BILL NUMBER: SB 337 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 16, 2015
AMENDED IN SENATE APRIL 13, 2015
INTRODUCED BY Senator Pavley
FEBRUARY 23, 2015
An act to amend Sections 3501, 3502, and 3502.1 of the Business
and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
SB 337, as amended, Pavley. Physician assistants.
Existing law, the Physician Assistant Practice Act, provides for
regulation of physician assistants and authorizes a physician
assistant to perform medical services as set forth by regulations
when those services are rendered under the supervision of a licensed
physician and surgeon, as specified. The act requires the supervising
physician and surgeon to review, countersign, and date a sample
consisting of, at a minimum, 5% of the medical records of patients
treated by the physician assistant functioning under adopted
protocols within 30 days of the date of treatment by the physician
assistant. The act requires the supervising physician and surgeon to
select for review those cases that by diagnosis, problem, treatment,
or procedure represent, in his or her judgment, the most significant
risk to the patient. A violation of those supervision requirements is
a misdemeanor.
This bill would require that the medical record for each episode
of care for a patient identify the physician and surgeon who is
responsible for the supervision of the physician assistant.
The bill would require a physician assistant who transmits an oral
order to identify the name of the supervising physician and surgeon
responsible for the patient. The bill would delete those
medical record review provisions, and, instead, require the
supervising physician and surgeon to use one or more of described
review mechanisms. By adding these new requirements, the violation of
which would be a crime, this bill would impose a state-mandated
local program by changing the definition of a crime.
The act authorizes a physician assistant, while under prescribed
supervision of a physician and surgeon, to administer or provide
medication to a patient, or transmit orally, or in writing on a
patient's record or in a drug order, an order to a person who may
lawfully furnish the medication or medical device. The act prohibits
a physician assistant from administering, providing, or issuing a
drug order to a patient for Schedule II through Schedule V controlled
substances without advance approval by a supervising physician and
surgeon for that particular patient unless the physician assistant
has completed an education course that covers controlled substances
and that meets approved standards. The act requires that the medical
record of any patient cared for by a physician assistant for whom a
physician assistant's Schedule II drug order has been issued or
carried out to be reviewed, countersigned, and dated by a supervising
physician and surgeon within 7 days.
This bill would delete that review and countersignature
requirement for a physician assistant's Schedule II drug order, and,
instead, require that the supervising physician and surgeon use one
of 2 described mechanisms to ensure adequate supervision of the
administration, provision, or issuance by a physician assistant of a
drug order to a patient for Schedule II controlled substances.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 3501 of the Business and Professions Code is
amended to read:
3501. (a) As used in this chapter:
(1) "Board" means the Physician Assistant Board.
(2) "Approved program" means a program for the education of
physician assistants that has been formally approved by the board.
(3) "Trainee" means a person who is currently enrolled in an
approved program.
(4) "Physician assistant" means a person who meets the
requirements of this chapter and is licensed by the board.
(5) "Supervising physician" or "supervising physician and surgeon"
means a physician and surgeon licensed by the Medical Board of
California or by the Osteopathic Medical Board of California who
supervises one or more physician assistants, who possesses a current
valid license to practice medicine, and who is not currently on
disciplinary probation for improper use of a physician assistant.
(6) "Supervision" means that a licensed physician and surgeon
oversees the activities of, and accepts responsibility for, the
medical services rendered by a physician assistant.
(7) "Regulations" means the rules and regulations as set forth in
Chapter 13.8 (commencing with Section 1399.500) of Title 16 of the
California Code of Regulations.
(8) "Routine visual screening" means uninvasive nonpharmacological
simple testing for visual acuity, visual field defects, color
blindness, and depth perception.
(9) "Program manager" means the staff manager of the diversion
program, as designated by the executive officer of the board. The
program manager shall have background experience in dealing with
substance abuse issues.
