BILL ANALYSIS                                                                                                                                                                                                    Ó






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          |SENATE RULES COMMITTEE            |                        SB 538|
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                                   THIRD READING 


          Bill No:  SB 538
          Author:   Block (D), et al.
          Amended:  4/16/15  
          Vote:     21  

           SENATE BUS, PROF. & ECON. DEV. COMMITTEE:  5-2, 4/27/15
           AYES:  Hill, Block, Galgiani, Hernandez, Wieckowski
           NOES:  Bates, Berryhill
           NO VOTE RECORDED:  Jackson, Mendoza

           SENATE APPROPRIATIONS COMMITTEE:  5-2, 5/26/15
           AYES:  Lara, Beall, Hill, Leyva, Mendoza
           NOES:  Bates, Nielsen

           SUBJECT:   Naturopathic doctorsNaturopathic doctors.


          SOURCE:    California Naturopathic Doctors Association


          DIGEST:  This bill expands the scope of practice for a  
          naturopathic doctor, including allowing a naturopathic doctor to  
          prescribe certain drugs without physician supervision and  
          perform minor procedures.  


          ANALYSIS:   


          Existing law:

           1)  Establishes the Naturopathic Medicine Committee (Committee)  
              within the Osteopathic Medical Board to enforce and  








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              administer the Naturopathic Doctors 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)  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))   

          This bill:

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

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

            3)  Authorizes an ND to utilize the cervix as a route of  
              administration.

            4)  Authorizes 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.  

            5)  Authorizes 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.

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

            7)  Prohibits an ND from any procedures using general or  
              spinal anesthesia, sclerotherapy, or procedures involving  
              the eye.  







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            8)  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.  

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

            10) Requires an ND to be subject to peer review reporting  
              provisions.
          Background

          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. 

          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.  

          Changes to furnishing authority of a ND.  Current law allows an  
          ND to furnish or order legend drugs and Schedule III - V and  
          drugs in accordance with standardized procedures or protocols  







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          developed by the naturopathic doctor and his or her supervising  
          physician and surgeon.  A physician may supervise up to four NDs  
          at a time.  

          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.  "Legend" drugs are controlled  
          substances but have even less potential for abuse than Schedule  
          V drugs.  
               
          Naturopathic 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 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.

          This bill 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.  
          
          Expanded minor procedures would be allowed.  Current law  
          authorizes an ND to provide repair and care incidental to  







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          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 abscess/trephination of subungual  
          hematoma.  

          This bill largely tracks these recommendations, but puts  
          greater restrictions on an ND to remove lesions.  It also  
          permits an ND to obtain samples of tissue by shave, punch,  
          or excisional biopsy, and utilize the cervix as a route of  
          administration, which will clarify an ND's ability to  
          administer common birth control devices.    

          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   No

          According to the Senate Appropriations Committee, this bill has  
          unknown additional enforcement costs to the Committee  
          (Naturopathic Doctors Fund).  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 Committee from  
          patients that will require investigation and potential  
          disciplinary action.  The extent to which this will occur is not  
          known.


          SUPPORT:   (Verified5/26/15)


          California Naturopathic Doctors Association (source)
          AARP
          Akasha Center for Integrative Medicine 







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          American Association of Naturopathic Physicians 
          Arizona Naturopathic Medical Association 
          Bastyr University 
          California Chiropractic Association 
          California Naturopathic Clinic
          California Naturopathic Medicine Committee 
          Center for Health Santa Cruz
          Endocrinology Association of Naturopathic Physicians 
          Integrative Medicine for the Underserved 
          National College of Natural Medicine
          Naturopathic Academy of Primary Care Physicians
          Oncology Association of Naturopathic Physicians 
          Paracelsus Natural Family Health Center 
          Pediatric Association of Naturopathic Physicians 
          Santa Cruz Naturopathic Medical Center 
          Southwest College of Naturopathic Medicine and Health Sciences
          Stengler Center for Integrative Medicine 
          Washington Association of Naturopathic Physicians 
          Women's View Medical Group, Inc.
          Numerous individuals 


          OPPOSITION:   (Verified5/26/15)


          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 
          California Radiological Society 
          California Society of Anesthesiologists 
          California Society of Dermatology and Dermatologic Surgery
          California Society of Plastic Surgeons 
          Kaiser Permanente 
          Medical Board of California
          Osteopathic Physicians and Surgeons of California

          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?. It is therefore vital to improve  
          patient access to licensed primary care doctors who are trained  
          to independently perform all primary care needs."  


          ARGUMENTS IN OPPOSITION:     The California Medical Association  
          and the California Academy of Family Physicians were in  
          opposition to the prior version of this bill and stated the  
          following:  "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."

          Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
          5/27/15 14:54:35


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