BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 670
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          SENATE THIRD READING
          SB 670 (Steinberg)
          As Amended  September 6, 2013
          Majority vote

           SENATE VOTE  :35-3  
           
           BUSINESS & PROFESSIONS  8-4     APPROPRIATIONS      11-5        
           
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          |Ayes:|Bonilla, Bocanegra,       |Ayes:|Gatto, Bocanegra,         |
          |     |Campos, Dickinson,        |     |Bradford,                 |
          |     |Gordon, Holden, Mullin,   |     |Ian Calderon, Campos,     |
          |     |Ting                      |     |Eggman, Gomez, Hall,      |
          |     |                          |     |Holden, Quirk, Weber      |
          |     |                          |     |                          |
          |-----+--------------------------+-----+--------------------------|
          |Nays:|Jones, Hagman,            |Nays:|Harkey, Bigelow,          |
          |     |Maienschein, Wilk         |     |Donnelly, Linder, Wagner  |
           ----------------------------------------------------------------- 
           
          SUMMARY  :  Permits the Medical Board of California (MBC) to limit  
          a physician's prescribing privileges for 30 days, permits MBC to  
          inspect and copy a deceased patient's medical records, clarifies  
          language relating to unprofessional conduct, and permits an  
          interim suspension order (ISO) to place restrictions on a  
          physician's prescribing privileges, as specified.  Specifically,  
           this bill  :   

          1)Permits MBC to impose limitations on the authority of a  
            physician and surgeon to prescribe, furnish, administer, or  
            dispense Schedule II, III, or IV drugs during a pending  
            investigation if MBC has probable cause to believe that the  
            physician and surgeon has prescribed, furnished, administered,  
            or dispensed Schedule II, III, or IV drugs in violation of the  
            Medical Practice Act (Act), and that not imposing limitations  
            on the authority of that physician and surgeon to prescribe,  
            furnish, administer, or dispense Schedule II, III, or IV drugs  
            will imminently endanger the public health, safety, or  
            welfare. 

          2)States that proof of imminent danger shall include, but not be  
            limited to, a pattern or practice of prescribing, furnishing,  
            administering, or dispensing Schedule II, III, or IV drugs  
            that has led to, or may lead to, death or great bodily injury.








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          3)Requires MBC to provide written notice to the affected  
            physician and surgeon by either 24-hour delivery service or  
            personal service at least 10 business days prior to the  
            effective date of any limitation being imposed.  

          4)Requires the written notice provided to the physician and  
            surgeon to state the effective date of the limitations, and  
            also include the following:

             a)   Affidavits showing that MBC has met the requirements for  
               issuing the prescribing limitations, including a summary of  
               the facts and evidence upon which MBC is relying;

             b)   An explanation of the time and manner in which the  
               physician and surgeon may respond to the notice of  
               limitations at an informal hearing, as specified; and,

             c)   Notice of the physician and surgeon's right to be  
               represented in an informal hearing, as specified.

          5)States that, upon the request of the physician and surgeon to  
            whom the limitations would apply, a committee of three MBC  
            members, appointed by the MBC executive director and comprised  
            of two physician and surgeons and one public member, shall  
            conduct an informal hearing prior to the effective date of any  
            limitation imposed.  

          6)Requires that the informal hearing determine whether or not  
            MBC has met its burden of proof, as specified.

          7)Authorizes the committee to delay the effective date of the  
            limitations for good cause in order to complete a hearing and  
            issue a decision.

          8)Requires the committee to take into account all materials and  
            testimony submitted by MBC and the physician and surgeon.

          9)Declares that the decision by the committee to sustain,  
            reject, or modify the limitations is final.

          10)Exempts the committee from the provisions of the Bagley-Keene  
            Open Meeting Act.

          11)States that the limitation must be discontinued unless,  








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            within 30 business days, MBC has filed and served a petition  
            for an ISO against the physician and surgeon.

          12)Requires MBC to remove any record of a physician and  
            surgeon's prescribing limitations from the board's Internet  
            Web site immediately after the limitations are dissolved or  
            when a petition for an ISO is served. 

          13)States that limitations imposed pursuant to this bill shall  
            not be deemed a reportable act by a state medical licensing  
            agency or board of medical examiners for purposes of the  
            National Practitioner Data Bank. 

          14)Authorizes MBC to adopt regulations or policies and  
            procedures to effectuate the ability for MBC to impose  
            limitations on a physician and surgeon's ability to prescribe,  
            furnish, administer, or dispense controlled substances. 

          15)Permits MBC to inspect and copy the medical records of a  
            deceased patient, in any investigation that involves the death  
            of that patient, without the authorization of the beneficiary  
            or personal representative of the deceased patient, or a court  
            order solely for the purpose of determining the extent to  
            which the death was the result of the physician and surgeon's  
            conduct in violation of the Act, if MBC provides a written  
            request to the physician and surgeon that includes a  
            declaration that MBC has been unsuccessful in locating or  
            contacting the deceased patient's beneficiary or personal  
            representative after reasonable efforts.