(10) "Delegation of services agreement" means the writing that
delegates to a physician assistant from a supervising physician the
medical services the physician assistant is authorized to perform
consistent with subdivision (a) of Section 1399.540 of Title 16 of
the California Code of Regulations.
(11) "Other specified medical services" means tests or
examinations performed or ordered by a physician assistant practicing
in compliance with this chapter or regulations of the Medical Board
of California promulgated under this chapter.
(12) "Medical records review meeting" means a meeting between the
supervising physician and surgeon and the physician
assistant during which a sample of medical records
is are reviewed to ensure adequate
supervision of the physician assistant functioning under protocols.
The number of medical records and the specific issues to be
reviewed shall be established in the delegation of services
agreement. Medical records review meetings may occur in
person or by electronic communication.
(b) A physician assistant acts as an agent of the supervising
physician when performing any activity authorized by this chapter or
regulations adopted under this chapter.
SEC. 2. Section 3502 of the Business and Professions Code is
amended to read:
3502. (a) Notwithstanding any other law, a physician assistant
may perform those medical services as set forth by the regulations
adopted under this chapter when the services are rendered under the
supervision of a licensed physician and surgeon who is not subject to
a disciplinary condition imposed by the Medical Board of California
prohibiting that supervision or prohibiting the employment of a
physician assistant. The medical record, for each episode of care for
a patient, shall identify the physician and surgeon who is
responsible for the supervision of the physician assistant.
When a physician assistant transmits an oral order, he or she shall
also identify the name of the supervising physician and surgeon
responsible for the patient.
(b) (1) Notwithstanding any other law, a physician assistant
performing medical services under the supervision of a physician and
surgeon may assist a doctor of podiatric medicine who is a partner,
shareholder, or employee in the same medical group as the supervising
physician and surgeon. A physician assistant who assists a doctor of
podiatric medicine pursuant to this subdivision shall do so only
according to patient-specific orders from the supervising physician
and surgeon.
(2) The supervising physician and surgeon shall be physically
available to the physician assistant for consultation when that
assistance is rendered. A physician assistant assisting a doctor of
podiatric medicine shall be limited to performing those duties
included within the scope of practice of a doctor of podiatric
medicine.
(c) (1) A physician assistant and his or her supervising physician
and surgeon shall establish written guidelines for the adequate
supervision of the physician assistant. This requirement may be
satisfied by the supervising physician and surgeon adopting protocols
for some or all of the tasks performed by the physician assistant.
The protocols adopted pursuant to this subdivision shall comply with
the following requirements:
(A) A protocol governing diagnosis and management shall, at a
minimum, include the presence or absence of symptoms, signs, and
other data necessary to establish a diagnosis or assessment, any
appropriate tests or studies to order, drugs to recommend to the
patient, and education to be provided to the patient.
(B) A protocol governing procedures shall set forth the
information to be provided to the patient, the nature of the consent
to be obtained from the patient, the preparation and technique of the
procedure, and the followup care.
(C) Protocols shall be developed by the supervising physician and
surgeon or adopted from, or referenced to, texts or other sources.
(D) Protocols shall be signed and dated by the supervising
physician and surgeon and the physician assistant.
(2) (A) The supervising physician and surgeon shall use one or
more of the following mechanisms to ensure adequate supervision of
the physician assistant functioning under the protocols:
(i) The supervising physician and surgeon shall review,
countersign, and date a sample consisting of, at a minimum, 5 percent
of the medical records of patients treated by the physician
assistant functioning under the protocols within 30 days of the date
of treatment by the physician assistant.
(ii) The supervising physician and surgeon and physician assistant
shall conduct at least 10 times annually a
medical records review meeting, which may occur in person or
by electronic communication. meeting, at
least once a month during at least 10 months of the year. During any
month in which a medical records review meeting occurs, the
supervising physician and surgeon and physician assistant shall
review an aggregate of at least 10 medical records of patients
treated by the physician assistant functioning under protocols.
Documentation of medical records reviewed during the month shall be
jointly signed and dated by the supervising physician and surgeon and
the physician assistant.
