BILL ANALYSIS �
SB 809
Page 1
Date of Hearing: August 13, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 809 (DeSaulnier and Steinberg) - As Amended: August 5, 2013
SENATE VOTE : 39-0
SUBJECT : Controlled substances: reporting.
SUMMARY : Establishes a funding mechanism to update and
maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) and Prescription Drug Monitoring
Program (PDMP), requires all prescribing health care
practitioners to apply to access CURES information, and
establishes processes and procedures for regulating prescribing
licensees through CURES and securing private information.
Specifically, this bill :
1)Assesses an annual six dollar fee on the following licensees
to pay the reasonable costs associated with operating and
maintaining CURES for the purpose of regulating those
licensees:
a) Physicians, dentists, podiatrists, veterinarians,
naturopathic doctors, pharmacists, registered nurse,
certified nurse-midwives, nurse practitioners, physician
assistants, and optometrists, as specified;
b) Wholesalers and nonresident wholesalers of dangerous
drugs, as specified;
c) Nongovernmental clinics, nonprofit clinics, and free
clinics, as specified; and,
d) Nongovernmental pharmacies, as specified.
2)Requires the assessed fee to be billed and collected by the
regulating agency of each licensee at the time of the
licensee's license renewal, and states that if the reasonable
regulatory cost of operating and maintaining CURES is less
than six dollars per licensee, the Department of Consumer
Affairs (DCA) may, by regulation, reduce the fee to the
reasonable regulatory cost.
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3)Requires the fees collected to be deposited in the CURES Fund,
which is created within the State Treasury.
4)Requires moneys in the CURES Fund to be, upon appropriation by
the Legislature, available to DCA to reimburse the Department
of Justice (DOJ) for costs to operate and maintain CURES for
the purposes of regulating the specified licensees.
5)Requires DCA to contract with DOJ on behalf of the Medical
Board of California (MBC), the Dental Board of California, the
California State Board of Pharmacy, the Veterinary Medical
Board, the Board of Registered Nursing, the Physician
Assistant Board of the Medical Board of California, the
Osteopathic Medical Board of California, the Naturopathic
Medicine Committee of the Osteopathic Medical Board, the State
Board of Optometry, and the California Board of Podiatric
Medicine to operate and maintain CURES for the purposes of
regulating licensees.
6)Requires DOJ, in conjunction with DCA and the appropriate
boards and committees, to do all of the following:
a) Identify and implement a streamlined application and
approval process to provide access to the CURES PDMP
database for pharmacists and licensed health care
practitioners eligible to prescribe Schedule II, Schedule
III, or Schedule IV controlled substances, and requires
every reasonable effort be made to implement a streamlined
application and approval process that a licensed health
care practitioner or pharmacist can complete at the time
that he or she is applying for licensure or renewing his or
her license;
b) Identify necessary procedures to enable licensed health
care practitioners and pharmacists with access to the CURES
PDMP to delegate their authority to order reports from the
CURES PDMP; and,
c) Develop a procedure to enable health care practitioners
who do not have a federal Drug Enforcement Administration
(DEA) number to opt out of applying for access to the CURES
PDMP.
7)Requires MBC to periodically develop and disseminate
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information and educational material regarding assessing a
patient's risk of abusing or diverting controlled substances
and information relating to CURES to each licensed physician
and surgeon and to each general acute care hospital in this
state; and further requires MBC to consult with the State
Department of Public Health, appropriate boards and
committees, and DOJ in developing the materials to be
distributed.
8)Requires a California pharmacy to report dispensing a Schedule
IV controlled substance issued by a prescriber in another
state for delivery to a patient in another state to CURES.
9)Requires DOJ to maintain CURES to assist health care
practitioners in their efforts to ensure appropriate
prescribing, ordering, administering, furnishing, and
dispensing of controlled substances.
10)Deletes provisions stating that the reporting of Schedules
III and IV controlled substances shall be contingent upon the
availability of adequate funds from DOJ.
