BILL ANALYSIS                                                                                                                                                                                                    �







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        |Hearing Date:April 8, 2013         |Bill No:SB                         |
        |                                   |352                                |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                          Bill No:        SB 352Author:Pavley
                   As Introduced:     February 20, 2013  Fiscal: No

        
        SUBJECT:  Medical assistants: supervision.
        
        SUMMARY:  Allows medical assistants to perform technical supportive  
        services, in doctor's offices and all medical clinics, under the  
        supervision of a physician assistant, nurse practitioner or nurse  
        midwife without a physician on the premises.  

        Existing law:
           
        1) Defines "medical assistant" as a person who may be unlicensed, who  
           performs basic administrative, clerical and technical supportive  
           services for a licensed physician, surgeon, podiatrist, a medical  
           or podiatry corporation, physician assistant, nurse practitioner,  
           nurse midwife or health care service plan.  (Business and  
           Professions Code (BPC)  � 2069(b)(1))

        2) Specifies that a medical assistant is at least 18 years of age and  
           has had at least the minimum amount of hours of appropriate  
           training pursuant to standards established by the Division of  
           Licensing.  (BPC � 2069(b)(1)) 

        3) Establishes the requirements which allow certifying organizations  
           to certify medical assistants (California Code of Regulations (CCR)  
           Title 16  � 1366.31)

        4) Requires a medical assistant to receive their training from either  
           of the two (CCR Title 16 � 1366.3(a)):

                a)        A secondary, postsecondary or adult education  
                  program in a public school authorized by the Department of  





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                  Education, in a community college program, or a  
                  postsecondary institution accredited by an accreditation  
                  agency recognized by the United States Department of  
                  Education or approved by the Bureau for Private  
                  Postsecondary Education.

                b)        A physician,  podiatrist, registered nurse, licensed  
                  vocational nurse, physician assistant or a qualified medical  
                  assistant.

        5) Requires a "qualified medical assistant" to meet one of three  
           criteria:  
        (CCR Title 16 � 1366.3(c))

                a)        Certified by a medical assistant certifying  
                  organization approved by the division.
                b)        Holds a credential to teach in a medical assistant  
                  training program at a community college. 

                c)        Is authorized to teach medical assistants in a  
                  private postsecondary institution accredited by an  
                  accreditation agency recognized by the United States  
                  Department of Education or approved by the Bureau for  
                  Private Postsecondary Education. 

        6) Specifies that a qualified medical assistant cannot train other  
           medical assistants to administer medication by inhalation.  (CCR  
           Title 16 �1366.3)

        7) Defines "technical supportive services" as simple routine medical  
           tasks and procedures that may be safely performed by a medical  
           assistant who has limited training and who functions under the  
           supervision of a licensed physician, surgeon, podiatrist, physician  
           assistant, nurse practitioner or nurse midwife.  (BPC � 2070(4)) 

        8) Allows the Division of Licensing to adopt and administer  
           regulations that establish standards for technical supportive  
           services that may be performed by a medical assistant.  
        (BPC � 2071)

        9) Defines "specific authorization" as a specific written order  
           prepared by the supervising physician, surgeon, podiatrist, nurse  
           practitioner or nurse midwife authorizing the procedures to be  
           performed on a patient.  (BPC � 2069(b)(2))

        10)Authorizes medical assistants to administer medication only by  





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           intradermal, subcutaneous or intramuscular injection and to perform  
           skin tests under the specific authorization and supervision of a  
           licensed physician, surgeon or podiatrist.  (BPC � 2069(a)(1)) 

        11)Authorizes medical assistants to perform venipuncture or skin  
           puncture for the purposes of withdrawing blood upon specific  
           authorization and under the supervision of a licensed physician,  
           surgeon, podiatrist, physician assistant, nurse practitioner or  
           nurse midwife.  
        (BPC � 2070)

