BILL ANALYSIS
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|Hearing Date:April 5, 2010 |Bill No:SB |
| |1150 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 1150Author:Negrete McLeod
As Introduced: February 18, 2010 Fiscal:Yes
SUBJECT: Healing arts.
SUMMARY: Requires for purposes of advertising that a health care
practitioner, as specified, include specific professional
designation following the health care practitioner's name.
Requires the Medical Board of California (MBC) to adopt
regulations on or before January 1, 2012, 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 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. Revises the existing definition of
"outpatient settings" to include fertility clinics that offer in
vitro fertilization. States that it is the intent of the
Legislature that the Department of Public Health (DPH), pursuant
to existing regulations, inspect the peer review process utilized
by acute care hospitals.
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
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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 or her license or other disciplinary action
including an administrative fine not to exceed $10,000.
2)Authorizes advertising by health care licensees to include certain
general information regarding the practitioner and requires
certain disclosures to be made regarding dentists, physicians
and surgeons, podiatrists and optometrists regarding the
advertising of their education, accreditation, certification or
specialty.
3)Specifies requirements for the recognition and advertising, or claims
or statements made by dentists, physicians and surgeons,
podiatrists and optometrists regarding board certification, or
recognition by an accrediting organization, multidisciplinary
board or association.
4)Requires a health care practitioner to disclose, while working, his
or her name and license status on a specified name tag at least
18-point type but provides if a health care practitioner is in a
practice or office where their license is prominently displayed,
they may opt to not wear a name tag.
5)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.
6)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.
7)Requires the MBC and the BRN to promulgate regulations to implement
changes determined to be necessary with regard to the use of
laser or intense pulse light devices for elective cosmetic
procedures by physicians and surgeons, nurses and physicians
assistants.
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8)Requires the MBC to post on its Internet Website specified
information in its possession, custody or control regarding
physicians and surgeons.
9)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.
10)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 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)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
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for accreditation at any time after receiving notification of
denial.
6)Authorizes the 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)Authorizes the MBC to evaluate the performance of an approved
accreditation agency no less than every three years, or in
response to a complaint against an agency, or complaints against
one or more outpatient settings accreditation by an agency that
indicated noncompliance by the agency with standards approved by
the MBC.
8)Provides that before suspending or revoking a certificate of
accreditation, the accrediting agency shall provide the
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.
9)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.
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. Requires DPH
to conduct periodic inspections of acute care hospitals no less
than once every three years.
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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, 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, 2012 to any advertisement that is published annually
and prior to July 1, 2011.
4)Requires the MBC to adopt regulations on or before January 1,
2012 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.
5)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. 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"
facilities those that offer in vitro fertilization, as
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specified.
2)Requires the MBC to adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
3)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.
4)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.
5)Requires an accrediting agency to immediately report to the MBC
if an outpatient setting's certificate for accreditation has
been denied.
6)Requires that every outpatient setting which is accredited to be
inspected by an accreditation agency and may also be inspected
by the MBC. Requires the MBC to ensure that accreditation
agencies inspect outpatient settings.
7)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 and as often as necessary by the MBC to ensure the quality
of care provided.
8)Requires reports on the results of each inspection to be kept on
file with the MBC or the accrediting 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.
9)Deletes the requirement that the MBC or the accrediting agency
give reasonable prior notice and present proper identification
prior to an inspection.
10) Requires rather than just authorizes
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the MBC to evaluate the performance of an approved accreditation
agency no less than every three years.
11) 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.
12) Requires an accreditation agency to
immediately report to the MBC if an 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.
13) Allows the MBC to issue a citation
to the accrediting agency if an accreditation agency is not
meeting the criteria set by the board. Specifies a system for
the issuance of a citation to an accreditation agency.
