BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       AB 1544                                      
          A
          AUTHOR:        Committee on Health                          
          B
          AMENDED:       As Introduced
          HEARING DATE:  July 15, 2009                                
          1
          CONSULTANT:                                                 
          5
          Hansel/cjt                                                  
          4
                                                                       
                                         4
                                        
                                     SUBJECT
                                         
                          Health facilities: licensure

                                     SUMMARY  

          Permits a hospital in good standing to apply to the  
          Department of Public Health (DPH) to establish an  
          outpatient clinic, without a prior onsite survey by DPH, if  
          certain conditions are met.  Limits the scope of services  
          that an outpatient clinic that is the subject of the  
          application may provide, as specified.  Requires DPH to  
          approve a completed initial application and issue a license  
          within 30 days, if the hospital and the proposed outpatient  
          service meet specified conditions.


                             CHANGES TO EXISTING LAW  

          Existing law:
          Provides for the licensing and regulation of health  
          facilities, including general acute care hospitals, acute  
          psychiatric hospitals, and special hospitals, as well as  
          for clinics, including community clinics and primary care  
          clinics, by DPH.

          Defines in law and regulations a number of special and  
                                                         Continued---



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          supplemental services that a hospital may offer, including  
          several that require a special permit from DPH, including  
          basic emergency medical services, a burn center, a  
          psychiatric unit, a intensive care newborn nursery,  
          cardiovascular surgery services, chronic dialysis, and  
          radiation therapy.

          Defines in regulations a hospital outpatient service as the  
          rendering of non-emergency health care services to patients  
          who remain in the hospital less than 24 hours with  
          appropriate staff, space, equipment and supplies.

          Requires DPH, upon the issuance and renewal of a license  
          for a general acute care hospital, acute psychiatric  
          hospital, or special hospital to separately identify on the  
          license each supplemental service, including the address of  
          where each outpatient service is provided and the type of  
          services provided at each outpatient location.  Requires  
          DPH, on or before July 1, 2010, to make this information  
          available on its website.

          Authorizes a primary care clinic that has held a valid,  
          unrevoked, and unsuspended license for at least the last  
          five years and that meets certain other requirements to  
          apply for, and be issued, a license to establish an  
          affiliate clinic, without the necessity of the department  
          first conducting an initial onsite survey, as specified.

          This bill:
          Permits a hospital in good standing to apply to DPH to  
          establish an outpatient clinic, without a prior onsite  
          survey by DPH, if certain conditions are met.

          Limits the scope of services that an outpatient clinic that  
          is the subject of the application may provide to primary  
          care services to patients who remain in the clinic less  
          than 24 hours.  Further specifies that outpatient services  
          may not include chronic dialysis treatment, outpatient  
          surgeries, or alternative birthing services.  Specifies the  
          information to be included in the DPH application.

          Requires DPH, upon receipt of a completed initial  
          application by an acute care, psychiatric, or special  
          hospital to add a new, or modify an existing, outpatient  
          service as a supplemental service, to within 30 days of  




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          receipt of the initial application, approve the additional  
          or modified outpatient service, add it to the hospital  
          license, and issue a new license, if the applicant meets  
          the following conditions:

           The hospital owns and operates the outpatient service  
            that is the subject of the application;

           The hospital has held a valid, unrevoked, or unsuspended  
            license for a minimum of five years;

           The hospital does not have a demonstrated history of  
            repeated or uncorrected violations of state licensing or  
            federal certification requirements that pose immediate  
            jeopardy to patients; and,

           The hospital does not have any pending actions against it  
            to suspend or revoke its license or terminate Medicare or  
            Medi-Cal certification.

          Requires DPH, if the hospital does not meet the conditions  
          specified above, to provide the hospital, in writing, the  
          basis for that determination.

          Provides that nothing shall prohibit DPH from conducting a  
          licensing application or complaint investigation after  
          receipt of the completed application.
          

