BILL ANALYSIS Ó SB 538 Page 1 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 SB 538 Page 2 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 SB 538 Page 3 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 SB 538 Page 4 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, SB 538 Page 5 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. SB 538 Page 6 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." SB 538 Page 7 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, SB 538 Page 8 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 SB 538 Page 9 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 SB 538 Page 10 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 SB 538 Page 11 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. SB 538 Page 12 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 SB 538 Page 13 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. SB 538 Page 14 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 SB 538 Page 15 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 SB 538 Page 16 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." SB 538 Page 17 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. SB 538 Page 18 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 SB 538 Page 19 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 SB 538 Page 20 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. SB 538 Page 21 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 SB 538 Page 22 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 SB 538 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