BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:   June 30, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


                      SB 538(Block) - As Amended April 16, 2015


          SENATE VOTE:  21-9


          SUBJECT:  Naturopathic doctors.


          SUMMARY:  Expands the scope of practice for Naturopathic Doctors  
          (NDs) by removing physician supervision for prescribing certain  
          drugs and permitting NDs to perform minor office procedures, as  
          specified.  


          EXISTING LAW:   


          1)Establishes the Naturopathic Medicine Committee (NMC) within  
            the Osteopathic Medical Board (OMB) to enforce and administer  
            the provisions of the Naturopathic Doctors Act (Act).   
            (Business and Professions Code (BPC) Sections 3610, 3612,  
            3620)


          2)Defines "naturopathic medicine" to mean a distinct and  
            comprehensive system of primary health care practiced by a ND  
            for the diagnosis, treatment, and prevention of human health  
            conditions, injuries, and disease.  (BPC Section 3613(c))
          3)Defines "naturopathy" to mean a noninvasive system of health  








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            practice that employs natural health modalities, substances,  
            and education to promote health.  (BPC Section 3613(e))


          4)Authorizes a ND to order and perform physical and laboratory  
            examinations for diagnostic purposes, including, but not  
            limited to, phlebotomy, clinical laboratory tests, speculum  
            examinations, orifical examinations, and physiological  
            function tests.  (BPC Section 3640(a))


          5)Authorizes a ND to order diagnostic imaging studies, including  
            X-ray, ultrasound, mammogram, bone densitometry, and others  
            consistent with naturopathic training as determined by the  
            NMC, but requires an ND to refer the studies to an  
            appropriately licensed health care professional to conduct the  
            study and interpret the results.  (BPC Section 3640(b))


          6)Authorizes a ND to provide the repair and care incidental to  
            superficial lacerations and abrasions, except suturing.  (BPC  
            Section 3640(c)(5))


          7)Authorizes a ND to remove foreign bodies located in the  
            superficial tissues.  (BPC Section 3640(c)(6))


          8)Authorizes a ND to utilize routes of administration that  
            include oral, nasal, auricular, ocular, rectal, vaginal,  
            transdermal, intradermal, subcutaneous, intravenous, and  
            intramuscular.  (BPC Section 3640(d))


          9)Permits a ND to furnish or order specified drugs when all of  
            the following apply:  (BPC Section 3640.5)


             a)   The drugs are furnished or ordered by a ND in accordance  








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               with standardized procedures or protocols developed by the  
               ND and his or her supervising physician and surgeon;
             b)   The ND is functioning pursuant to standardized  
               procedures or protocols, as specified, and the standardized  
               procedure or protocol is developed and approved by the  
               supervising physician and surgeon, the ND, and, where  
               applicable, the facility administrator or his or her  
               designee; 


             c)   The standardized procedure or protocol covering the  
               furnishing of drugs must specify which NDs may furnish or  
               order drugs, which drugs may be furnished or ordered under  
               what circumstances, the extent of the physician and surgeon  
               supervision, the method of periodic review of the ND's  
               competence, including peer review, and review of the  
               provisions of the standardized procedure; 


             d)   The furnishing or ordering of drugs by a ND occurs under  
               physician and surgeon supervision, as specified; 


             e)   Drugs furnished or ordered by a ND may include Schedule  
               III through V controlled substances, as specified, and can  
               be further limited to those drugs agreed upon by the ND and  
               the supervising physician and surgeon, as specified; and, 


             f)   The NMC has certified that the ND has satisfactorily  
               completed adequate coursework in pharmacology covering the  
               drugs to be furnished or ordered, as specified.  


          10)Permits a ND to independently prescribe and administer  
            epinephrine to treat anaphylaxis, natural and synthetic  
            hormones, vitamins, minerals, amino acids, glutathione,  
            botanicals and their extracts, homeopathic medicines,  
            electrolytes, sugars, and diluents, as specified.  (BPC  








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            Section 3640.7)
          11)Prohibits a ND from prescribing, dispensing or administering  
            a controlled substance, as specified; administering  
            therapeutic ionizing radiation or radioactive substances;  
            practicing or claiming to practice any other system or method  
            of treatment beyond what is authorized under the Act;  
            administering general or spinal anesthesia; performing an  
            abortion; performing any surgical procedure; or performing  
            acupuncture or traditional Chinese and Asian Medicine,  
            including Chinese herbal medicine unless licensed as an  
            Acupuncturist.  (BPC Section 3642)


          12)Specifies that physician and surgeon supervision, for the  
            purpose of furnishing or ordering drugs, does not require the  
            physical presence of the physician, but does include:  (BPC  
            3640.5(d))


             a)   Collaboration on the development of the standardized  
               procedure;
             b)   Approval of the standardized procedure; and,


             c)   Availability by telephonic contact at the time of  
               patient examination by the ND.