        12)Authorizes medical assistants to perform the following additional  
           technical supportive services  (CCR Title 16 � 1366(b)):

                a)        Administer medication orally, sublingually,  
                  topically, vaginally or rectally, or by providing a single  
                  dose to a patient for immediate self-administration; 
                b)        Administer medication by inhalation;
                c)        Perform electrocardiogram, electroencephalogram or  
                  plethysmography tests, except full body plethysmography; 
                d)        Apply and remove bandages and dressings;
                e)        Apply orthopedic appliances such as knee  
                  immobilizers, envelope slings, orthotics and similar  
                  devices; 
                f)        Remove casts, splints and other external devices; 
                g)        Obtain impressions for orthotics, padding and custom  
                  molded shoes; 
                h)        Select and adjust crutches to patient and instruct  
                  patient in proper use of crutches; 
                i)        Remove sutures or staples from superficial incisions  
                  or lacerations; 
                j)        Perform ear lavage to remove impacted cerumen; 
                aa)       Collect, by non-invasive techniques, and preserve  
                  specimens for testing including urine, sputum, semen and  
                  stool;
                bb)       Assist patients in ambulation and transfers;
                cc)       Prepare patients for and assist the physician,  
                  podiatrist, physician assistant or registered nurse in  
                  examinations or procedures including positioning, draping,  
                  shaving and disinfecting treatment sites; 
                dd)       Prepare a patient for gait analysis testing; 
                ee)       as authorized by the physician or podiatrist,  
                  provide patient information and instructions; 
                ff)       Collect and record patient data including height,  
                  weight, temperature, pulse, respiration rate and blood  
                  pressure, and basic information about the presenting and  





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                  previous conditions;
                gg)       Perform simple laboratory and screening tests  
                  customarily performed in a medical office; 
                hh)       Cut the nails of otherwise healthy patients; and
                ii)       Fit prescription lenses or use any optical device in  
                  connection with ocular exercises, visual training, vision  
                  training or orthoptics.

        13)Authorizes medical assistants to practice in any setting where  
           optometry or ophthalmology is practiced under the direct  
           responsibility and supervision of a physician, surgeon or  
           optometrist to do the following tasks  (BPC � 2544):

                a)        Prepare patients for examination;
                b)        Collect preliminary patient data, including taking a  
                  patient history;
                c)        Perform simple non-invasive testing of visual  
                  acuity, pupils and ocular motility;
                d)        Perform automated visual field testing;
                e)        Perform ophthalmic photography and digital imaging;
                f)        Perform tonometry;
                g)        Perform lensometry;
                h)        Perform non-subjective auto refraction in connection  
                  with subjective refraction procedures performed by an  
                  ophthalmologist or optometrist;
                i)        Administer cycloplegiacs, mydriatics and topical  
                  anesthetics that are not controlled substances, for  
                  ophthalmic purposes; and
                j)        Perform pachymetry, keratometry, A scans, B scans  
                  and electrodiagnostic testing.

        14)Permits a physician or surgeon at a community or free clinic to  
           authorize a nurse practitioner, nurse midwife or physician  
           assistant to provide supervision of medical assistants as they  
           follow written instructions provided by the physician when the  
           physician is not on site.  
        (BPC � 2069(a); Health and Safety Code (HSC) � 1204))

        This bill:

        1) Expands the types of settings where medical assistants can provide  
           technical supportive services from community and free clinics to  
           any medical setting.  

        2) Authorizes a physician or surgeon, in any medical setting, to  
           authorize a nurse practitioner, nurse midwife or physician  





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           assistant to provide supervision of medical assistants as they  
           follow written instructions provided by the physician when the  
           physician is not on site. 

        3) Specifies that the standards established for medical assistants  
           will be established by the Medical Board of California (MBC), and  
           specifies that the MBC shall not adopt regulations that violate  
           prohibitions on diagnosis or treatment. 

        4) Specifies that medical assistants shall not perform any tests or  
           examinations for which he or she is not authorized. 

        5) Prohibits a nurse practitioner, nurse midwife or physician  
           assistant to be a laboratory director of a clinical laboratory. 

        FISCAL EFFECT:   Unknown.  This bill has been keyed "non-fiscal" by  
        Legislative Counsel.

