BILL ANALYSIS                                                                                                                                                                                                    �



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          Date of Hearing:   August 13, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                               Susan A. Bonilla, Chair
                   SB 670 (Steinberg) - As Amended:  August 6, 2013

           SENATE VOTE  :   35-3
           
          SUBJECT  :   Physicians and surgeons: drug prescribing privileges:  
          investigation.

           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 controlled substances during a pending investigation  
            if MBC has probable cause to believe that the physician and  
            surgeon has prescribed, furnished, administered, or dispensed  
            controlled substances 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 controlled substances will endanger the public  
            health, safety, or welfare. 

          2)Requires MBC to provide written notice to the affected  
            physician and surgeon by personal service at least five  
            business days prior to the effective date of any limitation  
            being imposed.  

          3)States that the limitation must be discontinued unless, within  
            30 business days, MBC has filed and served a petition for an  
            ISO against the physician and surgeon.

          4)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. 









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          5)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.

          6)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.

          7)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. 

          8)States that the repeated failure by a physician and surgeon  
            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.  

          9)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. 

          10)Makes clarifying and technical amendments. 

           EXISTING LAW  :

         1)Licenses and regulates physicians and surgeons under the Act by  
            the MBC within the Department of Consumer Affairs (DCA) and  
            states that the protection of the public is the highest  
            priority of the MBC in exercising its functions. (Business and  
            Professions Code (BPC) 2000 et seq.) 









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         2)Authorizes investigators and representatives of the MBC, among  
            others, to inquire into any alleged violation of the Act or  
            any other federal or state law, regulation, or rule relevant  
            to the practice of medicine or podiatric medicine, and to  
            inspect documents relevant to those investigations, including  
            the inspection and copying of any document relevant to an  
            investigation where patient consent is given.  (BPC 2225)

          4)Requires a coroner to make a report to the MBC, among other  
            specified entities, when he or she receives information that  
            indicates that a death may be the result of a physician and  
            surgeon's, podiatrist's, or physician assistant's gross  
            negligence or incompetence.  
          (BPC 802.5)

          5)Requires the MBC to take action against any licensee who is  
            charged with unprofessional conduct, which is defined to  
            include, among other things, the repeated failure by a  
            licensee who is the subject of an MBC investigation, in the  
            absence of good cause, to attend and participate in an  
            interview scheduled by the mutual agreement of the licensee  
            and the board.  (BPC 2234)

          6)Under the Administrative Procedure Act, establishes a  
            Medical Quality Hearing Panel within the Office of  
            Administrative Hearings to conduct adjudicative hearings and  
            proceedings relative to licensees of the MBC under the terms  
            and conditions set forth in the APA, except as provided in  
            the Medical Practice Act.  (Government Code (GC) 11371,  
            11373)

          7)Authorizes an ALJ of the Medical Quality Hearing Panel to  
            issue an ISO suspending a license, or imposing drug testing,  
            continuing education, supervision of procedures, or other  
            licensee restrictions.  (GC 11529) 

          8)Requires an accusation to be filed and served upon a  
            physician and surgeon within 15 days of the ISO, otherwise  
            the ISO is dissolved.  (GC 11529(f)) 

          9)Requires MBC to disclose any revocation, suspension,  
            probation, or limitation on practice ordered by MBC,  
            including those made part of a probationary order or  
            stipulated agreement to an inquiring member of the public.   
            (BPC 803.1(a)(3))








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          10)Requires MBC to disclose any revocation, suspension,  
            probation, or limitation on practice ordered by MBC,  
            including those made part of a probationary order or  
            stipulated agreement, on the MBC's Internet Web site.  (BPC  
            2027(a)(9))

          11)Authorizes MBC to voluntarily appear to furnish pertinent  
            information, make recommendations regarding specific  
            conditions of probation, or provide any other assistance  
            necessary to promote the interests of justice and protect  
            the interests of the public in any criminal proceeding  
            against a physician and surgeon if the crime charged is  
            substantially related to the qualifications, functions, or  
            duties of the licensee.  (Penal Code 23)

