BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 679| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 679 Author: Travis Allen (R) Amended: 9/10/15 in Senate Vote: 27 - Urgency PRIOR VOTES NOT RELEVANT SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 8-0, 9/11/15 AYES: Hill, Bates, Berryhill, Block, Hernandez, Jackson, Mendoza, Wieckowski NO VOTE RECORDED: Galgiani SUBJECT: Controlled substances SOURCE: Author DIGEST: This bill extends the date by which specified health care practitioners and pharmacists must register with the Controlled Substance Utilization Review and Evaluation System (CURES) Prescription Drug Monitoring Program (PDMP) by six months, from January 1, 2016 to July 1, 2016. This measure contains an urgency clause. ANALYSIS: Existing law: 1) Establishes the Medical Practice Act which provides for the licensing and regulation of physicians and surgeons by the Medial Board of California (MBC) within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) §§ 2000 et seq.) 2) Establishes the Nursing Practice Act which provides for the AB 679 Page 2 certification and regulation of registered nurses, nurse practitioners and advanced practice nurses by the Board of Registered Nursing within DCA. (BPC §§ 2700 et seq.) 3) Authorizes a certified nurse-midwife to furnish or order drugs or devices, including controlled substances, if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the certified nurse-midwife's practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified. (BPC § 2746.51) 4) Authorizes a nurse practitioner to furnish or order drugs or devices, including controlled substances if it is consistent with a nurse practitioner's educational preparation or for which clinical competency has been established and maintained; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols, as specified. (BPC § 2836.1) 5) Establishes the Physician Assistant Practice Act which provides for the licensing of physician assistants by the Physician Assistant Committee, under the MBC, within the DCA. (BPC §§ 3500 et seq.) 6) Authorizes a physician assistant under the supervision of a physician and surgeon to administer or provide medication to a patient, or transmit orally or in writing a drug order under specified conditions and protocols adopted by the supervising physician and surgeon. (BPC § 3502.1) 7) Defines "dispense" as the furnishing of drugs or devices upon a prescription from a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor or upon an order to furnish drugs or transmit a prescription from a certified nurse-midwife, nurse practitioner, physician assistant, naturopathic doctor, or pharmacist acting within the scope of his or her practice. Dispense also means and refers to the furnishing of drugs or devices directly to a patient by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse-midwife, nurse AB 679 Page 3 practitioner, naturopathic doctor, or physician assistant acting within the scope of his or her practice. (BPC § 4024) 8) Classifies controlled substances in five schedules according to their danger and potential for abuse. (Health and Safety Code (HSC) §§ 11054-11058) 9) Establishes CURES to monitor Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of information related to the prescription of Schedule II, III and IV controlled substances to the Department of Justice (DOJ). (HSC § 11165) 10)Requires the dispensing pharmacy, clinic, or other dispenser to report specified information to CURES as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed, in a format specified by the DOJ. (HSC § 11165) 11)Requires a health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, and a pharmacist, to apply to participate in the CURES PDMP by January 1, 2016. (HSC § 11165.1) This bill: 1)Requires that a healthcare practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances submit an application to the DOJ to obtain approval to access CURES before July 1, 2016, or upon receipt of a federal Drug Enforcement Administration registration, whichever occurs later. 2)Requires a pharmacist to submit an application to the DOJ to obtain approval to access to CURES before July 1, 2016, or upon licensure, whichever occurs later. 3)Contains an urgency clause, stating that its immediate effect is necessary to ensure that health care practitioners and pharmacists are not out of compliance with the requirement to apply to access data contained in the CURES PDMP on January 1, AB 679 Page 4 2016. Background CURES. With rising levels of abuse, PDMPs have become a critical tool in assisting law enforcement and regulatory bodies with their efforts to reduce drug abuse. The California PDMP maintains the CURES database. CURES allows authorized users, including licensed healthcare prescribers eligible to prescribe controlled substances, pharmacists authorized to dispense controlled substances, law enforcement, and regulatory boards, to access patient controlled substance history information maintained in CURES. CURES is committed to assisting in the reduction of pharmaceutical drug diversion without affecting legitimate medical practice or patient care. Pharmacists are required to report information relating to dispensing Schedules II-IV controlled substances at least weekly, but use of CURES by prescribers and dispensers for prescription abuse prevention and intervention is voluntary. CURES' predecessor, the California Triplicate Prescription Program 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. 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. SB 809 (DeSaulnier, Chapter 400, Statutes of 2013) established a funding mechanism to update and maintain CURES, required all prescribing health care practitioners to apply to access CURES information, and established processes and procedures for regulating prescribing licensees through CURES and securing private information. DOJ is currently in the process of modernizing CURES to more efficiently serve prescribers, pharmacists and regulatory entities. DOJ originally anticipated that the new CURES 2.0 system would be operational on July 1, 2015, but among other functionalities, the streamlined registration process is now expected to be ready by July 1, 2016. AB 679 Page 5 This bill delays licensee registration requirements to align statutory mandates with the ready date of the new system, although there has been no indication from regulatory bodies that licensees were in danger of prosecution during those six months. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No SUPPORT: (Verified9/11/15) California Medical Association OPPOSITION: (Verified9/11/15) None received ARGUMENTS IN SUPPORT: Supporters argue that an important component of SB 809 (DeSaulnier) related to the application process for CURES has not yet come to fruition. In addition to the requirement for covered health care practitioners to apply for CURES, SB 809 required the DOJ, in conjunction with the DCA and the relevant licensing boards and commissions, to establish a streamlined application to help facilitate the application of the thousands of licenses who are required to meet the mandate. This streamlined application process was originally estimated to be available to licensees in the summer of 2015, which would have allowed six months for licensees to utilize the new process for their application. Though supporters expect a new, automated application process very soon, it is not yet available. The new application process will represent great progress toward establishing, as envisioned in SB 809, a system that meets the needs of health care providers and patients. However, supporters are concerned that the roll out of a new process in the few months before the application deadline will create AB 679 Page 6 unnecessary confusion among licensees. Extending the deadline to enroll by six months will allow time for the new process to be implemented and the changes to be fully communicated to the licensee community. A smooth enrollment process will help reinforce efforts to improve the CURES database and encourage its increased use. Prepared by:Sarah Huchel and Mark Mendoza / B., P. & E.D. / (916) 651-4104 9/11/15 14:06:22 **** END ****