BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 442                                       
          S
          AUTHOR:        Ducheny                                      
          B
          AMENDED:       August 12, 2010                             
          HEARING DATE:  August 19, 2010                              
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          CONSULTANT:                                                 
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          Chan-Sawin/cjt                                              
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                              PURSUANT TO S.R. 29.10
           
                                                                     
                                     SUBJECT
                                         
                         Clinic corporation:  licensing

                                     SUMMARY  

          Streamlines the administrative requirements for a clinic  
          corporation to apply for licensure for an affiliate primary  
          care clinic or a mobile health care unit operated as a  
          primary care clinic (collectively known as affiliate  
          clinics).  

                             CHANGES TO EXISTING LAW  

          Existing law:
          Defines a primary care clinic as an outpatient health  
          facility, operated by a nonprofit corporation, which  
          provides direct medical, surgical, dental, optometric, or  
          podiatric advice, services, or treatment to patients who  
          remain less than 24 hours.  

          Requires that primary care clinics be licensed by the  
          California Department of Public Health (DPH) and approved  
          for operation by DPH prior to obtaining a Medi-Cal provider  
          number or providing services.

          Requires DPH to issue a provisional license, upon approval  
                                                         Continued---



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          of a primary care clinic's initial licensure application,  
          which is good for six months from the date of issuance.   
          DPH is then required to conduct an on-site survey of the  
          clinic within 30 days prior to the expiration of the  
          provisional license and, if the clinic meets all licensure  
          requirements, issue a regular license.

          Permits a primary care clinic that has held a valid and  
          unsuspended license for at least the preceding five years,  
          with no history of repeated or uncorrected violations of  
          law or regulation that pose immediate jeopardy to a patient  
          and has no pending suspensions or revocation actions, to  
          apply to establish an affiliate clinic at an additional  
          site.

          Requires DPH to issue a regular license to an affiliate  
          clinic within 30 days, without first conducting an on-site  
          survey, if:
             1.   The parent primary care clinic has submitted a  
               completed application for licensure for the affiliate  
               clinic;
             2.   The parent and affiliate clinics' corporate  
               officers are the same, and the clinics are owned and  
               operated by the same nonprofit organization; 
             3.   The parent and affiliate clinic's operational  
               policies and procedures, and staff training are  
               substantially the same; and, 
             4.   The parent clinic has submitted evidence to DPH  
               establishing compliance with the minimum construction  
               standards of adequacy and safety of the affiliate's  
               physical plant as prescribed by the Office of  
               Statewide Health Planning and Development.

          Authorizes DPH to conduct a licensing inspection at any  
          time after receipt of the affiliate clinic licensing  
          application;

          Defines a mobile health care unit, commonly referred to as  
          a "mobile clinic," as a commercial coach that is licensed  
          by DPH as an independent freestanding clinic, or approved  
          by DPH as an adjunct of a licensed parent health facility  
          or clinic, and that provides medical, diagnostic, and  
          treatment services in order to ensure the availability of  
          quality health care services for patients in remote or  
          underserved areas, and patients who need specialized types  




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          of medical care.

          Authorizes DPH to issue a special permit to a clinic  
          approved to provide one or more specified specialized  
          services, such as birthing services, for which the state  
          has established separate standards.  

          Authorizes DPH to take various types of enforcement actions  
          against a primary care clinic that has violated state law  
          or regulation, including imposing fines, sanctions, civil  
          or criminal penalties, and suspension or revocation of the  
          clinic's license.
          
          This bill:
          Makes findings and declarations regarding the current  
          system for licensing affiliate clinics and the need to  
          streamline administrative processes through paperwork  
          reduction and elimination of duplication in the application  
          process.

          Clarifies that a clinic corporation can apply to establish  
          affiliate clinics on behalf of a primary care clinic, as  
          specified.  

          Defines "clinic corporation" as a nonprofit organization  
          that operates one or more affiliate clinics, and makes  
          other definitions, as specified.

          Adds, to the conditions already established in existing law  
          under which DPH is required to approve a license for an  
          affiliate clinic without first conducting an initial onsite  
          survey, that the clinic corporation and affiliate clinic  
          have the same medical director or directors and medical  
          policies, procedures, protocols, and standards.

          Requires the affiliate clinic licensure application to  
          consist solely of a simple form and supporting documents  
          containing:  the names, addresses and contact information  
          of the clinic corporation and affiliate clinic's  
          administrative officers; the affiliate clinic location and  
          hours of operation; evidence of compliance with minimum  
          safety standards related to the affiliate clinic's physical  
          plant; and, other pertinent information, as specified. 

          Requires the affiliate clinic application to be signed by  




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          an officer of the clinic corporation's board of directors,  
          or the clinic corporation's chief executive officer or  
          executive director.

          Requires the clinic corporation, in order to reduce  
          paperwork, eliminate errors, and streamline communications  
          between DPH and a clinic corporation that operates one or  
          more affiliate clinics, on behalf of all of the licensed  
          clinics it operates, to act as the administrative  
          headquarters for purposes of receiving from, and submitting  
          to, DPH communications, as specified. 

