BILL ANALYSIS Ó
SB 464
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Date of Hearing: June 30, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
SB 464(Hernandez) - As Amended May 22, 2015
SENATE VOTE: 27-2
SUBJECT: Healing arts: self-reporting tools.
SUMMARY: Authorizes a physician, a registered nurse (RN), a
certified nurse-midwife (CNM), a nurse practitioner (NP), a
physician assistant (PA), or a pharmacist, in accordance with
existing law for each practitioner, to use a self-screening tool
that will identify patient risk factors for the use of
self-administered hormonal contraceptives by a patient, and,
after an appropriate prior examination, prescribe, furnish, or
dispense, as applicable, self-administered hormonal
contraceptives to the patient.
EXISTING LAW:
1)Defines "dangerous drug" or "dangerous device" as any drug or
device unsafe for self-use in humans or animals, and includes
the following: (Business and Professions Code (BPC) § 4022)
a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or
words of similar import.
b) Any device that bears the statement: "Caution: federal
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law restricts this device to sale by or on the order of a
____," "Rx only," or words of similar import, the blank to
be filled in with the designation of the practitioner
licensed to use or order use of the device.
c) Any other drug or device that by federal or state law
can be lawfully dispensed only on prescription or furnished
pursuant to BPC § 4006.
2)Makes it unprofessional conduct for a physician and surgeon to
prescribe, dispense, or furnish dangerous drugs without an
appropriate prior examination and medical indication, with
exceptions. (BPC § 2242)
3)Makes it unlawful for a person or entity to prescribe,
dispense, or furnish, or cause to be prescribed, dispensed, or
furnished, dangerous drugs or dangerous devices, as defined in
BPC § 4022, on the Internet for delivery to any person in this
state, without an appropriate prior examination and medical
indication, except as authorized by BPC § 2242. (BPC §
2242.1)
4)Authorizes a registered nurse (RN) to dispense
self-administered hormonal contraceptives, as specified. The
RN must follow standardized procedures and protocols (SPPs),
including demonstrating competency in providing the
appropriate prior examination comprised of checking blood
pressure, weight, patient history and medication taken, and
family health history. The appropriate prior examination
shall be consistent with the evidence-based practice
guidelines adopted by the federal Centers for Disease Control
and Prevention (CDC) in conjunction with the United States
Medical Eligibility Criteria (US MEC) for Contraceptive Use.
(BPC § 2725.2)
5)Authorizes a certified nurse-midwife (CNM) to furnish or order
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drugs or devices, including controlled substance in accordance
with SPPs, as specified. (BPC § 2746.51)
6)Authorizes a nurse practitioner (NP) to furnish or order drugs
or devices, including controlled substance in accordance with
SPPs, as specified. (BPC § 2836.1)
7)Authorizes a physician assistant (PA) to administer or provide
medication to a patient or to transmit a drug order in
accordance with the PA's delegated services agreement (DSA),
as specified. (BPC § 3502.1)
8)Authorizes a pharmacist to furnish self-administered hormonal
contraceptives in accordance with SPPs. The SPPS must require
a patient to use a self-screening tool that will identify
patient risk factors for the use of self-administered hormonal
contraceptives, based on the current US MEC for Contraceptive
Use developed by the CDC. (BPC § 4052.3)
9)Defines "telehealth" as the mode of delivering health care
services and public health via information and communication
technologies to facilitate the diagnosis, consultation,
treatment, education, care management, and self-management of
a patient's health care while the patient is at the
originating site and the health care provider is at a distant
site. States that telehealth facilitates patient
self-management and caregiver support for patients and
includes real-time interactions and the transmission of
patient medical information.
