BILL ANALYSIS �
-----------------------------------------------------------------------
|Hearing Date:April 29, 2013 |Bill No:SB |
| |492 |
-----------------------------------------------------------------------
SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 492Author:Hernandez
As Amended:April 24, 2013 Fiscal:Yes
SUBJECT: Optometrist: practice: licensure.
SUMMARY: Permits an optometrist to diagnose, treat and manage
additional conditions with ocular manifestations; directs the
California Board of Optometry to establish educational and examination
requirements and permits optometrists to perform vaccinations and
surgical and non-surgical primary care procedures.
Existing law:
1)Establishes the California Board of Optometry (Board), within the
Department of consumer Affairs, which licenses optometrists and
regulates the practice of optometry. (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: (BPC � 3041)
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;
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
SB 492
Page 2
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.
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: (BPC �
3041(b)(1))
a) Infections;
b) Ocular allergies;
c) Ocular inflammation, non-surgical in cause except when
co-managed with the treating physician and surgeon;
d) Traumatic or recurrent conjunctival or corneal abrasions and
erosions;
e) Corneal surface disease and dry eyes;
f) Ocular pain, non-surgical in cause except when co-managed with
the treating physician and surgeon; and
g) Glaucoma in patients over the age of 18.
5)Permits optometrists to use the following therapeutic pharmaceutical
agents: (BPC � 3041(c))
a) Topical miotics;
b) Topical lubricants;
c) Anti-allergy agents;
d) Topical and oral anti-inflammatories;
e) Topical antibiotic agents;
f) Topical hyperosmotics;
g) Topical and oral anti-glaucoma agents;
h) Non-prescription medications;
i) Oral antihistamines;
j) Prescription oral non-steroidal anti-inflammatory agents;
aa) Oral antibiotics for treatment of ocular
disease;
bb) Topical and oral antiviral medication for
treatment of:
i) Herpes.
ii) Viral Keratitis.
iii) Herpes Simplex Viral conjunctivitis.
iv) Periocular herpes simplex viral dermatitis.
v) Varicella zoster viral keratitis.
vi) Varicella zoster viral conjunctivitis.
vii) Periocular varicella zoster viral dermatitis.
cc) Oral analgesics that are not controlled
substances; and
SB 492
Page 3
dd) Codeine with compounds and hydrocodone
with compounds with specific restrictions regarding usage
timeframe.
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 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 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.
This bill:
1)Adds the provision of habilitative optometric services to the
definition of the practice of optometry.
2)Allows an optometrist who is TPA certified to treat the lacrimal
gland, lacrimal drainage system and the sclera in patients under 12
years of age.
SB 492
Page 4
3)Allows an optometrist to treat ocular inflammation via surgical or
non-surgical means and deletes the requirement to co-manage the
treatment with the patient's treating physician and surgeon .
4)Allows an optometrist to treat ocular pain via surgical or
non-surgical means and deletes the requirement to co-manage the
treatment with the patient's treating physician and surgeon.
5)Permits optometrists to treat eye lid disorders.
6)Allows an optometrist to use all therapeutic pharmaceutical agents
approved by the FDA for use in treating eye conditions including
narcotic substances other than Schedule I drugs.
7)Removes the requirement for optometrists to only utilize specific
TPAs.
8)Allows TPA certified optometrists to remove sutures without prior
consultation with the treating physician and surgeon.
9)Removes the restriction that optometrists can only administer oral
fluorescein to patients suspected as having diabetic retinopathy.
10)Deletes the list of specific tests optometrists are permitted to
order and permits optometrists to order any laboratory and
diagnostic imaging tests.
11) Adds the provision that optometrists can administer
immunizations for influenza and shingles and additional
immunizations that may be necessary to protect public health during
a declared disaster or public health emergency.
12) Permits optometrists to diagnose diabetes, hypertension
and hyperlipidemia.
13) Specifies that an optometrist diagnosing or treating eye
or other disease shall be held to the same standard of care to which
physicians and surgeons and osteopathic physicians and surgeons are
held.
