BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:   August 13, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                               Susan A. Bonilla, Chair
                   SB 491 (Hernandez) - As Amended:  August 8, 2013

           SENATE VOTE  :   22-12
           
          SUBJECT  :   Nurse practitioners.

           SUMMARY  :   Permits a nurse practitioner (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.   
          Specifically,  this bill  :   

          1)Permits a 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 either:

             a)   He or she has practiced under the supervision of a  
               physician for at least 4,160 hours and is practicing in one  
               of the following settings:

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

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

               iii)   A group practice, including a professional medical  
                 corporation, another form of corporation controlled by  
                 physicians and surgeons, 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; or

             b)   He or she has practiced under the supervision of a  
               physician for at least 6,240 hours and maintains a list of  
               licensed health care providers most often used for the  
               purposes of obtaining information or advice.  









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          2)Permits an independent NP to do the following without  
            standardized procedures or protocols:

             a)   Order durable medical equipment, although nothing in  
               this bill shall prohibit a third-party payer from requiring  
               prior approval;

             b)   Certify disability after performing a physical  
               examination;

             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;

             d)   Assess patients, synthesize and analyze data, and apply  
               principles of health care;

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

             f)   Analyze multiple sources of data, including patient  
               history, general behavior, and signs and symptoms of  
               illness; identify alternative possibilities as to the  
               nature of a health care problem; and select, implement, and  
               evaluate appropriate treatment;

             g)   Establish a diagnosis by client history, physical  
               examination, and other criteria;

             h)   Order, furnish, or prescribe drugs or devices;

             i)   Refer patients to physicians or other licensed health  
               care providers; 

             j)   Delegate tasks to a medical assistant that are within  
               the medical assistant's scope of practice;

             aa)  Perform additional acts that require education and  
               training and that are recognized by the the Board of  
               Registered Nursing (BRN) as proper to be performed by a NP;

             bb)  Order hospice care as appropriate; and,

             cc)  Perform procedures that are necessary and consistent  
               with the NP's education and training.








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          3)Requires a NP to refer a patient to a physician and surgeon or  
            another licensed health care provider if a situation or  
            condition of the patient is beyond the NP's education or  
            training.

          4)Does not limit a NP's authority to practice nursing or limit  
            the scope of practice of a registered nurse. 

          5)Requires the Board of Registered Nursing (BRN) to adopt  
            regulations by July 1, 2015 establishing the means of  
            documenting completion of this bill's requirements. 

          6)Specifies that NPs shall not supplant physicians employed by a  
            clinic, health facility, or county medical facility

          7)States that no reimbursement is required by this bill 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, 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. 

           EXISTING LAW  : 

          1)Declares that the intent of the Legislature in amending  
            the Nursing Practice 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.   
            (Business and Professions Code (BPC) Code Section 2725  
            (a))

          2)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.  (BPC 2725 (a))

          3)Defines "standardized procedures" as either policies and  
            protocols developed by a health facility through  
            collaboration among administration and health  








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            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))

          4)Permits NPs to furnish and order drugs pursuant to  
            standardized procedures developed by the NP and the  
            supervising physician and surgeon when the drugs or  
            devices are consistent with the practitioner's  
            educational preparation or for which clinical competency  
            has been established and maintained.  (BPC 2836.1)

          5)Requires one physician to supervise every four  
            prescribing NPs. (BPC 2836.1)

          6)Permits BRN to employ such personnel as it deems  
            necessary to carry out the nursing law, and permits BRN  
            to adopt, amend, or repeal such rules and regulations as  
            may be reasonably necessary to enable it to carry into  
            effect the provisions of the nursing law.  (BPC 2715)

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           1)Purpose of this bill  .  This bill allows a prescribing NP to  
            practice independently of physician supervision and  
            standardized procedures after a period of supervised practice  
            if the NP has national certification and liability insurance.   
            This bill is author-sponsored.

           2)Author's statement  .  According to the author's office,  
            "Independent practice would allow NPs to choose to see  
            Medi-Cal patients, a decision that is now left up to the  
            physician they work for. Due to the excellent safety and  
            efficacy record NPs have earned historically, the Institutes  
            of Medicine and the National Council of State Boards of  
            Nursing have recommended full practice for NPs. Currently, 17  
            states allow NPs to practice at the full extent of their  
            training and education with independent practice."

           3)NP training and educational requirements  .  A NP is 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  








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            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 Masters degree, and many further pursue a doctorate in  
            nursing.  There are currently 17,531 NPs licensed in CA. 

            NPs may specialize in disciplines such as acute pediatric  
            care, adult gerontological care, family care, women's health,  
            and mental health nursing.    

           4)This bill in practice  .  This bill would require NPs who wish  
            to practice independently to be nationally certified.  To  
            qualify for national certification, an applicant must have  
            graduated from specified nationally accredited programs, have  
            a minimum of 500 clinical hours of faculty-supervised  
            practice, and demonstrated completed coursework in advanced  
            physical assessment, advanced pharmacology, and advanced  
            pathophysiology.  

