BILL ANALYSIS �
SB 616
Page 1
Date of Hearing: August 29, 2012
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
SB 616 (DeSaulnier) - As Amended: August 27, 2012
SENATE VOTE : (vote not relevant)
SUBJECT : Controlled substances: reporting.
SUMMARY : Creates a dedicated fund to maintain the Controlled
Substance Utilization Review and Evaluation System (CURES) and
requires a number of healing arts boards within the Department
of Consumer Affairs (DCA) to increase their licensure,
certification and renewal fees to maintain CURES, as specified.
Specifically, this bill :
1)Requires the following boards within DCA to increase the
licensure, certification and renewal fees charged to
practitioners under their supervision who are authorized to
prescribe or dispense Schedule II, Schedule III, or Schedule
IV controlled substances by up to $10 annually, if the
Attorney General (AG) determines that the ability of
regulatory agencies to adequately monitor prescribers and
dispensers of these controlled substances has been compromised
due to insufficient funding to cover the costs of CURES, or
because a permanent and ongoing funding source has not been
implemented by July 1, 2014:
a) Medical Board of California (MBC);
b) Dental Board of California;
c) California State Board of Pharmacy;
d) Veterinary Medical Board;
e) Board of Registered Nursing (BRN);
f) Physician Assistant Committee of the MBC;
g) Osteopathic Medical Board of California (OMBC);
h) State Board of Optometry; and,
SB 616
Page 2
i) California Board of Podiatric Medicine.
2)Prohibits the fee increase described above from exceeding the
reasonable costs associated with maintaining CURES, as
specified.
3)Requires the funds collected pursuant to 1), above, to be
deposited into CURES accounts, which this bill creates within
specified funds of each board, and to be available to the
Department of Justice (DOJ) upon Legislative appropriation
solely for maintaining CURES, as specified.
4)Establishes the CURES Fund in the State Treasury, which shall
consist of all funds made available to DOJ for the purpose of
funding CURES, and provides that money in the CURES Fund
shall, upon Legislative appropriation, be available for
allocation to DOJ for the purposes of funding CURES.
5)Requires DOJ to make available to the public information about
the amount and the source of all private grant funds it
receives for support of CURES.
6)Makes conforming and technical changes, and states legislative
findings and declarations.
EXISTING LAW :
1)Requires DOJ to maintain 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 or dispense these controlled
substances, contingent upon the availability of adequate funds
from the Contingent Fund of the MBC, the Pharmacy Board
Contingent Fund, the State Dentistry Fund, the BRN Fund, and
the OMBC Contingent Fund.
2)Provides that the reporting of Schedule III and Schedule IV
controlled substance prescriptions to CURES shall be
contingent upon the availability of adequate funds from DOJ,
allows DOJ to seek and use grant funds to pay the costs
incurred from this reporting, and prohibits funds from being
appropriated from the Contingent Fund of the MBC, the Pharmacy
Board Contingent Fund, the State Dentistry Fund, the BRN Fund,
SB 616
Page 3
the Naturopathic Doctor's Fund, or the OMBC Contingent Fund to
pay the costs of this reporting.
3)Requires CURES to operate under existing provisions of law to
safeguard patient privacy and confidentiality, and restricts
how, to whom, and for what purposes data from CURES may be
provided, as specified.
4)Requires a dispensing pharmacy or clinic to provide specified
information to DOJ on a weekly basis for each prescription for
a Schedule II, Schedule III, or Schedule IV controlled
substance, as specified.
5)Allows a licensed health care practitioner who is eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist to make a written request to DOJ to
access information stored on the Internet regarding the
controlled substance history of a patient maintained within
the DOJ, and allows DOJ to release to that 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 Prescription Drug Monitoring Program
(PDMP).
6)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 shall be
considered medical information subject to specified
confidentiality provisions.
7)Requires certain recordkeeping and reporting to DOJ when
Schedule II, III or IV controlled substances are prescribed,
administered or dispensed, as specified.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author, "While the
automated PDMP within the CURES program is a valuable
investigative, preventative, and educational tool for law
enforcement, regulatory boards, and health care providers,
recent budget cuts to the AG's Division of Law Enforcement have
resulted in insufficient funding to support the CURES PDMP. The
PDMP is necessary to ensure health care professionals have the
SB 616
Page 4
necessary data to make informed treatment decisions and to allow
law enforcement to investigate prescription drug diversion.
Without a dedicated funding source, the CURES PDMP is not
sustainable and will (be) suspended.
"The only funding currently available is through renewable
contracts with five separate regulatory boards and one grant.
