Amended in Senate April 30, 2014

Amended in Senate April 7, 2014

Senate Bill No. 830

Introduced by Senator Galgiani

January 6, 2014

An act to amend Sections 128745 and 128748 of the Health and Safety Code, relating to health care.

LEGISLATIVE COUNSEL’S DIGEST

SB 830, as amended, Galgiani. Health care: health facility data.

Existing law establishes the Office of Statewide Health Planning and Development, which is vested with all the duties, powers, responsibilities, and jurisdiction of the State Department of Public Health relating to health planning and research development. Existing law requires the office to publish certain risk-adjusted outcome reports for specified medical, surgical, or obstetric conditions or procedures, including a coronary artery bypass graft surgery. begin delete Existing law requires the office to collect the same data used for the most recent risk-adjusted model, as specified, and authorizes the office to add any clinical data elements included in the Society of Thoracic Surgeons’ database. Prior to any additions from the Society of Thoracic Surgeons’ database, existing law sets forth factors the office is required to assess. Existing law authorizes the office to add, delete, or revise any clinical data elements not included in the Society of Thoracic Surgeons’ database, as specified. end delete

This begin delete bill, end delete begin insert bill would instead require the office to publish annually, on July 1 of each year, risk-adjusted outcome reports for all coronary artery bypass graft surgeries and heart valve repair and replacement surgeries performed in the state. The bill, end insert commencing July 1, 2015, would additionally require the office to publish risk-adjusted outcome reports for begin delete all coronary artery bypass graft and heart valve repair and replacement surgeries, and end delete all percutaneous cardiac interventions and transcatheter valve procedures performed in the state, as specified. begin delete The bill would remove the office’s authorization to add, delete, or revise clinical data elements not included in the Society of Thoracic Surgeons’ database, would authorize the office to add any clinical data elements included in the National Cardiovascular Data Registry CATH/PCI and TAVR databases with regard to the reports for percutaneous cardiac interventions and transcatheter valve procedures, and would revise the factors to be considered before the office adds clinical data elements. end delete

Existing law requires the Director of the Office of Statewide Planning and Development to appoint, as specified, a 9-member clinical panel for each risk-adjusted outcome report on a medical, surgical, or obstetric condition or procedure that includes reporting data of an individual physician, including coronary artery bypass graft surgery. For the clinical panel authorized for coronary artery bypass graft surgery, existing law requires 3 members to be appointed from a list of names submitted by the California Medical Association.

This bill would begin insert increase the number of individuals appointed to a clinical panel from 9 to 12, including 3 members from a list of names submitted by the California Hospital Association. The bill would end insert instead require the office director to appoint 3 members from a list of 3 or more names submitted by the California Society of Thoracic Surgeons and would additionally require that one appointee be an interventionalist and a member of the Society of Angiography for a clinical panel authorized for coronary artery bypass surgery and heart valve repair and replacement surgery. The bill would additionally require the office director to appoint specified individuals, including, among others, 3 members from a list of names submitted by the California Chapter of the American College of Cardiology, to a clinical panel authorized for percutaneous cardiac interventions and transcatheter valve procedures.

The bill would require all heart valve repair and replacement begin delete transcatheter interventions or surgery end delete procedures begin insert , whether performed using surgical procedures or using transcatheter interventions, end insert to be reviewed by a joint subpanel of the coronary artery bypass graft surgery and heart valve repair and replacement surgery, and percutaneous cardiac intervention clinical panels, as provided.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 128745 of the Health and Safety Code
is amended to read:

128745.  

(a) Commencing July 1993, and annually thereafter,
the office shall publish risk-adjusted outcome reports in accordance
with the following schedule:

 

		Procedures and
Publication	Period	Conditions
Date	Covered	Covered
July 1993	1988-90	3
July 1994	1989-91	6
July 1995	1990-92	9

 

Reports for subsequent years shall include conditions and
procedures and cover periods as appropriate.

(b) The procedures and conditions required to be reported under
this chapter shall be divided among medical, surgical, and obstetric
conditions or procedures and shall be selected by the office. The
office shall publish the risk-adjusted outcome reports for surgical
procedures by individual hospital and individual surgeon unless
the office in consultation with medical specialists in the relevant
area of practice determines that it is not appropriate to report by
individual surgeon. The office, in consultation with the clinical
begin delete panel end delete begin insert panels end insert established by Section 128748 and medical specialists
in the relevant area of practice, may decide to report nonsurgical
procedures and conditions by individual physician when it is
appropriate. The selections shall be in accordance with all of the
following criteria:

(1) The patient discharge abstract contains sufficient data to
undertake a valid risk adjustment. The risk adjustment report shall
ensure that public hospitals and other hospitals serving primarily
low-income patients are not unfairly discriminated against.

