BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON
          BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
                              Senator Jerry Hill, Chair
                                2015 - 2016  Regular 

          Bill No:            SB 323          Hearing Date:    April 20,  
          2015
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          |Author:   |Hernandez                                             |
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          |Version:  |March 26, 2015                                        |
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          |Urgency:  |No                     |Fiscal:    |Yes              |
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          |Consultant|Sarah Huchel                                          |
          |:         |                                                      |
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                           Subject:  Nurse practitioners.

          SUMMARY:  Authorizes a nurse practitioner who holds a national  
          certification to practice without physician supervision in  
          specified settings.

          Existing law:
          
          1)Establishes the Board of Registered Nursing (BRN) to  
            administer and enforce the Nursing Practice Act (Act).   
            (Business and Professions Code (BPC) 
            § 2701) 

          2)Declares that the intent of the Legislature in amending  
            the Act is to recognize the existence of overlapping  
            functions between physicians and registered nurses and to  
            permit additional sharing of functions within organized  
            health care systems that provide for collaboration  
            between physicians and registered nurses.  (BPC § 2725  
            (a))

          3)Defines the practice of nursing as those functions,  
            including basic health care, that help people cope with  
            difficulties in daily living that are associated with  
            their actual or potential health or illness problems or  
            the treatment thereof, and that requires a substantial  
            amount of scientific knowledge or technical skill as  
            specified.  (BPC § 2725 (b))








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          4)Defines "standardized procedures" as either policies and  
            protocols developed by a health facility through  
            collaboration among administration and health  
            professionals or policies and protocols developed through  
            collaboration among administrators and health  
            professionals by an organized health care system which is  
            not a health care facility. (BPC § 2725 (c))

          5)States that the Legislature finds that the public  
            interest would be better served by the determination of  
            the legitimate use of the title "nurse practitioner" (NP)  
            by registered nurses.  (BPC § 2834)

          6)Requires licensure as a NP.  (BPC § 2835)

          7)Requires that for initial qualification or certification  
            as an NP, an individual must meet specified requirements  
            including having a valid and active Registered Nurse (RN)  
            license, possess a master's degree in nursing or graduate  
            degree in nursing and satisfactorily complete a NP  
            program approved by the BRN.  (BPC § 2835.5) 
          8)Provides that standardized procedures may be implemented  
            to authorize an NP to do the following:  order durable  
            medical equipment as specified; certify disability after  
            performance of a physical examination by the NP and  
            collaboration with a physician and surgeon; and approve,  
            sign, modify, or add to a plan of treatment or a plan of  
            care for individuals receiving home health services or  
            personal care services after consultation with the  
            treating physician and surgeon.  (BPC § 2835.7)

          9)Provides that the BRN shall establish categories of NPs  
            and standards for nurses to hold themselves out as NPs in  
            each category and provides what the BRN shall consider in  
            setting such standards.  (BPC § 2836)

          10)Provides that an NP may furnish or order drugs or  
            devices if specified conditions are met and are done in  
            accordance with standardized procedures or protocols and  
            the drugs or devices ordered are consistent with the NPs  
            educational preparation or for which clinical competency  
            has been established and maintained.  (BPC § 2836.1 (a))

          11)Provides that the furnishing or ordering of drugs or  








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            devices by a NP occurs under physician and surgeon  
            supervision but that supervision shall not be construed  
            to require the physical presence of the physician, but  
            does include collaboration on the development of the  
            standardized procedure, approval of the standardized  
            procedure, and availability by telephonic contact at the  
            time of patient examination by the NP.  (BPC § 2836.1  
            (d))

          12)Requires one physician to supervise every four  
            prescribing NPs. 
          (BPC § 2836.1 (e))

          13)Provides that drugs or devices furnished or ordered by  
            an NP may include Schedule II through Schedule V  
            controlled substances and shall be further limited to  
            those drugs agreed upon by the NP and the physician and  
            surgeon and specified in the standardized procedures.   
            (BPC § 2836.1 (f))

