BILL ANALYSIS                                                                                                                                                                                                    







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        |Hearing Date:April 20, 2009    |Bill No:SB                          |
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          SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
                         Senator Gloria Negrete McLeod, Chair

                      Bill No:        SB 674Author:Negrete McLeod
                        As Amended:April 2, 2009 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 a health care practitioner who is working in an  
        outpatient setting or clinic, as defined, to disclose their type  
        of license, instead of license status, on a name tag or verbally  
        disclose such information to patients.  Requires the Medical Board  
        of California (MBC) to adopt regulations on or before July 1, 2010  
        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.  Includes in  
        the existing law definition of outpatient settings fertility  
        clinics that offer in vitro fertilization or assisted reproduction  
        technology (ART) treatments.  Requires the Department of Public  
        Health (DPH), as part of its periodic inspections, 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  





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          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)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  





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          cosmetic procedures by physicians and surgeons, nurses and  
          physicians assistants.

        8)Requires the MBC to post on its Internet Web site 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. 





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        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 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,  





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          including acute care hospitals.  Requires DPH to conduct  
          periodic inspections of acute care hospitals no less than once  
          every three years.
        
        This bill, within the Business and Professions Code:

        1)Requires that any advertising by a chiropractor, dentist,  
          physician and surgeon, osteopathic physician and surgeon,  
          podiatrist, registered nurse, licensed vocational nurse,  
          psychologist, optometrist, physician assistant and naturopathic  
          doctor include specific professional designation following the  
          health care practitioner's name.

        2)Defines advertisement for purposes of #1) above to include  
          communication by means of mail, television, radio, motion  
          picture, newspaper, book, directory, Internet or other  
          electronic communication.  Excludes from the definition of  
          advertisement the following: medical directory released by a  
          health care service plan or a health insurer, a billing  
          statement from a health care practitioner to a patient, or  
          appointment reminder from a health care practitioner to a  
          patient.  Also excludes from the requirement in #1) above any  
          advertisement or business card disseminated by a health care  
          service plan relating to contracted providers, as specified. 

        3)Specifies that the requirement in #1) does not apply until  
          January 1, 2011 to any advertisement that is published annually  
          and prior to July 1, 2010. 

        4)Clarifies that a health care practitioner who is working in an  
          outpatient setting or clinic, as defined, must disclose their  
          type of license, instead of the existing law's requirement of  
          disclosing license status, on a name tag or verbally to  
          patients.

        5)Requires the MBC to adopt regulations on or before July 1, 2010,  
          regarding the appropriate level of physician availability needed  
          within clinics or other settings using laser or intense pulse  
          light devices for elective cosmetic procedures.  Specifies that  
          the regulations to be adopted will not apply to laser or intense  
          pulse light devices approved by the federal Food and Drug  
          Administration for over-the-counter use by a health care  
          practitioner or by an unlicensed person on himself or herself.

        6)Requires the MBC to post on its Internet Website an easy to  
          understand fact sheet to educate the public about cosmetic  





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          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 or ART  
          treatments. 
        
        2)Requires as part of the standards for operation and approval of  
          an outpatient setting that the outpatient setting submit for  
          approval by an accrediting agency at the time of accreditation,  
          a detailed plan, standardized procedures, and protocols to be  
          followed in the event of serious complications or side effects  
          from surgery, as specified.
        
        3)Requires the MBC to notify the public whether a setting is  
          accredited, certified, or licensed, or the setting's  
          accreditation, certification, or license has been revoked,  
          suspended or placed on probation, or the setting has received a  
          reprimand by the accreditation agency.
        
        4)Requires an accrediting agency to immediately report to the MBC  
          if an outpatient setting's certificate for accreditation has  
          been denied.
        
        5)Requires that every outpatient setting which is accredited to be  
          periodically inspected by the MBC or the accrediting agency.   
          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 to ensure the quality of care  
          provided.
        
        6)Requires reports on the results of each inspection to be kept on  
          file with the MBC or the 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.
        
        7)Deletes the requirement that the MBC or the accrediting agency  





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          give reasonable prior notice and present proper identification  
          prior to an inspection.
        
        8)Requires rather than just authorize the MBC to evaluate the  
          performance of an approved accreditation agency no less than  
          every three years.
        
        9)Provides that the outpatient setting shall agree with the  
          accrediting agency upon a plan of correction when they receive a  
          notice of any deficiencies from the accreditation agency and  
          that during the time of correction, the list of deficiencies and  
          the plan of correction shall be conspicuously posted in a clinic  
          location accessible to public view.   
        
        10)Requires DPH, during its routine state periodic inspection of  
          an acute care hospital, as specified, to also inspect the peer  
          review process utilized by the hospital. 
        
        FISCAL EFFECT:  Unknown.  This bill has been keyed "fiscal" by  
        Legislative Counsel.

        COMMENTS:

        1)Purpose.  The Author 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  
          the Medical Board of California. 

        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  





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          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,  
             hyaluronic acid fillers, chemical peel, laser hair removal,  
             and microdermabrasion.  

           Recognizing the need to educate the public when considering  
             cosmetic surgery, the  College of Physicians and Surgeons of  
             Ontario, Canada  posted a fact sheet entitled  What You Should  
             Know About Cosmetic Surgery  to assist consumers to make an  
             informed decision.  The fact sheet included an explanation of  
             the different kinds of doctors who provide services, the  





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             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  
               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  





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               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 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 and are commonly referred to as  
             outpatient settings.  Outpatient settings 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  
             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,  





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             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  
             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.  





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              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.  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  
             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,  





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             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  
             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  





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             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 per 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.Similar 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 passed  
             out of the Assembly Business and Professions Committee and is  
             pending on the Assembly Floor.  

           b)   AB 832  (Jones) requires surgical clinics, as defined, to  
             be licensed by DPH.  AB 832 is pending in Assembly Health  
             Committee.  

         2.Prior Related Legislation.

            a)   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.  
            
            b)   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  





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             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.

            c)   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.  
            
            d)   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.

            e)   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.   
             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.

        3.Arguments in Opposition.  The  American Nurses  
          Association/California  opposes this bill and states that  
          authorizing a health care practitioner to verbally disclose  
          their license does not inform the patient of who is caring for  
          them.  In addition, it states that there is no need to require  
          additional regulations for laser procedures or intense pulse  
          light devices and that the appropriate remedy is to enforce  
          existing law.
        
         





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        SUPPORT AND OPPOSITION:
        
         Support:   None on file as of April 10, 2009.

          Opposition:  None on file as of April 10, 2009.


        Consultant:              Rosielyn Pulmano