BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 622 Hearing Date: April 27,
2015
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|Author: |Hernandez |
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|Version: |April 9, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Optometry.
SUMMARY: Expands the scope of practice for optometrists to include
expanding ability to order tests, use pharmaceuticals --
including for off-label use, and perform laser and minor
procedures, and administer vaccines.
Existing law:
1)Establishes the State Board of Optometry (Board) within the
Department of Consumer Affairs, which licenses optometrists
and regulates the practice of optometry. (Business and
Professions Code (BPC) § 3010.5)
2)Authorizes the Board to establish educational and examination
requirements for licensure. (BPC § 3041.2)
3)Defines the practice of optometry as follows:
a) The prevention and diagnosis of disorders and
dysfunctions of the visual system;
b) Treatment and management of certain disorders and
dysfunctions of the visual systems;
c) Provision of rehabilitative optometric services;
d) Examination of the human eyes;
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e) Determination of the powers or range of human vision;
f) The prescribing or directing the use of any optical
device in connection with ocular exercises, visual
training, vision training or orthoptics;
g) Prescribing of contact lenses and glasses; and
h) The use of topical pharmaceutical agents for the purpose
of the examination of the human eye or eyes for any disease
or pathological condition. (BPC 3041)
4)Specifies that an optometrist who is certified to use
therapeutic pharmaceutical agents may also diagnose and treat
the human eye or eyes or any of its appendages for the
following conditions: infections; ocular allergies; ocular
inflammation, non-surgical in cause except when co-managed
with the treating physician and surgeon; traumatic or
recurrent conjunctival or corneal abrasions and erosions;
corneal surface disease and dry eyes; ocular pain,
non-surgical in cause except when co-managed with the treating
physician and surgeon; and glaucoma in patients over the age
of 18. (BPC § 3041(b)(1))
5)Permits optometrists to use specified therapeutic
pharmaceutical agents, including codeine with compounds and
hydrocodone with compounds provided that use does not exceed
three days. (BPC § 3041(c))
6)Specifies that an optometrist who is certified to use
therapeutic pharmaceutical agents may also perform the
following:
a) Corneal scraping with cultures;
b) Debridement of corneal epithelia;
c) Mechanical epilation;
d) Venipuncture for testing patients suspected of having
diabetes;
e) Suture removal, with prior consultation with the
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treating physician and surgeon;
f) Treatment or removal of sebaceous cysts by expression;
g) Administration of oral fluorescein to patients suspected
as having diabetic retinopathy;
h) Use of an auto-injector to counter anaphylaxis;
i) Ordering of smears, cultures, sensitivities, complete
blood count, mycobacterial culture, acid fast stain,
urinalysis, tear fluid analysis and X-rays necessary for
the diagnosis of conditions or diseases of the eye or
adnexa;
j) A clinical laboratory test or examination classified as
waived under CLIA [Clinical Laboratory Improvement
Amendments] necessary for the diagnosis of conditions and
diseases of the eye or adnexa;
aa) Punctal occlusion by plugs, excluding laser,
diathermy, cryotherapy or other means constituting surgery;
bb) The prescription of therapeutic contact lenses,
including lenses or devices that incorporate a medication
or therapy the optometrist is certified to prescribe or
provide;
cc) Removal of foreign bodies from the cornea, eyelid
and conjunctiva with any appropriate instrument other than
a scalpel or needle; and
dd) Lacrimal irrigation and dilation, excluding probing
of the nasal lacrimal tract for patients over 12 years of
age. (BPC § 3041(e))
This bill:
1)Adds "habilitative services" to the definition of the practice
of optometry.
2)Authorizes the Board to establish educational and examination
requirements for practices authorized in the Optometry
Practice Act, including determining education and examination
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requirements for the certifications established in the bill.
3)Authorizes the Board to allow optometrists to use nonsurgical
technology to treat a condition authorized by the Act.
4)Adds "conjunctival" to the types of surface diseases that an
optometrist who is certified to use therapeutic pharmaceutical
agents may diagnose and treat.
5)Removes exceptions to the types of infections of the anterior
segment and adnexa that an optometrist may treat.
6)Removes exceptions to the types of ocular inflammation,
nonsurgical in cause, that an optometrist may treat.
7)Allows an optometrist to treat eyelid disorders, including,
but not limited to, hypotrichosis and blepharitis.
8)Expands the number and type of drugs an optometrist certified
to use therapeutic pharmaceutical agents may use to include:
a) All oral and topical diagnostic and therapeutic
pharmaceutical agents that are not controlled substances.