          14)Requires that a NP complete a course in pharmacology  
            covering the drugs or devices to be furnished or ordered  
            and that a physician and surgeon may determine the extent  
            of supervision necessary in the furnishing or ordering of  
            drugs and devices by the NP.  (BPC § 2836.1 (g))

          15)Requires that all NPs who are authorized to furnish or  
            issue drug orders to controlled substances shall register  
            with the United States Drug Enforcement Administration  
            and that the furnishing or drugs or devices by NPs is  
            conditional on issuance by the BRN of a number to the NP  
            who has successfully completed the requirements as  
            specified and that the number provided shall be included  
            on all transmittals or orders by the NP.  
          (BPC § 2836.2 and 2836.3)



          

          This bill:

         1)Makes Legislative findings and declarations as to the  
            importance of NPs providing safe and accessible primary care.








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         2)Authorizes an NP who holds a national certification from a  
            national certifying body recognized by the BRN ("certified  
            NP") to practice without the supervision of a physician if the  
            certified NP practices in one of the following settings:

             a)   A clinic.

             b)   Specified health facilities, including a general acute  
               care hospital, acute psychiatric hospital, skilled nursing  
               facility, intermediate care facility, correctional  
               treatment center, and hospice facility, as specified.

             c)   A county medical facility.

             d)   An accountable care organization.

             e)   A group practice, including a professional medical  
               corporation, another form of corporation controlled by  
               physicians, a medical partnership, a medical foundation  
               exempt from licensure, or another lawfully organized group  
               of physicians that delivers, furnishes, or otherwise  
               arranges for or provides health care services.

             f)   A medical group, independent practice association, or  
               any similar association.

         3)Provides that in addition to any other practice authorized in  
            statute or regulation, a  "certified NP" practicing in  
            specified settings may do all of the following without  
            physician supervision, unless collaboration is specified:

             a)   Order durable medical equipment. 

             b)   Certify disability for purposes of unemployment after  
               performance of a physical examination by the certified NP  
               and collaboration, if necessary, with a physician.

             c)   Approve, sign, modify, or add to a plan of treatment or  
               plan of care for individuals receiving home health services  
               or personal care services after consultation, if necessary,  
               with the treating physician and surgeon. 

             d)   Assess patients, synthesize and analyze data, and apply  








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               principles of health care.

             e)   Manage the physical and psychosocial health status of  
               patients.

             f)   Analyze multiple sources of data, identify a  
               differential diagnosis, and select, implement, and evaluate  
               appropriate treatment.

             g)   Establish a diagnosis by client history, physical  
               examination, and other criteria, consistent with this  
               section, for a plan of care.

             h)   Order, furnish, prescribe, or procure drugs or devices.

             i)   Delegate tasks to a medical assistant pursuant to  
               standardized procedures and protocols developed by the NP  
               and medical assistant that are within the medical  
               assistant's scope of practice.

             j)   Order hospice care, as appropriate.

             aa)       Order and interpret diagnostic procedures.

             bb)       Perform additional acts that require education and  
               training and that are recognized by the nursing profession  
               as appropriate to be performed by an NP.

         4)Requires a "certified NP" to refer a patient to a physician or  
            other licensed health care provider if a situation or  
            condition of the patient is beyond the scope of the education  
            and training of the NP.

         5)Requires a "certified NP" to maintain professional liability  
            insurance appropriate for the practice setting.

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

          
          COMMENTS:
          








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          1.Purpose.  This bill is sponsored by the  Author  .  According to  
            the Author's office, this bill permits an NP to practice  
            without physician supervision if the NP is certified by  a  
            national certifying body, maintains professional liability  
            insurance that is appropriate for his or her practice setting,  
            and is practicing in one of the following settings:

             a)   A clinic, health facility, or county medical facility;

             b)   An accountable care organization, as specified; or,

             c)   A group practice, as specified.

            This bill also specifies the scope of practice for NPs and  
            specifically permits an independent NP in the settings listed  
            above to perform services that are widely agreed to be the  
            extent of services that NP perform today.  Finally, this bill  
            clarifies that an NP must refer a patient to a physician or  
            other licensed health care provider if a situation or  
            condition of the patient is beyond the NP's education or  
            training.