11)Requires DOJ to annually report to the Legislature and make
available to the public the amount and source of funds it
receives for support of CURES.
12)Permits DOJ to seek and use grant funds to pay the costs
incurred by the operation and maintenance of CURES.
13)Requires CURES to comply with all applicable federal and
state privacy and security laws and regulations.
14)Requires DOJ to establish policies, procedures, and
regulations regarding the use, access, evaluation, disclosure,
management, implementation, operation, storage, and security
of the information within CURES.
15)Requires a pharmacy, clinic, or other dispenser to report
specified information, including a prescribers national
provider identifier number, to DOJ as soon as reasonably
possible, but not more than seven days after the date a
controlled substance is dispensed.
16)Permits DOJ to invite stakeholders to assist, advise, and
make recommendations on the establishment of rules and
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regulations necessary to ensure the proper administration and
enforcement of the CURES database. All prescriber and
dispenser invitees must be licensees, as specified, in active
practice in California, and a regular user of CURES.
17)Requires DOJ, prior to upgrading CURES, to consult with
prescribers licensed by one of the relevant boards or
committees, the boards or committees themselves, and any other
stakeholders for the purpose of identifying desirable
capabilities and upgrades to the CURES Prescription Drug
Monitoring Program (PDMP).
18)Permits DOJ to establish a process to educate authorized
subscribers of the CURES PDMP on how to access and use the
CURES PDMP.
19)Requires a health care practitioner authorized to prescribe,
order, administer, furnish, or dispense Schedule II-IV
controlled substances or a pharmacist to, before January 1,
2016, or upon receipt of a federal Drug Enforcement
Administration (DEA) registration, whichever occurs later,
submit an application to DOJ to access information online
regarding the controlled substance history of a patient, as
specified.
20)Requires DOJ, upon approval of an application to access
patient information, release to the practitioner or pharmacist
the electronic history of controlled substances dispensed to
an individual under his or her care based on data contained in
the CURES PDMP.
21)States that a health care practitioner authorized to
prescribe Schedules II-IV controlled substances, or a
pharmacist, shall be deemed to have completed the requirements
to access individual patient information if he or she has
applied to access CURES PDMP at the time he or she applied for
licensure or renewal.
22)Permits DOJ to seek voluntarily contributed private funds
from insurers, health care service plans, and qualified
manufacturers for the purpose of supporting CURES. Insurers,
health care service plans, qualified manufacturers, and other
donors may contribute by submitting their payment to the
Controller for deposit into the CURES Fund. Contributions to
the CURES Fund shall be nondeductible for state tax purposes.
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23)Defines the following terms:
a) "Controlled substance" means a drug, substance, or
immediate precursor listed in any schedule in Section
11055, 11056, or 11057 of the Health and Safety Code (HSC);
b) "Health care service plan" means an entity licensed
pursuant to the Knox-Keene Health Care Service Plan Act of
1975 (Chapter 2.2 (commencing with Section 1340) of
Division 2 of HSC);
c) "Insurer" means an admitted insurer writing health
insurance, as defined in Section 106 of the Insurance Code,
and an admitted insurer writing workers' compensation
insurance, as defined in Section 109 of the Insurance Code;
and,
d) "Qualified manufacturer" means a manufacturer of a
controlled substance, but does not mean a wholesaler or
nonresident wholesaler of dangerous drugs, as specified, a
veterinary food-animal drug retailer, as specified, or an
individual regulated by the MBC, the Dental Board of
California, the California State Board of Pharmacy, the
Veterinary Medical Board, the Board of Registered Nursing,
the Physician Assistant Committee of the Medical Board of
California, the Osteopathic Medical Board of California,
the State Board of Optometry, or the California Board of
Podiatric Medicine.
24)Makes clarifying and technical amendments.
25)Makes legislative findings and declarations.
