AB 1731: CURES database: buprenorphine.
- Session Year: 2023-2024
- House: Assembly
- Latest Version Date: 2023-09-01
Current Status:
Passed
(2023-09-01: Chaptered by Secretary of State - Chapter 144, Statutes of 2023.)
Introduced
In Committee
First Chamber
In Committee
Second Chamber
Enacted
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 a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the patient activity report or information from the patient activity report obtained from CURES, as specified. Existing law exempts a health care practitioner from the duty to consult the CURES database in certain circumstances, including when a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substances does not exceed a nonrefillable 7-day supply of the controlled substance.
This bill would additionally exempt a health care practitioner from the duty to consult the CURES database when the health care practitioner prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
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 a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the patient activity report or information from the patient activity report obtained from CURES, as specified. Existing law exempts a health care practitioner from the duty to consult the CURES database in certain circumstances, including when a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substances does not exceed a nonrefillable 7-day supply of the controlled substance.
This bill would additionally exempt a health care practitioner from the duty to consult the CURES database when the health care practitioner prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
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 a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the patient activity report or information from the patient activity report obtained from CURES, as specified. Existing law exempts a health care practitioner from the duty to consult the CURES database in certain circumstances, including when a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substances does not exceed a nonrefillable 7-day supply of the controlled substance.
This bill would additionally exempt a health care practitioner from the duty to consult the CURES database when the health care practitioner prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
(a)(1)(A)(i)A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patients controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(ii)If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patients controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(iii)A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patients medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.
(B)For purposes of this paragraph, first time means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish 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 review a patients controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes 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 or pharmacists.
(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 to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises:
(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)Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.
(F)A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.
(2)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-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, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
(4)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patients treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-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.
(F)Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.
(5)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.
(6)(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, or furnished does not exceed a nonrefillable seven-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 they did not consult the database in the patients medical record.
(7)If the CURES database is not operational, as determined by the department, or 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 the cause of the temporary technological or electrical failure that is reasonably within the health care practitioners control.
(8)If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.
(9)If consultation of the CURES database would, as determined by the health care practitioner, result in a patients inability to obtain a prescription in a timely manner and thereby adversely impact the patients medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
(d)(1)A health care practitioner who 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 practitioners liability for the negligent failure to diagnose or treat a patient.
(e)All applicable state and federal privacy laws govern the duties required by this section.
(f)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.
(g)This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.
(a)(1)(A)(i)A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patients controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(ii)If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patients controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(iii)A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patients medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.
(B)For purposes of this paragraph, first time means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish 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 review a patients controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes 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 or pharmacists.
(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 to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises:
(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)Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.
(F)A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.
(2)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-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, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
(4)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patients treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-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.
(F)Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.
(5)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.
(6)(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, or furnished does not exceed a nonrefillable seven-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 they did not consult the database in the patients medical record.
(7)If the CURES database is not operational, as determined by the department, or 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 the cause of the temporary technological or electrical failure that is reasonably within the health care practitioners control.
(8)If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.
(9)If consultation of the CURES database would, as determined by the health care practitioner, result in a patients inability to obtain a prescription in a timely manner and thereby adversely impact the patients medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
(d)(1)A health care practitioner who 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 practitioners liability for the negligent failure to diagnose or treat a patient.
(e)All applicable state and federal privacy laws govern the duties required by this section.
(f)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.
(g)This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.
(a)(1)(A)(i)A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patients controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(ii)If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patients controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.
(iii)A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patients medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.
(B)For purposes of this paragraph, first time means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish 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 review a patients controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes 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 or pharmacists.
(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 to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises:
(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)Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.
(F)A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.
(2)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-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, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.
(3)(4)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patients treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-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.
(F)Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.
(4)(5)If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.
(5)(6)(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, or furnished does not exceed a nonrefillable seven-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 they did not consult the database in the patients medical record.
(6)(7)If the CURES database is not operational, as determined by the department, or 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 the cause of the temporary technological or electrical failure that is reasonably within the health care practitioners control.
(7)(8)If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.
(8)(9)If consultation of the CURES database would, as determined by the health care practitioner, result in a patients inability to obtain a prescription in a timely manner and thereby adversely impact the patients medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
(d)(1)A health care practitioner who 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 practitioners liability for the negligent failure to diagnose or treat a patient.
(e)All applicable state and federal privacy laws govern the duties required by this section.
(f)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.
(g)This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.