          2.NP Training and Educational Requirements.  An NP is a  
            registered nurse who possesses additional preparation and  
            skills in physical diagnosis, psycho-social assessment, and  
            management of health-illness needs in primary health care, and  
            who has completed a NP program that conforms to BRN standards.  
             NP programs are required to include 12 semester units or 18  
            quarter units of clinical practice 
          (3 hours of clinical practice each week equals one unit).  NPs  
            are required to have a Master's degree; and many further  
            pursue a doctorate in nursing.  As of September 2013, the BRN  
            reported 18,541 active, licensed NPs.  NPs may specialize in  
            disciplines such as acute pediatric care, adult gerontological  
            care, family care, women's health, and mental health nursing.   
              

          3.Standardized Procedures. The NP scope of practice is currently  
            determined by standardized procedures, which are the legal  
            mechanism for NPs to perform functions which would otherwise  
            be considered the practice of medicine.  The Medical Practice  
            Act authorizes physicians to diagnose mental and physical  
            conditions, to use drugs in or upon human beings, to sever or  
            penetrate tissue, and to use other methods in the treatment of  








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            diseases, injuries, deformities, or other physical or mental  
            conditions.  As a general rule, the performance of any of  
            these functions by a NP requires a standardized procedure.  

            Standardized procedures are defined as policies and protocols  
            developed by a health facility or organized health care  
            system, with input from administrators and health  
            professionals, which establish parameters for medical care.   
            An NP may perform standardized procedure functions only under  
            the conditions specified in a health care system's  
            standardized procedures, and must provide the system with  
            satisfactory evidence that he or she meets its experience,  
            training, and education requirements.

          4.Protocols.  Protocols are a part of standardized procedures  
            and are designed to describe the steps of medical care for  
            given patient situations.  They are used for management of  
            acute or episodic conditions, trauma, chronic conditions,  
            infectious disease contacts, routine gynecological problems,  
            contraception, health promotion exams, and ordering of  
            medications.  Protocols are developed in consultation with a  
            supervising physician.   

          5.Prescribing Authority.  NPs may furnish drugs by obtaining a  
            number from the United States Drug Enforcement Agency (DEA) to  
            prescribe Schedule II-V drugs pursuant to a protocol and  
            standardized procedures.  The DEA considers an NP to be a  
            "prescriber," but NPs who write prescriptions are considered a  
            "furnishing" NP under California law.  Furnishing is the  
            delegated authority to write prescriptions, and is done in  
            accordance with approved standardized procedures and  
            protocols.  Physician supervision is required and the  
            physician must be available, at least by telephonic means, at  
            the time the NP examines the patient.  Furnishing NPs are  
            required to be supervised by a physician, but non-furnishing  
            NPs are not.     

          6.Supervision Requirements.  A physician may supervise up to  
            four furnishing NPs.  The law does not specify the quality and  
            extent of supervision necessary, only that the physician be  
            available by phone when a NP examines a patient.  There is no  
            requirement that the physician work in the same facility with  
            the NP, meet regularly with the NP, review patient charts, or  
            be within a geographic proximity.   








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          7.NP as a Primary Care Provider.  The Institute of Medicine  
            (IOM), an independent nonprofit organization which is part of  
            the National Academy of Sciences, published a report in 2011,  
            in which it concluded that NPs deliver the same quality of  
            primary care as physicians.  IOM noted that although NPs are  
            most immediately sought for their medical skills in primary  
            care, they integrate practices from several disciplines,  
            including social work, nutrition, and physical therapy.

            The IOM report notes that some argue that NPs should not be  
            allowed to be independent primary care practitioners because  
            physicians are more qualified due to their extensive academic  
            and clinical training, and unique cognitive and technical  
            skills.  However, the IOM report noted that the contention  
            that NPs are less able than physicians to deliver care that is  
            safe, effective, and efficient is not supported by research.   
            Further, NPs are trained to refer out when conditions rise  
            beyond their competencies and have the ability to coordinate  
            care between providers.  

