BILL ANALYSIS Ó
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|Hearing Date:April 15, 2013 |Bill No: SB |
| |809 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 809Author:De Saulinier and Steinberg
As Introduced: February 22, 2013 Fiscal:Yes
SUBJECT: Controlled substances: reporting.
SUMMARY: An urgency measure which makes various changes to the
funding and operation of the Controlled Substances Utilization Review
and Evaluation System (CURES) Prescription Drug Monitoring Program
(PDMP). Establishes the CURES Fund in the State Treasury. Requires
practitioners who prescribe Schedule II, III and IV controlled
substances and pharmacists to enroll in and consult the CURES PDMP.
Increases licensing fees for prescribing health practitioners,
dispensers and wholesalers of controlled substances for the purpose of
providing ongoing funding to maintain the CURES PDMP. Levies a
one-time tax assessment on health insurance plans and workers
compensation insurers to fund the CURES modernization upgrade.
Imposes annual taxes on drug manufacturers of Schedule II, III, and IV
controlled substances doing business in California to maintain the
CURES PDMP.
Existing law, the Health and Safety Code (HSC), establishes the
California Uniform Controlled Substances Act which regulates
controlled substances. (HSC §§ 11000-11651)
1) Defines drug as:
a) Substances recognized as drugs in the official United States
Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
States, or official National Formulary, or any supplement to any
of them.
b) Substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
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animals.
c) Substances (other than food) intended to affect the structure
or any function of the body of man or animals. (Health and
Safety Code (HSC) § 11014)
2) Defines opiate as any substance having an addiction-forming or
addiction-sustaining liability similar to morphine or being capable
of conversion into a drug having addiction-forming or
addiction-sustaining liability. (HSC § 11020)
3) Classifies controlled substances in five schedules according to
their danger and potential for abuse. (HSC § 11054-11058)
4) Specifies that a prescription for a controlled substance shall only
be issued for a legitimate medical purpose and establishes
responsibility for proper prescribing on the prescribing
practitioner. States that a violation shall result in imprisonment
for up to one year or a fine of up to $20,000, or both. (HSC §
11153)
5) Requires special prescription forms for controlled substances to be
obtained from security printers approved by DOJ, establishes
certain criteria for features on the forms and requires controlled
substance prescriptions to be made on the specified form. (HSC §§
11161.5, 11162.1, 11164)
6) Establishes the Controlled Substances Utilization Review and
Evaluation System (CURES) for electronic monitoring of Schedule II,
III and IV controlled substance prescriptions. CURES provides for
the electronic transmission of Schedule II, III and IV controlled
substance prescription information to the Department of Justice
(DOJ) at the time prescriptions are dispensed. (HSC § 11165)
7) States that the purpose of CURES is to assist law enforcement and
regulatory agencies in controlling diversion and abuse of Schedule
II, III and IV controlled substances and for statistical analysis,
education and research. Specifies that DOJ shall maintain CURES,
contingent upon the availability of adequate funds from the
Contingent Fund of the Medical Board of California, the Pharmacy
Board Contingent Fund, the State Dentistry Fund, the Board of
Registered Nursing Fund and the Osteopathic Medical Board of
California Contingent Fund. (HSC § 11165 (a))
8) Provides that the reporting of Schedule III and IV controlled
substance prescriptions to CURES is contingent upon availability of
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adequate funds from DOJ and authorized DOJ to seek and use grant
funds for costs incurred but specifies that monies cannot be used
from the Funds outlined above for this purpose. (HSC § 11165 (b))
9) Establishes privacy protections for patient data and specifies that
CURES data can only be accessed by appropriate state, local and
federal persons or public agencies for disciplinary, civil or
criminal actions. Specifies that CURES data shall also only be
provided, as determined by DOJ, to other agencies or entities for
educating practitioners and others, in lieu of disciplinary, civil
or criminal actions. Authorizes non-identifying CURES data to be
provided to public and private entities for education, research,
peer review and statistical analysis. (HSC § 11165 (c))
10)Provides that pharmacies or clinics, in filling a controlled
substance prescription, shall provide weekly information to DOJ
including the patient's name, date of birth, the name, form,
strength and quantity of the drug, and the pharmacy name, pharmacy
number and the prescribing physician information. (HSC § 11165
(d))
11)Provides that a licensed health care practitioner eligible to
prescribe Schedule II, III or IV controlled substances, or a
pharmacist, may apply to participate in the CURES Prescription Drug
Monitoring Program (PDMP). Authorizes DOJ to deny an application
or suspend a subscriber for materially falsifying an application,
failing to maintain effective controls for access to the patient
activity report, suspended or revoked DEA registration, arrest for
a controlled substance arrest or accessing information for any
reason other than patient care. Under the PDMP, the participating
(subscribing) practitioner or pharmacist may access using the
Internet, the electronic history of controlled substances dispensed
to an individual under his or her care based on data contained in
CURES. Provides that an authorized subscriber shall notify DOJ
within 10 days of any changes to the subscriber account. (HSC §
11165.1 (a))
12)Provides that any request for, or release of, a controlled
substance history shall be made in accordance with guidelines
developed by DOJ. (HSC § 11165.1 (b))
13)Provides that the DOJ may initiate the referral of the history
controlled substances dispensed to an individual, based on the
CURES data, to licensed health care practitioners and pharmacists,
as specified. (HSC § 11165.1 (c))
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14)Provides that the history of controlled substances dispensed to a
patient based on CURES data that is received by a practitioner or
pharmacist shall be considered medical information, subject to
provisions of the Confidentiality of Medical Information Act. (HSC
§ 11165.1 (d))
15)Provides that DOJ may audit the PDMP system and its users.
