BILL ANALYSIS �
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|Hearing Date:April 15, 2013 |Bill No: SB |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 670Author:Steinberg
As Amended:April 8, 2013 Fiscal: Yes
SUBJECT: Physicians and surgeons: drug prescribing privileges:
investigation.
SUMMARY: Authorizes the Medical Board of California to inspect
medical records of a patient who died of a prescription drug overdose
without the consent of the patient's next of kin or a court order, as
specified; makes it unprofessional conduct for a licensee who is under
investigation to fail to attend and participate in an interview within
30 days from notification, as specified; authorizes an administrative
law judge to issue an interim suspension order limiting the authority
of a physician to prescribe, furnish, administer, or dispense
controlled substances; requires the Medical Board of California to
impose limitations on the authority of a physician and surgeon to
prescribe, furnish, administer, or dispense controlled substances
during a pending investigation if there is a reasonable suspicion that
the physician and surgeon has engaged in overprescribing drugs, or
other drug prescribing behavior that has resulted in the death of a
patient.
Existing law:
1)Licenses and regulates physicians and surgeons under the Medical
Practice Act (Act) by the Medical Board of California (MBC) within
the Department of Consumer Affairs (DCA) and states that the
protection of the public is the highest priority of the MBC in
exercising its functions. (Business and Professions Code (BPC) �
2000 et. seq.)
2)Authorizes investigators and representatives of the MBC, among
others, to inquire into any alleged violation of the Act or any
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other federal or state law, regulation, or rule relevant to the
practice of medicine or podiatric medicine, and to inspect documents
relevant to those investigations, including the inspection and
copying of any document relevant to an investigation where patient
consent is given. (BPC � 2225)
3)Provides for the professional review of specified healing arts
licentiates by a peer review body, as defined, including: (BPC �
805)
a) A medical or professional staff of any health care facility
or a licensed clinic, or a facility certified to participate in
the federal Medicare Program as an ambulatory surgical center.
b) A health care service plan or a disability insurer, as
specified.
c) Any medical, psychological, marriage and family therapy,
social work, dental, or podiatric professional society, as
specified.
d) A committee organized by any entity that functions for the
purpose of reviewing the quality of professional care provided
by members or employees of that entity.
4)Defines a licentiate, for purposes of item # 3) above, as a
physician and surgeon, doctor of podiatric medicine, clinical
psychologist, marriage and family therapist, clinical social
worker, or dentist. (BPC � 805)
5)Requires an 805 report to be filed by the chief of staff, chief
executive officer, medical director, or administrator of any peer
review body and the chief executive officer or administrator of a
health facility or clinic, as defined, with the MBC, among other
agencies having regulatory jurisdiction over a licensee within 15
days after the effective date of any specified action taken against
a licensee for a medical disciplinary cause or reason.
(BPC � 805)
6)Requires a coroner to make a report to the MBC, among other
specified entities, when he or she receives information that
indicates that a death may be the result of a physician and
surgeon's, podiatrist's, or physician assistant's gross negligence
or incompetence.
(BPC � 802.5)
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7)Requires the MBC to take action against any licensee who is charged
with unprofessional conduct. Unprofessional conduct is defined to
include, among other things, the repeated failure by a licensee who
is the subject of an MBC investigation, in the absence of good
cause, to attend and participate in an interview scheduled by the
mutual agreement of the licensee and the board. (BPC � 2234)
8)Under the Administrative Procedure Act (APA), establishes within
the Office of Administrative Hearings (OAH) a Medical Quality
Hearing Panel to conduct adjudicative hearings and proceedings
relative to licensees of the MBC under the terms and conditions set
forth in the APA, except as provided in the Medical Practice Act.
(Government Code (GC) �� 11371, 11373)
9)Authorizes an administrative law judge of the Medical Quality
Hearing Panel to issue an interim suspension order (ISO) suspending
a license, or imposing drug testing, continuing education,
supervision of procedures, or other licensee restrictions. (GC �
11529)
10)Requires that the burden and standards of proof to obtain an ISO
shall be those applicable to a preliminary injunction under Section
527 of the Code of Civil Procedure. (GC � 11529 (e))
This bill:
1)Authorizes the MBC, when it receives an 805 Report, or a Coroner's
Report as described above, that involves the death of a patient from
a prescription drug overdose, to inspect and copy the medical
records of the deceased patient without the consent of the patient's
next of
kin or a court order in order to determine the extent to which the
death was the result of a prescriber's inappropriate conduct.
