BILL ANALYSIS                                                                                                                                                                                                    Ó



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          SENATE THIRD READING
          SB 809 (DeSaulnier)
          As Amended  September 3, 2013
          Majority vote

           SENATE VOTE  :39-0  
           
           PUBLIC SAFETY       7-0          BUSINESS & PROFESSIONS     14-0
           
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          |Ayes:|Ammiano, Melendez,        |Ayes:|Bonilla, Jones,           |
          |     |Jones-Sawyer, Mitchell,   |     |Bocanegra, Campos,        |
          |     |Quirk, Skinner, Waldron   |     |Dickinson, Eggman,        |
          |     |                          |     |Gordon, Hagman, Holden,   |
          |     |                          |     |Maienschein, Mullin,      |
          |     |                          |     |Skinner, Ting, Wilk       |
          |-----+--------------------------+-----+--------------------------|
          |     |                          |     |                          |
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           APPROPRIATIONS      16-0                                        
           
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          |Ayes:|Gatto, Harkey, Bigelow,   |     |                          |
          |     |Bocanegra, Bradford, Ian  |     |                          |
          |     |Calderon, Campos, Eggman, |     |                          |
          |     |Gomez, Hall, Holden,      |     |                          |
          |     |Linder, Pan, Quirk,       |     |                          |
          |     |Wagner, Weber             |     |                          |
          |-----+--------------------------+-----+--------------------------|
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           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 $6 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,  








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               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, beginning April 1, 2014, 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 $6 per licensee, the Department of Consumer  
            Affairs (DCA) may, by regulation, reduce the fee to the  
            reasonable regulatory cost. 

          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  








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               database for pharmacists and licensed health care  
               practitioners eligible to prescribe, order, administer,  
               furnish, or dispense 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  
            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)Authorizes pharmacies to dispense Schedule III, IV, and V  
            controlled substances prescriptions from out-of-state  
            prescribers as specified.

          10)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. 

          11)Deletes provisions stating that the reporting of Schedules  
            III and IV controlled substances shall be contingent upon the  








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            availability of adequate funds from DOJ.

          12) 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.

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

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

          15)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.

          16)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. 

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

          18)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 PDMP.

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

          20)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  








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            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. 

          21)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.

          22)States that a health care practitioner authorized to  
            prescribe Schedules II-IV controlled substances, 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.

          23)Requires a pharmacist to submit an application, as specified,  
            to obtain approval to access CURES PDMP.

          24)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.

          25)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,








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             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.

          26)Makes clarifying and technical amendments.

          27)Makes legislative findings and declarations.
           
          EXISTING LAW  : 

          1)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.  

          2)Requires a dispensing pharmacy or clinic to provide specified  
            prescription data for each prescription for a Schedule II,  
            III, or IV controlled substance to DOJ on a weekly basis.  

          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.  

          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.  

          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  








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            relating to the transaction.  

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee, ongoing special fund costs in the $1.5 million range,  
          fully covered by the proposed fee structure, to staff and  
          maintain the upgraded PDMP.  The related costs to upgrade the  
          PDMP database - almost $3 million - received funding in the  
          2013-14 budget bill.  
           
           COMMENTS  :  According to the author, "SB 809 provides essential  
          funding to continue and strengthen the CURES Prescription Drug  
          Monitoring Program, 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 Prescription  
          Drug Monitoring Program.

          "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  
          and prescription painkillers are responsible for 75 percent 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. In California, on average,  
          there are six deaths every day from prescription drug overdose  
          and1.2 million emergency room visits related to the misuse or  
          abuse of pharmaceuticals.

          "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."

          Please see the policy committee analysis for a full discussion  
          of this bill.


           Analysis Prepared by  :    Shaun Naidu / PUB. S. / (916) 319-3744 


                                                                FN: 0002184









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