(2) The relative importance of the procedure and condition in
terms of the cost of cases and the number of cases and the
seriousness of the health consequences of the procedure or
condition.

(3) Ability to measure outcome and the likelihood that care
influences outcome.

(4) Reliability of the diagnostic and procedure data.

(c) (1) In addition to any other established and pending reports,
on or before July 1, 2002, the office shall publish a risk-adjusted
outcome report for coronary artery bypass graft surgery by hospital
for all hospitals opting to participate in the report. This report shall
be updated on or before July 1, 2003.

(2) In addition to any other established and pending reports,
begin delete commencing July 1, 2004, and every year thereafter, end delete the office
shall publish begin insert annually, on July 1 of each year, end insert risk-adjusted
outcome reports for coronary artery bypass graft surgery begin insert and heart
valve repair and replacement surgery end insert for all coronary artery bypass
graft surgeries begin insert and heart valve repair and replacement surgeries end insert
performed in the state. In each year, the reports shall compare
risk-adjusted outcomes by hospital, and in every other year, by
hospital and cardiac surgeon. Upon the recommendation of the
clinical panels established by Section 128748 based on statistical
and technical considerations, information on individual hospitals
and surgeons may be excluded from the reports.

begin delete

(3) In addition to any other established and pending reports,
commencing July 1, 2015, and every year thereafter, the office
shall publish risk-adjusted outcome reports for coronary artery
bypass graft surgery and heart valve repair and replacement surgery
for all coronary artery bypass graft surgeries and heart valve repair
and replacement surgeries performed in the state. In each year, the
reports shall compare risk-adjusted outcomes by hospital, and in
every other year, by hospital and cardiac surgeon. Upon the
recommendation of the clinical panels established pursuant to
Section 128748 based on statistical and technical considerations,
information on individual hospitals and surgeons may be excluded
from the reports.

end delete begin delete

(4)

end delete

begin insert (3) end insert  Unless otherwise recommended by the clinical panels
established by subdivision (d) of Section 128748, the office shall
collect the same data used for the most recent risk-adjusted model
developed for the California Coronary Artery Bypass Graft
Mortality Reporting Program. Upon recommendation of the clinical
panel, the office may add any clinical data elements included in
the Society of Thoracic Surgeons’ database. Prior to any additions
from the Society of Thoracic Surgeons’ database, the begin delete office shall
consider the utilization of sampling to the maximum extent
possible. end delete begin insert following factors shall be considered: end insert

begin insert

(A) Utilization of sampling to the maximum extent possible.

end insert begin insert

(B) Exchange of data elements as opposed to the addition of
data elements.

end insert begin insert

(4) Upon recommendation of the clinical panel, the office may
add, delete, or revise clinical data elements, but shall add no more
than a net of six elements not included in the Society of Thoracic
Surgeons’ database, to the data set over any five-year period.
Prior to any additions or deletions, all of the following factors
shall be considered:

end insert begin insert

(A) Utilization of sampling to the maximum extent possible.

end insert begin insert

(B) Feasibility of collecting data elements.

end insert begin insert

(C) Costs and benefits of collection and submission of data.

end insert begin insert

(D) Exchange of data elements as opposed to addition of data
elements.

end insert

(5) The office shall collect the minimum data necessary for
purposes of testing or validating a risk-adjusted model for the
coronary artery bypass graft and heart valve repair and replacement
report.

(6) Patient medical record numbers and any other data elements
that the office believes could be used to determine the identity of
an individual patient shall be exempt from the disclosure
requirements of the California Public Records Act (Chapter 3.5
(commencing with Section 6250) of Division 7 of Title 1 of the
Government Code).

(d) In addition to any other established and pending reports,
commencing July 1, 2015, and every year thereafter, the office
shall publish risk-adjusted outcome reports for percutaneous
cardiac intervention and transcatheter valve procedure for all
percutaneous cardiac intervention and transcatheter valve
procedures performed in the state. In each year, the reports shall
compare risk-adjusted outcomes by hospital, and in every other
year, by hospital and physician. Upon the recommendation of the
clinical begin delete panel end delete begin insert panels end insert established by Section 128748 based on
statistical and technical considerations, information on individual
hospitals and physicians may be excluded from the reports.