        COMMENTS:
        
        1. Purpose.  This bill is sponsored by the  California Academy of  
           Physician Assistants  . According to the author, current laws require  
           that a physician must be present at the practice site to supervise  
           a medical assistant.  However, medical assistants can work under  
           the supervision of a physician assistant, nurse practitioner or  
           nurse midwife in licensed community and free clinics.  With the  
           exception of these clinics, medical assistants are limited to  
           performing administrative and clerical duties and therefore may not  
           perform or assist with even the simplest technical supportive  
           services if the physician is not on the premises. 

        2. Background.  

         Medical Assistants and Their Scope of Practice.   According to the  
           United States Bureau of Labor and Statistics (BLS), the medical  
           assisting professions continue to be some of the fastest growing  
           employment categories.  The BLS projects that the number of medical  
           assistants will grow by 34%, from 483,600 in 2008, to 647,500 by  
           2018.  California employs nearly 82,000 medical assistants.   
           Medical assistants are unlicensed personnel who work in physician,  
           podiatrist or optometrist offices and clinics.  Medical assistants  
           may not work for inpatient care in licensed general acute care  
           hospitals.  Medical assistants can perform basic administrative,  
           clerical and technical supportive services when conditions  
           regarding supervision, training, specific authorization and records  
           are met. 





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            Training.   A medical assistant must receive training either  
           directly from a physician, surgeon, podiatrist, registered nurse,  
           licensed vocational nurse, physician assistant or a qualified  
           medical assistant.  Alternatively, a medical assistant may receive  
           training from a secondary, postsecondary or adult education program  
           in a public school authorized by the Department of Education, in a  
           community college program, or a postsecondary institution  
           accredited by an accreditation agency recognized by the United  
           States Department of Education or approved by the Bureau for  
           Private Postsecondary Education.
            
           Certification.  Medical assistants are regulated by the Medical  
           Board of California and may be certified.  There are two medical  
           assistant certifying agencies that are recognized by the National  
           Commission for Certifying Agencies.  These include: 1) the American  
           Association of Medical Assistants, who provide Certified Medical  
           Assistant certification and 2) the American Medical Technologists  
           who provide Registered Medical Assistant certification.   

           Supervision.   Medical assistants can be supervised by physicians,  
           surgeons, podiatrists or optometrists.  Additionally, if a medical  
           assistant is working in a community or free clinic, they may work  
           under the direct supervision of a physician assistant, nurse  
           practitioner or nurse midwife when the supervising physician or  
           surgeon is not on site, only if the physician or surgeon has  
           created a written protocol for the activities of the medical  
           assistant.  

            Authorization.   Medical assistants must receive specific  
           authorization before providing any technical services.  This  
           authorization may be in the form of a specific written order or  
           standing order prepared by the supervising physician, surgeon or  
           podiatrist.  The order must include an authorization for the  
           procedure to be performed and it must be noted in the patient's  
           medical record.

            Records.   Medical assistants are required to document all technical  
           supportive services in the patient's record.  In addition, when  
           practicing in a community or free clinic under the supervision of a  
           physician assistant, nurse practitioner or nurse midwife, the  
           delegation of supervision from the physician, surgeon or podiatrist  
           to the physician assistant, nurse practitioner or nurse midwife,  
           must be documented in a written standard protocol. 

            Community and Free Clinics.   In response to California's growing  





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           population and ensuing need to provide health care services, SB 111  
           was passed in 2001.  SB 111 permitted medical assistants to perform  
           technical supportive services in community and free clinics under  
           the direct supervision of a physician assistant, nurse practitioner  
           or nurse midwife.  

           There are four types of licensed community clinics in California:

               1)       Federally Qualified Health Center sites (FQHC)
               2)       Federally Qualified Health Center look-alike sites
               3)       Free clinic sites
               4)       Other independent, non-profit clinic sites

           A key distinction among these different designations is the type of  
           public funding support
           each clinic receives.  FQHC sites and FQHC look-alike sites both  
           meet eligibility requirements for two critical sources of funding  
           support: 1) enhanced Medi-Cal reimbursement rates and, 2) a federal  
           operating grant made available by Public Health Service Act (PHSA)  
           � 330.  Only FQHC clinics receive PHSA � 330 operating grants,  
           which are nationally competitive.  Conversely, FQHC look-alike  
           clinics have a non-competitive grant process.  

