BILL ANALYSIS                                                                                                                                                                                                    Ó







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        |Hearing Date:June 23, 2014         |Bill No:AB                         |
        |                                   |1841                               |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                              Senator Ted W. Lieu, Chair
                                           

                         Bill No:        AB 1841Author:Mullin
                         As Amended:  June 2, 2014Fiscal:  No

        
        SUBJECT:  Medical assistants.
        
        SUMMARY:  Authorizes a medical assistant to hand out properly labeled  
        and prepackaged prescription drugs to patients as part of their  
        existing authorization to provide "technical supportive services."

        Existing law:
        
       1)Establishes the Medical Practice Act (Act) which licenses and  
          regulates physicians and surgeons as well as regulating medical  
          assistants (MAs) by the Medical Board of California (MBC) within the  
          Department of Consumer Affairs (DCA).  (Business and Professions  
          Code (BPC) § 2000 et seq.)

       2)Defines a MA as a person who may be unlicensed, who performs basic  
          administrative, clerical, and technical supportive services, as  
          specified, for a licensed physician and surgeon or a licensed  
          podiatrist, a physician or podiatrist group, a medical or podiatry  
          corporation, a physician assistant, a nurse practitioner, a  
          certified nurse-midwife or for a health care service plan.  (BPC §  
          2069 (b) (1))

       3)Requires a MA to be at least 18 years of age and have at least the  
          minimum amount of hours of appropriate training pursuant to  
          standards established MBC, and further requires a MA to have a  
          certificate by the training institution or instructor indicating  
          satisfactory completion of the required training, and for each  
          employer to retain a copy of this certificate.  
       (BPC § 2069 (b) (1))






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       4)Authorizes a MA to administer medication only by intradermal,  
          subcutaneous, or intramuscular injections and perform skin tests and  
          additional technical supportive services upon the specific  
          authorization and supervision of a licensed physician and surgeon or  
          podiatrist.  A MA may also perform all these tasks and services upon  
          the specific authorization of a physician assistant, nurse  
          practitioner, or certified nurse-midwife. (BPC § 2069 (a) (1))

       5)Permits a supervising physician and surgeon to provide written  
          instructions to be followed by a MA in performing tasks or  
          supportive services.  The written instructions may delegate the  
          supervision of the MA in performing the tasks or services to a nurse  
          practitioner, certified nurse-midwife, or physician assistant within  
          the standardized procedures or protocols.  
       (BPC § 2069 (a) (2)

       6)Defines "technical supportive services" as simple routine medical  
          tasks and procedures that may be safely performed by a MA who has  
          limited training and who functions under the supervision of a  
          licensed physician and surgeon, podiatrist, physician assistant,  
          nurse practitioner or a certified nurse-midwife, as specified.  (BPC  
          § 2069 (b) (4))

       7)Permits a MA to perform venipuncture or skin puncture for the  
          purposes of withdrawing blood upon specific authorization and  
          supervision of a licensed physician and surgeon, podiatrist,  
          physician assistant, nurse practitioner or nurse-midwife if the MA  
          has met minimum training requirements established by MBC.  (BPC §  
          2070)

       8)Establishes the Pharmacy Law which provides for the licensure and  
          regulation of pharmacies, pharmacists and wholesalers of dangerous  
          drugs or devices by the Board of Pharmacy (BOP) within the DCA.

       9)Governs the prescribing, dispensing, or furnishing of dangerous drugs  
          by prescribers, defined to include a physician and surgeon,  
          podiatrist and certified nurse-midwife, as specified.  
       (BPC § 4170).