          12)Authorizes a superior court for the county in which any  
            person has engaged or is about to engage in any act which  
            constitutes a violation of the Act, upon a petition filed by  
            MBC with the approval of the DCA director, issue an  
            injunction or other appropriate order restraining such  
            conduct.  (BPC 125.5) 

           FISCAL EFFECT  :   Unknown

           COMMENTS :   

           1)Purpose of this bill  .  This bill gives MBC additional tools to  
            bring enforcement actions against a physician and surgeon  
            suspected of improper conduct.  SB 670 would allow MBC to  
            limit a physician's prescribing privileges for 30 days if it  
            determines public health, safety, or welfare is at risk, allow  
            MBC to inspect and copy the medical records of a deceased  
            patient if a patient's representative can't be found, and  
            declare that the repeated failure for a physician to attend a  
            physician interview, as part of an investigation, is  
            unprofessional conduct.  This bill is author-sponsored.

           2)Author's statement  .  According to the author's office, "Per  
            existing law, when patients have died as a result of physician  
            wrong-doing, the Medical Board can only access the deceased  
            patient's medical records with authorization from a 'next of  
            kin' or through a subpoena. ... A more direct mechanism for  
            the Board to access patient records is necessary.









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            "[Current law] was written to incentivize physicians to attend  
            physician interviews by making non-compliance unprofessional  
            conduct.  ?However, the law only allows the Medical Board to  
            pursue unprofessional conduct if the physician mutually agrees  
            to the interview and then fails to show up repeatedly.  ?To  
            expedite investigations and potential disciplinary action,  
            this provision needs to be updated to make it unprofessional  
            conduct for a physician's failure, in the absence of good  
            cause, to attend and participate in an interview scheduled  
            within 30 days of notification from the board.  

            "In order for the Medical Board to stop a physician from  
            practicing before disciplinary action is taken, the Board must  
            obtain an ISO.?An ISO is considered extraordinary relief and  
            ?the standard of proof is relatively high?. This process  
            allows patients to remain at significant risk of inappropriate  
            prescribing behavior, even when the Medical Board may have  
            probable cause to believe that the physician and surgeon is  
            abusing his/her prescribing privileges.  It is necessary to  
            provide the Board with better, more expedient, interim tools  
            for protecting patients from physicians who may be engaging in  
            inappropriate prescribing."

           3)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  
            unprofessional conduct.    

           4)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  








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            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. 

           5)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. 

           6)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  
            controlled substances 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 endanger  
            the public health, safety or welfare.  MBC must give the  
            physician five days' notice before the restrictions begin. 

            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 ten years.  Federal law also requires reporting of  
            limitations on a physician's license.        

           7)Interim Suspension Orders (ISO)  .  The ISO process was created  
            in 1990 to allow MBC to immediately halt the practice of very  
            dangerous physicians in egregious cases.  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  








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            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,  
            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.    

            The 2012 Los Angeles Times series, "Dying for Relief," and the  
            2013 Legislative Sunset Review process highlighted the  
            inefficiencies in MBC's enforcement activities.  One troubling  
            aspect was MBC's infrequent use of ISOs to stop physicians  
            from prescribing excessive drugs.    
           
            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  








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            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." 

           8)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 currentISO 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 6  
            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 4 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  
            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.









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            These provisions were originally suggested by the 2013 Sunset  
            Review staff 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.  

           9)Suggested committee amendment  .  Although MBC will likely meet  
            the higher 'clear and convincing' standard in order to sustain  
            a restriction on a physician's prescribing privileges, there  
            exists the possibility that an ISO will not be issued.  This  
            means that the record of the restriction on a physician's  
            license taken under a 'probable cause' standard could remain  
            public for ten years on MBC's Web site.
             
                On page 3, line 28, after "section.," add "These  
               regulations shall include, but not be limited to, removal  
               of any record of the limitations the board imposed pursuant  
               to subdivision (a) from the board's license look up  
               function on the board's internet Web site if the board  
               fails to file and serve an interim suspension order  
               pursuant to subdivision (b)"

           10)Suggested technical amendment  .  The following is to offer an  
            additional notification procedure that is mirrored by the ISO  
            process:

               On page 3, line 16, after "surgeon," add "at least five  
               business days prior to the effective date of any  
               limitations imposed pursuant to this subdivision by either  
               24 hour delivery service or personal service" and delete  
               everything after "surgeon" and lines 17 and 18.  