(1) The office shall collect the same data used for the National
Cardiovascular Data Registry Cath/PCI and begin delete TAVR end delete begin insert TVT end insert databases.
begin delete Upon recommendation of the clinical panel, the office may add
any clinical data elements included in the National Cardiovascular
Data Registry Cath/PCI and TAVR databases. Prior to any
additions from the National Cardiovascular Data Registry Cath/PCI
and TAVR databases, the office shall consider the utilization of
sampling to the maximum extent possible. end delete

begin insert

(2) Upon recommendation of the clinical panel, the office may
add, delete, or revise clinical data elements, but shall add no more
than a net of six elements not included in the Cardiovascular Data
Registry Cath/PCI and TVT databases, to the data set over any
five-year period. Prior to any additions or deletions, all of the
following factors shall be considered:

end insert begin insert

(A) Utilization of sampling to the maximum extent possible.

end insert begin insert

(B) Feasability of collecting data elements.

end insert begin insert

(C) Costs and benefits of collection and submission of data.

end insert begin insert

(D) Exchange of data elements as opposed to addition of data
elements.

end insert begin delete

(2)

end delete

begin insert (3) end insert  The office shall collect the minimum data necessary for
purposes of testing or validating a risk-adjusted model for the
percutaneous cardiac intervention and transcatheter valve procedure
report.

begin delete

(3)

end delete

begin insert (4) end insert  Patient medical record numbers and any other data elements
that the office believes could be used to determine the identity of
an individual patient shall be exempt from the disclosure
requirements of the California Public Records Act (Chapter 3.5
(commencing with Section 6250) of Division 7 of Title 1 of the
Government Code).

(e) The annual reports shall compare the risk-adjusted outcomes
experienced by all patients treated for the selected conditions and
procedures in each California hospital during the period covered
by each report to the outcomes expected. Outcomes shall be
reported in the five following groupings for each hospital:

(1) “Much higher than average outcomes,” for hospitals with
risk-adjusted outcomes much higher than the norm.

(2) “Higher than average outcomes,” for hospitals with
risk-adjusted outcomes higher than the norm.

(3) “Average outcomes,” for hospitals with average risk-adjusted
outcomes.

(4) “Lower than average outcomes,” for hospitals with
risk-adjusted outcomes lower than the norm.

(5) “Much lower than average outcomes,” for hospitals with
risk-adjusted outcomes much lower than the norm.

(f) For coronary artery bypass graft surgery begin insert and heart valve
repair and replacement surgery end insert reports and any other outcome
reports for which auditing is appropriate, the office shall conduct
periodic auditing of data at hospitals.

(g) The office shall publish in the annual reports required under
this section the risk-adjusted mortality rate for each hospital and
for those reports that include physician reporting, for each
physician.

(h) The office shall either include in the annual reports required
under this section, or make separately available at cost to any
person requesting it, risk-adjusted outcomes data assessing the
statistical significance of hospital or physician data at each of the
following three levels: 99-percent confidence level (0.01 p-value),
95-percent confidence level (0.05 p-value), and 90-percent
confidence level (0.10 p-value). The office shall include any other
analysis or comparisons of the data in the annual reports required
under this section that the office deems appropriate to further the
purposes of this chapter.

SEC. 2.  

Section 128748 of the Health and Safety Code is
amended to read:

128748.  

(a)  This section shall apply to any risk-adjusted
outcome report that includes reporting of data by an individual
physician.

(b)  (1)  The office shall obtain data necessary to complete a
risk-adjusted outcome report from hospitals. If necessary data for
an outcome report is available only from the office of a physician
and not the hospital where the patient received treatment, then the
hospital shall make a reasonable effort to obtain the data from the
physician’s office and provide the data to the office. In the event
that the office finds any errors, omissions, discrepancies, or other
problems with submitted data, the office shall contact either the
hospital or physician’s office that maintains the data to resolve the
problems.

(2)  The office shall collect the minimum data necessary for
purposes of testing or validating a risk-adjusted model. Except for
data collected for purposes of testing or validating a risk-adjusted
model, the office shall not collect data for an outcome report nor
issue an outcome report until the clinical panel established pursuant
to this section has approved the risk-adjusted model.