       10)Authorizes a pharmacy to employ a non-licensed person to type a  
          prescription label or otherwise enter prescription information into  
          a computer record system, but the responsibility for the accuracy of  
          the prescription information and the prescription as dispensed lies  
          with the registered pharmacist who initials the prescription or  
          prescription record.  At the direction of the registered pharmacist,  
          a non-licensed person may also request and receive refill  





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          authorization.  (California Code of Regulations, Title 16, Division  
          17, Article 11, Section 1793.3 (a))

       11)Authorizes a licensed nonprofit community clinic or free clinic, a  
          county owned or operated primary care clinic, a clinic operated by a  
          federally recognized Indian tribe or tribal organization, a clinic  
          operated by primary care community or free clinic, a student health  
          center, a nonprofit multispecialty clinic, as specified, to be  
          licensed by the BOP to purchase drugs at wholesale for  
          administration or dispensing, under the direction of a physician and  
          surgeon, to patients registered for care at the clinic, as  
          specified.  (BPC § 4180)

       12)Authorizes a surgical clinic, as specified, to be licensed by the  
          BOP to purchase drugs to purchase drugs at wholesale for  
          administration or dispensing, under the direction of a physician and  
          surgeon, to patients registered for care at the clinic, as  
          specified.  (BPC § 4190)

        This bill:

       1)Expands the definition of "technical supportive services" carried out  
          by a MA in a clinic described in Items 11 and 12 above, other than a  
          facility operated by the state, to include the following:

           a)   Handing a patient a properly labeled and prepackaged  
             prescription drug, excluding a controlled substance, ordered by a  
             licensed physician and surgeon, podiatrist, physician assistant,  
             nurse practitioner or certified nurse-midwife, as specified.

           b)   Requires that prior to a MA handing the medication to a  
             patient, a licensed physician and surgeon, podiatrist, physician  
             assistant, nurse practitioner, or certified nurse-midwife shall  
             verify that the medication and dosage for that specific patient  
             is correct, that the patient's name is affixed to the package and  
             shall provide the appropriate patient consultation regarding the  
             use of the drug.


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

        
        COMMENTS:
        
       1.Purpose.  This bill is sponsored by  Planned Parenthood Affiliates of  





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          California  to increase patient access to care by specifying medical  
          assistants' ability to include handing to a patient medication that  
          has already been packaged and labeled by the dispensing provider.   
          This authority is limited to facilities that are licensed by the  
          State Board of Pharmacy, excluding those operated by the state.  The  
          bill also excludes controlled substances, and requires the  
          medication be properly labeled by the ordering provider who has  
          appropriately counseled the patient on the medication.

       2.Background.  According to the Author, "Medical Assistants are  
          currently allowed to provide a range of supportive and medical  
          services like administer medication (including narcotics) orally,  
          topically, or through injection; perform skin tests; apply bandages,  
          remove casts and stitches, perform simple lab/ screening tests; and  
          perform technical supportive services upon training and  
          authorization of a licensed physician and surgeon.  MAs cannot  
          dispense and are not allowed to hand over medication of any kind to  
          patients."

       The Author further states that current practice in community health  
          centers relies on the use of MAs to support physicians and  
          clinicians (nurse practitioners, certified nurse-midwives, and  
          physician assistants).  Since MAs are not permitted to hand  
          medication to a patient, that administrative task must be done by  
          the physician or clinician, taking their time away from seeing more  
          patients and focusing on the care they have been trained to provide.  
           The Author states,  "After examining a patient, diagnosing them,  
          discussing options and providing education on any recommended  
          medication, the clinician must go back to the locked pharmacy closet  
          to select, package and label the appropriate medication and then  
          returns to the patient exam room to physically hand the patient the  
          medication.  This bill would allow a MA to take the medication,  
          after it has been pulled, packaged, and labeled, and physically hand  
          it to the patient."  

       The Author indicates that although this takes only several minutes for  
          each patient, it adds up significantly over time ultimately limiting  
          patient access.  "This minor increase in MAs ability to hand over  
          medication will free up other providers to see additional patients.   
          More fully utilizing the abilities of [MAs] will increase efficiency  
          in health facilities like community health centers and by seeing  
          more patients, health facilities will be able to reduce waiting  
          times and expand patient access to care.

       With millions of Californians newly enrolled in health care coverage  
          under the ACA [Affordable Care Act] and millions more eligible for  





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          coverage, expanding access to care is essential to ensuring that  
          these individuals have meaningful coverage.  California needs to  
          utilize all health care professionals and those that assist them to  
          the fullest extent of their abilities and potential to increase  
          access, improving our health care delivery system to better serve  
          the newly enrolled population and providing coverage for the  
          remaining uninsured."

