BILL ANALYSIS                                                                                                                                                                                                    Ó



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

          Bill No:            SB 538          Hearing Date:    April 13,  
          2015
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          |Author:   |Block                                                 |
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          |Version:  |April 6, 2015                                         |
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          |Urgency:  |No                     |Fiscal:    |Yes              |
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          |Consultant|Sarah Huchel                                          |
          |:         |                                                      |
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                           Subject:  Naturopathic doctors.

          SUMMARY:  Expands the scope of practice for a naturopathic doctor,  
          including allowing a naturopathic doctor to prescribe certain  
          drugs without physician supervision and review and interpret  
          diagnostic tests.  

          Existing law:
          
          1) Establishes the Naturopathic Medicine Committee (Committee)  
             within the Osteopathic Medical Board to enforce and  
             administer the Naturopathic Doctors Act (Act).  (Business and  
             Professions Code (BPC) §§ 3612 and 3620) 

          2) Authorizes a naturopathic doctor (ND) to order and perform  
             physical and laboratory examinations for diagnostic purposes,  
             including, but not limited to, phlebotomy, clinical  
             laboratory tests, orificial examinations, and physiological  
             function tests.  (BPC § 3640 (a))

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

          4) Authorizes an ND to utilize routes of administration that  







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             include oral, nasal, auricular, ocular, rectal, vaginal,  
             transdermal, intradermal, subcutaneous, intravenous, and  
             intramuscular.  (BPC § 3640 (c))

          5) Authorizes an ND to repair and care for superficial  
             lacerations and abrasions, except suturing.  (BPC § 3640  
             (c)(5))

          6) Requires an ND to furnish or order drugs (including Schedule  
             III - V) in accordance with standardized procedures or  
             protocols developed by the naturopathic doctor and his or her  
             supervising physician and surgeon.  (BPC § 3640.5 (a))

          7) Requires the standardized procedure or protocol covering the  
             furnishing of drugs to specify which drugs may be furnished  
             or ordered under what circumstances, the extent of 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.   (BPC § 3640.5  
             (d))

          8) Requires Schedule III drugs to be furnished or ordered by an  
             ND in accordance with a patient-specific protocol approved by  
             the treating or supervising physician.  
          (BPC § 3640.5 (f))   

          9) Prohibits an ND from performing any surgical procedure.  (BPC  
             § 3642 (f))

          10)Allows an ND to practice naturopathic childbirth attendance  
             after certification.  (BPC 3651) 
          
          This bill:

          1)Allows a naturopathic doctor (ND) to review and interpret the  
            results of diagnostic procedures, in addition to ordering and  
            performing.


          2)Specifies that these diagnostic procedures include those  
            commonly used by physicians and surgeons in general practice,  
            including:










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             a)   Venipuncture.


             b)   Electrocardiograms.


             c)   Obtaining samples of human tissue, consistent with the  
               practice of naturopathic medicine.  


          3)Removes the limitation that NDs may only order those  
            diagnostic imaging studies that the Committee determines are  
            consistent with ND training.


          4)Authorizes an ND to furnish durable medical equipment  
            consistent with naturopathic training as determined by the  
            Committee.


          5)Authorizes an ND to provide parenteral therapy, which is  
            defined as the administration of substances by means other  
            than through the gastrointestinal tract, including  
            intravenous, subcutaneous and intramuscular, and other areas  
            of the body, excluding the ventral and dorsal body cavities.


          6)Authorizes an ND to perform minor procedures, which means care  
            and operative procedures relative to superficial lacerations,  
            superficial lesions, and superficial abrasions, the removal of  
            foreign bodies located in superficial structures, aspiration  
            of joints, and the topical and parenteral use of substances  
            consistent with the practice of naturopathic medicine, in  
            accordance with rules established by the Committee.


          7)Allows an ND to utilize the cervix as a route of  
            administration.


          8)Authorizes an ND to furnish, prescribe, administer, and order  
            Schedule III-V drugs without supervision of a physician and  
            surgeon or in accordance with standardized procedures or  
            protocols.








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          9)Removes periodic review of the ND's competence, including peer  
            review.


          10)Authorizes an ND to furnish or order any drug approved by the  
            United States Food and Drug Administration that is not  
            classified and labeled "for prescription only" or any like  
            words.


          11)Makes technical and clarifying changes.

          
          FISCAL  
          EFFECT:  Unknown.  This bill has been keyed "fiscal" by  
          Legislative Counsel.
          
