BILL NUMBER: SB 482 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 1, 2016
AMENDED IN ASSEMBLY JUNE 21, 2016
AMENDED IN ASSEMBLY JUNE 6, 2016
AMENDED IN ASSEMBLY APRIL 7, 2016
AMENDED IN SENATE APRIL 30, 2015
AMENDED IN SENATE APRIL 16, 2015
INTRODUCED BY Senator Lara
FEBRUARY 26, 2015
An act to amend Section Sections 11165 and
11165.1 of, and to add Section 11165.4 to, the Health and
Safety Code, relating to controlled substances.
LEGISLATIVE COUNSEL'S DIGEST
SB 482, as amended, Lara. Controlled substances: CURES database.
Existing law classifies certain controlled substances into
designated schedules. Existing law requires the Department of Justice
to maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) for the electronic monitoring of the
prescribing and dispensing of Schedule II, Schedule III, and Schedule
IV controlled substances by all practitioners authorized to
prescribe prescribe, administer, furnish, or
dispense these controlled substances. Existing law requires
dispensing pharmacies and clinics to report specified information for
each prescription of a Schedule II, Schedule III, or Schedule IV
controlled substance to the department.
This bill would require a health care practitioner authorized to
prescribe, order, administer, furnish, or dispense
or furnish a controlled substance to consult the CURES
database to review a patient's controlled substance history no
earlier than 24 hours hours, or the previous
business day, before prescribing a Schedule II, Schedule III,
or Schedule IV controlled substance to the patient for the first time
and at least once every 4 months thereafter if the substance remains
part of the treatment of the patient. The bill would exempt a
veterinarian from this requirement. The bill would also exempt a
health care practitioner from this requirement under specified
circumstances, including, among others, if prescribing, ordering,
administering, furnishing, or dispensing or
furnishing a controlled substance to a patient receiving
hospice care, to a patient admitted to a specified facility,
facility for use while on facility premises, or
to a patient as part of a treatment for a surgical procedure in a
specified facility if the quantity of the controlled substance does
not exceed a nonrefillable 5-day supply of the controlled substance
that is to be used in accordance with the directions for use.
The bill would exempt a health care practitioner from this
requirement if it is not reasonably possible for him or her to access
the information in the CURES database in a timely manner, another
health care practitioner or designee authorized to access the CURES
database is not reasonably available, and the quantity of controlled
substance prescribed, ordered, administered, furnished, or dispensed
does not exceed a nonrefillable 5-day supply of the controlled
substance that is to be used in accordance with the directions for
use and no refill of the controlled substance is allowed.
The bill would require, if a health care practitioner authorized
to prescribe, order, administer, or furnish a controlled substance
is not required to consult the CURES database the first
time he or she prescribes, orders, administers, or furnishes a
controlled substance to a patient pursuant to one of those
exemptions, the health care practitioner to consult the CURES
database before subsequently prescribing a Schedule II, Schedule III,
or Schedule IV controlled substance to the patient and at least once
every 4 months thereafter if the substance remains part of the
treatment of the patient.
The
This bill would provide that a health care practitioner
who knowingly fails to consult the CURES database is required to be
referred to the appropriate state professional licensing board solely
for administrative sanctions, as deemed appropriate by that board.
The bill would make the above-mentioned provisions operative 6 months
after the Department of Justice certifies that the CURES database is
ready for statewide use.
The
This bill would also exempt a health care practitioner,
pharmacist, and any person acting on behalf of a health care
practitioner or pharmacist, when acting with reasonable care and in
good faith, from civil or administrative liability arising from any
false, incomplete, or inaccurate information submitted, to or
reported by, the CURES database or for any resulting failure of the
CURES database to accurately or timely report that information.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 11165 of the Health
and Safety Code is amended to read:
11165. (a) To assist health care practitioners in their efforts
to ensure appropriate prescribing, ordering, administering,
furnishing, and dispensing of controlled substances, law enforcement
and regulatory agencies in their efforts to control the diversion and
resultant abuse of Schedule II, Schedule III, and Schedule IV
controlled substances, and for statistical analysis, education, and
research, the Department of Justice shall, contingent upon the
availability of adequate funds in the CURES Fund, maintain the
Controlled Substance Utilization Review and Evaluation System (CURES)
for the electronic monitoring of, and Internet access to information
regarding, the prescribing and dispensing of Schedule II, Schedule
III, and Schedule IV controlled substances by all practitioners
authorized to prescribe, order, administer, furnish, or dispense
these controlled substances.
