BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 906|
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THIRD READING
Bill No: SB 906
Author: Correa (D)
Amended: 4/7/14
Vote: 21
SENATE HEALTH COMMITTEE : 7-0, 4/30/14
AYES: Hernandez, Morrell, De Le�n, DeSaulnier, Evans, Monning,
Wolk
NO VOTE RECORDED: Beall, Nielsen
SENATE APPROPRIATIONS COMMITTEE : 5-0, 5/12/14
AYES: De Le�n, Hill, Lara, Padilla, Steinberg
NO VOTE RECORDED: Walters, Gaines
SUBJECT : Elective Percutaneous Coronary Intervention Offsite
Program
SOURCE : Author
DIGEST : This bill creates the Elective Percutaneous Coronary
Intervention (PCI) Offsite Program in the Department of Public
Health (DPH) to certify an unlimited number of general acute
care hospitals that are licensed to provide cardiac
catheterization laboratory service in California, and that meet
prescribed, additional criteria, to perform scheduled, elective
PCI. Authorizes 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, as specified, by January 1, 2016. Requires the
Office of Statewide Health Planning and Development (OSHPD) to
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annually develop and make available to the public a report
regarding each participating hospital's performance, as
specified, and authorizes DPH to form an advisory oversight
committee for the purpose of analyzing those reports and
recommending changes. Also authorizes DPH to charge each
participating hospital a supplemental licensing fee not to
exceed the reasonable cost to DPH of overseeing the program.
ANALYSIS :
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 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 Elective 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 PCI 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 non-pilot hospitals, and a
representative from DPH, to oversee, monitor, and make
recommendations to DPH concerning the Elective 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 by November 30, 2013, including recommendations
for the continuation or termination of the pilot program.
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6. Requires DPH to prepare and submit a report to the
Legislature on the results of the Elective PCI Pilot Program
within 90 days of receiving the final report from the
advisory oversight committee. 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 Elective PCI Pilot
Program on January 1, 2015.
This bill:
1. Establishes the Elective PCI Offsite Program in DPH to allow
DPH to certify general acute care hospitals that are licensed
to provide cardiac catheterization laboratory service in
California, and that meet the requirements of this bill, to
perform scheduled, elective percutaneous transluminal
coronary angioplasty and stent placement for eligible
patients.
2. Defines various terms for purposes of this bill, including
that "elective PCI" means scheduled percutaneous transluminal
coronary angioplasty and stent placement, and does not
include urgent or emergency PCI that is scheduled on an ad
hoc basis, and that "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. Requires an eligible hospital, as defined, in order to
participate in the Elective PCI Offsite Program, to obtain
certification from DPH and to meet all of the following
requirements:
A. Demonstrate that it complies with the recommendations
of the Society for Cardiovascular Angiography and
Interventions, 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;
B. Provide evidence showing the full support from hospital
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administration in fulfilling the necessary institutional
requirements, including, but not limited to, appropriate
support services such as respiratory care and blood
banking; and
C. Participate in, and provide timely submission of data
to, the American College of Cardiology-National
Cardiovascular Data Registry, and confer rights to
transfer this data to OSHPD.
4. Requires an eligible hospital to submit an application to DPH
to obtain certification to participate in the Elective PCI
Offsite Program, and requires the application to include
sufficient information to demonstrate compliance with the
standards set forth in this bill, and to include other
specified information, including a description of backup
emergency services.
5. Permits an eligible hospital that was participating in the
Elective PCI Pilot Program to continue to perform elective
PCI and to be considered an offsite hospital provided that
the hospital obtains a certification under the provisions of
this bill by January 1, 2016.
6. Requires OSHPD, using data transferred from the American
College of Cardiology-National Cardiovascular Data Registry,
as specified under this bill, to annually develop and make
available to the public a report regarding each offsite
hospital's performance on mortality, a stroke rate, and an
emergency coronary artery bypass graft rate.
7. Permits DPH to establish an advisory oversight committee
composed of two interventionalists from offsite hospitals,
two interventionalists from hospitals that are not offsite
hospitals, and a representative of DPH, for the purpose of
analyzing the report issued by OSHPD and making
recommendations for changing the data to be included in
future reports issued by OSHPD.
8. Requires DPH to revoke a certification issued under this bill
if at any time an offsite hospital fails to meet the criteria
set forth in this bill. Permits an offsite hospital whose
certification is revoked to request an appeal, and specifies
that these hospitals are not precluded from reapplying for
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certification.
9. Permits DPH to charge offsite hospitals a supplemental
licensing fee, the amount of which cannot exceed the
reasonable cost to DPH of overseeing the program.
10.Permits DPH to contract with a professional entity with
medical program knowledge to meet the requirements of this
bill.
Background
Elective PCI Pilot Program background . According to the Senate
Health Committee analysis of SB 891 (Correa, Chapter 295,
Statutes of 2008), which created the Elective PCI Pilot Program,
the 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 Elective 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. Today,
45 states permit elective PCI without onsite surgery.
The six hospitals selected by DPH for the pilot program were:
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.
The final report from the Elective PCI Pilot Program Advisory
Oversight Committee (PCI AOC), dated November 19, 2013, found no
significant outcome differences between the six hospitals in the
pilot program, and the control group of 116 hospitals performing
these procedures with onsite cardiac surgery services. No
strong relationship was noted between hospital volumes and
overall safety and efficacy. Potential worse outliers were
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identified only in the non-pilot control group of hospitals with
onsite surgery.
Prior Legislation
SB 357 (Correa, Chapter 202, Statutes of 2013), extended the
January 1, 2014, sunset date for the Elective PCI Pilot Program
to January 1, 2015, and requires the final report by the PCI AOC
to be completed by November 30, 2013, rather than at the
conclusion of the pilot program.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
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).
Minor ongoing costs review compliance by participating
hospitals as part of the DPH's ongoing licensing enforcement
program (Licensing and Certification Program Fund).
Minor reporting costs by the OSHPD (California Health Data and
Planning Fund).
SUPPORT : (Verified 5/14/14)
American College of Cardiology - California Chapter
California Hospital Association
Los Alamitos Medical Center
ARGUMENTS IN SUPPORT : The California Hospital Association
(CHA) states in support that this bill allows DPH to certify
general acute care hospitals, which meet the requirements of
this bill, to perform scheduled, elective PCI angioplasty and
stent placement for patients. CHA notes that the results of the
pilot study found that the six California hospitals
participating in the pilot program demonstrated similar safety
and efficacy results for elective and non-elective PCIs when
compared to hospitals with onsite surgery.
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The Los Alamitos Medical Center also supports this bill, stating
that it was one of the pilot participants, and that it
successfully partnered with DPH to generate clinical and
economic data that positions California to move forward with a
permanent program, resulting in better outcomes for these
procedures along with enhanced patient safety.
JL:d 5/14/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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