       3.Medical Assistants.  MAs are unlicensed, but certificated,  
          individuals.  MAs must have a high school diploma or GED equivalent  
          and take a certificate course at an approved school.  Prior to  
          performing technical supportive services, a medical assistant must  
          receive training, as necessary, and it is the responsibility of the  
          supervising physician, podiatrist or instructor to assure the MA's  
          competence in performing that service at the appropriate standard of  
          care. 

       The MBC regulations establish the requirements which allow certifying  
          organizations to certify medical assistants.  According to the MBC,  
          the training may be administered under a licensed physician,  
          podiatrist, registered nurse, licensed vocational nurse, physician  
          assistant or qualified medical assistant, or in a secondary,  
          post-secondary, or adult education program in a public school  
          authorized by the Department of Education, in a community college  
          program, or a post-secondary institution accredited or approved by  
          the Bureau for Private Postsecondary Education.  To administer  
          medications by intramuscular, subcutaneous and intradermal  
          injections, perform skin tests, perform venipuncture or skin  
          puncture to withdraw blood, a MA must complete specified training  
          prescribed by the MBC regulations.

       MA's may perform specific functions as part of "technical supportive"  
          services in addition to administrative functions, including:

           a)   Administer medications 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;

           d)   Apply and remove bandages and dressings;

           e)   Remove sutures or staples from superficial incisions or  





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             lacerations; 

           f)   Collect by non-invasive techniques and preserve specimens for  
             testing, including urine, sputum, semen and stool;

           g)   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, and prepare a patient for gait  
             analysis testing;

           h)   As authorized by the physician or podiatrist, provide patient  
             information and instructions;

           i)   Collect and record patient data including height, weight,  
             temperature, pulse, respiration rate and blood pressure, and  
             basic information about the presenting and previous conditions;

           j)   Perform simple laboratory and screening tests customarily  
             performed in a medical office.

          This bill clarifies that MAs may hand out properly labeled and  
          prepackaged prescription drugs to patients as part of "technical  
          supportive services" in specified types of clinics.  Based upon  
          currently authorized abilities, this appears to be well within a  
          MA's scope of practice.

       4.Related Legislation.   SB 352  (Pavley, Chapter 352, Statutes of 2013)  
          authorized MAs to perform technical supportive services in any  
          medical setting upon specific authorization of a physician  
          assistant, nurse practitioner, or certified nurse-midwife without a  
          physician on the premises.  This bill removed the requirement that a  
          MA be supervised by a physician assistant, nurse practitioner, or  
          certified nurse-midwife only in specified community clinics.

        SB 1852  (Alpert, 2000) would have allowed MAs 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. (  Status  : SB 1852 died in Assembly Health Committee.)

        SB 252  (Alpert, Chapter 234, Statutes of 2003) specified that MAs are  
          not authorized to perform a clinical laboratory test or examination  





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          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  
          MAs to provide technical supportive services under the supervision  
          of a physician assistant, nurse practitioner or nurse midwife, but  
          those provisions were removed from the bill in response to  
          opposition.)

        SB 111  (Alpert, Chapter 358, Statues of 2001) authorized a medical  
          assistant to perform specified services in community and free  
          clinics under the supervision of a physician assistant, nurse  
          practitioner or nurse-midwife.  This bill authorized a physician and  
          surgeon in these specified clinics to provide written instructions  
          for MAs, 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.Arguments in Support.  In sponsoring the bill,  Planned Parenthood  
          Affiliates of California  writes that this minor expansion of MA  
          duties will increase access to care in health care settings,  
          including Planned Parenthood, by reducing waiting times caused, in  
          part, by clinicians who must package the medications and then  
          themselves hand it to the patient.  "Authorizing MAs to hand over  
          pre-packaged/pre-labeled medication is consistent with (if not less  
          complicated than) the level and complexity and range of medical and  
          technical support services they are already authorized to perform,  
          including administering narcotics and giving injections."  Finally,  
          Planned Parenthood argues that authorizing MAs to hand over  
          medication frees up the clinician from this administrative duty and  
          allows them to see more patients and spend more time with each  
          patient answering questions.