          13)Prohibits a physician and surgeon from supervising more than  
            four NDs at one time.  
          THIS BILL: 


          14)Permits a ND to order diagnostic imaging studies consistent  
            with the practice of naturopathic medicine instead of as  
            determined by the NMC.


          15)Clarifies that a ND may provide, in addition to dispense,  








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            administer, order, or furnish, specified extracts,  
            hydrotherapies and devices consistent with the naturopathic  
            training as determined by the NMC.


          16)Authorizes a ND to utilize a cervical route of administration  
            only for the purpose of administering barrier contraception.  


          17)Authorizes a ND to perform "parenteral therapy" and perform  
            "minor procedures" instead of only performing repair and care  
            incidental to superficial lacerations and abrasions and the  
            removal of foreign bodies located in the superficial tissue.


          18)Defines "minor procedures" to mean care and operative  
            procedures relative to superficial lacerations, superficial  
            clinically benign lesions less than one centimeter and not  
            located on the face, and superficial abrasions, and the  
            removal of foreign bodies located in superficial structures  
            and the topical and parenteral use of substances consistent  
            with rules established by the NMC.


          19)Authorizes a ND to obtain samples of superficial human tissue  
            by means of shave, punch, or excisional biopsy consistent with  
            the practice of naturopathic medicine. 


          20)Specifies that "minor procedures" do not include general or  
            spinal anesthesia, sclerotherapy, or procedures involving the  
            eye.


          21)Defines "parenteral therapy" to mean the administration of  
            substances by means other than through the gastrointestinal  
            tract, including intravenous, subcutaneous, intramuscular, and  
            other areas of the body, excluding the ventral and dorsal body  
            cavities.  








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          22)Authorizes a ND to administer, furnish, order, or prescribe  
            Schedule IV through V controlled substances, as specified,  
            without the supervision of a physician and surgeon, except  
            chemotherapeutics.  


          23)Maintains the requirement that in order to administer,  
            prescribe, furnish, or order Schedule III drugs, a ND must act  
            under the supervision of a physician and surgeon.  


          24)States that when Schedule III controlled substances are  
            administered, furnished, ordered, or prescribed by a ND, the  
            controlled substances must be administered, furnished, ordered  
            or prescribed in accordance with a patient-specific protocol  
            approved by the treating or supervising physician and a copy  
            of the section of the ND's standardized procedure or protocol  
            relating to controlled substances must be provided, upon  
            request, to a licensed pharmacist who dispenses drugs when  
            there is uncertainty about the ND furnishing the order.


          25)Requires a ND to be subject to peer review reporting  
            provisions, as specified.  


          FISCAL EFFECT:  According to the Senate Appropriations Committee  
          Analysis dated May 26, 2015, this bill will result in "unknown  
          additional enforcement costs to the [NMC].  By expanding the  
          scope of practice for naturopathic doctors to allow them to  
          prescribe certain medications without supervision and perform  
          minor procedures, there may be additional complaints to the  
          [NMC] from patients that will require investigation and  
          potential disciplinary action. The extent to which this will  
          occur is not known."










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          COMMENTS:  


          Purpose.  This bill is sponsored by the  California Naturopathic  
          Doctors Association  .  According to the author, "[NDs] are  
          primary care doctors who attend four-year post-graduate  
          accredited naturopathic medical schools recognized by the U.S.  
          Department of Education.  As a part of their education, they  
          complete a minimum of 1,200 hours in clinical rotations, and a  
          thorough curriculum in basic and clinical science that includes  
          biochemistry, pharmacology, lab diagnosis, epidemiology,  
          pathology, neuroscience, and clinical physical diagnosis.

          Like other primary care doctors, NDs diagnose, prevent, and  
          treat disease.  [NDs] are licensed to perform physical exams,  
          order laboratory tests and imaging (x-rays, MRIs, mammograms,  
          etc.), draw blood, and perform CLIA-waived laboratory testing  
          in-office, administer IVs and injections, and prescribe drugs  
          (including most controlled substances).  NDs are licensed in 16  
          other states, some dating back to 1919, with no malpractice  
          claims filed nationally according to both Verdictsearch and the  
          National Practitioner Databank, maintained by the U.S.  
          Department of Health and Human Services.  Despite their medical  
          education and safety record, some limitations remain in  
          California which prevent[s] these healthcare professionals from  
          performing all of the duties that are typically part of primary  
          care practice and are important for patient care. 

