BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 534
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          Date of Hearing:  September 10, 2013

                            ASSEMBLY COMMITTEE ON HEALTH
                                 Richard Pan, Chair
                SB 534 (Ed Hernandez) - As Amended:  September 4, 2013

           SENATE VOTE  :  Not relevant.
           
          SUBJECT  :  Health and care facilities.

           SUMMARY  :  Requires, until the California Departments of Public  
          Health (DPH) and Developmental Services (DDS) adopt regulations  
          for licensure for Intermediate Care Facilities for the  
          Developmentally Disabled - Nursing (ICF/DD-N), these facilities  
          comply with applicable federal certification standards.   
          Requires chronic dialysis clinics, surgical clinics, and  
          rehabilitation clinics to comply with federal certification  
          standards until DPH has adopted regulations for those  
          facilities.  Creates a specific exemption to current law, which  
          requires congregate living health facilities (CLHFs) to be  
          freestanding, that allows for multiple CLHFs to exist in one  
          multifloor building if certain requirements are met.   
          Specifically,  this bill  :  

          1)Requires, until DPH adopts regulations relating to the  
            provision of services by a chronic dialysis clinic, a surgical  
            clinic, or rehabilitation clinic, the following facilities  
            licensed or seeking licensure to comply with the following  
            federal certification standards in effect immediately  
            preceding January 1, 2013:

             a)   Requires a chronic dialysis clinic to comply with  
               applicable federal certification standards for an end stage  
               renal disease clinic;

             b)   Requires a surgical clinic to comply with applicable  
               federal certification standards for an ambulatory surgical  
               clinic (ASC); and,

             c)   Requires a rehabilitation clinic to comply with  
               applicable federal certification standards for a  
               comprehensive outpatient rehabilitation facility.

          1)Requires until the DPH and DDS adopt regulations pursuant to  
            existing law, relating to services by ICF/DD-N, licensed  








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            facilities to comply with applicable federal certification  
            standards in effect immediately preceding January 1, 2013.

          2)Creates a specific exemption to current law, which requires  
            CLHFs to be freestanding, that allows for multiple CLHFs to  
            exist in one multifloor building if all of the following  
            requirements are met:

             a)   Each facility meets other applicable building standards  
               not related to multiple floors;

             b)   Each facility is separated by a wall, floor, or other  
               permanent partition but may share an elevator, stairs, or  
               stairwell, and need not be freestanding;

             c)   The proposal to develop proximate CLHFs is supported by  
               the county health department and the board of supervisors  
               in the county in which the facilities are proposed for one  
               of the following locations:
               i)     McClellan Air Force Base Building No. 522, located  
                 at 3201 James Way, McClellan, California;

               ii)    McClellan Air Force Base Building No. 523, located  
                 at 3207 James Way, McClellan, California;

               iii)   McClellan Air Force Base Building No. 524, located  
                 at 5621 Dudley Blvd, McClellan California; and,

               iv)    McClellan Air Force Base Building No. 525, located  
                 at 5327 Dudley Blvd, McClellan, California.

          4)Adds finding and declarations that this is a special law and  
            is necessary and a general law cannot be made applicable  
            within the meaning of the California Constitution because of  
            the unique circumstances relating to the need for CLHFs in and  
            around Sacramento County.

           EXISTING LAW  :

          1)Establishes licensure for specified clinics by DPH, including  
            primary care clinics as well as specialty clinics which  
            include:  surgical clinics, chronic dialysis clinics, and  
            rehabilitation clinics.

          2)Requires DPH to adopt reasonable rules and regulations as may  








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            be necessary to enable DPH to carry out the purposes of  
            provisions of law governing the various types of clinics  
            licensed by DPH.

          3)Requires those regulations to prescribe the kinds of services  
            which may be provided by clinics in each category of licensure  
            and the minimum standards of adequacy, safety, and sanitation  
            of the physical plant and equipment, minimum standards for  
            staffing with duly qualified personnel, and minimum standards  
            for providing the services offered.  Requires these minimum  
            standards to be based on the type of facility, the needs of  
            the patients served, and the types and levels of services  
            provided.

          4)Licenses and regulates various types of facilities by DPH,  
            including ICF/DD-N, which is defined as a facility with a  
            capacity of four to 15 beds that provides 24-hour personal  
            care, developmental services, and nursing supervision for  
            persons with developmental disabilities who have intermittent  
            recurring needs for skilled nursing care but have been  
            certified by a physician as not requiring continuous skilled  
            nursing care.

