BILL ANALYSIS �
SB 670
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Date of Hearing: August 13, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 670 (Steinberg) - As Amended: August 6, 2013
SENATE VOTE : 35-3
SUBJECT : Physicians and surgeons: drug prescribing privileges:
investigation.
SUMMARY : Permits the Medical Board of California (MBC) to
limit a physician's prescribing privileges for 30 days, permits
MBC to inspect and copy a deceased patient's medical records,
clarifies language relating to unprofessional conduct, and
permits an interim suspension order (ISO) to place restrictions
on a physician's prescribing privileges, as specified.
Specifically, this bill :
1)Permits MBC to impose limitations on the authority of a
physician and surgeon to prescribe, furnish, administer, or
dispense controlled substances during a pending investigation
if MBC has probable cause to believe that the physician and
surgeon has prescribed, furnished, administered, or dispensed
controlled substances in violation of the Medical Practice Act
(Act), and that not imposing limitations on the authority of
that physician and surgeon to prescribe, furnish, administer,
or dispense controlled substances will endanger the public
health, safety, or welfare.
2)Requires MBC to provide written notice to the affected
physician and surgeon by personal service at least five
business days prior to the effective date of any limitation
being imposed.
3)States that the limitation must be discontinued unless, within
30 business days, MBC has filed and served a petition for an
ISO against the physician and surgeon.
4)Authorizes MBC to adopt regulations or policies and procedures
to effectuate the ability for MBC to impose limitations on a
physician and surgeon's ability to prescribe, furnish,
administer, or dispense controlled substances.
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5)Permits MBC to inspect and copy the medical records of a
deceased patient, in any investigation that involves the death
of that patient, without the authorization of the beneficiary
or personal representative of the deceased patient, or a court
order solely for the purpose of determining the extent to
which the death was the result of the physician and surgeon's
conduct in violation of the Act, if MBC provides a written
request to the physician and surgeon that includes a
declaration that MBC has been unsuccessful in locating or
contacting the deceased patient's beneficiary or personal
representative after reasonable efforts.
6)Prohibits MBC from inspecting a deceased patient's medical
records without a court order when the beneficiary or personal
representative of the deceased patient has been located and
contacted, but has refused to consent to MBC inspecting and
copying the medical records.
7)Makes Legislative findings and declarations that the authority
created in MBC to inspect a deceased's records according to
this bill, and a physician and surgeon's compliance with that
request, are consistent with the public interest and benefit
activities of the federal Health Insurance Portability and
Accountability Act.
8)States that the repeated failure by a physician and surgeon
who is the subject of an investigation by MBC, in the absence
of good cause, to attend and participate in an interview
scheduled by MBC is unprofessional conduct.
9)Permits an administrative law judge (ALJ) of the Medical
Quality Hearing Panel to issue an ISO limiting the authority
of a physician and surgeon to prescribe, furnish, administer
or dispense controlled substances.
10)Makes clarifying and technical amendments.
EXISTING LAW :
1)Licenses and regulates physicians and surgeons under the Act by
the 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.)
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2)Authorizes investigators and representatives of the MBC, among
others, to inquire into any alleged violation of the Act or
any 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)
4)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)
5)Requires the MBC to take action against any licensee who is
charged with unprofessional conduct, which 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)
6)Under the Administrative Procedure Act, establishes a
Medical Quality Hearing Panel within the Office of
Administrative Hearings 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)
7)Authorizes an ALJ of the Medical Quality Hearing Panel to
issue an ISO suspending a license, or imposing drug testing,
continuing education, supervision of procedures, or other
licensee restrictions. (GC 11529)
8)Requires an accusation to be filed and served upon a
physician and surgeon within 15 days of the ISO, otherwise
the ISO is dissolved. (GC 11529(f))
9)Requires MBC to disclose any revocation, suspension,
probation, or limitation on practice ordered by MBC,
including those made part of a probationary order or
stipulated agreement to an inquiring member of the public.
