BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 674|
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THIRD READING
Bill No: SB 674
Author: Negrete McLeod (D)
Amended: 6/1/09
Vote: 21
SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE : 8-0, 4/20/09
AYES: Negrete McLeod, Corbett, Correa, Florez, Oropeza,
Romero, Walters, Yee
NO VOTE RECORDED: Wyland, Aanestad
SENATE APPROPRIATIONS COMMITTEE : 12-0, 5/28/09
AYES: Kehoe, Cox, Corbett, Denham, DeSaulnier, Hancock,
Leno, Oropeza, Runner, Walters, Wyland, Yee
NO VOTE RECORDED: Wolk
SUBJECT : Healing arts
SOURCE : Author
DIGEST : This bill requires for purposes of
advertising that a health care practitioner, as
specified, include specific professional designation
following the health care practitioners name.
Requires the Medical Board of California (MBC) to
adopt regulations on or before January 1, 2011 on the
appropriate level of physician availability necessary
within clinics using laser or intense pulse light
devices for elective cosmetic surgery. Requires the
MBC to post on its Internet website a fact sheet to
educate the public about cosmetic surgery, and the
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risks involved with such surgeries. Makes a number of
changes regarding the approval, oversight and
inspection of outpatient settings, as defined, by the
MBC and accreditation agencies approved by the MBC,
and in developing a plan of corrective action for any
deficiencies found by the accreditation agencies or
the MBC during inspections, or otherwise. Includes in
the existing law definition of outpatient settings
fertility clinics that offer in vitro fertilization.
Requires the Department of Public Health, as part of
its periodic inspections, inspect the peer review
process utilized by acute care hospitals.
ANALYSIS :
Existing law, the Business and Professions Code:
1.Provides that it is unlawful for health care licensees
to disseminate or cause to be disseminated any form of
public communication, as defined, containing false,
fraudulent, misleading, deceptive statement, or image,
as specified, to induce the provision of services or the
rendering of a product relating to a professional
practice or business for which he or she is licensed,
and provides that any person so licensed who violates
this provision is guilty of a misdemeanor and that such
violation shall constitute good cause for revocation or
suspension of his/her license or other disciplinary
action including an administrative fine not to exceed
$10,000.
2.Requires the MBC in conjunction with the Board of
Registered Nursing (BRN), and in consultation with the
Physician Assistant Committee (PAC) and professionals in
the field, to review issues and problems relating to the
use of laser or intense light pulse devices for elective
cosmetic procedures by physicians and surgeons, nurses,
and physician assistants.
3.Specifies that the review conducted by the MBC, the BRN
and the PAC shall include the appropriate level of
physician supervision needed, the appropriate level of
training to ensure competency, guidelines for
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standardized procedures and protocols that address
patient selection, education, instruction and informed
consent, use of topical agents, and procedures to be
followed in the event of complications or side effects
from treatment and procedures for governing emergency
and urgent care situations.
4.Requires the MBC to post on its Internet website
specified information in its possession, custody or
control regarding physicians and surgeons.
5.Declares that in this state, significant surgeries are
being performed in unregulated out-of-hospital settings
and that without appropriate oversight some of these
settings may be operating in a manner which is injurious
to the public health, welfare and safety, and although
health professionals delivering health care services in
these settings are licensed, further quality assurance
is needed to ensure that health care services are safe
and effectively performed in these settings.
6.Provides that no physician or surgeon may perform
procedures in an outpatient setting, as defined, using
anesthesia, unless accredited pursuant to the Health and
Safety Code, Section 1248 et seq.
Existing law, the Health and Safety Code, Section 1248 et
seq.:
1.Defines "outpatient setting" as any facility, clinic,
unlicensed clinic, center, office, or other setting that
is not part of a general acute care facility where
anesthesia is used.
2.Defines "accrediting agency" as a public or private
organization that is approved to issue certificates of
accreditation to outpatient settings by the MBC pursuant
to specified requirements.
3.Requires the MBC to adopt standards for accreditation of
outpatient settings, as defined, and in approving
accreditation agencies to perform accreditation of
outpatient settings, ensure that the certification
program shall, at a minimum, include standards for
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specified aspects of settings' operations.
4.Requires the MBC to obtain and maintain a list of all
accredited, certified, and licensed outpatient settings,
and to notify the public, upon inquiry, whether a
setting is accredited, certified, or licensed, or
whether the setting's accreditation, certification, or
license has been revoked.