          [This bill] removes barriers for patients seeking medical care  
          from licensed naturopathic doctors, by allowing them to  
          prescribe medications, such as blood pressure medications and  
          antibiotics, without a written supervision agreement and to  
          perform minor procedures, such as applying stitches and removing  
          warts. These barriers interfere with patient access to  
          appropriate, timely primary care. For example, if a patient who  
          regularly sees a naturopathic doctor comes in with strep throat,  








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          an ND can diagnose them but must send the contagious patient to  
          a medical doctor (MD) for an antibiotic. Given California's  
          primary care shortage, it may take weeks for the patient to get  
          an appointment with an MD, so the patient would likely visit an  
          emergency room or urgent care for a simple prescription. Delays  
          in care for simple medical procedures and medications may result  
          in minor medical conditions becoming major medical problems. For  
          example, a patient who delays taking antibiotics for strep  
          throat in a timely manner can experience lifelong complications  
          to the joints, kidneys, and heart as a result of acute rheumatic  
          fever or glomerulonephritis. [NDs] are already educated and  
          trained to perform these minor procedures and independently  
          prescribe these medications and are already safely performing  
          these functions of primary care in [nine] other states. [This  
          bill] will ensure that patients seeking primary care from a  
          naturopathic doctor can receive appropriate care without the  
          added time, cost, and health risk of finding another physician  
          for a routine prescription or procedure." 

          Naturopathic Medicine Committee.  The practice of Naturopathic  
          Medicine has been formally regulated in California since 2003.   
          SB 907 (Burton) Chapter 485, Statutes of 2003, established the  
          regulatory entity, known today as the NMC, which licenses and  
          regulates NDs and enforces the practice act.  The NMC is housed  
          within the OMB.  The NMC is authorized for 2.0 staff positions  
          and is currently staffed by an Executive Officer (EO) and a  
          licensing and enforcement analyst.  These two staff persons are  
          responsible for all licensing and disciplinary-related  
          activities for the NMC and its approximately 500 licensed NDs  
          practicing in California.  The NMC notes that it has one of the  
          lowest enforcement caseloads within the DCA where the majority  
          of enforcement related cases pertain to misuse of title and not  
          violations committed by its licensees.  

          At the time SB 907 was enacted, California was only the 12th  
          state to recognize the practice of naturopathic medicine and  
          regulate NDs.  Today, that number has grown to 17 states.  As  
          currently drafted, this bill seeks to expand the scope of  
          practice of NDs by expanding the types of procedures that can be  








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          done in an office visit and also removes the physician  
          supervision requirement for NDs who wish to prescribe Schedule  
          IV and V drugs.  This bill would maintain the supervision  
          requirements for NDs who wish to prescribe Schedule III drugs.  

          Naturopathic Medicine.  According to the NMC, the practice of  
          naturopathic medicine is a distinct and comprehensive system of  
          primary healthcare practiced by a ND for the diagnosis,  
          treatment, and prevention of human health conditions, injuries  
          and disease.  A ND may be considered as a primary care provider  
          who uses herbs, supplements, vitamins, homeopathy, nutritional  
          counseling, some prescription medicines, and other treatments to  
          help the body.  Naturopathic medicine is distinguished by the  
          six principles on which its practice is based.  These principles  
          include: 
               
             1)   The Healing Power of Nature: NDs trust in the body's  
               inherent wisdom to heal itself. 

             2)   Identify and Treat the Cause: Look beyond the symptoms  
               to effectively address the underlying cause(s) of illness. 

             3)   First Do No Harm: Seek to utilize the most natural,  
               least invasive and least toxic therapies first. 

             4)   Doctor as Teacher: The primary role of an ND is a  
               teacher who educates and encourages people to take  
               responsibility for their own health and to take steps to  
               achieve and maintain optimal health. 

             5)   Treat the Whole Person: Total health includes physical,  
               emotional, mental, genetic, environmental, social,  
               spiritual, and other factors. 

             6)   Prevention: Encourage and emphasize disease prevention  
               and focus on promoting health and wellness. 

