BILL ANALYSIS
SB 674
Page 1
Date of Hearing: July 7, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 674 (Negrete McLeod) - As Amended: June 1, 2009
SENATE VOTE : 31-2
SUBJECT : Healing arts.
SUMMARY : Revises and expands the Medical Board of California's
(MBC) oversight of outpatient settings; permits MBC to adopt
standards for outpatient settings that offer in vitro
fertilization; requires the Department of Public Health (DPH),
as part of its periodic inspections, to inspect the peer review
process utilized by acute care hospitals; requires 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, requires MBC specified healing arts licensees to include
professional designations behind their names in advertisements.
Specifically, this bill :
Outpatient Settings
1)Requires outpatient settings to submit to an accreditation
agency for approval, at the time of accreditation, 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 and to govern emergency and urgent care situations.
2)Requires 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license has been revoked, suspended, or placed on probation,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.
3)Requires an accreditation agency to immediately report to MBC
if an outpatient setting's certificate for accreditation has
been denied.
4)Requires every accredited outpatient setting to be inspected
by an accreditation agency and be subject to inspection by
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MBC.
5) Requires MBC to ensure that accreditation agencies inspect
outpatient settings according to the following parameters:
a) The frequency of inspection is to depend upon the type
and complexity of the outpatient setting to be inspected;
b) Inspections are to be conducted no less often than once
every three years by the accreditation agency and as often
as necessary by MBC to ensure the quality of care provided;
and,
c) Permits 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
compliance with, or investigate an alleged violation of,
any standard of the accreditation agency or any provision
of existing law.
6)Requires an 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. Existing law requires the outpatient setting to
provide notice of deficiencies, but does not require the
agreement of the outpatient setting or a plan of correction.
Requires the outpatient setting to publicly post a list of
deficiencies and the plan of correction during the time it is
working towards compliance.
7)Requires reports on the results of any inspection to be kept
on file with MBC or the accreditation agency along with the
plan of correction and the outpatient setting's 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.
8)Requires the accreditation agency to immediately report to MBC
if the outpatient setting has been issued a reprimand or if
the outpatient setting's certification of accreditation has
been suspended or revoked or if the outpatient setting has
been placed on probation.
9)Requires, rather than permits, MBC to evaluate the performance
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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 MBC.
Outpatient Settings and In Vitro Fertilization
10)Adds facilities that offer in vitro fertilization to the
definition of "outpatient settings" in existing law.
11)Authorizes MBC to adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
Peer Review Process
12)Requires DPH to inspect the peer review process utilized by a
hospital during a state periodic inspection of an acute care
hospital.
Laser or Intense Light Devices
13)Requires 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.
14)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.
15)Requires MBC to post on its Internet Web site an
easy-to-understand fact sheet to educate the public about
cosmetic surgery and its risks, and a comprehensive list of
questions for patients to ask their physician and surgeon
regarding cosmetic surgery.
Professional Designations
16)Requires the following licensees to include the appropriate
professional initials immediately after the licensee's name in
advertisements:
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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;"
j) A physician assistant shall include the designation
"PA;" and,
aa) A naturopathic doctor shall include the designation
"ND;"
17)Defines "advertisement" to include communication by mail,
television, radio, motion picture, newspaper, book, directory,
Internet, or other electronic communication.
18)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
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providers.
19)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.
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EXISTING LAW :
1)Defines "outpatient setting" as a facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility and where anesthesia, except local
anesthesia or peripheral nerve blocks, or both, is used in
compliance with the community standard of practice, in doses
that, when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving
protective reflexes.
2)Defines "accrediting agency" as a public or private
organization that is approved to issue certificates of
accreditation to outpatient settings by MBC pursuant to
specified requirements.
3)Requires 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 setting
operations.
4)Requires 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 clinic's accreditation,
certification, or license has been revoked.
5)Requires accreditation of an outpatient setting to be denied
by the accreditation agency if the outpatient setting does not
meet specified standards and allows the outpatient setting to
reapply for accreditation at any time after receiving
notification of denial.
6)Authorizes MBC or an accrediting agency to, upon reasonable
prior notice and presentation of proper identification, enter
and inspect any outpatient setting that is accredited by an
accreditation agency at any reasonable time to ensure
compliance with, or investigate an alleged violation of any
standard of accrediting agency or any provision of the
specified law.
7)Provides that before suspending or revoking a certificate of
accreditation, the accrediting agency must provide the
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outpatient setting with notice of deficiencies and reasonable
time to supply information demonstrating compliance with the
standards of the accrediting agency, as well as, the
opportunity for a hearing on the matter upon request of the
outpatient setting.
8)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.
9)Defines in vitro fertilization as the laboratory medical
procedures involving the actual in vitro fertilization
process.
10)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.