EXISTING LAW :
1)Establishes CURES and requires DOJ to maintain CURES for the
electronic monitoring of the prescribing and dispensing of
Schedule II, III, and IV controlled substances by all
practitioners authorized to prescribe or dispense these
controlled substances. (Health and Safety Code (HSC) Section
11165(a))
2)Requires a dispensing pharmacy or clinic to provide specified
prescription data for each prescription for a Schedule II,
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III, or IV controlled substance to DOJ on a weekly basis.
(HSC 11165(d))
3)Allows a licensed health care practitioner who is eligible to
prescribe Schedule II, III, or IV controlled substances, or a
pharmacist, to make a written request to DOJ for the history
of controlled substances dispensed to an individual under his
or her care, and allows DOJ to provide that information to
that health care practitioner or pharmacist. (HSC 11165.1(a))
4)Provides that the history of controlled substances dispensed
to an individual based on data contained in CURES that is
received by a practitioner or pharmacist from DOJ pursuant to
this section shall be considered medical information subject
to specified confidentiality provisions. (HSC 11165.1(d))
5)Requires every practitioner, other than a pharmacist, who
prescribes or administers a controlled substance classified in
Schedule II, III or IV to record specified information
relating to the transaction. (HSC 11190)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill establishes a funding
mechanism for DOJ to update and maintain the CURES/PDMP
prescription monitoring system for the benefit of DCA
prescribing licensees and the public. By doing so, the author
aims to increase the quality and usability of the system to
improve monitoring for excessive or inappropriate prescribing.
This bill is sponsored by the Attorney General's office.
2)Author's statement . According to the author's office, "SB 809
provides essential funding to continue and strengthen the
CURES PDMP, a vital resource for medical professionals and law
enforcement to detect and prevent prescription drug abuse and
addiction, and save lives. Without dedicated funding, the
CURES program will be suspended and California will join
Missouri as the only state in the nation without a PDMP.
"Prescription drug abuse is the Nation's fastest-growing drug
problem and has been classified as a public health epidemic by
the Centers for Disease Control and Prevention. One hundred
people die from drug overdoses every day in the United States
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and prescription painkillers are responsible for 75% of these
deaths, claiming more lives than heroin and cocaine combined,
and fueling a doubling of drug-related deaths in the United
States over the last decade.
"SB 809 provides sufficient and sustainable revenue to
maintain the CURES program operations, sustain full
modernization, and improve program participation and
utilization by requiring all practitioners and pharmacists to
enroll in the CURES PDMP."
3)Background . CURES' predecessor, the California Triplicate
Prescription Program (TPP) was created in 1939 and was
replaced by CURES in 1998. In 2009, the PDMP system was
introduced as a searchable, client-facing component of CURES.
Presently, the database contains over 100 million entries of
controlled substance drugs that have been dispensed in
California. In 2012, the program responded to more than
800,000 requests. There are currently 174,338 prescribers
registered to use the system, and 38,290 pharmacists.
Pharmacists are required to report dispensations of Schedules
II-IV controlled substances at least weekly, but use of PDMP
by prescribers and dispensers for prescription abuse
prevention/intervention is voluntary.
The California Budget Act of 2011 eliminated all General Fund
support of CURES and PDMP, which included funding for system
support, staff support and related operating expenses. To
perform the minimum critical functions and to avoid shutting
down the program, the Department opted to assign staff to
perform temporary dual job assignments on a part time basis.
Although some tasks are being performed, the program is faced
with a constant backlog (e.g., four-week backlog on processing
new user applications, six-week response time on emails,
twelve week backlog on voicemails, etc.)
CURES is currently overseen by a single employee, and is on a
lifeline budget of $400,000. According to a March 2013
article in the Los Angeles Times, doctors requesting
information or seeking help from the database have received
email responses stating, "Unfortunately, due to budget
restrictions, there is no staff to accept or respond to your
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communication."
