BILL ANALYSIS Ó SB 906 Page 1 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. SB 906 Page 2 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 SB 906 Page 3 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. SB 906 Page 4 Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097 FN: 0004938