BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 809| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- 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, CONTINUED SB 809 Page 2 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 CONTINUED SB 809 Page 3 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 CONTINUED SB 809 Page 4 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 CONTINUED SB 809 Page 5 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 CONTINUED SB 809 Page 6 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. CONTINUED SB 809 Page 7 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 CONTINUED SB 809 Page 8 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 CONTINUED SB 809 Page 9 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 CONTINUED SB 809 Page 10 (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 **** END **** CONTINUED