(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes and to order diagnostic imaging studies, consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling.

This bill would, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified. The bill would require the period of supervision of a naturopathic doctor for the administering, furnishing, ordering, or prescribing of Schedule III and Schedule IV drugs to be 12 months, after which the naturopathic doctor would be authorized to prescribe independently. The bill would waive from that supervision requirement a naturopathic doctor who has completed a residency program, as specified, or who has practiced for at least 12 months in another state where independent prescribing is within a naturopathic doctors scope of practice. drugs. The bill would authorize a naturopathic doctor to administer, furnish, order, or prescribe Schedule III and Schedule IV controlled substances pursuant to a standardized procedure or protocol and under the supervision of a physician and surgeon, as specified.

(3)Existing law, notwithstanding any provision of the Naturopathic Doctors Act, authorizes a naturopathic doctor to independently prescribe and administer certain things, including, among others, epinephrine to treat anaphylaxis.

This bill would additionally authorize a naturopathic doctor to independently prescribe and administer all legend drugs and administer, furnish, order, or prescribe Schedule V controlled substances after 12 months of supervision, residency, or practice in a state that allows a naturopathic doctor to prescribe medications independently. and any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified, after the completion of 12 months of physician and surgeon supervision, as specified, and would waive that supervision requirement for a naturopathic doctor who has completed a residency program, as specified, or who has a license in good standing and practiced for at least 12 months in another state where independent prescribing is within a naturopathic doctors scope of practice in that other state.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes and to order diagnostic imaging studies, consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling.

This bill would, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified. The bill would require the period of supervision of a naturopathic doctor for the administering, furnishing, ordering, or prescribing of Schedule III and Schedule IV drugs to be 12 months, after which the naturopathic doctor would be authorized to prescribe independently. The bill would waive from that supervision requirement a naturopathic doctor who has completed a residency program, as specified, or who has practiced for at least 12 months in another state where independent prescribing is within a naturopathic doctors scope of practice.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes and to order diagnostic imaging studies, consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling.

This bill would, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes and to order diagnostic imaging studies, consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling.

This bill would, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish, furnish devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes, purposes and to order diagnostic imaging studies, as specified. consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling. The act also authorizes a naturopathic doctor to utilize routes of administration that include, among others, intramuscular.

This bill would revise and recast those provisions and would expressly, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish, or perform parenteral therapy and minor procedures. The bill would define terms for those purposes. The bill would authorize a naturopathic doctor to use a cervical route of administration only for the purpose of administering barrier contraception. devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule IV through Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes, and to order diagnostic imaging studies, as specified. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling. The act also authorizes a naturopathic doctor to utilize routes of administration that include, among others, intramuscular.

This bill would revise and recast those provisions and would expressly authorize a naturopathic doctor to order, perform, review, and interpret the results of diagnostic procedures commonly used by physicians and surgeons in general practice and to dispense, administer, order, prescribe, provide, furnish, or perform parenteral therapy and minor procedures, among other duties. procedures. The bill would include cervical routes of administration among the authorized routes of administration. The bill would define terms for those purposes. The bill would authorize a naturopathic doctor to use a cervical route of administration only for the purpose of administering barrier contraception.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from furnishing, prescribing, administering, or ordering administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon. surgeon for Schedule IV through Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled for prescription only, except chemotherapeutics, that is not classified.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes, and to order diagnostic imaging studies, as specified.

This bill would revise and recast those provisions and would expressly authorize a naturopathic doctor to order, perform, review, and interpret the results of diagnostic procedures commonly used by physicians and surgeons in general practice and to dispense, administer, order, prescribe, provide, furnish, or perform parenteral therapy and minor procedures, among other duties. The bill would include cervical routes of administration among the authorized routes of administration. The bill would define terms for those purposes.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from furnishing, prescribing, administering, or ordering drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete the other certain provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon.

(1)Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes, and to order diagnostic imaging studies, as specified.