          5)Requires DPH and DDS to jointly develop and implement  
            licensing regulations appropriate for ICF/DD-N and ICF/DD-CN  
            facilities.  Requires, among other things, that the  
            regulations ensure that residents of an ICF/DD-N and ICF/DD-CN  
            receive appropriate medical and nursing services and  
            developmental program services in a normalized, least  
            restrictive physical and programmatic environment appropriate  
            to individual resident need.

          6)Defines a CLHF as a residential home with a capacity of no  
            more than 12 beds that provides inpatient care, including the  
            following basic services:  medical supervision, 24-hour  
            skilled nursing and supportive care, pharmacy, dietary,  
            social, and recreational.
          7)Requires CLHFs to provide one of the following services:

             a)   Services for mentally alert, physically disabled persons  
               who may be ventilator dependent; 

             b)   Services for persons who have a diagnosis of terminal  
               illness, a diagnosis of a life-threatening illness, or  
               both; or,








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             c)   Services for persons who are catastrophically and  
               severely disabled.

          8)Requires a CLHF license to specify which of the types of  
            persons described in 7) above to whom a facility is licensed  
            to provide services.

          9)Requires a CLHF to have a non-institutional, homelike  
            environment.

          10)Prohibits, pursuant to state regulations, a license from  
            being issued to any skilled nursing facility which does not  
            conform to the State Fire Marshal's requirements on fire and  
            life safety, state requirements on environmental impact, and  
            to local fire safety, zoning, and building ordinances.

           FISCAL EFFECT  :  As amended, this bill has not been analyzed by a  
          fiscal committee.  
          
           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  According to the author, 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 are already required to meet federal requirements  
            in order to receive Medicare and Medicaid funding; this bill  
            gives authority to state regulators to enforce these standards  
            until such time that DPH adopts regulations specific to these  
            facilities.  
             
             According to the author, McClellan Business Park wishes to  
            establish CLHFs within the former McClellan Air Force Base in  
            North Highlands in Sacramento County.  The health care  
            facilities would be housed initially in two three-story  
            buildings that were formerly used to house military personnel.  
             There are two more buildings in close proximity that could be  
            used for CLHFs at a later date.  Each floor would be  
            separately licensed, there would be no co-mingling of patients  
            between floors, and all facilities would provide a home-like  
            environment for residents.  However, current law requires  
            CLHFs to be "freestanding."  









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            According to the author McClellan Business Park believes that  
            it can comply with all CLHF requirements except for the  
            requirement to be "freestanding" as interpreted by DPH and  
            this legislation is needed to grant such authority in this  
            very limited situation. This bill only grants the authority  
            for the four specific buildings described by their addresses.   
             

           2)BACKGROUND  .  According to DPH, as of April 2, 2013, there are  
            173 designated health care facilities that have been issued a  
            state license.  This includes 98 chronic dialysis clinics, 57  
            ICF/DD-N's, 16 surgical clinics, and two rehabilitation  
            clinics.  Among these four facility types, 166 facilities  
            (96%) had an active license while the rest, seven (4%) did  
            not.  To date, DPH has not adopted state regulations for these  
            facilities, but relies on the federal certification standards  
            to determine licensure.
          DPH is currently in the process of drafting regulations for the  
            ICF/DD facilities, however, the Committee staff is not aware  
            of any regulations in process for the surgical clinics,  
            chronic dialysis clinics, and rehabilitation clinics.
           
             With regard to CLHFs, California Health and Safety Code  
            (Section 1267.15) states that CLHFs shall be freestanding, but  
            this does not preclude their location on the premises of a  
            hospital.  Congregate living health facilities shall be  
            separately licensed.  

            According to DPH, because neither code nor regulation defines  
            "freestanding" DPH defers to the common dictionary definition  
            of freestanding which is "standing alone, on its own  
            foundation, free of support or attachment."

           3)FEDERAL REGULATORY STANDARDS  .  The federal regulatory  
            standards for chronic dialysis clinics (referred to as End  
            Stage Renal Centers in federal regulations), surgical clinics  
            (referred to as ASC in federal regulations), and  
            rehabilitation clinics, among other things, set forth the  
            various standards required at each facility in order to  
            qualify for Medicare and Medicaid participation by the Centers  
            for Medicare and Medicaid Services (CMS).  Depending on the  
            facility in question, the regulations set requirements for the  
            facilities management and governing body, what services may be  
            offered and safety and cleanliness standards.  Standards also  
            include, but are not limited to, requirements covering patient  








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            rights, the administration of anesthesia, if applicable,  
            medical records, privacy, and infection control.  The federal  
            regulatory standards for ASCs also include as part of their  
            requirements for coverage with CMS that the ASC must comply  
            with state licensure requirements.   
           