14) States the intent of the Legislature
that the DPH, pursuant to its existing regulation, inspect the
peer review process utilized by acute care hospitals as part of
its periodic inspections of those hospitals.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1)Purpose. The Autho r is the Sponsor of this measure. The Author
states that
this bill 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. The Author
points out that recent events involving a woman who gave birth
to octuplets revealed that fertility clinics operate with little
or no state oversight. A clinic that assists women in any
reproductive technology should operate under specified
standards, guidelines and procedures and since most of these
clinics are physician-owned, this bill would require these
clinics to be accredited by an accrediting agency approved by
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the MBC.
In addition, the Author 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 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 Author cites the Donda
West story. Donda West, the mother of famous artist Kanye West,
died less than 24 hours after undergoing a 5 1/2 -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.
2)Background.
a) 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,
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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 in making 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.
b) 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 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:
i) SB 1423 (Figueroa, Chapter 873, Statutes of 2006)
required 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.
ii) SB 835 (Figueroa, 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
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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.
iii) SB 836 (Figueroa, Chapter 856, Statutes of 1999)
expanded and revised the prohibition against fraudulent
advertising by health practitioners.
iv) SB 837 (Figueroa, 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.
c) Accredited Outpatient Settings vs. Licensed Surgical
Clinics. The Health and Safety Code makes a distinction
between clinics licensed by the Department of Public Health
(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 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 are commonly
referred to as outpatient settings. Outpatient setting is
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
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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 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
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standards set forth in Health and Safety Code Section 1248
et.seq."
d) Recent Review by the MBC, BRN and PAC of Issues Involving
Use of Certain Cosmetic Procedures. SB 1423 (Figueroa,
Chapter 873, Statutes of 2006) required the MBC in
conjunction with 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.
The MBC and the BRN have held meetings, discussions and
heard testimony from a number of organizations representing
nurses, physicians, physician assistants, patients and the
laser industry. The discussions included recommendations on
training of personnel that use laser equipment, the
appropriate level of physician supervision at these
facilities, the appropriate advertising to inform patients of
the practitioners' credentials and degrees, who should own or
control these facilities, liability and establishing
standardized procedural rules. The discussions and meetings
revealed that there is frequent disregard of the law in the
use of laser or intense pulse light devices in the treatment
of patients.
Two statements were approved by both boards in these
discussions; the first outlines the responsibilities of
physicians in cosmetic procedures, including the supervision
of allied health staff performing laser procedures, and the
second is a revised statement to better inform consumers on
cosmetic procedures, currently available on MBC's Website but
includes the following, "An appropriate examination must be
conducted before treatments are performed. This exam must be
conducted by a physician, or the doctor may delegate the
examination to licensed nurse practitioners or physician
assistants. Physicians may not delegate this examination to
registered nurses."
e) Assisted Reproductive Technology (ART). According to the
Centers for Disease Control (CDC), 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 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
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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 the CDC.
f) Recent Legislation on Fertility Clinics in Other States.
Recent events involving the birth of octuplets by a Southern
California woman has sparked legislation in several states
relating to fertility clinics. For example, in Georgia, The
Ethical Treatment of Human Embryos Act was introduced. This
bill defines an embryo as a biological human being and
prohibits destruction of frozen embryos. Currently,
Louisiana is the only state in the nation with a similar law
prohibiting discarding of human embryos. In Missouri, HB 810
was introduced and seeks to enact guidelines from the
American Society of Reproductive Medicine (ASRM). The
guidelines include a recommendation on the number of embryos
that should be implanted on a woman based on her age and
prognosis for a successful pregnancy. In most cases, ASRM
guidelines call for two or three embryos, though women older
than 40 could be implanted with up to five embryos.
g) Industry Standards for ART. Currently there are two
organizations that physicians who practice reproductive
medicine generally belong. One is the ASRM and the other is
the Society for Reproductive Technology, an affiliate of
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ASRM. Both organizations provide practice guidelines and
minimum standards regarding assisted hatching, blastocyst
transfer and gamete and embryo donation. It should be noted
that the guidelines adopted by ASRM and SART are not
mandatory guidelines. In addition, it appears that about 20%
of clinics that belong to either organizations adhere to the
guidelines, and usually the only penalty for violating the
guidelines is expulsion from the professional organization.