                                  FISCAL IMPACT  

          According to the Assembly Appropriations Committee,  
          one-time fee-supported special fund costs of $200,000 to  
          promulgate regulations and establish the processes  
          contained in
          this bill.  Ongoing fee-supported special fund costs of  
          $50,000.  This bill increases hospitals' ability to care  
          for patients in a less costly environment and in a more  
          timely way than under current law.
                            BACKGROUND AND DISCUSSION  

          According to background information submitted by the  
          Assembly Committee on Health, AB 1544 would streamline the  
          approval process for outpatient primary care clinics  
          operated by hospitals, if the hospital maintains an  




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          existing hospital license in good standing.  The committee  
          states that timely access to primary and preventive care is  
          critical to reducing health care costs and improving health  
          care access.  At this point, outpatient clinic services  
          need to be expanded, yet the current system of approving  
          new hospital-based clinics is often lengthy, making it more  
          costly and difficult for hospitals to offer these services.  
           The author notes that legislation passed in 2003 and 2008  
          allows primary care clinics to offer new or ancillary  
          services by means of a streamlined approval process,  
          without having to have an onsite survey and that AB 1544  
          would simply adopt a similar process for hospitals.

          DPH licensing functions
          DPH's Licensing and Certification Division (L&C) is  
          responsible for licensing health care facilities and  
          primary care clinics, including conducting licensing  
          inspections (called "surveys") of new facilities and  
          reviewing license applications.  In addition to the initial  
          onsite survey, DPH L&C conducts periodic follow-up surveys  
          of health facilities to ensure their ongoing compliance  
          with licensing requirements.  

          Affiliate clinic licensing provisions
          In response to complaints from primary care clinics about  
          the amount of time it was taking L&C to review applications  
          and conduct initial surveys of new clinics, the Legislature  
          enacted SB 937 (Ducheny) in 2003.  Among other things, SB  
          937 allows a primary care clinic that has held a valid,  
          unrevoked, and unsuspended license for at least the  
          immediately preceding five years, with no demonstrated  
          history of repeated or uncorrected licensing violations  
          that pose immediate jeopardy to a patient, and that has no  
          pending action to suspend or revoke its license, to file an  
          application to establish
          a primary care clinic at an additional site, referred to as  
          an "affiliate clinic."  The department must approve a  
          license for the affiliate clinic, within 30 days of receipt  
          of a completed application, without the necessity of first  
          conducting an initial onsite survey, if several conditions  
          are met, including that the parent and affiliate clinics'  
          corporate officers are the same, the parent and affiliate  
          clinics are both owned and operated by the same nonprofit  
          organization with the same board of directors, and the  
          parent clinic submits evidence of compliance with minimum  




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          construction standards for clinics.  

          Arguments in support
          The California Hospital Association (CHA) states that  
          hospitals are frustrated at the amount of time it takes for  
          their clinics to be approved by DPH.  A hospital operated  
          clinic in Reedley had to wait seven months to be surveyed,  
          during which time it had to forego 2,800 patient visits.   
          In Modesto, Fairfield, Clear Lake, and Lodi similar delays  
          have been encountered.  CHA states that hospitals are  
          attempting to respond to the health care needs of their  
          communities by opening and expending outpatient primary  
          care clinics, as a means of relieving overcrowded emergency  
          departments and providing access to health care services  
          for uninsured and underinsured patients.  CHA argues that  
          the expedited approval process outlined in the bill would  
          provide hospitals that are seeking to provide these  
          services parity with non-hospital based primary care  
          clinics, and would reduce the amount of time that new and  
          expanded clinics must wait for surveys before they can  
          commence operations.

          Arguments in opposition
          DPH states that under AB 1544, even if it chose to conduct  
          an initial onsite survey within 30 days after an  
          application by a hospital to start or expand a clinic, and  
          found licensing deficiencies, it would be required to  
          approve the special permit, because the bill provides no  
          option to deny the application, which could jeopardize  
          patient safety.  DPH also argues that the bill would give  
          preferential treatment to clinics that are  
          hospital-operated vis-?-vis other primary clinics (except  
          for affiliate clinics), which would be subject to the 100  
          day timeline in existing law for receipt of licenses.  DPH  
          also expresses concern that it is inappropriate to apply  
          the same standards to outpatient settings of hospitals and  
          affiliate clinics of primary care clinics.  While the  
          operational standards for affiliate clinics are the same as  
          those of primary care clinics that seek to establish them,  
          the standards for primary care clinics are fundamentally  
          different from those of hospitals.  Thus, the fact that a  
          hospital is in good standing on its hospital license is not  
          indicative of its ability to operate an outpatient clinic.   
          Finally, DPH states that it would need to promulgate  
          regulations in order to implement the bill. 




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          Prior legislation
          AB 2010 (DeSaulnier), Chapter 90, Statutes of 2008,  
          clarifies that affiliate clinics are exempt from  
          provisional licensing requirements that otherwise apply to  
          clinics that have not previously been licensed.