            NPs have been slowly granted practice autonomy in other states  
            over the last decade.  According to information provided by  
            the American Association of Nurse Practitioners, 21 states  
            allow NPs to evaluate patients, diagnose, order and interpret  
            diagnostic tests, and initiate and manage treatment under the  
            exclusive license authority of the state board of nursing.   
            Today, nurse practitioners (which make up slightly less than a  
            quarter of all primary care professionals), together with  
            physicians and physician assistants, provide most of the  
            primary care in the United States.  The demand for a larger  
            primary care workforce will grow as access to coverage,  
            service settings, and services increases under the federal  
            Affordable Care Act (ACA). 

          8.Primary Care Access and Medi-Cal.  The ACA was passed in March  
            2010 to provide quality, affordable healthcare for all  
            Americans and improve the quality and efficiency of that care.  
             California was an early adopter of the ACA and has been a  
            leader in enrolling eligible residents.  According to the  
            Kaiser Family Foundation, nearly 3.4 million previously  
            uninsured Californians recently gained coverage under the ACA.  
             Primary care providers will be responsible for health  
            promotion, disease prevention, early diagnosis, and the  








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            coordination of care with other providers for these new  
            entrants to the market.    

            Accessing these providers will be a challenge given the  
            current state of the nation's health care workforce  
            restrictions.  The Association of American Medical Colleges  
            estimates a nationwide shortage of 45,000 primary care  
            physicians by 2020.  According to a 2013 article in the  
            journal Health Affairs, this shortage is caused not only by an  
            increase in the number of people with health insurance, but  
            overall population growth, population aging, and an ongoing  
            decrease in the number of medical school graduates choosing to  
            practice primary care.  The article stated, "Increasing the  
            role of NPs as primary care providers can be an important  
            approach to increasing primary care capacity." 

            Permitting independent practice by NPs will allow greater  
            access to care for Medi-Cal and Medicare populations.   
            Medi-Cal is the state's Medicaid health insurance program,  
            funded by both the federal and state government for low-income  
            families and children, people with disabilities, pregnant  
            women, and seniors.  Medicare is the federal government health  
            insurance program for seniors and persons with disabilities.    
             
                
             The California HealthCare Foundation reports that presently,  
            adults with Medi-Cal are nearly twice as likely to report  
            difficulty getting a doctor appointment than other insured  
            adults in California.  In 2008, there were only 50 primary  
            care providers for every 100,000 Medi-Cal beneficiaries in  
            California, well below the federal guidelines of 60 to 80 per  
            100,000.  NPs are limited in their ability to be reimbursed  
            for care covered by Medi-Cal due to physician supervision  
            constraints.       

            According to the Centers for Medicare and Medicaid Services,  
            fewer American doctors are treating patients enrolled in the  
            Medicare health program, reflecting physician frustration with  
            its payment rates and rules.  The number of doctors who opted  
            out of Medicare last year nearly tripled from three years  
            earlier.  Other doctors are limiting the number of Medicare  
            patients they treat even if they don't formally opt out of the  
            system.









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            NPs in California may currently only treat Medicare patients  
            if their supervising physician is a Medicare provider.   
            According to an article in the medical journal Health Affairs,  
            Medicare, Medicaid, and private insurers typically reimburse  
            NPs at rates that are just 75-85% of what they pay physicians  
            for the same services.  NPs generally have less overhead than  
            physicians (lower educational debt loads and fewer equipment  
            costs because of the lower complexity of procedures  
            performed), and are therefore more likely to work for a lower  
            reimbursement.  

            A 2013 study published in the journal Health Affairs found  
            that between 1998 and 2010 the number of Medicare patients  
            receiving care from NPs increased fifteen times.  Those states  
            which allowed greater NP autonomy saw a 2.5 times greater  
            likelihood of patients' receiving their primary care from NPs  
            than did the most restrictive states.  The authors concluded  
            that "Relaxing state restrictions on NP practice should  
            increase the use of NPs as primary care providers, which in  
            turn would reduce the current national shortage of primary  
            care providers." 