          In order to be licensed as a ND in California, an individual  
          must meet educational and training requirements including  








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          possession of a Doctorate Degree of Naturopathic Medicine from  
          an approved naturopathic school.  As part of the program  
          requirements, a student must have completed a minimum of 4,100  
          total hours in basic and clinical sciences, naturopathic  
          philosophy, modalities, and medicine.  NDs have limited  
          abilities to complete hospital residencies, but perform a  
          minimum of 1,200 hours of supervised clinical training approved  
          by a naturopathic medical school.  In California, there is one  
          approved school to provide naturopathic education and only eight  
          total schools nationwide.  In addition, to be licensed in  
          California, NDs are required to take and pass the Naturopathic  
          Physicians Licensing Examination (NPLEX) or an equivalent  
          examination approved by the North American Board of Naturopathic  
          Examiners.  


          The National Institutes of Health (NIH).  According to  
          information provided by the NIH's National Center for  
          Complementary and Integrative Health, "?people visit  
          naturopathic practitioners for various health-related purposes,  
          including primary care, overall well-being, and  complementary  
          treatment (used in addition to conventional medical treatment)."   
           In addition, regarding the efficacy and safety of the practice,  
          the NIH reports that "some of the individual therapies used in  
          naturopathy have been researched for their efficacy, with  
          varying results. The complex treatment approaches that  
          naturopathic physicians often use are challenging to study, and  
          little scientific evidence is currently available on overall  
          effectiveness. Related research is under way but is in the early  
          stages."


          Recommendations Based on NMC Subcommittee Reports.  As part of  
          the enabling legislation, the NMC was required to two establish  
          two specified subcommittees: 1) a naturopathic formulary  
          advisory committee and 2) a naturopathic childbirth attendance  
          advisory subcommittee.  The function of the formulary advisory  
          committee was to review the naturopathic education, training,  
          and practice requirements and make specified recommendations  








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          regarding the prescribing, ordering, and furnishing authority of  
          NDs and supervision protocols.  The childbirth committee was to  
          review the practice of naturopathic childbirth attendance.  Both  
          of the subcommittees were required to consult with physician and  
          surgeons and licensed NDs in developing the findings and  
          recommendations.  As a result of this requirement, the NMC  
          convened the formulary advisory committee consisting of two NDs,  
          two physicians, and one attorney to review whether it would be  
          appropriate to expand the procedures permitted in current law.  


          After a review of the training, education, and practice of NDs,  
          the advisory group reached consensus that a ND should be allowed  
          to perform the following four additional procedures without  
          physician supervision: 1) prescribe and administer local  
          anesthetic solutions, their adjuncts and diluents; 2) remove  
          clinically benign skin lesions; 3) repair skin lacerations,  
          including suturing; and 4) perform incision and drainage of  
          abscess/trephination of subungual hematoma.  This bill seeks to  
          enact the recommendations made in the NMC's 2007 report to the  
          Legislature, but specifies that the removal of clinically benign  
          skin lesions are to be limited to less than one centimeter and  
          not located on the face.  


          Minor Procedures.  Under the act, NDs are permitted to perform a  
          range of healthcare related tasks independent of physician  
          supervision except with respect to prescribing certain Schedule  
          drugs.  Currently, NDs can provide repair and care incidental to  
          superficial lacerations and abrasions, except suturing.  The  
          sponsor illustrates that a ND would be prepared to clean a wound  
          but not provide the suture if necessary.  NDs are permitted to  
          remove foreign bodies in the superficial tissues, and have the  
          authority to order lab tests but cannot study or interpret the  
          results.  In addition, NDs can administer certain vitamins,  
          netraceuticals, minerals, enzymes and nonprescription drugs as  
          identified by the federal Food, Drug Cosmetic Act, consistent  
          with specified routes of administration.  









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          This bill would authorize NDs to expand their current scope of  
          practice to include minor office procedures, specifically care  
          and operative procedures relative to superficial lacerations,  
          superficial clinically benign lesions less than one centimeter,  
          excluding the face, and superficial abrasions.  This bill also  
          clarifies that NDs are able to utilize a cervical route of  
          administration for the purpose of administering barrier  
          contraception.  In addition, a ND would also be permitted to  
          obtain samples of superficial human tissue by means of shave,  
          punch, or excisional biopsy consistent with the practice of  
          naturopathic medicine, which does not include general or spinal  
          anesthesia, sclerotherapy, or procedures involving the eye.  As  
          currently written, this bill would not require the supervision  
          of a physician and surgeon to perform any of the procedures  
          within the proposed new scope of practice.  


