BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 809
                                                                  Page  1

            Date of Hearing:   August 13, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                               Susan A. Bonilla, Chair
           SB 809 (DeSaulnier and Steinberg) - As Amended:  August 5, 2013

           SENATE VOTE  :   39-0
           
          SUBJECT  :   Controlled substances:  reporting.

           SUMMARY  :   Establishes a funding mechanism to update and  
          maintain the Controlled Substance Utilization Review and  
          Evaluation System (CURES) and Prescription Drug Monitoring  
          Program (PDMP), requires all prescribing health care  
          practitioners to apply to access CURES information, and  
          establishes processes and procedures for regulating prescribing  
          licensees through CURES and securing private information.   
          Specifically,  this bill  :   

          1)Assesses an annual six dollar fee on the following licensees  
            to pay the reasonable costs associated with operating and  
            maintaining CURES for the purpose of regulating those  
            licensees:

             a)   Physicians, dentists, podiatrists, veterinarians,  
               naturopathic doctors, pharmacists, registered nurse,  
               certified nurse-midwives, nurse practitioners, physician  
               assistants, and optometrists, as specified;

             b)    Wholesalers and nonresident wholesalers of dangerous  
               drugs, as specified;

             c)   Nongovernmental clinics, nonprofit clinics, and free  
               clinics, as specified; and,

             d)   Nongovernmental pharmacies, as specified. 

          2)Requires the assessed fee to be billed and collected by the  
            regulating agency of each licensee at the time of the  
            licensee's license renewal, and states that if the reasonable  
            regulatory cost of operating and maintaining CURES is less  
            than six dollars per licensee, the Department of Consumer  
            Affairs (DCA) may, by regulation, reduce the fee to the  
            reasonable regulatory cost. 








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          3)Requires the fees collected to be deposited in the CURES Fund,  
            which is created within the State Treasury.  

          4)Requires moneys in the CURES Fund to be, upon appropriation by  
            the Legislature, available to DCA to reimburse the Department  
            of Justice (DOJ) for costs to operate and maintain CURES for  
            the purposes of regulating the specified licensees.

          5)Requires DCA to contract with DOJ on behalf of the Medical  
            Board of California (MBC), the Dental Board of California, the  
            California State Board of Pharmacy, the Veterinary Medical  
            Board, the Board of Registered Nursing, the Physician  
            Assistant Board of the Medical Board of California, the  
            Osteopathic Medical Board of California, the Naturopathic  
            Medicine Committee of the Osteopathic Medical Board, the State  
            Board of Optometry, and the California Board of Podiatric  
            Medicine to operate and maintain CURES for the purposes of  
            regulating licensees.

          6)Requires DOJ, in conjunction with DCA and the appropriate  
            boards and committees, to do all of the following:

             a)   Identify and implement a streamlined application and  
               approval process to provide access to the CURES PDMP  
               database for pharmacists and licensed health care  
               practitioners eligible to prescribe Schedule II, Schedule  
               III, or Schedule IV controlled substances, and requires  
               every reasonable effort be made to implement a streamlined  
               application and approval process that a licensed health  
               care practitioner or pharmacist can complete at the time  
               that he or she is applying for licensure or renewing his or  
               her license; 

             b)   Identify necessary procedures to enable licensed health  
               care practitioners and pharmacists with access to the CURES  
               PDMP to delegate their authority to order reports from the  
               CURES PDMP; and,

             c)   Develop a procedure to enable health care practitioners  
               who do not have a federal Drug Enforcement Administration  
               (DEA) number to opt out of applying for access to the CURES  
               PDMP.

          7)Requires MBC to periodically develop and disseminate  








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            information and educational material regarding assessing a  
            patient's risk of abusing or diverting controlled substances  
            and information relating to CURES to each licensed physician  
            and surgeon and to each general acute care hospital in this  
            state; and further requires MBC to consult with the State  
            Department of Public Health, appropriate boards and  
            committees, and DOJ in developing the materials to be  
            distributed.

          8)Requires a California pharmacy to report dispensing a Schedule  
            IV controlled substance issued by a prescriber in another  
            state for delivery to a patient in another state to CURES.

          9)Requires DOJ to maintain CURES to assist health care  
            practitioners in their efforts to ensure appropriate  
            prescribing, ordering, administering, furnishing, and  
            dispensing of controlled substances. 