(b) The Department of Justice may seek and use grant funds to pay
the costs incurred by the operation and maintenance of CURES. The
department shall annually report to the Legislature and make
available to the public the amount and source of funds it receives
for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable
federal and state privacy and security laws and regulations.
(2) CURES shall operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data obtained
from CURES shall only be provided to appropriate state, local, and
federal public agencies for disciplinary, civil, or criminal purposes
and to other agencies or entities, as determined by the Department
of Justice, for the purpose of educating practitioners and others in
lieu of disciplinary, civil, or criminal actions. Data may be
provided to public or private entities, as approved by the Department
of Justice, for educational, peer review, statistical, or research
purposes, provided that patient information, including any
information that may identify the patient, is not compromised.
Further, data disclosed to any individual or agency as described in
this subdivision shall not be disclosed, sold, or transferred to any
third party. The Department of Justice shall establish policies,
procedures, and regulations regarding the use, access, evaluation,
management, implementation, operation, storage, disclosure, and
security of the information within CURES, consistent with this
subdivision.
(3) In accordance with federal and state privacy laws and
regulations, a health care practitioner may provide a patient with a
copy of the patient's CURES patient activity report and keep a copy
of the report in the patient's medical record if reasonable care has
been taken to ensure that the report is provided or kept in
compliance with subdivision (d) of Section 11165.1.
(d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, as defined in the controlled
substances schedules in federal law and regulations, specifically
Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of
the Code of Federal Regulations, the dispensing pharmacy, clinic, or
other dispenser shall report the following information to the
Department of Justice as soon as reasonably possible, but not more
than seven days after the date a controlled substance is dispensed,
in a format specified by the Department of Justice:
(1) Full name, address, and, if available, telephone number of the
ultimate user or research subject, or contact information as
determined by the Secretary of the United States Department of Health
and Human Services, and the gender, and date of birth of the
ultimate user.
(2) The prescriber's category of licensure, license number,
national provider identifier (NPI) number, if applicable, the federal
controlled substance registration number, and the state medical
license number of any prescriber using the federal controlled
substance registration number of a government-exempt facility.
(3) Pharmacy prescription number, license number, NPI number, and
federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled substance
dispensed.
(5) Quantity of the controlled substance dispensed.
(6) International Statistical Classification of Diseases, 9th
revision (ICD-9) or 10th revision (ICD-10) Code, if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(e) The Department of Justice may invite stakeholders to assist,
advise, and make recommendations on the establishment of rules and
regulations necessary to ensure the proper administration and
enforcement of the CURES database. All prescriber and dispenser
invitees shall be licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, in active practice in California, and a regular
user of CURES.
(f) The Department of Justice shall, prior to upgrading CURES,
consult with prescribers licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, one or more of the boards or committees identified
in subdivision (d) of Section 208 of the Business and Professions
Code, and any other stakeholder identified by the department, for the
purpose of identifying desirable capabilities and upgrades to the
CURES Prescription Drug Monitoring Program (PDMP).
(g) The Department of Justice may establish a process to educate
authorized subscribers of the CURES PDMP on how to access and use the
CURES PDMP.
SECTION 1. SEC. 2. Section 11165.1
of the Health and Safety Code is amended to read:
11165.1. (a) (1) (A) (i) A health care practitioner authorized to
prescribe, order, administer, furnish, or dispense Schedule II,
Schedule III, or Schedule IV controlled substances pursuant to
Section 11150 shall, before July 1, 2016, or upon receipt of a
federal Drug Enforcement Administration (DEA) registration, whichever
occurs later, submit an application developed by the Department of
Justice to obtain approval to access information online regarding the
controlled substance history of a patient that is stored on the
Internet and maintained within the Department of Justice, and, upon
approval, the department shall release to that practitioner the
electronic history of controlled substances dispensed to an
individual under his or her care based on data contained in the CURES
Prescription Drug Monitoring Program (PDMP).
