BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



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                                 UNFINISHED BUSINESS


          Bill No:  SB 809
          Author:   DeSaulnier (D) and Steinberg (D), et al.
          Amended:  9/3/13
          Vote:     21

           
           SENATE BUSINESS, PROF. & ECON. DEV. COMM.  :  7-2, 4/15/13
          AYES:  Price, Block, Corbett, Galgiani, Hernandez, Hill, Padilla
          NOES:  Emmerson, Wyland
          NO VOTE RECORDED:  Yee

           SENATE GOVERNANCE & FINANCE COMMITTEE  :  5-2, 5/8/13
          AYES:  Wolk, Beall, DeSaulnier, Hernandez, Liu
          NOES:  Knight, Emmerson

           SENATE APPROPRIATIONS COMMITTEE  :  5-1, 5/23/13
          AYES:  De León, Hill, Lara, Padilla, Steinberg
          NOES:  Gaines
          NO VOTE RECORDED:  Walters

           SENATE FLOOR  :  23-14, 5/28/13 (FAIL)
          AYES:  Beall, Block, Corbett, De León, DeSaulnier, Evans,  
            Hancock, Hernandez, Hill, Hueso, Jackson, Lara, Leno, Lieu,  
            Liu, Monning, Padilla, Pavley, Price, Steinberg, Torres, Wolk,  
            Wright
          NOES:  Anderson, Berryhill, Calderon, Cannella, Correa, Fuller,  
            Gaines, Galgiani, Huff, Knight, Nielsen, Roth, Wyland, Yee
          NO VOTE RECORDED:  Emmerson, Walters, Vacancy

           SENATE FLOOR  :  39-0, 5/30/13
          AYES:  Anderson, Beall, Berryhill, Block, Calderon, Cannella,  
            Corbett, Correa, De León, DeSaulnier, Emmerson, Evans, Fuller,  
            Gaines, Galgiani, Hancock, Hernandez, Hill, Hueso, Huff,  
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            Jackson, Knight, Lara, Leno, Lieu, Liu, Monning, Nielsen,  
            Padilla, Pavley, Price, Roth, Steinberg, Torres, Walters,  
            Wolk, Wright, Wyland, Yee
          NO VOTE RECORDED:  Vacancy

           ASSEMBLY FLOOR  :  77-1, 9/9/13 - See last page for vote


           SUBJECT  :    Controlled substances:  reporting

           SOURCE  :     Attorney General Kamala Harris


           DIGEST  :    This bill 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.    

           Assembly Amendments  remove the urgency clause; require CURES to  
          operate under existing provisions of law to safeguard the  
          privacy and confidentiality of patients and specifies the manner  
          in which data obtained from CURES is provide to specified  
          entities; and make clarifying and technical amendments.

           ANALYSIS  :    Existing law, under the Health and Safety Code,  
          establishes the California Uniform Controlled Substances Act  
          which regulates controlled substances.  

          Existing law, under the Business and Professions Code:

           1. Establishes various Acts which provide for the licensing,  
             certification, and regulation of health practitioners by  
             boards within the Department of Consumer Affairs (DCA).

           2. Provides that a certified nurse-midwife or nurse  
             practitioner may furnish or order drugs or devices, including  
             controlled substances, in accordance with standardized  
             procedures or protocols as specified.  

           3. Establishes the Pharmacy Law which provides for the  
             licensure and regulation of pharmacies, pharmacists and  

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             wholesalers of dangerous drugs or devices by the Board of  
             Pharmacy within the DCA.  

           4. Specifies certain requirements regarding the dispensing and  
             furnishing of dangerous drugs and devices, and prohibits a  
             person from furnishing any dangerous drug or device except  
             upon the prescription of a physician, dentist, podiatrist,  
             optometrist, veterinarian or naturopathic doctor.  

           5. Requires the MBC to periodically develop and disseminate  
             information and educational materials regarding various  
             subjects, including pain management techniques, to each  
             licensed physician and surgeon and to each general acute care  
             hospital in California.

          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,  
                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 DCA  
             may, by regulation, reduce the fee to the reasonable  
             regulatory cost. 