Authorizes DOJ to establish, through regulations, a system for
issuing a citation to a PDMP subscriber. Provides that the
citation may contain an order or abatement to pay a fine if the
subscriber is in violation of the CURES PDMP statutes or
regulations. Terminates a subscriber account if a citation is not
contested and a fine is not paid. Provides that administrative
fines shall be deposited in the CURES Program Special Fund,
available upon appropriation to support costs associated with
informal and formal hearings, maintenance and updates to the CURES
PDMP. (HSC § 11165.2)
16)Requires health practitioners who prescribe or administer a
controlled substance classified in Schedule II to make a record
containing the name and address of the patient, date, and the
character, name, strength, and quantity of the controlled substance
prescribed, as well as the pathology and purpose for which the
controlled substance was administered or prescribed. (HSC § 11190
(a) and (b))
17)Requires prescribers who are authorized to dispense Schedule II,
III or IV controlled substance in their office or place of practice
to record and maintain information for three years for each such
prescription that includes the patient's name, address, gender, and
date of birth, prescriber's license and license number, federal
controlled substance registration number, state medical license
number, NDC number of the controlled substance dispensed, quantity
dispensed, diagnosis code, if available, and original date of
dispensing. Requires that this information be provided to DOJ on a
monthly basis. (HSC § 11190 (c))
Existing law, the Business and Professions Code (BPC):
1) Establishes the Medical Practice Act which provides for the
licensing and regulation of physicians and surgeons by the Medial
Board of California (MBC) within the Department of Consumer Affairs
(DCA).
2) Establishes the Dental Practice Act which provides for the
licensing and regulation of dentists by the Dental Board of
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California within DCA.
3) Establishes the Veterinary Medicine Practice Act which provides for
the licensing and regulation of veterinarians and registered
veterinary technicians by the Veterinary Medical Board within DCA.
4)Establishes the Nursing Practice Act which provides for the
certification and regulation of registered nurses, nurse
practitioners and advanced practice nurses by the Board of
Registered Nursing within DCA.
5)Provides that a certified nurse-midwife may furnish or order drugs
or devices, including controlled substances, if furnished or ordered
incidentally to the provision of family planning services, routine
health care or perinatal care, or care rendered consistent with the
certified nurse-midwife's practice; occurs under physician and
surgeon supervision; and is in accordance with standardized
procedures or protocols as specified. (BPC § 2746.51)
6)Provides that a nurse practitioner may furnish or order drugs or
devices, including controlled substances, if it is consistent with a
nurse practitioner's educational preparation or for which clinical
competency has been established and maintained; occurs under
physician and surgeon supervision; and is in accordance with
standardized procedures or protocols as specified. (BPC § 2836.1)
7) Establishes the Physician Assistant Practice Act which provides for
the licensing of physician assistants by the Physician Assistant
Committee, under the MBC, within the DCA.
8) Provides that a physician assistant while under the supervision of
a physician and surgeon may administer or provide medication to a
patient, or transmit orally or in writing a drug order under
specified conditions and protocols adopted by the supervising
physician and surgeon. (BPC § 3502.1)
9) Establishes the Osteopathic Act which provides for the licensing
and regulation of osteopathic physicians and surgeons by the
Osteopathic MBC within DCA.
10)Establishes the Naturopathic Doctors Act which provides for the
licensing of naturopathic doctors by the Naturopathic Medicine
Committee within the Osteopathic Medical Board of California within
DCA.
11)Establishes the Optometry Practice Act which provides for the
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licensure of optometrists by the California State Board of
Optometry within DCA.
12)Establishes the Podiatric Act which provides for the licensure of
doctors of podiatric medicine by the California Board of Podiatric
Medicine within the DCA.
13)Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy within the DCA.
