BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 357
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          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