            This bill also requires an NP to have worked under physician  
            supervision for the equivalent of two years of full-time work  
            for certain practice models, and three years for solo  
            practice.  These timelines are based on the work of Patricia  
            Benner, who described domains and competencies for advanced  
            nursing practice, and the research of Karen Bryckzynski, who  
            explored the clinical practice of NPs.  These competencies are  
            referenced by the U.S. Department of Health and Human Services  
            in guidance reports.  

           5)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  
            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.  A  








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            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.

           5)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.   

           6)Prescribing authority  .  NPs may furnish drugs by obtaining a  
            DEA number to prescribe Schedule II-V drugs pursuant to a  
            protocol and standardized procedures.  The DEA considers a 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.     

           7)Supervision requirements  .  Of the 17,500 NPs in California,  
            12,500 are furnishing NPs.  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, meets regularly with the NP, review patient charts, or  
            be within a geographic proximity.   

           8)The Affordable Care Act (ACA) & NP Autonomy  .  The federal  
            Affordable Care Act (ACA) was passed in March 2010 to provide  
            quality, affordable healthcare for all Americans and improve  
            the quality and efficiency of that care.  The January 2014  
            implementation date of ACA will result in millions more  
            Californians entering the primary care market.  Primary care  
            providers will be responsible for health promotion, disease  
            prevention, early diagnosis, and the coordination of care with  








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            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.  This shortage is exacerbated by the fact  
            that fewer physicians are choosing to enter the field of  
            primary care than are leaving it. 

            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 notes that the contention  
            that APRNs 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.  16 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 ACA. 

           11)Improving access to primary care .  It is estimated that the  
            majority of the seven million Californians currently without  
            health insurance will be able to access primary care after the  








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            implementation of ACA.  According to the sponsor, allowing  
            independent NP practice will likely make that care more  
            accessible, reducing the strain on the already overburdened  
            physician population.  NPs have been found to have a greater  
            propensity to care for underserved populations and frequently  
            have less student debt, making them more likely to work in  
            environments with lower profit margins, such as rural areas.  
            There are two major ways in which the independent practice for  
            NPs provided by this bill may provide increased access to  
            primary acre services:  

              a)   Retail clinics  .  Retail clinics have grown substantially  
               over the last decade.  Retail clinics are medical clinics  
               who contract to operate out of  pharmacies, grocery stores,  
               and "big box" stores, such as Target. California's ban on  
               the corporate practice of medicine limits operation of  
               these clinics to professional medical corporations, so  
               these clinics must be 51% physician owned.  Retail clinics  
               primarily provide care for simple acute conditions-such as  
               bronchitis and vaccinations-typically delivered by a nurse  
               practitioner.  

               The Rand Corporation, a nonprofit research organization,  
               reports that the overall cost of care at retail clinics is  
               substantially lower than in physician offices, urgent care  
               centers, and emergency departments - and the care is  
               comparable in quality.  The Rand Corporation study further  
               indicates that these clinics do not appear to be disrupting  
               the traditional physician-client relationship, because 60%  
               of retail clinic consumers report having no primary care  
               physician.  

               It is anticipated that these clinics may proliferate if NPs  
               are able to operate without physician supervision because  
               it would become more cost-effective for these clinics to  
               employ greater numbers of NPs.  Retail clinics are  
               currently constrained by the 1:4 ratio of physician  
               supervision of prescribing NPs.   

              b)   Medi-Cal and Medicare populations  .  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  








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               women, and seniors.  Medicare is the federal government  
               health insurance program for seniors and persons with  
               disabilities.    
                
                ACA is expanding Medi-Cal eligibility and the California  
               HealthCare Foundation estimates that more than 1.4 million  
               Californians will be newly eligible for coverage.
               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.

               NPs in California may 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.  

           14)Accountability provisions  .  This bill will require  
            independent NPs to have 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.    








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          15)Arguments in support  .  AARP writes, "With the implementation  
            of the Affordable Care Act and the expansion of Medi-Cal,  
            millions more Californians will be seeking affordable, quality  
            health care.  We need to make better use of the health care  
            resources we have in our state.  This bill does this by  
            allowing nurse practitioners to practice up to the full extent  
            of their education and training and provide quality health  
            care without (to an extent) unnecessary, restrictive  
            oversight.  By removing most of the unnecessary supervision  
            requirements, SB 491 will increase Californians' access to and  
            choice among quality health professionals, reduce wait times  
            and reduce paperwork burdens.
             
             "Nurse practitioners are educated and trained to provide high  
            quality primary health care.  They diagnose and manage  
            patients' care, prescribe medications and refer patients to  
            specialists.  Decades of evidence, recently noted by the  
            Institute of Medicine and the National Governors Association,  
            demonstrate that nurse practitioners provide safe, effective  
            care whether or not they are supervised by physicians."