14)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor. (BPC § 4059)
This bill:
1) States the following findings and declarations:
a) CURES is a valuable investigative, preventive, and educational
tool for law enforcement, regulatory boards, educational
researchers, and the health care community.
b) Recent budget cuts to the Attorney General's Division of Law
Enforcement (DLE) have resulted in insufficient funding to
support the CURES PDMP.
c) The PDMP is necessary to ensure health care professionals have
the necessary data to make informed treatment decisions and to
allow law enforcement to investigate diversion of prescription
drugs and without a dedicated funding source, the CURES PDMP is
not sustainable.
d) Each year CURES responds to more than 60,000 requests from
practitioners and pharmacists helping identify and deter drug
abuse and diversion of prescription drugs through accurate and
rapid tracking of Schedule II, Schedule III, and Schedule IV
controlled substances, helping practitioners make better
prescribing decisions, helping reduce misuse, abuse, and
trafficking of those drugs.
e) Schedule II, Schedule III, and Schedule IV controlled
substances have had deleterious effects on private and public
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interests, including the misuse, abuse, and trafficking in
dangerous prescription medications resulting in injury and death.
f) The Legislature intends to work with stakeholders to fully
fund the operation of CURES which seeks to mitigate those
deleterious effects, and which has proven to be a cost-effective
tool to help reduce the misuse, abuse, and trafficking of those
drugs.
1) Requires the following health practitioner boards to increase
licensure, certification and renewal fees for licensees under their
supervision authorized to prescribe controlled substances by up to
1.16 percent annually and clarifies that in no case shall the fee
increase exceed the reasonable costs association with maintaining
CURES:
a) Medical Board of California
b) Dental Board of California
c) California State Board of Pharmacy
d) Veterinary Medical Board
e) Board of Registered Nursing
f) Physician Assistant Committee of the Medical Board of
California
g) Osteopathic Medical Board of California
h) State Board of Optometry
i) California Board of Podiatric Medicine
1) Requires the Board of Pharmacy to increase licensure, certification
and renewal fees for wholesalers, out-of-state wholesalers of
dangerous drugs and veterinary food-animal drug retailers up to
1.16 percent annually. Clarifies that in no case shall the fee
increase exceed the reasonable costs association with maintaining
CURES.
2) Creates CURES accounts within the Contingent Fund of the MBC, the
State Dentistry Fund, the Pharmacy Board Contingent Fund, the
Veterinary Medical Board Contingent Fund, the Board of Registered
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Nursing Fund, the Osteopathic Medical Board of California
Contingent Fund, the Optometry Fund and the Board of Podiatric
Medicine Fund. Provides that the monies collected from licensing
fees for CURES shall be deposited into the CURES account in each
fund.
3) Provides that monies in the various CURES accounts shall be
deposited into the CURES Fund, established within the State
Treasury, consisting of all funds made available to DOJ to maintain
CURES.
4) Requires DOJ to provide public notice of the amount and source of
all private grant funds it receives for support of CURES.
5) Requires a licensed health care practitioner eligible to prescribe
Schedule II, III or IV controlled substances, or a pharmacist, to
provide a notarized 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 or her care based
on data contained in the CURES PDMP. Requires DOJ to notify
applicants, the Secretary of State, the Secretary of the Senate,
the Chief Clerk of the Assembly and the Legislative when CURES is
upgraded and can handle the amount of new system users and include
notification on the DOJ website.
6) Establishes the Controlled Substance Utilization Review and
Evaluation System (CURES) Tax Law with the following definitions:
a) "Controlled substance" is a drug, substance or immediate
precursor in Schedule II, Schedule III or Schedule IV.
b) "Insurer" means a health insurer licensed by the
Department of Insurance, a health care service plan licensed
by the Department of Managed Health Care or a workers'
compensation insurer.
c) "Qualified manufacturer" is a manufacturer of a
controlled substance doing business in California 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.
1) Imposes an annual tax on all qualified manufacturers for the
purpose of establishing and maintaining enforcement of CURES.
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2) Imposes a one-time tax on all insurers for the purpose of upgrading
CURES.
3) Requires each qualified manufacturer and insurer to prepare a
return to be filed with the State Board of Equalization (BOE) and
file the return on or before the last day of the month, along with
a remittance for the amount of tax due for the quarter.
4) Requires BOE to administer and collect the taxes. Provides that
all taxes, interest, penalties and other amounts, less refunds and
cost of administration, shall be deposited into the CURES Fund.
Authorizes BOE to create rules and regulations to administer and
enforce the collection of these taxes.
5) States that this is an urgency measure, necessary to take effect
immediately so that the public is protected from the continuing
threat of prescription drug abuse at the earliest possible time.