As a result, funding for CURES and PDMP in state fiscal year
2011-12 consists of $296,000 that can be used only for PDMP
system data and maintenance. The DOJ has determined they will
use California Justice Information Services (CJIS) general fund
monies to keep the current PDMP running at minimal capacity
through June 30, 2013. However, the program cannot be sustained
beyond fiscal year 12/13 unless funding is identified."
Background . The purpose of CURES is to assist 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. Established in 1997, CURES is a state
database of dispensed prescription drugs with a high potential
for misuse. Initially intended to electronically monitor the
prescribing and dispensing of Schedule II controlled substances,
CURES provides real-time electronic transmission of specified
prescription data to DOJ. The data is analyzed for indications
that controlled substances are being improperly prescribed, or
that drug abusers are obtaining prescriptions from multiple
doctors ("doctor shopping").
In September 2009, DOJ launched PDMP, which allows
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 information regarding
the controlled substance history of patients through a secure
Web site. Prior to adoption of PDMP, doctors and pharmacists
had to request information by fax, mail or phone and wait days
for a response. Under PDMP, 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 in
assuring patient safety.
SB 616
Page 5
According to a June 2012 report on CURES 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, DOJ opted 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...
"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...In addition, the federal
Bureau of Justice Assistance recently authorized the extension
of the 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."
The federal Controlled Substances Act of 1970 regulates the
manufacture, distribution, and dispensing of controlled
substances, and ranks into five schedules drugs known to have
potential for physical or psychological harm, based on their
potential for abuse, their accepted medical use, and their
accepted safety under medical supervision.
Schedule I controlled substances have a high potential for abuse
and no generally accepted medical use. 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
SB 616
Page 6
physical dependence. Schedule II drugs can be narcotic 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.
This bill requires a number of healing arts boards to increase
their licensing, certification and renewal fees by up to $10 if
the AG determines that the ability of regulatory agencies to
adequately monitor prescribers and dispensers of these
controlled substances has been compromised due to insufficient
funding to cover the costs of CURES, or because a permanent and
ongoing funding source has not been implemented by July 1, 2014.
This provision was recently amended into this bill, and has not
yet been heard in a policy committee.
According to DOJ, which has withdrawn its support of this bill
due to this recent amendment, a workgroup comprised of a broad
range of stakeholder interests including health care plans,
doctors, pharmacists and others began meeting earlier this year
to address CURES' funding shortfall and to develop an agreement
on a solution. The workgroup has been discussing upgrades to
PDPM that are needed and an appropriate fee structure for
ongoing maintenance. Despite funding cuts, DOJ has secured
funding to maintain CURES operations until July 1, 2013, and
expects to finalize an agreement for upgrades and associated
fees before then. While DOJ supported the prior version of this
bill, recent amendments circumvent the stakeholder process now
underway at DOJ by implementing a fee structure that is still
being considered and has not yet been approved by the workgroup.
Opposition . The California Chapter of the American College of
Emergency Physicians (California ACEP) states, "California ACEP
is supportive of the CURES program, as the program performs an
important public service benefit in helping to control substance
abuse. Emergency physicians aggressively treat acute pain and
in doing so, want to ensure they do not enable chronic
prescription drug abusers who visit an ER.
"Substance abuse is a public health problem. Overdoses, mostly
from prescription drugs, have no become the No. 1 cause of
SB 616
Page 7
accidental deaths in the United States, surpassing motor vehicle
accidents. According to the Centers for Disease Control and
Prevention, eleven people die every day in California from
prescription drug overdoses. The costs of this public health
crisis are borne by taxpayers and private insurers and the
savings from a successful CURES program are recouped by the
same.
"Unfortunately, SB 616 places the responsibility of the funding
of the CURES program solely on the backs of physicians and
health care providers. This bill takes a step into uncharted
territory where physicians - simply because they are the ones
treating the patients - are asked to fund health care research,
health care and wellness programs that benefit the entire
public."
Previous Legislation :
SB 360 (DeSaulnier), Chapter 418, Statutes of 2011, updates
CURES to reflect the new PDMP and authorizes DOJ to initiate
administrative enforcement actions to prevent the misuse of
confidential information collected through CURES.
SB 1071 (DeSaulnier) of the 2010 imposes 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. This bill was held in Senate
Health Committee.
SB 734 (Torlakson), Chapter 487, Statutes of 2005, makes various
technical and clarifying changes to CURES.
SB 151 (Burton), Chapter 406, Statutes of 2003, makes CURES
permanent, among other provisions.
AB 3042 (Takasugi), Chapter 738, Statutes of 1996, establishes
CURES as a three-year pilot program.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
SB 616
Page 8
California Chapter of the American College of Emergency
Physicians
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301