(c)  For each risk-adjusted outcome report on a medical, surgical,
or obstetric condition or procedure that includes reporting of data
by an individual physician, the office director shall appoint a
clinical panel, which shall have begin delete nine end delete begin insert 12 end insert members. Three members
shall be appointed from a list of three or more names submitted
by the physician specialty society that most represents physicians
performing the medical, surgical, and obstetric procedure for which
data is collected. Three members shall be appointed from a list of
three or more names submitted by the California Medical
Association. begin insert Three members shall be appointed from a list of names
submitted by the California Hospital Association. end insert Three members
shall be appointed from lists of names submitted by consumer
organizations. At least one-half of the appointees from the lists
submitted by the physician specialty society and the California
Medical Association, and at least one appointee from the lists
submitted by consumer organizations, shall be experts in collecting
and reporting outcome measurements for physicians or hospitals.
The panel may include physicians from another state. The panel
shall review and approve the development of the risk-adjustment
model to be used in preparation of the outcome report.

(d)  For the clinical panel authorized by subdivision (c) for
coronary artery bypass graft surgery and heart valve repair and
replacement surgery, three members shall be appointed from a list
of three or more names submitted by the California Chapter of the
American College of Cardiology. Three members shall be
appointed from a list of three or more names submitted by the
California Society of Thoracic Surgeons. begin insert Three members shall be
appointed from a list of names submitted by the California Hospital
Association. end insert Three members shall be appointed from lists of names
submitted by consumer organizations. At least one-half of the
appointees from the lists submitted by the California Chapter of
the American College of Cardiology and the California Society of
Thoracic Surgeons, and at least one appointee from the lists
submitted by consumer organizations, shall be experts in collecting
and reporting outcome measurements for physicians and surgeons
or hospitals, and one appointee shall be an interventionalist and
member of the Society of Angiography and Intervention. The panel
may include physicians from another state. The panel shall review
and approve the development of the risk-adjustment model to be
used in preparation of the outcome report.

(e) For the clinical panel authorized by subdivision (c) for
percutaneous cardiac interventions and transcatheter valve
procedures, three members shall be appointed from a list of three
or more names submitted by the California Chapter of the
American College of Cardiology. Three members shall be
appointed from a list of three or more names submitted by the
California Medical Association. begin insert Three members shall be appointed
from a list of names submitted by the California Hospital
Association. end insert Three members shall be appointed from lists of names
submitted by consumer organizations. At least one-half of the
appointees from the lists submitted by the California Chapter of
the American College of Cardiology and the California Medical
Association, and at least one appointee from the lists submitted
by consumer organizations, shall be experts in collecting and
reporting outcome measurements for physicians and surgeons or
hospitals, and one appointee shall be a cardiovascular surgeon and
a member of the California Society of Thoracic begin delete Surgery. end delete begin insert Surgeons. end insert
The panel may include physicians from another state. The panel
shall review and approve the development of the risk-adjustment
model to be used in preparation of the outcome report.

(f) All heart valve repair and replacement begin delete transcatheter
interventions or surgery end delete procedures begin insert , whether performed using
surgical procedures or using transcatheter interventions, end insert shall
also be reviewed by a joint subpanel of the coronary artery bypass
graft surgery and heart valve repair and replacement surgery and
percutaneous cardiac intervention panels. The subpanel shall be
comprised of begin delete three end delete begin insert four end insert members appointed from the clinical panel
established in subdivision (d), begin delete three end delete begin insert four end insert members appointed from
the panel established in begin delete subdivisions end delete begin insert subdivision end insert (e), and shall be
chaired by one member of the office. The subpanel may make
recommendations to the panels established in subdivisions (d) and
(e) relating to valve repair and replacement begin insert surgeries or end insert
transcatheter begin delete interventions or surgery procedures. end delete begin insert intervention
procedures. end insert

(g)  Any report that includes reporting by an individual physician
shall include, at a minimum, the risk-adjusted outcome data for
each physician. The office may also include in the report, after
consultation with the clinical panel, any explanatory material,
comparisons, groupings, and other information to facilitate
consumer comprehension of the data.

(h)  Members of a clinical panel shall serve without
compensation, but shall be reimbursed for any actual and necessary
expenses incurred in connection with their duties as members of
the clinical panel.