6) Makes various technical changes.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by California Attorney General
Kamala Harris . According to the Author, the automated prescription
drug management program (PDMP) within the CURES program is a
valuable investigative, preventative, and educational tool for law
enforcement, regulatory boards, and health care providers, but
recent budget cuts to the Attorney General's Division of Law
Enforcement have resulted in insufficient funding to support the
CURES PDMP. The Author states that the PDMP is necessary to ensure
health care professionals have the 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 July 1,
2013. To keep the program going and increase its effectiveness, SB
809 includes an urgency clause and establishes funds to upgrade the
system to be fully modernized and provides dedicated ongoing
funding to ensure the program is sustainable.
2. Controlled Substances. Through the Controlled Substances Act of
1970, the federal government regulates the manufacture,
distribution and dispensing of controlled substances. The act
ranks into five schedules those drugs known to have potential for
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physical or psychological harm, based on three considerations: (a)
their potential for abuse; (b) their 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, ecstasy, 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 controlled substances have a currently accepted
medical use in treatment, less potential for abuse but are known to
be mixed in specific ways to achieve a narcotic-like end product.
Examples include drugs include Vicodin, Zanex, Ambien and other
anti-anxiety drugs.
Schedule V drugs have a low potential for abuse, a currently
accepted medical use and are available over the counter.
The three classes of prescription drugs that are most commonly
abused are: opioids, which are most often prescribed to treat pain;
central nervous system (CNS) depressants, which are used to treat
anxiety and sleep disorders and; stimulants, which are prescribed
to treat the sleep disorder narcolepsy and attention-deficit
hyperactivity disorder (ADHD). Each class can induce euphoria, and
when administered by routes other than recommended, such as
snorting or dissolving into liquid to drink or inject, can
intensify that sensation. Opioids, in particular, act on the same
receptors as heroin and, therefore, can be highly addictive.
Common opioids are: hydrocodone (Vicodin), oxycodone (OxyContin),
propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine
(Demerol), and diphenoxylate (Lomotil).
3. Prescription Drug Abuse. For the past number of years, abuse of
prescription drugs (taking a prescription medication that is not
prescribed for you, or taking it for reasons or in dosages other
than as prescribed) to get high has become increasingly prevalent.
Federal data shows the past year abuse of prescription pain killers
now ranks second, just behind marijuana, as the nation's most
widespread illegal drug problem. According to the 2008 National
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Survey on Drug Use and Health (NSDUH), approximately 52 million
Americans aged 12 or older reported non-medical use of any
psychotherapeutic at some point in their lifetimes, representing
20.8% of the population aged 12 or older. The National Institute
on Drug Abuse's (NIDA) research report Prescription Drugs: Abuse
and Addiction states that the elderly are among those most
vulnerable to prescription drug abuse or misuse because they are
prescribed more medications than their younger counterparts.
Persons 65 years of age and above comprise only 13 percent of the
population, yet account for approximately one-third of all
medications prescribed in the United States. Older patients are
more likely to be prescribed long-term and multiple prescriptions,
which could lead to unintentional misuse. The report also notes
that studies suggest that women are more likely (in some cases, 55
percent more likely) than men to be prescribed an abusable
prescription drug, particularly narcotics and antianxiety drugs. A
2010 report, Monitoring the Future Study, showed that as many as 4
percent of high school students and 3 percent of young adults say
they have used OxyContin in the past year.
Abuse can stem from the fact that prescription drugs are legal and
potentially more easily accessible, as they can be found at home in
a medicine cabinet. Data shows that individuals who misuse
prescription drugs, particularly teens, believe these substances
are safer than illicit drugs because they are prescribed by a
health care professional and thus are safe to take under any
circumstances. NIDA data states that in actuality, prescription
drugs act directly or indirectly on the same brain systems affected
by illicit drugs, thus, their abuse carries substantial addiction
liability and can lead to a variety of other adverse health
effects.
The Senate Committee on Labor held a hearing on March 20, 2013
entitled Opioids and the Workers Compensation System: A Discussion
on Mitigating Abuse and Ensuring Access during which the committee
reviewed a series of studies conducted by the California Workers'
Compensation Institute (CWCI) which highlighted a rise in opiod
prescriptions by physicians in the state workers' compensation
system. The studies identified trends in widespread, potent use of
Schedule II drugs by patients with low back pain, significant
growth in the prescribing of all Schedule II drugs in the workers'
compensation system and found that 6.7 percent of all prescriptions
in the system for the first half of 2011 alone were for opiods.
