BILL ANALYSIS
SB 1150
Page 1
Date of Hearing: June 29, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1150 (Negrete McLeod) - As Introduced: February 18, 2010
SENATE VOTE : 31-1
SUBJECT : Healing arts.
SUMMARY : Requires health care provider advertisements to show
license designations, 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, requires MBC to post
a factsheet on cosmetic surgery, requires MBC to adopt standards
for out patient settings that offer in vitro fertilization, and
makes changes to MBC oversight of accreditation agencies.
Specifically, this bill :
Professional Designations
1)Requires advertising by the following licensees to include the
following specified designations:
a) A chiropractor shall include the designation "DC" or the
word "chiropractor" immediately following the
chiropractor's name;
b) A dentist shall include the designation "DDS" or "DMD"
immediately following the dentist's name;
c) A physician and surgeon shall include the designation
"MD" immediately following the physician and surgeon's
name;
d) An osteopathic physician and surgeon shall include the
designation "DO" immediately following the osteopathic
physician and surgeon's name;
e) A podiatrist shall include the designation "DPM"
immediately following the podiatrist's name;
f) A registered nurse (RN) shall include the designation
"RN" immediately following the RN's name;
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g) A licensed vocational nurse shall include the
designation "LVN" immediately following the licensed
vocational nurse's name;
h) A psychologist shall include the designation "Ph.D."
immediately following the psychologist's name;
i) An optometrist shall include "Opt. D." or "O.D."
immediately following the optometrist's name;
j) A physician assistant (PA) shall include the designation
"PA" immediately following the PA's name; and,
aa) A naturopathic doctor (ND) shall include the
designation "ND" immediately following the ND's name.
However, if the ND uses the term or designation "Dr." in an
advertisement, he or she shall further identify himself, as
specified.
2)For purposes of this bill, defines "advertisement" as a
communication by means of mail, television, radio, motion
picture, newspaper, book, directory, Internet, or other
electronic communication and states that advertisements do not
include a 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 an appointment reminder
from a health care practitioner to a patient.
3)States that advertising requirements in this bill shall not
apply until January 1, 2012 to any advertisement that is
published annually and prior to July 1, 2011.
4)States that this bill does not apply to any advertisement or
business card disseminated by a health care service plan, as
specified.
Cosmetic Surgery
5)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 by January 1, 2012. States that
these regulations shall not apply to laser or intense pulse
light devices approved by the federal Food and Drug
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Administration (FDA) for over-the-counter use by a health care
practitioner or by an unlicensed person on himself or herself
and states that this section shall not be construed to modify
the prohibition against the unlicensed practice of medicine.
6)Requires MBC to post on its Internet Web site an
easy-to-understand factsheet to educate the public about
cosmetic surgery and procedures, including their risks.
Requires a comprehensive list of questions for patients to ask
their physician and surgeon regarding cosmetic surgery, to be
included with the fact sheet.
Outpatient Settings
7)Adds in vitro fertilization facilities, as defined, to the
definition of "outpatient setting," in existing law,
authorizing MBC oversight.
8)Requires outpatient settings to, at the time of accreditation,
submit for approval by an accreditation agency of a detailed
plan, 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.
9)Requires MBC to adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
10) Requires MBC to notify the public whether an outpatient
setting is accredited, certified, or licensed, or if the
outpatient setting's accreditation, certification, or license
has been revoked, suspended, or placed on probation, or if the
setting has received a reprimand by the accreditation agency.
11) Requires the accreditation agency to immediately report to
MBC if the outpatient setting has been issued a reprimand, if
its certification of accreditation has been suspended or
revoked, or if it has been placed on probation.
12) Requires every accredited outpatient setting to be
inspected by the accreditation agency and permits MBC
inspection.
13) Requires MBC to ensure that accreditation agencies inspect
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outpatient settings. Requires the frequency of inspection to
depend upon the type and complexity of the outpatient setting
to be inspected, and requires inspections 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.
14) Deletes the requirement that MBC or the accreditation
agency give reasonable prior notice and present proper
identification to enter and inspect any setting that is
accredited by an accreditation agency.
15) Requires the setting to agree with the accreditation
agency on a plan of correction that gives the setting
reasonable time to supply information demonstrating compliance
with the standards of the accreditation agency, as well as the
opportunity for a hearing on the matter upon the request of
the setting. Requires a list of deficiencies and the plan of
correction to be conspicuously posted in a setting accessible
to public view during that allotted time.