(BPC § 2290.5(a)(6))
10)Requires a health care provider initiating the use of
telehealth to inform the patient about the use of telehealth
and obtain verbal or written consent from the patient for the
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use of telehealth as an acceptable mode of delivering health
care services and public health. The consent must be
documented. (BPC § 2290.5(b))
THIS BILL:
11)Authorizes six types of healing arts licensees to use a
self-screening tool that will identify patient risk factors
for the use of self-administered hormonal contraceptives by a
patient, and, after an appropriate prior examination,
prescribe, furnish, or dispense, as applicable,
self-administered hormonal contraceptives to the patient.
12)Authorizes the patient to self-report blood pressure, weight,
height, and patient health history with the self-screening
tool that identifies patient risk factors.
13)This bill includes the following licensees:
a) Physician and surgeons;
b) RNs acting in accordance with BPC § 2725.2;
c) CNMs acting within the scope of BPC § 2746.51;
d) NPs acting within the scope of BPC § 2836.1;
e) PAs acting within the scope of BPC § 3502.1; and,
f) Pharmacists acting within the scope of BPC § 4052.3.
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FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by Planned Parenthood
Affiliates of California . According to the author, "In
California, about half of all pregnancies are unintended. Women
with unintended pregnancies are less likely to receive prenatal
care, and health outcomes are worse for both mother and baby.
According to a 2015 study by the Guttmacher Institute, the
annual public cost of unintended pregnancies in California is
more than $1.75 billion. Hormonal contraception has been proven
safe and effective at preventing pregnancy, and the American
College of Obstetricians and Gynecologists recently recommended
that women should self-screen for contraindications using
checklists to increase their access to hormonal contraceptives.
Existing law is not clear as to whether self-screening tools can
be used to transmit relevant medical and family history
information from a patient to her provider for the purposes of
accessing hormonal contraception. Enabling the use of
self-screening tools will allow health care providers to make
greater use of existing and developing technology, and will
increase access to oral contraception for all women."
Background. Existing law allows the six healing arts licensees
included in this bill to provide self-administered hormonal
contraceptives to patients through varying mechanisms:
1)Physicians are required to perform an appropriate prior
examination.
2)PAs must be authorized by a supervising physician through a
DSA and perform an appropriate prior examination.
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3)The NPs, CNMs, and RNs must follow SPPs developed with a
supervising physician and perform an appropriate prior
examination.
4)Pharmacists must follow SPPs developed with an authorized
prescriber, which require a patient to use a self-screening
tool to screen for counter-indications, and must refer the
patient to a primary care provider or clinic after denial or
provision of the drug.
Every provider besides a pharmacist is required to perform an
appropriate prior exam. However, existing law does not
specifically define an appropriate prior exam. According to the
Medical Board of California (MBC), a physician has complete
authority to determine what type of prior exam would be
appropriate, so long as the exam fits the standard of care for
the patient.
The standard of care is an objective test used to determine the
quality of the services a physician is expected to provide.
According to the 2013 MBC Expert Reviewer Guidelines, the
standard of care means "the level of skill, knowledge and care
in diagnosis and treatment ordinarily possessed and exercised by
another reasonably careful and prudent physician in the same or
similar circumstances." The standard is objective because it
takes into account current, medically-acceptable behavior, not
an individual physician's subjective opinion.
Therefore, an appropriate exam is what would be considered
acceptable for the particular patient, based on current evidence
and practices. As a result, under existing law, a physician
could determine that, given the patient's prior medical history
and situation, an appropriate prior examination would be to
require a patient to fill out a questionnaire, if similarly
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situated physicians would do the same. Other possible
appropriate prior exams could range from blood pressure checks
to full physical exams, depending on what the physician believed
was needed to ensure the patient's medical need, safety, and the
efficacy of the drug.
Prior Exams by Non-Physicians. An appropriate prior examination
differs for PAs and nurses because they must follow written
guidelines developed with a supervising physician or entity.
The guidelines will be based on the standard of care for varying
types of patients and situations. For PAs, the written
guidelines are called DSAs, which include a formulary. For
nurses, they are called SPPs. Because PAs and nurses must
follow the guidelines, they are limited to a prior examination
that adheres to the guidelines.