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Date
|
Status
|
|---|---|
| Sep 1, 2023 | Chaptered by Secretary of State - Chapter 144, Statutes of 2023. |
| Sep 1, 2023 | Approved by the Governor. |
| Aug 29, 2023 | Enrolled and presented to the Governor at 11:30 a.m. |
| Aug 17, 2023 | In Assembly. Ordered to Engrossing and Enrolling. |
| Aug 17, 2023 | Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0. Page 2136.). |
| Jun 8, 2023 | Ordered to third reading. |
| Jun 8, 2023 | From Consent Calendar. |
| Jun 6, 2023 | Read second time. Ordered to Consent Calendar. |
| Jun 5, 2023 | From committee: Do pass. To Consent Calendar. (Ayes 13. Noes 0.) (June 5). |
| May 3, 2023 | Referred to Com. on B., P. & E. D. |
| Apr 18, 2023 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Apr 17, 2023 | Read third time. Passed. Ordered to the Senate. (Ayes 79. Noes 0. Page 1181.) |
| Apr 12, 2023 | Read second time. Ordered to Consent Calendar. |
| Apr 11, 2023 | From committee: Do pass. To Consent Calendar. (Ayes 18. Noes 0.) (April 11). |
| Mar 9, 2023 | Referred to Com. on B. & P. |
| Feb 18, 2023 | From printer. May be heard in committee March 20. |
| Feb 17, 2023 | Read first time. To print. |
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Date
|
Description
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Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 17, 2023 | Assembly 3rd Reading AB1731 Santiago By Roth | Senate Floor |
Passed |
|
| Jun 5, 2023 | Do pass and be ordered to the Consent Calendar | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Apr 17, 2023 | AB 1731 Santiago Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Apr 11, 2023 | Do pass. To Consent Calendar. | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
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Organization
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Position
|
Date
|
|---|---|---|
| California Chapter of the American College of Emergency Physicians | ** Support | |
| California Hospital Association | ** Support | |
| California Medical Association | ** Support | |
| Medical Board of California | ** Support |
SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 1731 |
THIRD READING
Bill No: AB 1731
Author: Santiago (D)
Introduced: 2/17/23
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 13-0, 6/5/23
AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Glazer, Niello, Smallwood-Cuevas, Wahab, Wilk
ASSEMBLY FLOOR: 79-0, 4/17/23 (Consent) - See last page for vote
SUBJECT: CURES database: buprenorphine
SOURCE: California Chapter of the American College of Emergency Physicians
DIGEST:
This bill exempts a health care practitioner who prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital from requirements under current law to consult the state’s prescription drug monitoring program (PDMP) database, the Controlled Substance Utilization Review and Evaluation System (CURES).
ANALYSIS:
Existing law:
- Establishes various practice acts in the Business and Professions Code (BPC) governed by various boards within the Department of Consumer Affairs (DCA) which provide for the licensing and regulation of health care professionals including: physicians and surgeons (under the Medical Practice Act), dentists (under the Dental Practice Act), veterinarians (under the Veterinary Medicine Practice Act); registered nurses, nurse practitioners (NP) and certified nurse-midwives (CNM) (under the Nursing Practice Act); physician assistants (PA) (under the Physician Assistant Practice Act); osteopathic physicians and surgeons (under the Osteopathic Medical Practice Act); naturopathic doctors (ND) (under the Naturopathic Doctors Act); optometrists (under the Optometry Practice Act); doctors of podiatric medicine (under the Podiatric Act) and; pharmacies, pharmacists and wholesalers of dangerous drugs or devices (under the Pharmacy Law). (Business and Professions Code (BPC) §§ 500 et seq.)
- 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 ND. (BPC § 4059)
- Establishes the Uniform Controlled Substances Act which regulates controlled substances and defines an opiate as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)
- Classifies controlled substances into five schedules according to their danger and potential for abuse. (HSC §§ 11054-11058)
- Prohibits any person other than a physician, dentist, podiatrist, veterinarian, ND (according to certain supervision and protocol requirements), pharmacist (according to certain authorization and according to certain policies and procedures), CNM (if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the CNM’s practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified), NP (if it is consistent with a NP’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); a pharmacist or registered nurse or PA acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC §§ 128125 et seq.); an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance.
(HSC § 11150) - States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
- Prohibits medical professionals from prescribing, administering, or dispensing a controlled substance to an addict, as defined. (HSC § 11156)
- Establishes CURES, a PDMP maintained by the Department of Justice (DOJ) for the purpose of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165(a))
- Requires health care practitioners in receipt of a federal Drug Enforcement Administration (DEA) registration providing authorization to prescribe controlled substances, as well as pharmacists, to register for access to the CURES database. (HSC § 11165.1(a))
- Requires health care practitioners to 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 least once every six months thereafter if the substance remains part of the treatment of the patient. Provides numerous exemptions from the duty to consult CURES, including for certain patient populations and under various circumstances, including health care practitioners who prescribe, order, or furnish a controlled substance in the emergency department of a general acute care hospital, when the quantity of the controlled substance does not exceed a nonrefillable seven-day supply. (HSC § 11165.4)
This bill exempts a health care practitioner who prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital from the duty consult CURES.
Background
Buprenorphine. Itself a type of opioid, buprenorphine is a Schedule III controlled substance used in medication-assisted treatment of opioid addiction. Buprenorphine is what is referred to as a partial opioid agonist; this essentially means that it provides a much lower degree of euphoria than other opioids like oxycodone and heroin, and is considered to be less prone to abuse or dependence. In medication-assisted treatment of addiction, buprenorphine is used similarly to methadone, but with reduced side effects. Buprenorphine is frequently marketed under the brand name Subutex, as well as Suboxone when combined with naloxone, an opioid antagonist.
As an opioid classified as a Schedule III controlled substance, buprenorphine can only be prescribed or administered by a licensed practitioner in possession of a DEA registration. Prior federal restrictions on buprenorphine under the federal Drug Addiction Treatment Act of 2000 allowed for only specially trained physicians to prescribe buprenorphine through an “X-waiver” process. Further restricting the availability of buprenorphine treatments was federal law limiting the number of patients a physician in receipt of an X-waiver may treat. The Drug Addiction Treatment Act of 2000 originally capped the number of patients per physician at ten; this cap was raised under the Obama administration to allow up to 100 patients to be treated with buprenorphine per approved physicians who have held the waiver for two years, and up to 275 patients at three years. In January of 2021, the federal Department of Health and Human Services announced that it was eliminating the X-waiver entirely. As the federal restrictions on prescribing buprenorphine have incrementally loosened, the number of prescriptions has gone up substantially.
