BILL NUMBER: SB 482 CHAPTERED
BILL TEXT
CHAPTER 708
FILED WITH SECRETARY OF STATE SEPTEMBER 27, 2016
APPROVED BY GOVERNOR SEPTEMBER 27, 2016
PASSED THE SENATE AUGUST 30, 2016
PASSED THE ASSEMBLY AUGUST 24, 2016
AMENDED IN ASSEMBLY AUGUST 19, 2016
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 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, 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, 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, or furnish a controlled substance to
consult the CURES database to review a patient's controlled substance
history no earlier than 24 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 and a
pharmacist 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, or furnishing a controlled substance to a patient
receiving hospice care, to a patient admitted to a specified 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 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.
This bill would provide that a health care practitioner who 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 and that the department has adequate staff,
user support, and education, as specified.
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, inaccurate, or misattributed information submitted
to, reported by, or relied upon in the CURES database or for any
resulting failure of the CURES database to accurately or timely
report that information.
Existing law requires the operation of the CURES database to
comply with all applicable federal and state privacy and security
laws and regulations. Existing law authorizes the disclosure of data
obtained from the CURES database to agencies and entities only for
specified purposes and requires the Department of Justice to
establish policies, procedures, and regulations regarding the use,
access, disclosure, and security of the information within the CURES
database.
This bill would authorize a health care practitioner to provide a
patient with a copy of the patient's CURES patient activity report if
no additional CURES data is provided. The bill would also prohibit a
regulatory board whose licensees do not prescribe, order,
administer, furnish, or dispense controlled substances from obtaining
data from the CURES database.
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) (A) 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, unless authorized by, or pursuant to, state and federal
privacy and security laws and regulations. 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.
(B) Notwithstanding subparagraph (A), a regulatory board whose
licensees do not prescribe, order, administer, furnish, or dispense
controlled substances shall not be provided data obtained from CURES.
(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 as long as no
additional CURES data is provided and keep a copy of the report in
the patient's medical record 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.
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,
inaccurate, or misattributed information submitted to, reported by,
or relied upon in the CURES database or for any resulting failure of
the CURES database to accurately or timely report that information.
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, 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 to 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, 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,
or the previous business day, before he or she 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 while the
patient is admitted to any of the following facilities or during an
emergency transfer between any of the following 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) 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 a controlled substance to a patient as part of the
patient's treatment for a surgical 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, 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,
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, 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 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 five-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 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 and that the department has adequate staff, which, at a
minimum, shall be consistent with the appropriation authorized in
Schedule (6) of Item 0820-001-0001 of the Budget Act of 2016 (Chapter
23 of the Statutes of 2016), user support, and education. 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.