PAs, CNMs, and NPs and the supervising physician have broad
discretion in determining drug prescribing guidelines. RNs,
however, have specific requirements for the prior examination
for providing hormonal contraceptives. For instance, the SPPs
must require RNs to demonstrate competency in providing the
appropriate prior examination comprised of checking blood
pressure, weight, and patient and family health history,
including medications taken by the patient.
While the SPP must require that RNs demonstrates "competency" in
providing an appropriate prior exam that consists of checking
various patient health measures, the actual type of prior exam
that is appropriate is not defined. Existing law only specifies
that an appropriate prior examination must be consistent with
the evidence-based practice guidelines adopted by the CDC in
conjunction with the US MEC.
The CDC's US MEC is a set of recommendations on who can safely
use contraceptives (essentially a list of risk factors). It is
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unclear which evidence-based practice guidelines the language
refers to, but it may refer to the US MEC companion document
adopted by the CDC, the U.S. Selected Practice Recommendations
for Contraceptive Use (US SPR), which is discussed in the next
section.
Finally, pharmacists (besides advanced practice pharmacists) are
different from the other providers because their scope of
practice does not ordinarily permit them to perform an
appropriate prior exam to the same extent as the other
practitioners. Instead, existing law requires them to operate
under SPPs that require them to use a self-screening tool that
is consistent with the CDC's US MEC.
Self-Screening Tools. The sponsors argue that it is not clear
that a provider may have a patient self-report data using a
self-screening tool to provide self-administered hormonal
contraception. Therefore, this bill aims to clarify that a
provider may do so.
Existing law does not define "self-screening tool." However,
according to the federal National Institutes of Health (NIH),
screenings are medical tests that look for indications or risk
factors for a particular condition. A self-screening tool would
be a tool that a patient uses to alert a provider of those
conditions. For instance, filling out a medical history form
could be a type of self-screening tool.
For contraceptives, the screening tool would identify risk
factors in a patient that would suggest which contraceptives may
not be safe for the patient to take. That is why pharmacists
are required to use a self-screening tool instead of performing
an appropriate prior exam. Pharmacists ask the patient to use a
screening tool in order to screen the patient for the risk
factors identified in the US MEC for a particular form of
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contraception.
For physicians, nurses, and PAs, the standard of care for
self-administered hormonal contraceptives could allow for a
self-screening tool. For example, according to the CDC's US SPR
(noted above), the companion document to the US MEC, some forms
of hormonal contraceptives need minimal or no initial
examinations. The US SPR is a set of evidence-based practice
recommendations on how a provider should use the US MEC risk
factors. The CDC adapted both documents for U.S. practices from
the recommendations of the World Health Organization (WHO).
According to the US SPR recommendations, self-administered
hormonal contraceptives are generally safe and effective and
require minimal examinations. The only recommended initial
examination for combined hormonal contraceptives is a blood
pressure test. However, women with limited access to healthcare
can take the measure in a nonclinical setting (such as a
pharmacy) and self-report the data to a provider. For
progestin-only pills, there are no initial exams that would make
taking the pill safer or more effective. For all
contraceptives, body weight is never needed for an initial
prescription.
Therefore, the standard of care for starting hormonal oral
contraceptives requires very little examination and testing. As
a result, existing law could allow a physician to determine that
an appropriate prior examination for a combined oral
contraceptive prescription is a self-screening tool that
reported blood pressure data from the patient to the physician.
Further, existing law already requires RN SPPs to be consistent
with the evidence-based practice guidelines adopted by the CDC
in conjunction with the US MEC, which may be the CDC's US SPR.
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If so, a set of RN SPPs could potentially allow a RN provide
progestin-only pills after a brief phone consultation without
taking any measurements, where the consultation is considered
the prior examination. The defining factors are the standard of
care (US MEC) and the adequacy of the screening tool as a prior
examination, which this bill does not address.
