BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 830
AUTHOR: Galgiani
AMENDED: April 7, 2014
HEARING DATE: April 24, 2014
CONSULTANT: Marchand
SUBJECT : Health care: health facility data.
SUMMARY : Requires the Office of Statewide Health Planning and
Development 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 percutaneous cardiac
interventions and transcatheter valve procedures performed in
California.
Existing law:
1.Establishes the Office of Statewide Health Planning and
Development (OSHPD), and designates OSHPD as the single state
agency to collect specified health facility or clinic data for
use by all state agencies.
2.Requires hospitals to make and file with OSHPD certain
specified reports, including a Hospital Discharge Abstract
Data Record that is required to include 19 specified data
elements for each admission, including information on
diagnoses and disposition of the patient.
3.Permits OSHPD to make additions or deletions to the data
elements required in the discharge reports, but limits OSHPD
to adding no more than a net of 15 elements to each data set
over any five-year period, and requires OSHPD to consider
costs and benefits of data collection and other factors prior
to adding or deleting any data element.
4.Requires OSHPD, commencing July 1993, and annually thereafter,
to publish risk-adjusted outcome reports in accordance with a
schedule that requires reports to be published on three
conditions or procedures each year for three years, for a
total of nine reports by July 1995, and requires reports for
subsequent years to include conditions and procedures and
cover periods as appropriate. Requires the procedures and
conditions to be reported to be equally divided among medical,
Continued---
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surgical and obstetric conditions or procedures, and to be
selected by OSHPD in accordance with specified criteria.
5.Requires OSHPD, in addition to other established reports,
beginning July 1, 2004, to publish a risk-adjusted outcome
report for coronary artery bypass graft (CABG) surgery for all
CABG surgeries performed in the state. Requires the reports to
compare risk-adjusted outcomes by hospital in every year, and
by cardiac surgeon in every other year, but permits
information on individual hospitals and surgeons to be
excluded from the reports based upon the recommendation of a
clinical panel for statistical and technical considerations.
6.Requires OSHPD to appoint a clinical panel of nine members for
each risk-adjusted outcome report that includes reporting of
data by an individual physician. Specifies that for the
clinical panel for the CABG report, three members are to be
appointed from a list of names submitted by the California
Chapter of the American College of Cardiology, three members
from a list submitted by the California Medical Association,
and three members from a list submitted by consumer
organizations.
This bill:
1.Requires OSHPD, beginning July 1, 2015, to include "heart
valve repair and replacement surgeries" in their annual
risk-adjusted outcome reports for CABG surgeries.
2.Requires OSHPD, beginning July 1, 2015, to publish annual
risk-adjusted outcome reports for all percutaneous cardiac
interventions (PCI) and transcatheter valve procedures
performed in California. Requires these reports to include
risk-adjusted outcomes by hospital in every year, and by
physician in every other year.
3.Requires OSHPD, for purposes of the new PCI and transcatheter
valve procedure reports, to collect the same data used for the
National Cardiovasular Data Registry Cath/PCI and TAVR
databases. Permits OSHPD to add any clinical data elements
included in these same national databases, after first
considering the utilization of sampling to the maximum extent
possible.
4.Requires OSPHD, for purposes of the new PCI and transcatheter
valve procedure reports, to collect the minimum data necessary
for the purposes of testing or validating a risk-adjusted
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model.
5.Exempts, for purposes of the new PCI and transcatheter valve
procedure reports, patient medical record numbers and any
other data elements that OSHPD believes could be used to
determine the identity of an individual patient from the
disclosure requirements of the California Public Records Act.
6.Revises the manner in which members are appointed to the
clinical review panel for the CABG report by requiring three
of the members to be appointed from a list submitted by the
California Society of Thoracic Surgeons, instead of by the
California Medical Association, and by requiring at least one
appointee of the nine members to be an interventionalist and
member of the Society of Angiography and Intervention.