This bill would revise and recast those provisions and would expressly authorize a naturopathic doctor to order, perform, review, and interpret the results of diagnostic procedures commonly used by physicians and surgeons in general practice and to dispense, administer, order, prescribe, provide, furnish, or perform parenteral therapy and minor procedures, among other duties. The bill would include cervical routes of administration among the authorized routes of administration. The bill would define terms for those purposes.

(2)Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in ScheduleV.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from furnishing, prescribing, administering, or ordering drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete the other provisions described above restricting the authority of naturopathic doctors to furnish or order drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon.

SENATE THIRD READING

STR Bill Id:

Author:(Hueso)

As Amended Ver:6

Majority vote

SENATE VOTE: 21-9

SUMMARY: Authorizes Naturopathic Doctors (NDs) to prescribe specified prescription drugs independently of physician supervision after 12 months of physician supervision, unless an ND meets specified exemption requirements to prescribe independently without meeting the 12 month supervision requirement. Specifically, this bill:

1. Permits an ND to order diagnostic imaging studies consistent with the practice of naturopathic medicine instead of as determined by the Naturopathic Medicine Committee (NMC).
2. Defines "devices" to include specified equipment consistent with the naturopathic training as determined by the NMC.
3. Prohibits a physician and surgeon from supervising more than four NDs at one time.
4. Authorizes an ND to independently administer, furnish, order or prescribe Schedule V controlled substances and any drug approved by the federal Food and Drug Administration and labeled "for prescription only" or words of similar import, except chemotherapeutics, as specified, after the completion of 12 consecutive months of supervision by a physician and surgeon.
5. Specifies that the supervision requirements for 1) above, follow the same procedures and protocols as specified in Business and Professions Code Section 3640.5.
6. Waives the supervision requirements specified in 1) above, if either:
   1. The ND has completed a residency program of at least 12 months that is approved by the Council on Naturopathic Medical Education or any other agency approved by the Naturopathic Medicine Committee; or,
   2. The ND has a license in good standing and has practiced for at least 12 months in another state where independent prescribing of the substances and drugs, as specified, is permitted for an ND in that other state.
7. Makes other technical amendments.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill will result in Minor and absorbable costs to the Osteopathic Medical Board to oversee the new requirements (Naturopathic Doctors Fund).

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. [United States] 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 [magnetic resonance imaging], mammograms, etc.), draw blood, and perform CLIA [Clinical Laboratory Improvement Amendments]-waived laboratory testing in-office, administer IVs [intravenous] 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."

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 Osteopathic Medical Board (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 Department of Consumer Affairs 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. As currently drafted, this bill seeks to remove the physician supervision requirement, after completion of 12 consecutive months of supervision, for NDs who wish to prescribe Schedule V, and those drugs approved by the federal Food and Drug Administration labeled "for prescription only". This bill would maintain the supervision requirements for NDs who wish to prescribe all other currently authorized drugs under current law.

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. An 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 an ND in California, an individual must meet educational and training requirements including 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."

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.

According to the U.S. Drug Enforcement Agency, drugs, substances, and certain chemicals used to make drugs are classified into five 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. This bill would authorize NDs to independently administer, furnish, order or prescribe Schedule V controlled substances, as specified, and those drugs which are approved by the federal Food and Drug Administration and labeled "for prescription only" independently after completion of 12 consecutive months of physician supervision. For those NDs who have completed an approved residency program or have a license from another state in good standing with independent prescribing authority, they are exempt from the 12-month supervision requirement.

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.

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 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 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 NDs. 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 part of the proposals in the NMC's last sunset report by and removing physician supervision for the furnishing and ordering of specified drugs after a 12-month supervision period. The NMC's next sunset review is scheduled to take place in 2017.

