BILL ANALYSIS �
SB 906
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Date of Hearing: June 18, 2014
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
SB 906 (Correa) - As Amended: June 4, 2014
Policy Committee: HealthVote:18-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill establishes the Elective Percutaneous Intervention
(PCI) Offsite Program, administered by the Department of Public
Health (DPH), to certify eligible hospitals, as defined, as able
to perform PCI (angioplasty). It also:
1)Requires the Office of Statewide Health Planning and
Development (OSHPD) to collect data and issue a report on
hospital performance on PCI procedures.
2)Authorizes DPH to:
a) Charge participating hospitals a supplemental licensing
fee to cover the department's reasonable costs of
overseeing the program.
b) Establish an advisory oversight committee to make
recommendations regarding data to be collected.
c) Contract with a professional entity with medical program
knowledge to meet program requirements.
FISCAL EFFECT
1)Approximately $300,000 annually to OSHPD (California Health
Data and Planning Fund) to collect and analyze information
related to PCI procedures, and to produce an annual report.
Costs may be somewhat lower in future years as data procedures
and analytical methodology are routinized.
2)One-time costs of about $110,000 for initial licensing of
hospitals by DPH (Licensing and Certification Program Fund).
3)Minor ongoing costs to review compliance by participating
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hospitals as part of the Department's ongoing licensing
enforcement program (Licensing and Certification Program
Fund).
COMMENTS
1)Purpose . This bill seeks to allow hospitals meeting certain
criteria to offer elective PCI. Currently, pursuant to state
regulations, a hospital must conduct cardiac surgery on-site
in order to offer PCI on a non-emergency basis. Recent
studies suggest that outcomes for PCI conducted in locations
without access to on-site cardiac surgery are comparable to
those with on-site cardiac surgery.
2)Background . PCI, also known as angioplasty, is a procedure to
open narrowed or blocked coronary arteries that supply blood
to the heart. It is conducted by inserting a catheter through
blood vessels to coronary arteries, and inflating a balloon.
A small mesh tube called a stent may also be placed in order
to restore blood flow through narrow or blocked arteries.
PCI is often performed on an emergency basis in the hospital
when patients are experiencing chest pain, or after a heart
attack. In contrast, elective PCI may be conducted in
asymptomatic patients. For example, an individual may be
referred for an angiogram after a stress test, and the
physician may discover during a diagnostic angiogram that an
artery is showing signs of blockage, and insert a stent.
Currently, some hospitals have cardiac catheterization
laboratories that perform diagnostic work (an angiogram), but
they cannot simultaneously perform the angioplasty on an
elective basis unless they also offer onsite cardiac surgery.
Relevant professional societies have been reluctant to
recommend offering elective PCI without on-site cardiac
surgery as a backup, because in rare instances, complications
from the procedure may require cardiac surgery. They
recognize, however, that it has become fairly common in spite
of this concern. The most recent 2011 guidelines offer
guidance for elective PCI in hospitals that lack on-site
cardiac surgery, including recommendations about appropriate
planning, rigorous patient selection, and transport
capabilities. PCI is already allowed on an emergency basis in
California hospitals without on-site cardiac surgery.
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3)Elective PCI Pilot Program . SB 891 (Correa), Chapter 295,
Statues of 2008, established a pilot to allow DPH to study the
safety of elective PCI in hospitals without on-site cardiac
surgery services. Six California hospitals participated in
the study. According to the November 19, 2013 final report
from a 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
on-site surgery. The report has not yet been published in a
peer-reviewed journal.
Pursuant to SB 357 (Correa), Chapter 202, Statues of 2013, DPH
was required to submit a report to the Legislature
recommending whether elective PCI without on-site cardiac
surgery should be continued in California and, if so, under
what conditions. According to statute, based on the timing of
the final report from the oversight committee last fall, the
DPH report was due in late February 2014. DPH indicates the
report is under review and is not available at this time.
4)Elective PCI Identified as an Overused Procedure .
Prestigious national health care quality entities recently
highlighted elective PCI as one of five medical procedures
with a high potential for overuse. Use of medical treatments
and interventions when not clinically appropriate can increase
health care costs and expose patients to harm without
providing benefit. A July 2013 paper titled "Proceedings from
the National Summit on Overuse," describes findings of work
group members that reviewed 72,000 elective PCIs; only 50%
were classified as appropriate, 38% as uncertain, and 11.6% as
inappropriate. Other studies have found that 6-8% of PCIs are
not appropriate (performed in patients in whom that treatment
was not necessary, or when a medical or surgical intervention
would be more clinically effective). Recommendations for
curbing overuse include "Appropriate Use Criteria" developed
by professional societies, standardized referral practices and
interpretation of noninvasive testing, ensuring patient
consent is adequately informed, and increased public and
professional education. Because many hospitals provide
elective PCI currently, the extent to which this bill may
increase the number of elective PCI procedures is unknown.
There are currently 62 hospitals in California authorized to
perform cardiac catheterization laboratory services that do
not offer on-site cardiac surgery, which would potentially
seek to offer elective PCI through this program. According to
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Health Care Blue Book, fair prices for PCI in California
exceed $20,000 per procedure. Data indicates approximately
25,000 elective PCI procedures were performed in 2009, as well
as significant regional variation in the use of elective PCI.
5)Related Legislation . SB 830 (Galgiani) requires 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.
6)Previous Legislation . SB 891 (Correa), Chapter 295, Statues of
2008 created the PCI Pilot Program. SB 357 (Correa), Chapter
202, Statues of 2013, extended the January 1, 2014 sunset date
for the PCI Pilot Program to January 1, 2015, and required the
final report by the oversight committee to be completed by
November 30, 2013.
7)Comments . This bill would expand the availability of an
elective procedure statewide based on results from a pilot
program that have not yet been published in a peer-reviewed
journal, and before DPH recommendations related to the pilot
are available. Given DPH recommendations are forthcoming, the
committee may wish to ensure the department is provided
adequate flexibility to incorporate its recommendations into
the program structure. Additional criteria not included in the
bill, or the ability to require more specificity in meeting
certain criteria included in the bill, may be important to
ensure patient safety.
In addition, it is unclear whether requirements in the bill to
adhere to standards published by professional societies also
serve to address potential overuse. Given as many as one in
10 elective PCI procedures may be inappropriate according to
national experts, the committee may wish to consider
referencing best practices with respect to preventing overuse
of elective PCI to reduce unnecessary health care costs and
promote quality of care, as it contemplates making the
procedure more widely available.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081
SB 906
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