BILL ANALYSIS �
SB 360
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Date of Hearing: August 17, 2011
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
SB 360 (DeSaulnier) - As Amended: July 7, 2011
Policy Committee: Public
SafetyVote:7-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill:
1)Authorizes the Department of Justice (DOJ) to enforce access
requirements of its Web-based Prescription Drug Monitoring
Program (PDMP) by conducting PDMP audits to protect against
unauthorized use, such as sharing patient data with third
parties, accessing information of patients not under the
physician's care, and selling patient data. DOJ may establish
by regulation a citation process, which may contain an
abatement order and an administrative fine not to exceed
$2,500. Specifically, these provisions:
a) Allow, in addition to requesting a hearing, a cited PDMP
subscriber to request an informal citation conference with
DOJ.
b) Require administrative fines be deposited in a DOJ fund
for costs associated with DOJ's controlled substances
database, the Controlled Substance Utilization Review and
Evaluation System (CURES).
c) Provide that a PDMP application by a practitioner or
pharmacist may be denied for cause, including, but not
limited to:
i) Falsifying an application
ii) Failure to maintain effective controls for access to
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the patient activity report
iii) Suspension or revocation of a Drug Enforcement
Administration (DEA) registration
iv) An arrest or conviction for a controlled substance
offense or violation of this section
v) Accessing PDMP information for any reason not
related to patient care
2)Expands and modifies a series of requirements imposed on
security printers (persons approved to produce controlled
substance prescription forms) by DOJ, including:
a) Requiring names and addresses of owners, partners,
representatives, or others with access to controlled
substance prescription forms; a signed statement regarding
any prior criminal convictions for these parties, and
fingerprints.
b) Clarifying the fee to process security printer
applications shall be sufficient to cover inspections of
security printers in addition to the other specified
processes.
c) Requiring a security printer to obtain the customer's
photo identification and ship controlled substance
prescription forms only to an address verified by the DEA
or Medical Board of California.
d) Requires DOJ to impose sanctions on security printers
who violate statutes and regulations, including failure to
comply with guidelines. Sanctions are a fine of up to
$1,000 for a first violation, a fine of up to $2,500 for a
subsequent violation; and disciplinary proceedings for
suspension or revocation of security printer status for a
third or subsequent violations.
FISCAL EFFECT
1)Unknown significant annual GF costs, in the range of $150,000,
for developing regulations, conducting PDMP audits, and
holding citation conferences and hearings, offset to some
degree by dedicated citation revenue.
DOJ states a willingness and ability to absorb the cost of
regulations. Moreover, DOJ does not anticipate a significant
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number of audits, citations or hearings, contending the
deterrent value of the enforcement mechanism will suffice in
most cases.
2)Unknown, likely minor and absorbable administrative costs to
DOJ for security printer process changes, offset to an unknown
degree by increased fines.
COMMENTS
1)Rationale . The intent of the author and sponsor (DOJ) is to
create a process whereby DOJ can protect against improper and
unauthorized use of the PDMP.
According to the author, "SB 360 will help to prevent the
misuse of confidential information collected through the CURES
and ensure the integrity of the program and process for
practitioners and pharmacists to appropriately use patient's
controlled substances history information."
Regarding the changes to the security printer processes, the
author states, "While the DOJ has established guidelines for
the security of prescription forms, current law lacks
sufficient safeguards against theft and fraudulent use of
prescription pads and the DOJ has seen an increase in criminal
enterprises involved in prescription form theft and fraud. SB
360 provides additional requirements and sanctions for
Security Printers to deter fraudulent use of prescription pads
and the illegal distribution of controlled substances."
2)CURES and PDMP . The state's controlled substances dispensary
database is known as the Controlled Substance Utilization
Review and Evaluation System. According to DOJ, CURES contains
over 100 million entries of controlled substance drugs
dispensed in California. Each year the CURES program responds
to more than 60,000 requests from practitioners and
pharmacists via the online PDMP system, which makes it easier
for authorized health practitioners to review controlled
substance information via the automated Patient Activity
Report (PAR) in an effort to identify and deter drug abuse and
diversion through accurate and rapid tracking of controlled
substances.
The goal of CURES and PDMP is to reduce pharmaceutical drug
diversion without affecting legitimate medical practice or
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patient care.
3)Support . According to DOJ, "The PDMP is a valuable
investigative, preventative, and educational tool for law
enforcement, regulatory boards, and health care providers.
However, current efforts at maintaining privacy and control of
CURES data are inadequate to protect confidential patient
information, and to deter misuse of confidential CURES data.
SB 360 authorizes DOJ to initiate administrative enforcement
actions to prevent and deter misuse of confidential patient
information collected through the CURES program.
"Under existing law, DOJ also manages the California Security
Prescription Printer Program, including approval of "Security
Prescription Printer" applications. Fraudulent prescriptions
are lucrative. One blank prescription pad of 500 prescriptions
can generate millions of dollars from the illegal sale of
controlled substances such as Oxycontin, Xanax, or Vicodin.
DOJ has seen an increase in criminal enterprises, from gangs
to organized crime, involved in prescription drug fraud.
Current law lacks adequate safeguards against the theft and
illegal distribution of prescription pads from Security
Prescription Printers. SB 360 provides additional requirements
and sanctions for Security Printers and their employees who
have direct contact with, or access to, controlled substance
prescription drug forms to deter fraudulent prescriptions and
illegal distribution of controlled substances."
4)Prior Legislation .
a) AB 2548 (Block), 2010, was similar to the CURES/PDMP
provisions of SB 360, and was held on this committee's
Suspense File.
b) AB 3042 (Takasugi), Statutes of 1996, established CURES
as a three-year pilot program.
c) SB 151 (Burton), Statutes of 2004, made the CURES system
permanent.
Analysis Prepared by : Geoff Long / APPR. / (916) 319-2081
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