          According to information provided by the California Naturopathic  
          Doctors Association, naturopathic students receive up to 72  
          hours of classroom training in minor procedures, which includes  
          both didactic and lab instruction, and are required to obtain  
          check-offs from clinical faculty indicating their competency in  
          performing minor procedures prior to graduation.  The California  
          Naturopathic Doctors Association reports that 13 of the 17  
          states which license and regulate NDs allow minor procedures to  
          be included within the scope of practice of NDs.  


          Prescription Authority with Physician Supervision.  The use of  
          physician and surgeon supervision is common for many medical  
          professions in California.  Supervision generally includes the  
          development of procedures and protocols as determined by the  
          supervisor and supervisee.  Under current law, NDs are permitted  
          to furnish or order Schedule III-V drugs under the standardized  
          procedures and protocols developed by the ND and the supervising  
          physician.  This bill would authorize NDs to administer,  
          furnish, order or prescribe Schedule IV and V drugs and those  
                                                           drugs that are not on the "schedule" considered "legend" drugs  








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          without the supervision of a physician or surgeon.  


          According to the U.S. Drug Enforcement Agency, drugs,  
          substances, and certain chemicals used to make drugs are  
          classified into five (5) distinct categories or schedules  
          depending upon the drug's acceptable medical use and the drug's  
          abuse or dependency potential.  Schedule I drugs have the  
          highest potential for abuse while Schedule V is the lowest.   
          Those drugs that are still considered controlled substances but  
          have even less potential for abuse than Schedule V are part of  
          the "legend" such as certain antibiotics and some routine  
          vaccinations.  This bill would make it clear that NDs would not  
          be authorized to prescribe chemotherapeutics regardless of  
          supervision.  NDs report that they are required to obtain 60  
          hours of continuing education (CE) every license-renewal cycle,  
          and 20 of those hours are required to be in  
          pharmacotherapeutics.  


             Schedule III and IV  controlled substances have a currently  
            accepted medical use in treatment, less potential for abuse  
            but are known to be mixed in specific ways to achieve a  
            narcotic-like end product.  Examples include drugs Tylenol  
            with Codeine, Ambien, Xanax, and other anti-anxiety drugs.


             Schedule V  drugs have a low potential for abuse relative to  
            substances listed in Schedule IV and consist primarily of  
            preparations containing limited quantities of certain  
            narcotics.  Examples include Robitussin with Codeine and  
            Lomotil.


             Legend Drugs  are controlled substances that are considered to  
            have a lower potential for abuse than Schedule V drugs, such  
            as some antibiotics.










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          Other States.  Currently, there are 17 other states which  
          license and regulate NDs: Alaska, Arizona, California, Colorado,  
          Connecticut, District of Columbia, Hawaii, Kansas, Maine,  
          Maryland, Minnesota, Montana, New Hampshire, North Dakota,  
          Oregon, Utah, Vermont, and Washington.  Although education and  
          examination requirements appear to be consistent (four-year  
          post-graduate degree and passage of the national licensing  
          examination), each state is responsible for determining the  
          scope of practice for NDs along with establishing the laws and  
          regulations necessary to oversee the profession.  While the  
          scope of practice for NDs varies across the states, all NDs are  
          guided by the same six principles.  According to information  
          provided by the California Naturopathic Doctors Association,  
          only 10 of the 17 states which license NDs have prescribing  
          privileges, and only California requires supervision.  Only 13  
          of the 17 states permit "minor procedures" which can vary  
          depending on state statutes and regulations.  

          Difference Between Naturopathic Medicine and Naturopathy.  In  
          California, there is a distinction between the practice of  
          "naturopathy" and "naturopathic medicine."  An individual does  
          not need a license to practice "naturopathy" and "homeopathy,"  
          however; individuals must inform clients that they are providing  
          unlicensed healing arts services as specified in the BPC.   
          "Naturopaths" are not prohibited from using the term  
          "naturopath" but cannot call themselves a ND without the proper  
          NMC-issued license demonstrating they have met the appropriate  
          educational and testing requirements.  As noted by the NIH, the  
          traditional educational requirements for naturopaths are  
          different from the requirements for NDs in that a naturopath's  
          education ranges from none to specific degrees and coursework.  
          In addition, the programs vary in length and content and are not  
          accredited by organizations recognized for accreditation  
          purposes by the U.S. Department of Education.  Further,  
          traditional naturopaths are not subject to licensing.  On the  
          other hand, NDs are required to obtain a four-year post-graduate  
          degree, from an accredited institution, take and pass an  
          examination, and are subject to specified licensure and practice  








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          acts in 17 states.  


