BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 464|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
UNFINISHED BUSINESS
Bill No: SB 464
Author: Hernandez (D)
Amended: 5/22/15
Vote: 21
PRIOR SENATE VOTES NOT RELEVANT
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 8/27/15
(pursuant to Senate Rule 29.10)
AYES: Hill, Berryhill, Block, Galgiani, Hernandez, Jackson,
Mendoza, Wieckowski
NO VOTE RECORDED: Bates
ASSEMBLY FLOOR: 73-1, 8/20/15 - See last page for vote
SUBJECT: Healing arts: self-reporting tools
SOURCE: Planned Parenthood Affiliates of California
DIGEST: This bill permits a physician, registered nurse (RN),
certified nurse-midwife (CNM), nurse practitioner (NP),
physician assistant (PA), and pharmacist to use a self-screening
tool to aid the prescription of self-administered hormonal
contraceptives.
Assembly Amendments delete the contents of the bill and replace
it with the current version.
ANALYSIS:
Existing law:
1)Prohibits a person or entity from prescribing, dispensing, or
furnishing, or causing to be prescribed, dispensed, or
SB 464
Page 2
furnished, dangerous drugs or dangerous devices on the
Internet for delivery to any person in this state, without an
appropriate prior examination and medical indication, except
as specified. (BPC § 2242.1)
2)Authorizes a RN to dispense a self-administered hormonal
contraceptive (SAHC) in accordance with standardized
procedures, which shall include demonstration of 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. 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 for Contraceptive Use (USMEC). (BPC § 2725.2)
3)Authorizes a pharmacist to furnish SAHC in accordance with
standardized procedures developed and approved by both the
Board of Pharmacy (BOP) and the Medical Board of California
(MBC) in consultation with other entities, as specified, and
requires that the protocol mandate the use of a patient
self-screening tool to identify risk factors for the use of
SAHC, based on current USMEC developed by the federal CDC.
(BPC § 4052.3)
This bill:
1)Authorizes a physician, RN, CNM, NP, PA, and pharmacist to use
a self-screening tool that will identify patient risk factors
for the use of SAHC by a patient, and, after an appropriate
prior examination, prescribe, furnish, or dispense, as
applicable, SAHC to the patient.
2)Permits blood pressure, weight, height, and patient health
history to be self-reported using the self-screening tool.
Background
Telehealth and Self-Screening Tools. Current law defines
telehealth as "the mode of delivering health care services and
SB 464
Page 3
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." Telehealth is neither a
distinct technology nor a type of care; it is the remote
provision of healthcare services according to the same
professional standards governing in-person care.
Telehealth may be facilitated by many mediums, including
telephone, videoconferencing, store-and-forward technology, and
increasingly, by mobile devices connected to the Internet.
A self-screening tool is not defined in law; it is any
instrument by which an individual reports health information.
BOP is developing a paper checklist as its self-screening tool,
and there exist mobile apps that record consumers' answers in
response to online prompts that are also considered
self-screening tools.
Requirements for Prescribing SAHC. Current law authorizes a
physician, RN, CNM, NP, PA, or a pharmacist to prescribe,
furnish, or dispense SAHC. However, current laws and
regulations are not specific as to the exact protocols required
for each licensee to provide SAHC to patients.
Physician: An appropriate prior examination is mandated by law
prior to a physician prescribing a SAHC. However, an in-person
examination is not required and a physician is expected to use
his or her professional judgment in determining the appropriate
standard of care for each patient.
RN, CNM, NP, PA: These licensees are required to furnish or
dispense SAHC pursuant to standardized procedures, which are the
legal mechanism for non-physicians to perform functions which
would otherwise be considered the practice of medicine,
including prescribing drugs. Standardized procedures are
policies and protocols developed by a health facility or
organized health care system, with input from administrators and
health professionals, which establish parameters for medical
care. These licensees are also required to conduct an
appropriate prior examination before dispensing or furnishing
SB 464
Page 4
SAHC on the Internet for delivery to any person in this state,
but what constitutes an appropriate prior examination is
undefined.
As part of their standardized procedures for dispensing SAHC,
RNs are required to demonstrate competency in providing an
appropriate prior examination, which is comprised of checking
blood pressure, weight, and collecting patient and family health
history. Current law further states that the appropriate prior
examination by a RN shall be consistent with the evidence-based
practice guidelines adopted by the CDC.