CURES. The CURES database was first established in 1996 as a “technologically sophisticated” database containing prescription records collected through California’s Triplicate Prescription Program, which provided the DOJ with copies of all Schedule II drug prescriptions. Subsequent legislation made CURES the state’s sole prescription record repository and added Schedule III, IV, and V drugs to the database. In 2008, CURES was upgraded to function as a PDMP, allowing health professionals, regulators, and law enforcement to conduct web-based searches of the system to inform prescribing practices and support investigations. Budget problems later plagued the database as the elimination of the DOJ’s Bureau of Narcotics Enforcement effectively defunded the CURES program. Users of the system complained that the PDMP offered insufficient client support and was plagued with technical issues. In response, Attorney General Kamala Harris sponsored legislation to overhaul the database with revenue newly derived from a license fee charged to healing arts professionals. The resulting system, commonly referred to as “CURES 2.0,” was considered to be a significantly improved, state-of-the-art tool for addressing the abuse and diversion of opioids and other prescription drugs.
Every dispenser of controlled substances and every health practitioner authorized by the DEA to prescribe controlled substances is required to obtain a login for access to CURES. For each dispensed Schedule II, III, IV, or V drug, pharmacists are required to report basic information about the patient and their prescription within one working day. This information is then made available to other system users in a variety of possible contexts. For example, physicians may query a patient’s prescription history prior to writing a new prescription; pharmacists can check the system before agreeing to fill a prescription for a controlled substance; regulators may review a licensee’s prescribing practices as part of a disciplinary investigation; and law enforcement can incorporate a search of the system into a potential criminal case of drug diversion. The vast majority of these searches (over 99%) are made by prescribers and dispensers seeking to review a patient’s prescription history as a component of exercising informed clinical judgment before providing access to opioids or other controlled substances.
Access to CURES data is limited by a number of state and federal privacy laws. This includes the federal Health Insurance Portability and Accountability Act (HIPAA), the California Medical Information Act, and the Information Practices Act. Whether law enforcement use of the system implicates the Fourth Amendment’s protections against unreasonable searches has historically been a topic of discussion. In 2017, the Supreme Court of California ruled in Lewis v. Superior Court that privacy interests are justified by the state’s interest in preventing drug diversion.
Health practitioners are required to consult the CURES database prior to writing a prescription for a Schedule II, III, or IV drug for the first time, and then at least once every six months as long as the prescription continues to be renewed. There are a number of existing exemptions to this requirement:
- If the health care practitioner is a veterinarian or a pharmacist;
- If the health care practitioner prescribes, orders, or furnishes the controlled substance to be administered to a patient in a specified facility, or for us while on the facility premises;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient as part of the patient’s treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in one of several specified facilities;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient who is terminally ill;
- It is not reasonably possible for a health care practitioner 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 the controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance;
- If the CURES database is not operational, as determined by the DOJ, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure;
- If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner; or
- If consultation of the CURES database would, as determined by the health care practitioner, result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
Because buprenorphine is a Schedule III controlled substance, prescriptions of the drug are tracked in CURES, and health care practitioners are also required to consult CURES before prescribing buprenorphine consistent with the requirement for prescribing other opioids. However, the author and sponsors of this bill contend that the duty to consult CURES may not be practical for buprenorphine. The purpose of consulting CURES is to inform practitioners as to whether there is indication that a patient may have opioid use disorder before prescribing additional pain medication. In the case of buprenorphine, the prescription would be provided to treat opioid use disorder, such an indication would only further encourage the prescription.
Considering that buprenorphine still has some potential for abuse or diversion as a partial agonist, its federal classification as a Schedule III drug and its general inclusion in California’s opioid abuse prevention laws is arguably appropriate. However, the author contends that the administrative impediment of consulting CURES in an emergency department setting prior to prescribing buprenorphine is not merited by the relatively lower risk of adverse consequences compared to prescriptions for pain management medication. Further, there is a cogent state interest in increasing the availability of buprenorphine, particularly as overdoses across the state continue to grow. This bill seeks to reflect that balance by exempting prescriptions for buprenorphine in hospital emergency departments from the duty to consult the CURES database.
FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No
SUPPORT: (Verified 6/6/23)
California Chapter of the American College of Emergency Physicians (source)
California Hospital Association
California Medical Association
Medical Board of California
OPPOSITION: (Verified 6/6/23)
None received
ARGUMENTS IN SUPPORT: Supporters appreciate removing unnecessary processes that keep emergency physicians from treating their patients as quickly as possible and note that providing a buprenorphine exemption from CURES consultation requirements in the emergency department will save time and enable patients to receive timely treatment.
ASSEMBLY FLOOR: 79-0, 4/17/23
AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner Horvath, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon
NO VOTE RECORDED: Haney
Prepared by: Sarah Mason / B., P. & E.D. /
6/8/23 10:02:27
**** END ****
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Richard Roth, Chair
2023 - 2024 Regular
Bill No: AB 1731 Hearing Date: June 5, 2023
Author: | Santiago | ||
Version: |
| ||
Urgency: | Fiscal: | ||
Consultant: | |||
Subject: CURES database: buprenorphine
SUMMARY:
Exempts a health care practitioner who prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital from requirements under current law to consult the state’s prescription drug monitoring program (PDMP) database, the Controlled Substance Utilization Review and Evaluation System (CURES).
