BILL ANALYSIS                                                                                                                                                                                                    �



                                                                            



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                                    THIRD READING


          Bill No:  SB 670
          Author:   Steinberg (D)
          Amended:  5/24/13
          Vote:     21

           
           SENATE BUSINESS, PROF. & ECON. DEV. COMM.  :  8-0, 4/15/13
          AYES:  Price, Block, Corbett, Galgiani, Hernandez, Hill,  
            Padilla, Yee
          NO VOTE RECORDED:  Emmerson, Wyland

           SENATE APPROPRIATIONS COMMITTEE  :  7-0, 4/29/13
          AYES:  De Le�n, Walters, Gaines, Hill, Lara, Padilla, Steinberg


           SUBJECT  :    Physicians and surgeons:  drug prescribing  
          privileges:  investigation

           SOURCE  :     Author


           DIGEST  :    This bill authorizes the Medical Board of California  
          (MBC) to inspect medical records of a patient, in any case where  
          a patient has died, without the consent of the patient's next of  
          kin or a court order; makes it unprofessional conduct for a  
          licensee who is under investigation by the MBC 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 (ISO) limiting the  
          authority of a physician to prescribe, furnish, administer, or  
          dispense controlled substances; and requires the MBC to impose  
          limitations on the authority of a physician and surgeon to  
          prescribe, furnish, administer, or dispense controlled  
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          substances during a pending investigation if there is probable  
          cause to believe that the physician and surgeon has prescribed,  
          furnished, administered, or dispensed controlled substances in  
          violation of the Medical Practice Act (MPA); and makes  
          legislative findings and declarations.

           Senate Floor Amendments  of 5/24/13 (1) revise the provision  
          requiring the MBC to impose limitations on a physician's  
          authority to prescribe, furnish, administer or dispense  
          controlled substances during a pending investigation, to instead  
          require the MBC to have probable cause that the physician has  
          prescribed, furnished or dispensed controlled substances in  
          violation of the MPA; (2) authorize the MBC to inspect medical  
          records without the consent of a patient's next of kin or a  
          court order in any case where a patient has died; and (3) make  
          legislative findings and declarations that this authority is  
          consistent with the public interest and benefit activities of  
          the federal Health Insurance Portability and Accountability Act  
          (HIPAA).

           ANALYSIS  :    

          Existing law:

          1. Licenses and regulates physicians and surgeons under the MPA  
             by the MBC and states that the protection of the public is  
             the highest priority of the MBC in exercising its functions.
           
          2. Authorizes investigators and representatives of the MBC,  
             among others, to inquire into any alleged violation of the  
             MPA 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.  

          3. Provides for the professional review of specified healing  
             arts licentiates (as a physician and surgeon, doctor of  
             podiatric medicine, clinical psychologist, marriage and  
             family therapist, clinical social worker, or dentist) by a  
             peer review body, as defined.

          4. Requires a coroner to make a report to the MBC, among other  
             specified entities, when he/she receives information that  

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             indicates that a death may be the result of a physician and  
             surgeon's, podiatrist's, or physician assistant's gross  
             negligence or incompetence.  

          5. 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 MBC. 

          6. Under the Administrative Procedure Act (APA), establishes  
             within the Office of Administrative Hearings 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 MPA.  

          7. Authorizes an administrative law judge 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.   

          8. Requires that the burden and standards of proof to obtain an  
             ISO shall be those applicable to a preliminary injunction  
             under Code of Civil Procedure Section 527.  

          This bill:

          1. Authorizes the MBC, in any case that involves the death of a  
             patient, 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 the physician and surgeon's  
             conduct in violation of the MPA.

          2. Revises the definition of unprofessional conduct under the  
             MPA 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  

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             limiting the authority of a physician to prescribe, furnish,  
             administer, or dispense controlled substances. 

          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 probable cause to believe  
             that the physician and surgeon has prescribed, furnished,  
             administered, or dispensed controlled substances in violation  
             of the MPA.

          5. Makes legislative findings and declarations that the  
             authority created in the MBC pursuant to this bill, and a  
             physician and surgeon's compliance with this bill, are  
             consistent with the public interest and benefit activities of  
             HIPAA.

           Background
           
           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% of the overdose deaths in 2010, involved  
          pharmaceutical drugs, with opiods associated with approximately  
          75% 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.  CDC also  
          acknowledges the value of PDMPs in taking regulatory action  

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          against health care providers who do operate outside the limits  
          of appropriate medical practice when it comes to prescription  
          drug prescribing.

           Drug deaths and MBC enforcement issues  .  In late 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 five-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.  71  
             physicians in the four counties wrote 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 three or more  
             patients who died; four of the physicians had 10 or more  
             patients who fatally overdosed; and one physician had 16  
             patients who died.

          The Times found that the 71 physicians with three 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  

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          murder charges in the overdose deaths of three patients.  The  
          remaining physicians had clean records with the MBC, according  
          to the Times.

           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.   
          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.

           Comments
           
          According to the author's office, Senator Steinberg was prompted  
          to pursue the legislation following the recent Los Angeles Times  
          investigation that uncovered significant issues with physicians,  
          overprescribing and patient deaths.  To speed up investigations  
          in cases where patients have died as a result of prescription  
          drug overdose, this bill seeks to:

             Authorize the MBC, in any case that involves the death of a  
             patient, 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 the physician and surgeon's  
             conduct in violation of the MPA.

             Revise the 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  
          bill seeks to require the 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 there is probable cause to believe that the  
          physician and surgeon has prescribed, furnished, administered,  
          or dispensed controlled substances in violation of the MPA.

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           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
          Local:  No

          According to the Senate Appropriations Committee:

             One-time costs between $75,000 and $150,000 for the MBC to  
             adopt regulations (Contingent Fund of the MBC).

             Minor cost savings to the MBC due to streamlined processes  
             when conducting investigations (Contingent Fund of the MBC).

          The Committee states that this bill expands some of the MBC's  
          authority to investigate and sanction licensees.  According to  
          MBC, the changes in this bill are likely to streamline the  
          investigatory process.  For example, by simplifying the process  
          for gaining access to medical records or by requiring licensees  
          under investigation to meet with the MBC staff earlier in an  
          investigation.  Thus, the overall impact of this bill is likely  
          to be reduced investigation costs.

           SUPPORT  :   (Verified  5/28/13)

          Center for Public Interest Law

           OPPOSITION  :    (Verified  5/28/13)

          California Medical Association

           ARGUMENTS IN SUPPORT  :    The Center for Public Interest Law  
          writes that this bill will provide needed tools to the MBC to  
          protect patients from potentially dangerous physicians who  
          improperly prescribe drugs, and that each of the bill's reforms  
          will save lives.

           ARGUMENTS IN OPPOSITION  :    The California Medical Association  
          writes, "We continue to have concerns about the lack of due  
          process afforded by the expansion of the MBC's authority.  SB  
          670 gives the MBC the ability to suspend a physician's ability  
          to prescribe controlled substances without allowing the  
          physician to refute the allegation.  The MBC should and does  
          have the authority, through the interim suspension order, to  
          intercede when there is an immediate concern about patient  
          safety.  This process includes important due process  

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          protections.  The state is not served by physicians who  
          prescribe inappropriately.  However, justice and due process are  
          not served by an overly rapid system of investigation that  
          assumes guilt before evidence proves otherwise.  The latter  
          could easily impact physician practice in a way that discourages  
          the most appropriate treatment when that treatment involves  
          prescribing a controlled substance."


          MW:k  5/28/13   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

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