11)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.
12)Requires 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.
13)Specifies that the review conducted by MBC, BRN and PAC
pursuant to 12) above must 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.
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14)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 statements, or images, 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.
FISCAL EFFECT : According to the Senate Appropriations
Committee analysis, this bill would have fiscal costs from MBC's
Contingent Fund for outpatient facility inspections of $170,000
in fiscal year (FY) 2009-10; $464,000 in FY 2010-11; and,
$350,000 in FY 2011-12.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author's office, this
bill attempts to guarantee the public's safety by
strengthening the regulation and oversight of surgical clinics
performing cosmetic procedures and clinics that perform in
vitro fertilization. The author maintains that the number of
cosmetic procedures performed in the United States is
increasing at an alarming rate. The author indicates that, in
California, cosmetic surgery can be performed by any licensed
physician, and many physicians, who may or may not have been
trained appropriately are conducting increasingly complex
procedures in settings outside of hospitals such as outpatient
surgery clinics and doctor's offices. The author also
indicates that a clinic that assists women in any reproductive
technology should operate under specified standards,
guidelines, and procedures. According to the author, this
bill would ensure that quality of care standards are in place
at these clinics and checked by the appropriate credentialing
agency.
Additionally the author maintains that medical spas, or
facilities offering less invasive surgeries such as 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.
According to the author, 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 treatment safely and patients are
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aware of the potential risks.
2)INCREASED POPULARITY OF COSMETIC SURGERY . According to a 2007
study by the American Society of Plastic Surgeons (ASPS),
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.
ASPS indicates that the top five surgical procedures in 2008
were breast augmentation, liposuction, nose reshaping, eyelid
surgery, and tummy tuck. Additionally, ASPS points out that
there were 10.7 million minimally-invasive cosmetic procedures
performed in 2008, the top-five of which were Botox,
hyaluronic acid fillers, chemical peel, laser hair removal,
and microdermabrasion.
3)ACCREDITED OUTPATIENT SETTINGS . Clinics that are
physician-owned and are accredited by an accreditation agency
approved by MBC are referred to as "outpatient settings."
Outpatient settings are defined in law 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 must be accredited by one of four accreditation bodies
approved by 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 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.
4)CAPEN V. SHEWRY . Existing law's distinction on which clinics
are licensed by DPH and fall under the jurisdiction of 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
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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 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 v. Shewry
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 MBC. In an effort to clarify MBC's authority
over outpatient settings after Capen v. Shewry , MBC submitted
a letter on October 18, 2007 to Judge Coleman Blease, who
issued the opinion in the Capen v. Shewry case. MBC stated
that "the law does not give MBC the authority to regulate
clinics owned and operated by physicians and just gives 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."
5)ASSISTED REPRODUCTIVE TECHNOLOGY . According to the Centers
for Disease Control (CDC), Assisted Reproductive Technology
(ART) includes all fertility treatments in which both eggs and
sperm are handled. In general, ART procedures involve
surgically removing eggs from a woman's ovaries, combining
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them with sperm in the laboratory, and returning them to the
woman's body or donating them to another woman. CDC points
out that of the approximately 62 million women of reproductive
age in 2002, about 1.2 million, or 2%, had an
infertility-related medical appointment within the previous
year, and 8% had an infertility-related medical visit at some
point in the past. Infertility services include medical tests
to diagnose infertility, medical advice and treatments to help
a woman become pregnant, and services other than routine
prenatal care to prevent miscarriage. CDC also states that
the number of infants born after ART doubled in the United
States from 1996-2004, and in 2005, more than 134,000 ART
procedures were performed and approximately 52,000 infants
were born as a result of these procedures. According to a CDC
2008 report, infants conceived with ART are two to four times
more likely to have certain types of birth defects than
children conceived naturally.
The Fertility Clinic Success Rate and Certification Act of 1992,
or Wyden Act, is federal legislation that was implemented to
ensure the quality of ART services and to furnish consumers
with reliable information on pregnancy success rates of
individual ART clinics. The Wyden Act requires each ART
program to report annually to the Secretary of the Health and
Human Services Agency through the CDC, regarding pregnancy
success rates and each embryo laboratory used by the program
and whether certified under the Wyden Act. According to the
2006 ART report, there are over 60 fertility clinics that
reports success rates to CDC.
Currently there are two organizations for physicians who
practice reproductive medicine; the American Society for
Reproductive Freedom (ASRM) and the Society for Reproductive
Technology (SART), an affiliate of ASRM. Both organizations
provide practice guidelines and minimum standards regarding
assisted hatching, blastocyst transfer and gamete, and embryo
donation. The guidelines adopted by ASRM and SART are not
mandatory guidelines. According to the author of this bill,
about 20% of clinics that belong to either organization adhere
to the guidelines, and usually the only penalty for violating
the guidelines is expulsion from the professional
organization.
