BILL ANALYSIS                                                                                                                                                                                                    Ó




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          |SENATE RULES COMMITTEE            |                        SB 396|
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                                UNFINISHED BUSINESS 


          Bill No:  SB 396
          Author:   Hill (D)
          Amended:  6/29/15  
          Vote:     21  

           SENATE BUS, PROF. & ECON. DEV. COMMITTEE:  9-0, 4/20/15
           AYES:  Hill, Bates, Berryhill, Block, Galgiani, Hernandez,  
            Jackson, Mendoza, Wieckowski

           SENATE HEALTH COMMITTEE:  9-0, 4/29/15
           AYES:  Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,  
            Pan, Roth, Wolk

           SENATE APPROPRIATIONS COMMITTEE:  7-0, 5/28/15
           AYES:  Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen

           SENATE FLOOR:  40-0, 6/1/15
           AYES:  Allen, Anderson, Bates, Beall, Berryhill, Block,  
            Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall,  
            Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson,  
            Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning,  
            Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Runner,  
            Stone, Vidak, Wieckowski, Wolk

           ASSEMBLY FLOOR:  79-0, 8/20/15 (Consent) - See last page for  
            vote

           SUBJECT:   Health care:  outpatient settings and surgical  
                     clinics:  facilities:  licensure and enforcement


          SOURCE:    Author


          DIGEST:  This bill requires a Medicare-certified clinic and an  








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          accredited outpatient setting, as specified, to request a report  
          from the appropriate healthcare regulatory board regarding the  
          filing of a peer review report; requires licensees who perform  
          procedures in outpatient settings to be subject to peer review  
          every two years and that the governing body review the findings  
          of those reports; and, specifies that inspections of accredited  
          outpatient surgical centers may be unannounced with a 60-day  
          warning of the pending inspection.  




          Assembly Amendments: 




          1)Strike requirements that an outpatient setting and a facility  
            certified to participate in the federal Medicare Program as an  
            ambulatory surgical center are required to report specified  
            information and a fee to the Office of Statewide Health  
            Planning and Development.




          2)Strike provisions permitting a physician, podiatrist, or  
            dentist to apply for licensure by the Department of Public  
            Health (DPH) and strike provisions stating that a surgical  
            clinic shall be eligible for licensure by the DPH regardless  
            of physician, podiatrist, or dentist ownership. 




          3)Require that the findings of the peer review be reported to  
            the governing body instead of the accrediting agency.  Require  
            that the peer review process that results in the findings be  
            reviewed by the accrediting agency at the next survey to  
            determine if the outpatient setting meets applicable  
            accreditation standards.









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          4)Permit, rather than require, that visits subsequent to the  
            initial accreditation inspection be unannounced.  Require the  
            accrediting agency to notify the outpatient setting that such  
            inspections will occur within 60 days. 


          ANALYSIS:   


          Existing law:  


          1)Defines an "outpatient setting" to mean any facility, clinic,  
            unlicensed clinic, center, office, or other setting that is  
            not part of a general acute care facility, as specified, and  
            where anesthesia or peripheral nerve blocks, or both, is used  
            when in compliance with the community standard of practice, in  
            doses that, when administered have the probability of placing  
            a patient at risk for loss of the patient's life-preserving  
            protective reflexes; and, specifies that "outpatient setting"  
            also means facilities that include in vitro fertilization.   
            (Health and Safety Code (HSC) § 1248(b).


          2)Defines an "accreditation agency" to mean a public or private  
            organization that is approved to issue certificates of  
            accreditation to outpatient settings by the Medical Board of  
            California (MBC), as specified.  (HSC § 1248(c))
          3)Requires the MBC to adopt standards for accreditation and, in  
            approving accreditation agencies to perform accreditation of  
            outpatient settings, must ensure that the certification  
            program meet specified standards and requirements.  (HSC §  
            1248.15)


          4)Defines "peer review" to mean a process in which a peer review  
            body reviews the basic qualifications, staff privileges,  
            employment, medical outcomes, or professional conduct of  
            licentiates to make recommendations for quality improvement  








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            and education, if necessary, in order to determine whether a  
            licentiate may practice or continue to practice in a health  
            care facility, clinic, or other setting providing medical  
            services, and, if so, to determine the parameters of that  
            practice and assess and improve the quality of care rendered  
            in a health care facility, clinic, or other setting providing  
            medical services.  (Business and Professions Code (BPC) §  
            805(a)(1)(A))


          5)Requires the chief of staff of a medical or professional staff  
            or other chief executive officer, medical director, or  
            administrator of any peer review body and the chief executive  
            officer or administrator of any licensed health care facility  
            or clinic to file an "805 report" with the relevant agency  
            within 15 days after the effective date on which any of the  
            following occurs as a result of an action of a peer review  
            body:  


             a)   A licentiate's application for staff privileges or  
               membership is denied or rejected for a medical disciplinary  
               cause or reason;
             b)   A licentiate's membership, staff privileges, or  
               employment is terminated or revoked for a medical  
               disciplinary cause or reason; or, 


             c)   Restrictions are imposed, or voluntarily accepted, on  
               staff privileges, membership, or employment for a  
               cumulative total of 30 days or more for any 12-month  
               period, for a medical disciplinary cause or reason.  (BPC §  
               805(b))


