BILL ANALYSIS
SB 674
Page 1
Date of Hearing: June 30, 2009
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Mary Hayashi, Chair
SB 674 (Negrete McLeod) - As Amended: June 1, 2009
SENATE VOTE : 31-2
SUBJECT : Healing arts.
SUMMARY : Requires specified healing arts licensees to include
professional designations behind their names in advertisements;
requires the Medical Board of California (MBC) to adopt
regulations regarding the appropriate level of physician
availability needed within clinics or other settings using laser
or intense pulse light devices for elective cosmetic procedures;
permits MBC to adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization; and
revises accreditation requirements and procedures.
Specifically, this bill :
1)Requires the following licensees to include the appropriate
professional initials immediately after the licensee's name in
advertisements:
a) A chiropractor shall include the designation "DC;"
b) A dentist shall include the designation "DDS" or "DMD;"
c) A physician and surgeon shall include the designation
"MD;"
d) An osteopathic physician and surgeon shall include the
designation "DO;"
e) A podiatrist shall include the designation "DPM;"
f) A registered nurse shall include the designation "RN;"
g) A licensed vocational nurse shall include the
designation "LVN;"
h) A psychologist shall include the designation "Ph.D;"
i) An optometrist shall include the designation "OD;"
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j) A physician assistant shall include the designation
"PA;" and,
aa) A naturopathic doctor shall include the designation
"ND;"
2)Defines "advertisement" to include communication by mail,
television, radio, motion picture, newspaper, book, directory,
Internet, or other electronic communication.
3)Exempts the following from the definition of "advertisement:"
a) A medical directory released by a health care service
plan or a health insurer;
b) A billing statement from a health care practitioner to a
patient;
c) An appointment reminder from a health care practitioner
to a patient; and,
d) Any advertisement or business card disseminated by a
health care service plan indicating its contracting
providers.
4)States that the new advertising requirements shall apply on
January 1, 2011 to any advertisement that is published
annually and prior to July 1, 2010.
5)Requires the MBC to adopt regulations regarding the
appropriate level of physician availability needed within
clinics or other settings using laser or intense pulse light
devices for elective cosmetic procedures.
6)Prohibits the regulations promulgated by MBC for laser or
intense pulse light devices for elective cosmetic procedures
from applying 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.
7)Requires the MBC to post on its Internet Web site an
easy-to-understand factsheet to educate the public about
cosmetic surgery and its risks, and a comprehensive list of
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questions for patients to ask their physician and surgeon
regarding cosmetic surgery.
8)Includes facilities that offer in vitro fertilization in the
definition of "outpatient setting."
9)Requires outpatient settings to submit to an accreditation
agency detailed plans, standardized procedures, and protocols
to be followed in the event of serious complications or side
effects from surgery that would place a patient at high risk
for injury or harm.
10)Permits MBC to adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
11)Requires the MBC to automatically notify the public about an
outpatient setting's accreditation, certification, or
licensure, and if a 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.
12)Requires an accreditation agency to immediately report to the
MBC if an outpatient setting's certificate for accreditation
has been denied.
13)Requires every accredited outpatient setting to be inspected
by an accreditation agency and be subject to inspection by the
MBC.
14) Requires the MBC to ensure that accreditation agencies
inspect outpatient settings according to the following
parameters:
a) The frequency of inspection shall depend upon the type
and complexity of the outpatient setting to be inspected;
b) Inspections shall be conducted no less often than once
every three years by the accreditation agency and as often
as necessary by the MBC to ensure the quality of care
provided; and,
c) Permits the MBC or the accreditation agency to enter and
inspect any outpatient setting that is accredited by an
accreditation agency at any reasonable time to ensure
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compliance with, or investigate an alleged violation of,
any standard of the accreditation agency or any provision
of this chapter.
15)Requires an accreditation agency to provide the outpatient
setting with notice of any deficiencies before suspending or
revoking a certificate of accreditation and requires the
outpatient setting to agree with the accreditation agency on a
plan of correction that gives the outpatient setting
reasonable time to supply information demonstrating
compliance. Requires the outpatient setting to publicly post
a list of deficiencies and the plan of correction during the
time it is working towards compliance.
