BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 357
          AUTHOR:        Correa
          AMENDED:       April 4, 2013
          HEARING DATE:  April 17, 2013
          CONSULTANT:    Marchand

           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 pilot  
          program.

          Existing law:
          1.Licenses and regulates general acute care hospitals by the  
            Department of Public Health (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 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 percutaneous transluminal coronary  
            angioplasty 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 nonpilot hospitals, and a representative  
            from DPH, to oversee, monitor, and make recommendations to DPH  
                                                         Continued---



          SB 357 | Page 2




            concerning the 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 at the conclusion of the pilot program, including  
            recommendations for the continuation or termination of the  
            pilot program.

          6.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 pilot program. 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 PCI Pilot Program  
            on January 1, 2014.
          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 to  
            conduct a final report by July 31, 2013, rather than at the  
            conclusion of the pilot program.

          3.Requires the report that DPH is required to submit to the  
            Legislature to be completed within 90 days of receiving the  
            final report from the advisory oversight committee, 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 pilot program.

          4.Contains an urgency clause that will make this bill effective  
            upon enactment.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal  
          committee

           COMMENTS  :  
           1.Author's statement. The intent of SB 891 (Correa), Chapter  
            295, Statutes of 2008, which created the PCI Pilot Program  
            allowing six acute care hospitals to provide cardiac  
            catheterization services without on-site surgery services, was  
            to have a report with the recommendations from the advisory  
            committee to be submitted to DPH prior to the end of the pilot  
            program, but there was a drafting error. The author states  




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            that this bill corrects the drafting error, allowing the pilot  
            hospitals to continue with the PCI Pilot Program while DPH  
            reviews the data from the advisory committee, and allows the  
            Legislature an opportunity to take action after reviewing the  
            report on the pilot project.

          2.What is percutaneous transluminal coronary angioplasty?   
            According to Stanford Medical Center online health library,  
            percutaneous transluminal coronary angioplasty is performed to  
            open blocked coronary arteries cause by coronary artery  
            disease and to restore arterial blood flow to the heart tissue  
            without open-heart surgery. A special catheter with a tiny  
            balloon at its tip is inserted into the coronary artery to be  
            treated. The balloon is inflated once the catheter has been  
            placed into the narrowed area of the coronary artery. The  
            inflation of the balloon compresses the fatty tissue in the  
            artery and makes a larger opening inside the artery for  
            improved blood flow. Once the artery has been opened, a stent  
            is placed in the artery. A stent is a tiny, expandable metal  
            coil that is inserted into the newly-opened area of the artery  
            to help keep the artery from narrowing or closing again.

          3.PCI Pilot Program background.  According to the Senate Health  
            Committee analysis of SB 891 (Correa), Chapter 295, Statutes  
            of 2008, which created the PCI Pilot Program, 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 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.

            The six hospitals selected by DPH for the 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.




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            The most recent update from the PCI Pilot Program Advisory  
            Oversight Committee, dated January 17, 2013, found no  
            significant outcome differences between the six hospitals in  
            the pilot program, and the control group of hospitals  
            performing these procedures with onsite cardiac surgery  
            services.

          4.Prior legislation. SB 891 (Correa), Chapter 295, Statutes of  
            2008, enacted the PCI Pilot Program that this bill is seeking  
            to revise.

          5.Support.  The California Hospital Association (CHA) states in  
            support that the PCI Pilot Program expanded patients' access  
            to care, particularly benefitting underinsured and poor  
            patients who are often the least likely to undergo PCI due to  
            barriers accessing specialized cardiac services such as  
            geography, distance, culture, race, language, poverty and lack  
            of education. However, CHA states that there was a drafting  
            error in the original legislation that requires the program to  
            end prior to the Legislature making a determination whether or  
            not to extend the program. CHA states that there is very good  
            evidence at this time that the program should be extended, and  
            that interruption in the program would mean the patients  
            relying on the program could not receive the services.

          The California Chapter of the American College of Cardiology  
            (ACC) also supports this bill, stating that 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 pilot program, however there was a  
            drafting error. The ACC states that this bill addresses the  
            drafting error by enabling the pilot hospitals to continue  
            with the pilot program while DPH reviews the data from the  
            advisory committee and makes a recommendation to the  
            Legislature on whether the program should continue and if so  
            under what circumstances.

          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.

           SUPPORT AND OPPOSITION  :
          Support:  California Hospital Association




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                    California Chapter of the American College of  
                    Cardiology
                    Clovis Community Medical Center
                    Doctors Medical Center
                    Kaiser Permanente Walnut Creek Medical Center
                    Los Alamitos Medical Center
                    Placer County Water Agency
                    St. Rose Hospital
                    Sutter Roseville Medical Center
          
          Oppose:   None received

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