BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 534
                                                                  Page  1

          Date of Hearing:   August 6, 2013

                   ASSEMBLY COMMITTEE ON AGING AND LONG-TERM CARE
                                Mariko Yamada, Chair
                    SB 534 (Hernandez) - As Amended:  July 3, 2013

           SENATE VOTE  :   34-0
           
          SUBJECT  :   Health and other care facilities.

           SUMMARY  :   

          1)Requires chronic dialysis clinics, surgical clinics, and  
            rehabilitation clinics to comply with federal certification  
            standards in effect immediately preceding January 1, 2013  
            until the Department of Public Health (DPH) adopts regulations  
            relating to the provision of those services.

          2)Requires DPH, by July 1, 2017, to conduct at least one public  
            hearing and submit a report to appropriate legislative  
            committees, describing the extent to which the federal  
            certification standards are sufficient, or not, as a basis for  
            state licensing standards, and make recommendations for any  
            California specific standards which may be necessary.

          3)Requires health facilities categorized as "intermediate care  
            facility/developmentally disabled-nursing" (ICF/DD-N), and  
            "intermediate care facility/developmentally  
            disabled-continuous nursing" (ICF/DD-CN), to comply with  
            specified federal certification standards until the DPH and  
            the Department of Developmental Services (DDS) comply with  
            existing law to jointly develop and implement appropriate  
            licensing regulations.

          4)Repeals these provisions on January 1, 2018.  

           EXISTING LAW  : 

          1)Establishes a range of duties and powers for the DPH,  
            including adopting, and occasionally amending or repealing,  
            reasonable rules and regulations, including those for various  
            types of clinics, necessary to carry out the purposes of law.

          2)Requires those regulations to prescribe standards of adequacy,  
            safety, sanitation, staffing, and standards for providing the  








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            services offered.  

          3)Requires DPH to propose licensing fees for all clinics and  
            facilities within its regulatory jurisdiction at a level that,  
            along with support from federal funds, will not require the  
            Licensing and Certification Division to seek General Funds to  
            support its activities. 

          4)Requires DPH and DDS to jointly develop and implement  
            licensing and Medi-Cal regulations appropriate for ICF/DD-N  
            and ICF/DD-CN facilities to assure residents receive  
            appropriate medical and nursing services, along with  
            developmental program services, in the least restrictive  
            physical and programmatic environment appropriate to resident  
            need. 

          5)Requires DDS to review and approve an applicant facility's  
            program plan as a prerequisite to the licensing and  
            certification process, rather than as a part of the process.

           FISCAL EFFECT  :   The Assembly Appropriations Committee has not  
          yet analyzed this measure.  SB 534 was placed on Senate Second  
          Reading pursuant to Senate Rule 28.8.

           COMMENTS  :   

           AUTHORS STATEMENT  : "This bill would require four health facility  
          categories currently regulated by DPH to comply with  
          facility-specific federal certification requirements to meet  
          state licensing requirements until DPH adopts state regulations.  
           These facilities already meet federal requirements in order to  
          receive Medicare and Medicaid funding; this bill simply gives  
          authority to state regulators to enforce these standards until  
          such time that DPH adopts regulations specific to these  
          facilities."

           FEDERAL, STATE REGULATIONS  :  Technical, operational, and legal  
          details that make laws work on a day-to-day basis, known as  
          regulations, are often required to implement laws.  The federal  
          regulatory standards for chronic dialysis clinics (referred to  
          as "end stage renal centers" in federal regulations), surgical  
          clinics (known as "ambulatory surgical clinics" in federal  
          regulations), and rehabilitation clinics, describe standards  
          which would qualify them to seek reimbursement from the Medicare  
          program or the Medicaid program.  The federal regulations  








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          currently in place which impact the facilities addressed in SB  
          534 are known as Title 42 of the Code of Federal Regulation and  
          pertain to public health, social welfare, and civil rights.   
          They set forth standards to assure quality, cleanliness,  
          adequate medical and/or nursing staff, patient's rights, and  
          privacy.  In addition, regulations for ICF/DD-N and ICF/DD-CN  
          address active treatment services, client behavior and facility  
          practices.

           BACKGROUND  :  According to the DPH, health care facilities in  
          California are licensed, regulated, inspected, and/or certified  
          by a number of public and private agencies at the state and  
          federal levels, including the DPH Licensing and Certification  
          Program (L&C) and the federal Centers for Medicare and Medicaid  
          Services (CMS).  These agencies have separate -- yet sometimes  
          overlapping -- jurisdictions.  L&C is responsible for ensuring  
          health care facilities comply with state laws and regulations.   
          In addition, L&C cooperates with CMS to ensure that facilities  
          accepting Medicare and Medi-Cal meet federal requirements.  L&C  
          also oversees the certification of nurse assistants, home health  
          aides, hemodialysis technicians, and the licensing of nursing  
          home administrators.