7.Requires, for purposes of establishing the clinical review
panel for the new PCI and transcatheter valve procedure
reports, that three members be appointed from a list submitted
by the California Chapter of the American College of
Cardiology, three members appointed from a list submitted by
the California Medical Association, and three members
appointed from a list submitted by consumer organizations.
Requires, of the nine members, that one appointee be a
cardiovascular surgeon and a member of the California Society
of Thoracic Surgery.
8.Requires all heart valve repair and replacement transcatheter
interventions or surgery procedures to also be reviewed by a
joint subpanel of the CABG clinical review panel and the PCI
and transcatheter valve procedure clinical review panel.
Requires this subpanel to be comprised of three members of the
CABG review panel and three members of the PCI and
transcatheter valve procedure review panel, and to be chaired
by one member from OSHPD. Permits this subpanel to make
recommendations to the CABG review panel and the PCI and
transcatheter valve procedure review panel relating to valve
repair and replacement transcatheter interventions or surgery
procedures.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, SB 680
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(Figueroa), Chapter 898, Statutes of 2001, provided for the
collection and analysis of clinical data concerning coronary
artery bypass graft surgery (CABG) and the publishing of
reports by OSHPD of the results including a discussion of the
findings, conclusions, and trends concerning the overall
quality of medical outcomes for these procedures.
Over the last decade, important changes in technology and
patterns of care for coronary artery disease and other cardiac
conditions have occurred. The use of angioplasty and stents
(percutaneous coronary intervention or PCI) has become more
prevalent than CABG surgery. However, OSHPD is only authorized
to collect and report detailed clinical data for CABG at this
time.
This bill, commencing July 1, 2015, would update current
medical procedures by requiring OSHPD to publish risk-adjusted
outcome reports for PCI including the use of angioplasty or
stents, and transcatheter valve procedures.
2.Background of risk adjusted outcome reports. Under current
law, OSHPD collects data from hospitals about every patient
discharged. The information collected includes date of birth,
sex, admission date, discharge date, principal diagnosis,
other diagnoses, principal procedures, and disposition of the
patient. OSHPD uses this data, in part, to produce required
"risk-adjusted" reports of outcomes of various procedures and
treatments performed at hospitals. Risk-adjustment, simply
stated, means that the results are adjusted to take into
account the condition of the patient. In this manner,
outcomes from hospitals that treat a disproportionately high
number of sick or frail patients, for instance, can be
compared with hospitals treating younger or healthier
patients. While the raw outcome data for the hospital with a
high number of sick patients might show a relatively high
number of deaths, the "risk-adjusted" report might show both
hospitals have equivalent outcomes. The first risk-adjusted
report, on Acute Myocardial Infarction (heart attacks), was
published in December 1993, and was subsequently updated in
May 1996 and December 1997. In 2006, 2007 and 2008, OSHPD
published risk-adjusted outcome reports for 30-day mortality
rates for Community Acquired Pneumonia, based on data
collected for the years 2001-2005.
CABG reports
Pursuant to SB 680 (Figueroa) of 2001, OSHPD began publishing
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CABG risk-adjusted outcome reports for both hospitals and
surgeons beginning in 2006 for data collected in 2003, and
have continued publishing these reports each year, including
having just published the 2011 hospital-level CABG report last
month. Unlike prior reports based on OSHPD discharge data,
OSHPD states that publication of the CABG reports required
establishing a clinical data registry for hospital data
submissions and collection of surgeon information. According
to OSHPD, the CABG Outcomes Reporting Program is the largest
public reporting program on CABG surgery outcomes in the
United States. According to the most recent report, the
operative mortality rate for isolated CABG surgery in
California was 2.01 percent in 2011, which represents a 31
percent reduction in the operative mortality rates since 2003
(2.91percent), the first year of mandated reporting.