5.Defines treatment for infertility as procedures
consistent with established medical practices in the
treatment of infertility by licensed physicians and
surgeons including, but not limited to, diagnosis,
diagnostic tests, medication, surgery, and gamete
intrafallopian transfer. Defines in vitro fertilization
as the laboratory medical procedures involving the
actual in vitro fertilization process.
6.Defines acute care hospital as a health facility having
a duly constituted governing body with overall
administrative and professional responsibility and an
organized medical staff that provides 24-hour inpatient
care, including the following basic services: medical,
nursing, surgical, anesthesia, laboratory, radiology,
pharmacy, and dietary services.
7.Requires DPH to license and inspect health facilities,
including acute care hospitals, and requires DPH to
conduct periodic inspections of acute care hospitals no
less than once every three years.
This bill, within the Business and Professions Code:
1.Requires that any advertising by a chiropractor,
dentist, physician and surgeon, osteopathic physician
and surgeon, podiatrist, registered nurse, licensed
vocational nurse, psychologist, optometrist, physician
assistant and naturopathic doctor include specific
professional designation following the health care
practitioner's name.
2.Defines advertisement for purposes of #1) above to
include communication by means of mail, television,
radio, motion picture, newspaper, book, directory,
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Internet or other electronic communication. Excludes
from the definition of advertisement the following:
medical directory released by a health care service plan
or a health insurer, a billing statement from a health
care practitioner to a patient, or appointment reminder
from a health care practitioner to a patient. Also
excludes from the requirement in #1) above any
advertisement or business card disseminated by a health
care service plan relating to contracted providers, as
specified.
3.Specifies that the requirement in #1) does not apply
until January 1, 2011 to any advertisement that is
published annually and prior to July 1, 2010.
4.Clarifies that a health care practitioner who is working
in an outpatient setting or clinic, as defined, must
disclose their type of license, instead of the existing
law's requirement of disclosing license status, on a
name tag or verbally to patients.
5.Requires the MBC to adopt regulations on or before
January 1, 2011, regarding the appropriate level of
physician availability needed within clinics or other
settings using laser or intense pulse light devices for
elective cosmetic procedures. Specifies that the
regulations to be adopted will not apply to laser or
intense pulse light devices approved by the federal Food
and Drug Administration for over-the-counter use by a
health care practitioner or by an unlicensed person on
himself or herself.
6.Requires the MBC to post on its Internet Website an easy
to understand fact sheet to educate the public about
cosmetic surgery and procedures, including their risks,
and requires the fact sheet to include a comprehensive
list of questions for patients to ask their physician
and surgeon regarding cosmetic surgery.
This bill, within the Health and Safety Code, Section 1248
et seq.:
1.Includes in the existing definition of "outpatient
setting" those facilities that offer in vitro
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fertilization, and allows MBC to adopt standards that it
deems necessary for outpatient settings for these
facilities that it deems necessary.
2.Requires as part of the standards for operation and
approval of an outpatient setting that the outpatient
setting submit for approval by an accrediting agency at
the time of accreditation, a detailed plan, standardized
procedures, and protocols to be followed in the event of
serious complications or side effects from surgery, as
specified.
3.Requires the MBC to notify the public whether a setting
is accredited, certified, or licensed, or the setting's
accreditation, certification, or license has been
revoked, suspended or placed on probation, or the
setting has received a reprimand by the accreditation
agency.
4.Requires an accreditation agency to immediately report
to the MBC if an outpatient setting's certificate for
accreditation has been denied.
5.Requires that every outpatient setting which is
accredited, to be inspected by the accreditation agency
and may also be inspected by the MBC. Requires the MBC
ensure that accreditation agencies inspect outpatient
settings. Requires that the frequency of inspections
depends upon the type and complexity of the outpatient
setting to be inspected, and that inspections be
conducted no less than once every three years by the
accreditation agency and as often as necessary by the
MBC to ensure the quality of care provided.
6.Requires reports on the results of each inspection to be
kept on file with the MBC or the accreditation agency
along with the plan of correction and the outpatient
setting comments and that the inspection report may
include a recommendation for re-inspection, and that all
inspection reports, lists of deficiencies, and plans of
correction be public records open to public inspection.
7.Deletes the requirement that the MBC or the
accreditation agency give reasonable prior notice and
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present proper identification prior to an inspection.
8.Requires rather than just authorize the MBC to evaluate
the performance of an approved accreditation agency no
less than every three years.