           Free clinics are statutorily required to not directly charge  
           patients for receipt of treatment.  Further, free clinics are not  
           supported by enhanced Medi-Cal reimbursements or a PHSA � 330  
           operating grant and are supported largely by private donations.   
           (HSC Division 2, Chapter 1, Article 1 � 1204;  
           http://www.chcf.org/topics/almanac/inde.cfm?itemId=133890)

           Since the passage of SB 111, neither the Physician Assistant  
           Committee nor the Board of Registered Nursing of the Department of  
           Consumer Affairs have received any patient safety complaints or  
           enacted any disciplinary action related to physician assistants,  
           nurse practitioners or nurse midwifes supervising medical  
           assistants in community and free clinics. 

           Though this bill does not propose an expansion of duties for  
           medical assistants, in the wake of the Patient Protection and  
           Affordable Care Act, the growing demand for health care services  
           and utilization of health information technology (HIT) to track  
           medical data, it is important to note the discomfort that other  
           allied health professionals have and may experience with  
           supervising medical assistants or embracing them and their expanded  
           role (utilization of HIT mechanisms such as inputting data in  
           electronic health records) as part of a medical team.  A study  





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           published in 2010 examined the expanded role of medical assistants  
           as they worked in community and free clinics.  According to the  
           study, respondents were asked about the challenges the clinics  
           faced in creating innovative or expanded roles for medical  
           assistants.  Clinic managers and medical directors cited the lack  
           of resources available to provide the extra training needed for  
           medical assistants to learn new roles as the most significant  
           challenge.   Another challenge was the acceptance of the role of  
           the medical assistants by the rest of the primary care team.   
           Concurrently, there existed consensus that these types of  
           challenges were generally overcome with time.  Staff reported  
           enthusiasm when they observed how the medical assistants' functions  
           made a difference in patient flow and the overall quality of  
           patient care.  Thus, despite initial trepidation, health  
           professionals who supervised medical assistants came to value the  
           role of the medical assistant as they worked within community and  
           free clinic settings.  
           (http://futurehealth.ucsf.edu/Public/PublicationsandResources/Conten 
           t.aspx?topic=Medical_Assistants_in_Community_Clinics:__Perspectives_ 
           on_Innovation_in_Role_Development)

        1. Arguments in Support.  According to the  Sponsor  , physician  
           assistants have been delegated the task of supervising medical  
           assistants when the physician is not physically present in  
           specified licensed community clinics for over a decade.  As such,  
           CAPA proposes to eliminate legal restrictions and barriers to  
           efficient coordinated care by allowing physicians to delegate the  
           task of medical assistant supervision to a physician assistant  
           across all outpatient medical settings.  This change is necessary  
           if California hopes to accommodate the dramatic increase in  
           patients expected to result from the Patient Protection and  
           Affordable Care Act.  

           The  California Association for Nurse Practitioners  supports the  
           bill.  They indicate SB 352 will expand the current practice that  
           occurs in community clinics of allowing nurse practitioners and  
           physician assistants to supervise medical assistants to all  
           settings.  This model has been in place for over ten years with no  
           complications.  Allowing nurse practitioners to supervise medical  
           assistants in this way has enabled them to focus their time and  
           services on patient care, delegating some very basic functions to a  
           medical assistant.  Expanding this practice to all settings will  
           allow nurse practitioners to increase the number of patients they  
           will be able to see, providing much needed increased access to  
           health care.  SB 352 makes no changes to the scope of practice of  
           either a medical assistant or a nurse practitioner but instead  





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           removes the limitations in current law that do not permit this  
           supervision model in a non-clinic setting. 