h) Informational Hearing on the Peer Review Process - Lack of
Oversight. On March 9, 2009, this Committee held an
informational hearing on physician peer review entitled, "Is
the Physician Peer Review A Broken System?" The
informational hearing provided a brief overview of peer
review in California and included discussions on how
hospitals and other entities conduct peer review. The
hearing also included a discussion on a legislatively
mandated report on peer review authored by Lumetra which
pointed out that the peer review process in California is
broken and in need of a major fix for it to truly serve the
people. In addition, DPH testified during the hearing on its
oversight of acute care hospitals and the peer review
process.
1.Related Legislation This Session.
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 is on
the Senate Inactive File.
b) AB 2566 (Carter) would make a business organization that
provides outpatient elective cosmetic medical procedures or
treatments, that is owned and operated in violation of the
prohibition against employment of licensed physicians and
surgeons and podiatrists, and that contracts with or employs
these licensees to facilitate the offer or provision of those
procedures or treatments that may only be provided by these
licensees, guilty of a violation of the prohibition against
knowingly making or causing to be made any false or
fraudulent claim for payment of a health care benefit. AB
2566 is referred to the Assembly Business and Professions
Committee and the Assembly Public Safety Committee.
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2.Prior Related Legislation.
a) SB 674 (Negrete McLeod) of 2009 is substantially similar
to the provisions of this bill and would have made 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. SB 674 was vetoed by the Governor who indicated:
"While some provisions may provide marginal improvements to
consumer protection, I cannot support this bill when it fails
to address the need for stronger licensing and oversight of
outpatient surgical centers. The continued reliance by the
medical community on external accreditation agencies without
enforcement capability is an insufficient solution for
protecting patients. As outpatient surgeries continue to
increase in number and complexity, surgical centers cannot
continue to perform procedures in an unregulated and
unenforced environment.
I would ask the medical community to work with my
Administration next year to bring consistent and effective
oversight to this growing industry in the shared interest of
protecting patient safety."
b) AB 832 (Jones) of 2009 would have required the DPH to
convene a workgroup, no later than February 1, 2010, to
consider and develop recommendations for state oversight and
monitoring of ambulatory surgical clinics, as defined, to
ensure public health and safety. AB 832 would have required
the workgroup to submit its conclusions and recommendations
to the appropriate policy committees of the Legislature no
later than July 1, 2010. AB 832 died in the Assembly
Appropriations Committee.
c) AB 252 (Carter) of 2009 would have authorized the
revocation of the license of a physician and surgeon who
practices medicine with a business organization that offers
to provide or provides outpatient elective cosmetic medical
procedures or treatments knowing that the practice is owned
or operated in violation of the prohibition against the
corporate practice of medicine. In his veto message, the
Governor indicated that AB 252 is duplicative of existing law
and unnecessary.
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d) SB 1454 (Ridley-Thomas) of 2008 is substantially related
to the provisions of this bill and would have, among other
provisions, made 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. SB 1454 died on the
Assembly Floor.
e) AB 2968 (Carter) of 2008 would have enacted the Donda West
Law, which would prohibit elective cosmetic surgery on a
patient unless, prior to surgery, the patient has completed a
physical examination by, and has received written clearance
for the procedure from, a licensed physician and surgeon. AB
2968 was vetoed by the Governor because of the budget delay.
f) AB 2122 (Plescia) of 2008 would have established the
California Outpatient Surgery Patient Safety and Improvement
Act which requires surgical clinics to meet prescribed
licensing requirements and standards, including compliance
with Medicare conditions of participation. AB 2122 was held
in the Assembly Appropriations suspense file.