          16)Prohibits MBC from inspecting a deceased patient's medical  
            records without a court order when the beneficiary or personal  
            representative of the deceased patient has been located and  
            contacted, but has refused to consent to MBC inspecting and  
            copying the medical records.

          17)Makes legislative findings and declarations that the  
            authority created in MBC to inspect a deceased's records  
            according to this bill, and a physician and surgeon's  
            compliance with that request, are consistent with the public  
            interest and benefit activities of the federal Health  
            Insurance Portability and Accountability Act. 

          18)States that the repeated failure by a physician and surgeon  








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            who is the subject of an investigation by MBC, in the absence  
            of good cause, to attend and participate in an interview  
            scheduled by MBC is unprofessional conduct.  

          19)Permits an administrative law judge (ALJ) of the Medical  
            Quality Hearing Panel to issue an ISO limiting the authority  
            of a physician and surgeon to prescribe, furnish, administer  
            or dispense controlled substances. 

          20)Makes clarifying and technical amendments. 
               
          21)Declares that the informal hearing created by this bill  
            imposes a limitation on the public's right of access to the  
            meetings of public bodies or the writings of public officials  
            and agencies within the meaning of Section 3 of Article I of  
            the California Constitution.  

          22)Makes findings and declarations that the protection of  
            confidential medical information is of great interest to the  
            state and to the health care system, and that the privacy  
            rights of the patients whose treatment occasioned the hearing  
            would be impaired if the hearing were open to the public. 

           FISCAL EFFECT  :   According to the Assembly Appropriations  
          Committee: 

          1)Costs to MBC to adopt regulations, not likely to exceed  
            $100,000.

          2)MBC may experience some minor costs associated with use of the  
            tools allowed in this bill, as well as some level of increased  
            efficiency in investigation and enforcement; however, it is  
            unlikely to impact the number of cases or total workload  
            significantly.

           COMMENTS  :   

           1)Physician interviews  .  MBC reports that current statutory  
            requirements are too lax and do not encourage physicians to  
            attend mandatory investigatory interviews in a timely fashion.  
             This bill eliminates the "mutual agreement" provision that  
            requires MBC and the physician to jointly determine a meeting  
            time.  This bill states that the repeated failure of a  
            physician under investigation to attend and participate in an  
            interview scheduled by MBC, in the absence of good cause, is  








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            unprofessional conduct.    

           2)Deceased patient records  .  According to MBC, if it is  
            investigating a physician whose patient has died, MBC must  
            receive written authorization from the patient's next of kin  
            in order to obtain the patient's medical records.  However,  
            the next of kin may not be found, and MBC still needs those  
            medical records to determine if a physician is prescribing  
            appropriately.

            This bill would allow MBC to inspect and copy a deceased  
            patient's medical records if MBC provides a written request to  
            the physician and surgeon that includes a declaration that MBC  
            has been unsuccessful in locating or contacting the deceased  
            patient's beneficiary or personal representative after  
            reasonable efforts.  MBC would be prohibited from inspecting  
            and copying those records if the beneficiary or personal  
            representative refuses authorization. 

           3)Current enforcement options  .  MBC has a variety of options  
            available to halt the practice of a physician who it  
            determines is a risk to the public:  MBC may issue an ISO or a  
            temporary restraining order, require certain conditions as  
            part of bail, or agree to a stipulated agreement to restrict  
            or halt practice.  MBC can also require a physician to cease  
            practice if the physician has failed to comply with a term or  
            condition of their probation.

          This bill is intended to supplement current enforcement actions,  
            especially for those cases in which a physician's prescribing  
            behavior is particularly egregious and available remedies are  
            insufficient. 

           4)This bill's prescription restriction provisions  . This bill  
            would permit MBC to impose limitations on the authority of a  
            physician to prescribe, furnish, administer, or dispense  
            Schedule II, III, or IV drugs during a pending investigation  
            if MBC has probable cause to believe that the physician has  
            used his or her prescribing privileges in violation of the  
            Act, and that the failure to impose such restrictions would  
            imminently endanger the public health, safety or welfare.  MBC  
            must give the physician 10 days' notice before the  
            restrictions begin, which shall include information giving the  
            basis for the restrictions. A physician and surgeon has the  
            option of convening an informal hearing of committee of three  








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            MBC members to determine whether the limitations are  
            appropriate based on evidence provided by the MBC and the  
            physician and surgeon. 

            These restrictions would remain in place for 30 days, and  
            would be dissolved unless the physician is served with an ISO.  
             Under current law, this action would be posted on MBC's Web  
            site for 10 years.  However, if the temporary restrictions  
            were not followed by an ISO, this bill requires MBC to delete  
            any references to the restriction on MBC's Web site.  This  
            bill would not require reporting of the temporary prescribing  
            limitations to the National Practitioner Data Bank.  