(BPC 803.1(a)(3))
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10)Requires MBC to disclose any revocation, suspension,
probation, or limitation on practice ordered by MBC,
including those made part of a probationary order or
stipulated agreement, on the MBC's Internet Web site. (BPC
2027(a)(9))
11)Authorizes MBC to voluntarily appear to furnish pertinent
information, make recommendations regarding specific
conditions of probation, or provide any other assistance
necessary to promote the interests of justice and protect
the interests of the public in any criminal proceeding
against a physician and surgeon if the crime charged is
substantially related to the qualifications, functions, or
duties of the licensee. (Penal Code 23)
12)Authorizes a superior court for the county in which any
person has engaged or is about to engage in any act which
constitutes a violation of the Act, upon a petition filed by
MBC with the approval of the DCA director, issue an
injunction or other appropriate order restraining such
conduct. (BPC 125.5)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill gives MBC additional tools to
bring enforcement actions against a physician and surgeon
suspected of improper conduct. SB 670 would allow MBC to
limit a physician's prescribing privileges for 30 days if it
determines public health, safety, or welfare is at risk, allow
MBC to inspect and copy the medical records of a deceased
patient if a patient's representative can't be found, and
declare that the repeated failure for a physician to attend a
physician interview, as part of an investigation, is
unprofessional conduct. This bill is author-sponsored.
2)Author's statement . According to the author's office, "Per
existing law, when patients have died as a result of physician
wrong-doing, the Medical Board can only access the deceased
patient's medical records with authorization from a 'next of
kin' or through a subpoena. ... A more direct mechanism for
the Board to access patient records is necessary.
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"[Current law] was written to incentivize physicians to attend
physician interviews by making non-compliance unprofessional
conduct. ?However, the law only allows the Medical Board to
pursue unprofessional conduct if the physician mutually agrees
to the interview and then fails to show up repeatedly. ?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 board.
"In order for the Medical Board to stop a physician from
practicing before disciplinary action is taken, the Board must
obtain an ISO.?An ISO is considered extraordinary relief and
?the standard of proof is relatively high?. This process
allows patients to remain at significant risk of inappropriate
prescribing behavior, even when the Medical Board may have
probable cause to believe that the physician and surgeon is
abusing his/her prescribing privileges. It is necessary to
provide the Board with better, more expedient, interim tools
for protecting patients from physicians who may be engaging in
inappropriate prescribing."
3)Physician interviews . MBC reports that current statutory
requirements are too lax and do not encourage physicians to
attend mandatory investigatory interviews in a timely fashion.
This bill eliminates the "mutual agreement" provision that
requires MBC and the physician to jointly determine a meeting
time. This bill states that the repeated failure of a
physician under investigation to attend and participate in an
interview scheduled by MBC, in the absence of good cause, is
unprofessional conduct.
4)Deceased patient records . According to MBC, if it is
investigating a physician whose patient has died, MBC must
receive written authorization from the patient's next of kin
in order to obtain the patient's medical records. However,
the next of kin may not be found, and MBC still needs those
medical records to determine if a physician is prescribing
appropriately.
This bill would allow MBC to inspect and copy a deceased
patient's medical records if MBC provides a written request to
the physician and surgeon that includes a declaration that MBC
has been unsuccessful in locating or contacting the deceased
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patient's beneficiary or personal representative after
reasonable efforts. MBC would be prohibited from inspecting
and copying those records if the beneficiary or personal
representative refuses authorization.
5)Current enforcement options . MBC has a variety of options
available to halt the practice of a physician who it
determines is a risk to the public: MBC may issue an ISO or a
temporary restraining order, require certain conditions as
part of bail, or agree to a stipulated agreement to restrict
or halt practice. MBC can also require a physician to cease
practice if the physician has failed to comply with a term or
condition of their probation.
This bill is intended to supplement current enforcement actions,
especially for those cases in which a physician's prescribing
behavior is particularly egregious and available remedies are
insufficient.
6)This bill's prescription restriction provisions . This bill
would permit MBC to impose limitations on the authority of a
physician to prescribe, furnish, administer, or dispense
controlled substances during a pending investigation if MBC
has probable cause to believe that the physician has used his
or her prescribing privileges in violation of the Act, and
that the failure to impose such restrictions would endanger
the public health, safety or welfare. MBC must give the
physician five days' notice before the restrictions begin.
These restrictions would remain in place for 30 days, and
would be dissolved unless the physician is served with an ISO.
Under current law, this action would be posted on MBC's Web
site for ten years. Federal law also requires reporting of
limitations on a physician's license.