The CDC recommended in their June 14, 2013 Morbidity and
Mortality Weekly Report that, "among healthy women, few
examinations or tests are needed before initiation of combined
hormonal contraceptives." They recommend that blood pressure be
measured and that weight and body mass may be useful for
monitoring SAHC use over time. However, nothing in the CDC
recommendation states that a RN must measure blood pressure and
weight for each patient prior to furnishing SAHC, and it is
reasonable to infer that an accurate self-reporting of the same
information would yield the necessary information.
Pharmacist: Pharmacists may furnish SAHC in accordance with
standardized procedures developed and approved by the BOP and
MBC. These standardized procedures have not yet been adopted,
but the law states they must include a patient self-screening
tool to identify risk factors based on the same CDC guidelines
as required by RN protocols. The initial regulations formalizing
the standardized procedures approved by the MBC and BOP required
that the pharmacist also measure a patient's seated blood
pressure, in addition to the information collected by the
self-screening tool. However, at the July 29, 2015 BOP meeting,
the BOP voted to modify the protocol so that a pharmacist may
accept self-reported blood pressure at his or her discretion.
This modification must now be approved by the MBC.
This bill acknowledges the need for patient health information,
including blood pressure and weight, to appropriately recommend
a SAHC, but permits practitioners to rely on information
provided by the patient, rather than measured by the
practitioner.
SB 464
Page 5
Self-Reported Health Metrics and Safety of SAHC. Accepting
self-reported medical information for SAHC is supported by
numerous medical reports and journals because of the nature of
the drugs themselves, effective self-screening, and the greater
risks of unintended pregnancies.
For example, the American College of Obstetricians and
Gynecologists (ACOG) advocated for over-the-counter availability
of SAHCs in 2014, noting that the primary risk associated with
SAHC, venous thromboembolism (blood clots) is "extremely low,"
and that women can self-screen for contraindications. Further,
the risk of blood clots due to SAHC is lower than the same risk
of clotting in pregnancy. A 2014 article in the American
Journal of Obstetrics and Gynecology reported on a study
indicating that on average, there is a low prevalence of medical
contraindications in women of reproductive age overall, so there
is a very small portion of the population for whom information
on a self-screening tool is truly vital.
This bill aims to clarify that existing and potential telehealth
providers operate in accordance with current law by stating that
practitioners who are currently authorized to provide SAHC may
do so by relying on self-reported health information.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Assembly Appropriations analysis, this bill
will have negligible costs to affected professional licensing
boards within the Department of Consumer Affairs.
SUPPORT: (Verified8/27/15)
Planned Parenthood Affiliates of California (source)
California Medical Association
California Primary Care Association
SB 464
Page 6
Community Action Fund of Planned Parenthood of Orange and San
Bernardino Counties
Icebreaker Health
NARAL Pro-Choice California
Planned Parenthood Action Fund of Santa Barbara, Ventura and San
Luis Obispo Counties
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Advocacy Project Los Angeles County
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
Planned Parenthood Pasadena and San Gabriel Valley
Numerous individuals.
OPPOSITION: (Verified8/27/15)
California Catholic Conference
California Nurses Association
California Right to Life Committee, Inc.
ARGUMENTS IN SUPPORT: "Planned Parenthood supports efforts to
better serve our patients through the development and expansion
of telehealth services. Telehealth is a safe, effective delivery
system that expands access to health care for people who
otherwise would have to travel a long distance to see a
provider.
"SB 464 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 California Catholic Conference
writes in opposition, "Young girls, and other minors under the
age of 18, would be able to receive contraceptives ? without an
actual medical exam and without the consent of their parent(s)
or guardian(s). Further, without any oversight, these dangerous
SB 464
Page 7
drugs could easily get into the wrong hands of human traffickers
or the hands of young people."
ASSEMBLY FLOOR: 73-1, 8/20/15
AYES: Achadjian, Alejo, Baker, Bigelow, Bloom, Bonilla, Bonta,
Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu,
Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier,
Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson,
Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández,
Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine,
Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty,
Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell,
Olsen, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas,
Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner,
Weber, Wilk, Williams, Wood, Atkins
NOES: Gallagher
NO VOTE RECORDED: Travis Allen, Brough, Chu, Harper, Patterson,
Waldron
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104,
Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/28/15 15:24:23
**** END ****