          AB 937 (Ducheny), Chapter 602, Statutes of 2003, among  
          other provisions, authorizes a primary care clinic that has  
          held a valid, unrevoked, and unsuspended license for at  
          least the last five years, and that meets certain other  
          requirements, to apply for, and be issued, a license to  
          establish an affiliate clinic, without the necessity of the  
          department first conducting an initial onsite survey, in  
          accordance with criteria set forth by the bill.

          AB 951 (Florez), Chapter 525, Statutes of 2001, creates the  
          Centralized Application
          Unit in the Licensing and Certification Division within  
          DPH.  Requires all applications for clinic licenses to be  
          reviewed for completeness by the Unit within two weeks and  
          requires completed applications to be scheduled for surveys  
          within 30 days of receipt.  Requires DPH to routinely  
          review the Unit and its regional offices to determine if  
          applications for clinic licenses are processed in a timely  
          and effective manner.

                                  PRIOR ACTIONS

           Assembly Floor:     79-0
          Assembly Appropriations:17-0
          Assembly Health:    18-0
                                         

                                    COMMENTS
           
          1.  Suggested amendments to reflect author's intent.
             Staff suggest a number of amendments to ensure the bill  
            reflects the author's intent.  These would include  
            amendments to clarify that the scope of services that can  
            be offered in a hospital outpatient clinic is limited to  
            primary care services, that outpatient clinics meet all  
            applicable operating standards that otherwise apply to  
            outpatient services offered by hospitals, and that DPH  
            would not be precluded from conducting an on-site survey  




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            prior to approving an application, and could deny an  
            application if it found licensing deficiencies.
          
            Suggested amendments:
            
            a.  On page 3, lines 18 - 29, amend as follows:
            
            (b) Within 30 days after receipt of a completed  
          application by a
            licensed general acute care hospital, acute psychiatric  
          hospital, or
            a special hospital that meets the requirements of  
          subdivision (c) to
            add or modify an outpatient service as a supplemental  
          service, the
            department shall approve the additional or modified  
          outpatient
            service, add it to the hospital license, and issue a new  
          license,
            unless the applicant does not meet the requirements of  
          this section.
            Notwithstanding any other law, the issuance of a new  
          license pursuant
            to this section shall not require an initial onsite  
          survey. If the
            department determines that the applicant does not meet  
          the
            requirements of this section, the department shall  
          provide the
            hospital, in writing, the particular basis for this  
          determination.  Nothing
            shall preclude the department from conducting an on-site  
          inspection
            prior to issuing a license pursuant to this section, and  
          from denying
            an application if it finds licensing deficiencies as a  
          result of that
            inspection.
            
            b.  On page 4, lines 18 - 27, amend as follows:
            
            (e) The outpatient service that is the subject of the  
          application
            shall  provide  be limited to providing primary health care  
          service to




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            patients who remain in the outpatient clinic for less  
          than 24 hours.
               (f) The outpatient service that is the subject of the  
          application
            shall not provide chronic dialysis treatment or  
          alternative birthing
            services or perform outpatient surgeries that are  
          provided by a
            surgical clinic, or any other service not identified in  
          subdivision (e).
               (g) Nothing in this section shall prohibit the  
          department from
            conducting a licensing inspection or complaint  
          investigation after
            receipt of the completed application.
               (h)  The outpatient service that is the subject of the  
          application shall
            comply with all applicable standards that apply to  
          outpatient services, 
            including all requirements that apply to the hospital,  
          including, but 
            not limited to requirements applicable to life safety,  
          building standards,
            infection control, medical records, personnel policies,  
          governance,
            and patient rights.


            

                                    POSITIONS  
                                        
          Support:  Adventist Health
                 Catholic Healthcare West
                 California Hospital Association
                 Chapman Medical Center
                 Chino Valley Medical Center
                 Colusa Regional Medical Center
                 Desert Valley Hospital
                 Hospital Association of San Diego and Imperial  
          Counties
                 Montclair Hospital Medical Center
                 Pacific Hospital of Long Beach
                 Palomar Pomerado Health
                 Private Essential Access Community Hospitals




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                 San Antonio Community Hospital
                 San Dimas Community Hospital
                 Scripps Mercy Hospital
                 Shasta Regional Hospital
                 Sierra Kings District Hospital
                 Victor Community Hospital


          Oppose:  California Department of Public Health






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