           5)Interim Suspension Orders (ISO)  .  An ISO is a broad instrument  
            of enforcement that can impose conditions as minor as a drug  
            test or as major as the suspension of a physician's license to  
            practice medicine.  The procedural safeguards in the ISO  
            process are designed to protect against inappropriate use of  
            the most severe discipline.  

            Existing law authorizes an ALJ of the Medical Quality Hearing  
            Panel within the Office of Administrative Law to issue an  
            order to suspend for an interim period (an ISO) a physician's  
            license, impose drug testing, require continuing education or  
            supervision of procedures, or other license restrictions.   
            However, an ISO may only restrict a physician's prescribing  
            abilities if the physician is already under probation and  
            prescribing limits are part of the terms and conditions of  
            that probation. 
             
             To obtain an ISO against a physician, MBC must present  
            affidavits in support of the ISO to the ALJ showing that the  
            physician has, or is about to, violate the Medical Practice  
            Act or that the physician is unable to practice safely due to  
            a mental or physical condition, and that permitting the  
            physician to continue practice will endanger the public  
            health, safety, or welfare.  It is at the ALJ's discretion to  
            issue the ISO as requested by MBC, and ALJs have the authority  
            to deny or alter the requested ISO.  

            Current law requires that a physician be notified 15 days in  
            advance of a pending ISO, so that the physician may  
            participate in a hearing about the validity of the ISO's  
            issuance.  The notice must include affidavits and all the  
            other information provided in support of the order.  However,  








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            an ISO may be granted immediately if MBC can demonstrate that  
            "serious injury to the public" would result otherwise.  After  
            the ISO issuance, MBC has 15 days to file and serve an  
            accusation (which is the document enumerating the formal  
            charges against the physician's license) and 30 days to hold a  
            hearing.  In practical terms, this requires MBC to have its  
            investigation, evidence, and findings nearly complete before  
            petitioning for an ISO.  An ISO effectively imposes  
            restrictions on a physician's practice for 45 days prior to a  
            hearing.    

            According to MBC, it sought 36 ISOs in FY 2011-12 and 28 were  
            granted, out of a population of 126,483 physicians.  In  
            discussing the challenges faced with obtaining an ISO, MBC  
            pointed out that it must meet a very high standard of evidence  
            to obtain an ISO, and filing a formal accusation within 15  
            days of the ISO's issuance is a very tight timeline.  MBC  
            defended its low use of ISOs by stating "An ISO is considered  
            extraordinary relief ? [and] before an ISO can be requested,  
            there are a number of steps that must be taken (gathering  
            medical records, obtaining patient consent, medical consultant  
            review, etc.) in order to prove that a licensee's continued  
            practice presents an immediate danger to public health,  
            safety, or welfare." 

           6)SB 670 and the ISO process  .  This bill creates a more rapid  
            process for MBC to impose limitations on a physician's  
            prescribing ability, compared to the current ISO process.   
            This bill would allow MBC, not an ALJ, to impose limitations  
            using a lower standard of proof (probable cause) than that  
            used in the ISO process (clear and convincing).  
             
             According to MBC, it is anticipated that most, if not all,  
            restrictions issued according to this bill would be followed  
            by an ISO.  To prepare for an ISO requires approximately six  
            months investigation time to gather the evidence necessary to  
            prevail at an ISO hearing (following the accusation).  Should  
            MBC issue an order restricting prescribing privileges  
            according to the terms of this bill, and with the further  
            intention of issuing an ISO, MBC will already have had at  
            least four months of investigation time to develop evidence  
            against the physician.     
           
             By tying this new enforcement tool to the existing ISO  
            process, MBC has to eventually meet the same higher burden of  








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            proof, but this mechanism allows MBC to protect the public for  
            an additional 30 days while it gathers its case against the  
            physician.  If followed by an ISO, this bill would restrict a  
            physician's ability to prescribe for 75 days before a hearing.  
               
             
             This new enforcement tool does not require MBC to  
            automatically remove a physician's prescription power, but  
            rather gives MBC the ability to limit a physician's  
            prescribing authority within a spectrum.  MBC may choose to  
            limit the types of drugs a physician may prescribe, requires  
            certain types of prescriptions be co-signed by another doctor,  
            or limit a physician ability to prescribe to certain patients,  
            among some options.

            These provisions were originally suggested in the 2013 Joint  
            Sunset Review Committee's analysis, which raised the idea of  
            lowering standard for an ISO in cases of restricting a  
            physician's prescribing privileges and lengthening the  
            timeframes for the filing of an accusation.  

            This bill would also permit an ISO to limit a physician's  
            authority to prescribe, furnish, administer, or dispense  
            controlled substances without those limitations being a  
            condition of a physician's probation.  


           Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301 



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