Other outcome-reports Existing law requires OSHPD to have been
publishing a minimum of nine risk-adjusted reports in addition
to the CABG report since 1995, with the procedures and
conditions chosen by OSHPD and divided among medical,
surgical, and obstetrical conditions or procedures. These
reports were to have included reports for both hospitals and
physicians, unless OSHPD determined it was not appropriate to
report by individual physician. However, with the exception of
the Acute Myocardial Infarction and the Community Acquired
Pneumonia reports described above, and the annual CABG
reports, OSHPD did not publish any other risk-adjusted outcome
reports until January of 2009. At that time, OSHPD began
publishing a series of reports, called "Inpatient Mortality
Indicators," using a set of quality indicators and other
measures developed by the federal Agency for Healthcare
Research and Quality (AHRQ). Using the indicators established
by AHRQ, OSHPD inputs data on California hospitals that it
collects through discharge reports. Prior to publishing the
Inpatient Mortality Indicator reports for any given procedure
or condition, OSHPD uses statistical risk adjustment tools to
ensure that all California hospitals are assessed fairly.
Because these Inpatient Mortality Indicator reports are
calculated using hospital discharge data, they are necessarily
limited to comparing hospitals, and do not report at the
physician level as is done with the CABG reports. According
to OSHPD, the most recently published AHRQ Inpatient Mortality
Indicator reports (published in June of 2013 for data from
2010 and 2011) includes six procedures (Esophageal Resection,
Pancreatic Resection, Abdominal Aortic Aneurysm Repair,
Craniotomy, Percutaneous Transluminal Coronary Angioplasty,
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and Carotid Endarterectomy) and six conditions (Acute
Myocardial Infarction, Congestive Heart Failure, Acute Stroke,
Gastrointestinal Hemorrhage, Hip Fracture, and Pneumonia).
3.What are these procedures? Generally speaking, the reports
modified and added by this bill have to do with both
traditional, open heart surgery procedures (the CABG surgery
as well as the heart valve repair and replacement surgeries),
and with non-surgical interventional procedures using
catheters that are threaded through blood vessels into the
affected area of the heart (PCI and transcatheter valve
procedures). According to OSHPD data, between 1997 and 2012,
PCI volume decreased slightly from 44,350 to 42,941 (a 3
percent decline), while isolated CABG surgeries (those
performed without other major surgeries) decreased by 58
percent (from 28,178 to 11,725).
a. CABG. Coronary artery bypass graft surgery is
open-heart surgery which involves using a piece of blood
vessel taken from elsewhere in the body and grafted onto
the coronary arteries to create a detour or bypass around
the blocked portion of the coronary artery. OSHPD has
been required to publish risk-adjusted outcome reports
for all hospitals and physicians on this procedure since
2004.
b. Heart valve repair and replacement. Heart valve
surgery, according to the Mayo Clinic, is an open-heart
surgical procedure to repair or replace one or more of
the four valves in your heart that is suffering from a
heart valve disease and is not functioning properly.
c. PCI. Percutaneous coronary intervention, also known
as angioplasty, is described as a nonsurgical procedure.
According to the Mayo Clinic, PCI involves temporarily
inserting and inflating a tiny balloon where your artery
is clogged to help widen the artery, and it is often
combined with the permanent placement of a small wire
mesh tube called a stent to help prop the artery open.
d. Transcatheter valve procedures. According to the
Mayo Clinic, transcatheter aortic valve replacement
(TAVR) is a minimally invasive procedure to replace a
narrowed aortic valve that fails to open properly (aortic
stenosis), and is typically reserved for people who can't
undergo open-heart surgery or for people for whom surgery
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presents too many risks. TAVR involves replacing a
damaged aortic valve with one made from cow heart tissue,
and is performed using a catheter inserted through the
leg or through a tiny incision in the chest.
