BILL ANALYSIS Ó
SB 809
Page 1
Date of Hearing: June 25, 2013
Counsel: Shaun Naidu
ASSEMBLY COMMITTEE ON PUBLIC SAFETY
Tom Ammiano, Chair
SB 809 (DeSaulnier) - As Amended: May 28, 2013
SUMMARY : Creates a dedicated fund to maintain the Controlled
Substance Utilization Review and Evaluation System (CURES)
Prescription Drug Monitoring Program (PDMP) by the Department of
Justice (DOJ). Specifically, this bill :
1)Makes legislative findings and declarations relative to CURES.
2)Requires the following health practitioner boards to
additionally charge licensees under their supervision that are
authorized to prescribe, order, administer, furnish, or
dispense controlled substances a fee of up to 1.16% of the
renewal fee that the license was subject to as of July 1,
2013, assessed annually. This fee is due and payable at the
time the licensee renews his or her license and must be
submitted with the licensee's renewal fee, and in no case
exceed the reasonable costs associated with operating and
maintaining CURES: Medical Board of California (MBC), Dental
Board of California (DBC), Board of Pharmacy (BOP), Veterinary
Medical Board (VMB), Board of Registered Nursing (BRN),
Physician Assistant Committee of the MBC, Osteopathic Medical
Board (OMB), Naturopathic Medicine Committee of the OMB, Board
of Optometry (CBO), and the Board of Podiatric Medicine (BPM).
3)Requires the BOP to additionally charge fees for wholesalers
and out-of-state wholesalers of dangerous drugs and veterinary
food-animal drug retailers of up to 1.16% of the renewal fee
that the wholesaler or nonresident wholesaler was subject to
as of July 1, 2013, assessed annually. This fee is due and
payable at the time the wholesaler or nonresident wholesaler
renews its license and must be submitted with the wholesaler's
or nonresident wholesaler's renewal fee. Clarifies that in no
case shall this fee exceed the reasonable costs associated
with operating and maintaining CURES.
4)Creates CURES accounts within various specified funds and
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requires that the monies collected from licensing fees for
CURES be deposited into the CURES account in each fund.
5)Requires that monies in the various CURES accounts be
deposited into the CURES Fund, established within the State
Treasury, consisting of all funds made available to DOJ to
operate and maintain CURES.
6)Requires the MBC to periodically develop and disseminate
information and education 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. Requires MBC to consult with the Department of Health
Care Services and DOJ in developing the materials, as
specified.
7)Authorizes DOJ to seek and use grant funds to pay the costs
incurred by the operation and maintenance of CURES. Requires
DOJ to report annually to the Legislature and make available
to the public the amount and sources of funds it receives for
support of CURES. Prohibits grant funds from being
appropriated from specified accounts for the purpose of
funding CURES.
8)Requires that the operation of CURES comply with all
applicable federal and state privacy and security laws and
regulations.
9)Authorizes DOJ to establish policies, procedures, and
regulations regarding using, accessing, evaluating, managing,
implementing, operating, storing, and securing the information
within CURES.
10)Allows DOJ to 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. Requires all prescriber invitees to be
licensed, as specified, in active practice in California, and
a regular user of CURES.
11)Requires DOJ, prior to upgrading CURES, to consult with
licensed prescribers by one or more of the identified
regulatory boards or commissions and any other stakeholder
identified by DOJ for the purpose of identifying desirable
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capabilities and upgrades to the CURES PDMP.
12)Allows DOJ to establish a process to educate authorized
subscribers of CURES on how to access and use CURES.
13)Strongly encourages licensed health care practitioners
eligible to prescriber Schedule II, III, or IV controlled
substances and pharmacists to access and consult the
electronic history of controlled substance dispensed to an
individual under his or her care prior to prescribing or
dispensing a Schedule II, III, or IV controlled substance.
14)Requires a licensed health care practitioner eligible to
prescribe Schedule II, III or IV controlled substances, or a
pharmacist, to submit an application to participate in the
CURES PDMP. Requires DOJ, upon approval of the practitioner
or pharmacist subscriber, to release the electronic history of
controlled substances dispensed to an individual under his/her
care based on data contained in the CURES PDMP. Increases,
from 10 to 30 days, the time in which an authorized subscriber
must notify DOJ of any changes to the subscriber account.
Requires DOJ to notify applicants, the Secretary of State, the
Secretary of the Senate, the Chief Clerk of the Assembly, and
the Legislature Counsel when CURES is upgraded and can
accommodate all users and include notification on the DOJ Web
site, but not before June 1, 2015.
15)Requires DOJ to seek private funds from insurers, health care
service plans, and qualified manufacturers for the purpose of
supporting CURES; permits specified insurers, health care
service plans, and qualified manufacturers to make voluntary
contributions to the CURES Fund, which will be nondeductible
for state tax purposes; and requires DOJ to make information
about funds it receives for support of CURES publicly
available.