14) Allows an optometrist to consult with and refer to a
physician and surgeon or appropriate health care provider if a
situation or condition occurs that is beyond the optometrist's
education and training.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
SB 492
Page 5
Legislative Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by the Author. According to the
Author, SB 492 is intended to allow optometrists to practice to the
full extent of their education and training in order to expand
access to the health care delivery system for the millions of
Californians who will have new access to coverage through the
implementation of the federal Patient Protection and Affordable Care
Act (ACA). The bill will allow optometrists to diagnose, treat and
manage specific eye disorders and common diseases such as diabetes,
hypertension and hyperlipidemia. The bill will also expand the
drugs optometrists can prescribe and it will permit optometrists to
administer immunizations and to perform surgical and non-surgical
procedures.
2.Background.
a) The Patient Protections and Affordable Care Act. On March 23,
2010, President Obama signed the Patient Protection and
Affordable Care Act (ACA) into federal statute. The ACA, which
states will begin implementing in 2014, represents one of the
most significant government expansions and regulatory overhauls
of the United States health care system since the passage of
Medicare and Medicaid in 1965. The ACA is aimed at increasing
the rate of health insurance coverage for Americans and reducing
the overall costs of health care. It provides a number of
mechanisms including mandates, subsidies and tax credits to
employers and individuals in order to increase the coverage rate.
Additional reforms aim to improve health care outcomes and
streamline the delivery of health care. One salient provision is
the requirement for insurance companies to cover all applicants
and offer the same rates regardless of pre-existing medical
conditions.
Opponents of the ACA turned to the federal courts to challenge
its constitutionality. On June 28, 2012, the United States
Supreme Court upheld the constitutionality of most of ACA in the
case of National Federation of Independent Business vs. Sebelius.
Specifically, the Supreme Court upheld the mandate for
individuals to purchase health insurance if not covered by their
employers on the basis that it is a tax rather than protection
under the Commerce Clause. However, the Supreme Court determined
that states could not be forced to participate in the expansion
of Medicaid. As such, all provisions of the ACA will continue in
SB 492
Page 6
effect or will take effect as scheduled subject to states
determination on Medicaid expansion. In California, efforts are
well underway to implement the ACA including Medicaid expansion,
also referred to as "Medi-Cal" in California, by 2014.
b) Primary Care Workforce Shortage. As a result of
implementation of the ACA, about 4.7 million additional
Californians will be eligible for health insurance beginning in
2014. It is anticipated that the newly insured will increase
demand for health care on an already strained system. For
example, according to estimates obtained from the Council on
Graduate Medical Education (CGME), the number of primary care
physicians actively practicing in California is far below the
state's need. The distribution of these primary care physicians
is also poor. In 2008, there were 69,460 actively practicing
primary care physicians in California, of which only 35 percent
reported they actually practiced primary care. This equates to
63 active primary care physicians per 100,000 persons. However,
according to the CGME, 60 to 80 primary care physicians are
needed per 100,000 persons in order to adequately meet the needs
of the population. When the same metric is applied regionally,
only 16 of California's 58 counties fall within the needed supply
range for primary care physicians. In other words, less than one
third of Californians live in a community where they have access
to adequate health care services.
c) Shortage of Optometrists. According to a report prepared by
the Center for the Health Professions at the University of
California San Francisco, the number of optometrist licenses in
California has declined, but the number of licensees with a
secondary practice location has increased. According to the
California Board of Optometry, there are approximately 9000
optometrists in California, the largest population of
optometrists in the United States. These optometrists are
generally concentrated in coastal counties, the Bay Area and
counties in the Sacramento region. Several counties have no
licensed optometrists with an address of record in those
counties, and a number of other counties have ratios that
indicate there is approximately one optometrist for every 10,000
people.
d) Optometry and Ophthalmology. This bill would expand the types
of procedures an optometrist is authorized to execute. This
would include some tasks that have been traditionally performed
by ophthalmologists. This bill would also require optometrists
to consult with ophthalmologists as needed. As such, the current
SB 492
Page 7
education, training and scope of each profession is outlined
below.
i) Optometrist Education, Training and Scope. After
completion of an undergraduate degree, optometrists complete
four years of and accredited optometry college after which they
are awarded the Doctor of Optometry degree. Some optometrists
also undertake an optional one year non-surgical residency
program to enhance their experience in a particular area.
Students graduate with 2500-3000 patient encounters; these
include a mix of post-surgical, medical and routine visits.
Optometrists are trained to diagnose mild to severe eye
problems such as serious eye infections, inflammations of the
eye, trauma, foreign bodies and glaucoma. They also examine
the eye for vision prescription and corrective lenses.
