BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 337|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: SB 337
Author: Pavley (D)
Amended: 4/13/15
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 9-0, 4/20/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SUBJECT: Physician assistants
SOURCE: California Academy of Physician Assistants
DIGEST: This bill 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.
ANALYSIS:
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
SB 337
Page 2
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) § 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 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) § 1399.545
(a))
4) 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))
5) 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))
6) 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))
7) Authorizes the MBC or the Board to establish other
alternative mechanisms for the adequate supervision of the
PA. (BPC § 3502 (c)(3))
SB 337
Page 3
8) 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))
9) 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))
10) 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))
11) 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 (DEA). (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
SB 337
Page 4
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
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.
1) Deems that compliance by a PA and supervising physician
with this bill shall also deem compliance with specified
regulations.
2) 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.
Background
According to the author, "This bill is ? 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 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
SB 337
Page 5
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."
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.
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, and most PA training programs require prior health care
experience. As of June 2013, there were 9,101 active California
PA licensees.
Existing law requires a supervising physician to authorize
specific practice authority to a PA through a delegation of
service agreement and protocols, and current law mandates that
the supervising physician be physically or electronically
available to his or her PA at the time of treatment. In
addition, 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 their detailed practice
agreements. This bill provides two additional mechanisms for
the supervising physician to choose from to ensure adequate PA
supervision:
1)The supervising physician and PA shall conduct and document a
SB 337
Page 6
medical records review meeting at least 10 times annually,
which may occur in person or by electronic communication; or,
2)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 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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
SUPPORT: (Verified5/13/15)
California Academy of Physician Assistants (source)
CAPG
Planned Parenthood Affiliates of California
Numerous individuals
OPPOSITION: (Verified5/13/15)
California Pharmacists Association
ARGUMENTS IN SUPPORT: The source of this bill, the California
Academy of Physician Assistants, write, "With the implementation
SB 337
Page 7
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
337 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."
ARGUMENTS IN OPPOSITION: The California Pharmacists Association
writes, "It has been stated that a major driver for the changes
proposed by this bill is the DEA's reclassification of
hydrocodone combination products (HCPs) from Schedule III of the
federal Controlled Substances Act to Schedule II. We
acknowledge that this action by the DEA has increased workload
for physicians who supervise PAs. Indeed, the reclassification
has significantly increased workload for pharmacists as well?.
However, heightened scrutiny of the prescribing and dispensing
of HCPs was the exact intent of the DEA when it reclassified
them?. The DEA is attempting to curb overprescribing of HCPs to
reduce abuse and ensure more judicious use of these drugs. This
bill would counter the efforts of the DEA by reducing
supervision of PAs relative to their prescribing of HCPs and all
other Schedule II drugs."
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
SB 337
Page 8
5/22/15 13:54:33
**** END ****