16)Defines the following terms for purposes of state law
relative to CURES:
a) "Controlled substance" as a drug, substance, or
immediate precursor listed in Schedule II, III, or IV.
b) "Health care service plan" to mean an entity licensed
pursuant to the Knox-Keene Health Care Service Plan Act of
1975.
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c) "Insurer" to mean an admitted insurer writing health
insurance and an admitted insurer writing workers'
compensation insurance, as they are defined in the
Insurance Code.
d) "Qualified manufacturer" to mean a manufacturer of a
controlled substance which is not a wholesaler or
out-of-state wholesaler of dangerous drugs, a veterinary
food-animal drug retailer or a licensee of any of the
above-mentioned boards.
17)Makes various technical and conforming changes.
EXISTING LAW :
1)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,
III, or IV controlled substance to DOJ on a weekly basis.
(HSC Section 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 Section
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 Section
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
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relating to the transaction. (HSC Section 11190.)
FISCAL EFFECT : Unknown
COMMENTS :
1)Author's Statement : According to the author, "SB 809 provides
essential funding to continue and strengthen the CURES
Prescription Drug Monitoring Program, 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 Prescription Drug Monitoring Program.
"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
and prescription painkillers are responsible for 75 percent 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. In California, on average,
there are six deaths every day from prescription drug overdose
and1.2 million emergency room visits related to the misuse or
abuse of pharmaceuticals.
"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."
2)Background : The CURES was established in 1997 by AB 3042
(Takasugi), Chapter 738, Statutes of 1996, in response to
recommendations of the Controlled Substance Prescription
Advisory Council. (SCR 74, 1992.) CURES is a state database
of dispensed prescription drugs with a high potential for
misuse. The program initially was intended to electronically
monitor the prescribing and dispensing of Schedule II
controlled substances, such as Oxycodone. The CURES program
provides for real-time electronic transmission of specified
prescription data to DOJ. Essentially, the data is analyzed
for indications that controlled substances are being
improperly prescribed, or that drug abusers are obtaining
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prescriptions from many doctors (doctor shopping).
In September 2009, DOJ launched the Prescription Drug Monitoring
Program (PDMP) system allowing pre-registered users, including
licensed health care prescribers eligible to prescribe
controlled substances, pharmacists authorized to dispense
controlled substances, law enforcement, and regulatory boards,
to access real-time patient controlled substance history
information through a secure website. Prior to the adoption
of PDMP, doctors and pharmacists had to request information by
fax, mail, or phone and wait days for a response. Under the
system, a registered person authorized to prescribe or
dispense a controlled substance is able to instantly look up a
new patient's controlled substance history to determine
whether the patient legitimately needs medication or is doctor
shopping. The system also assists persons authorized to
prescribe or dispense controlled substances to assure patient
safety.
3)Patient Privacy : Under existing law, certain protections are
put in place to ensure the privacy of patients and consumers
whose information are entered into CURES. (HSC Section
11165(c).) Specifically, it provides that DOJ can release
CURES data in limited circumstances for specified purposes.
For example, data obtained from CURES can be provided only to
appropriate state, local, and federal entities for
disciplinary, civil, or criminal purposes and to other
entities as determined by DOJ for educating practitioners.
(Id.) This bill removes this patient privacy provision and
replaces it with language that allows DOJ to establish
policies, procedures, and regulations regarding the use,
access, and security of CURES information. (Page 8, lines
29-32.) A policy consideration presented by this bill is
whether the committee prefers to have provisions regarding the
access to and release of personal consumer medical information
determined by DOJ or through the legislative process, where
there is a great deal of public input and accountability.
4)Funding : According to a June 2012 report prepared by DOJ,
"Currently, there is no permanent funding to support the
CURES/PDMP program. The California Budget Act of 2011
eliminated all General Fund support of CURES/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
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to assign five 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.) In addition, since January 23, 2012, four
unpaid Regional Occupational Program (ROP) students have been
assigned to assist with the workload. Their assignments ended
at the conclusion of the school year effective May 31, 2012.
DOJ intends on replacing these unpaid students with paid
students to ensure some continuity; however, this is a
temporary solution and will not resolve the long-term issue of
insufficient staff support.
"The only funding currently available is through renewable
contracts with five separate regulatory boards and one grant.
As a result, funding for CURES/PDMP in state fiscal year (FY)
2011-12 consists of $296,000 that can be used only for PDMP
system data and maintenance. The contracts are renewed every
two to three years (depending on the board) contingent upon
the availability of adequate board funds (Health & Safety Code
11165). In addition, the federal Bureau of Justice Assistance
(BJA) recently authorized the extension of the Fiscal Year
(FY) 2010 Harold Rogers grant to DOJ into state FY 2012-13,
allowing CURES/PDMP to carry over approximately $340,000 in
unspent grant funds specified for outreach and system
development. While DOJ has been able to successfully renew
contracts with the boards and receive grant funding this year,
these sources of funding are not permanent and may not be
available in future years and cannot be used to fund staff
positions. In addition, these two funding sources are
insufficient to operate and maintain the PDMP system, make
necessary enhancements or fully fund a PDMP modernization
effort. The DOJ has once again applied for the current Harold
Rogers grant, however, it will not provide sufficient funding
for the ongoing costs of the program." (CURES 2.0, An
Integrated Approach to Preventing Prescription Drug Abuse and
Diversion, June 2012.)