          9.Accountability Provisions.  This bill will require independent  
            NPs to have professional liability insurance.  Presently,  
            supervising physicians are partially accountable for an NP's  
            practice and a physician's license is at stake for  
            unprofessional conduct by a supervised NP.  Independence will  
            require that the NP be wholly accountable for his or her  
            actions, and the required liability insurance would arguably  
            help protect consumers in the event of a malpractice action.    


          10.Arguments in Support.  Supporters of this bill include  
            patient and employer representatives, healthcare systems,  
            insurers, nursing organizations, pharmacists, naturopaths, and  
            academic institutions.  Supporters recognize the extensive  
            training and certification of NPs ensure patient safety and  
            believe passage of this bill will increase both healthcare  
            access and provider participation in Medi-Cal.

            The  California Association of Physician Groups (CAPG)  writes  
            that since the implementation of ACA, "?California has added 5  
            million newly insured patients to the healthcare system.   
            Recently, newly insured patients tried to find doctors once  








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            they had obtained coverage but found that many practitioners  
            had closed their practices to new patients ?. California has  
            an aging primary care physician and osteopathic workforce.   
            Other states have proven that NPs with full practice authority  
            function well in that role, and there is a wealth of national  
            studies that have analyzed the environments in which full  
            practice authority has been legislated and all have concluded  
            that it is a safe and effective means to increase access to  
                                                                                   quality care. While there is a wealth of studies that support  
            this concept, there is little or no evidence to refute it. 
            
            "Our members are engaged in the service of providing access to  
            health care. This bill increases the ability to provide access  
            in meaningful ways to cope with the expansion of the patient  
            base in California.  It modernizes licensure law to reflect  
            the current reality.  It allows Nurse Practitioners to  
            practice to the full extent of their education and training."

             California Health & Wellness  write, "The State's movement of  
            the rural market from fee-for-service to managed care in  
            November 2013 marked an important first step in proving rural  
            health care delivery for Medi-Cal beneficiaries.  We believe  
            that. . . 
            SB 323 is an important next step that will create new access  
            points in the health care delivery system - a particularly  
            crucial need in the Medi-Cal program." 

          11.Arguments in Opposition.  Opponents are physician  
            organizations and individuals who are concerned that NPs are  
            insufficiently qualified to practice without supervision and  
            limiting their independent practice to specific settings, as  
            defined in the bill, does not guarantee interdependent  
            practice teams. 

            The  California Chapter of the American College of Cardiology  
            (CA-ACC)  writes, "CA-AAC worries this bill would fracture  
            health care teams comprised of multiple health care providers  
            working together to provide coordinated care.  Nurse  
            practitioners are an important part of these health care  
            delivery teams working in conjunction with supervising  
            physicians.  Nurse practitioners however, do not have  
            sufficient education and training to examine and diagnose  
            completely independent of physicians and such a practice puts  
            patients at risk.








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            "Additionally, the bill introduces potential conflicts of  
            interest and undermines the corporate ban on the practice of  
            medicine because nurse practitioners are not covered by the  
            ban.  A hospital or clinic is incentivized to hire  
            non-physicians in order to direct those employees to maximize  
            profits."

            The  California Society of Plastic Surgeons  writes, "The  
            dangers around having unqualified health practitioners  
            performing cosmetic medical procedures are seen by our members  
            on a regular basis.  Many times a patient will come to us only  
            after they have had a cosmetic procedure performed by a  
            practitioner resulting in poor outcomes.  Patients are  
            embarrassed and grief stricken over the outcomes, realizing  
            they may not be reversible.  NPs do not have the training or  
            education to be performing cosmetic medical procedures such as  
            procedures utilizing lasers.  There are many complications  
            that can arise when using lasers and having a physician  
            supervise the NP is essential to ensuring patient safety."

          12.Prior Related Legislation.   SB 491  (Hernandez, 2013) would  
            have permitted an NP to practice independently after a period  
            of physician supervision if the NP has national certification  
            and liability insurance, and authorizes the NP to perform  
            various other specified tasks related to the practice of  
            nursing without protocols.  
          (  Status:   This bill was held in Assembly Appropriations  
            Committee.)  

