BILL ANALYSIS                                                                                                                                                                                                    Ó







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        |Hearing Date:April 15, 2013        |Bill No: SB                        |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                        Bill No:        SB 670Author:Steinberg
                         As Amended:April 8, 2013 Fiscal: Yes

        
        SUBJECT:  Physicians and surgeons: drug prescribing privileges:  
        investigation.
        
        SUMMARY:  Authorizes the Medical Board of California to inspect  
        medical records of a patient who died of a prescription drug overdose  
        without the consent of the patient's next of kin or a court order, as  
        specified; makes it unprofessional conduct for a licensee who is under  
        investigation to fail to attend and participate in an interview within  
        30 days from notification, as specified; authorizes an administrative  
        law judge to issue an interim suspension order limiting the authority  
        of a physician to prescribe, furnish, administer, or dispense  
        controlled substances; requires the Medical Board of California to  
        impose limitations on the authority of a physician and surgeon to  
        prescribe, furnish, administer, or dispense controlled substances  
        during a pending investigation if there is a reasonable suspicion that  
        the physician and surgeon has engaged in overprescribing drugs, or  
        other drug prescribing behavior that has resulted in the death of a  
        patient.

        Existing law:
        
       1)Licenses and regulates physicians and surgeons under the Medical  
          Practice Act (Act) by the Medical Board of California (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.) 

       2)Authorizes investigators and representatives of the MBC, among  
          others, to inquire into any alleged violation of the Act or any  





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          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)

       3)Provides for the professional review of specified healing arts  
          licentiates by a peer review body, as defined, including:  (BPC §  
          805)

           a)   A medical or professional staff of any health care facility  
             or a licensed clinic, or a facility certified to participate in  
             the federal Medicare Program as an ambulatory surgical center.

           b)   A health care service plan or a disability insurer, as  
             specified.

           c)   Any medical, psychological, marriage and family therapy,  
             social work, dental, or podiatric professional society, as  
             specified.

           d)   A committee organized by any entity that functions for the  
             purpose of reviewing the quality of professional care provided  
             by members or employees of that entity.
            
        4)Defines a licentiate, for purposes of item # 3) above, as a  
          physician and surgeon, doctor of podiatric medicine, clinical  
          psychologist, marriage and family therapist, clinical social  
          worker, or dentist.  (BPC § 805)

        5)Requires an  805 report  to be filed by the chief of staff, chief  
          executive officer, medical director, or administrator of any peer  
          review body and the chief executive officer or administrator of a  
          health facility or clinic, as defined, with the MBC, among other  
          agencies having regulatory jurisdiction over a licensee within 15  
          days after the effective date of any specified action taken against  
          a licensee for a medical disciplinary cause or reason.  
        (BPC § 805)

        6)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)






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        7)Requires the MBC to take action against any licensee who is charged  
          with unprofessional conduct.  Unprofessional conduct 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)

        8)Under the Administrative Procedure Act (APA), establishes within  
          the Office of Administrative Hearings (OAH) a Medical Quality  
          Hearing Panel 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)

        9)Authorizes an administrative law judge of the Medical Quality  
          Hearing Panel to issue an interim suspension order (ISO) suspending  
          a license, or imposing drug testing, continuing education,  
          supervision of procedures, or other licensee restrictions.  (GC §  
          11529) 

        10)Requires that the burden and standards of proof to obtain an ISO  
          shall be those applicable to a preliminary injunction under Section  
          527 of the Code of Civil Procedure.  (GC § 11529 (e))

        This bill:
        
       1)Authorizes the MBC, when it receives an 805 Report, or a Coroner's  
          Report as described above, that involves the death of a patient from  
          a prescription drug overdose, to inspect and copy the medical  
          records of the deceased patient without the consent of the patient's  
          next of 


       kin or a court order in order to determine the extent to which the  
          death was the result of a prescriber's inappropriate conduct.

       2)Revises the definition of unprofessional conduct under the Act to  
          include the 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 within 30 days of notification  
          from the MBC.

       3)Authorizes an administrative law judge to issue an ISO limiting the  
          authority of a physician to prescribe, furnish, administer, or  
          dispense controlled substances. 






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       4)Requires the MBC, notwithstanding the authority of an administrative  
          law judge, to impose limitations on the authority of a physician and  
          surgeon to prescribe, furnish, administer, or dispense controlled  
          substances during a pending investigation if there is a reasonable  
          suspicion that the physician and surgeon has engaged in either of  
          the following:

           a)   Overprescribing drugs.

           b)   Other behavior related to his or her drug prescribing  
             privileges that has resulted in the death of a patient.

        FISCAL EFFECT:  Unknown.  This bill has been keyed "fiscal" by  
        Legislative Counsel.

        COMMENTS:
        
       1.Purpose.  This bill is sponsored by the Author, President Pro Tem  
          Darrell Steinberg, who was prompted to pursue the legislation  
          following the recent Los Angeles Times investigation that uncovered  
          significant issues with physicians, overprescribing and patient  
          deaths.