          Sunset Review.  The NMC was last reviewed by the Senate  
          Business, Professions and Economic Development (BPED) and  
          Assembly Business, Professions and Consumer Protection (BPCP)  
          Committees in 2013.  As part of that report, the NMC made  
          recommendations to alter the formulary and sought expansion of  
          the scope of practice for ND's.  At that time, the BPED  
          Committee raised several issues in the staff report pertaining  
          to the NMC's ability to establish disciplinary guidelines as  
          well as a number of other enforcement related activities.  The  
          Committee report ultimately recommended that the NMC focus on  
          certain administrative and enforcement issues such as updating  
          its strategic plan, enhancing data collection, and establishing  
          disciplinary guidelines rather than changing the scope of  
          practice of NDs.  This bill builds on some of those proposals in  
          the NMC's last sunset report by expanding the scope of practice  
          for NDs to perform minor procedures, and remove physician  
          supervision for the furnishing and ordering of specified drugs.   
          The NMC will not be up for sunset review until 2017, meaning  
          that the recommendations made in the sunset review report for  
          the NMC will not be discussed for another year, potentially  
          after this legislation would be enacted.  


          Prior Related Legislation.  SB 1446 (McLeod), Chapter 333,  
          Statutes of 2012, allowed naturopathic doctors to independently  
          prescribe and administer vitamins, minerals, amino acids,  
          glutathione, botanicals and their extracts, homeopathic  
          medicines, electrolytes, sugars, and diluents, as specified.  It  
          also required NDs to demonstrate compliance with specified  
          requirements, including the successful completion of specified  
          coursework by a provider approved by the Committee, in order to  
          qualify for intravenous therapy administration, and clarifies  
          the types of substances a ND may prescribe and administer.

          SB 1246 (McLeod), Chaptered 523, Statutes of 2010, included NDs  
          in the list of health care practitioners who could perform  








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          specified clinical laboratory tests, defined a naturopathic  
          assistant for purposes of the practice act, and specifies  
          certain functions for naturopathic assistants.

          AB X4 20 (Strickland), Chapter 18, Statutes of 2008, abolished  
          the Bureau of Naturopathic Medicine and created the NMC within  
          the OMB.  

          SB 907 (Burton), Chapter 485, Statutes of 2003, established the  
          Act to be administered by the Bureau of Naturopathic Medicine  
          within the DCA.

          ARGUMENTS IN SUPPORT: 


          The  California Naturopathic Doctors Association  writes in  
          support, "This bill addresses existing limitations in the  
          Naturopathic Practice Act.  Specifically, the legislation will  
          allow [NDs] to prescribe Schedule III-V and legend drugs without  
          a written supervision agreement as well as perform minor  
          procedures with the training of a ND.  NDs are licensed primary  
          care doctors with the broadest independent scope of any medical  
          profession other than MDs or DOs."


          The  AARP  , writes in support, AARP supports Medicare and Medicaid  
          policies that result in the efficient delivery of optimal care  
          for beneficiaries with chronic illness and disabling conditions,  
          including approaches that encourage an interdisciplinary care  
          team approach.  AARP also acknowledges that the fact that health  
          care costs must be contained.  One of the means to achieve this  
          objective is reforming [the] delivery of healthcare services to  
          allow access by beneficiaries to other providers.  Passage of  
          [this bill] will not only eliminate arcane barriers so that  
          naturopathic doctors may practice fully within their education  
          and training, it will ensure that restrictions to practice  
          unfettered from arcane barriers.  By eliminating current  
          barriers faced by naturopathic doctors, access by beneficiaries  
          to other providers will not be restricted."  








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          ARGUMENTS IN OPPOSITION:


          The  Osteopathic Physicians and Surgeons of California (OPSC)   
          writes in opposition, "OPSC's most significant concern with the  
          provisions in [this bill] relate to patient safety.  [This bill]  
          would allow NDs to independently prescribe controlled  
          substances, expand the diagnostic procedures that [NDs] may  
          order and allow NDs to review and interpret the results of these  
          procedures.  The bill would also allow NDs to conduct parenteral  
          therapy and conduct "minor procedures.  The length and focus of  
          education and training for NDs is dramatically different than  
          that of MDs or Dos."  


