BILL NUMBER: SB 482AMENDED BILL TEXT AMENDED IN ASSEMBLY JUNE 21, 2016 AMENDED IN ASSEMBLY JUNE 6, 2016 AMENDED IN ASSEMBLY APRIL 7, 2016 AMENDED IN SENATE APRIL 30, 2015 AMENDED IN SENATE APRIL 16, 2015 INTRODUCED BY Senator Lara FEBRUARY 26, 2015 An act to amend Section 11165.1 of, and to add Section 11165.4 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGEST SB 482, as amended, Lara. Controlled substances: CURES database. Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department. This bill would require a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a controlled substance to consult the CURES database to review a patient's controlled substance history no earlier than 24 hours before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at leastannuallyonce every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, furnishing, or dispensing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would exempt a health care practitioner from this requirement if it is not reasonably possible for him or her to access the information in the CURES database in a timely manner, another health care practitioner or designee authorized to access the CURES database is not reasonably available, and the quantity of controlled substance prescribed, ordered, administered, furnished, or dispensed does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use and no refill of the controlled substance is allowed. The bill would provide that a health care practitioner who knowingly fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use. The bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, or inaccurate information submitted, to or reported by, the CURES database or for any resulting failure of the CURES database to accurately or timely report that information. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 11165.1 of the Health and Safety Code is amended to read: 11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances pursuant to Section 11150 shall, before July 1, 2016, or upon receipt of a federal Drug Enforcement Administration (DEA) registration, whichever occurs later, submit an application developed by the Department of Justice to obtain approval to access information online regarding the controlled substance history of a patient that is stored on the Internet and maintained within the Department of Justice, and, upon approval, the department shall release to that practitioner the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP). (ii) A pharmacist shall, before July 1, 2016, or upon licensure, whichever occurs later, submit an application developed by the Department of Justice to obtain approval to access information online regarding the controlled substance history of a patient that is stored on the Internet and maintained within the Department of Justice, and, upon approval, the department shall release to that pharmacist the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in the CURES PDMP. (B) An application may be denied, or a subscriber may be suspended, for reasons which include, but are not limited to, the following: (i) Materially falsifying an application for a subscriber. (ii) Failure to maintain effective controls for access to the patient activity report. (iii) Suspended or revoked federal DEA registration. (iv) Any subscriber who is arrested for a violation of law governing controlled substances or any other law for which the possession or use of a controlled substance is an element of the crime. (v) Any subscriber accessing information for any other reason than caring for his or her patients. (C) Any authorized subscriber shall notify the Department of Justice within 30 days of any changes to the subscriber account. (2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code. (b) Any request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the Department of Justice. (c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, or Schedule IV controlled substances, the Department of Justice may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual. (d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the Department of Justice pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code. (e) Information concerning a patient's controlled substance history provided to a prescriber or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, and 1308.14 of Title 21 of the Code of Federal Regulations. (f) A health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from any false, incomplete, or inaccurate information submitted to, or reported by, the CURES database or for any resulting failure of the CURES database to accurately or timely report that information. SEC. 2. Section 11165.4 is added to the Health and Safety Code, to read: 11165.4. (a) (1) (A) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense a controlled substance shall consult the CURES database to review a patient's controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at leastannuallyonce every four months thereafter if the substance remains part of the treatment of the patient. (B) For purposes of this paragraph, "first time" means the initial occurrence in which a health care practitioner, in his or her role as a health care practitioner, intends to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient. (2) A health care practitioner shall obtain a patient's controlled substance history from the CURES database no earlier than 24 hours before he or she prescribes, orders, administers, furnishes, or dispenses a Schedule II, Schedule III, or Schedule IV controlled substance to the patient. (b) The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians. (c) The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances: (1) If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered or dispensed to a patient while the patient is admitted to any of the following facilities or during an emergency transfer between any of the following facilities: (A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2. (B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2. (C) A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2. (D) A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2. (2) When a health care practitioner prescribes, orders, administers, furnishes, or dispenses a controlled substance in the emergency department of a general acute care hospital if the quantity of the controlled substance does not exceed a10-dayseven-day supply of the controlled substance to be used in accordance with the directions for use. (3) If a health care practitioner prescribes, orders, administers, furnishes, or dispenses a controlled substance to a patient as part of the patient's treatment for a surgical procedure, if the quantity of the controlled substance does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities: (A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2. (B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2. (C) A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2. (D) A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2. (E) A place of practice, as defined in Section 1658 of the Business and Professions Code. (4) If a health care practitioner prescribes, orders, administers, furnishes, or dispenses a controlled substance to a patient currently receiving hospice care, as defined in Section 1339.40. (5) (A) If all of the following circumstances are satisfied: (i) It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner. (ii) Another health care practitioner or designee authorized to access the CURES database is not reasonably available. (iii) The quantity of controlled substance prescribed, ordered, administered, furnished, or dispensed does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed. (B) A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason he or she did not consult the database in the patient's medical record. (6) If the CURES database is not operational, as determined by the department, or when it cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within his or her control. (7) If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner. (8) If the CURES database cannot be accessed because of exceptional circumstances, as demonstrated by a health care practitioner. (d) (1) A health care practitioner who knowingly fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. (2) This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient. (e) This section is not operative until six months after the Department of Justice certifies that the CURES database is ready for statewide use. The department shall notify the Secretary of State and the office of the Legislative Counsel of the date of that certification. (f) All applicable state and federal privacy laws govern the duties required by this section. (g) The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.