           The  California Optometric Association  supports the bill because  
           they believe it will expand access and allow more patients to  
           receive care.  They state, "?deploying these professionals in a  
           team-based delivery model where they work collaboratively with  
           physician assistants, nurse practitioners or midwives will allow  
           California to meet the demands placed on its health care systems  
           created by a rapidly aging physician population and expansion of  
           health insurance coverage."

           The  United Nurses Associations of California/Union of Health Care  
           Professionals  supports the bill.  They indicate that with the  
           implementation of the Patient Protection and Affordable Care Act,  
           change is necessary in California in order to accommodate the  
           dramatic increase in patients expected to result from health care  
           reform. 

           The  California Academy of Family Physicians  indicates with the  
           large influx of newly insured individuals in California nearing, it  
           is necessary to continue to find more efficient ways of ensuring  
           adequacy in the delivery of primary care.  The Academy applauds  
           efforts that streamline delivery of quality care while preserving  
           the team based approach that is best for patients. 

         4.  Related Legislation.   SB 1852  (Alpert, 2000) would have allowed  
         medical assistants to 
           perform specified tasks and services which they were only permitted  
           to perform upon the specific authorization and under the direct  
           supervision of a physician or podiatrist upon the specific  
           authorization of a physician's assistant, a nurse practitioner or a  
           nurse-midwife in a licensed clinic, as specified, that is enrolled  
           as a Medi-Cal provider in the Family Planning, Access, Care, and  
           Treatment Waiver Program. ( Note  : This bill died in Assembly Health  
           Committee after opposition from the California Nurses Association  
           and the California Association for Medical Laboratory Technology.)

            SB 252  (Alpert, Chapter 234, Statutes of 2003) specified medical  
           assistants are not authorized to perform a clinical laboratory test  
           or examination and does not authorize a nurse practitioner,  
           nurse-midwife or physician assistant to be a laboratory director of  
           a clinical laboratory. (  Note : This bill originally included a  
           provision for medical assistants to provide technical supportive  
           services under the supervision of a physician assistant, nurse  
           practitioner or nurse midwife, but those provisions were removed  





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           from the bill in response to opposition.)

            SB 111  (Alpert, Chapter 358, Statues of 2001) amended the Medical  
           Practice Act to authorize a medical assistant to perform specified  
           services in community and free clinics under the supervision of a  
           physician assistant, nurse practitioner or nurse-midwife. The bill  
                                                                             authorized a physician and surgeon in these specified clinics to  
           provide written instructions for medical assistants, regarding the  
           performance of tasks or duties, while under the supervision of a  
           physician assistant, nurse practitioner or nurse midwife when the  
           supervising physician and surgeon was not on site.

        5.   Suggested Technical Amendments.   

           The Board of Registered Nursing requires that all nurse midwives be  
           certified.  As such, the following are recommended technical and  
           conforming changes:

           Page 2, line 8, before "nurse-midwife" insert:  certified
            Page 2, line 11, before "nurse-midwife" insert:  certified
            Page 2, line 16, before "nurse-midwife" insert:  certified   
           Page 2, line 20, before "nurse-midwife" insert:  certified  
           Page 2, line 24, before "nurse-midwife" insert:  certified  
           Page 2, line 36, before "nurse-midwife" insert:  certified  
           Page 3, line 8, before "nurse-midwife" insert:  certified  
           Page 3, line 13, before "nurse-midwife" insert:  certified  
           Page 3, line 24, before "nurse-midwife" insert:  certified  
           Page 3, line 31, before "nurse-midwife" insert:  certified  
           Page 4, line 5, before "nurse-midwife" insert:  certified  
           Page 4, line 17, before "nurse-midwife" insert:  certified  
        

        SUPPORT AND OPPOSITION:
        
         Support:  

        California Academy of Physician Assistants (Sponsor)
        California Association for Nurse Practitioners
        California Optometric Association
        United Nurses Associations of California/Union of Health Care  
        Professionals
        California Academy of Family Physicians

         Opposition:  

        California Nurses Association (As of April 3, 2013.)





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        Consultant: Le Ondra Clark, Ph.D.