BILL ANALYSIS Ó SB 809 Page 1 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 ----------------------------------------------------------------- |Ayes:|Ammiano, Melendez, |Ayes:|Bonilla, Jones, | | |Jones-Sawyer, Mitchell, | |Bocanegra, Campos, | | |Quirk, Skinner, Waldron | |Dickinson, Eggman, | | | | |Gordon, Hagman, Holden, | | | | |Maienschein, Mullin, | | | | |Skinner, Ting, Wilk | |-----+--------------------------+-----+--------------------------| | | | | | ----------------------------------------------------------------- APPROPRIATIONS 16-0 ----------------------------------------------------------------- |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, SB 809 Page 2 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 SB 809 Page 3 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 SB 809 Page 4 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 SB 809 Page 5 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, SB 809 Page 6 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 SB 809 Page 7 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 SB 809 Page 8