16) Requires reports on the results of any inspection be kept
on file with MBC or the accreditation agency along with the
plan of correction and the setting comments. Permits the
inspection report to include a recommendation for
reinspection. Requires all inspection reports, lists of
deficiencies, and plans of correction to be public records
open to public inspection.
Accrediting Agencies
17) Permits MBC to issue a citation to the accreditation
agency if it is not meeting MBC's criteria.
18) Permits MBC to establish, by regulation, a system to issue
a citation to an accreditation agency that is not meeting
MBC's criteria. Requires this system to meet the requirements
of existing law, as applicable, except that both of the
following apply:
a) Failure of an agency to pay an administrative fine
assessed pursuant to a citation within 30 days of the date
of the assessment, unless the citation is being appealed,
may result in MBC's termination of approval of the agency.
Where a citation is not contested and a fine is not paid,
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the full amount of the assessed fine will be added to the
renewal fee, as specified. Approval of an agency is
prohibited from being renewed without payment of the
renewal fee and fine; and,
b) Administrative fines collected pursuant to the system
are required to be deposited in the Outpatient Setting Fund
of the MBC.
19) 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 as part of its periodic inspection of those
specified hospitals.
20) Makes technical amendments.
EXISTING LAW :
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 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)Requires a health care practitioner to disclose, while
working, his or her name and license status on a specified
name tag in 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.
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4)Requires the MBC and the Board of Registered Nurses to
promulgate regulations to implement necessary changes on the
use of laser or intense pulse light devices for elective
cosmetic procedures by physicians and surgeons, nurses, and
PAs.
5)Requires the MBC to adopt standards for accreditation of
settings, as defined, and in approving accreditation agencies
to perform accreditation of settings, ensure that the
certification program shall, at a minimum, include standards
for specified aspects of settings' operations.
6)Requires accreditation of a setting to be denied by the
accreditation agency if the setting does not meet specified
standards and allows the setting to reapply for accreditation
at any time after receiving notification of denial.
7)Provides that before suspending or revoking a certificate of
accreditation, the accrediting agency shall provide the
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 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. Defines in vitro
fertilization as the laboratory medical procedures involving
the actual in vitro fertilization process.
9)Requires DPH to license and inspect health facilities,
including acute care hospitals.
10) Requires DPH to conduct periodic inspections of acute care
hospitals no less than once every three years.
FISCAL EFFECT : According to Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2010-11 2011-12 2012-13 Fund
Outpatient facility inspections $289 $213
$213Special*
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(MBC)
* MBC Contingent Fund
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, recent events
involving a mother who gave birth to octuplets revealed that
fertility clinics operate with little state oversight. This
bill would address this problem by requiring these clinics to
be accredited by an accrediting agency approved by MBC and
will require MBC to adopt standards for accreditation of
fertility clinics' operations. Additionally, cosmetic
procedures, such as breast augmentation, liposuction, nose
reshaping, eyelid surgery, and tummy tuck are increasing in
popularity and can be performed by any licensed physician in
settings outside of hospitals such as outpatient surgery
centers and doctors' offices. Less invasive surgeries such as
laser surgery and Botox surgery, which are performed in
medical spas are being performed in malls and city office
buildings across the country. While the FDA 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. The author states that this bill will guarantee the
public's safety by strengthening regulation and oversight of
fertility clinics and surgical centers performing cosmetic
procedures and ensuring that quality of care standards are
checked by the appropriate credentialing agency.
2)INCREASED POPULARITY OF COSMETIC SURGERY . According to the
American Society of Plastic Surgeons' (ASPS) Web site,
cosmetic procedures represent a $10.3 billion industry with
about 12.1 million cosmetic procedures being performed in
2008. According to ASPS, the top five procedures are as
follows: breast augmentation, liposuction, nose reshaping,
eyelid surgery, and tummy tuck. Additionally, ASPS notes that
less-invasive cosmetic procedures such as chemical peel, laser
hair removal, and microdermabrasion are also increasing in
popularity with 10.7 million procedures being performed in
2008. In California, cosmetic surgery can be performed by any
licensed physician ranging from pediatrician to plastic
surgeon.