2)Revises the definition of unprofessional conduct under the Act to
include the failure by a licensee who is the subject of an MBC
investigation, in the absence of good cause, to attend and
participate in an interview scheduled within 30 days of notification
from the MBC.
3)Authorizes an administrative law judge to issue an ISO limiting the
authority of a physician to prescribe, furnish, administer, or
dispense controlled substances.
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4)Requires the MBC, notwithstanding the authority of an administrative
law judge, to impose limitations on the authority of a physician and
surgeon to prescribe, furnish, administer, or dispense controlled
substances during a pending investigation if there is a reasonable
suspicion that the physician and surgeon has engaged in either of
the following:
a) Overprescribing drugs.
b) Other behavior related to his or her drug prescribing
privileges that has resulted in the death of a patient.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by the Author, President Pro Tem
Darrell Steinberg, who was prompted to pursue the legislation
following the recent Los Angeles Times investigation that uncovered
significant issues with physicians, overprescribing and patient
deaths.
According to the Author's staff, to speed up investigations in cases
where patients have died as a result of prescription drug overdose,
this measure seeks to:
Authorize the MBC, if it receives an 802.5 Report or 805
Report that involves the death of a patient from a prescription
drug overdose, to inspect and copy the medical records of the
deceased patient without the consent of the patient's next of
kin or a court order in order to determine the extent to which
the death was the result of a prescriber's inappropriate
conduct.
Revise definition of unprofessional conduct to include the
failure by a licensee who is the subject of an MBC
investigation, in the absence of good cause, to attend and
participate in an interview scheduled within 30 days of
notification from the MBC.
In order to ensure potentially dangerous doctors are not able to
continue prescribing, while an investigation is pending, this
measure seeks to:
Require the MBC to impose limitations on the authority of a
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physician and surgeon to prescribe, furnish, administer, or
dispense controlled substances during a pending investigation
if there is a reasonable suspicion that the physician has
engaged in overprescribing drugs or other behavior related to
his or her drug prescribing privileges that has resulted in the
death of a patient.
1.Need For This Bill. The Author describes the need for the bill as
follows:
a) Obtaining Patient Information . Per existing law above, in
circumstances where patients (often times suffering from
addiction) have died as a result of a physician abusing his/her
prescribing privileges, the MBC can only access the deceased
patient's medical records with authorization from a "next of kin"
or through a subpoena. The lack of a concerned patient releasing
his/her medical records (the patient is deceased) and
difficulties finding the next of kin in addiction cases creates a
significant barrier to the ability of the MBC to quickly
investigate and potentially pursue disciplinary action against a
physician whose abuse of prescribing privileges has led to
patient death. A more direct mechanism for the MBC to access
patient records is necessary in these unique circumstances.
b) Physician Interviews . BPC Section 2234 (h) was written to
incentivize physicians to attend physician interviews by making
non-compliance unprofessional conduct. The reason this provision
was placed in statute was that the failure of physicians to
attend necessary interviews was adding to the MBC's investigatory
timelines, and many times subpoenas would be needed to compel
physicians to attend. However, the law only allows the MBC to
pursue unprofessional conduct if the physician mutually agrees to
the interview and then fails to show up repeatedly. This creates
a significant loophole where physicians can significantly
lengthen the time of investigations, and the time to potential
disciplinary action by failing to mutually agree on an interview
time. To expedite investigations and potential disciplinary
action, this provision needs to be updated to make it
unprofessional conduct for a physician's failure, in the absence
of good cause, to attend and participate in an interview
scheduled within 30 days of notification from the MBC. This
issue was raised in the MBC 2012 Sunset Report.
c) Interim Suspension Orders (ISO) . In order for the MBC to stop
a physician from practicing before disciplinary action is taken,
they must obtain an interim suspension order (ISO). The ISO can
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fully restrict a physician's license, or place prescribing or
other restrictions on the license, but not fully prohibit the
physician from practicing. An ISO is considered extraordinary
relief and pursuant to Government Code Section 11529, a standard
of proof must be met in order to be granted an ISO. The standard
of proof is relatively high, and must be consistent with the
burden and standards of proof applicable to a preliminary
injunction entered under Section 527 of the Code of Civil
Procedure.