       According to the Author's staff, to speed up investigations in cases  
          where patients have died as a result of prescription drug overdose,  
          this measure seeks to:

                  Authorize the MBC, if it receives an 802.5 Report or 805  
               Report that involves the death of a patient from a prescription  
               drug overdose, to inspect and copy the medical records of the  
               deceased patient without the consent of the patient's next of  
               kin or a court order in order to determine the extent to which  
               the death was the result of a prescriber's inappropriate  
               conduct.

                  Revise definition of unprofessional conduct to include the  
               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 within 30 days of  
               notification from the MBC.

          In order to ensure potentially dangerous doctors are not able to  
          continue prescribing, while an investigation is pending, this  
          measure seeks to:

                  Require the MBC to impose limitations on the authority of a  





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               physician and surgeon to prescribe, furnish, administer, or  
               dispense controlled substances during a pending investigation  
               if there is a reasonable suspicion that the physician has  
               engaged in overprescribing drugs or other behavior related to  
               his or her drug prescribing privileges that has resulted in the  
               death of a patient. 

       1.Need For This Bill.  The Author describes the need for the bill as  
          follows:

           a)    Obtaining Patient Information  .  Per existing law above, in  
             circumstances where patients (often times suffering from  
             addiction) have died as a result of a physician abusing his/her  
             prescribing privileges, the MBC can only access the deceased  
             patient's medical records with authorization from a "next of kin"  
             or through a subpoena.  The lack of a concerned patient releasing  
             his/her medical records (the patient is deceased) and  
             difficulties finding the next of kin in addiction cases creates a  
             significant barrier to the ability of the MBC to quickly  
             investigate and potentially pursue disciplinary action against a  
             physician whose abuse of prescribing privileges has led to  
             patient death.  A more direct mechanism for the MBC to access  
             patient records is necessary in these unique circumstances.

           b)    Physician Interviews  .  BPC Section 2234 (h) was written to  
             incentivize physicians to attend physician interviews by making  
             non-compliance unprofessional conduct.  The reason this provision  
             was placed in statute was that the failure of physicians to  
             attend necessary interviews was adding to the MBC's investigatory  
             timelines, and many times subpoenas would be needed to compel  
             physicians to attend.  However, the law only allows the MBC to  
             pursue unprofessional conduct if the physician mutually agrees to  
             the interview and then fails to show up repeatedly.  This creates  
             a significant loophole where physicians can significantly  
             lengthen the time of investigations, and the time to potential  
             disciplinary action by failing to mutually agree on an interview  
             time.  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 MBC.  This  
             issue was raised in the MBC 2012 Sunset Report.

           c)    Interim Suspension Orders (ISO)  .  In order for the MBC to stop  
             a physician from practicing before disciplinary action is taken,  
             they must obtain an interim suspension order (ISO).  The ISO can  





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             fully restrict a physician's license, or place prescribing or  
             other restrictions on the license, but not fully prohibit the  
             physician from practicing.  An ISO is considered extraordinary  
             relief and pursuant to Government Code Section 11529, a standard  
             of proof must be met in order to be granted an ISO.  The standard  
             of proof is relatively high, and must be consistent with the  
             burden and standards of proof applicable to a preliminary  
             injunction entered under Section 527 of the Code of Civil  
             Procedure. 

           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.  As the investigation  
             progresses and the Attorney General's office reviews the case, a  
             determination is made as to whether there is enough evidence to  
             warrant requesting an ISO.  Even after the ISO is requested, if  
             an Administrative Law Judge (ALJ) determines there is  
             insufficient evidence, the ISO request can be denied.  Also, due  
             to a 15-day time restraint to file an accusation after being  
             granted an ISO, and a 30-day time restraint between the  
             accusation being filed and a hearing being set, this means an  
             investigation must be nearly complete in order to file for an  
             ISO.  Depending on the case, gathering the appropriate materials  
             necessary to complete the investigation and request an ISO can be  
             a time-consuming process.

           This process allows patients (often times suffering from addiction)  
             to remain at significant risk of inappropriate prescribing  
             behavior, even when the MBC may have reasonable suspicion to  
             believe that the physician and surgeon has engaged in  
             overprescribing drugs, or other behavior related to his or her  
             drug prescribing privileges, that has resulted in the death of a  
             patient.  It is necessary, in these  limited circumstances  , to  
             provide the MBC with a better, more expedient, fair interim tool  
             for protecting patients from physicians who may be engaging in  
             inappropriate prescribing.