          The  California Society for Anesthesiologists  writes in  
          opposition, "[This bill] would expand the scope of practice of  
          [NDs] and erodes provisions in current law that protects  
          consumers.  In particular, this bill deletes the current  
          requirement that [NDs] furnish controlled substances in  
          accordance with standardized procedures of protocols developed  
          by the [ND] and his or her supervising physician.  Naturopathic  
          theory and practice are not based on the body of basic knowledge  
          related to health, disease, and medical treatment which has been  
          widely accepted by the scientific community.  The scope and  
          quality of naturopathic education do not prepare its  
          practitioners to make either adequate diagnosis or provide  
          appropriate treatment."


          POLICY ISSUE(S):


          Expanded Prescribing Authority.  This bill would expand the  
          scope of practice for NDs by removing physician supervision for  
          NDs to prescribe Schedule IV and V drugs and those drugs not  
          listed on the Schedule, commonly known as legend drugs.   








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          Although the NMC reports a very small caseload related to  
          enforcement, given the limited size of the NMC and the potential  
          for new enforcement-related issues to arise as a result of  
          enhanced prescribing privileges, the Committee may wish to  
          consider allowing a limited expansion of prescribing authority  
          to permit NDs to prescribe Schedule V and legend drugs without  
          supervision, but maintain the restrictions for prescribing  
          Schedule III and IV, which currently require physician  
          supervision as defined in current law.  With this enhanced  
          prescribing authority, NDs would be able to prescribe certain  
          antibiotics and provide certain vaccinations.  

          Expansion of Scope and Training Limitations.  This bill expands  
          the scope of practice for NDs by allowing NDs to perform "minor  
          procedures" including care and operative procedures relative to  
          superficial lacerations, clinically benign lesions less than one  
          centimeter that are not located on the face, and obtaining  
          samples of superficial human tissues without the supervision of  
          a physician and surgeon.  While the sponsors of this bill  
          explain that current law prevents NDs from performing all of the  
          primary care duties for which they are trained to perform, it is  
          unclear what this expansion of scope would permit NDs to do, and  
          how far the reach would be for performing "minor procedures."  

          In addition, it is unclear which specific "minor procedures" NDs  
          are trained to perform during their clinical studies and if  
          there are any potential "minor procedures" which would be  
          authorized in this bill that are outside of a ND's training.  It  
          may be more beneficial to identify and specify the procedures  
          that a ND is not able to provide to clients as a result of the  
          limitations of its current scope of practice and what "minor  
          procedures" are necessary for the care and treatment of patients  
          that NDs regularly treat.  

          It is unknown how many patients see a ND while under the care of  
          another medical provider such as a physician and surgeon.  The  
          lack of patient-centered data regarding the expected services of  
          a ND underscores the difficulty in determining the need to  
          expand the scope of practice of NDs.  Although the NMC and the  








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          subcommittees completed the statutory review and concluded that  
          an expanded scope of practice is justified, an additional study  
          encompassing a much broader spectrum of participants, including  
          education providers and other stakeholders may provide enhanced  
          information which would further support any need for scope  
          expansion.  Instead of expanding the scope of NDs at this time,  
          the Committee may wish to request the author to remove the  
          provisions authorizing NDs to perform "minor procedures." 

          Residency Requirement.  In order to be licensed as a ND in  
          California, a person must complete a four year, post-graduate  
          naturopathic medical education program from an institution  
          accredited by the Council on Naturopathic Education or an  
          equivalent education program that meets specified requirements.   
          The program requirements include a minimum of 4,100 total hours.  
           Of those 4,100 hours, 2,500 must be in academic instruction and  
          1,200 must consist of supervised clinical training approved by  
          the naturopathic medical school.  Upon completion of  
          naturopathic medical school, prospective licensees are not  
          required to complete or attend a residency program which is  
          common for physicians and surgeons.  While some naturopathic  
          medical institutions provide an optional one-year residency  
          program, it is not consistent and not required for all NDs  
          licensed in California. 

          Increasing the capacity for residency programs for NDs after  
          completion of naturopathic medical school should be a starting  
          point for NDs in discussing future scope expansions.  Enhanced  
          residency training would help demonstrate competency for NDs in  
          performing "minor procedures" and determining what those  
          necessary procedures would be. 

          NMC Oversight and Sunset Review.  The NMC is responsible for the  
          licensing and enforcement of NDs in California.  Although the  
          NMC reports it has one of the smallest caseload relative to  
          enforcement, that could increase given the proposals of this  
          bill in expanding the scope of practice for NDs.  The NMC is  
          currently staffed by two individuals who are responsible for all  
          licensing, enforcement and administrative-related duties of the  








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          NMC.  Given the NMC's limited staff capacity, it could be  
          difficult for the NMC to handle an expanded caseload of  
          enforcement-related concerns relative to the increase in NDs'  
          scope.  