The use of pharmaceutical agents shall be limited to the
use for which the drug has been approved for marketing by
the federal Food and Drug Administration (FDA).
b) Permits off-label drug use if all of the following
requirements are met:
i) The drug is approved by the FDA.
ii) The drug has been recognized for treatment of the
condition by either of the following:
iii) The American Hospital Formulary Service's Drug
Information.
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iv) Two articles from major peer reviewed medical
journals that present data supporting the proposed
off-label use or uses as generally safe and effective,
unless there is clear and convincing contradictory
evidence presented in a major peer reviewed medical
journal.
9)Extends from three to five days the time that codeine with
compounds and hydrocodone with specified compounds may be
used.
10)Allows an optometrist to collect a blood specimen by finger
prick method.
11)Authorizes an optometrist to order any clinical laboratory
and imaging tests, including those waived by CLIA, related to
the practice of optometry, rather than just specified types.
12)Permits an optometrist to perform a skin test on the
superficial lawyer of the skin to diagnose ocular allergies.
13)Allows an optometrist to prescribe biological or
technological corneal devices.
14)Allows an optometrist to use a needle to remove objects from
the cornea, eyelid, and conjunctiva.
15)Authorizes an optometrist to use mechanical lipid extraction
on meibomian glands and nonsurgical techniques.
16)Authorizes an optometrist to administer injections for the
diagnoses or treatment of conditions of the eye and adnexa,
excluding intraorbital injections and injections administered
for cosmetic effect, provided that the optometrist has
satisfactorily received four hours of continuing education.
17)Expands the definition of glaucoma by including an "increase
in intraocular pressure caused by steroid medication."
18)Establishes a certification process for an optometrist to
perform certain laser procedures.
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19)Establishes a certification course for an optometrist to
perform minor procedures. Minor procedures are defined as
removal, destruction, or drainage of lesions of the eyelid and
adnexa clinically evaluated by the optometrist to be
noncancerous, not involving the eyelid margin, lacrimal supply
or drainage systems, no deeper than the orbicularis muscle,
and smaller than five millimeters in diameter, and closure of
a wound, as specified.
20)Authorizes an optometrist to independently initiate and
administer vaccines listed on the routine immunization
schedules recommended by the federal Advisory Committee on
Immunization Practices (ACIP), in compliance with individual
ACIP vaccine recommendations, and published by the federal
Centers for Disease Control and Prevention (CDC) for persons
three years of age and older, if the optometrist does all of
the following:
a) Complete an immunization training program endorsed by
the CDC or the Accreditation Council for Pharmacy Education
that, at a minimum, includes hands-on injection technique,
clinical evaluation of indications and contraindications of
vaccines, and the recognition and treatment of emergency
reactions to vaccines, and shall maintain that training.
b) Be certified in basic life support for health care
professionals.
c) Comply with all state and federal recordkeeping and
reporting requirements, including providing documentation
to the patient's primary care provider and entering
information in the appropriate immunization registry
designated by the immunization branch of the State
Department of Public Health.
FISCAL
EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1)Purpose. This bill is sponsored by the Author . According to
the Author's office, "As a result of implementation of the
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ACA, about 3 million additional Californians are eligible for
health insurance and the recently insured are increasing
demand for health care on an already strained system.
Californians deserve timely access to high quality care
offered by a range of safe, efficient, and regulated
providers. In California we have a robust network of
providers that are well-trained, evenly distributed throughout
the state, regulated by the Department of Consumer Affairs and
well positioned to pay particular attention to currently
underserved areas. Optometrists are one such provider group
who receive a doctorate level training preparing them to be
primary eye care providers, and independently diagnose and
treat conditions of the eye. SB 622 will remove restrictions
in current law to permit optometrists to examine, prevent,
diagnose, and treat conditions and disorders of the visual
system and the human eye to the full extent of their training.
This includes the use of two types of therapeutic lasers by
optometrists with postdoctoral advanced certification that
have been developed for treatment of glaucoma and post-
surgical cataract care, conditions that disproportionately
affect patient groups that generally lack sufficient access to
physicians. SB 622 is a limited expansion of scope for
optometrists that is consistent with their education and
training, and is a logical advancement of the profession that
has been proven safe in other states."