          6)Requires a health facility, health care service plan, medical  
            care foundation, or medical staff , as specified, request a  
            report prior to granting or renewing staff privileges for any  
            physician and surgeon, psychologist, podiatrist, or dentist,  
            from the MBC, the Board of Psychology, the Osteopathic Medical  
            Board, or the Dental Board of California to determine if any  
            805 report indicating that the applying physician and surgeon,  








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            psychologist, podiatrist, or dentist has been denied staff  
            privileges, been removed from a medical staff, or had his or  
            her staff privileges restricted, as specified.  (BPC §  
            805.5(a))

          This bill:


           1) Requires an ambulatory surgery center (ASC) certified to  
             participate in the federal Medicare program and an accredited  
             outpatient setting, as specified, to request a report from  
             the appropriate regulatory board prior to granting or  
             renewing staff privileges for any physician and surgeon,  
             psychologist, podiatrist, or dentist to determine if any  
             report has been made indicating that the applicant has been  
             denied staff privileges, been removed from a medical staff,  
             or had his or her staff privileges restricted.

           2) Extends by one year, until March 1, 2016, the due date for  
             the report regarding the vertical enforcement and prosecution  
             model required of the MBC, in consultation with the  
             Department of Justice and the Department of Consumer Affairs.

          3)Requires each licensee who performs procedures in an  
            outpatient setting that requires accreditation to be peer  
            reviewed at least every two years.  The peer review shall be a  
            process in which the basic qualifications, staff privileges,  
            employment, medical outcomes, or professional conduct of a  
            licensee is reviewed to make recommendations for quality  
            improvement and education, if necessary, including when the  
            outpatient setting has only one licensee. The peer review  
            shall be performed by licensees who are qualified by education  
            and experience to perform the same types of, or similar,  
            procedures. 


          4)Requires that the findings of the peer review be reported to  
            the governing body.  












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          5)Requires that the accrediting agency review the peer review  
            process at the next survey to determine if the outpatient  
            setting meets applicable accreditation standards.




          6)Permits visits subsequent to the initial accreditation  
            inspection to be unannounced.  Requires the accrediting agency  
            to notify the outpatient setting that such inspections will  
            occur within 60 days. 


           7) Makes technical and minor clarifying changes.   

          Background

          ASC regulation. ASCs are facilities for surgical patients who do  
          not need to be admitted to a hospital and remain on site for  
          less than 24 hours.  As medical care continues to shift from  
          inpatient (hospital) type settings to clinics, many patients are  
          using ASCs or "same-day" surgery centers for a wide variety of  
          procedures.  

          According to a study of ASCs by the California Healthcare  
          Foundation there are at least 750 ASCs in California.  This  
          number is likely larger because there is no centralized source  
          for data on ASCs due to their diffuse regulation.  Generally,  
          ASCs which are non-physician owned are regulated by DPH, and  
          physician-owned ASCs are regulated by the MBC, which, in turn,  
          requires accreditation by one of four approved accrediting  
          agencies.  

          Peer Review.  Peer review is a process in which physicians  
          evaluate colleagues' work to determine compliance with the  
          standard of care.  A negative peer review report triggers the  
          filing of an "805 report" to the appropriate regulatory body. 

          This bill will expand the list of entities which must request an  
          805 report to include a facility certified to participate in the  
          Medicare program as an ASC or an accredited outpatient setting,  
          as specified, to determine if a report has been made indicating  








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          that a licensee has had staff privileges revoked or restricted.   
           

          This bill will also require physicians working in accredited  
          outpatient settings to be subjected to the peer review process  
          every two years, and requires the findings from those reports to  
          be reported to the governing body. 

          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   Yes

          According to the Assembly Appropriations Committee, there are  
          minor and absorbable costs to the MBC (Contingent Fund of the  
          MBC).




          SUPPORT:   (Verified8/24/15)


          California Ambulatory Surgery Association
          Medical Board of California


          OPPOSITION:   (Verified8/24/15)


          None received

          ARGUMENTS IN SUPPORT: The Medical Board of California writes in  
          support, "[This bill] would require peer review evaluations  
          every two years for physicians and surgeons working in  
          ambulatory surgery centers and would allow the accredited  
          outpatient setting facility inspections performed by  
          accreditation agencies to be unannounced (after the initial  
          inspection) and would require at least a 60 day window to be  
          given to facilities for unannounced inspections?The [MBC]  
          believes that for consumer protection, physicians working in  
          [ambulatory surgery centers] should be subject to peer review  
          evaluations, which would be given to the governing body of the  
          outpatient setting and be reviewed by the accreditation agency  








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          at the next inspection of the outpatient setting"  


          ASSEMBLY FLOOR:  79-0, 8/20/15
          AYES:  Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,  
            Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,  
            Chau, Chávez, Chiu, Cooley, Cooper, Dababneh, Dahle, Daly,  
            Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina  
            Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,  
            Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden,  
            Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder,  
            Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina,  
            Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,  
            Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez,  
            Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,  
            Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
          NO VOTE RECORDED:  Chu


          Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
          8/24/15 13:21:59


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