4. Prescription Drug Deaths. A recent Centers for Disease Control
(CDC) analysis found that drug overdose deaths increased for the
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11th consecutive year in 2010 and prescription drugs, particularly
opiod analgesics, are the top drugs leading the list of those
responsible for fatalities. According to CDC, 38,329 people died
from a drug overdose in 2010, up from 37,004 deaths in 2009, and
16,849 deaths in 1999. CDC found that nearly 60 percent of the
overdose deaths in 2010, involved pharmaceutical drugs, with opiods
associated with approximately 75 percent of these deaths. Nearly
three out of four prescription drug overdoses are caused by opioid
pain relievers. CDC recommends the use of PDMPs with a focus on
both patients at highest risk in terms of prescription painkiller
dosage, numbers of prescriptions and numbers of prescribers, as
well as prescribers who deviate from accepted medical practice and
those with a high proportion of doctor shoppers among their
patients. CDC also recommends that PDMPs link to electronic health
records systems so that the information is better integrated into
health care providers' day-to-day practices. CDC believes that
state benefits programs like Medicaid and workers' compensation
should consider monitoring prescription claims information and PDMP
data for signs and inappropriate use of controlled substances. The
organization also acknowledges the value of PDMPs in taking
regulatory action against health care providers who do operate
outside the limits of appropriate medical practice when it comes to
prescription drug prescribing.
A current Los Angeles Times series, "Dying For Relief," has
highlighted the role of prescription drugs in overdose deaths as
determined through the examination of coroners' reports. Reporters
conducted an analysis of coroners' reports for over 3000 deaths
occurring in four counties (Los Angeles, Orange, Ventura and San
Diego) where toxicology tests found a prescription drug in the
deceased's system, usually a painkiller, anti-anxiety drug or other
narcotic; coroners' investigators reported finding a container of
the same medication bearing the doctor's name, or records of a
prescription; the coroner determined that the drug caused or
contributed to the death. The analysis found that in nearly half
of the cases where prescription drug toxicity was listed as the
cause of death, there was a direct connection to a prescribing
physician. The Times created a database, the first of its kind,
linking overdose deaths to the doctors who prescribed drugs. They
also found that more than 80 of the doctors whose names were listed
on prescription bottles found at the home of or on the body of a
decedent had been the prescribing physician for 3 or more dead
patients. Their analysis found that one doctor was linked to as
many as 16 dead patients. The approach that these reporters have
taken is unique in that they are specifically talking about abuse
and subsequent death to patients taking drugs prescribed by their
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doctors.
5. Prescription Drug Monitoring and CURES. With rising levels of
abuse, PDMPs are a critical tool in assisting law enforcement and
regulatory bodies with their efforts to reduce drug diversion. 49
states currently have monitoring programs (Missouri is the only
state currently without a PDMP. California has the oldest
prescription drug monitoring program in the nation. Of these 50
programs throughout the nation, seven are or will be housed at the
state's Department of Justice, 18 are or will be housed at a state
Department of Health or substance abuse agency and 25 are or will
be housed at a state Board of Pharmacy or state professional
licensing agency. There is currently momentum to share data across
these programs from state to state.
In California, the Controlled Substance Utilization Review and
Evaluation System (CURES) is an electronic tracking program that
reports all pharmacy (and specified types of prescriber) dispensing
of controlled drugs by drug name, quantity, prescriber, patient,
and pharmacy.
AB 3042 (Takasugi, Chapter 738, Statutes of 1996) established a
three year pilot program, beginning in July 1997, for the
electronic monitoring of prescribing and dispensing of Schedule II
controlled substances. Subsequent legislation ( SB 1308 , Committee
on Business and Professions, Chapter 655, Statutes of 1999)
extended the sunset date on the CURES program to July 1, 2003 and
required DOJ to submit annual status reports on the program to the
Legislature. In 2002, the Legislature passed AB 2655 (Matthews,
Chapter 345, Statutes of 2002) which extended the CURES program to
2008 and provided access to CURES data by licensed health care
providers. Finally, in 2003, SB 151 (Burton, Chapter 406, Statutes
of 2003) made the program permanent. In 2009, then Attorney
General Brown launched an online CURES system at DOJ to replace the
previous system that required mailing or faxing written requests
for information, giving health professionals (doctors, pharmacists,
midwives, and registered nurses), law enforcement agencies and
medical profession regulatory boards instant computer access to
patients' controlled-substance records.
Data from CURES is managed by DOJ to assist state law enforcement
and regulatory agencies in their efforts to reduce prescription
drug diversion. CURES provides information that offers the ability
to identify if a person is "doctor shopping" (when a
prescription-drug addict visits multiple doctors to obtain multiple
prescriptions for drugs, or uses multiple pharmacies to obtain
prescription drugs). Information tracked in the system contains
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the patient name, prescriber name, pharmacy name, drug name, amount
and dosage, and is available to law enforcement agencies,
regulatory bodies and qualified researchers. The system can also
report on the top drugs prescribed for a specific time period,
drugs prescribed in a particular county, doctor prescribing data,
pharmacy dispensing data and is a critical tool for assessing
whether multiple prescriptions for the same patient may exist. In
addition to the Board, CURES data can be obtained by the MBC,
Dental Board of California, Board of Registered Nursing,
Osteopathic Medical Board of California and Veterinary Medical
Board.