2)The Practice of Optometry. An optometrist (Doctor of
Optometry or O.D.) is an independent primary health care
professional for the eye. Optometrists examine, diagnose,
treat, and manage diseases, injuries, and disorders of the
visual system, the eye, and associated structures, as well as
identify related systemic conditions affecting the eye. ODs
prescribe medications, low vision rehabilitation, vision
therapy, spectacle lenses, contact lenses, and perform certain
surgical procedures. Optometrists have a narrower scope of
practice than do ophthalmologists, but are held to the
identical standard of care for the same treatments they
provide.
An O.D. degree requires both an undergraduate education in a
college or university and four years of professional education
at a college of optometry. Some optometrists also undertake
an optional one year non-surgical residency program to enhance
their experience in a particular area. Students graduate with
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2,500-3,000 patient encounters; these include a mix of
post-surgical, medical and routine visits.
In order to be licensed to practice by the California Board of
Optometry, an individual must obtain an O.D. degree, pass the
three part National Board of Examiners in Optometry
examination, and the California Optometric State Law
Examination. There are currently 9,100 optometrists in
practice in California.
Optometrists are trained to diagnose mild to severe eye
problems such as serious eye infections, inflammations of the
eye, trauma, foreign bodies and glaucoma (pressure inside the
eyeball). They also examine the eye for vision prescription
and corrective lenses. Optometrists may also pursue any of
five additional state certifications to perform certain
advanced procedures: use of diagnostic pharmaceutical agents
(DPA); use of therapeutic pharmaceutical agents (TPA);
lacrimal irrigation and dilation for individuals over the age
of 12 + TPA (TPL); diagnosis and treatment of open angle
glaucoma for adults + TPA (TPG); and a combination of TPA, TPL
and TPG.
3)The Practice of Ophthalmology. An ophthalmologist is a
physician and surgeon who has specialty training in the
anatomy, function and diseases of the eye. The central focus
of ophthalmology is surgery and management of complex eye
diseases. An ophthalmologist specializes in the refractive,
medical and surgical care of the eyes and visual system, and
in the prevention of disease and injury.
To become an ophthalmologist, an individual must obtain an
undergraduate degree, complete four years of graduate
education at an accredited medical school and earn a Medical
Degree, complete a one year internship, and a three or four
year residency. Many ophthalmologists pursue additional
fellowship training in specialized areas such as the retina,
glaucoma treatment or the cornea. Ophthalmologists may become
certified by the American Board of Ophthalmology, which
requires serving as primary surgeon or first assistant to the
primary surgeon on a minimum of 364 eye surgeries.
There are currently 1,800-2,100 ophthalmologists in California,
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not all of whom are in active practice.
4)Prior Legislation. SB 492 (Hernandez) would have created an
advanced practice certificate, enabling optometrists to
perform a limited range of therapeutic laser procedures for
the eye and surgical procedures related to the eyelid, as well
as certain injections and immunizations, and generally revised
the Optometry Practice Act to clarify and expand the range of
an optometrist's scope of practice.
( Status: Held on the Assembly Floor.)
SB 1406 (Correa) (Chapter 352, Statutes of 2008) specified
permissible procedures for certified optometrists, and created
the Glaucoma Diagnosis and Treatment Advisory Committee to
establish glaucoma certification requirements.
SB 929 (Polanco) (Chapter 676, Statutes of 2000) expanded the
scope of lawful practice for optometrists by specifying
additional diseases and conditions that optometrists may treat
(in particular certain types of glaucoma) with specified
medications, and by specifying the extent of physician
involvement that is required under various circumstances.
SB 668 (Polanco) (Chapter 13, Statutes of 1996) expanded the
scope of practice of optometrists to provide for the diagnosis
and treatment of specified conditions or diseases of the human
eye or its appendages, and to use other therapeutic
pharmaceutical agents.
5)Arguments in Support. The California Optometric Association
writes, "Doctors of optometry have a critical role to play in
providing primary care and making the promise of the
Affordable Care Act a reality. They already provide the vast
majority of eye care in the Medi-Cal program and they are
located in all but one California county (Alpine). In order
to improve access to health care in California, we must
provide timely care where and when it's needed by utilizing
the full complement of our clinical abilities."
Western University of Health Sciences writes, "[SB 622] makes
sense. It requires the same, or higher, standards set by
residency education in ophthalmology. It ensures that doctors
of optometry will have the appropriate knowledge and skills
required to implement the new elements of care that are
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included in this bill. The legislation has checks and
balances in place to ensure that doctors of optometry can
safely provide these services to their patients.