Analysis Prepared by: Elissa Silva / B. & P. / (916) 319-3301 FN: 0004509

Date of Hearing: August 10, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 538

Author:(Hueso) – As Amended Ver:August 4, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

As proposed to be amended, this bill provides a minor expansion of the scope of practice for naturopathic doctors (NDs). Specifically, this bill:

1. After a 12-month period of supervision by a physician, allows NDs to prescribe Schedule V drugs (those with some, albeit low, potential for abuse) and drugs that are not classified on the DEA schedule, without physician supervision.
2. Provides the period of supervision must be waived if: (a) the naturopathic doctor has completed an approved residency program of at least 12 months, or (b) the naturopathic doctor has practiced for at least 12 months in another state where independent prescribing is within the scope of naturopathic doctors. Specifies this supervision period must be completed once.
3. Modifies under what circumstances an ND may order diagnostic imaging studies and dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment.

FISCAL EFFECT:

Minor and absorbable costs to the Osteopathic Medical Board to oversee the new requirements (Naturopathic Doctors Fund).

COMMENTS:

1. Purpose. This bill intends to remove barriers for patients seeking medical care from licensed NDs, by allowing them to prescribe routine and low-risk medications, such as blood pressure medications and antibiotics, without a written supervision agreement after a 12-month period of supervision. It also allows independent prescribing of such drugs if a specified residency program has been completed, or if an ND has practiced for 12 months in another state where independent prescribing is within their scope.
2. Naturopathic Doctors. NDs are licensed and regulated by the Naturopathic Medicine Committee within the Osteopathic Medical Board. NDs must complete four years of post-graduate training and take a national standardized licensing examination, but they are not required to complete a residency training program, as are medical doctors.

An 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.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by a supervising physician. Naturopathic doctors can order diagnostic imaging studies such as x-rays, but must refer those studies to a properly licensed health care professional to interpret the results.

1. Drug Schedules. Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are the least dangerous. Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).
2. Prior Legislation. SB 1446 (McCleod), Chapter 333, Statutes of 2012, allowed NDs to independently prescribe and administer vitamins, minerals, amino acids, and other substances.
3. Recent Amendments. Amendments taken August 4^th, 2016 add a 12-month period of physician supervision, with certain exceptions, prior to allowing independent prescribing.
4. Support. This bill is sponsored by the California Naturopathic Doctors Association and supported by numerous natural and integrative medicine groups. They support the ability of NDs to offer more expansive primary care services.
5. Opposition. Numerous groups representing physicians, as well as Kaiser Permanente, opposed a previous version of this bill. Amendments taken in the Assembly Business and Professions on August 17, 2015 removed many of the opposition's concerns. However, some physician groups remain opposed to the expansion of NDs' prescribing abilities, citing the belief NDs are inadequately prepared to prescribe the specified drugs without supervision.
6. Author amendments. The author notes the August 4^th amendments to the bill inadvertently add independent prescribing to the subdivision related to Schedule III and IV drugs, instead of the subdivision related to Schedule V and legend drugs. The author proposes amendments to correct this error, such that the supervision requirement for prescribing Schedule III and IV drugs will remain the same as current law. The amendments also clarify the supervision period must be completed once.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: August 3, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 538

Author:(Hueso) – As Amended Ver:June 29, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

FOR VOTE ONLY

SUMMARY:

This bill provides a minor expansion of the scope of practice for naturopathic doctors (NDs). Specifically, this bill:

1. Allows NDs to prescribe Schedule V drugs (those with some, albeit low, potential for abuse) and drugs that are not classified on the DEA schedule, without physician supervision.
2. Modifies under what circumstances an ND may order diagnostic imaging studies and dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment.

FISCAL EFFECT:

Minor and absorbable costs to the Osteopathic Medical Board to oversee the new requirements (Naturopathic Doctors Fund).

COMMENTS:

1. Purpose. This bill intends to remove barriers for patients seeking medical care from licensed NDs, by allowing them to prescribe routine and low-risk medications, such as blood pressure medications and antibiotics, without a written supervision agreement.
2. Naturopathic Doctors. NDs are licensed and regulated by the Naturopathic Medicine Committee within the Osteopathic Medical Board. NDs must complete four years of post-graduate training and take a national standardized licensing examination, but they are not required to complete a residency training program, as are medical doctors. An 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.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by a supervising physician. Naturopathic doctors can order diagnostic imaging studies such as x-rays, but must refer those studies to a properly licensed health care professional to interpret the results.