          The sunset review process provides a formal mechanism for the  
          DCA; the Legislature; the regulatory boards, bureaus and  
          committees; interested parties; and stakeholders to make  
          recommendations for improvements to the authority of consumer  
          protection boards and bureaus. The NMC was last reviewed in 2013  
          and will be reviewed in 2017 by the policy committees of the  
          Legislature as required by law.  At that time, the NMC will have  
          updated information about enforcement and licensing issues for  
          the NMC which will include updated data about enforcement cases  
          as it relates to additional prescribing authority for NDs if  
          this bill were to pass and permit NDs to have specified  
          prescribing authority without physician supervision.  


          AMENDMENTS:


          The following amendments will address the policy concerns noted  
          above by removing the provisions of this bill which authorize a  
          ND to perform minor office procedures; revise the prescribing  
          authority to authorize NDs to prescribe Schedule V and "legend"  
          drugs without physician supervision and restore Schedule IV  
          prescribing authority as defined in current law; and, remove a  
          clarifying amendment which authorizes a ND to utilize a cervical  
          route of administration only for the purpose of administering  
          barrier contraception in order to avoid confusion with an NDs  
          current scope of practice related to administering specified  
          birth control methods.


          On page 3, in Section 3640(c), restore former paragraphs 5 and 6  
          to existing law. 










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          On page 3, strike line 35.


          On page 4, strike line 1.


          On page 4, strike lines 15-32.


          On page 4, line 5, strike A naturopathic doctor may utilize a  
          cervical route and strike lines 6-7. 


          On page 5, in line 1, after Schedule III, insert:  and Schedule  
          IV


           On page 5, in line 20, after Schedule III, insert:  and Schedule  
          IV


           On page 5, in line 22, after III insert:  and Schedule IV , and  
          after III insert:  through Schedule IV


           On page 5, line 31, after Schedule III insert:  and Schedule IV  


          On page 6, line 18, strike Schedule IV through


          On page 7, in line 7, after Schedule III, insert:  through  
          Schedule IV


           On page 7, in line 21, after Schedule III insert:  through  
          Schedule IV










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           REGISTERED SUPPORT:


          California Naturopathic Doctors Association (sponsor)
          AARP
          Akasha Center for Integrative Medicine
          Bastyr University
          Berkeley Naturopathic Medical Group
          California Naturopathic Clinic
          Endocrinology Association of Naturopathic Physicians
          LiveWell Center 
          National College of Natural Medicine
          Naturopathic Academy of Primary Care Physicians
          Naturopathic Medicine Committee
          Oncology Association of Naturopathic Physicians
          Oregon Association of Naturopathic Physicians
          Paracelsus Natural Family Health Center, Inc. 
          Pediatric Association of Naturopathic Physicians
          San Diego Center for Integrative Medicine 
          Santa Cruz Naturopathic Medical Center
          Stengler Center for Integrative Medicine
          Women's View Medical Group
          Southwest College of Naturopathic Medicine and Health Sciences  
          (4/6/15 version)
          California Chiropractic Association (4/6/15 version)
          Integrative Medicine for the Underserved (4/6/15 version)
          Arizona Naturopathic Medical Association (Introduced version)
          Center for Health Santa Cruz (Introduced version)
          Washington Association of Naturopathic Physicians (Introduced  
          version)
          Hundreds of Individuals

          REGISTERED OPPOSITION:


          American Osteopathic Association
          California Chapter of the American College of Emergency  
          Physicians 
          California Society of Anesthesiologists








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                                                                    Page  23





          California Society of Plastic Surgeons
          Medical Board of California
          Osteopathic Physicians and Surgeons of California
          Union of American Physicians and Dentists
          American Congress of Obstetricians and Gynecologists, District  
          IX (4/6/15 version)
          California Society of Dermatology and Dermatologic Surgery  
          (4/6/15 version)
          California Medical Association (4/6/15 version)
          California Academy of Family Physicians (4/6/15 version)
          Kaiser Permanente (4/6/15 version)
          American Academy of Pediatrics (4/6/15 version)
          California Chapter of the American College of Cardiology (4/6/15  
          version)
          California Radiological Society (4/6/15 version) 
          California Orthopedic Association (Introduced version)




          Analysis Prepared by:Elissa Silva / B. & P. / (916) 319-3301