6)Arguments in Opposition. The California Academy of Family
Physicians write, "Physicians see many benefits from working
collaboratively with other health care professionals to meet
patient care demand, but the framework of care delivery should
be within the scope of practice that each health care
professional is qualified to perform. Arbitrarily allowing
allied health care professionals to render services that are
beyond a provider's scope can lead to increased costs through
over-utilization of tests, over prescribing of medications,
and excess referrals to specialists; and in this case, the
potential for incredible harm to patients."
The California Medical Association writes, "Optometrists serve
an important function in the health care community.
Specifically, optometrists are health practitioners involved
exclusively with vision problems, including examining the eyes
to determine the presence of vision problems, determining
visual acuity, and prescribing spectacles, contact lenses, and
eye exercises. SB 622 proposes expanding the optometrist
scope of practice to include a wide range of services that
optometrists simply do not have the education, training, and
experience to provide."
7)Author's Proposed Amendments: Following lengthy negotiations
with stakeholders, the Author is proposing the following
amendments:
a) Authorizes the Board to establish educational and
examination requirements by regulation for licensure to
ensure the competence of optometrists to practice pursuant
to the Act, except as specified in the sections related to
certification for minor procedures and lasers.
b) Authorizes the Board to promulgate regulations
authorizing optometrists to use noninvasive, nonsurgical
technology to treat a condition authorized by the Act. To
qualify to use each new technology authorized, the Board
shall require a licensee to take a minimum of four hours'
education and perform an appropriate number of complete
clinical procedures on live human patients.
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c) Removes referral requirements related to the treatment
of ocular inflammation, as specified.
d) Allows an optometrist to treat hypotrichosis and
blepharitis.
e) Restores current law related to the use of drugs.
f) Removes referral protocols for the use of certain drugs.
g) Restores ordering of additional tests to existing law,
but expands ability to order CLIA waived tests.
h) Authorizes an optometrist, as part of additional "minor
procedures," to administer injections for the diagnosis or
treatment of conditions of the eye and adnexa authorized by
the Act, excluding intraorbital injections and injections
administered for cosmetic effect.
i) Expands the definition of glaucoma by including that
caused by an "increase in intraocular pressure caused by
steroid medication," but specifies that an optometrist may
only treat this type of glaucoma if the optometrist has
prescribed the steroid, or has consulted with and received
approval from, the prescriber.
j) Establishes a certification process for an optometrist
to perform certain laser procedures, requiring 25 hours of
education and 24 complete clinical procedures on live human
patients.
aa) Establishes continuing education hours for optometrists
certified to perform laser procedures.
bb) Establishes a certification course for an optometrist to
perform minor procedures. Minor procedures are defined as
removal, destruction, or drainage of lesions of the eyelid
and adnexa clinically evaluated by the optometrist to be
noncancerous, not involving the eyelid margin, lacrimal
supply or drainage systems, no deeper than the orbicularis
muscle, and smaller than five millimeters in diameter, and
closure of a wound, as specified. Specifies that minor
procedures do not include blepharoplasty or other cosmetic
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surgery procedures that reshape normal structures of the
body in order to improve appearance and self-esteem.
Requires 25 hours of education and 32 complete clinical
procedures on live human patients.
cc) Establishes continuing education requirements for
optometrists certified to perform minor procedures.
dd) Authorizes an optometrist to earn a certificate to
administer immunizations for influenza, herpes zoster, and
pneumococcus if the optometrist does all of the following:
i) Completes an immunization training program endorsed
by the CDC, or the Accreditation Council for Pharmacy
Education that, at a minimum, includes hands-on injection
technique, clinical evaluation of indications and
contraindications of vaccines, and the recognition and
treatment of emergency reactions to vaccines, and shall
maintain that training.
ii) Is certified in basic life support for health care
professionals.
iii) Complies with all state and federal recordkeeping
and reporting requirements, including providing
documentation to the patient's primary care provider and
entering information in the appropriate immunization
registry designated by the immunization branch of the
State Department of Public Health.
a) Declares as unprofessional conduct the failure for an
optometrist to refer a patient to an appropriate physician
if an examination of the eyes indicates a substantial
likelihood of any pathology that requires the attention of
that physician.
SUPPORT AND OPPOSITION:
Support:
California Optometric Association
Western University of Health Sciences
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Opposition:
American Federation of State, County and Municipal Employees
(AFSCME)
Blind Childrens Center
California Academy of Eye Physicians & Surgeons (CAEPS)
California Academy of Family Physicians (CAFP)
California Medical Association (CMA)
California Society of Plastic Surgeons (CSPS)
Latino Physicians of California (LPOC)
Ventura County American Chinese Medical Dental Association (VC
AC M/D)
Numerous Individuals
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