Since 2009, more than 8,000 doctors and pharmacists have signed up
to use CURES, which has more than 100 million prescriptions. The
system also has been accessed more than 1 million times for patient
activity reports and has been key in investigations of doctor
shoppers and nefarious physicians. According to the AG's office,
CURES assisted in targeting the top 50 doctor shoppers in the
state, who averaged more than 100 doctor and pharmacy visits to
collect massive quantities of addictive drugs and the crackdown led
to the arrest of dozens of suspects. CURES also provided
information with the prescribing history of a Southern California
physician accused of writing hundreds of fraudulent prescriptions
to feed his patients' drug addictions, seven of whom died from
prescription-drug overdoses. The system has also been successful
in alerting law enforcement and licensed medical professionals to
signs of illegal drug diversions, including a criminal ring that
stole the identities of eight doctors, illegally wrote
prescriptions, stole the identities of dozens of innocent citizens
who they designated as patients in order to fill the fraudulent
prescriptions, resulting in the group obtaining more than 11,000
pills of highly addictive drugs like OxyContin and Vicodin.
While California has the largest number of practitioners,
pharmacies and patients, the DOJ reports that without a dedicated
funding source, the CURES PDMP is not sustainable and will be
suspended by July 1, 2013. Specifically, the California Budget Act
of 2011 imposed budget cuts to the DLE and eliminated all General
Fund support for CURES and the PDMP, which included funding for
system support, staff support and related operating expenses.
Currently, to perform the minimum critical functions and to avoid
shutting down the program, DOJ 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, including a four-week timeframe to process new user
applications, six-week response time on emails, twelve week backlog
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on voicemails and other significant delays in productivity.
According to DOJ, the only funding currently available for CURES is
through one grant and renewable contracts with the MBC, Dental
Board of California, Board of Registered Nursing, Osteopathic
Medical Board of California and Veterinary Medical Board. As a
result, funding for CURES and PDMP in state fiscal year 2012-13
consists of $296,000 that can be used only for PDMP system data and
maintenance. DOJ reports that it will use California Justice
Information Services (CJIS) general fund monies to keep the current
PDMP running at minimal capacity through June 30, 2013.
The Medical Board of California and Board of Pharmacy held a "Joint
Forum to Promote Appropriate Prescribing and Dispensing" on
February 21-22, 2013 at which the boards addressed public policy
issues relating to prescription drugs, including the CURES PDMP.
Pharmacists, doctors, prosecutors, investigators, and board
representatives all weighed in on the current and future direction
of the CURES program. Several speakers and most of the public
commenters opined that the CURES user interface is outdated, slow,
and difficult to navigate, which discourages prescribers and
dispensers from using it. Despite the current shortcomings of the
program, the boards called upon the Legislature to fund CURES and
provide for its improvement. Stakeholders and the boards noted
that the CURES system is a key tool for identifying patients who
are engaging in doctor or pharmacy shopping, where the patient uses
multiple doctors or pharmacies to facilitate access to prescription
drugs beyond the patient's medical needs, either to feed the
patient's personal addiction or to supply drugs to others. It was
reported that the CURES system also has the potential to be used to
identify over-prescribing practitioners and over-dispensing
pharmacies. The boards noted that they are interested in using
CURES PDMP to identify patterns of prescribing and dispensing that
indicate a licensee might be engaging in prohibited behavior. Some
proposed changes to improve the efficacy of the CURES system
discussed at the forum include technological updates and making
prescriber participation mandatory. To the boards and
stakeholders, making participation in CURES mandatory, and
requiring every prescriber to check a patient's CURES report prior
to prescribing a controlled substance, may be an important method
of identifying potential problems and avoiding prescribing more
drugs than are medically necessary.
6. CURES 2.0. DOJ is proposing a modernization program for CURES,
CURES 2.0 which "seeks to quickly and efficiently serve the state's
large medical practitioner community as well as meet the demanding
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analytical and information requirements of the criminal justice
community".
DOJ reports in CURES 2.0: An Integrated Approach to Preventing Drug
Abuse and Diversion that the current CURES PDMP demands heavy
personnel resources for information processing and dissemination.
The system also requires the equivalent of seven IT staff but is
slow, frequently freezes and is not capable of accommodating a
large influx of new users. The current registration process for
the program is time intensive and requires manual data entry and
work. DOJ also notes that the system is currently reactive in
nature and has limited reporting and analytical capabilities, as
well as underutilized, with only 3.6 percent of the eligible
prescriber and pharmacist licensee field registered as users of
CURES. The current system also has discrepancies between its two
data sources that can result in unreliable information.