(iii) The supervising physician and surgeon shall supervise the
care provided by the physician assistant through a review of
those cases or patients deemed appropriate cases
involving treatment by the physician assistant functioning under
protocols adopted by the supervising physician and surgeon. The
review methods used shall be identified in the delegation of
services agreement, and review may occur in person or by
electronic communication. agreement and shall include
no less than an aggregate of 10 cases per month for at least 10
months of the year. Documentation of the cases reviewed during the
month shall be jointly signed and dated by the supervising physician
and surgeon and the physician assistant.
(B) In complying with subparagraph (A), the supervising physician
and surgeon shall select for review those cases that by diagnosis,
problem, treatment, or procedure represent, in his or her judgment,
the most significant risk to the patient.
(3) Notwithstanding any other law, the Medical Board of California
or the board may establish other alternative mechanisms for the
adequate supervision of the physician assistant.
(d) No medical services may be performed under this chapter in any
of the following areas:
(1) The determination of the refractive states of the human eye,
or the fitting or adaptation of lenses or frames for the aid thereof.
(2) The prescribing or directing the use of, or using, any optical
device in connection with ocular exercises, visual training, or
orthoptics.
(3) The prescribing of contact lenses for, or the fitting or
adaptation of contact lenses to, the human eye.
(4) The practice of dentistry or dental hygiene or the work of a
dental auxiliary as defined in Chapter 4 (commencing with Section
1600).
(e) This section shall not be construed in a manner that shall
preclude the performance of routine visual screening as defined in
Section 3501.
(f) Compliance by a physician assistant and supervising physician
and surgeon with this section shall be deemed compliance with Section
1399.546 of Title 16 of the California Code of Regulations.
SEC. 3. Section 3502.1 of the Business and Professions Code is
amended to read:
3502.1. (a) In addition to the services authorized in the
regulations adopted by the Medical Board of California, and except as
prohibited by Section 3502, while under the supervision of a
licensed physician and surgeon or physicians and surgeons authorized
by law to supervise a physician assistant, a physician assistant may
administer or provide medication to a patient, or transmit orally, or
in writing on a patient's record or in a drug order, an order to a
person who may lawfully furnish the medication or medical device
pursuant to subdivisions (c) and (d).
(1) A supervising physician and surgeon who delegates authority to
issue a drug order to a physician assistant may limit this authority
by specifying the manner in which the physician assistant may issue
delegated prescriptions.
(2) Each supervising physician and surgeon who delegates the
authority to issue a drug order to a physician assistant shall first
prepare and adopt, or adopt, a written, practice specific, formulary
and protocols that specify all criteria for the use of a particular
drug or 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. The
drugs listed in the protocols shall constitute the formulary and
shall include only drugs that are appropriate for use in the type of
practice engaged in by the supervising physician and surgeon. When
issuing a drug order, the physician assistant is acting on behalf of
and as an agent for a supervising physician and surgeon.
(b) "Drug order," for purposes of this section, means an order for
medication that is dispensed to or for a patient, issued and signed
by a physician assistant acting as an individual practitioner within
the meaning of Section 1306.02 of Title 21 of the Code of Federal
Regulations. Notwithstanding any other provision of law, (1) a drug
order issued pursuant to this section shall be treated in the same
manner as a prescription or order of the supervising physician, (2)
all references to "prescription" in this code and the Health and
Safety Code shall include drug orders issued by physician assistants
pursuant to authority granted by their supervising physicians and
surgeons, and (3) the signature of a physician assistant on a drug
order shall be deemed to be the signature of a prescriber for
purposes of this code and the Health and Safety Code.
(c) A drug order for any patient cared for by the physician
assistant that is issued by the physician assistant shall either be
based on the protocols described in subdivision (a) or shall be
approved by the supervising physician and surgeon before it is filled
or carried out.