g) AB 543 (Plescia) of 2007 would have required surgical
clinics to meet specified operating and staffing standards,
including compliance with Medicare conditions of
participation. Would have required surgical clinics to limit
surgical procedures, as specified, and to develop and
implement policies and procedures consistent with Medicare
conditions of participation, including interpretive
guidelines. AB 543 was vetoed by Governor Schwarzenegger
because among other things the bill did not establish
appropriate time limits for performing surgery under general
anesthesia and directed DPH to pursue legislation that
establishes licensure standards for these facilities that are
consistent with federal requirements and protect the health
and safety of patients.
h) AB 2308 (Plescia) of 2006 would have required the
Department of Health Services (now DPH) to convene a
workgroup to develop licensure criteria to protect patients
receiving care in surgical clinics, and to submit workgroup
conclusions and recommendations to the appropriate policy
committees of the Legislature no later than March 1, 2007.
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AB 2308 would have revised existing law to replace the term
"licensed surgical clinic" with "ambulatory surgical centers"
or "ASCs." AB 2308 was vetoed by the Governor because it
mandates creation of another advisory committee and provides
an unrealistic timeframe to operate.
3.Oppose Unless Amended. The California Hospital Association
(CHA) has taken an "oppose unless amended" position on the
provisions of this bill stating the intent of the Legislature
that the DPH (DPH), pursuant to its existing regulations,
inspect the peer review process utilized by acute care hospitals
as part of its periodic inspection of these hospitals. CHA
believes that such provisions are unnecessary because the DPH
already has authority to inspect hospitals for compliance with
California hospital licensing requirements, including
requirements related to hospital medical staffs.
4.Policy Issue : Should the Authority of the DPH to Inspect the
Peer Review Process of Health Facilities be Clear? Although the
CHA argues that language is unnecessary to reflect the DPH's
role in reviewing the peer review process of hospitals, it has
become clear from testimony of DPH and by those conducting the
Lumetra Report that clarification is needed.
One particularly disturbing illustration of the failure to inspect
the peer review process of a health facility took place at
Redding Medical Center (RMC). RMC is one of two hospitals in
Redding, California, with 238 beds, and which was owned by Tenet
Healthcare Corporation (Tenet). RMC operated an open-heart
surgery program called the California Heart Institute which drew
patients from many areas of Northern California. In 2003, Tenet
agreed to pay $54 million to resolve government accusations that
doctors at RMC conducted unnecessary health procedures and
operations on more than 600 patients between 1995 and 2002.
According to several newspaper articles and a Congressional
report entitled How Peer Review Failed at Redding Medical
Center, Why It is Failing Across the Country and What Can Be
Done About It, two directors of RMC (Dr. Chae Hyun Moon and Dr.
Fidel Realyvasquez) were performing 4 - 5 times as many cardiac
procedures and surgeries than would have been expected for the
hospital and the population it served. Although staff
physicians complained to RMC administrators beginning in 1996,
no corrective action was taken until there was a Federal Bureau
of Investigation raid in 2002, prompted by a complaint by a
priest.
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Although hospital administrators and state regulators received
numerous reports of potential quality of care issues at RMC, no
inspection was made of this facility nor was any corrective
action taken. The Redding Report authors concluded that the two
directors of the program along with hospital administration, and
staff blocked peer review; successfully hiding the negligent
medical practice for ten years. In fact, one of the directors,
Dr. Moon, had been subject to hospital suspension every single
day of 1992. Rather than being restricted, Dr. Moon was one of
the busiest physicians at the Center during that time.
While the Redding Medical Center case is a particularly egregious
example of some of the problems of the physician peer review
process, it illustrates how the process can be manipulated and
sub-standard physician performance can be overlooked, hidden, or
ignored for an extended period of time without appropriate
oversight. The Redding Report pointed out that there is a long
history of similar cases in which effective peer review could
have made a difference.
NOTE : Double-referral to Rules Committee (second.)
SUPPORT AND OPPOSITION:
Support: Procter & Gamble Company
Opposition : California Hospital Association
Consultant:Rosielyn Pulmano