A modernized system as outlined by DOJ will result in fewer staff
required to maintain the PDMP as well as increased analytical
capabilities for regulatory boards and law enforcement to
investigate and prevent drug diversion. According to DOJ, CURES
2.0 will
provide a streamlined program, system and enrollment process;
integration with current major health information systems; timely
Patient Activity Reports to prescribers and dispensers; inquiry
capabilities to law enforcement and regulatory boards; and, a
method of secure data exchange among PDMP users and DOJ. According
to DOJ, the modernized PDMP will enhance information sharing about
prescription drug dispensing and prescribing while "promoting
legitimate medical practice and quality patient care" and implement
two "newly created State of California Regional Investigative
Prescription Teams (SCRIPT), a collaborative effort to
significantly diminish the availability and use of illegally
obtained prescription drugs through education, training and
apprehending those responsible for the distribution and diversion
of prescription drugs". The modernization effort would take
approximately 12 to 16 months to complete once funding has been
secured and system design efforts begin. The costs associated with
CURES 2.0, as provided by DOJ, are as follows:
---------------------------------------------------------------
| PDMP Modernization One-Time Cost - Two Year Period |
---------------------------------------------------------------
|-------------------------------------------+-------------------|
| Item | Amount|
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|-------------------------------------------+-------------------|
| Hardware (Server, storage and network) | $520,541|
|-------------------------------------------+-------------------|
| Software (Licensing and maintenance) | $542,102|
|-------------------------------------------+-------------------|
| Design, Development, and Implementation | $1,032,000|
| (Consultant contract based on 4 contract | |
| staff working an estimate of 8600 hours | |
| at $120 per hour) | |
|-------------------------------------------+-------------------|
| Estimated One-Time Cost |$2,090,643 |
| | |
---------------------------------------------------------------
The $2,090,643 cost above would be for modernizing the
Prescription Drug Monitoring Program (PDMP) to meet the needs of
medical practitioners and law enforcement.
---------------------------------------------------------------
| Transitional System Cost - Two Year Period |
---------------------------------------------------------------
|-------------------------------------------+-------------------|
| System | |
|-------------------------------------------+-------------------|
| Information Technology | $1,300,000|
| Staff (7) | |
|-------------------------------------------+-------------------|
| Electronic Data Service | $260,000|
| (to obtain pharmacy data) | |
|-------------------------------------------+-------------------|
| Maintenance (hardware, | $270,000|
| software) | |
|-------------------------------------------+-------------------|
|Estimated Cost to Operate System During |$1,830,000 |
|Two Year Period: | |
---------------------------------------------------------------
The $1,830,000 cost identified above would be necessary to
operate and maintain the current PDMP until data could be
migrated to the modernized PDMP. This bill seeks to fund the
modernization effort and transitional system through the proposed
onetime tax assessment on health insurance plans and workers
compensation insurers.
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---------------------------------------------------------------
|CURES 2.0 Program and System Cost Ongoing - Year Three |
---------------------------------------------------------------
|-------------------------------------------+-------------------|
| Program | |
|-------------------------------------------+-------------------|
| CURES Support Staff (9) | $ 776,554|
|-------------------------------------------+-------------------|
| Travel/Training (system | $15,000|
| registration outreach; training | |
| system users; stakeholder | |
| meetings) | |
|-------------------------------------------+-------------------|
| System | |
|-------------------------------------------+-------------------|
| Information Technology | $500,000|
| Staff (5) | |
|-------------------------------------------+-------------------|
| Electronic Data Service | $130,000|
| (to obtain pharmacy data) | |
|-------------------------------------------+-------------------|
| Maintenance (hardware, | $200,000|
| software) | |
|-------------------------------------------+-------------------|
| Total:|$1,621,554 |
| | |
---------------------------------------------------------------
The $1,621,554 cost identified above would be the cost of
staffing, operating, and maintaining the modernized PDMP on a
yearly basis. This cost would include any necessary hardware
and/or software upgrades. This bill seeks to fund this effort
through the proposed 1.16 percent increase in licensing fees for
prescribers, pharmacists and wholesalers. As proposed, this fee
increase would result in approximately:
$9 increase on the current $808 licensing fee for
physicians and surgeons
$4 increase on the current $365 licensing fee for
dentists
$2 increase on the current $150 licensing fee for
pharmacists
$7 increase on the current $600 licensing fee for
wholesalers, including out-of-state wholesalers
$5 increase on the current $405 licensing fee for
veterinary retailers
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$3 increase on the current $290 licensing fee for
veterinarians
$2 increase on the current $140 licensing fee for
nurse midwives
$2 increase on the current $140 licensing fee for
nurse practitioners
$3 increase on the current $300 licensing fee for
physician assistants
$5 increase on the current $400 licensing fee for
osteopathic physicians and surgeons
$5 increase on the current $425 licensing fee for
optometrists
$10 increase on the current $900 licensing fee for
permanent doctors of podiatric medicine
---------------------------------------------------------------
|Statewide SCRIPT Team |
---------------------------------------------------------------
|-------------------------------------------+-------------------|
| Program - SCRIPT Team (19) | $ 4,307,343|
|-------------------------------------------+-------------------|
| Total:|$ |
| |4,307,343 |
| | |
---------------------------------------------------------------
The $4,307,343 cost identified above would fund two State of
California Regional Investigative Prescription Teams (SCRIPT), with
one team located in Northern California and one in Southern
California. These SCRIPT teams would be tasked with investigating
prescription drug diversion, coordinating cases with the MBC, as
well as the coordination of state, federal and local law
enforcement efforts. These teams would provide statewide
jurisdiction for cases involving organized diversion and the misuse
of scheduled medication. This bill seeks to fund the SCRIPT teams
through an annual tax levy on narcotic drug manufacturers who do
business in this state.