Optometrists may apply for certification to administer
therapeutic pharmaceutical agents (TPA); to perform lacrimal
irrigation and dilation (TPL); and to diagnose and treat
primary open angle glaucoma (TLG).
ii) Ophthalmologist Education, Training and Scope. After
obtaining an undergraduate degree, ophthalmologists complete
four years at an accredited medical school and earn a Medical
Degree. This is followed by a one year internship and a three
or four year surgical residency. Many ophthalmologists pursue
additional fellowship training in specialized areas such as
retina, glaucoma or 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.
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.
e) Current and Proposed Scope of Practice for Optometrists. This
bill would expand the scope of practice for optometrists. The
following chart illustrates some of the salient changes that
would be made to the current scope of practice for optometrists.
------------------------------------------------------------------------- f) Other States. Since 1997, there have been over 45 attempts in
over 20 states by optometry associations to expand the scope of
SB 492
Page 8
practice for optometrists including legislating surgery
privileges. However, with the exception of Oklahoma and West
Virginia, most states continue to prohibit optometrists from
performing surgery, and their statutes specify that the license to
practice optometry does not include the right to practice
medicine. States such as Colorado and North Carolina specifically
exclude surgery from their definition of the practice of
optometry. Other states have statutes that delineate between
laser and non-laser surgery.
3.Arguments in Support. Blue Shield of California supports the bill.
In their letter they state, "Expanding the range of services that
these practitioners are able to provide will improve access and
quality of care as they are well trained and highly educated
professionals that are already providing integral health services."
The Bay Area Council also supports the bill. They note that the bill
would expand the range of services optometrists can perform to help
ensure that the citizens of our state have access to high-quality
primary care.
Californians for Patient Care also supports the bill. In their
letter they note, "It is widely noted that there are not enough
trained medical professionals to appropriately care for the influx of
new patients. We believe it is important that qualified, educated
and trained optometrists be allowed to practice to the extent of
their licenses to best serve California's patient population
throughout the state."
The California Pharmacists Association wrote a joint letter with the
California Society of Health-System Pharmacists. They write, "CSHP
and CPhA believe that it is vital to better utilize all health care
providers consistent with their training and education to address
current workforce shortages. By empowering nurse practitioners to
provide additional services with greater flexibility, SB 492 is an
important part of the equation to meet health system demand."
The California Optometric Association believes that this legislation,
"?addresses the health care provider gap by expanding the scope of
practice of optometry. Optometrists are positioned and prepared to
be part of the solution to meeting the additional health care needs
upon enactment of the ACA in 2014."
The United Nurses Associations of California/ Union of Health Care
Professionals supports the bill. In their letter they indicate, "SB
492 would allow optometrists to practice to the full extent of their
education and training in order to expand access to the health care
SB 492
Page 9
delivery system for the millions of Californians who will have new
access to coverage through implementation of the federal ACA."
4.Support if Amended. The California Hospital Association has taken a
support if amended position. They indicate, "Doctors of optometry
are extensively trained and educated according to national standards.
Optometrists provide valuable services in the community and have an
opportunity to be an integral component in the new clinical delivery
systems of the future. For this reason, CHA supports these
provisions and sees value in offering amendments to promote safe and
effective care delivery by and optometrist. Our proposed amendments
would address issues specifically related to the medical acts
performed by an optometrist in the new provisions, and assurance that
appropriate safeguards and quality mechanisms are embedded in the SB
492 provisions to protect the public safety."
The California Association of Physician Groups supports the bill if
it is amended. They propose the following amendments:
Section 3041(a)(2) is overbroad and should be amended to
state: "drugs for the treatment of ocular problems including
narcotic pain medications for the treatment of pain related to
ocular problems."
Section 3041(a)(3) is problematic because most eye surgery
is performed with topical or local anesthetic. Cataract
surgery, for instance, is done with topical/local anesthesia.
Perhaps this section can be better defined, such as, "?primary
care procedures on the lids, and conjunctiva and cornea that
only require topical or local anesthesia."
Section (5)(b). Because there can be complications from
the administration of certain vaccines, notably live vaccines,
we suggest that this scope expansion requires an optometrist to
have more knowledge of the patient than is reasonable given the
limited access to patient records under independent practice,
when outside of an integrated, coordinated care system. We
recommend against this section under independent practice.