(1) A physician assistant shall not administer or provide a drug
or issue a drug order for a drug other than for a drug listed in the
formulary without advance approval from a supervising physician and
surgeon for the particular patient. At the direction and under the
supervision of a physician and surgeon, a physician assistant may
hand to a patient of the supervising physician and surgeon a properly
labeled prescription drug prepackaged by a physician and surgeon,
manufacturer as defined in the Pharmacy Law, or a pharmacist.
(2) A physician assistant shall not administer, provide, or issue
a drug order to a patient for Schedule II through Schedule V
controlled substances without advance approval by a supervising
physician and surgeon for that particular patient unless the
physician assistant 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 physician assistant training program. If
the physician assistant 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. Completion of the requirements set forth in this
paragraph shall be verified and documented in the manner established
by the board prior to the physician assistant's use of a registration
number issued by the United States Drug Enforcement Administration
to the physician assistant to administer, provide, or issue a drug
order to a patient for a controlled substance without advance
approval by a supervising physician and surgeon for that particular
patient.
(3) Any drug order issued by a physician assistant shall be
subject to a reasonable quantitative limitation consistent with
customary medical practice in the supervising physician and surgeon's
practice.
(d) A written drug order issued pursuant to subdivision (a),
except a written drug order in a patient's medical record in a health
facility or medical practice, shall contain the printed name,
address, and telephone number of the supervising physician and
surgeon, the printed or stamped name and license number of the
physician assistant, and the signature of the physician assistant.
Further, a written drug order for a controlled substance, except a
written drug order in a patient's medical record in a health facility
or a medical practice, shall include the federal controlled
substances registration number of the physician assistant and shall
otherwise comply with Section 11162.1 of the Health and Safety Code.
Except as otherwise required for written drug orders for controlled
substances under Section 11162.1 of the Health and Safety Code, the
requirements of this subdivision may be met through stamping or
otherwise imprinting on the supervising physician and surgeon's
prescription blank to show the name, license number, and if
applicable, the federal controlled substances registration number of
the physician assistant, and shall be signed by the physician
assistant. When using a drug order, the physician assistant is acting
on behalf of and as the agent of a supervising physician and
surgeon.
(e) The supervising physician and surgeon shall use either of the
following mechanisms to ensure adequate supervision of the
administration, provision, or issuance by a physician assistant of a
drug order to a patient for Schedule II controlled substances:
(1) The medical record of any patient cared for by a physician
assistant for whom the physician assistant's Schedule II drug order
has been issued or carried out shall be reviewed, countersigned, and
dated by a supervising physician and surgeon within seven days.
(2) If the physician assistant has documentation evidencing the
successful completion of an education course that covers controlled
substances, and that controlled substance education course (A) meets
the standards, including pharmacological content, approved
by the board, established in Sections 1399.610 and
1399.612 of Title 16 of the California Code of Regulations, and
(B) is provided either by an accredited continuing education
provider or by an approved physician assistant training program,
and (C) satisfies Sections 1399.610 and 1399.612 of Title 16
of the California Code of Regulations, the supervising
physician and surgeon 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 physician assistant for
whom the physician assistant's Schedule II drug order has been issued
or carried out. Completion of the requirements set forth in this
paragraph shall be verified and documented in the manner established
in Section 1399.612 of Title 16 of the California Code of
Regulations. Physician assistants who have a certificate of
completion of the course described in paragraph (2) of subdivision
(c) shall be deemed to have met the education course requirement of
this subdivision.
(f) All physician assistants who are authorized by their
supervising physicians to issue drug orders for controlled substances
shall register with the United States Drug Enforcement
Administration (DEA).
(g) The board shall consult with the Medical Board of California
and report during its sunset review required by Article 7.5
(commencing with Section 9147.7) of Chapter 1.5 of Part 1 of Division
2 of Title 2 of the Government Code the impacts of exempting
Schedule III and Schedule IV drug orders from the requirement for a
physician and surgeon to review and countersign the affected medical
record of a patient.
SEC. 4. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.