Existing law:
- Establishes various practice acts in the Business and Professions Code (BPC) governed by various boards within the Department of Consumer Affairs (DCA) which provide for the licensing and regulation of health care professionals including: physicians and surgeons (under the Medical Practice Act), dentists (under the Dental Practice Act), veterinarians (under the Veterinary Medicine Practice Act); registered nurses, nurse practitioners (NP) and certified nurse-midwives (CNM) (under the Nursing Practice Act); physician assistants (PA) (under the Physician Assistant Practice Act); osteopathic physicians and surgeons (under the Osteopathic Medical Practice Act); naturopathic doctors (ND) (under the Naturopathic Doctors Act); optometrists (under the Optometry Practice Act); doctors of podiatric medicine (under the Podiatric Act) and; pharmacies, pharmacists and wholesalers of dangerous drugs or devices (under the Pharmacy Law). (Business and Professions Code (BPC) §§ 500 et seq.)
- 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 ND. (BPC § 4059)
- Establishes the Uniform Controlled Substances Act which regulates controlled substances and defines an opiate as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)
- Classifies controlled substances into five schedules according to their danger and potential for abuse. (HSC §§ 11054-11058)
- Prohibits any person other than a physician, dentist, podiatrist, veterinarian, ND (according to certain supervision and protocol requirements), pharmacist (according to certain authorization and according to certain policies and procedures), CNM (if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the CNM’s practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified), NP (if it is consistent with a NP’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); a pharmacist or registered nurse or PA acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC §§ 128125 et seq.); an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance.
(HSC § 11150) - States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
- Prohibits medical professionals from prescribing, administering, or dispensing a controlled substance to an addict, as defined. (HSC § 11156)
- Establishes CURES, a PDMP maintained by the Department of Justice (DOJ) for the purpose of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165(a))
- Requires health care practitioners in receipt of a federal Drug Enforcement Administration (DEA) registration providing authorization to prescribe controlled substances, as well as pharmacists, to register for access to the CURES database. (HSC § 11165.1(a))
- Requires health care practitioners to 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 least once every six months thereafter if the substance remains part of the treatment of the patient. Provides numerous exemptions from the duty to consult CURES, including for certain patient populations and under various circumstances, including health care practitioners who prescribe, order, or furnish a controlled substance in the emergency department of a general acute care hospital, when the quantity of the controlled substance does not exceed a nonrefillable seven-day supply. (HSC § 11165.4)
This bill exempts a health care practitioner who prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital from the duty consult CURES.
FISCAL EFFECT:
COMMENTS:
Purpose. This bill is sponsored by the California Chapter of the American College of Emergency Physicians. According to the Author, “Existing law requires physicians in the emergency department to check the CURES database when prescribing a controlled substance. The problem that exists for emergency physicians relates to prescribing buprenorphine. When an emergency physician is prescribing buprenorphine, they also are assisting the patient by setting up an appointment at a drug treatment program. This is the “medication assisted treatment” model otherwise known as MAT. Commonly, the emergency physician will prescribe enough buprenorphine in order for the patient to get to their first appointment at the drug treatment center. Emergency physicians only prescribe buprenorphine for patients wanting to go get drug treatment. Buprenorphine acts to suppress the cravings that come with addictive drugs. Buprenorphine is not a drug that patients are seeking to get high. Emergency physicians report there is no information in CURES that will stop them from prescribing buprenorphine.”
The Author notes that “The specific problem occurring is many patients can’t get an appointment with a drug treatment program for 10-14 days. As a result, the emergency physician is required to check CURES before prescribing the buprenorphine because the prescription is more than seven days. The issue with this scenario is the time it takes to check the CURES database. It can take anywhere from 5-10 minutes to check CURES. If the physician is having problems with their password, which is not uncommon with the CURES database, it can take more than 10 minutes. Speaking with an emergency physician at an inner-city emergency department in San Diego they may prescribe buprenorphine 8-10 times per day. This translates to a minimum of 40 minutes to almost two hours every day at one emergency department is spent checking CURES rather than treating patients.”
“AB 1731 would create a small exemption for emergency physicians when prescribing buprenorphine to not be required to check CURES. Emergency physicians understand the value of checking the CURES database to see if a patient is a drug seeker or may have been prescribed an inordinate amount of a controlled substance. Once again, for prescribing buprenorphine, due to its unique drug profile of suppressing cravings of addictive drugs, is not a risk for abuse.”
- Background.
Opioids. Opioids are a class of drugs prescribed and administered by health professionals to manage pain. The term “opioid” is commonly used to describe both naturally occurring opiates derived from the opium poppy as well as their manufactured synthetics. Common examples of prescription opioids include oxycodone (OxyContin, Percocet); hydrocodone (Vicodin, Norco, Lorcet); codeine; and morphine. Heroin is also an opioid, but is ineligible for lawful prescription in the United States. In addition to providing pain relief, opioids can be used as a cough suppressant, an antidiarrheal, a method of sedation, and a treatment for shortness of breath.
The majority of pharmaceutical opioids are Schedule II drugs under the federal Controlled Substances Act, considered by the DEA to have a high potential for abuse that may lead to severe psychological or physical dependence. However, combination drugs containing lower doses of opioids combined with other active ingredients are typically less restricted; for example, cough syrups containing low doses of codeine are frequently classified Schedule V medications.
In October of 2017, the White House declared the opioid crisis a national public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention (CDC), as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year. The California Department of Public Health estimated that nearly 2,000 Californians died of an opioid overdose in 2016.