Section (5)(c)(a). As written, this would allow for the
treatment of diabetes; not the ocular manifestations of
diabetes, but the illness itself. Temporal Arteritis is
another very serious illness, for example, with ocular
manifestations. We suggest a similar limitation as outlined in
the preceding section.
SB 492
Page 10
1.Arguments in Opposition. The California Medical Association opposes
the bill. They outline several concerns in their letter. Included
is the provision of primary care services that optometrists would be
permitted to do if the bill passed. CMA believes that this is
"?beyond the existing scope of practice related to visual disorders
and could result in serious harm to patients." They also note that
optometrists "?do not have the training and experience necessary to
provide comprehensive primary care. In addition, "SB 492 would allow
optometrists to practice medicine without being subject to the
Medical Practice Act. Currently, optometrists are licensed by the
Board of Optometry. Under SB 492, the scope of practice for
optometrists would be expanded to the point where they would be
practicing as ophthalmologists, who are required to have a medical
license, without being subject to the controls and oversight of the
Medical Practice Act."
The California Association for Medical Laboratory Technology also
opposes the bill. They note in their letter, "While we recognize the
ability of optometrists to perform certain waived tests limited to
their scope of practice, we have concerns about the broad range of
testing contained in this bill. Of greater concern is whether or not
optometrists receive the proper education and training to perform as
a laboratory director."
The California Academy of Eye Physicians & Surgeons is concerned
about the expanded scope of practice for optometrists permitted by SB
492. Specifically, they are concerned about the provisions that
would allow optometrists to conduct eye surgeries and prescribe
medications by all routes with no additional training."
The Union of American Physicians and Dentists shares the Author's
concerns regarding expanding health care access to residents of the
State of California. However, SB 492 is a questionable solution. SB
492 rolls out an uncertain health care delivery system with patients
subject to unintended consequences of the bill. Medical supervision
over optometrists is critical to safe patient outcomes. SB 492
raises serious patient safety concerns in allowing optometrists to
prescribe medication and perform surgical procedures without and
medical supervision."
The Blind Children's Center notes, "While we support some increased
role for optometrists in helping to provide health care, we question
whether optometrists, with only a 4-year optometry school education,
have the training, education and experience to perform the procedures
authorized by the bill. Many of these procedures should only be
performed by experts with many more years of training and
SB 492
Page 11
experience."
The Lighthouse for Christ Mission Eye Center and the Canvasback
Missions, Inc. oppose the bill and state in their letters, "The bill
would give optometrists greatly increased privileges, including the
ability to treat any disease that might have a "manifestation" in the
eye without additional specific training requirements. The Board of
Optometry, whose members have no experience doing surgery or treating
the added diseases would be allowed to decide those training
requirements."
Here4Them Inc. , provides aid to children and adults who have been
abandoned, orphaned, disadvantaged, threatened or are in high risk
situations. They oppose the bill and note, "Since we have organized
cataract surgery projects, we are well aware of the importance of
skilled professionals for eye surgeries. When one is used to highly
qualified medical ophthalmologists with 100% success rates in
surgery, how could the possibility of less trained professionals even
be a consideration? It is important to provide more access to health
care, but not at the cost of the best possible care."
The California Society of Anesthesiologists also opposes SB 492. In
their letter they argue,
"SB 492 would allow the diagnosis and initiation of treatment of any
condition with ocular manifestation. This is a broad and unclear
authorization that has not attained scientific consensus. It is not
a sufficient basis to authorize comprehensive primary care. Also, by
granting full drug prescribing authority to optometrists, the bill
would add a new category of authorized controlled substance
prescribers at a time when more controls are being sought over
excessive prescribing."
The California Chapter of the American College of Emergency
Physicians writes, "While we share the legitimate concern about the
lack of access to care, which currently exists and which may be
exacerbated by the implementation of the affordable care act, we are
adamantly opposed to any solution which would allow health care
practitioners to treat patients well outside their areas of training
and expertise."
The California Society of Plastic Surgeons believes that the practice
of optometry does not include performing surgery. They state that
optometrists do not have the training or education to be performing
these types of medical procedures nor do they have training in the
administration of local anesthesia.