           3. Requires the fees collected to be deposited in the CURES  

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             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 Board of Pharmacy, the Veterinary Medical Board, the  
             Board of Registered Nursing, the Physician Assistant Board of  
             the MBC, the Osteopathic Medical Board, the Naturopathic  
             Medicine Committee of the Osteopathic Medical Board, the  
             Board of Optometry, and the 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, 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/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.

              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  

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             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  
             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  
             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  

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             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 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/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/she has applied to  
             access CURES PDMP at the time he/she applied for licensure or  
             renewal.

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


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           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  
             State 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 in Schedule II, III, or IV.

              B.    "Health care service plan" means an entity licensed  
                pursuant to the Knox-Keene Health Care Service Plan Act of  
                1975.

              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.

              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 Board of Pharmacy, the Veterinary Medical  
                Board, the Board of Registered Nursing, the Physician  
                Assistant Committee of the MBC, the Osteopathic Medical  
                Board, the Board of Optometry, or the Board of Podiatric  
                Medicine.

           26.Makes clarifying and technical amendments.

           27.Makes legislative findings and declarations.

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

          According to the Assembly Appropriations Committee, ongoing  
          special fund costs in the $1.5 million range, fully covered by  

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          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.

           SUPPORT  :   (Verified  9/9/13)

          Attorney General Kamala Harris (source) 
          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
          Behind the Orange Curtain, the Documentary
          California Academy of Physician Assistants
          California Association for Nurse Practitioners 
          California Association of Joint Powers Authority
          California Association of Oral and Maxillofacial Surgeons 
          California Chapter of the American College of Emergency  
          Physicians 
          California Coalition on Workers' Compensation
          California Hospital Association
          California Joint Powers Insurance Authority
          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 Board of Pharmacy
          California State Sheriffs' Association
          Center for Public Interest Law
          City and County of San Francisco
          CompPharma
          County Alcohol and Drug Program Administrators Association of  
          California 
          County of San Diego
          CSAC Excess Insurance Authority

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          Department of Insurance
          Deputy Sheriffs' Association of San Diego County
          Employers Group
          Gallagher Bassett Services, Inc.
          Golden Oak Cooperative Corporation
          Grimmway Farms
          Health Officers Association of California
          Healthcare Distribution Management Association
          Independent Insurance Agents and Brokers of California
          Los Angeles County District Attorney's Office
          Medical Oncology Association of Southern California, Inc.
          Metro Risk Management
          Michael Sullivan and 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 and Environmental Medical Association
          Western Propane Gas Association

           ARGUMENTS IN SUPPORT  :    According to the author's office, the  
          automated PDMP within the CURES program is a valuable  
          investigative, preventative, and educational tool for law  
          enforcement, regulatory boards, and health care providers, but  
          recent budget cuts to the Attorney General's Division of Law  
          Enforcement have resulted in insufficient funding to support the  
          CURES PDMP.  The author's office states that the PDMP is  
          necessary to ensure health care professionals have the necessary  
          data to make informed treatment decisions and to allow law  
          enforcement to investigate prescription drug diversion.  Without  
          a dedicated funding source, the CURES PDMP is not sustainable  
          and will be suspended July 1, 2013.  To keep the program going  
          and increase its effectiveness, this bill establishes funds to  
          upgrade the system to be fully modernized and provides dedicated  
          ongoing funding to ensure the program is sustainable.

          The bill's sponsor, California Attorney General Kamala Harris  

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          (AG), notes that without the funding this bill provides, the AG  
          will be forced to disband the CURES program later this year,  
          making California one of only two states in the nation without a  
          PDMP and that closing the CURES program would "exacerbate a  
          prescription drug diversion problem that is already the fastest  
          growing drug problem in the United States."


           ASSEMBLY FLOOR  :  77-1, 9/9/13
          AYES:  Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,  
            Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian  
            Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,  
            Dahle, Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth  
            Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon, Gorell, Gray,  
            Grove, Hagman, Hall, Harkey, Roger Hernández, Holden, Jones,  
            Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,  
            Mansoor, Medina, Melendez, Mitchell, Morrell, Mullin,  
            Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson, Perea,  
            V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas, 
          Skinner, Stone, Ting, Wagner, Waldron, Weber, Wieckowski, Wilk,  
            Williams, Yamada, John A. Pérez
          NOES:  Donnelly
          NO VOTE RECORDED:  Vacancy, Vacancy

          MW:k  9/9/13   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

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