The nature of the country’s opioid crisis has evolved over the past several years as illicitly manufactured fentanyl has replaced prescribed pain management medication as the dominant source of opioid-related overdoses. Fentanyl is a synthetic opioid that is up to 100 times stronger than morphine. Fentanyl is often pressed into pills to imitate more common (and less potent) pharmaceutical products, and other drugs can be unknowingly “laced” with fentanyl. Over 70,000 Americans died of a fentanyl overdose in 2021, including 5,961 deaths in California – approximately 83% of all opioid-related deaths in California.
The abuse of prescription drugs was historically viewed as a criminal concern analogous to street narcotics cases regularly investigated by law enforcement. In recent years, however, an expert consensus has evolved around the opinion that the opioid crisis must be addressed through the lens of public health policy. It is widely accepted that health professionals must continue to play a critical role in any meaningful solutions through safe-prescribing and the medication-assisted treatment of opioid use disorder.
Buprenorphine. Itself a type of opioid, buprenorphine is a Schedule III controlled substance used in medication-assisted treatment of opioid addiction. Buprenorphine is what is referred to as a partial opioid agonist; this essentially means that it provides a much lower degree of euphoria than other opioids like oxycodone and heroin, and is considered to be less prone to abuse or dependence. In medication-assisted treatment of addiction, buprenorphine is used similarly to methadone, but with reduced side effects. Buprenorphine is frequently marketed under the brand name Subutex, as well as Suboxone when combined with naloxone, an opioid antagonist.
As an opioid classified as a Schedule III controlled substance, buprenorphine can only be prescribed or administered by a licensed practitioner in possession of a DEA registration. Prior federal restrictions on buprenorphine under the federal Drug Addiction Treatment Act of 2000 allowed for only specially trained physicians to prescribe buprenorphine through an “X-waiver” process. Further restricting the availability of buprenorphine treatments was federal law limiting the number of patients a physician in receipt of an X-waiver may treat. The Drug Addiction Treatment Act of 2000 originally capped the number of patients per physician at ten; this cap was raised under the Obama administration to allow up to 100 patients to be treated with buprenorphine per approved physicians who have held the waiver for two years, and up to 275 patients at three years. In January of 2021, the federal Department of Health and Human Services announced that it was eliminating the X-waiver entirely. As the federal restrictions on prescribing buprenorphine have incrementally loosened, the number of prescriptions has gone up substantially.
CURES. The CURES database was first established in 1996 as a “technologically sophisticated” database containing prescription records collected through California’s Triplicate Prescription Program, which provided the DOJ with copies of all Schedule II drug prescriptions. Subsequent legislation made CURES the state’s sole prescription record repository and added Schedule III, IV, and V drugs to the database. In 2008, CURES was upgraded to function as a PDMP, allowing health professionals, regulators, and law enforcement to conduct web-based searches of the system to inform prescribing practices and support investigations. Budget problems later plagued the database as the elimination of the DOJ’s Bureau of Narcotics Enforcement effectively defunded the CURES program. Users of the system complained that the PDMP offered insufficient client support and was plagued with technical issues. In response, Attorney General Kamala Harris sponsored legislation to overhaul the database with revenue newly derived from a license fee charged to healing arts professionals. The resulting system, commonly referred to as “CURES 2.0,” was considered to be a significantly improved, state-of-the-art tool for addressing the abuse and diversion of opioids and other prescription drugs.
Every dispenser of controlled substances and every health practitioner authorized by the DEA to prescribe controlled substances is required to obtain a login for access to CURES. For each dispensed Schedule II, III, IV, or V drug, pharmacists are required to report basic information about the patient and their prescription within one working day. This information is then made available to other system users in a variety of possible contexts. For example, physicians may query a patient’s prescription history prior to writing a new prescription; pharmacists can check the system before agreeing to fill a prescription for a controlled substance; regulators may review a licensee’s prescribing practices as part of a disciplinary investigation; and law enforcement can incorporate a search of the system into a potential criminal case of drug diversion. The vast majority of these searches (over 99%) are made by prescribers and dispensers seeking to review a patient’s prescription history as a component of exercising informed clinical judgment before providing access to opioids or other controlled substances.
Access to CURES data is limited by a number of state and federal privacy laws. This includes the federal Health Insurance Portability and Accountability Act (HIPAA), the California Medical Information Act, and the Information Practices Act. Whether law enforcement use of the system implicates the Fourth Amendment’s protections against unreasonable searches has historically been a topic of discussion. In 2017, the Supreme Court of California ruled in Lewis v. Superior Court that privacy interests are justified by the state’s interest in preventing drug diversion.
Health practitioners are required to consult the CURES database prior to writing a prescription for a Schedule II, III, or IV drug for the first time, and then at least once every six months as long as the prescription continues to be renewed. There are a number of existing exemptions to this requirement:
- If the health care practitioner is a veterinarian or a pharmacist;
- If the health care practitioner prescribes, orders, or furnishes the controlled substance to be administered to a patient in a specified facility, or for us while on the facility premises;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient as part of the patient’s treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in one of several specified facilities;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient who is terminally ill;
- It is not reasonably possible for a health care practitioner 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 the controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance;
- If the CURES database is not operational, as determined by the DOJ, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure;
- If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner; or
- If consultation of the CURES database would, as determined by the health care practitioner, result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
Because buprenorphine is a Schedule III controlled substance, prescriptions of the drug are tracked in CURES, and health care practitioners are also required to consult CURES before prescribing buprenorphine consistent with the requirement for prescribing other opioids. However, the author and sponsors of this bill contend that the duty to consult CURES may not be practical for buprenorphine. The purpose of consulting CURES is to inform practitioners as to whether there is indication that a patient may have opioid use disorder before prescribing additional pain medication. In the case of buprenorphine, the prescription would be provided to treat opioid use disorder, such an indication would only further encourage the prescription.