(ii) A pharmacist shall, before July 1, 2016, or upon licensure,
whichever occurs later, submit an application developed by the
Department of Justice to obtain approval to access information online
regarding the controlled substance history of a patient that is
stored on the Internet and maintained within the Department of
Justice, and, upon approval, the department shall release to that
pharmacist the electronic history of controlled substances dispensed
to an individual under his or her care based on data contained in the
CURES PDMP.
(B) An application may be denied, or a subscriber may be
suspended, for reasons which include, but are not limited to, the
following:
(i) Materially falsifying an application for a subscriber.
(ii) Failure to maintain effective controls for access to the
patient activity report.
(iii) Suspended or revoked federal DEA registration.
(iv) Any subscriber who is arrested for a violation of law
governing controlled substances or any other law for which the
possession or use of a controlled substance is an element of the
crime.
(v) Any subscriber accessing information for any other reason than
caring for his or her patients.
(C) Any authorized subscriber shall notify the Department of
Justice within 30 days of any changes to the subscriber account.
(2) A health care practitioner authorized to prescribe, order,
administer, furnish, or dispense Schedule II, Schedule III, or
Schedule IV controlled substances pursuant to Section 11150 or a
pharmacist shall be deemed to have complied with paragraph (1) if the
licensed health care practitioner or pharmacist has been approved to
access the CURES database through the process developed pursuant to
subdivision (a) of Section 209 of the Business and Professions Code.
(b) Any request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with guidelines
developed by the Department of Justice.
(c) In order to prevent the inappropriate, improper, or illegal
use of Schedule II, Schedule III, or Schedule IV controlled
substances, the Department of Justice may initiate the referral of
the history of controlled substances dispensed to an individual based
on data contained in CURES to licensed health care practitioners,
pharmacists, or both, providing care or services to the individual.
(d) The history of controlled substances dispensed to an
individual based on data contained in CURES that is received by a
practitioner or pharmacist from the Department of Justice pursuant to
this section is medical information subject to the provisions of the
Confidentiality of Medical Information Act contained in Part 2.6
(commencing with Section 56) of Division 1 of the Civil Code.
(e) Information concerning a patient's controlled substance
history provided to a prescriber or pharmacist pursuant to this
section shall include prescriptions for controlled substances listed
in Sections 1308.12, 1308.13, and 1308.14 of Title 21 of the Code of
Federal Regulations.
(f) A health care practitioner, pharmacist, and any person acting
on behalf of a health care practitioner or pharmacist, when acting
with reasonable care and in good faith, is not subject to civil or
administrative liability arising from any false, incomplete, or
inaccurate information submitted to, or reported by, the CURES
database or for any resulting failure of the CURES database to
accurately or timely report that information.
SEC. 2. SEC. 3. Section 11165.4 is
added to the Health and Safety Code, to read:
11165.4. (a) (1) (A) (i) A health care
practitioner authorized to prescribe, order, administer,
furnish, or dispense or furnish 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 once every four months thereafter if 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 an exemption described in subdivision (c), to consult the
CURES database the first time he or she prescribes, orders,
administers, or furnishes a controlled substance to a patient, he or
she shall consult the CURES database to review the patient's
controlled substance history before subsequently prescribing a
Schedule II, Schedule III, or Schedule IV controlled substance to the
patient and at least once every four months thereafter if the
substance remains part of the treatment of the patient.
(B) For purposes of this paragraph, "first time" means the initial
occurrence in which a health care practitioner, in his or her role
as a health care practitioner, intends to prescribe, order,
administer, furnish, or dispense 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 obtain a patient's controlled
substance history from the CURES database no earlier than 24
hours hours, or the previous business day,
before he or she prescribes, orders, administers,
furnishes, or dispenses 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.
(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: facilities 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.
(2) When If a health care
practitioner prescribes, orders, administers, furnishes, or
dispenses or furnishes a controlled substance in
the emergency department of a general acute care hospital
if 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,
furnishes, or dispenses or furnishes a
controlled substance to a patient as part of the patient's treatment
for a surgical procedure, if procedure and
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,
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 or furnishes 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 or furnished 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.