Senate Bill No. 337

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 introduced, 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 percent 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” 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.

begin insert

(12) “Medical records review meeting” means a meeting
between the supervising physician and the physician assistant
during which a sample of medical records is 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.

end insert

(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 begin delete provision of end delete 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. begin insert 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 end insert begin insert . 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. end insert

(b)  begin insert (1) end insert begin insert   end insert Notwithstanding any other begin delete provision of end delete 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.

begin delete

The

end delete

begin insert (2) end insert begin insert   end insert begin insert The end insert supervising physician and surgeon shall be physically
available to the physician assistant for consultation when begin delete such end delete begin insert that end insert
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.

begin delete

(2) 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. The 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.

end delete begin insert

(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:

end insert begin insert

(i) The supervising physician and surgeon reviews, countersigns,
and dates 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.

end insert begin insert

(ii) The supervising physician and surgeon and physician
assistant conduct and document a medical records review meeting
at least once each quarter during the calendar year.

end insert begin insert

(iii) The supervising physician and surgeon supervises the care
provided by the physician assistant 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, by telephone, by electronic
messaging, or using video conferencing technology.

end insert begin insert

(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.

end insert

(3) Notwithstanding any other begin delete provision of end delete law, the Medical
Board of California or begin insert the end insert 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.

begin insert

(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.

end insert

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 begin delete may end delete begin insert shall end insert 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
begin delete the provisions of end delete 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.

begin delete

(e) 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 and countersigned
and dated by a supervising physician and surgeon within seven
days.

end delete begin insert

(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:

end insert begin insert

(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.

end insert begin insert

(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, (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.

end insert

(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 begin delete Division 1.2
(commencing with Section 473) end delete begin insert 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 end insert 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.