           16)Arguments in opposition  .  The California Medical Association  
            writes, "Allowing nurse practitioner practice without  
            standardized protocols and physician supervision reduces  
            patient safety and quality of care. Patients are best served  
            by a physician-led team that can provide high quality and  
            cost-effective care. Nurse practitioners are an important part  
            of the healthcare team and, when practicing under physician  
            supervision, can significantly increase access to quality  
            medical care in a community. Current law requires that nurse  
                                                            practitioner practice include the development and use of  
            standardized protocols and physician review and approval of  
            patient treatment plans. These requirements are in place to  
            ensure that patient care includes the involvement and  
            oversight of a physician who is substantially more qualified  
            and experienced to oversee patient care, both in depth and in  
            years of education and training, than a nurse practitioner  
            practicing alone."   

           17)Author's amendment  .  The author would like to amend the bill  
            to remove the independent practice pathway in which an NP may  
            practice without physician supervision after at least 6,240  
            hours of supervised practice.  








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           18)Related legislation  .  AB 1000 (Wieckowski and Maienschein)  
            would allow patients to self-refer to a physical therapist  
            (PT) and receive treatment for 45 calendar days or 12 visits,  
            whichever comes first, before being seen by a physician and  
            receiving sign off on the treatment plan initiated by a PT.   
            AB 1000 is currently in the Senate Appropriations Committee.
             
             AB 1208 (Pan) defines a "medical home" and "patient centered  
            medical home" as a health care delivery model in which a  
            patient establishes an ongoing relationship with a personal  
            primary care physician or other licensed health care provider  
            acting within the scope of his or her practice. The bill  
            states that the provider shall work in a physician-led  
            practice team to provide comprehensive, accessible, and  
            continuous evidence-based primary and preventative care, and  
            to coordinate the patient's health care needs across the  
            health care system in order to improve quality and health  
            outcomes in a cost-effective manner.  AB 1208 is currently on  
            the Senate floor. 

            SB 352 (Pavley) authorizes medical assistants to perform  
            technical supportive services in any medical setting upon  
            specific authorization of a physician assistant, NP, or  
            certified nurse-midwife without a physician on the premises.   
            SB 352 is currently on the Assembly floor. 

           19)Previous legislation  .  SB 726 (Ashburn) of 2010 was an effort  
            to promote healthcare in rural areas allow qualified health  
            care districts and qualified rural hospitals, as specified, to  
            directly employ physicians under an existing pilot project.   
            SB 726 was held in the Senate Business, Professions, and  
            Economic Development Committee.

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          AARP
          American Nurses Association
          American Nurses Association, California
          Association of California Healthcare Districts
          Bay Area Council
          Blue Shield of California
          Board of Registered Nursing








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          C.W. Brower, Inc.
          California Association for Nurse Practitioners
          California Association of Clinical Nurse Specialists
          California Association of Nurse Anesthetists, Inc.
          California Association of Physician Groups
          California Association of Public Hospitals and Health Systems
          California Family Health Center
          California Federation of Teachers
          California Hospital Association
          California Nurse-Midwives Association
          California Optometric Association
          California Pharmacists Association
          California Primary Care Association
          California Society of Health-System Pharmacists
          California State Association of Occupational Health Nurses
          Californians for Patient Care
          City of Turlock
          Congress of California Seniors
          Dignity Health
          Indiana State Nurses Association
          Latino Community Roundtable
          National Asian American Coalition
          National Association for the Advancement of Colored People 
          National Association of Pediatric Nurse Practitioners
          Private Essential Access Community Hospitals
          Stanford Hospital and Clinics
          United Nurses Associations of California/Union of Health Care  
          Professionals
          University of California
          University of California, San Francisco
          Western University of Health Sciences
          134 individuals

           Opposition 
           
          Aesthetic Institute
          AFSCME
          Alameda-Contra Costa Medical Association
          American Academy of Pediatrics, California
          American Federation of State, County and Municipal Employees,  
          AFL-CIO
          American Society for Dermatologic Surgery Association
          Blind Children's Center
          CalDerm
          California Academy of Eye Physicians and Surgeons








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          California Academy of Family Physicians
          California Chapter of the American College of Emergency  
          Physicians
          California Medical Association
          California Podiatric Medical Association
          California Psychiatric Association
          California Right to Life Committee, Inc.
          California Society of Anesthesiologists
          California Society of Plastic Surgeons
          Canvasback Missions, Inc.
          Consumer Attorneys of California
          Diabetes Coalition of California
          Here For Them, Inc.
          Latino Physicians of California
          Let's Face it Together
          Lighthouse Mission for Christ
          Medical Board of California
          Minority Health Institute, Inc.
          Osteopathic Physicians and Surgeons of California
          The Dream Machine Foundation
          Time for Change Foundation
          Union of American Physicians and Dentists/AFSCME-Local 206
          Ventura County American Chinese Medical Dental Association
          111 individuals


           Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301