3)ACCREDITED OUTPATIENT SETTINGS . Clinics that are
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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 . In 2007, a California appellate court ruled
that ambulatory surgical clinics (ASCs) owned, in whole or in
part, by physicians, would no longer be eligible for licensure
by DPH. As a result, DPH ceased licensure activities of ASCs
owned by physicians, although it continued to perform Medicare
certification for those facilities. Prior to the Capen v.
Shewry ruling, DPH interpreted the exemption from licensure
in law for physician-owned clinics to mean that each licensed
health practitioner at the clinic had to have at least some
share in the ownership (or leasehold) and operation of the
clinic. DPH interpreted the law in this way to ensure that a
practitioner at the clinic could not disclaim responsibility
for its operation should a problem arise. Although following
Capen v. Shewry , DPH is not renewing or granting any licenses
to a surgical clinic with any degree of physician ownership,
it continues to certify these centers for Medicare purposes.
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."
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5)ASSISTED REPRODUCTIVE TECHNOLOGY . According to the Centers
for Disease Control and Prevention (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 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 federal
Department of Health and Human Services 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.
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6)PEER REVIEW IN HOSPITALS . Physician peer review is one of the
regimes used to ensure that quality of care is delivered while
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 Consumer Attorneys of California supports this
bill as it will strengthen oversight on the quality of care
standards at fertility clinics and surgical centers that carry
out cosmetic procedures. According to supporters, no formal
government entity has officially had authority over these
facilities, instead relying on four private agencies to
accredit and inspect fertility and outpatient centers.
Supporters state that this bill will put MBC expressly in
charge of inspection at these facilities and require
accrediting agencies to report directly to the MBC if
accreditation of outpatient setting was denied or revoked.
8)OPPOSE UNLESS AMENDED . The California Hospital Association
(CHA) opposes a provision in this bill that states the
Legislature's intent that DPH, "pursuant to existing
regulations, inspect the peer review process utilized by acute
care hospitals as part of its periodic inspection of
hospitals." CHA states that peer review plays an essential
role in assuring the quality and safety of care provided in
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California hospitals and strongly supports this process.
According to CHA, the intent language in this bill is
unnecessary because DPH already has the authority to inspect
hospitals for compliance with hospital licensing requirements,
including requirements related to hospital medical staff.
9)RELATED LEGISLATION . AB 583 (Hayashi) of 2009 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, and requires
supervising physicians and surgeons to post their hours in
each office. AB 583 is currently on the Senate Inactive File.
10) PREVIOUS LEGISLATION .
a) SB 674 (Negrete McLeod) of 2009 would have required a
health care practitioner, as specified, include specific
professional designation following the health care
practitioner's name in advertisements; required MBC to
adopt regulations on the appropriate level of physician
availability necessary within clinics or other settings
using laser or intense pulse light devices for elective
cosmetic surgery; required certain healing arts licensees
to include in advertisements certain words or designations
following their names indicating the particular educational
degree they hold or healing art they practice, as
specified; and, authorized MBC to issue an accreditation
agency a citation, including an administrative fine, in
accordance with a specified system established by MBC if
the agency is not meeting the criteria set by the MBC.
SB 674 was vetoed by Governor Schwarzenegger, who stated,
"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."
b) AB 832 (Jones) would have required DPH to convene a
workgroup to develop recommendations regarding the
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oversight of ASCs to address issues raised in recent
litigation, Capen v. Shewry . Findings of Capen v. Shewry
led DPH to conclude DPH no longer has the authority to
license certain ASCs. AB 832 was held in the Assembly
Appropriations Committee.
c) SB 1454 (Ridley-Thomas) of 2008 would have revised
requirements related to health care provider advertising
and disclosures, would have required MBC to adopt
regulations regarding supervision levels for settings
providing elective cosmetic procedures, as specified, and
would have made various changes relating to accreditation
and reporting procedures of outpatient settings. SB 1454
died on the Assembly Floor.
11)DOUBLE REFERRAL . This bill was previously heard in Assembly
Business, Professions, and Consumer Protection Committee where
it passed 11-0 on June 22, 2010.
REGISTERED SUPPORT / OPPOSITION :
Support
Consumer Attorneys of California
Medical Board of California
Proctor & Gamble Company
Oppose Unless Amended
California Hospital Association
Analysis Prepared by : Martin Radosevich / HEALTH / (916)
319-2097