Considering that buprenorphine still has some potential for abuse or diversion as a partial agonist, its federal classification as a Schedule III drug and its general inclusion in California’s opioid abuse prevention laws is arguably appropriate. However, the author contends that the administrative impediment of consulting CURES in an emergency department setting prior to prescribing buprenorphine is not merited by the relatively lower risk of adverse consequences compared to prescriptions for pain management medication. Further, there is a cogent state interest in increasing the availability of buprenorphine, particularly as overdoses across the state continue to grow. This bill seeks to reflect that balance by exempting prescriptions for buprenorphine in hospital emergency departments from the duty to consult the CURES database.
- Arguments in Support. Supporters appreciate removing unnecessary processes that keep emergency physicians from treating their patients as quickly as possible and note that providing a buprenorphine exemption from CURES consultation requirements in the emergency department will save time and enable patients to receive timely treatment.
SUPPORT AND OPPOSITION:
Support:
California Chapter of The American College of Emergency Physicians
California Hospital Association
California Medical Association
Medical Board of California
Opposition:
None received
-- END --
Date of Hearing: April 11, 2023
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Marc Berman, Chair
ABPCA Bill Id:AB 1731
Author:(Santiago) – As Introduced Ver:February 17, 2023
SUBJECT: CURES database: buprenorphine.
SUMMARY: Exempts a health care practitioner who prescribes, orders, administers, or furnishes buprenorphine in the emergency department of a hospital from the duty to consult the state’s prescription drug monitoring program (PDMP) database.
EXISTING LAW:
- Allows only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, registered nurse, certified nurse-midwife, optometrist, or out-of-state prescriber to write or issue a prescription. (Health and Safety Code (HSC) § 11150)
- States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
- Prohibits medical professionals from prescribing, administering, or dispensing a controlled substance to an addict, as defined. (HSC § 11156)
- Establishes the Controlled Substance Utilization Review and Evaluation System (CURES), a PDMP maintained by the Department of Justice (DOJ) for the purpose of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165(a))
- Requires pharmacists and other dispensers to report information to CURES within one working day relating to prescriptions of Schedule II, III, IV, and V controlled substances. (HSC § 11165(d))
- Requires health care practitioners in receipt of a federal Drug Enforcement Administration (DEA) registration providing authorization to prescribe controlled substances, as well as pharmacists, to register for access to the CURES database. (HSC § 11165.1(a))
- Allows the DOJ to conduct audits of CURES and its users and issue citations and fines for system misuse. (HSC § 11165.2)
- Requires health care practitioners to 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 least once every six months thereafter if the substance remains part of the treatment of the patient. (HSC § 11165.4(a))
- Exempts veterinarians and pharmacists from the duty to consult the CURES database. (HSC § 11165.4(b))
- Exempts health care practitioners who prescribe, order, or furnish a controlled substance to be administered to a patient on the premises of specified facilities from the duty to consult the CURES database. (HSC § 11165.4(c)(1))
- Exempts health care practitioners who prescribe, order, or furnish a controlled substance in the emergency department of a general acute care hospital from the duty to consult the CURES database when the quantity of the controlled substance does not exceed a nonrefillable seven-day supply. (HSC § 11165.4(c)(2))
- Exempts health care practitioners who prescribe, order, or furnish a controlled substance in certain facilities as part of a patient’s treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure from the duty to consult the CURES database when the quantity of the controlled substance does not exceed a nonrefillable seven-day supply. (HSC § 11165.4(c)(3))
- Exempts health care practitioners who prescribe, order, administer, or furnish a controlled substance to a patient who is terminally ill from the duty to consult the CURES database. (HSC § 11165.4(c)(4))
- Exempts health care practitioners from the duty to consult the CURES database when it is not reasonably possible for the practitioner to access the database in a timely manner, another practitioner is not reasonably available, and the quantity of the controlled substance prescribed does not exceed a nonrefillable seven-day supply. (HSC § 11165.4(c)(5))
- Exempts health care practitioners from the duty to consult the CURES database when the database is nonoperational or cannot be accessed due to technology limitations. (HSC § 11165.4(c)(6-7)
- Exempts health care practitioners from the duty to consult the CURES database when consultation would result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply. (HSC § 11165.4(c)(8)
- Provides that a health care practitioner who fails to consult the CURES database is subject to their state professional licensing board for administrative sanction. (HSC § 11165.4(d)
- Provides dedicated funding for the CURES program through an annual license fee assessed for licensees authorized to prescribe or dispense controlled substances in California. (Business and Professions Code § 208)
THIS BILL:
- Exempts health care practitioners who prescribe, order, administer, or furnish buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital from the duty to consult CURES, with no limitation on quantity.
FISCAL EFFECT: This bill is keyed nonfiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the California Chapter of the American College of Emergency Physicians. According to the author:
“AB 1731 is a time-saving measure that will help our emergency physicians provide quality care to their patients. Currently, emergency physicians are required to review CURES before prescribing more than seven days of a medication to ensure patients are not abusing controlled substances. While this system is an effective resource keeping our community members safe, there are instances in the Emergency Department (ED) where this requirement is unnecessary and time-consuming. When prescribing buprenorphine, an opioid antagonist that reduces opioid withdrawal symptoms, the requirement to review CURES will not change whether the emergency physician will write the patient a prescription. Being that California’s EDs are overcrowded, we must ensure our physicians have the ability to use their time wisely. Removing the requirement to review CURES before prescribing buprenorphine to patients who are seeking a safe means to detox from addictive drugs will allow for emergency physicians to treat other patients in need of urgent care in a timely manner.”
