BILL ANALYSIS Ó
SB 538
Page 1
SENATE THIRD READING
SB
538 (Hueso)
As Amended August 15, 2016
Majority vote
SENATE VOTE: 21-9
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Business & |8-4 |Bonilla, Jones, Dodd, |Baker, Chang, |
|Professions | |Eggman, Holden, |Gatto, Wilk |
| | |Mullin, Ting, Wood | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |11-1 |Bonilla, Calderon, |Bigelow |
| | |Eggman, Gallagher, | |
| | |Eduardo Garcia, | |
| | |Holden, Jones, | |
| | |Obernolte, Quirk, | |
| | |Wagner, Wood | |
| | | | |
| | | | |
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SUMMARY: Authorizes Naturopathic Doctors (NDs) to prescribe
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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:
a) 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,
b) The ND has a license in good standing and has practiced
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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,
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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
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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
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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,
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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
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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
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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