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

Senate Bill No. 482

Introduced by Senator Lara

February 26, 2015

An act to amend begin delete Section end delete begin insert Sections 11165 and end insert 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 begin delete prescribe end delete begin insert prescribe, administer, furnish, end insert 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, begin delete furnish, or dispense end delete begin insert or furnish end insert a controlled substance to consult the CURES database to review a patient’s controlled substance history no earlier than 24 begin delete hours end delete begin insert hours, or the previous business day, end insert 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, begin delete furnishing, or dispensing end delete begin insert or furnishing end insert a controlled substance to a patient receiving hospice care, to a patient admitted to a specified begin delete facility, end delete begin insert facility for use while on facility premises, end insert 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. begin delete 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 delete begin insert The bill would require, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to end insert begin insert 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. end insert

begin delete

The

end delete

begin insert This end insert 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.

begin delete

The

end delete

begin insert This end insert 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:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 11165 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin insert

(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.

end insert

(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.

begin delete SECTION 1. end delete

begin insert SEC. 2. end insert   

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.

begin delete SEC. 2. end delete

begin insert SEC. 3. end insert   

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

11165.4.  

(a) (1) (A)  begin insert (i) end insert begin insert   end insert A health care practitioner authorized
to prescribe, order, administer, begin delete furnish, or dispense end delete begin insert or furnish end insert 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.

begin insert

(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.

end insert

(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,
begin delete furnish, or dispense end delete begin insert or furnish end insert 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
begin delete hours end delete begin insert hours, or the previous business day, end insert before he or she
prescribes, orders, administers, begin delete furnishes, or dispenses end delete begin insert or furnishes end insert
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 begin delete or dispensed end delete to a patient
while the patient is admitted to any of the following facilities or
during an emergency transfer between any of the following

begin delete facilities: end delete begin insert facilities for use while on facility premises: end insert

(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)  begin delete When end delete begin insert If end insert a health care practitioner prescribes, orders,
administers, begin delete furnishes, or dispenses end delete begin insert or furnishes end insert a controlled
substance in the emergency department of a general acute care
hospital begin delete if end delete begin insert and end insert the quantity of the controlled substance does not
exceed a begin insert nonrefillable end insert 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,
begin delete furnishes, or dispenses end delete begin insert or furnishes end insert a controlled substance to a
patient as part of the patient’s treatment for a surgical begin delete procedure,
if end delete begin insert procedure and end insert 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 begin delete use, end delete begin insert use end insert 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,
begin delete furnishes, or dispenses end delete begin insert or furnishes end insert 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) begin delete   end delete begin insert   end insert The quantity of controlled substance prescribed, ordered,
administered, begin delete furnished, or dispensed end delete begin insert or furnished end insert 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.