        Medical Board of California  (MBC) believes the bill will help further  
          the Board's mission of increasing access to care, and writes in  
          support that allowing MAs to hand over properly labeled,  
          pre-packaged medication is a minor increase in the MAs duties, and  
          one that does not compromise consumer protection, since the  
          physician would have to label the medication for the patient,  
          package the medication, and provide the appropriate consultation.

        
       California Association for Nurse Practitioners  (CANP) states that with  
          millions of Californians entering the health care system due to ACA  
          implementation, healthcare providers' ability to deliver care as  
          efficiently as possible is essential to meet the often pent-up  





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          demand for services of these newly eligible individuals.  The  
          already strained delivery system is experiencing increased pressure,  
          particularly in underserved areas, where NPs play a critical role in  
          providing care.  AB 1841 will assist with this problem by allowing  
          medical assistants to furnish patients with pre-labeled,  
          pre-packaged medication, only after the medication has been selected  
          and packaged by a physician or advanced practice clinician, such as  
          an NP. This will allow primary care practitioners, including NPs, to  
          dedicate more time to providing patient care.

       The  Association of California Healthcare Districts  (ACHD) states that  
          millions of Californians rely on public health facilities and  
          programs for vital health care services.  Additionally, many of our  
          Community Based Healthcare Districts specialize in promoting  
          community health care, focusing on prevention, food access, and  
          disease management.  In many parts of California, Healthcare  
          Districts act as the sole provider of health care services in their  
          communities.  ACHD states:  "As more Californians are now eligible  
          for care, it is important that health care staff is utilized  
          efficiently to accommodate patients as they seek care and medical  
          services.  AB 1841 creates greater staffing efficiency by utilizing  
          medical assistants to assist with handing patients a pre-packaged  
          and pre-authorized prescription.  By allowing medical assistants to  
          assist in this responsibility, doctors, nurses and other medical  
          staff can focus on other patient needs"

       6.Oppose Unless Amended.   California Society of Health-System  
          Pharmacists  (CSHP) opposes this bill unless it is amended, stating,  
          "we support the intent of the bill to reduce waiting times, expand  
          access, and improve patient care and satisfaction in community  
          clinics, and we appreciate the recent amendments to specify patient  
          education, we are still concerned by the language, especially as it  
          lacks recognition of pharmacists as providers in community clinics."  
           CSHP indicates that with the passage of  SB 493  (Hernandez, Chapter  
          469, Statutes of 2013) pharmacists are recognized as providers and  
          may offer certain services that are often provided telephonically  
          and collaboratively with physicians in clinic settings.  CSHP has  
          indicated a willingness to work with the Author in his efforts to  
          expand access and improve patient care.

       7.Arguments in Opposition.   California Right to Life Committee, Inc.   
          argues that allowing unlicensed healthcare professionals to hand a  
          patient "a properly labeled and prepackaged prescription drug,"  
          creates a completely unnecessary barrier to Doctor/ patient  
          communication.






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       "Even the most educated Medical Assistants with the highest  
          certifications do not receive pharmacy training, neither are Medical  
          Assistants allowed to diagnose or to perform any task that requires  
          assessment - including commenting on the safety and/or efficacy of a  
          prescribed drug.  This bill makes it much harder for a patient to  
          obtain a consultation with a professional qualified to address their  
          questions and assess their health needs."

       Committee staff notes that the bill explicitly requires the licensed  
          physician and surgeon, podiatrist, physician assistant, nurse  
          practitioner, or certified nurse-midwife to provide the appropriate  
          patient consultation regarding the use of the drug prior to the MA  
          handing it to the patient.


        SUPPORT AND OPPOSITION:
        
         Support: 

        Planned Parenthood Affiliates of California (Sponsor)
        Association of California Healthcare Districts
        California Association for Nurse Practitioners
        Medical Board of California

         Oppose Unless Amended:  

        California Society of Health-System Pharmacists

         Opposition:  

        California Right to Life Committee, Inc.



        Consultant:G. V. Ayers