Before an ISO can be requested, there are a number of steps that
must be taken (gathering medical records, obtaining patient
consent, medical consultant review, etc.) in order to prove that
a licensee's continued practice presents an immediate danger to
public health, safety, or welfare. As the investigation
progresses and the Attorney General's office reviews the case, a
determination is made as to whether there is enough evidence to
warrant requesting an ISO. Even after the ISO is requested, if
an Administrative Law Judge (ALJ) determines there is
insufficient evidence, the ISO request can be denied. Also, due
to a 15-day time restraint to file an accusation after being
granted an ISO, and a 30-day time restraint between the
accusation being filed and a hearing being set, this means an
investigation must be nearly complete in order to file for an
ISO. Depending on the case, gathering the appropriate materials
necessary to complete the investigation and request an ISO can be
a time-consuming process.
This process allows patients (often times suffering from addiction)
to remain at significant risk of inappropriate prescribing
behavior, even when the MBC may have reasonable suspicion to
believe that the physician and surgeon has engaged in
overprescribing drugs, or other behavior related to his or her
drug prescribing privileges, that has resulted in the death of a
patient. It is necessary, in these limited circumstances , to
provide the MBC with a better, more expedient, fair interim tool
for protecting patients from physicians who may be engaging in
inappropriate prescribing.
3. Prescription Drug Deaths. A recent Centers for Disease Control
(CDC) analysis found that drug overdose deaths increased for the
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
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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 Prescription Drug
Monitoring Programs (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.
4. Drug Deaths and MBC Enforcement Issues. In November and December
of 2012, the Los Angeles Times published a series of four articles
titled "Dying For Relief," which were the outcome of an intensive
review of the epidemic of prescription drug-related deaths in four
Southern California counties (Los Angeles, Orange, Ventura and San
Diego). In the investigation, reporters examined coroners' records
and interviewed doctors, regulators, law enforcement officials and
relatives of those who died from overdoses. In these cases
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;
and the coroner determined that the drug caused or contributed to
the death. The investigators also created and analyzed a
searchable database of 3,700 drug related deaths during a 5-year
span (2005-2011) in Southern California to identify those tied to
doctors' prescriptions.
An examination of coroner records by the Times found that:
" In 47% of those cases (1,762 deaths) drugs for which the
deceased had a prescription were the sole cause or a
contributing cause of death.
" A small number of doctors were associated with a
disproportionate number of those fatal overdoses. 0.1% of the
practicing physicians (71 physicians) in the 4 counties wrote
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prescriptions for drugs that caused or contributed to 298
deaths. That is 17% of the total deaths linked to doctors'
prescriptions.
" Each of the 71 physicians prescribed drugs to 3 or more
patients who died.
" 4 of the physicians had 10 or more patients who fatally
overdosed.
" One physician had 16 patients who died.
The Times found that the 71 physicians with 3 or more fatal
overdoses among their patients are primarily pain specialists,
general practitioners and psychiatrists. Four of the physicians
have been convicted of drug offenses in connection with their
prescriptions, and a fifth is awaiting trial on second-degree murder
charges in the overdose deaths of 3 patients. The remaining
physicians had clean records with the MBC, according to the Times.
1. Sunset Review Oversight Hearing. Earlier this year, the Senate
Business, Professions and Economic Development Committee and the
Assembly Business, Professions and Consumer Protection Committee
held a Joint Oversight Hearing of the MBC. At that hearing,
testimony was heard from the MBC, consumers, parents, consumer
groups, professional associations and the public at large. That
hearing primarily focused on the enforcement program of the MBC.
The question was raised about the MBC's effectiveness in protecting
consumers from dangerous practitioners in the medical field.
This bill is closely related to other bills that impact the MBC's
enforcement processes. See "Related Legislation" below.
2. 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 616 (DeSaulnier) 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.
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Imposes annual taxes on drug manufacturers of Schedule II, III, and
IV controlled substances doing business in California to maintain
the CURES PDMP. The bill is also up for consideration in this
Committee today.
SB 304 (Price) makes changes stemming from the Committee's Sunset
Oversight Hearing of the MBC on March 11, 2013. That bill has been
referred to this Committee for consideration.
SUPPORT AND OPPOSITION:
Support :None received as of April 9, 2013
Opposition: None received as of April 9, 2013
Consultant:G. V. Ayers