1. Drug Schedules. Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are the least dangerous. Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).
2. Prior Legislation. SB 1446 (McCleod), Chapter 333, Statutes of 2012) allowed NDs to independently prescribe and administer vitamins, minerals, amino acids, and other substances.
3. Recent Amendments. Amendments taken June 29, 2016 simply change authorship and make a technical change; the current content of the bill is largely the same as the August 17, 2015 version.
4. Support. This bill is sponsored by the California Naturopathic Doctors Association and supported by numerous natural and integrative medicine groups. They support the ability of NDs to offer more expansive primary care services.
5. Opposition. Numerous groups representing physicians, as well as Kaiser Permanente, opposed a previous version of this bill. Amendments taken in the Assembly Business and Professions on August 17, 2015 removed many of the opposition's concerns. However, some physician groups remain opposed to the expansion of NDs' prescribing abilities, citing the belief NDs are inadequately prepared to prescribe the specified drugs without supervision.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: August 26, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

SBPCA Bill Id:SB 538

Author:(Block) – As Amended Ver:August 17, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill provides a minor expansion of the scope of practice for naturopathic doctors (NDs). Specifically, this bill:

1. Allows NDs to prescribe Schedule V drugs (those with some, albeit low, potential for abuse) and drugs that are not classified on the DEA schedule, without physician supervision.

2. Modifies under what circumstances an ND may order diagnostic imaging studies and dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment.

FISCAL EFFECT:

Minor and absorbable costs to the Osteopathic Medical Board to oversee the new requirements (Naturopathic Doctors Fund).

COMMENTS:

1. Purpose. This bill intends to remove barriers for patients seeking medical care from licensed NDs, by allowing them to prescribe routine and low-risk medications, such as blood pressure medications and antibiotics, without a written supervision agreement.

2. Naturopathic Doctors. NDs are licensed and regulated by the Naturopathic Medicine Committee within the Osteopathic Medical Board. NDs must complete four years of post-graduate training and take a national standardized licensing examination, but they are not required to complete a residency training program, as are medical doctors. An 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.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by a supervising physician. Naturopathic doctors can order diagnostic imaging studies such as x-rays, but must refer those studies to a properly licensed health care professional to interpret the results.

3. Drug Schedules. Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are the least dangerous. Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).

4. Prior Legislation. SB 1446 (McCleod), Chapter 333, Statutes of 2012) allowed NDs to independently prescribe and administer vitamins, minerals, amino acids, and other substances.

5. Support. This bill is sponsored by the California Naturopathic Doctors Association and supported by numerous natural and integrative medicine groups. They support the ability of NDs to offer more expansive primary care services.

6. Opposition. Numerous groups representing physicians, as well as Kaiser Permanente, opposed a previous version of this bill. The bill was substantially amended in Assembly Business and Professions to remove many of the opposition's concerns. Some of the groups were opposed to the expansion of NDs' prescribing abilities, which remains in the bill. They cite the belief NDs are inadequately prepared to prescribe drugs without supervision.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: August 19, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

SBPCA Bill Id:SB 538

Author:(Block) – As Amended Ver:August 17, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill provides a minor expansion of the scope of practice for naturopathic doctors (NDs). Specifically, this bill:

1. Allows NDs to prescribe Schedule V drugs (those with some, albeit low, potential for abuse) and drugs that are not classified on the DEA schedule, without physician supervision.

2. Modifies under what circumstances an ND may order diagnostic imaging studies and dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment.

FISCAL EFFECT:

Minor and absorbable costs to the Osteopathic Medical Board to oversee the new requirements (Naturopathic Doctors Fund).

COMMENTS:

1. Purpose. This bill intends to remove barriers for patients seeking medical care from licensed NDs, by allowing them to prescribe routine and low-risk medications, such as blood pressure medications and antibiotics, without a written supervision agreement.

