Amended in Assembly June 6, 2016

Amended in Assembly April 7, 2016

Amended in Senate April 30, 2015

Amended in Senate April 16, 2015

Senate Bill No. 482

Introduced by Senator Lara

February 26, 2015

An act to begin delete add Section 11165.4 to end delete begin insert amend Section 11165.1 of, and to add Section 11165.4 to, end insert 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.

begin delete

This bill would require all prescribers, as defined, prescribing a Schedule II or Schedule III controlled substance, to consult a patient’s electronic history in the CURES database before prescribing the controlled substance to the patient for the first time. The bill would also require the prescriber to consult the CURES database at least annually when the prescribed controlled substance remains part of the patient’s treatment. The bill would prohibit prescribing an additional Schedule II or Schedule III controlled substance to a patient with an existing prescription until the prescriber determines that there is a legitimate need for the controlled substance.

end delete begin delete

The bill would make the failure to consult a patient’s electronic history in the CURES database a cause for disciplinary action by the prescriber’s licensing board and would require the licensing boards to notify all prescribers authorized to prescribe controlled substances of these requirements. The bill would provide that a prescriber is not in violation of these requirements if a specified condition exists, including any time that the CURES database is suspended or not accessible, an inability to access the CURES database in a timely manner because of an emergency, when the controlled substance is prescribed to a patient receiving hospice care, or when the controlled substance is directly administered to the patient by the person prescribing the controlled substance. The bill would make its provisions operative upon the Department of Justice’s certification that the CURES database is ready for statewide use.

end delete begin insert

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 least annually 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.

end insert begin insert

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.

end insert begin insert

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.

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Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 11165.1 of the end insert begin insert Health and Safety Code end insert

begin insert is amended to read: end insert

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 begin delete shall be considered end delete begin insert is end insert 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.

begin insert

(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.

end insert

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 11165.4 is added to the end insert begin insert Health and Safety
Code end insert begin insert , to read: end insert

begin insert

begin insert 11165.4. end insert   

(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 least annually 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 a 10-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.

end insert

begin delete

SECTION 1.  

Section 11165.4 is added to the Health and Safety
Code, to read:

11165.4.  

(a) A prescriber shall access and consult the CURES
database for the electronic history of controlled substances
dispensed to a patient under his or her care before prescribing a
Schedule II or Schedule III controlled substance for the first time
to that patient and at least annually when that prescribed controlled
substance remains part of his or her treatment. If the patient has
an existing prescription for a Schedule II or Schedule III controlled
substance, the prescriber shall not prescribe an additional controlled
substance until the prescriber determines that there is a legitimate
need for that controlled substance.

(b) Failure to consult a patient’s electronic history as required
by subdivision (a) is cause for disciplinary action by the
prescriber’s licensing board. The licensing boards of all prescribers
authorized to write or issue prescriptions for controlled substances
shall notify these licensees of the requirements of this section.

(c) A prescriber is not liable in a civil action solely for failing
to consult the CURES database as required pursuant to subdivision
(a).

(d) The requirement in subdivision (a) does not apply, and a
prescriber is not in violation of this section, if any of the following
conditions are met:

(1) The CURES database is suspended or inaccessible, the
Internet is not operational, the data in the CURES database is
inaccurate or incomplete, or it is not possible to query the CURES
database in a timely manner because of an emergency.

(2) The controlled substance is prescribed to a patient receiving
hospice care.

(3) The controlled substance is prescribed to a patient as a part
of a surgical procedure that has or will occur in a licensed health
care facility and the prescription is nonrefillable.

(4) The controlled substance is directly administered to the
patient by the prescriber or another person authorized to prescribe
a controlled substance.

(e) This section shall not become operative until 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 Legislative Counsel of the date of that certification.

(f) For purposes of this section, “prescriber” means a health
care practitioner who is authorized to write or issue prescriptions
under Section 11150, excluding veterinarians.

(g) A violation of this section shall not be subject to the
provisions of Section 11374.

(h) All applicable state and federal privacy laws govern the
duties required by this section.

(i) 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.

end delete