          10)Deletes provisions stating that the reporting of Schedules  
            III and IV controlled substances shall be contingent upon the  
            availability of adequate funds from DOJ. 

          11)Requires DOJ to annually report to the Legislature and make  
            available to the public the amount and source of funds it  
            receives for support of CURES.

          12)Permits DOJ to seek and use grant funds to pay the costs  
            incurred by the operation and maintenance of CURES.

          13)Requires CURES to comply with all applicable federal and  
            state privacy and security laws and regulations.

          14)Requires DOJ to establish policies, procedures, and  
            regulations regarding the use, access, evaluation, disclosure,  
            management, implementation, operation, storage, and security  
            of the information within CURES.

          15)Requires a pharmacy, clinic, or other dispenser to report  
            specified information, including a prescribers national  
            provider identifier number, to DOJ as soon as reasonably  
            possible, but not more than seven days after the date a  
            controlled substance is dispensed. 

          16)Permits DOJ to invite stakeholders to assist, advise, and  
            make recommendations on the establishment of rules and  








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            regulations necessary to ensure the proper administration and  
            enforcement of the CURES database. All prescriber and  
            dispenser invitees must be licensees, as specified, in active  
            practice in California, and a regular user of CURES. 

          17)Requires DOJ, prior to upgrading CURES, to consult with  
            prescribers licensed by one of the relevant boards or  
            committees, the boards or committees themselves, and any other  
            stakeholders for the purpose of identifying desirable  
            capabilities and upgrades to the CURES Prescription Drug  
            Monitoring Program (PDMP).

          18)Permits DOJ to establish a process to educate authorized  
            subscribers of the CURES PDMP on how to access and use the  
            CURES PDMP.

          19)Requires a health care practitioner authorized to prescribe,  
            order, administer, furnish, or dispense Schedule II-IV  
            controlled substances or a pharmacist to, before January 1,  
            2016, or upon receipt of a federal Drug Enforcement  
            Administration (DEA) registration, whichever occurs later,  
            submit an application to DOJ to access information online  
            regarding the controlled substance history of a patient, as  
            specified. 

          20)Requires DOJ, upon approval of an application to access  
            patient information, release to the practitioner or pharmacist  
            the electronic history of controlled substances dispensed to  
            an individual under his or her care based on data contained in  
            the CURES PDMP.

          21)States that a health care practitioner authorized to  
            prescribe Schedules II-IV controlled substances, or a  
            pharmacist, shall be deemed to have completed the requirements  
            to access individual patient information if he or she has  
            applied to access CURES PDMP at the time he or she applied for  
            licensure or renewal.

          22)Permits DOJ to seek voluntarily contributed private funds  
            from insurers, health care service plans, and qualified  
            manufacturers for the purpose of supporting CURES.  Insurers,  
            health care service plans, qualified manufacturers, and other  
            donors may contribute by submitting their payment to the  
            Controller for deposit into the CURES Fund.  Contributions to  
            the CURES Fund shall be nondeductible for state tax purposes.








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          23)Defines the following terms:

             a)   "Controlled substance" means a drug, substance, or  
               immediate precursor listed in any schedule in Section  
               11055, 11056, or 11057 of the Health and Safety Code (HSC);

             b)   "Health care service plan" means an entity licensed  
               pursuant to the Knox-Keene Health Care Service Plan Act of  
               1975 (Chapter 2.2 (commencing with Section 1340) of  
               Division 2 of HSC);

             c)    "Insurer" means an admitted insurer writing health  
               insurance, as defined in Section 106 of the Insurance Code,  
               and an admitted insurer writing workers' compensation  
               insurance, as defined in Section 109 of the Insurance Code;  
               and,

             d)   "Qualified manufacturer" means a manufacturer of a  
               controlled substance, but does not mean a wholesaler or  
               nonresident wholesaler of dangerous drugs, as specified, a  
               veterinary food-animal drug retailer, as specified, or an  
               individual regulated by the MBC, the Dental Board of  
               California, the California State Board of Pharmacy, the  
               Veterinary Medical Board, the Board of Registered Nursing,  
               the Physician Assistant Committee of the Medical Board of  
               California, the Osteopathic Medical Board of California,  
               the State Board of Optometry, or the California Board of  
               Podiatric Medicine.

          24)Makes clarifying and technical amendments.

          25)Makes legislative findings and declarations.