7. Related Legislation. SB 62 (Price) requires coroners' reports to
be transmitted to various health practitioner boards in the event
that cause of death is determined to be prescription drug overdose.
The bill is also up for consideration in this Committee today.
SB 670 (Steinberg) provides the Medical Board of California with
additional authority to inspect medical records and to limit the
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prescribing ability of physicians during a pending investigation if
there is a reasonable suspicion the physician has engaged in
overprescribing of controlled substances that resulted in a
patient's death. The bill is also up for consideration in this
Committee today.
SB 616 (DeSaulnier) of 2012 would have increased fees, up to $10
per licensee that is authorized to prescribe or dispense controlled
substances, to fund CURES. The measure failed passage in the
Assembly Committee on Business, Professions and Consumer
Protection.
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 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. Fees
would have been collected by the BOE, at the rate of $0.0025 per
pill included in Schedule II, III, and IV. The bill was held in
the Senate Committee on Health.
AB 2986 (Mullin, Chapter 286, Statutes of 2006) required designated
prescription forms for controlled substances and prescriptions for
controlled substances to contain additional information identifying
the final consumer and any refill information.
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 151 (Burton, Chapter 406, Statutes of 2004) makes CURES
permanent, among other provisions.
AB 3042 (Takasugi, Chapter 738, Statutes of 1996) establishes CURES
as a three-year pilot program.
8. Arguments in Support. California Attorney General Kamala Harris
(AG) writes in support of this bill, noting that without the
funding it provides, the AG will be forced to disband the CURES
program later this year, making California one of only two states
in the nation without a PDMP and that closing the CURES program
would "exacerbate a prescription drug diversion problem that is
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already the fastest growing drug problem in the United States".
According to the Healthcare Distribution Management Association ,
this bill outlines a fair and equitable approach to funding CURES.
The group believes that PDMPs are worthwhile and can be effective
in the fight against abuse of controlled substances and other
prescription drugs.
9. Arguments of California Medical Association (CMA). CMA writes in a
"Support if Amended" position to this bill, stating that that while
physicians are strong supporters of the CURES database and
recognize its potential to ensure appropriate prescribing, CMA
would like the bill to:
Ensure that the CURES funding mechanism is "equitable
and protects the Medical Board's resources to adequately
regulate its licensees."
Remove the requirement that the database be checked
before a prescriber writes a prescription.
Clarify the use of CURES data for investigative and
regulatory purposes so that when allegations of inappropriate
prescribing based on CURES data are made, there is medical
review conducted by physicians to evaluate the occurrence of
inappropriate prescribing.
1. Arguments in Opposition. Pharmaceutical Research and Manufacturers
of America (PhRMA) states that this bill creates an open-ended and
permanent funding requirement on manufacturers to finance a
"strike-team" to enforce California's anti-drug efforts. PhRMA
supports the use of PDMPs and believes these and related
enforcement programs should be funded with state General Fund
dollars, federal grant monies or other fiscal resources rather than
a tax on the industry.
NOTE : Double-referral to Senate Committee on Governance and Finance
second.
SUPPORT AND OPPOSITION:
Support:
California Attorney General Kamala Harris (Sponsor)
California Narcotics Officers Association
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California Pharmacists Association
California Police Chiefs Association
California State Sheriffs' Association
Center for Public Interest Law (CPIL)
City and County of San Francisco
Healthcare Distribution Management Association
Troy and Alanna Pack Foundation
University of California
Support If Amended:
California Medical Association (CMA)
Opposition:
Pharmaceutical Research and Manufacturers of America (PhRMA)
Consultant: Sarah Mason