BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 906
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          SENATE THIRD READING
          SB 906 (Correa)
          As Amended August 18, 2014
          Majority vote

           SENATE VOTE  :36-0  
           
           HEALTH              18-0        APPROPRIATIONS      17-0        
           
           ----------------------------------------------------------------- 
          |Ayes:|Pan, Maienschein,         |Ayes:|Gatto, Bigelow,           |
          |     |Ammiano, Bonilla, Bonta,  |     |Bocanegra, Bradford, Ian  |
          |     |Chesbro, Gomez, Gonzalez, |     |Calderon, Campos,         |
          |     |Roger Hernández,          |     |Donnelly, Eggman, Gomez,  |
          |     |Lowenthal, Mansoor,       |     |Holden, Jones, Linder,    |
          |     |Nazarian, Nestande,       |     |Pan, Quirk,               |
          |     |Patterson, Ridley-Thomas, |     |Ridley-Thomas, Wagner,    |
          |     |Rodriguez, Wagner,        |     |Weber                     |
          |     |Wieckowski                |     |                          |
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           SUMMARY :  Creates the Elective Percutaneous Coronary  
          Intervention (PCI) Program in the Department of Public Health  
          (DPH) to certify general acute care hospitals that are licensed  
          to provide urgent and emergent cardiac catheterization  
          laboratory services in California, to perform scheduled,  
          elective percutaneous transluminal coronary angioplasty (PTCA)  
          and stent placement for eligible patients.  

           EXISTING LAW  :  Provides for the licensing and regulation of  
          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.

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee: 

          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 the data  
            procedures and analytical methodology is routinized.   








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          2)One-time costs of about $110,000 for initial licensing of  
            hospitals by DPH (Licensing and Certification Program Fund).

          3)Potential one-time costs for regulations, likely in the range  
            of $50,000 (Licensing and Certification Program Fund), if DPH  
            finds any additional criteria beyond those enumerated in the  
            bill are necessary to ensure patient safety or quality of  
            care.

          4)Ongoing costs to review compliance by participating hospitals  
            as part of the Department's ongoing licensing enforcement  
            program would be calculated and charged to hospitals as  
            allowed by this bill (Licensing and Certification Program  
            Fund).

           COMMENTS  :  According to the author, until the passage of SB 891  
          (Correa), Chapter 295, Statues of 2008, only California  
          hospitals licensed to provide cardiac surgery, such as bypass  
          surgery, were permitted to perform scheduled, elective PCI  
          treatment.  SB 891 created the Elective PCI Pilot Program, which  
          allowed six California general acute care hospitals licensed to  
          provide cardiac catheterization services, that have off-site  
          cardiac surgery backup, and that met the specified rigorous  
          selection criteria, to perform scheduled, elective PCI for low  
          to medium risk patients.  The author argues that expanding  
          access to quality healthcare and addressing health disparities  
          is important to improving patients' quality of life and this  
          bill is prompted by studies showing that elective PCI for low to  
          medium risk patients can be safely and effectively performed in  
          hospitals without cardiac surgery services so long as they meet  
          certain requirements, including that they have in place  
          stringent patient selection criteria and a transfer agreement  
          that ensures transfer to a hospital with cardiac surgery  
          services within 60 minutes or less.  

          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.  The American Heart  
          Association reports that PCI is typically performed by PTCA, or  
          threading a catheter - a slender balloon-tipped tube - from the  








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          artery in the groin to a trouble spot in an artery of the heart.  
           The balloon is then inflated, compressing the plaque and  
          dilating 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.

          Six hospitals participated in the PCI Pilot Program:  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 maintained their  
          eligibility to participate throughout the entire program.

          Since the beginning of the pilot program in California, there  
          have been many studies in the United States on PCI without  
          onsite surgery.  Seven studies of primary PCI showed no  
          difference for in-hospital or 30 day mortality between offsite  
          or onsite surgery.  Additionally there was no difference in the  
          seven studies in the occurrence of emergency coronary artery  
          bypass surgery after primary PCI, between onsite or offsite  
          surgery.  There are eight studies that have examined urgent and  
          elective PCI comparing PCI with onsite surgery and offsite  
          surgery.  There was no difference in mortality or a need for  
          emergency coronary artery bypass surgery between the two sites,  
          in these studies.

          According to the November 19, 2013, final report from the  
          California 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 onsite surgery.  The oversight committee recommends that  
          the pilot program be continued in the six hospitals until  
          California law is changed to allow elective PCI without on-site  
          cardiac surgery under the conditions required by the pilot  
          program.










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           Analysis Prepared by  :    Lara Flynn / HEALTH / (916) 319-2097 

                                                                FN: 0004938