BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 337 Hearing Date: April 20,
2015
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|Author: |Pavley |
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|Version: |April 13, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Physician assistants.
SUMMARY: Establishes alternative means for a supervising physician to
ensure adequate supervision of a physician assistant for routine
care and the administration, provision, or issuance of a
Schedule II drug.
Existing law:
1) Declares that the Physician Assistant Practice Act (Act) is
established to encourage the utilization of physician
assistants (PAs) by physicians, and by physicians and
podiatrists practicing in the same medical group, and to
provide that existing legal constraints should not be an
unnecessary hindrance to the more effective provision of
health care services. It is also the purpose of the Act to
allow for innovative development of programs for the
education, training, and utilization of PAs. (Business and
Professions Code (BPC) Section 3500)
2) Establishes the Physician Assistant Board (Board) within the
jurisdiction of the Medical Board of California (MBC) to
administer and enforce the Act. (BPC § 3504)
3) Requires a PA and his or her supervising physician to
establish written guidelines for the adequate supervision of
the PA, and the requirement may be satisfied by the
supervising physician adopting protocols for some or all of
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the tasks performed by the PA. (BPC § 3502 (c)(1))
4) Requires a supervising physician to be available in person or
by electronic communication at all times when the PA is
caring for patients. (Title 16, California Code of
Regulations (CCR) Section 1399.545 (a))
5) Requires a supervising physician to delegate to a PA only
those tasks and procedures consistent with the supervising
physician's specialty or usual and customary practice and
with the patient's health and condition, and requires the
supervising physician to observe or review evidence of the
PA's performance of all tasks and procedures to be delegated
to the PA until assured of competency.
(16 CCR § 1399.545 (b)(c))
6) Requires the PA and supervising physician to establish in
writing transport and back-up procedures for the immediate
care of patients who are in need of emergency care beyond the
PA's scope of practice for such times when a supervising
physician is not on the premises. (16 CCR § 1399.545 (d))
7) Requires a supervising physician to review, countersign, and
date a sample consisting of, at a minimum, five percent of
the medical records of patients treated by the PA within 30
days of the date of treatment. Requires the supervising
physician to select for review those cases that by diagnosis,
problem, treatment, or procedure represent the most
significant risk to the patient. (BPC § 3502 (c)(2))
8) Authorizes the MBC or the Board to establish other
alternative mechanisms for the adequate supervision of the
PA. (BPC § 3502 (c)(3))
9) Requires a supervising physician who delegates the authority
to issue a drug order to a PA to prepare and adopt a
formulary and protocols that specify all criteria for the use
of a particular drug of device, and any contraindications for
the selection. Protocols for Schedule II controlled
substances shall address the diagnosis of illness, injury, or
condition for which the Schedule II controlled substance is
being administered, provided, or issued. (BPC §
3502.1(a)(2))
SB 337 (Pavley) Page 3
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10)Requires a supervising physician to review and countersign
within seven days the record of any patient cared for by a PA
for whom the PA's Schedule II drug order has been issued or
carried out. (BPC § 3502.1 (e))
11)Allows a PA to administer Schedule II - Schedule V drug
orders without advance approval from a supervising physician
if the PA has completed an education course that covers
controlled substances and that meets standards, including
pharmacological content, approved by the Board. The education
course shall be provided either by an accredited continuing
education provider or by an approved PA training program. If
the PA will administer, provide, or issue a drug order for
Schedule II controlled substances, the course shall contain a
minimum of three hours exclusively on Schedule II controlled
substances. (BPC § 3502.1 (c)(2))
12)Requires PAs who are authorized by their supervising
physician to issue drug orders for controlled substances to
register with the United States Drug Enforcement
Administration. (BPC § 3502.1 (f))
This bill:
1)Defines "medical records review meeting" as a meeting between
the supervising physician and the PA during which a sample of
medical records is reviewed to ensure adequate supervision of
the PA functioning under protocols. The number of medical
records and the specific issues to be reviewed shall be
established in the delegation of services agreement.