4.Data collection modeled on national registries. As part of
requiring OSHPD to publish a new risk-adjusted outcome report
for PCI and transcatheter valve procedures, this bill requires
OSHPD to collect the same data used for related databases
collected and maintained by the National Cardiovascular Data
Registry (NCDR). According to its website, NCDR is the
American College of Cardiology's suite of data registries
helping hospitals and private practices measure and improve
the quality of cardiovascular care they provide. The NCDR
encompasses six hospital-based registries and one outpatient
registry. This bill requires OSHPD to collect the same data
that two of NCDR's registries already collect: the NCDR
CathPCI Registry, and the Transcatheter Valve Therapy (TVT)
Registry. According to NCDR, the CathPCI Registry establishes
a national standard for understanding treatments and outcomes
of cardiac disease patients who receive diagnostic
catheterizations and/or PCI procedures. The CathPCI Registry
measures patient demographics, provider and facility
characteristics, history/risk factors, cardiac status, treated
lesions, intracoronary device utilization and adverse event
rates, appropriate use criteria for coronary
revascularization, and compliance with ACC/AHA Clinical
Guidelines recommendations, among other data elements.
According to NCDR, the TVT Registry is a benchmarking tool
developed to track patient safety and real-world outcomes
related to the transcatheter aortic valve replacement (TAVR)
procedure. Created by The Society of Thoracic Surgeons and the
American College of Cardiology, the TVT Registry is designed
to monitor the safety and efficacy of this new procedure for
the treatment of aortic stenosis. The TVT Registry measures
patient demographics, provider and facility characteristics,
history/risk factors, cardiac status and detailed health
status, well-defined indications for the procedure, pre, intra
and post procedure data points and adverse event rates, and
outcomes at 30 days and one year.
5.Prior legislation. SB 680 (Figueroa) required OSHPD to publish
risk-adjusted outcome reports for CABG surgery, required the
existing risk-adjusted outcome reports that OSHPD is required
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to publish to also report data by individual physician where
appropriate, and made various other changes to the provisions
of law required OSHPD to publish risk-adjusted outcome
reports.
6.Support. The California Society of Thoracic Surgeons (CSTS)
states in support that public reports of CABG surgery results
for both hospitals and individual surgeons have been produced
for ten years now, and that during this time, the results have
shown a significant decrease in mortality and complication
rates over this period. CSTS states that the reports can claim
at least some of the credit for this improvement, by
highlighting and thus eliminating or correcting outlier
providers. CSTS notes, however, that over the last decade, the
incidence of CABG surgery has decreased by 50 percent, while
the use of PCI has also decreased but is still much more
prevalent than CABG. According to CSTS, there are now 4 times
more PCI procedures than CABG surgeries being performed in
California, and the importance of PCI compared to CABG is
obvious from both a clinical quality and an economic
perspective. According to CSTS, recent results show that the
PCI mortality rates exceed CABG rates by a significant amount
(2.41 percent versus 1.63 percent). While a database for PCI
did not exist when CABG reporting began, there is now a
national database known as the National Cardiovascular Data
Registry. CSTS states that this voluntary database is now in
use by more than 90 percent of hospitals, making collection of
PCI data feasible. Because OSHPD is only authorized to collect
and report detailed clinical data for CABG at this time, it
would need legislative authorization to expand its mission to
PCI. Finally, CSTS notes that heart valve surgery has evolved
into a more frequent procedure with the advent of new
technologies, and that transcatheter valve replacement and
repair techniques are also emerging as viable therapy, and
there is a need to compare the results of these different
methods of treating heart valve disease.
7.Support if amended. The California Hospital Association (CHA)
supports this bill if amended to clarify that OSHPD will
obtain the data from the national databases to which hospitals
are already reporting, rather than require hospitals to
undertake duplicative reporting to multiple places, as long as
the hospital gives permission for the national databases to
transfer the data to OSHPD. CHA is also requesting an
amendment to provide CHA with appointments on the clinical
review panels, along with the existing appointees representing
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physician groups. CHA argues that it is important that these
advisory panels include individuals with expertise in hospital
information technology, data collection, analysis and
interpretation.