6)PEER REVIEW IN HOSPITALS . Physician peer review is one of the
regimes used to ensure that quality of care is delivered while
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minimizing medical errors and managing patient risk. During a
peer review, physicians evaluate their colleagues' work to
determine compliance with the standards of care. Reviews are
intended to detect incompetent or unprofessional physicians
early and terminate, suspend, or limit their practice if
necessary. According to the March 2009 Senate Health
Committee Informational Hearing report, Is Peer Review A
Broken System?, there is reluctance among physicians to serve
on peer review committees due to the risk of involvement in
related future litigation, including medical malpractice
lawsuits against a physician under review. Additionally, the
report states there has been rising concern relating to "sham
peer review" which is the use of the peer review system to
discredit, harass, discipline, or otherwise negatively affect
a physician's ability to practice medicine or exercise
professional judgment for a non-medical or patient
safety-related reason. DPH's Licensing and Certification
Program licenses, regulates, and inspects hospitals and other
health care facilities throughout California. DPH regulations
require all hospitals to have an organized medical staff and
to also have formal peer review procedures in place as part of
their licensing requirements.
7)SUPPORT . The California Society of Dermatology and
Dermatologic Surgery (CalDerm) and the American Society for
Dermatologic Surgery Association (ASDSA) state that their
members have seen an explosion in so-called med-spas where
many procedures are done without appropriate oversight and
support the provisions in this bill that require 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. The California Medical Association (CMA) states
this bill will strengthen the existing process for accrediting
outpatient surgery centers through increased reporting from
the accrediting organizations and MBC. CMA maintains that
this bill is a well-thought out, balanced and comprehensive
measure that builds upon current law to further protect
patients. MBC supports the prior version of this bill and
states that this bill would address many aspects of keeping
consumers informed of issues and protected from unscrupulous
providers.
8)OPPOSITION . The American Nurses Association/California
(ANA\C) states that, MBC and the Nursing Board held hearings
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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. ANA\C
maintains that creating a new law will not change the current
practice.
9)PREVIOUS AND RELATED LEGISLATION .
a) AB 583 (Hayashi) requires health care practitioners
to display their educational degree, license type and
status, and board certification on either their
nametag or in their offices, as specified. Requires
supervising physicians and surgeons to post their
hours in each office. AB 583 passed out of Senate
Business, Professions and Economic Development
Committee and is pending on the Senate Floor.
b) AB 832 (Jones) would have required DPH to convene a
workgroup to develop recommendations regarding the
oversight of ambulatory surgical clinics (ASC) to
address issues raised in recent litigation, Capen v.
Shewry . Findings of Capen v. Shewry led DPH to
conclude the department no longer has the authority to
license certain ASCs. AB 832 was held in the Assembly
Appropriations Committee.
c) SB 1423 (Figueroa) Chapter 873, Statutes of 2006,
requires 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.
d) SB 835 (Figueroa) of 1999, would have enacted the
Cosmetic Surgery Patient Disclosure Act, requiring
physicians who perform cosmetic surgery, as defined,
to provide MBC with specified information, including
training, board certifications, and number of
procedures performed, and requires 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.
e) SB 836 (Figueroa), Chapter 856, Statutes of 1999,
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expands and revised the prohibition against fraudulent
advertising by health practitioners.
f) 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.
10)SECOND COMMITTEE OF REFERRAL : This bill is double referred
and passed the Assembly Committee on Business and Professions
with a vote of 10-0 on June 30, 2009.
11)POLICY QUESTIONS .
a) This bill assigns to MBC, and to four external private
accrediting bodies, three of which are out-of-state,
additional responsibilities related to accreditation of
outpatient settings. This bill requires the MBC, or the
accrediting bodies, to conduct inspections every three
years, and assigns standard-setting responsibilities and
monitoring activities similar to the duties of DPH as the
state's licensing agency for health facilities. However,
existing law and this bill do not provide other licensing
tools to MBC and the accrediting agencies, such as a system
of fines and penalties for violation of the standards and
requirements. Additionally, what, if any, authority does
the Legislature have over private, external accrediting
bodies to ensure they meet the requirements of this bill?
b) Is DPH the appropriate entity for oversight of the peer
review process in hospitals, a system for monitoring the
professional conduct of medical professionals, rather than
MBC, which has direct responsibility for licensing of
physicians and surgeons?
REGISTERED SUPPORT / OPPOSITION :
Support
American Society of Dermatologic Surgery Association
California Society of Dermatology and Dermatologic Surgery
California Medical Association
California Society of Plastic Surgeons
Medical Board of California (prior version)
Proctor & Gamble Company (prior version)
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Opposition
American Nurses Association/California
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097