2)Requires the medical record to identify the physician who is
responsible for the supervision of the PA for each episode of
care for a patient. When a PA transmits an oral order, he or
she shall also identify the name of the supervising physician
responsible for the patient.
3)Provides two additional mechanisms for the supervising
physician to choose from to ensure adequate PA supervision:
a) The supervising physician and PA shall conduct and
document a medical records review meeting at least 10 times
annually which may occur in person or by electronic
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communication.
b) The supervising physician shall supervise the care
provided by the PA through a review of those cases or
patients deemed appropriate by the supervising physician.
The review methods used shall be identified in the
delegation of services agreement, and may occur in person
or by electronic communication.
4)Deems that compliance by a PA and supervising physician with
this bill shall also deem compliance with specified
regulations.
5)Creates the following additional mechanism for a supervising
physician to ensure adequate supervision of the
administration, provision, or issuance by a PA of a Schedule
II drug order. If the PA has documentation evidencing the
successful completion of an education course that meets
specified standards, the supervising physician shall review,
countersign, and date, within seven days, a sample consisting
of the medical records of at least 20 percent of the patients
cared for by the PA for whom the PA's Schedule II drug order
has been issued or carried out.
FISCAL
EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by the California Academy of
Physician Assistants . According to the Author, "Existing law,
promulgated over 30 years ago, narrowly defines documentation
of required supervision in the form of medical record
co-signature, established for use with paper medical charts, by
the supervising physician for adequate supervision of the PA
to be recorded. Existing law also authorizes either in-person
or electronic supervision of a PA. Given this authorization,
PAs are well suited to expand the access of care for the care
team and may serve as the lead clinician on-site for the
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delivery of care. While established criteria for documenting
supervision works well is some settings, it does not reflect
or allow for documentation of supervision in many current
models of team-based care.
"This bill is also needed to address an issue related to
co-signatures on Schedule II medications. In August of 2014
the DEA published a final rule, effective October 6, 2014,
following recommendations from the U.S. Food and Drug
Administration (FDA) to up-schedule or reclassify hydrocodone
combination products (HCP) from a Schedule III controlled
substance to a Schedule II. The rescheduling of HCPs has had
a significant impact, and unintended consequence, on some
practices throughout California as existing law requires a
100% physician co-signature requirement on these medications
within 7 days. This can be particularly challenging for
practices that employ PAs to practice medicine in areas such
as pain management, orthopedics, general surgery and several
other practice types. The new ruling restricts the ability of
a practice to fully utilize the PAs they employ as there is no
other profession with prescribing privileges that has that
level of mandate for documentation. Further, a co-signature
mandate of 100% is overly burdensome for physicians in various
practice types.
"Existing law requires a supervising physician to be available
in-person or through electronic communication at all times
when a PA is providing care for a patient. Given the many
models of team-based care supervising physicians and PA often
practice at different locations and lead PA run clinics as
well as assume significant administrative responsibilities.
In this context, a 100% mandate on co-signatures creates a
barrier to efficient team-based care and stands to jeopardize
access to appropriate treatment of pain for those patients
with legitimate need."
2.Background. A PA performs many of the same diagnostic,
preventative and health maintenance services as a physician,
but PAs are limited in practice to those duties delegated by a
supervising physician. These services may include, but are
not limited to, the following:
Taking health histories.
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Performing physical examinations.
Ordering X-rays and laboratory tests.
Ordering respiratory, occupational, or physical therapy
treatments.
Performing routine diagnostic tests.
Establishing diagnoses.
Treating and managing patient health problems.
Administering immunizations and injections.
Instructing and counseling patients.
Providing continuing care to patients in the home,
hospital, or extended care facility.
Providing referrals within the health care system.
Performing minor surgery.
Providing preventative health care services.
Acting as first or second assistants during surgery.
Responding to life-threatening emergencies.
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A PA must attend a specialized medical training program
associated with a medical school that includes classroom
studies and clinical experience. An academic degree and/or
certificate is awarded upon graduation. Many PAs already have
two- or four-year academic degrees before entering a PA
training program. Most PA training programs require prior
health care experience.
