BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                   SJR 13|
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                                 THIRD READING


          Bill No:  SJR 13
          Author:   Oropeza (D)
          Amended:  As introduced
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  11-0, 7/8/09
          AYES:  Alquist, Strickland, Aanestad, Cedillo, Cox,  
            DeSaulnier, Leno, Maldonado, Negrete McLeod, Pavley, Wolk


           SUBJECT  :    New dialysis clinic licensure and certification

           SOURCE  :     California Dialysis Council


           DIGEST  :    This resolution urges the federal Centers for  
          Medicare and Medicaid Services to adopt regulations, and  
          the Congress and President to enact legislation, to improve  
          and speed up the process for timely licensure and  
          certification surveys of new dialysis clinics to provide  
          patients with access to these services as soon as possible,  
          and to eliminate the chilling impact on new clinic  
          construction in California.

           ANALYSIS  :    Existing federal law establishes conditions  
          for participation that health care providers, including  
          specialty clinics, must meet to participate in the Medicare  
          and Medicaid programs.

          Existing state law (1) provides for the regulation and  
          oversight by the Department of Public Health (DPH) of  
          primary care clinics and specialty clinics, and (2)  
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          includes as a type of specialty clinic a "chronic dialysis  
          clinic," which is a clinic that provides less than 24-hour  
          care for the treatment of patients with end-stage renal  
          disease, including renal dialysis services.


          This resolution:

          1. Urges the federal Centers for Medicare and Medicaid  
             Services (CMS) to adopt regulations, and the Congress  
             and President to enact legislation, to improve and speed  
             up the process for timely licensure and certification  
             surveys of new dialysis clinics to provide patients with  
             access to these services as soon as possible, and to  
             eliminate the chilling impact on new clinic construction  
             in California.

          2. Cites several factors demonstrating a need for more  
             timely licensure and certification of new dialysis  
             clinics, including:  

             A.    The need to expand the number of dialysis  
                clinics in California to keep pace with the growing  
                population of dialysis patients, driven by the  
                growth in hypertension and diabetes, which are the  
                two primary diagnoses leading to chronic kidney  
                disease and kidney failure.

             B.    A new dialysis clinic must have a state  
                licensure survey and a separate CMS certification  
                survey before the clinic may be reimbursed for  
                treating Medicare patients, and new dialysis  
                clinics must wait months, and more than a year in  
                some instances, for state surveyors to perform the  
                licensure and certification surveys.

             C.    The current state of the licensure and  
                certification process reduces the incentive for  
                dialysis providers to consider California locations  
                for new dialysis clinics and increases the  
                potential for future access problems for California  
                patients.

             D.    In areas where all dialysis clinics are at  







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                maximum capacity, some Medicaid and Medicare  
                patients must be kept in acute care hospitals, at  
                much greater cost, while they wait for availability  
                at a dialysis clinic so that they may transfer to a  
                long-term care facility and obtain outpatient  
                dialysis care at the clinic.

             E.    CMS requires state surveyors in the Licensing  
                and Certification Division of the DPH to perform  
                surveys pursuant to a four tier survey process, in  
                which new dialysis clinic surveys are placed in  
                Tier III.

             F.    CMS requires the department to complete all  
                functions categorized as Tier I or Tier II prior to  
                completing functions in Tier III, but provides  
                insufficient funding for the completion of the Tier  
                I and Tier II functions. 

          3. States that CMS should either separate new dialysis  
             clinic surveys from other functions in the four tier  
             process, move new dialysis clinic surveys into Tier I or  
             Tier II, or provide adequate funding to ensure the  
             completion of Tier I, II, and III functions on a timely  
             basis.

          4. States that the new CMS requirement for a "justification  
             letter" for new dialysis clinics further slows the  
             process and should be eliminated and CMS should permit  
             the department surveyors to better utilize their  
             resources by allowing state licensure surveys to be  
             completed simultaneously with CMS certification surveys.

           Background
           
          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 U.S. Department of Health and Human  
          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  







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          ensure that facilities accepting Medicare and Medi-Cal  
          (California's version of the federal Medicaid program)  
          payments meet federal requirements.

          According to the DPH L&C Division, a facility that has  
          submitted a licensing application is first subject to a  
          licensing survey, which focuses on building standards,  
          policies and procedures, the credentialing of staff, and  
          equipment and supplies.  A facility that wishes to receive  
          Medicare and Medicaid payments must submit a separate  
          application to CMS.  Once that application is approved, L&C  
          conducts a federal certification survey.  This survey is  
          designed to ensure that the facility can provide services  
          in accordance with federal regulations.  The only way a  
          facility can demonstrate this is to begin admitting  
          patients/residents and providing services prior to billing  
          the federal programs.  

          According to DPH, it is unable to estimate the length of  
          time it takes to conduct the initial licensing and  
          certification surveys, but believes it has improved the  
          timeliness of the surveys.  The timelines for the surveys  
          further varies among its field offices, depending on their  
          workload.  DPH L&C does not receive federal funding for its  
          licensing survey work, which is funded through license  
          facility fees, but does receive federal funding for the  
          certification surveys.  While CMS contends that the state  
          is receiving sufficient funding to conduct Tier 1 through 3  
          survey work, funding for Tier 4 facilities, including for  
          initial certification surveys, is generally acknowledged to  
          be inadequate.  According to DPH, while additional federal  
          funding for surveyor positions would help reduce backlogs,  
          it would also need authorization through the budget for  
          additional surveyor positions in order to make use of the  
          new funds.

          According to DPH, given the fact that a facility cannot  
          operate without first having a license and that the federal  
          certification survey evaluates how a facility is actually  
          delivering care to patients in accordance with federal  
          regulations, concurrent licensing and certification surveys  
          cannot currently be done simultaneously.

           FISCAL EFFECT  :    Fiscal Com.:  No







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           SUPPORT  :   (Verified  7/13/09)

          California Dialysis Council (source)

           ARGUMENTS IN SUPPORT  :    The California Dialysis Council,  
          the sponsor of this resolution, states that given that the  
          population of dialysis patients in California continues to  
          grow, driven by the surge in diabetes and hypertension, and  
          given the delays in opening new facilities due to the  
          separate licensing and certification surveys that must be  
          conducted, it is essential that CMS and the Congress  
          address this problem, as requested by the resolution.


          CTW:do  7/13/09   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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