           11)Arguments in support  .  "The Center for Public Interest Law  
            (CPIL) is pleased to support SB 670 (Steinberg), which will  
            provide needed tools to the Medical Board (Board) of  
            California to protect patients from potentially dangerous  
            physicians, especially those who unlawfully prescribe  
            narcotics.
             
             "Disciplinary matters involving improper prescription of drugs  








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            are unique, warranting unique legislative attention and  
            approaches. Unlike in virtually every other disciplinary  
            matter where the patient either initiates the investigation or  
            actively cooperates, when it comes to prescription drug  
            investigations, the patient is frequently an addict and an  
            active collaborator in the physician unlawful conduct. This  
            lack of cooperation from the patient makes administrative  
            action against the physician in this setting uniquely  
            complicated, expensive, and time-consuming, to the peril of  
            patients, and undermining the Board's authority and its  
            core-mission.

            "SB 670 permits the Board the discretion if need-be  
            temporarily to suspend or limit just the prescribing  
            privileges of a physician without having to temporarily  
            suspend an entire license during if during an investigation  
            the Board has probable cause to believe a violation of law has  
            occurred (probable cause being the legal standard for an  
            arrest or for a grand jury indictment). The bill also  
            clarifies that abuse of prescription drug prescribing  
            privileges may serve as the foundation for a formal Interim  
            Suspension Order.

            "More broadly, the bill fixes loopholes in current laws that  
                                     have allowed determined bad actors to game or delay an  
            investigation, without justification. If a Board is  
            investigating a case where a patient has died allegedly due to  
            unlawful conduct, the measure allows the Board to inspect the  
            medical records of a deceased person without the permission of  
            the next of kin to inquire whether the Medical Practice Act  
            has been violated. The bill also rightly expands the  
            definition of unprofessional conduct to include the failure of  
            a licensee who is under investigation to attend an interview  
            with the Medical Board within 30 days of notification. A  
            failure to attend such a well-noticed, important meeting  
            should not permit a physician to delay an investigation, to  
            his continuing benefit and the possible detriment of patients.  


            "Each of these reforms will save lives. We urge you to support  
            this important piece of legislation."    

           12)Arguments in opposition  .  The California Medical Association  
            writes, "SB 670 gives the MBC the ability to suspend or limit  
            a physician's ability to prescribe controlled substances  








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            without providing the physician an opportunity to challenge  
            the basis for such action, a foundational component of due  
            process. Additionally, the authority to limit the physician's  
            prescribing authority would be based on the low evidentiary  
            standard of probable cause. We believe clear and convincing is  
            the appropriate standard. 

            "Allowing the MBC to take adverse actions on a physician's  
            license without allowing the physician any ability to respond  
            to the charges combined with a low evidentiary standard  
            increases the likelihood that an action taken is subsequently  
            vacated. Yet damage to a physician's ability to practice will  
            already be done."  

           13)Related legislation .  SB 304 (Price) extends the time period  
            between issuing an ISO and filing an accusation from 15 to 30  
            days.  SB 304 is currently in the Assembly Business,  
            Professions, and Consumer Protection Committee.  

            SB 62 (Price and Lieu) requires a coroner to report to MBC  
            when he or she receives information indicating that a death  
            was caused by a Schedule II, III, or IV drug, as specified.   
            SB 62 is currently in the Assembly Appropriations Committee. 

           14)Previous legislation  .  AB 1127 (Brownley) (Chapter 115,  
            Statutes of 2011) declared it unprofessional conduct for a  
            physician and surgeon to repeatedly fail, in the absence of  
            good cause, to attend and participate in an interview  
            scheduled by the mutual agreement of the physician and MBC.   

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Center for Public Interest Law
           
            Opposition 
           
          California Medical Association
          California Academy of Family Physicians

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










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