2. Naturopathic Doctors. NDs are licensed and regulated by the Naturopathic Medicine Committee within the Osteopathic Medical Board. NDs must complete four years of post-graduate training and take a national standardized licensing examination, but they are not required to complete a residency training program, as are medical doctors. An 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.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by a supervising physician. Naturopathic doctors can order diagnostic imaging studies such as x-rays, but must refer those studies to a properly licensed health care professional to interpret the results.

3. Drug Schedules. Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are the least dangerous. Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).

4. Prior Legislation. SB 1446 (McCleod), Chapter 333, Statutes of 2012) allowed NDs to independently prescribe and administer vitamins, minerals, amino acids, and other substances.

5. Support. This bill is sponsored by the California Naturopathic Doctors Association and supported by numerous natural and integrative medicine groups. They support the ability of NDs to offer more expansive primary care services.

6. Opposition. Numerous groups representing physicians, as well as Kaiser Permanente, opposed a previous version of this bill. The bill was substantially amended in Assembly Business and Professions to remove many of the opposition's concerns. Some of the groups were opposed to the expansion of NDs' prescribing abilities, which remains in the bill. They cite the belief NDs are inadequately prepared to prescribe drugs without supervision.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: June 30, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

SBPCA Bill Id:SB 538

Author:(Block) – As Amended Ver: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 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)

   1. The drugs are furnished or ordered by a ND in accordance with standardized procedures or protocols developed by the ND and his or her supervising physician and surgeon;

   2. 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;

   3. 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;

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

   5. 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,

   6. 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 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))

    1. Collaboration on the development of the standardized procedure;

    2. Approval of the standardized procedure; and,

    3. 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:

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

2. Clarifies that a ND may provide, in addition to dispense, administer, order, or furnish, specified extracts, hydrotherapies and devices consistent with the naturopathic training as determined by the NMC.

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

4. 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.

5. 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.

6. 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.

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

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 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.

10. 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.

11. 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.

12. 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."

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, 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 12^th 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 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 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 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.

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 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.

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 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 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."

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. 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 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 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.

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

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

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

 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 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 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.

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 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 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.: Yes Local: 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: (Verified 5/26/15)

California Naturopathic Doctors Association (source)

AARP

Akasha Center for Integrative Medicine

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: (Verified 5/26/15)

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 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

5/31/15 12:13:32

**** END ****

 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 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 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.

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 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 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.: Yes Local: 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: (Verified 5/26/15)

California Naturopathic Doctors Association (source)

AARP

Akasha Center for Integrative Medicine

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: (Verified 5/26/15)

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 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 ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 538 (Block) - Naturopathic doctors

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

SB 538 would expand the scope of practice for naturopathic doctors, to allow them to prescribe certain drugs without physician supervision and to perform minor procedures.

Fiscal Impact:

• 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.

Background:

Under current law, naturopathic doctors are licensed and regulated by the Naturopathic Medicine Committee, which is within the Osteopathic Medical Board. Naturopathic doctors must complete four years of post-graduate training and take a national standardized licensing examination. Naturopathic doctors are not required to complete a residency training program, as are medical doctors.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by the naturopathic doctor’s supervising physician. Naturopathic doctors can order diagnostic imaging studies (e.g. x-rays), but must refer those studies to a properly licensed health care professional to interpret the results.

Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are considered the least dangerous. Schedule IV drugs include mild narcotics, depressants, stimulants, and tranquilizers (such as Xanax, Ambien, and Valium). Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).

Proposed Law:

SB 538 would expand the scope of practice for naturopathic doctors, to allow them to prescribe certain drugs without physician supervision and to perform minor procedures.

Specific provisions of the bill would:

• Expand the kinds of imaging studies a naturopathic doctor can order;

• Authorize a naturopathic doctor to perform operative procedures relative to superficial lacerations, certain superficial lesions, and superficial abrasions;

• Authorize a naturopathic doctor to prescribe, administer, or order Schedule IV, V, and unclassified prescription drugs without physician supervision.