          COMMENTS:
          
          1)Purpose.  This bill is sponsored by the  California  
            Naturopathic Doctors Association  .  According to the author's  
            office, this bill expands the scope of practice for an ND as  
            follows:  allows an ND to prescribe legend and Schedule III-V  
            drugs without physician supervision or pursuant to a  
            standardized protocol; expands the types of diagnostic  
            procedures in an ND's practice and allows an ND to review and  
            interpret the results; allows an ND to study and interpret the  
            results of diagnostic imaging studies; expands the types of  
            "minor procedures" an ND may perform.  

          2)Naturopathic Medicine.  According to the Committee,  
            Naturopathic medicine is a distinct and comprehensive system  
            of primary health care that uses natural methods and  
            substances to support and stimulate the body's self-healing  
            process.  It is distinguished by the principles on which its  
            practice is based.  These principles include: 

             a)   The Healing Power of Nature: NDs trust in the body's  
               inherent wisdom to heal itself. 

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








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

             d)   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. 

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

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

            Naturopathic medicine includes the combination of a variety of  
            natural medicines and treatments.  NDs are clinically trained  
            in both natural and conventional approaches to medicine and  
            can prescribe all natural and synthetic hormones, epinephrine,  
            and vitamins, minerals, and amino acids independent of  
            physician supervision.  California NDs complete 72  
            pharmacology course hours in school and are required to  
            complete a minimum of 20 hours of pharmacotherapeutic training  
            every two years as part of their 60 hour continuing education  
            requirement.  

            NDs attend four year, graduate-level, accredited naturopathic  
            medical schools, are trained as primary care providers, and  
            take a national, standardized licensing examination.  NDs have  
            limited opportunities to complete hospital residencies, but  
            perform at least 1500 hours of clinical rotations at clinics  
            and private doctors' offices during their education program.   
            California is one of 17 states that license NDs, and over 500  
            ND licenses have been issued to date. There is one  
            naturopathic medicine school in California, located in San  
            Diego.  

          3)Naturopathic and Allopathic Medicine.  While NDs report that  
            they are trained as primary care providers, the National  
            Institute of Health (NIH) considers naturopathy (which  
            includes the practice by naturopathic doctors) complimentary  
            medicine.  It cautions that "the complex treatment approaches  
            that naturopathic [doctors] often use are challenging to  








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            study, and little scientific evidence is currently available  
            on overall effectiveness. Related research is under way but is  
            in the early stages."



            NIH states that:


                 Naturopathy is not a complete substitute for  
               conventional care.  Relying exclusively on naturopathic  
               treatments and avoiding conventional medical care may be  
               harmful or, in some circumstances have serious health  
               consequences.

                 Some beliefs and approaches of naturopathic  
               practitioners are not consistent with conventional  
               medicine, and their safety may not be supported by  
               scientific evidence. 
          
          4)Sunset Review of the Committee.  The Committee underwent a  
            Sunset Review in 2013 at which time the Senate Business,  
            Professions, and Economic Development (BPED) Committee  
            expressed concern about the Committee's abilities to handle  
            administrative concerns and enforcement activities.  It was  
            recommended that the Committee establish disciplinary  
            guidelines, update their strategic plan that expired in 2012,  
            and report to the Legislature by January 1, 2014 on any  
            progress in meeting its goals and objectives.  Until progress  
            occurs, it was recommended that there be no scope expansion  
            for NDs.  

            A new Executive Officer (EO) joined the Committee after 2014,  
            and has shown substantial leadership in refocusing the  
            Committee's efforts.  While disciplinary guidelines have not  
            yet been passed, they are in draft form and the EO has assured  
            this Committee that they and a revised Strategic Plan will be  
            in effect in the next few months.  The EO has hired additional  
            staff and reports substantial compliance with the 2013 Sunset  
            concerns.   
          
          5)Arguments in Support.  The  California Naturopathic Doctors  
            Association  writes, "The vast majority of naturopathic doctors  
            practice primary care medicine.  Unfortunately, current law  








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            creates obstacles for patients who have chosen to see an ND  
            for their primary care needs.  Specifically, these patients  
            must be referred out for medication management or minor  
            procedures, such as stitching a cut, despite the fact that  
            their doctor is trained to do these things.  Both of these  
            limitations increase cost and delay care for patients.  This  
            delay in care can result in patient harm if acute conditions  
            (e.g. strep throat) are not treated in a timely manner.  In  
            addition, current scope limitations are a barrier to the  
            growth of the naturopathic profession in California,  
            compounding the primary care provider shortage in this state.

             "Increasing demands for primary care doctors and health care  
             services are adding stress to an already overburdened health  
             care system.  It is therefore vital to improve patient access  
             to licensed primary care doctors who are trained to  
             independently perform all primary care needs."  