7)Interim Suspension Orders (ISO) . The ISO process was created
in 1990 to allow MBC to immediately halt the practice of very
dangerous physicians in egregious cases. An ISO is a broad
instrument of enforcement that can impose conditions as minor
as a drug test or as major as the suspension of a physician's
license to practice medicine. The procedural safeguards in
the ISO process are designed to protect against inappropriate
use of the most severe discipline.
Existing law authorizes an ALJ of the Medical Quality Hearing
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Panel within the Office of Administrative Law to issue an
order to suspend for an interim period (an ISO) a physician's
license, impose drug testing, require continuing education or
supervision of procedures, or other license restrictions.
However, an ISO may only restrict a physician's prescribing
abilities if the physician is already under probation and
prescribing limits are part of the terms and conditions of
that probation.
To obtain an ISO against a physician, MBC must present
affidavits in support of the ISO to the ALJ showing that the
physician has, or is about to, violate the Medical Practice
Act or that the physician is unable to practice safely due to
a mental or physical condition, and that permitting the
physician to continue practice will endanger the public
health, safety, or welfare. It is at the ALJ's discretion to
issue the ISO as requested by MBC, and ALJs have the authority
to deny or alter the requested ISO.
Current law requires that a physician be notified 15 days in
advance of a pending ISO, so that the physician may
participate in a hearing about the validity of the ISO's
issuance. The notice must include affidavits and all the
other information provided in support of the order. However,
an ISO may be granted immediately if MBC can demonstrate that
"serious injury to the public" would result otherwise. After
the ISO issuance, MBC has 15 days to file and serve an
accusation (which is the document enumerating the formal
charges against the physician's license) and 30 days to hold a
hearing. In practical terms, this requires MBC to have its
investigation, evidence, and findings nearly complete before
petitioning for an ISO. An ISO effectively imposes
restrictions on a physician's practice for 45 days prior to a
hearing.
The 2012 Los Angeles Times series, "Dying for Relief," and the
2013 Legislative Sunset Review process highlighted the
inefficiencies in MBC's enforcement activities. One troubling
aspect was MBC's infrequent use of ISOs to stop physicians
from prescribing excessive drugs.
According to MBC, it sought 36 ISOs in FY 2011/12 and 28 were
granted, out of a population of 126,483 physicians. In
discussing the challenges faced with obtaining an ISO, MBC
pointed out that it must meet a very high standard of evidence
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to obtain an ISO, and filing a formal accusation within 15
days of the ISO's issuance is a very tight timeline. MBC
defended its low use of ISOs by stating "An ISO is considered
extraordinary relief ? [and] 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."
8)SB 670 and the ISO process . This bill creates a more rapid
process for MBC to impose limitations on a physician's
prescribing ability, compared to the currentISO process. This
bill would allow MBC, not an ALJ, to impose limitations using
a lower standard of proof (probable cause) than that used in
the ISO process (clear and convincing).
According to MBC, it is anticipated that most, if not all,
restrictions issued according to this bill would be followed
by an ISO. To prepare for an ISO requires approximately 6
months' investigation time to gather the evidence necessary to
prevail at an ISO hearing (following the accusation). Should
MBC issue an order restricting prescribing privileges
according to the terms of this bill, and with the further
intention of issuing an ISO, MBC will already have had at
least 4 months of investigation time to develop evidence
against the physician.
By tying this new enforcement tool to the existing ISO
process, MBC has to eventually meet the same higher burden of
proof, but this mechanism allows MBC to protect the public for
an additional 30 days while it gathers its case against the
physician. If followed by an ISO, this bill would restrict a
physician's ability to prescribe for 75 days before a hearing.
This new enforcement tool does not require MBC to
automatically remove a physician's prescription power, but
rather gives MBC the ability to limit a physician's
prescribing authority within a spectrum. MBC may choose to
limit the types of drugs a physician may prescribe, requires
certain types of prescriptions be co-signed by another doctor,
or limit a physician ability to prescribe to certain patients,
among some options.
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These provisions were originally suggested by the 2013 Sunset
Review staff analysis, which raised the idea of lowering
standard for an ISO in cases of restricting a physician's
prescribing privileges and lengthening the timeframes for the
filing of an accusation.
This bill would also permit an ISO to limit a physician's
authority to prescribe, furnish, administer, or dispense
controlled substances without those limitations being a
condition of a physician's probation.