The California Chapter of the American College of Cardiology
(CA-ACC) has also taken a support if amended position, and is
asking for three amendments. First, CA-ACC states that it is
important for OSHPD to have the flexibility to add elements to
the outcome reports, which would help better capture the risks
associated with a patient's condition, and that giving OSHPD
the flexibility to add, change, or delete elements in the
outcome reports will allow them to keep pace with the changing
nature of the procedures. Second, CA-ACC recommends adding
language, which would exclude certain cases hich qualify as
"compassionate care" as these cases are the riskiest for
cardiologists with some mortality rates as high as 70 percent.
Finally, CA-ACC suggests revising the composition of the
clinical review panels to provide broader representation of
the groups participating in the outcome reporting. CA-ACC has
suggested language that would keep the total number of
appointees to these panels the same at nine members, but would
make some changes as to which organizations are represented by
these members, including having one of the members be from
CHA.
8.Should OSHPD have the ability to add or revise data elements
for new report? For purposes of the new PCI and transcatheter
valve procedure reports, this bill contains provisions
requiring OSHPD to collect the same data that is used for
specified national data registries. The language in these
provisions (beginning on page 6, line 1) is modeled on
existing provisions of law pertaining to the collection of
data for the CABG report. However, some of the new language
does not make sense in the context of the new report. For
example, the first sentence requires OSHPD to collect the
"same data" as used in specified national databases, while the
second sentence permits OSHPD add data elements that are
included in the same specified national databases; if OSHPD is
already required to use all of the data elements of the
databases, there would never be any reason to add data
elements that come from the same databases.
More significantly, with regard to the existing CABG report,
OSHPD has a limited ability to add, delete, or revise clinical
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data elements, upon recommendation of the clinical review
panel, after considering specified factors. This bill does
not contain a similar provision for the new PCI and
transcather valve procedure report. One of the reasons why a
clinical review panel might recommend adding new clinical data
elements is to ensure that all appropriate factors are being
taken into consideration when adjusting outcomes for risk.
While the existing data elements included in the national
registries may currently be adequate to publish accurate
risk-adjusted outcome reports, if at any point in the future
the clinical review panel believes additional data elements
are warranted that are not in the national databases, then new
legislation would be required. The author may wish to
consider amending this bill to incorporate similar provisions
permitting OSHPD to revise data elements upon the
recommendation of a clinical review panel.
9.Author's amendments. On page 4, beginning on line 37, and
continuing through line 13 of page 5, this bill deletes or
otherwise makes changes to the ability of OSHPD to add
clinical data elements to the existing CABG report (which is
being modified by this bill to include heart valve repair and
replacement surgery). The author has indicated that this was
a drafting error, and is planning on offering amendments to
restore these lines to existing law.
10.Technical amendments.
a. On page 4, lines 17-28, this bill adds a new
paragraph, nearly identical to the paragraph that
precedes it, to incorporate the addition of heart valve
repair and replacement to the existing CABG report.
Rather than add a new paragraph, the author may wish to
consider simply revising the preceding paragraph (page 4,
lines 7-16) to add heart valve repair and replacement
surgery, and to delete a reference to the 2004
commencement date, so that it would take effect with the
next regularly scheduled CABG report on July 1, 2015.
b. Beginning on Page 6, line 2, this bill makes several
references to a TAVR database. The actual title of the
NCDR database that incorporates the procedure known as
transcatheter aortic valve replacement, or TAVR, is the
"TVT Registry," which stands for transcatheter valve
therapy. References to TAVR should be replaced with TVT.
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c. Beginning on page 9, line 9, this bill creates a
joint subpanel of the two clinical review panels
established for the existing CABG report and the new PCI
and transcatheter valve procedure report. It appears the
intent is to direct this new subpanel to review all heart
valve repair and replacement procedures, whether done as
traditional surgical procedures (thereby falling under
the CABG report) or done using transcatheter
interventions (which would fall under the new PCI and
transcatheter procedure report). The author may wish to
consider amendments making this clearer.
SUPPORT AND OPPOSITION :
Support: California Society of Thoracic Surgeons
Oppose: None received
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