          6)Arguments in Opposition.  The  California Medical Association   
            and the  California Association of Family Physicians  write in  
            opposition to the current version of this bill: "The  
            distinctive philosophy of naturopathic medicine and many of  
            its methods of diagnosis and treatment are unscientific in  
            concept, biologically improbable and clinically unproven.   
            Moreover, regardless of its theory, the scope and quality of  
            naturopathic education do not prepare its practitioners to  
            make either an adequate diagnosis or provide appropriate  
            treatment independent of medical doctors. Naturopathic  
            services are not covered by Medicare or most insurance  
            policies for good reason: a lack of evidence of appropriate  
            effectiveness.  Only 17 states allow the practice of  
            naturopathic medicine and California is the only large state  
            among them."

          7)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  








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            administer.

             SB 1246  (McLeod, Chaptered 523, Statutes of 2010) included NDs  
            in the list of health care practitioners who could perform  
            specified clinical laboratory tests, defined a naturopathic  
            assistant for purposes of the 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  
            Naturopathic Medicine Committee within the Osteopathic MBC.  

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

          8)Measure as Proposed to be Amended by the Author.  The bill as  
            proposed to be amended in Committee would do the following  
            (see attached Mock-up Version of the Amendments):

             a)   Would authorize an ND to order diagnostic imaging  
               studies "consistent with the practice of naturopathic  
               medicine," rather than only those determined appropriate by  
               the Committee.

             b)   Would clarify that an ND may order, provide, or furnish  
               devices consistent with the naturopathic training as  
               determined by the Committee.

             c)   Would authorize an ND to utilize the cervix as a route  
               of administration.

             d)   Would authorize an ND to perform operative procedures  
               relative to superficial lacerations, superficial clinically  
               benign lesions less than one centimeter and not located on  
               the face, and superficial abrasions.  

             e)   Would authorize an ND to use topical and parenteral use  
               of substances consistent with the practice of naturopathic  
               medicine in accordance with rules established by the  
               Committee.  

             f)   Would authorize an ND to obtain samples of superficial  
               human tissue by means of shave, punch, or excisional biopsy  








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               consistent with the practice of naturopathic medicine.

             g)   Would prohibit an ND from any procedures using general  
               or spinal anesthesia, sclerotherapy, or procedures  
               involving the eye.  

             h)   Would define "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.  

             i)   Would authorize an ND to prescribe, administer, or order  
               Schedule IV, V, and unclassified drugs labeled "for  
               prescription only," except chemotherapeutics, without  
               physician supervision.

             j)   Would require an ND to be subject to peer review  
               reporting provisions.
          
          9)Changes to Furnishing Authority of a Naturopathic Doctor.   
            Current law allows an ND to furnish or order legend drugs and  
            Schedule III - V and drugs in accordance with standardized  
            procedures or protocols developed by the naturopathic doctor  
            and his or her supervising physician and surgeon.  A physician  
            may supervise up to four NDs at a time.  
            
             a)   Drug classifications.  Drugs, substances, and certain  
               chemicals used to make drugs are classified into five  
               schedules depending upon the drug's acceptable medical use  
               and the drug's abuse or dependency potential. Schedule I is  
               considered the most dangerous class and Schedule V  
               represents the least concerning of the Scheduled drugs.  

               Schedule IV drugs include the mild narcotics, depressants,  
               stimulants, and tranquilizers.  Drugs such as Xanax,  
               Ambien, Tramadol, and Valium are in this group.  Schedule V  
               drugs consist primarily of preparations containing limited  
               quantities of certain narcotic and stimulant drugs, and  
               include cough syrups with codeine, Lyrica, and Lomotil.  

               "Legend" drugs are controlled substances but have even less  
               potential for abuse than Schedule V drugs.  Antibiotics and  
               insulin are considered legend drugs.   








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             b)   Committee recommendation to remove supervision. Current  
               law establishes a Naturopathic Formulary Advisory  
               Subcommittee (Subcommittee) to review naturopathic  
               education, training, and practice and make specific  
               recommendations regarding prescribing, ordering, furnishing  
               authority, and appropriate supervision protocols.  The  
               Subcommittee is composed of an equal number of  
               representatives from the clinical and academic settings of  
               physicians and surgeons, pharmacists, and naturopathic  
               doctors.  The Subcommittee presented its initial report in  
               2007.  

