BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 538| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- 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 SB 538 Page 2 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. SB 538 Page 3 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 SB 538 Page 4 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 SB 538 Page 5 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 SB 538 Page 6 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 SB 538 Page 7 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 **** END ****