9.Provides that the outpatient setting shall agree with
the accrediting agency upon a plan of correction when
they receive a notice of any deficiencies from the
accreditation agency and that during the time of
correction, the list of deficiencies and the plan of
correction shall be conspicuously posted in a clinic
location accessible to public view.
10.Requires DPH, during its routine state periodic
inspection of an acute care hospital, as specified, to
also inspect the peer review process utilized by the
hospital.
Comments
The author's office indicates that the number of cosmetic
procedures performed in the United States is increasing at
an alarming rate. According to the American Society of
Plastic Surgeons (ASPS), over 12 million cosmetic
procedures were performed in 2008, and $10.3 billion were
spent on cosmetic procedures in the United States.
Consumers are also inundated everyday with advertisements
on how to look and feel better fast. Medical spas, or
facilities offering botox injections, laser hair removal,
and microdermabrasion are increasing in popularity and are
emerging in malls, city office buildings and store fronts
across the country. Although the Federal Food and Drug
Administration oversees the safety of machines and
skin-care products used, there is little regulation of
these medical spas to guarantee that practitioners in these
facilities are administering treatments safely and patients
are aware of the potential risks associated with any
treatments.
The author's office also points out that the statistics on
these procedures belie the potential risks associated with
any type of surgery. To illustrate the magnitude of the
risks that could be associated with cosmetic surgery, the
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Author cites the Donda West story. Donda West, the mother
of famous artist Kanye West, died less than 24 hours after
undergoing a five and one-half hour operation which
involved significant liposuction, a partial reduction of
her right breast and implants on both breasts. Although
the autopsy report revealed that, "Ms. West died from some
pre-existing coronary artery disease and multiple
postoperative factors following surgery," it is unclear if
and what post-operative care and monitoring she was given.
In addition, news reports also revealed that although Donda
West's preoperative screening by her doctor, Dr. Adams,
indicated a possible heart condition and other factors, Dr.
Adams decided to proceed with the surgery in which
complications resulted.
Background
Popularity of Plastic Surgery . ASPS' website states that
the about 12.1 million cosmetic procedures were performed
in 2008, representing a $10.3 billion industry. ASPS
indicates that the top five surgical procedures were breast
augmentation, liposuction, nose reshaping, eyelid surgery,
and tummy tuck. Moreover, ASPS points out that there were
10.7 million minimally-invasive cosmetic procedures 2008.
The top five minimally-invasive procedures were Botox,
hyaluronic acid fillers, chemical peel, laser hair removal,
and microdermabrasion.
Recognizing the need to educate the public when considering
cosmetic surgery, the College of Physicians and Surgeons of
Ontario, Canada posted a fact sheet entitled What You
Should Know About Cosmetic Surgery to assist consumers to
make an informed decision. The fact sheet included an
explanation of the different kinds of doctors who provide
services, the various issues that consumers should be aware
when considering cosmetic surgery, and a list of questions
to ask before making a decision about having cosmetic
surgery. This bill includes a provision requiring the MBC
to also post on its website a fact sheet for consumers.
Prior Efforts Dealing with Cosmetic Surgery Practices . In
California, cosmetic surgery can be performed by any
licensed physician; from a plastic surgeon to a
pediatrician. Many physicians, who may or may not be
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trained in cosmetic procedures, are conducting increasingly
complex procedures in settings outside of hospitals such as
outpatient surgery centers and doctors' offices. It is
also common for doctors performing complex cosmetic
surgeries to receive their only training from weekend
courses or instructional videos. Currently, there are no
uniform standards for physician training related to
cosmetic surgery, and the regulation of outpatient settings
in which these surgeries occur need to be strengthened to
ensure public safety. The Legislature attempted to regulate
the practice of cosmetic surgery in previous years with the
introduction of several bills including:
SB 1423 (Figueroa), Chapter 873, Statutes of 2006, requires
the MBC in conjunction with the BRN to promulgate
regulations on or before January 1, 2009 to implement
changes relating to the use of laser or intense pulse light
devices for cosmetic procedures by physicians and surgeons,
nurses, and physician assistants.
SB 835 (Figueroa), of 1999, would have enacted the Cosmetic
Surgery Patient Disclosure Act, which would have required
physicians who perform cosmetic surgery, as defined, to
provide the MBC with specified information, including
training, board certifications, and number of procedures
performed, and requires the MBC to make this information
available to the public upon request and post the
information on the internet. SB 835 was vetoed by then
Governor Davis who indicated that the methods prescribed by
the measure were unduly burdensome.