Internet and Phone Applications for Self-Reporting. According
to the sponsors, this bill will allow providers to prescribe
self-administered hormonal contraceptives through phone and
internet applications (mobile apps) that are used as
self-screening tools. However, because self-reporting through
self-screening tools is already permitted, there is currently no
prohibition against the use of a mobile app for that purpose.
Existing law allows internet prescribing for direct delivery
after an appropriate examination and medical indication. It
also permits the use of telehealth after written consent.
The reason for the explicit requirement for internet
prescribing, which is duplicative of the regular prescription
requirements, is due to the fear of online pharmacies illegally
providing dangerous drugs to patients without medical need. In
2004, the MBC issued an action report that stated, "Internet
prescribing is illegal when a legitimate physician-patient
relationship does not exist. Some physicians have attempted to
legitimize their Internet prescribing by engaging in the review
of questionnaires, which Internet users will complete, although
there is no way to confirm the patient is reporting accurate or
truthful information."
"In-person examinations not only enhance the opportunity to
confirm if a patient needs the identified medication or to rule
out other medical conditions, but ensures the patient is advised
of alternative treatment options and is aware of potential side
effects. For some patients, certain drugs are contraindicated
and serious injury, including death, can follow."
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However, at the time, the MBC cited drugs like Vicodin and
Viagra being sold at discounted prices without a doctor-patient
relationship. However, drugs like Vicodin are prone to abuse
and additional screening is important in those situations (see
DEA Schedule II-III categorization). In addition, drugs like
Viagra have many risk factors and are counter-indicated for many
medications.
On the other hand, the efficacy for hormonal contraceptives is
well-known and accepted, and the risk factors are minimal.
Therefore, the standard of care would require a more stringent
prior exam for a scheduled drug like Vicodin than it would for
hormonal contraceptives. While in-person examinations would be
useful in many situations, the law does not require it.
Further, technology and internet security have progressed in the
eleven years since the MBC report. Therefore, internet
prescribing and the use of mobile applications as a
self-screening tool are already allowed if the appropriate prior
examination was performed.
Other States. Oregon H 2879, of this legislative session, would
permit pharmacists to prescribe hormonal contraceptive patches
and self-administered oral hormonal contraceptives.
Prior Related Legislation. SB 493 (Hernandez), Chapter 469,
Statutes of 2013, among other things, authorized a pharmacist to
furnish self-administered hormonal contraception in accordance
with SPPs that require the patient to use a self-screening tool
to identify patient risk factors for the contraceptives.
ARGUMENTS IN SUPPORT:
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Planned Parenthood Affiliates of California (sponsors) write in
support, "[this bill] seeks to help improve preventive health
services by increasing access to services in rural communities
through the utilization of telemedicine by allowing patients to
provide information to a health provider through a
self-screening tool, including family history, blood pressure,
or weight. As technology advances, telehealth will include
models where patients communicate directly with a distant
provider and are not physically present in a provider's office."
ARGUMENTS IN OPPOSITION:
The Union of American Physicians and Dentists writes in
opposition, "[this bill] provides for no "prescribing"
safeguards, and disperses oversight across several State Boards.
State lawmakers have an obligation to enact legislation, which
places patient safety as a number one priority."
POLICY ISSUE FOR CONSIDERATION:
Because the use of a self-screening tool for the purposes of
providing contraceptives is already permitted, the Committee may
wish to consider the necessity of this bill.
REGISTERED SUPPORT:
Planned Parenthood Affiliates of California (sponsor)
California Primary Care Association
California Women's Law Center
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Icebreaker Health
Planned Parenthood Los Angeles
Planned Parenthood Mar Monte
Planned Parenthood Northern California
Planned Parenthood Orange and San Bernardino Counties
Planned Parenthood Pasadena and San Gabriel Valley
Planned Parenthood Santa Barbara, Ventura, & San Luis Obispo
Counties
Five MDs
REGISTERED OPPOSITION:
Union of American Physicians and Dentists
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301
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