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 (Steinberg and DeSaulnier) - 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. SB 809 Page 2 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 SB 809 Page 3 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 SB 809 Page 4 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. SB 809 Page 5 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, SB 809 Page 6 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 SB 809 Page 7 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 SB 809 Page 8 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. SB 809 Page 9 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 SB 809 Page 10 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