           4)SUPPORT  .   DPH, in support of the prior version of this bill,  
            states that this bill will enable it to adopt existing federal  
            regulatory standards as the state licensing standards for  
            chronic dialysis clinics, rehabilitation clinics, surgical  
            clinics, and ICF/DD-Ns.  DPH states that it functions as the  
            regulatory agency for approximately 30 different types of  
            health care facilities and clinics.  DPH states that it does  
            not have state licensing standards in place for chronic  
            dialysis clinics, rehabilitation clinics, surgical clinics,  
            and ICF/DD-Ns.  Federal standards for these facilities exist,  
            but DPH lacks the statutory authority to enforce the  
            standards.  In the absence of such authority, DPH states that  
            it may only recommend action by CMS to stop Medicare and  
            Medicaid program funding if the health care facility is out of  
            compliance.  
             
             McClellan Business Park supports the recent amendment which  
            would help to establish CLHFs within the former McClellan Air  
            Force Base in North Highlands (Sacramento County), stating,  
            current law requires CLHFs to be "freestanding" but does not  
            define whether this means having separate foundations or, as  
            is used more commonly, independently standing relative to a  
            hospital.  By defining the term "freestanding" for McClellan  
            Business Park only, this bill will help DPH to determine  
            whether this project should go forward based on its merits.

            The Sacramento County Public Health Officer, Olivia Kasirye,  
            MD, MS, writes in support of this bill that with the  
            implementation of the Patient Protection and Affordable Care  
            Act and changes to requirements for hospitals to take measures  
            to prevent readmission of patients, the CLHFs will provide  
            much needed services for those patients that still require  
            skilled nursing care, while at the same time help free up  
            hospital beds and prevent readmissions.  
            Phil Serna, District 1 Supervisor for Sacramento County, which  
            includes McClellan Business Park, also supports this bill,  
            stating, it has been demonstrated that injuries sustained by  
            service men and women in the Iraq and Afghanistan conflicts  
            coupled with California's aging demographics, and advances in  








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            medical care, have all increased the demand for CLHFs.  

           5)RELATED LEGISLATION  .  AB 1312 (Brown) of 2013 authorizes DPH  
            to, without taking regulatory action, update references in  
            regulations to health care standards of practice adopted by a  
            recognized state or national association.  AB 1312 was held in  
            Assembly Health Committee.

           6)PREVIOUS LEGISLATION  .  

             a)   The California Ambulatory Surgery Association has  
               sponsored several bills intended to establish  
               state-specific licensure criteria for ASCs:

               i)     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 ASCs 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.

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

               iii)   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.

             b)   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 ASCs,  
               to ensure public health and safety.  AB 832 was held in the  
               Assembly Appropriations Committee.

             c)   SB 135 (Ed Hernandez), Chapter 673, Statutes of 2012,  
               establishes a new health facility licensing category of  








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               hospice facility, and permits a licensed and certified  
               hospice services provider to provide inpatient hospice  
               services through the operation of a hospice facility,  
               either as a free-standing health facility, or adjacent to,  
               physically connected to, or on the building grounds of  
               another health facility or a residential care facility

             d)   SB 177 (Strickland), Chapter 331, Statutes of 2011,  
               raises the bed limit for congregate living health  
               facilities that serve terminally ill patients in counties  
               that have populations of more than 400,000 but less than  
               500,000 persons.

             e)   SB 666 (Aanestad), Chapter 443, Statutes of 2005,  
               increases the capacity of a CLHF from no more than six beds  
               to no more than 12 beds.  Maintains an exception to allow  
               CLHFs which serve terminally ill patients and which are  
               located in counties with 500,000 or more persons to have 25  
               beds.

             f)   AB 3535 (Wright), Chapter 1459, Statutes of 1986,  
               creates the CLHF licensure category, and defines a CLHF as  
               a residential home with a capacity of no more than six  
               beds, which provides inpatient care to mentally alert,  
               physically disabled residents, who may be ventilator  
               dependent.

           REGISTERED SUPPORT / OPPOSITION :

           Support 
           
          Olivia Kasirye, MD, MS, Sacramento County Public Health Officer
          Phil Serna, District 1, Sacramento County Supervisor
          California Department of Public Health (prior version)
          McClellan Business Park
          Sacramento County Board of Supervisors

           Opposition 
           
          None on file.


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










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