           EXISTING LAW  :

          1)Establishes CURES and requires DOJ to maintain CURES for the  
            electronic monitoring of the prescribing and dispensing of  
            Schedule II, III, and IV controlled substances by all  
            practitioners authorized to prescribe or dispense these  
            controlled substances.  (Health and Safety Code (HSC) Section  
            11165(a))

          2)Requires a dispensing pharmacy or clinic to provide specified  
            prescription data for each prescription for a Schedule II,  








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            III, or IV controlled substance to DOJ on a weekly basis.   
            (HSC 11165(d))

          3)Allows a licensed health care practitioner who is eligible to  
            prescribe Schedule II, III, or IV controlled substances, or a  
            pharmacist, to make a written request to DOJ for the history  
            of controlled substances dispensed to an individual under his  
            or her care, and allows DOJ to provide that information to  
            that health care practitioner or pharmacist.  (HSC 11165.1(a))

          4)Provides that the history of controlled substances dispensed  
            to an individual based on data contained in CURES that is  
            received by a practitioner or pharmacist from DOJ pursuant to  
            this section shall be considered medical information subject  
            to specified confidentiality provisions.  (HSC 11165.1(d))

          5)Requires every practitioner, other than a pharmacist, who  
            prescribes or administers a controlled substance classified in  
            Schedule II, III or IV to record specified information  
            relating to the transaction.  (HSC 11190)

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           1)Purpose of this bill  .  This bill establishes a funding  
            mechanism for DOJ to update and maintain the CURES/PDMP  
            prescription monitoring system for the benefit of DCA  
            prescribing licensees and the public.  By doing so, the author  
            aims to increase the quality and usability of the system to  
            improve monitoring for excessive or inappropriate prescribing.  
            This bill is sponsored by the Attorney General's office.  

           2)Author's statement  .  According to the author's office, "SB 809  
            provides essential funding to continue and strengthen the  
            CURES PDMP, a vital resource for medical professionals and law  
            enforcement to detect and prevent prescription drug abuse and  
            addiction, and save lives. Without dedicated funding, the  
            CURES program will be suspended and California will join  
            Missouri as the only state in the nation without a PDMP.

            "Prescription drug abuse is the Nation's fastest-growing drug  
            problem and has been classified as a public health epidemic by  
            the Centers for Disease Control and Prevention. One hundred  
            people die from drug overdoses every day in the United States  








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            and prescription painkillers are responsible for 75% of these  
            deaths, claiming more lives than heroin and cocaine combined,  
            and fueling a doubling of drug-related deaths in the United  
            States over the last decade. 

            "SB 809 provides sufficient and sustainable revenue to  
            maintain the CURES program operations, sustain full  
            modernization, and improve program participation and  
            utilization by requiring all practitioners and pharmacists to  
            enroll in the CURES PDMP."

           3)Background  .  CURES' predecessor, the California Triplicate  
            Prescription Program (TPP) was created in 1939 and was  
            replaced by CURES in 1998.  In 2009, the PDMP system was  
            introduced as a searchable, client-facing component of CURES.   


            Presently, the database contains over 100 million entries of  
            controlled substance drugs that have been dispensed in  
            California.  In 2012, the program responded to more than  
            800,000 requests.  There are currently 174,338 prescribers  
            registered to use the system, and 38,290 pharmacists.  

            Pharmacists are required to report dispensations of Schedules  
            II-IV controlled substances at least weekly, but use of PDMP  
            by prescribers and dispensers for prescription abuse  
            prevention/intervention is voluntary. 

            The California Budget Act of 2011 eliminated all General Fund  
            support of CURES and PDMP, which included funding for system  
            support, staff support and related operating expenses. To  
            perform the minimum critical functions and to avoid shutting  
            down the program, the Department opted to assign staff to  
            perform temporary dual job assignments on a part time basis.  
            Although some tasks are being performed, the program is faced  
            with a constant backlog (e.g., four-week backlog on processing  
            new user applications, six-week response time on emails,  
            twelve week backlog on voicemails, etc.) 

            CURES is currently overseen by a single employee, and is on a  
            lifeline budget of $400,000.  According to a March 2013  
            article in the Los Angeles Times, doctors requesting  
            information or seeking help from the database have received  
            email responses stating, "Unfortunately, due to budget  
            restrictions, there is no staff to accept or respond to your  








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            communication."  


