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

Senate Bill No. 482

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, 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, 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 begin insert and a pharmacist end insert 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 begin delete knowingly end delete 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 begin delete use. end delete begin insert use and that the department had adequate staff, user support, and education, as specified. end insert

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, begin delete or inaccurate end delete begin insert inaccurate, or misattributed end insert information begin delete submitted, to or reported by, end delete begin insert submitted to, reported by, or relied upon in end insert the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

begin insert

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.

end insert begin insert

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.

end insert

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)  begin insert (A) end insert begin insert   end insert 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 begin delete party. end delete begin insert party, unless authorized by, or pursuant to, state
and federal privacy and security laws and regulations. end insert 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

(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.

end 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 begin insert as long as
no additional CURES data is provided end insert and keep a copy of the
report in the patient’s medical record begin delete if reasonable care has been
taken to ensure that the report is provided or kept end delete 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, begin delete or
inaccurate end delete begin insert inaccurate, or misattributed end insert information submitted to,
begin delete or end delete reported by, begin insert or relied upon in end insert 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 begin insert to end insert 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 begin delete veterinarians. end delete begin insert veterinarians or
pharmacists. end insert

(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 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,
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.

begin delete

(8) If the CURES database cannot be accessed because of
exceptional circumstances, as demonstrated by a health care
practitioner.

end delete begin insert

(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.

end insert

(d) (1) A health care practitioner who begin delete knowingly end delete 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 begin delete use. end delete begin insert 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. end insert 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.