BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 538 Hearing Date: April 27,
2015
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|Author: |Block |
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|Version: |April 16, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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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))
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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.
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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
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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:
a) The Healing Power of Nature: NDs trust in the body's
inherent wisdom to heal itself.
b) Identify and Treat the Cause: Look beyond the symptoms
to effectively address the underlying cause(s) of illness.
c) First Do No Harm: Seek to utilize the most natural,
least invasive and least toxic therapies first.
d) 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.
e) Treat the Whole Person: Total health includes physical,
emotional, mental, genetic, environmental, social,
spiritual, and other factors.
f) 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
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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
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and his or her supervising physician and surgeon. A physician
may supervise up to four NDs at a time.
a) 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.
b) 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
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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.
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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
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hired additional staff and reports substantial compliance with
the 2013 Sunset concerns.
7.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."
8.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."
9.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
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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
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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)
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