16)Requires reports on the results of any inspection to be kept
on file with the MBC or the accreditation agency along with
the plan of correction and the outpatient setting comments.
Permits the inspection report to include a recommendation for
reinspection and requires all inspection reports, lists of
deficiencies, and plans of correction to be public records
open to inspection.
17)Requires the accreditation agency to immediately report to
the MBC if:
a) The outpatient setting has been issued a reprimand;
b) The outpatient setting's certification of accreditation
has been suspended or revoked; or,
c) If the outpatient setting has been placed on probation.
18)Requires, rather than permits, the MBC to evaluate the
performance of an approved accreditation agency no less than
once every three years, or in response to complaints against
an agency, or complaints against one or more outpatient
settings accreditation by an agency that indicates
noncompliance by the agency with the standards approved by the
MBC.
19)Requires the Department of Public Health (DPH) to inspect the
peer review process utilized by the hospital during a state
periodic inspection of an acute care hospital.
EXISTING LAW :
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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.
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 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 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 specified aspects of settings'
operations.
5)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.
6)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.
FISCAL EFFECT : Unknown
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COMMENTS :
Purpose of this bill . According to the author's office, "SB 674
attempts to guarantee the public's safety by strengthening the
regulation and oversight of fertility clinics and surgical
centers performing cosmetic procedures, and ensures that quality
of care standards are in place at these clinics and checked by
the appropriate credentialing agency."
Background . According to a 2007 study by the American Society
of Plastic Surgeons, almost 12 million cosmetic plastic surgery
procedures were performed in 2007, a 7% increase from 2006 and a
59% increase from 2000. The study concludes that, as with all
surgical procedures, cosmetic surgery carries with it certain
risks-if performed poorly, it can be disfiguring or
life-threatening. In California, cosmetic surgery can be
performed by any licensed physician; from a plastic surgeon to a
pediatrician.
Medical spas or facilities offering botox injections, laser hair
removal, and microdermabrasion are emerging in malls, city
office buildings, and store fronts across the country. Although
the federal Food and Drug Administration oversees the safety of
the 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
treatment.
The Health and Safety Code makes a distinction between clinics
licensed by the DPH and 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 those not part of a hospital which provide ambulatory
surgical care for patients who remain fewer 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.
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
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defined as a facility where anesthesia is used in doses that do
not have the probability of placing the patient at risk for loss
of life. These clinics are accredited by one of four
accreditation bodies 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.
Arguments in support . The California Society of Dermatology and
Dermatologic Surgery (CalDerm) writes, "CalDerm's members have
seen an explosion in so-called med-spas where many procedures
are done without appropriate oversight. SB 674 asks the MBC to
adopt regulations regarding the appropriate level of physician
availability needed within clinics or other settings using laser
or intense pulse light devices for elective cosmetic procedures.
"And because of some clever, if not deceptive advertising, many
prospective patients are not aware of the lack of qualifications
of some of those who perform these procedures. SB 674 will make
it harder for non-physicians to imply in advertisements that
they are physicians."
Arguments in opposition . The American Nurses
Association/California writes, "The Medical Board and Nursing
Board held hearings in California to review existing law and the
standards required for laser procedures or intense pulse light
devices for elective cosmetic procedures. Both Boards
determined that the necessary laws for training and supervision
are already in place. However, these laws are not being
enforced. Creating a new law will not change the current
practice."
Related legislation :
SB 1423 (Figueroa), Chapter 873, Statutes of 2006, requires the
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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, requiring 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 the
Governor who indicated in his veto message 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
was held in the Assembly Appropriations Committee.
Double-referred : This bill is double-referred to the Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
American Society for Dermatologic Surgery Association
California Society of Plastic Surgeons
California Society of Dermatology and Dermatologic Surgery
The Medical Board of California
The Procter and Gamble Company
Opposition
The American Nurses Association/California
Analysis Prepared by : Sarah Huchel / B. & P. / (916) 319-3301