As of June 2013, there were 9,101 active California PA
licensees.
1.Supervision. Existing law has very specific requirements for
a supervising physician to delegate practice authority to a
PA, and the supervising physician must be physically or
electronically available to his or her PA at the time of
treatment. In addition to this, a supervising physician must
review, countersign, and date a sample of at least five
percent of a PA's cases within 30 days of treatment.
The Author argues that the five percent review requirement is
outdated and unnecessary, given the close working relationship
between PAs and physicians and existing delegation of service
agreements and protocols. This bill provides two additional
mechanisms for the supervising physician to choose from to
ensure adequate PA supervision:
a) The supervising physician and PA shall conduct and
document a medical records review meeting at least 10 times
annually, which may occur in person or by electronic
communication; or,
b) The supervising physician shall supervise the care
provided by the PA through a review of those cases or
patients deemed appropriate by the supervising physician.
The review methods used shall be identified in the
delegation of services agreement, and may occur in person
or by electronic communication.
This bill also establishes an additional method to supervise a
PA's furnishing of Schedule II drugs. Current law requires a
supervising physician to review and countersign a medical
record within seven days of each PA's issuance of a Schedule
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II drug order. According to the Author, this practice is also
unduly burdensome and proposes that, if a PA has documentation
evidencing the successful completion of an education course
that meets specified Board standards, the supervising
physician may instead review, countersign, and date, within
seven days, a sample of at least 20 percent of the medical
records for patients cared for by the PA for whom the PA's
Schedule II drug order has been issued.
2.Arguments in Support. The Sponsor of this bill, the
California Academy of Physician Assistants , write, "With the
implementation of the Patient Protection and Affordable Care
Act, Covered California reported enrolling 3.4 million (1.4
through Covered CA plans and 1.9 in Medi-Cal) previously
uninsured people in the first open enrollment year (2014).
This bill recognizes the need to increase access to high
quality, cost-effective and efficient team-based practice
across all medical settings in order to meet the rising demand
for health care services throughout the state.
"The physician/PA team is unique as PAs are licensed health
professionals who practice medicine as members of a
physician-led team, delivering a broad range of medical and
surgical services at the direction of and under the
supervision of his or her supervising physician. The
supervising physician delegates to a PA specified medical
tasks and procedures, consistent with his or her scope of
practice, based on education, training and experience.
"Established over 30 years ago, existing law stipulates
supervision criteria between a supervising physician and
surgeon and the Physician Assistant (PA). It narrowly defines
documentation of this required supervision in the form of the
supervising physician co-signature on the medical record. SB
377 increases the options for documenting supervision between
a supervising physician and PA would allow for flexibility at
the practice level to reflect current models of team-based
care."
3.Prior Related Legislation. SB 1069 (Pavley, Chapter 512,
Statutes of 2010) authorized a PA, pursuant to a delegation of
services agreement, to order durable medical equipment,
certify unemployment insurance disability, and for individuals
receiving home health services or personal care services,
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after consultation with the supervising physician, approve,
sign, modify, or add to a plan of treatment or plan of care.
This bill also authorized PAs to conduct specified medical
examinations and sign corresponding medical certificates for
various individuals.
AB 3 (Bass, Chapter 376, Statutes of 2007) created the
"California Team Practice Improvement Act" which deleted the
prohibition on the authority of a PA to issue a drug order for
specified classes of controlled substances if the PA has
completed a specified education course, required a PA and his
or her supervising physician to establish written supervisory
guidelines and protocols, increased to four the number of PAs
a physician may supervise, and specified that services
provided by a PA are included as covered benefits under the
Medi-Cal program.
AB 2626 (Plescia, Chapter 452, Statutes of 2004) removed the
requirement for the supervising physician to review, co-sign
and date each prescription written by a PA and limited the
co-signature requirement to each Schedule II drug order
written by a PA.
SUPPORT AND OPPOSITION:
Support:
California Academy of Physician Assistants (Sponsor)
Numerous individuals
Opposition:
None on file as of April 14, 2015.
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