9)Suggested committee amendment . Although MBC will likely meet
the higher 'clear and convincing' standard in order to sustain
a restriction on a physician's prescribing privileges, there
exists the possibility that an ISO will not be issued. This
means that the record of the restriction on a physician's
license taken under a 'probable cause' standard could remain
public for ten years on MBC's Web site.
On page 3, line 28, after "section.," add "These
regulations shall include, but not be limited to, removal
of any record of the limitations the board imposed pursuant
to subdivision (a) from the board's license look up
function on the board's internet Web site if the board
fails to file and serve an interim suspension order
pursuant to subdivision (b)"
10)Suggested technical amendment . The following is to offer an
additional notification procedure that is mirrored by the ISO
process:
On page 3, line 16, after "surgeon," add "at least five
business days prior to the effective date of any
limitations imposed pursuant to this subdivision by either
24 hour delivery service or personal service" and delete
everything after "surgeon" and lines 17 and 18.
11)Arguments in support . "The Center for Public Interest Law
(CPIL) is pleased to support SB 670 (Steinberg), which will
provide needed tools to the Medical Board (Board) of
California to protect patients from potentially dangerous
physicians, especially those who unlawfully prescribe
narcotics.
"Disciplinary matters involving improper prescription of drugs
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are unique, warranting unique legislative attention and
approaches. Unlike in virtually every other disciplinary
matter where the patient either initiates the investigation or
actively cooperates, when it comes to prescription drug
investigations, the patient is frequently an addict and an
active collaborator in the physician unlawful conduct. This
lack of cooperation from the patient makes administrative
action against the physician in this setting uniquely
complicated, expensive, and time-consuming, to the peril of
patients, and undermining the Board's authority and its
core-mission.
"SB 670 permits the Board the discretion if need-be
temporarily to suspend or limit just the prescribing
privileges of a physician without having to temporarily
suspend an entire license during if during an investigation
the Board has probable cause to believe a violation of law has
occurred (probable cause being the legal standard for an
arrest or for a grand jury indictment). The bill also
clarifies that abuse of prescription drug prescribing
privileges may serve as the foundation for a formal Interim
Suspension Order.
"More broadly, the bill fixes loopholes in current laws that
have allowed determined bad actors to game or delay an
investigation, without justification. If a Board is
investigating a case where a patient has died allegedly due to
unlawful conduct, the measure allows the Board to inspect the
medical records of a deceased person without the permission of
the next of kin to inquire whether the Medical Practice Act
has been violated. The bill also rightly expands the
definition of unprofessional conduct to include the failure of
a licensee who is under investigation to attend an interview
with the Medical Board within 30 days of notification. A
failure to attend such a well-noticed, important meeting
should not permit a physician to delay an investigation, to
his continuing benefit and the possible detriment of patients.
"Each of these reforms will save lives. We urge you to support
this important piece of legislation."
12)Arguments in opposition . The California Medical Association
writes, "SB 670 gives the MBC the ability to suspend or limit
a physician's ability to prescribe controlled substances
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without providing the physician an opportunity to challenge
the basis for such action, a foundational component of due
process. Additionally, the authority to limit the physician's
prescribing authority would be based on the low evidentiary
standard of probable cause. We believe clear and convincing is
the appropriate standard.
"Allowing the MBC to take adverse actions on a physician's
license without allowing the physician any ability to respond
to the charges combined with a low evidentiary standard
increases the likelihood that an action taken is subsequently
vacated. Yet damage to a physician's ability to practice will
already be done."
13)Related legislation . SB 304 (Price) extends the time period
between issuing an ISO and filing an accusation from 15 to 30
days. SB 304 is currently in the Assembly Business,
Professions, and Consumer Protection Committee.
SB 62 (Price and Lieu) requires a coroner to report to MBC
when he or she receives information indicating that a death
was caused by a Schedule II, III, or IV drug, as specified.
SB 62 is currently in the Assembly Appropriations Committee.
14)Previous legislation . AB 1127 (Brownley) (Chapter 115,
Statutes of 2011) declared it unprofessional conduct for a
physician and surgeon to repeatedly fail, in the absence of
good cause, to attend and participate in an interview
scheduled by the mutual agreement of the physician and MBC.
REGISTERED SUPPORT / OPPOSITION :
Support
Center for Public Interest Law
Opposition
California Medical Association
California Academy of Family Physicians
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301
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