Related Legislation:

SB 1446 (McCleod, Statutes of 2012) allows naturopathic doctors to independently prescribe and administer vitamins, minerals, amino acids, and other substances.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 538 (Block) - Naturopathic doctors

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

SB 538 would expand the scope of practice for naturopathic doctors, to allow them to prescribe certain drugs without physician supervision and to perform minor procedures.

Fiscal Impact:

• 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.

Background:

Under current law, naturopathic doctors are licensed and regulated by the Naturopathic Medicine Committee, which is within the Osteopathic Medical Board. Naturopathic doctors must complete four years of post-graduate training and take a national standardized licensing examination. Naturopathic doctors are not required to complete a residency training program, as are medical doctors.

Under current law, naturopathic doctors can furnish or prescribe Schedule III – V drugs, in accordance with standardized procedures established by the naturopathic doctor’s supervising physician. Naturopathic doctors can order diagnostic imaging studies (e.g. x-rays), but must refer those studies to a properly licensed health care professional to interpret the results.

Drugs are classified into five schedules depending on the drug’s medical use and potential for abuse or dependency. Schedule I drugs are considered the most dangerous and Schedule V are considered the least dangerous. Schedule IV drugs include mild narcotics, depressants, stimulants, and tranquilizers (such as Xanax, Ambien, and Valium). Schedule V drugs include drugs with limited quantities of narcotic and stimulant drugs (such as cough syrups with codeine).

Proposed Law:

SB 538 would expand the scope of practice for naturopathic doctors, to allow them to prescribe certain drugs without physician supervision and to perform minor procedures.

Specific provisions of the bill would:

• Expand the kinds of imaging studies a naturopathic doctor can order;

• Authorize a naturopathic doctor to perform operative procedures relative to superficial lacerations, certain superficial lesions, and superficial abrasions;

• Authorize a naturopathic doctor to prescribe, administer, or order Schedule IV, V, and unclassified prescription drugs without physician supervision.

Related Legislation:

SB 1446 (McCleod, Statutes of 2012) allows naturopathic doctors to independently prescribe and administer vitamins, minerals, amino acids, and other substances.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: SB 538 Hearing Date: April 27, 2015

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 perform minor procedures.

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 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. 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.

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.

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:

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.

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 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. 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.

1. 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.

2. 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 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 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.

5. 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 largely tracks these recommendations, but puts greater restrictions on an ND to remove lesions. This bill would specify that an ND may perform operative 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.

6. 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 the guidelines 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.

6. Arguments in Support. The California Naturopathic Doctors Association writes, “The vast majority of naturopathic doctors practice primary care medicine. Unfortunately, current law 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 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.”

6. 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 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.

SUPPORT AND OPPOSITION:

Support:

California Naturopathic Doctor Association (Sponsor)

AARP

Akasha Center for Integrative Medicine

American Association of Naturopathic Physicians

Arizona Naturopathic Medical Association

Bastyr University

California Chiropractic Association (CCA)

California Naturopathic Clinic

California Naturopathic Medicine Committee

Center for Health Santa Cruz

Endocrinology Association of Naturopathic Physicians

Integrative Medicine for the Underserved (IM4US)

National College of Natural Medicine

Naturopathic Academy of Primary Care 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

The Oncology Association of Naturopathic Physicians

Washington Association of Naturopathic Physicians

Women’s View Medical Group, Inc.

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

California Radiological Society

California Society of Anesthesiologists

California Society of Dermatology and Dermatologic Surgery

California Society of Plastic Surgeons

Kaiser Permanente

Osteopathic Physicians and Surgeons of California (OPSC)

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: SB 538 Hearing Date: April 13, 2015

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 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:

1. Venipuncture.

2. Electrocardiograms.

3. 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.

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:

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.

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 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.

4. Arguments in Support. The California Naturopathic Doctors Association writes, “The vast majority of naturopathic doctors practice primary care medicine. Unfortunately, current law 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.”

4. 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.”

4. 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 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):
   
   

   1. 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.

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

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

4. 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.

5. 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.

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

8. 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.

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

10. 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.

1. 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.

2. 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 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 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

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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