          L&C serves as the regulatory authority for about 30 separate  
          types of health care facilities and clinics.  DPH does not  
          currently have state-level enforcement standards in place for  
          licensed ambulatory surgery clinics, chronic dialysis clinics,  
          rehabilitation clinics, or intermediate care facility  
          classifications.  Nonetheless, federal Medicaid and Medicare  
          certification standards exist.  State law does not authorize the  
          use of those standards in lieu of state-specific standards.   
          When compliance with federal standards is lacking, the only  
          existing recourse for DPH is to recommend action by CMS to stop  
          funding, which carries long-term consequences which could be  
          detrimental to access.  SB 534 links state licensing enforcement  
          to federal certification standards and allows the state to  
          enforce the federal standards without resorting immediately to a  
          recommendation to withhold federal funding.  DPH reports that  
          draft regulations for the ICF/DD-N category are expected to be  
          submitted to the Office of Administrative Law by March of 2014.   
          According to DPH, SB 534 will link enforcement to standards  
          which will likely improve care for patients being treated in  
          these settings.  The following are descriptions of the classes  
          of facilities addressed by SB 534:









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           Surgical clinics are entities that operate exclusively for the  
            purpose of providing surgical services to patients not  
            requiring hospitalization and in which the expected duration  
            of services would not exceed 24 hours following an admission.

           Chronic dialysis clinics provide outpatient maintenance  
            dialysis services, or home dialysis training and support  
            services, or both, and may be independent or hospital-based.

           Rehabilitation clinics are nonresidential facilities  
            established for the purpose of providing diagnostic,  
            therapeutic, and restorative services to outpatients for the  
            rehabilitation of injured, disabled, or sick persons, at a  
            single fixed location, generally under the supervision of a  
            physician.

           ICF/DD-N is a 4- to 15-bed facility that provides 24-hour  
            personal care, developmental
            services, and nursing supervision for developmentally disabled  
            persons who have intermittent recurring needs for skilled  
            nursing care but have been certified by a physician and  
            surgeon as not requiring continuous skilled nursing care. 

          The Department has prioritized its regulation packages such that  
          those that have an impact to the health and safety of patients  
          are completed first.  The Department anticipates using the  
          federal standards at licensed dialysis, surgical and  
          rehabilitation clinics, and no state level regulations are under  
          development.  Federal standards are focused on the provision of  
          quality healthcare and patient safety in health care facilities.


           RELATED LEGISLATION  :

          AB 2308 (Plescia) of 2006, would have required the Department of  
          Health Services (now DPH) to convene a workgroup to develop  
          licensure criteria to protect patients receiving care in  
          surgical centers and to submit workgroup conclusions and  
          recommendations to the appropriate policy committees of the  
          Legislature no later than March 1, 2007.  AB 2308 was vetoed by  
          the Governor.

          AB 543 (Plescia) of 2007 would have established licensing  
          requirements for surgical clinics and would have required,  
          effective January 1, 2008, that all surgical clinics meet  








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          specified operating and staffing standards.  AB 543 was vetoed  
          by the Governor.

          AB 2122 (Plescia) of 2008 would have established the California  
          Outpatient Surgery Patient Safety and Improvement Act which  
          would have required surgical clinics to meet prescribed  
          licensing requirements and standards, including compliance with  
          Medicare Conditions of Participation.  AB 2122 was held in the  
          Assembly Appropriations Committee.

          SB 1170 (Alquist ) of 2008 would have required the DPH, the DDS,  
          and the DHCS to promulgate emergency regulations setting forth  
          training standards for intermediate care facility (ICF) and  
          intermediate care facility/developmentally disabled-nursing  
          (ICF/DD-N) staff.  
          SB 1180 was held in Senate Appropriations Committee.

          AB 832 (Jones) of 2009, was also sponsored by DPH and would have  
          required DPH to convene a workgroup, no later than February 1,  
          2010, to consider and develop recommendations for state  
          oversight and monitoring of surgical clinics, to ensure public  
          health and safety.  AB 832 was held in the Assembly  
          Appropriations Committee.

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          California Department of Public Health (CDPH) - Sponsor
           
            Opposition 
           
          None on file.

           Analysis Prepared by  :    Robert MacLaughlin / AGING & L.T.C. /  
          (916) 319-3990