Background.
Overview of the Opioid Crisis. Opioids are a class of drugs prescribed and administered by health professionals to manage pain. The term “opioid” is commonly used to describe both naturally occurring opiates derived from the opium poppy as well as their manufactured synthetics. Common examples of prescription opioids include oxycodone (OxyContin, Percocet); hydrocodone (Vicodin, Norco, Lorcet); codeine; and morphine. Heroin is also an opioid, but is ineligible for lawful prescription in the United States.
In addition to providing pain relief, opioids can be used as a cough suppressant, an antidiarrheal, a method of sedation, and a treatment for shortness of breath. The majority of pharmaceutical opioids are Schedule II drugs under the federal Controlled Substances Act, considered by the DEA to have a high potential for abuse that may lead to severe psychological or physical dependence. However, combination drugs containing lower doses of opioids combined with other active ingredients are typically less restricted; for example, cough syrups containing low doses of codeine are frequently classified Schedule V medications.
In October of 2017, the White House declared the opioid crisis a national public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention (CDC), as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year. The California Department of Public Health estimated that nearly 2,000 Californians died of an opioid overdose in 2016.
The nature of the country’s opioid crisis has evolved over the past several years as illicitly manufactured fentanyl has replaced prescribed pain management medication as the dominant source of opioid-related overdoses. Fentanyl is a synthetic opioid that is up to 100 times stronger than morphine. Fentanyl is often pressed into pills to imitate more common (and less potent) pharmaceutical products, and other drugs can be unknowingly “laced” with fentanyl. Over 70,000 Americans died of a fentanyl overdose in 2021, including 5,961 deaths in California – approximately 83% of all opioid-related deaths in California.
The abuse of prescription drugs was historically viewed as a criminal concern analogous to street narcotics cases regularly investigated by law enforcement. In recent years, however, an expert consensus has evolved around the opinion that the opioid crisis must be addressed through the lens of public health policy. It is widely accepted that health professionals must continue to play a critical role in any meaningful solutions through safe-prescribing and the medication-assisted treatment of opioid use disorder.
Buprenorphine. Itself a type of opioid, buprenorphine is a Schedule III controlled substance used in medication-assisted treatment of opioid addiction. Buprenorphine is what is referred to as a partial opioid agonist; this essentially means that it provides a much lower degree of euphoria than other opioids like oxycodone and heroin, and is considered to be less prone to abuse or dependence. In medication-assisted treatment of addiction, buprenorphine is used similarly to methadone, but with reduced side effects. Buprenorphine is frequently marketed under the brand name Subutex, as well as Suboxone when combined with naloxone, an opioid antagonist.
As an opioid classified as a Schedule III controlled substance, buprenorphine can only be prescribed or administered by a licensed practitioner in possession of a DEA registration. Prior federal restrictions on buprenorphine under the federal Drug Addiction Treatment Act of 2000 allowed for only specially trained physicians to prescribe buprenorphine through an “X-waiver” process. Further restricting the availability of buprenorphine treatments was federal law limiting the number of patients a physician in receipt of an X-waiver may treat. The Drug Addiction Treatment Act of 2000 originally capped the number of patients per physician at ten; this cap was raised under the Obama administration to allow up to 100 patients to be treated with buprenorphine per approved physicians who have held the waiver for two years, and up to 275 patients at three years. In January of 2021, the federal Department of Health and Human Services announced that it was eliminating the X-waiver entirely.
As the federal restrictions on prescribing buprenorphine have incrementally loosened, the number of prescriptions has gone up substantially. The following chart is available through the California Department of Public Health’s Opioid Overdose Surveillance Dashboard, which utilizes data from the CURES database. The chart shows the rate of buprenorphine prescriptions per 1,000 residents statewide.
CURES. The CURES database was first established in 1996 as a “technologically sophisticated” database containing prescription records collected through California’s Triplicate Prescription Program, which provided the DOJ with copies of all Schedule II drug prescriptions. Subsequent legislation made CURES the state’s sole prescription record repository and added Schedule III, IV, and V drugs to the database. In 2008, CURES was upgraded to function as a PDMP, allowing health professionals, regulators, and law enforcement to conduct web-based searches of the system to inform prescribing practices and support investigations.
Budget problems later plagued the database as the elimination of the DOJ’s Bureau of Narcotics Enforcement effectively defunded the CURES program. Users of the system complained that the PDMP offered insufficient client support and was plagued with technical issues. In response, Attorney General Kamala Harris sponsored legislation to overhaul the database with revenue newly derived from a license fee charged to healing arts professionals. The resulting system, commonly referred to as “CURES 2.0,” was considered to be a significantly improved, state-of-the-art tool for addressing the abuse and diversion of opioids and other prescription drugs.
Every dispenser of controlled substances and every health practitioner authorized by the DEA to prescribe controlled substances is required to obtain a login for access to CURES. For each dispensed Schedule II, III, IV, or V drug, pharmacists are required to report basic information about the patient and their prescription within one working day. This information is then made available to other system users in a variety of possible contexts. For example, physicians may query a patient’s prescription history prior to writing a new prescription; pharmacists can check the system before agreeing to fill a prescription for a controlled substance; regulators may review a licensee’s prescribing practices as part of a disciplinary investigation; and law enforcement can incorporate a search of the system into a potential criminal case of drug diversion. The vast majority of these searches (over 99%) are made by prescribers and dispensers seeking to review a patient’s prescription history as a component of exercising informed clinical judgment before providing access to opioids or other controlled substances.