          Requires DPH to maintain a complete corporate file  
          containing information about each clinic corporation  
          operating one or more affiliate clinics, and for the file  
          to include specified information.

          Prohibits a clinic corporation from being required to  
          resubmit information, materials, or documents, as  
          specified, as part of an affiliate clinic application,  
          unless the information, materials, or documents are  
          necessary to complete the corporate file.

          Requires a clinic corporation to submit to DPH, on behalf  
          of all licensed affiliate clinics operated by the clinic  
          corporation, a single report of change that is applicable  
          to all affiliate clinics operated by the clinic  
          corporation, including a change in a principal officer or  
          general manager of the governing body, the medical  
          director, and the clinic administrator, as required by law.

          Permits a clinic corporation to submit to DPH, on behalf of  
          all licensed affiliate clinics operated by the clinic  
          corporation that are within the same license renewal month,  
          a single payment for all affiliate clinic licensure renewal  
          fees.

          Makes other technical and clarifying changes.

                                  FISCAL IMPACT  

          According to the Assembly Appropriations Committee  
          analysis, minor absorbable workload to DPH to continue  
          oversight of licensing and certification of health clinics.





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                            BACKGROUND AND DISCUSSION  

          According to the author, primary care clinics are at the  
          core of the state's health care safety net and primary care  
          delivery systems.  The author asserts that the current  
          system for licensing and certification of clinics is  
          outdated and inefficient, which causes providers and the  
          state to waste scarce financial and human resources.  

          The author states that most clinic organizations operate  
          multiple clinic sites, ranging in numbers from 2 to 25,  
          under the governance of a single board of directors and  
          medical director, using common business practices,  
          policies, procedures, and medical oversight.  Despite this,  
          under current law, each clinic site must be separately  
          licensed, which requires clinics to often submit the same  
          information on separate licensing applications, even when  
          the information is identical or unchanged.  The author  
          believes that this process is not only administratively  
          burdensome and duplicative, it does not account for the  
          role of the governing clinic organization, and that the  
          delays in the processing of licensing applications often  
          inhibit clinics from providing and/or billing for  
          much-needed services in their communities.  The author  
          states that, to avoid the state licensing process, many  
          clinics are opting to open "intermittent clinics," which  
          operate at or less than 20 hours per week, and do not  
          require state licensure.

          According to the author and sponsors, the parent primary  
          care clinic or clinic corporation is currently required, in  
          its application for affiliate clinic licensure, to submit  
          approximately 210 pages of duplicative information, with  
          original signatures of each corporate officer, board  
          member, and clinic manager for every new clinic  
          application, including:  clinic corporation's  
          organizational chart; copy of the non-profit corporation  
          filing statement from the California Secretary of State;  
          Articles of Incorporation; corporation bylaws; copy of the  
          Internal Revenue Service letter of determination  
          acknowledging tax-exempt nonprofit corporation status; list  
          of all clinics operated by the clinic corporation,  
          including name, address, and contact information;  
          administrative organization; and, an applicant's individual  
          information form which must be completed and signed by each  




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          board member, the corporation's President/CEO, the officers  
          of the corporation, and the clinic manager, often resulting  
          in a minimum of six pages per individual.

          The author and sponsor maintain that the supporting  
          documents that will remain required under the provisions of  
          this bill include, but are not limited to: certificate of  
          occupancy from a local authority; grant deed, bill of sale,  
          or sublease or rental agreement of the clinic location;  
          proof that the clinic meets Title 24 building standard  
          requirements; transfer agreement between the affiliate  
          clinic and a local hospital; fire safety inspection  
          request; and, services to be provided at the clinic.

          Primary care clinic licensure in California
          According to DPH, there are currently 972 primary care  
          clinics currently licensed in California.  In order to  
          obtain a license, a primary care clinic must submit an  
          application and fee to DPH, and pass an initial licensure  
          survey conducted by DPH.  Upon receipt of a completed  
          application for a clinic license, DPH has up to 100 days to  
          either grant or deny the license.  

          Existing law requires DPH to issue a provisional license,  
          good for six months from the date of issuance, to a clinic  
          that has not been previously licensed.  DPH is required to  
          inspect the clinic within 30 days prior to the termination  
          of the provisional license, and, if the clinic meets all  
          licensure requirements, issue a regular license.  Clinics  
          that do not meet the requirements for licensure, but make  
          progress toward meeting the requirements, may have their  
          provisional license renewed by DPH for another six months.

          Already established primary care clinics that wish to  
          establish additional clinic sites, referred to as  
          "affiliate clinics," are granted an expedited licensure  
          process to open additional "affiliate clinics."  Affiliate  
          clinics are eligible for licensure based upon their parent  
          clinic's compliance history.  In order to apply to  
          establish an affiliate clinic, a parent clinic is required  
          to have held a valid, unrevoked, and unsuspended license  
          for the preceding five years.  In addition, the parent  
          clinic must have no demonstrable history of repeated or  
          uncorrected violations that pose immediate jeopardy to  
          patients, as well as no pending action to suspend or revoke  




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          the parent clinic's license.  