            This bill will require all pharmacists or health care  
            practitioners authorized to prescribe, order, administer,  
            furnish, or dispense Schedule II-IV controlled substances to  
            submit an application to DOJ to access information online  
            regarding the controlled substance history of a patient by  
            January 2016.  The updated CURES/PDMP will comply with all  
            state and federal security and privacy issues. Disciplinary,  
            civil or criminal actions will be taken by DOJ and/or the  
            appropriate licensing board for any misuse or inappropriate  
            accessing of patient data.

           4)Arguments in support  .  California Medical Association writes,  
            "Physicians have long been and continue to be strong  
            supporters of the CURES database, which compiles prescription  
            information of Schedule II, III, and IV drugs dispensed in  
            California. We recognize its potential to help ensure  
            appropriate prescribing and as a tool for addressing the abuse  
            and diversion of prescription drugs. CMA supports CURES being  
            upgraded and maintained. Even in its current underfunded and  
            antiquated state, CURES provides valuable information that  
            supports appropriate prescribing of controlled substances. An  
            upgrade that is easy for physicians and other prescribers and  
            dispensers to access, moves closer to real time provision of  
            dispensing data, and that is integrated with other states'  
            PDMPs is welcome."

           5)Previous legislation  .  SB 734 (Torlakson) (Chapter 487,  
            Statutes of 2005) authorized tamper resistant online access to  
            the CURES system for authorized physicians, pharmacists and  
            law enforcement pending the acquisition of private funding.

            SB 1071 (DeSaulnier) of 2010 would have imposed a tax on  
            manufacturers or importers of Schedule II, III and IV  
            controlled substances to pay for ongoing costs of the CURES  
            program, to be collected by the State Board of Equalization at  
            the rate of $0.0025 per pill included in Schedules II, III,  
            and IV.  SB 1071 was held in Senate Health Committee.

            SB 360 (DeSaulnier) (Chapter 418, Statutes of 2011) authorized  
            DOJ to initiate administrative enforcement actions to prevent  
            the misuse of confidential information collected through the  
            CURES program. 








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            SB 616 (DeSaulnier) of 2012 would have increased fees up to  
            $10 per licensee for those licensees authorized to prescribe  
            or dispense controlled substances to pay for CURES.  SB 616  
            was held in the Assembly Business, Professions, and Consumer  
            Protection Committee.  

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          California Attorney General's Office (sponsor)
          ALPHA Fund
          American Cancer Society Cancer Action Network
          American Medical Association
          Association of California Healthcare Districts
          Association of California Insurance Companies
          Association of California Life and Health Insurance Companies
          Association of Northern California Oncologists 
          California Academy of Family Physicians
          California Association for Nurse Practitioners
          California Association of Joint Powers Authorities
          California Association of Oral and Maxillofacial Surgeons
          California Board of Pharmacy
          California Chapter of the American College of Emergency  
          Physicians
          California Coalition on Workers' Compensation
          California Department of Insurance
          California Hospital Association
          California JPIA
          California Labor Federation
          California Medical Association
          California Narcotic Officers Association
          California Pharmacists Association
          California Police Chiefs Association
          California Professional Association of Specialty Contractors
          California Retailers Association
          California Self-Insurers Association
          California Society of Health-System Pharmacists
          California Special Districts Association
          California State Association of Counties
          California State Sheriff's Association
          Center for Public Interest Law
          City and County of San Francisco
          CompPharma








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          County Alcohol and Drug Program Administrators Association of  
          California  
          County of San Diego
          CSAC Excess Insurance Authority
          Deputy Sheriffs' Association of San Diego County
          Employers Group
          Gallagher Bassett Services, Inc. 
          Golden Oak Cooperative Corporation
          Grimmway Farms
          Health Officers Association of California
          Independent Insurance Agents and Brokers of California
          Los Angeles District Attorney's Office
          Medical Board of California
          Medical Oncology Association of Southern California, Inc. 
          Metro Risk Management
          Michael Sullivan & Associates
          National Association of Chain Drug Stores
          National Coalition Against Prescription Drug Abuse
          Nordstrom
          Safeway
          Schools Insurance Authority
          Schools Insurance Group
          Sedgwick Claims Management Services
          Shaw, Jacobsmeyer, Crain, and Claffey
          South Orange County Coalition
          Troy and Alana Pack Foundation
          University of California
          Western Occupational & Environmental Medical Association
          Western Propane Gas Association
           
            Opposition 
           
          California Optometric Association 

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