               This report found that there were a limited number of  
               physicians who had training in naturopathic philosophy or  
               practice or who have had the extensive clinical experience  
               in naturopathic modalities to make them appropriate  
               supervisors for NDs, and the few physicians who were  
               willing and well-trained for ND supervision had difficulty  
               getting malpractice coverage for supervision. The Committee  
               reported concerns from both physicians who had difficulty  
               getting malpractice insurance and NDs who had difficulty  
               finding supervision.  This was frustrating for  
               practitioners, as the Subcommittee noted that "malpractice  
               companies routinely insure MDs who supervise other medical  
               professionals such as nurse practitioners and physician  
               assistants, [who] have a lesser entry-level training and  
               education requirement than NDs."  The Subcommittee  
               concluded "the supervision provision is untenable," but at  
               that point did not recommend independent prescribing  
               privileges. 

               On January 1, 2014, the Subcommittee reported to the  
               Committee that it unanimously agreed to support elimination  
               of physician supervision and indicated: 

                    Since the original report we have had almost  
                    another 7 years of experience with the public  
                    receiving Naturopathic medical care in the state  
                    of California. The current scope does not put any  
                    restrictions on medications prescribed other than  
                    those listed in statute (exclusion of schedule 1  
                    & 2) or those agreed upon between the MD/NO in  
                    their supervision agreement. We have seen in the  








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                    last years an excellent safety record with no  
                    reports of patient harm or disciplinary action.   
                    Elimination of the MD supervision would remove  
                    barriers to access to care for patients of NDs  
                    unable to secure a supervising MD. The previous  
                    formulary report discussed NDs who are having  
                    difficulty finding an MD supervisor and MDs  
                    experiencing difficulty in securing malpractice  
                    coverage to do the supervision. They [the  
                    previous Subcommittee] concluded the supervision  
                    provision is untenable. ?. [Physician]  
                    supervision should be eliminated. 

                This bill, as proposed to be amended, is more  
               restrictive than the Subcommittee recommended, and  
               will allow an ND to furnish only Schedule IV-V drugs  
               and legend drugs, except chemotherapeutics, without  
               physician supervision or pursuant to standardized  
               procedures or protocols.  
           
          10)Expanded Minor Procedures Would Be Allowed.  Current law  
            authorizes an ND to provide repair and care incidental to  
            superficial lacerations and abrasions, except suturing,  
            and permits an ND to remove foreign bodies located in the  
            superficial tissues.  
            
            The Committee convened an advisory group in 2007  
            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 an ND should be  
            allowed to perform the following four additional  
            procedures:  
            1) prescribe and administer local anesthetic solutions,  
            their adjuncts and diluents; 2) removal of clinically  
            benign skin lesions; 3) repair of skin lacerations,  
            including suturing; and 4) incision and drainage of  
            abcess/trephination of subungual hematoma.  

             This bill, as proposed to be amended, largely tracks  
            these recommendations, but puts greater restrictions on  
            an ND to remove lesions.  The measure as proposed to be  
            amended would specify that an ND may perform operative  








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            procedures relative to superficial clinically benign  
            lesions less than one centimeter and not located on the  
            face.  It would also permit an ND to obtain samples of  
            tissue by shave, punch, or excisional biopsy, and utilize  
            the cervix as a route of administration, which would  
            clarify an ND's ability to administer common birth  
            control devices  .    
          

          SUPPORT AND OPPOSITION FOR  THE APRIL 6, 2015 BILL VERSION  :
          
           Support:  

          California Naturopathic Doctor Association (Sponsor)
          AARP
          California Naturopathic Medicine Committee 
          Bastyr University 
          Santa Cruz Naturopathic Medical Center 
          Stengler Center for Integrative Medicine 
          Washington Association of Naturopathic Physicians 
          Pediatric Association of Naturopathic Physicians 
          Paracelsus Natural Family Health Center 
          The Oncology Association of Naturopathic Physicians 
          Naturopathic Academy of Primary Care Physicians
          Endocrinology Association of Naturopathic Physicians 
          California Naturopathic Clinic
          Arizona Naturopathic Medical Association 
          Akasha Center for Integrative Medicine 
          American Association of Naturopathic Physicians 
          Center for Health Santa Cruz
          Southwest College of Naturopathic Medicine and Health Sciences
          National College of Natural Medicine
          1,155 Individuals 

           Opposition:  

          American Academy of Pediatrics
          American Congress of Obstetricians and Gynecologists  
          California Academy of Family Physicians
          California Chapter of the American College of Cardiology 
          California Chapter of the American College of Emergency  
          Physicians 
          California Medical Association 
          California Orthopaedic Association 








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          California Radiological Society 
          California Society of Anesthesiologists 
          California Society of Dermatology and Dermatologic Surgery
          California Society of Plastic Surgeons 
          Kaiser Permanente 


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