          The parent clinic is required to submit a completed  
          application and an application fee, establish that the  
          parent clinic and the affiliate clinic have the same  
          corporate officers and are owned and operated by the same  
          organization with the same board of directors, and provide  
          evidence of compliance with minimum safety standards  
          related to the affiliate clinic's physical plant.  If the  
          parent clinic meets these requirements, DPH is required to  
          issue a license to the affiliate clinic within 30 days.   
          Affiliate clinics are exempt from provisional licensure  
          requirements, and are not required to be surveyed to  
          qualify for licensure.  However, affiliate clinics must  
          still pay license fees.
          
          Arguments in support
          According to Planned Parenthood Affiliates of California  
          (PPAC), one of the co-sponsors of this bill, under current  
          law, each time a clinic corporation applies for a new  
          affiliate clinic license; numerous documents must be  
          submitted to DPH.  PPAC states that many of these documents  
          are duplicates of papers already on file with DPH from the  
          clinic corporation, and this bill simply streamlines the  
          current overlyburdensome process and eliminates the  
          duplicate submissions of information currently required.   
          PPAC further argues that this bill modernizes the current  
          affiliate clinic licensure process so that primary care  
          clinics can more efficiently open their doors and meet the  
          growing needs of individuals and families in their  
          communities.
          
          Prior legislation
          AB 2010 (DeSaulnier), Chapter 90, Statutes of 2008, exempts  
          affiliate clinics from provisional licensure requirements.

          SB 1213 (Ducheny), Chapter 360, Statutes of 2008, requires  
          mobile clinics to notify DPH at least 24 hours prior to  
          providing services at a new site, and waives any notice  
          requirement in the event the mobile clinic is responding to  
          federal, state, or local public health emergencies. 

          SB 937 (Ducheny), Chapter 602, Statutes of 2003, revises  
          provisions relating to the licensure and operation of  
          clinics, and authorizes a primary care clinic that has been  




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          licensed and in good standing for five years to file an  
          application to establish an affiliate clinic at an  
          additional site.

          AB 2404 (Reyes), Chapter 111, Statutes of 2002, prohibits  
          the Department of Health Services (DHS), now DPH, from  
          requiring the licensure of each site where a mobile clinic  
          provided services, and instead requires a mobile clinic to  
          report to DHS at least 15 days prior to its first visit to  
          a new site, and to report to local authorities to obtain  
          necessary approvals

          AB 951 (Florez), Chapter 525, Statutes of 2001, requires  
          DHS (now DPH), to establish a centralized licensing  
          application unit to review applications, and train clinic  
          surveyors in order to process license applications in a  
          more timely, uniform, and cost-effective manner.
          AB 2259 (Woodruff), Chapter 1020, Statutes of 1993,  
          provides for the licensure of mobile clinics to ensure the  
          availability of quality health care services for patients  
          in remote or underserved areas, and imposed various  
          licensure requirements and safety standards on mobile  
          clinics.

          SB 1140 (Royce), Chapter 1456, Statutes of 1987, requires  
          provisional licensure for clinics, and other types of  
          health facilities.

                                     COMMENTS
           
          1.  Bill reflects recent amendments
          When the bill was heard in Senate Health Committee on April  
          22, 2009, it proposed a new single, consolidated license  
          structure and process for clinic corporations and their  
          affiliated clinics.  The amendments taken in the Assembly,  
          as reflected in the current version, instead proposed to  
          streamline the existing affiliate clinic licensing process,  
          to decrease the administrative burdens faced by clinics and  
          clinic corporations when establishing a new affiliate  
          clinic site.  

                                  PRIOR ACTIONS

           Senate Health:                     n/a (prior version)
          Senate Appropriations:n/a (prior version)




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          Senate Floor:       n/a (prior version)
          Assembly Health:         19-0
          Assembly Appropriations: 17-0 
          Assembly Floor:          74-0      

                                    POSITIONS  

          Support:   California Family Health Council, Inc.  
          (cosponsor)
                 California Primary Care Association (cosponsor)
                 Planned Parenthood Affiliates of California  
          (cosponsor)
                 Central Valley Health Network
                 Community Clinic Association of Los Angeles County
                 Family Health Centers of San Diego
                 Family HealthCare Network
                 Mountain Health & Community Services, Inc.
                 Planned Parenthood Advocacy Project, Los Angeles  
          County
                 Planned Parenthood Mar Monte
                 Planned Parenthood of Orange and San Bernardino  
          Counties
                 Planned Parenthood of San Diego & Riverside Counties
                 Planned Parenthood of Santa Barbara, Ventura and San  
          Luis Obispo Counties
          
          Oppose:  None received

                                   -- END --