Access to CURES data is limited by a number of state and federal privacy laws. This includes the federal Health Insurance Portability and Accountability Act (HIPAA), the California Medical Information Act, and the Information Practices Act. Whether law enforcement use of the system implicates the Fourth Amendment’s protections against unreasonable searches has historically been a topic of discussion. In 2017, the Supreme Court of California ruled in Lewis v. Superior Court that privacy interests are justified by the state’s interest in preventing drug diversion.
As of October 2018, health practitioners are required to consult the CURES database prior to writing a prescription for a Schedule II, III, or IV drug for the first time, and then at least once every six months as long as the prescription continues to be renewed. There are a number of existing exemptions to this requirement:
- If the health care practitioner is a veterinarian or a pharmacist;
- If the health care practitioner prescribes, orders, or furnishes the controlled substance to be administered to a patient in a specified facility, or for us while on the facility premises;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient as part of the patient’s treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in one of several specified facilities;
- If the health care practitioner prescribes, orders, administers, or furnishes the controlled substance to a patient who is terminally ill;
- It is not reasonably possible for a health care practitioner 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 the controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance;
- If the CURES database is not operational, as determined by the DOJ, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure;
- If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner; or
- If consultation of the CURES database would, as determined by the health care practitioner, result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.
Because buprenorphine is a Schedule III controlled substance, prescriptions of the drug are tracked in CURES, and health care practitioners are also required to consult CURES before prescribing buprenorphine consistent with the requirement for prescribing other opioids. However, the author and sponsors of this bill contend that the duty to consult CURES may not be practical for buprenorphine. The purpose of consulting CURES is to inform practitioners as to whether there is indication that a patient may have opioid use disorder before prescribing additional pain medication. In the case of buprenorphine, the prescription would be provided to treat opioid use disorder, such an indication would only further encourage the prescription.
Considering that buprenorphine still has some potential for abuse or diversion as a partial agonist, its federal classification as a Schedule III drug and its general inclusion in California’s opioid abuse prevention laws is arguably appropriate. However, the author contends that the administrative impediment of consulting CURES in an emergency department setting prior to prescribing buprenorphine is not merited by the relatively lower risk of adverse consequences compared to prescriptions for pain management medication. Further, there is a cogent state interest in increasing the availability of buprenorphine, particularly as overdoses across the state continue to grow. This bill seeks to reflect that balance by exempting prescriptions for buprenorphine in hospital emergency departments from the duty to consult the CURES database.
Current Related Legislation. AB 663 (Haney) would allow for controlled substances approved for the treatment of opioid use disorder to be dispensed at mobile pharmacy units. This bill is pending in this committee.
Prior Related Legislation. AB 528 (Low, Chapter 677, Statutes of 2019) reduced the required timeframe in which pharmacists are required to report dispensed prescriptions to CURES from seven days to the following business day, added Schedule V drugs to CURES, and changed the requirement for health practitioners to continue consulting the CURES database from every four months to every six months beginning July 1, 2021.
AB 1751 (Low, Chapter 478, Statutes of 2018) provides a framework for the CURES PDMP to connect with other states that comply with California’s patient privacy and data security standards.
AB 1753 (Low, Chapter 479, Statutes of 2018) allows the DOJ links uniquely serialized prescription pads with CURES.
AB 2086 (Gallagher, Chapter 274, Statutes of 2018) allows prescribers of controlled substances to review a list of patients for whom they are listed as being the prescriber in CURES.
AB 40 (Santiago, Chapter 607, Statutes of 2017) required the DOJ to facilitate interoperability between health information technology systems and the CURES database, subject to a memorandum of understanding setting minimum security and privacy requirements.
SB 482 (Lara, Chapter 708, Statutes of 2016) mandated that health practitioners consult a patient’s history in CURES prior to prescribing them a Schedule II, III, or IV controlled substance for the first time and then at least once every four months as long as the prescription continued to be renewed.
SB 809 (DeSaulnier, Chapter 400, Statutes of 2013) established new healing arts license fees to fund the development and maintenance a new and improved “CURES 2.0” database.
AB 2986 (Mullin, Chapter 286, Statutes of 2006) added Schedule IV drugs to the CURES database.
SB 734 (Torlakson, Chapter 487, Statutes of 2005) created the framework to upgrade the CURES prescription database into a searchable, client-facing PDMP.
SB 151 (Burton, Chapter 406, Statutes of 2003) made CURES the state’s permanent prescription tracking program and added Schedule III drugs to the database.
AB 3042 (Takasugi, Chapter 345, Statutes of 2002) first established CURES as a pilot project operating concurrently with the state’s Triplicate Prescription Program.
ARGUMENTS IN SUPPORT:
The California Chapter of the American College of Emergency Physicians (California ACEP) is sponsoring this bill. According to California ACEP, “stopping to check CURES before prescribing to patients who are seeking a safe means to detox from opiates while awaiting treatment, takes away time that emergency physicians could use to treat a trauma victim or a patient in cardiac arrest. California’s EDs are already overburdened and overcrowded; mandatory checking of CURES for buprenorphine prescriptions unnecessarily adds to the time spent away from patients.”
ARGUMENTS IN OPPOSITION:
None on file.
REGISTERED SUPPORT:
California Chapter of the American College of Emergency Physicians (Sponsor)
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301
Bill Author
Bill Co-Author(s):