This bill will require all pharmacists or health care
practitioners authorized to prescribe, order, administer,
furnish, or dispense Schedule II-IV controlled substances to
submit an application to DOJ to access information online
regarding the controlled substance history of a patient by
January 2016. The updated CURES/PDMP will comply with all
state and federal security and privacy issues. Disciplinary,
civil or criminal actions will be taken by DOJ and/or the
appropriate licensing board for any misuse or inappropriate
accessing of patient data.
4)Arguments in support . California Medical Association writes,
"Physicians have long been and continue to be strong
supporters of the CURES database, which compiles prescription
information of Schedule II, III, and IV drugs dispensed in
California. We recognize its potential to help ensure
appropriate prescribing and as a tool for addressing the abuse
and diversion of prescription drugs. CMA supports CURES being
upgraded and maintained. Even in its current underfunded and
antiquated state, CURES provides valuable information that
supports appropriate prescribing of controlled substances. An
upgrade that is easy for physicians and other prescribers and
dispensers to access, moves closer to real time provision of
dispensing data, and that is integrated with other states'
PDMPs is welcome."
5)Previous legislation . SB 734 (Torlakson) (Chapter 487,
Statutes of 2005) authorized tamper resistant online access to
the CURES system for authorized physicians, pharmacists and
law enforcement pending the acquisition of private funding.
SB 1071 (DeSaulnier) of 2010 would have imposed a tax on
manufacturers or importers of Schedule II, III and IV
controlled substances to pay for ongoing costs of the CURES
program, to be collected by the State Board of Equalization at
the rate of $0.0025 per pill included in Schedules II, III,
and IV. SB 1071 was held in Senate Health Committee.
SB 360 (DeSaulnier) (Chapter 418, Statutes of 2011) authorized
DOJ to initiate administrative enforcement actions to prevent
the misuse of confidential information collected through the
CURES program.
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SB 616 (DeSaulnier) of 2012 would have increased fees up to
$10 per licensee for those licensees authorized to prescribe
or dispense controlled substances to pay for CURES. SB 616
was held in the Assembly Business, Professions, and Consumer
Protection Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Attorney General's Office (sponsor)
ALPHA Fund
American Cancer Society Cancer Action Network
American Medical Association
Association of California Healthcare Districts
Association of California Insurance Companies
Association of California Life and Health Insurance Companies
Association of Northern California Oncologists
California Academy of Family Physicians
California Association for Nurse Practitioners
California Association of Joint Powers Authorities
California Association of Oral and Maxillofacial Surgeons
California Board of Pharmacy
California Chapter of the American College of Emergency
Physicians
California Coalition on Workers' Compensation
California Department of Insurance
California Hospital Association
California JPIA
California Labor Federation
California Medical Association
California Narcotic Officers Association
California Pharmacists Association
California Police Chiefs Association
California Professional Association of Specialty Contractors
California Retailers Association
California Self-Insurers Association
California Society of Health-System Pharmacists
California Special Districts Association
California State Association of Counties
California State Sheriff's Association
Center for Public Interest Law
City and County of San Francisco
CompPharma
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County Alcohol and Drug Program Administrators Association of
California
County of San Diego
CSAC Excess Insurance Authority
Deputy Sheriffs' Association of San Diego County
Employers Group
Gallagher Bassett Services, Inc.
Golden Oak Cooperative Corporation
Grimmway Farms
Health Officers Association of California
Independent Insurance Agents and Brokers of California
Los Angeles District Attorney's Office
Medical Board of California
Medical Oncology Association of Southern California, Inc.
Metro Risk Management
Michael Sullivan & Associates
National Association of Chain Drug Stores
National Coalition Against Prescription Drug Abuse
Nordstrom
Safeway
Schools Insurance Authority
Schools Insurance Group
Sedgwick Claims Management Services
Shaw, Jacobsmeyer, Crain, and Claffey
South Orange County Coalition
Troy and Alana Pack Foundation
University of California
Western Occupational & Environmental Medical Association
Western Propane Gas Association
Opposition
California Optometric Association
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301