          13.Policy Issue.  This bill replaces the present code section  
            authorizing an NP to order durable medical equipment, certify  
            disability, and approve, sign, modify, or add to a plan of  
            treatment or plan of care for individuals receiving home  
            health services or personal care services pursuant to  
            standardized procedures.  If this bill were to pass, an NP who  
            is not nationally certified and not practicing in the settings  
            specified in this bill may not be authorized to do the items  
            above pursuant to standardized procedures.

          14.Recommended Author's Amendment.  It is recommended that the  
            author clarify that NPs who are not authorized to practice  
            independently may continue to order durable medical equipment,  
            certify disability, and approve, sign, modify, or add to a  








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            plan of treatment or plan of care for individuals receiving  
            home health services or personal care services pursuant to  
            standardized procedures.  It is also recommended that  
            2835.7(b) be clarified to pertain only to those NPs who are  
            authorized to practice independently.  For code clarity,  
            Section Two of this bill should be renumbered and the original  
            language of 2835.7 be retained. 

            On page 3, line 9, strike "2835.7" and add "2837"

            On page 3, line 11, strike "2835.7" and add 2837"

            On page 4, line 2, after "practitioner," add "who meets the  
            qualifications of (a)"

            On page 4, line 3, after "following" add "without supervision  
            of a physician and surgeon"

            On page 5, above line 6, add "SEC.3.   Section 2837 of the  
            Business and Professions Code is amended to read: 

            2838.  Nothing in this article shall be construed to limit the  
            current scope of practice of a registered nurse authorized  
            pursuant to this chapter.

            SEC. 4.  No reimbursement is required by this act pursuant to  
            Section 6 of Article XIII                         B of the  
            California Constitution because the only costs that may be  
            incurred by a local agency or school district will be incurred  
            because this act creates a new crime or infraction, eliminates  
            a crime or infraction, or changes the penalty for a crime or  
            infraction, within the meaning of Section 17556 of the  
            Government Code, or changes the definition of a crime within  
            the meaning of Section 6 of Article XIII          B of the  
            California Constitution.

            On page 5, strike lines 6-14. 

          
          SUPPORT AND OPPOSITION:
          
           Support:  

          AARP








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          AltaMed Health Services Corporation
          Alzheimers Association
          American Nurses Association\California (ANA\C)
          Anthem Blue Cross
          Association of California Nurse Leaders
          Bay Area Council
          Blue Shield of California (BSC)
          California Association for Nurse Practitioners (CANP)
          California Association of Nurse Anesthetists (CANA)
          California Association of Physician Groups (CAPG)
          California Association of Public Hospitals and Health Systems  
          (CAPH)
          California Council of Community Mental Health Agencies
          California Family Health Council (CFHC)
          California Health & Wellness (CH&W)
          California Hospital Association (CHA)
          California Naturopathic Doctors Association (CNDA)
          California Pharmacists Association
          California Primary Care Association (CPCA)
          California Senior Legislature
          California Society of Health-System Pharmacists
          Congress of California Seniors (CCS)
          Johns Hopkins University Division of Occupational and  
          Environment Medicine
          Maxim Healthcare Services, Inc.
          MemorialCare Health System
          Pacific Clinics
          Private Essential Access Community Hospitals (PEACH)
          Providence Health & Services
          Sharp HealthCare
          Small Business Majority
          Stanford Health Care (SHC)
          St. Joseph Health
          United Nurses Associations of California/Union of Health Care  
          Professionals (UNAC/UHCP)
          University of California 
          Western University of Health Sciences
          Several individuals 

           Opposition:  

          California Chapter of the American College of Cardiology  
          (CA-ACC)
          California Chapter of the American College of Emergency  








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          Physicians (California ACEP)
          California Medical Association
          California Society of Plastic Surgeons (CSPS)
          California Academy of Family Physicians (CAFP)
          Numerous individuals
          

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