SB 492
Page 12
2.Oppose Unless Amended. The Osteopathic Physicians & Surgeons of
California (OPSC) have taken an oppose unless amended position on SB
492. They state, "While optometrists play an important role in the
provision of health care to patients in California, their current
education and training requirements fall far short of the knowledge
base necessary to safely and appropriately treat the complete health
of patients. OPSC finds it unconscionable that a health care
provider with education and training limited to a specific area of
the body be given broad authority to provide treatment that has
implications for health of the entire body."
The California Academy of Family Physicians also has an oppose unless
amended position.
They note, "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
independently practice medicine or to render services that are beyond
a providers scope can lead to increased costs through over
utilization of tests, over prescribing of medications and excess
referrals to specialists."
3.Current Related Legislation. SB 491 (Hernandez, 2013) deletes the
requirement that Nurse Practitioners perform certain tasks pursuant
to standardized procedures and/or consultation with a physician or
surgeon and authorizes a Nurse Practitioner to perform those tasks
independently. Also requires, after July 1, 2016, that Nurse
Practitioners possess a certificate from a national certifying body
in order to practice. ( Note : The bill is up for consideration before
the BP&ED Committee today)
SB 493 (Hernandez, 2013) authorizes a pharmacist to administer drugs
and biological products that have been ordered by a prescriber.
Expands other functions pharmacists are authorized to perform, and
authorizes pharmacists to order and interpret tests for the purpose
of monitoring and managing the efficacy and toxicity of drug
therapies and to independently initiate and
administer routine vaccinations. Also establishes board recognition
for an advanced practice pharmacist. ( Note : The bill is up for
consideration before the BP&ED Committee today)
4.Prior Related Legislation. SB 668 (Polanco, Chapter 13, Statutes of
1996) expanded the scope of practice of optometrists to provide for
SB 492
Page 13
the diagnosis and treatment of specified conditions or diseases of
the human eye or its appendages, and to use other therapeutic
pharmaceutical agents.
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 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.
9.Author's Amendments. The following amendments reflect the Author's
efforts to address many of the concerns of the opposition that are
highlighted in the opposition's comments above. The amendments do
the following: (See the mock-up of amendments attached.)
Specifies the eyelid disorders that can be treated by an
optometrist including: hypotrichosis and blepharitis.
Removes the provision for optometrists to treat ocular
inflammation and ocular pain that is the result of surgery and
restores the requirement for optometrists to consult with a
physician and surgeon for treatment of these conditions.
Specifies FDA approved drugs that TPA certified optometrist
can prescribe including codeine with compounds and hydrocodone
with compounds and limits the use of these agents to three days.
Permits an optometrist to order appropriate laboratory or
diagnostic imaging test for specified conditions.
Removes the provision for an optometrist to treat the lacrimal
gland, the lacrimal drainage system and the sclera in patients
under 12 years of age.
Only permits an optometrist to use a clinical laboratory test
or examination classified as CLIA-waived for the diagnosis of
conditions and diseases of the eye or adnexa.
Allows an optometrist to diagnose and treat conditions of the
SB 492
Page 14
visual system and test for and diagnose diabetes mellitus,
hypertension and hypercholesterolemia.
Requires an optometrist to notify the treating physician and
surgeon if sutures are removed from a patient.
Specifies record keeping requirements for consultations
between optometrists and physicians and surgeons.
SUPPORT AND OPPOSITION:
Support:
Bay Area Council
Blue Shield of California
California Optometric Association
California Pharmacists Association/ California Society of
Health-System Pharmacists
Californians for Patient Care
United Nurses Associations of California/Union of Health Care
Professionals
Western University of Health Sciences
57 individuals
Support if Amended:
California Association of Physician Groups
California Hospital Association
Opposition:
California Medical Association
Blind Children's Center
California Academy of Eye Physicians & Surgeons
California Association for Medical Laboratory Technology
California Society of Anesthesiologists
Canvasback Missions Inc.
Here4Them
Lighthouse for Christ Mission Eye Center
Union of American Physicians and Dentists
American College of Emergency Physicians- California Chapter
California Society of Plastic Surgeons
Over 100 letters from employees and parents of children of the Blind
Children's Center
Hundreds of individuals
SB 492
Page 15
Oppose Unless Amended:
California Academy of Family Physicians
Osteopathic Physicians & Surgeons of California
Consultant: Le Ondra Clark, Ph.D.