5)Controlled Substances : The federal government regulates the
manufacture, distribution, and dispensing of controlled
substances through the Controlled Substances Act of 1970. The
act ranks into five schedules those drugs known to have
potential for physical or psychological harm, based on three
considerations: (a) their potential for abuse, (b) their
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accepted medical use, and (c) their accepted safety under
medical supervision.
Schedule I controlled substances have a high potential for abuse
and no generally accepted medical use such as heroin and LSD.
Schedule II controlled substances have a currently-accepted
medical use in treatment, or a currently-accepted medical use
with severe restrictions, and have a high potential for abuse
and psychological or physical dependence. Schedule II drugs
can be narcotics or non-narcotic. Examples of Schedule II
controlled substances include morphine, methadone, Ritalin,
Demerol, Dilaudid, Percocet, Percodan, and Oxycontin.
Schedule III and IV drugs include Vicodin, Zanex, Ambien and
other anti-anxiety drugs that generally have less potential
for abuse than Schedule II drugs but are known to be mixed in
specific ways to achieve a narcotic-like end product.
Schedule V drugs are available over the counter.
6)Argument in Support : According to the California Attorney
General's Office (AGO) , "Prescription drug abuse is the
fastest-growing drug problem in the United States. While
there has been a decrease in the use of some illegal drugs
like cocaine, data from the National Survey on Drug Use and
Health shows that 7 million people, or nearly one-third of
people 12 years old and over who used drugs for the first
time, began by using a prescription drug non-medically in
2010. The majority of the CURES funding was cut during the
Fiscal Year 2011-2012 budget and CURES and the PDMP have since
been staffed by a single AGO employee. Additionally, the
current PDMP is a dated, unstable program that has needed an
upgrade to meet the needs of prescribers and pharmacists.
"The current budget funds the upgrade of the PDMP, and this
legislation is necessary to provide the ongoing funding to
operate and maintain the program."
7)Prior Legislation :
a) SB 360 (DeSaulnier), Chapter 418, Statutes of 2011,
updated CURES to reflect the new PDMP and authorized DOJ to
initiate administrative enforcement actions to prevent the
misuse of confidential information collected through the
CURES program. SB 360 also provided additional
requirements and sanctions for security prescription
printers and their employees who have direct contact with,
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or access to, controlled-substance prescription-drug forms.
b) SB 616 (DeSaulnier), of the 2011-12 Legislative Session,
would have created a dedicated fund to maintain the CURES.
SB 616 failed passage in the Assembly Business, Professions
and Consumer Protection Committee.
c) SB 1071 (DeSaulnier), of the 2009-10 Legislative
Session, would have imposed a per-pill tax upon every
manufacturer and importer of controlled substances
classified as Schedule II, III, or IV to be allocated to
DOJ for the cost of the CURES program. SB 1071 failed
passage in the Senate Health Committee.
d) AB 2968 (Mullin), Chapter 286, Statutes of 2006, added
more information to the requirements for a physician to
prescribe a controlled substance, and required electronic
monitoring of Schedule IV drugs.
e) SB 734 (Torlakson), Chapter 487, Statutes of 2005, made
various technical and clarifying changes to CURES.
f) SB 151 (Burton), Chapter 406, Statutes of 2004, made the
CURES reporting system permanent.
g) AB 3042 (Takasugi), Chapter 738, Statutes of 1996,
established CURES as a three-year pilot program.
REGISTERED SUPPORT / OPPOSITION :
Support
California Attorney General Kamala Harris (Sponsor)
American Cancer Society Cancer Action Network
American College of Emergency Physicians, California Chapter
American Medical Association
California Association for Nurse Practitioners
California Association of Oral and Maxillofacial Surgeons
California Department of Insurance
California Medical Association
California Labor Federation
California Narcotic Officers Association
California Pharmacists Association
California Primary Care Association
California Police Chiefs Association
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California Society of Health-System Pharmacists
California State Board of Pharmacy
California State Sheriff's Association
Center for Public Interest Law
City and County of San Francisco
County Alcohol and Drug Program Administrators Association of
California
Deputy Sheriffs' Association of San Diego County
Healthcare Distribution Management Association
Health Officers Association of California
Kaiser Permanente
Medical Board of California
National Coalition Against Prescription Drug Abuse
South Orange County Coalition
Troy and Alana Pack Foundation
Western Occupational and Environmental Medical Association
University of California
One private individual
Opposition
None
Analysis Prepared by : Shaun Naidu / PUB. S. / (916) 319-3744