SB 836 (Figueroa), Chapter 856, Statutes of 1999, expands
and revised the prohibition against fraudulent advertising
by health practitioners.
SB 837 (Figueroa), of 1999 would have required cosmetic
surgery procedures to be performed in a licensed acute care
hospital or in a licensed or accredited outpatient surgery
setting. SB 837 died in the Assembly Appropriations
Committee.
Accredited Outpatient Settings vs. Licensed Clinics . The
Health and Safety Code makes a distinction between clinics
licensed by the Department of Public Health (DPH) and
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outpatient settings that are accredited by an outside
accrediting agency under the oversight of the MBC. Clinics
licensed by the DPH are non-physician owned, while clinics
accredited by an accreditation agency approved by the MBC
are physician owned and operated. DPH-licensed clinics
include a clinic that is not part of a hospital and
provides ambulatory surgical care for patients who remain
less than 24-hours. As part of their licensure, clinics
under DPH's jurisdiction undergo inspection and must have
in place minimum standards of safety and staffing. On the
other hand, clinics that are physician-owned and are
accredited by an accreditation agency approved by the MBC
and are commonly referred to as outpatient settings.
Outpatient settings are defined as a facility where
anesthesia is used in doses that when administered does not
have the probability of placing the patient at risk for
loss of the patient's life. These clinics are accredited
by one of four accreditation bodies that are approved by
the MBC. These accrediting agencies must ensure that
certification programs include standards for the operation
of outpatient settings such as safety and emergency
training requirements, licensure or certification of allied
health staff, provision of onsite equipment, medication and
trained personnel in a medical emergency, permit surgery
only by a licensee who has admitting privileges at a local
accredited or licensed acute care hospital, as defined, and
a system for patient care and monitoring procedures The
four accrediting agencies approved by the MBC are the
American Association for Accreditation of Ambulatory
Surgery Facilities Inc., Accreditation Association for
Ambulatory Health Care, the Institute for Medical Quality
and the Joint Commission.
Existing law's distinction on which clinics are licensed by
the DPH and fall under the jurisdiction of the MBC is
unclear and has been the subject of litigation. In Capen
v. Shewry (2007) 147 Cal.App.4th 680, the issue before the
court was whether a surgical clinic that is wholly owned
and operated by a licensed physician, in which non-owner,
non-lessee, physicians will practice is required to obtain
a license from DPH. The facts of the case reveal that the
plaintiff, Dr. Capen, is a licensed physician who is
building a surgical clinic that he will wholly own and
operate, in which non-owner, non-lessee physicians will
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practice. He was informed by DPH (then DHS) that a license
is required of the clinic because of the physicians who do
not share in its ownership and operation. Dr. Capen sued
DHS and argued that the existing law provisions governing
the authority of DPH to license facilities is ambiguous.
At issue in Capen is Section 1204 (b)(1) of the Health and
Safety Code which states that "a surgical clinic is a
clinic that is not part of a hospital and that provides
ambulatory surgical care for patients who remain less than
24 hours. A surgical clinic does not include any place or
establishment owned or leased and operated as a clinic or
office by one or more physicians or dentists in individual
or group practice, regardless of the name used publicly to
identify the place or establishment, provided, however,
that physicians or dentists may, at their option, apply for
licensure." The court indicated that the provisions of
Section 1204(b)(1) where clinics "owned or leased by one or
more physicians in individual or group practice" was
ambiguous because it could be interpreted to require an
ownership or lease interest either by one physician in
group practice or by all of the physicians in the group.
As a result, the court held that Section 1204(b)(1) is void
since it did not follow the Administrative Procedure Act.
The Court concluded that physician-owned-and-operated
surgical clinics are not subject to licensing by DPH and
are to be regulated by the MBC. In an effort to clarify
MBC's authority over outpatient settings after Capen, MBC
submitted a letter on October 18, 2007 to Judge Coleman
Blease, who issued the opinion in the Capen case. MBC
stated that "the law does not give the MBC the authority to
regulate clinics owned and operated by physicians. It just
gives the MBC the authority to approve accrediting agencies
that are in compliance with the standards set forth in
Health and Safety Code Section 1248 et.seq."
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2009-10 2010-11
2011-12 Fund
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Outpatient facility $170 $464 $350
Special*
inspection
*Medical Board of California Contingent Fund
SUPPORT : (Verified 6/2/08)
CA Society of Plastic Surgeons
Medical Board of California
Proctor and Gamble
OPPOSITION : (Verified 6/2/09)
American Nurses Association of California
JJA:do 6/2/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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