        3. Prescription Drug Deaths.  A recent Centers for Disease Control  
           (CDC) analysis found that drug overdose deaths increased for the  
           11th consecutive year in 2010 and prescription drugs, particularly  
           opiod analgesics, are the top drugs leading the list of those  
           responsible for fatalities.  According to CDC, 38,329 people died  
           from a drug overdose in 2010, up from 37,004 deaths in 2009, and  
           16,849 deaths in 1999.  CDC found that nearly 60 percent of the  





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           overdose deaths in 2010, involved pharmaceutical drugs, with opiods  
           associated with approximately 75 percent of these deaths.  Nearly  
           three out of four prescription drug overdoses are caused by opioid  
           pain relievers.  CDC recommends the use of Prescription Drug  
           Monitoring Programs (PDMPs) with a focus on both patients at  
           highest risk in terms of prescription painkiller dosage, numbers of  
           prescriptions and numbers of prescribers as well as prescribers who  
           deviate from accepted medical practice and those with a high  
           proportion of doctor shoppers among their patients.  CDC also  
           recommends that PDMPs link to electronic health records systems so  
           that the information is better integrated into health care  
           providers' day-to-day practices.  CDC believes that state benefits  
           programs like Medicaid and workers' compensation should consider  
           monitoring prescription claims information and PDMP data for signs  
           and inappropriate use of controlled substances.  The organization  
           also acknowledges the value of PDMPs in taking regulatory action  
           against health care providers who do operate outside the limits of  
           appropriate medical practice when it comes to prescription drug  
           prescribing.

        4. Drug Deaths and MBC Enforcement Issues.  In November and December  
           of 2012, the Los Angeles Times published a series of four articles  
           titled "Dying For Relief," which were the outcome of an intensive  
           review of the epidemic of prescription drug-related deaths in four  
           Southern California counties (Los Angeles, Orange, Ventura and San  
           Diego).  In the investigation, reporters examined coroners' records  
           and interviewed doctors, regulators, law enforcement officials and  
           relatives of those who died from overdoses.  In these cases  
           toxicology tests found a prescription drug in the deceased's  
           system, usually a painkiller, anti-anxiety drug or other narcotic;  
           coroners' investigators reported finding a container of the same  
           medication bearing the doctor's name, or records of a prescription;  
           and the coroner determined that the drug caused or contributed to  
           the death.  The investigators also created and analyzed a  
           searchable database of 3,700 drug related deaths during a 5-year  
           span (2005-2011) in Southern California to identify those tied to  
           doctors' prescriptions.

        An examination of coroner records by the Times found that:

             "      In 47% of those cases (1,762 deaths) drugs for which the  
               deceased had a prescription were the sole cause or a  
               contributing cause of death.
             "      A small number of doctors were associated with a  
               disproportionate number of those fatal overdoses.  0.1% of the  
               practicing physicians (71 physicians) in the 4 counties wrote  





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               prescriptions for drugs that caused or contributed to 298  
               deaths. That is 17% of the total deaths linked to doctors'  
               prescriptions.
             "      Each of the 71 physicians prescribed drugs to 3 or more  
               patients who died.
             "      4 of the physicians had 10 or more patients who fatally  
               overdosed.
             "      One physician had 16 patients who died.

          The Times found that the 71 physicians with 3 or more fatal  
          overdoses among their patients are primarily pain specialists,  
          general practitioners and psychiatrists.  Four of the physicians  
          have been convicted of drug offenses in connection with their  
          prescriptions, and a fifth is awaiting trial on second-degree murder  
          charges in the overdose deaths of 3 patients.  The remaining  
          physicians had clean records with the MBC, according to the Times.

        1. Sunset Review Oversight Hearing.  Earlier this year, the Senate  
           Business, Professions and Economic Development Committee and the  
           Assembly Business, Professions and Consumer Protection Committee  
           held a Joint Oversight Hearing of the MBC.  At that hearing,  
           testimony was heard from the MBC, consumers, parents, consumer  
           groups, professional associations and the public at large.  That  
           hearing primarily focused on the enforcement program of the MBC.   
           The question was raised about the MBC's effectiveness in protecting  
           consumers from dangerous practitioners in the medical field.

        This bill is closely related to other bills that impact the MBC's  
           enforcement processes.  See "Related Legislation" below. 
        
        2. Related Legislation.   SB 62  (Price) requires coroners' reports to  
           be transmitted to various health practitioner boards in the event  
           that cause of death is determined to be prescription drug overdose.  
            The bill is also up for consideration in this Committee today.

         SB 616  (DeSaulnier) makes various changes to the funding and operation  
           of the Controlled Substances Utilization Review and Evaluation  
           System (CURES) Prescription Drug Monitoring Program (PDMP).   
           Establishes the CURES Fund in the State Treasury.  Requires  
           practitioners who prescribe Schedule II, III and IV controlled  
           substances and pharmacists to enroll in and consult the CURES PDMP.  
            Increases licensing fees for prescribing health practitioners,  
           dispensers and wholesalers of controlled substances for the purpose  
           of providing ongoing funding to maintain the CURES PDMP.  Levies a  
           one-time tax assessment on health insurance plans and workers  
           compensation insurers to fund the CURES modernization upgrade.   





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           Imposes annual taxes on drug manufacturers of Schedule II, III, and  
           IV controlled substances doing business in California to maintain  
           the CURES PDMP.  The bill is also up for consideration in this  
           Committee today.

         SB 304  (Price) makes changes stemming from the Committee's Sunset  
           Oversight Hearing of the MBC on March 11, 2013.  That bill has been  
           referred to this Committee for consideration.

        
        SUPPORT AND OPPOSITION:
        
         Support  :None received as of April 9, 2013

         Opposition:  None received as of April 9, 2013


        Consultant:G. V. Ayers