superior to national benchmarks established by the American
College of Cardiology;
c) Has an on-call schedule with operation of the cardiac
catheterization lab 24 hours per day, 365 days a year;
d) Employs experienced intensive care unit nursing staff
who have demonstrated competency with invasive hemodynamic
monitoring, temporary pacemaker operation, and intraaortic
balloon pump management;
e) Has a well-equipped and maintained cardiac
catheterization lab with high resolution digital imaging
capability;
f) Has a written transfer agreement for the emergency
transfer of patients to a facility with cardiac surgery
services;
g) Has onsite rigorous data collection, outcomes analysis,
benchmarking, quality improvement, and formalized periodic
case review; and,
h) Participates in the American College of
Cardiology-National Cardiovascular Data Registry (NCDR).
5)Requires patient selection to be based on the
interventionalist's professional medical judgment, which may
include, but is not limited to, consideration of the patient's
risk, and the patient's overall health status.
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6)Establishes an AOC, 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.
7)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.
8)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 to also include a comparison of elective
PCI performed in connection with the Elective 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.
9)Sunsets the provisions of law creating the PCI Pilot Program
on January 1, 2014.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
extends the PCI Pilot Program allowing six acute care
hospitals to provide cardiac catheterization services without
on-site heart surgery services. 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 PCI Pilot Program, however, there was a drafting error.
This bill would address the drafting error from SB 891
(Correa), Chapter 295, Statutes of 2008, by requiring the
oversight committee to conduct its final report by July 31,
2013, which would be submitted to DPH. DPH would have 90 days
to submit their report to the Legislature. This bill will
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enable the PCI Pilot Program hospitals to continue with the
PCI Pilot Program while DPH reviews the data from the AOC.
Also, this will allow DPH to make the required report to the
Legislature, which will make recommendations on whether the
program should continue and if so under what conditions.
2)BACKGROUND . According to the American Heart Association
(AHA), 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. AHA
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
(widening) 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 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.
According to the Assembly Health Committee analysis of SB 891,
which created the PCI Pilot Program, a 2005 joint report of
the American College of Cardiology, AHA, and the Society for
Cardiovascular Angiography and Interventions (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
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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 other
countries' guidelines do not distinguish between facilities
with and without onsite back-up cardiac surgery.
3)B 891 IMPLEMENTATION . According to DPH and an AOC
presentation dated July, 23, 2010, the University of
California, Davis (UCD), is providing services to DPH
including Institutional Review Board, consent and transfer
agreement review, pilot hospital training, website data
collection and storage, auditing, risk modeling, and
statistical analysis throughout the term of the pilot. Pilot
hospitals provide quarterly reports to DPH and the AOC with
statistical data and patient information relating to the
number of elective PCIs performed and the outcomes of those
procedures, as well as, recommendations for modifications to
the PCI Pilot Program to deliver improved patient care. UCD
provides monthly reports to DPH on mortality and complication
rates at pilot hospitals, hospitals presenting late or
incomplete data on a repeat basis, and audit results of all
fatal cases.
UCD also provides quarterly reports to DPH with data from
interim statistical analyses; adverse events, including events
at the original PCI facility and at centers to which these
patients have been transferred; details of patients
transferred to cardiothoracic surgery including name,
demographics, complication and/or reason for transfer,
door-to-balloon times, time from balloon to surgery center and
Operating Room anesthesia and patients' survival at discharge.
Each facility that passed the Elective PCI Pilot Program
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application review process was scheduled for an onsite,
unannounced survey of their Cardiac Catheter Lab and
facilities related to cardiac care. Special focus was placed
on review of the policies and procedures of each facility to
ensure they were in alignment with the current Title 22
(Health Facility Licensing) and Centers for Medicare and
Medicaid Services regulations, as well as, the statutory
regulations for the PCI Pilot Program and industry standard
guidelines.
The six hospitals selected by DPH for the PCI 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. All six hospitals have maintained
their eligibility to participate throughout the entire
program.
Pursuant to SB 891, the AOC is required to submit at least two
reports to DPH during the pilot period. To date, the AOC has
provided DPH with five reports on the program, the most recent
dated January 17, 2013. The reports compare the treatment
results of the six PCI pilot hospitals and 116 non-pilot
hospitals that report data to NCDR. According to DPH and the
AOC, all five reports found no significant outcome differences
between the six hospitals in the PCI Pilot Program, and the
control group of hospitals performing these procedures with
onsite cardiac surgery services.
UCD will also provide a final report to DPH on primary outcomes,
including in-hospital mortality and/or need for emergent
cardiac surgery; secondary outcomes, including major adverse
cardiovascular events including, but not limited to, death or
stroke; and, additional outcomes including, but not limited
to, heart failure, blood transfusions, or major bleeding
events within 72 hours.
DPH is required to provide a final report to the Legislature
within 90 days after the termination of the PCI Pilot Program
which will recommend whether elective PCI without onsite
cardiac surgery should be continued in California, and if so,
under what conditions.
4)SUPPORT . The California Hospital Association writes in
support of this bill that SB 891 expanded patients' access to
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care, particularly benefiting underinsured and poor patients
who are often the least likely to undergo PCI due to barriers
to accessing specialized cardiac services such as geography,
distance, culture, race, language, poverty, and lack of
education. However, there was a drafting error in SB 891 that
would require the program to end prior to the Legislature
making a determination whether or not to extend the program.
There is very good evidence at this time that the program
should be extended. Interruption in the program would mean
the patients relying on the program could not receive the
services.
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.
5)PREVIOUS LEGISLATION .
a) SB 891 created the PCI Pilot Program with a sunset date
of January 1, 2014.
b) SB 276 (Corbett) of 2012 would have required DPH to
promulgate regulations regarding the type of medical
procedures that can be performed in the cardiac
catheterization laboratory of a hospital that also has
on-site cardiac surgery services, and permitted hospitals
to perform certain specified procedures until such
regulations were adopted.
c) AB 491 (Ma), Chapter 772, Statutes of 2012, authorizes
two general acute care hospitals to provide cardiac
catheterization services in a connected outpatient
facility.
REGISTERED SUPPORT / OPPOSITION :
Support
California Chapter of the American College of Cardiology
California Hospital Association
Clovis Community Medical Center
Doctors Medical Center
Kaiser Permanente Walnut Creek Medical Center
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Los Alamitos Medical Center
St. Rose Hospital
Sutter Roseville Medical Center
Opposition
None on file.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097