Amended in Senate April 13, 2015

Senate BillNo. 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 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,begin delete 5 percentend deletebegin insert 5%end insert 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 abegin delete patient,end deletebegin insert patientend insert 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:

P2    1

SECTION 1.  

Section 3501 of the Business and Professions
2Code
is amended to read:

3

3501.  

(a) As used in this chapter:

4(1) “Board” means the Physician Assistant Board.

5(2) “Approved program” means a program for the education of
6physician assistants that has been formally approved by the board.

P3    1(3) “Trainee” means a person who is currently enrolled in an
2approved program.

3(4) “Physician assistant” means a person who meets the
4requirements of this chapter and is licensed by the board.

5(5) “Supervising physician”begin insert or “supervising physician and
6surgeon”end insert
means a physician and surgeon licensed by the Medical
7Board of California or by the Osteopathic Medical Board of
8California who supervises one or more physician assistants, who
9possesses a current valid license to practice medicine, and who is
10not currently on disciplinary probation for improper use of a
11physician assistant.

12(6) “Supervision” means that a licensed physician and surgeon
13oversees the activities of, and accepts responsibility for, the medical
14services rendered by a physician assistant.

15(7) “Regulations” means the rules and regulations as set forth
16in Chapter 13.8 (commencing with Section 1399.500) of Title 16
17of the California Code of Regulations.

18(8) “Routine visual screening” means uninvasive
19nonpharmacological simple testing for visual acuity, visual field
20defects, color blindness, and depth perception.

21(9) “Program manager” means the staff manager of the diversion
22program, as designated by the executive officer of the board. The
23program manager shall have background experience in dealing
24with substance abuse issues.

25(10) “Delegation of services agreement” means the writing that
26delegates to a physician assistant from a supervising physician the
27medical services the physician assistant is authorized to perform
28consistent with subdivision (a) of Section 1399.540 of Title 16 of
29the California Code of Regulations.

30(11) “Other specified medical services” means tests or
31examinations performed or ordered by a physician assistant
32practicing in compliance with this chapter or regulations of the
33Medical Board of California promulgated under this chapter.

34(12) “Medical records review meeting” means a meeting
35between the supervising physician and the physician assistant
36during which a sample of medical records is reviewed to ensure
37adequate supervision of the physician assistant functioning under
38protocols. The number of medical records and the specific issues
39to be reviewed shall be established in the delegation of services
40agreement.

P4    1(b) A physician assistant acts as an agent of the supervising
2physician when performing any activity authorized by this chapter
3or regulations adopted under this chapter.

4

SEC. 2.  

Section 3502 of the Business and Professions Code is
5amended to read:

6

3502.  

(a) Notwithstanding any other law, a physician assistant
7may perform those medical services as set forth by the regulations
8adopted under this chapter when the services are rendered under
9the supervision of a licensed physician and surgeon who is not
10subject to a disciplinary condition imposed by the Medical Board
11of California prohibiting that supervision or prohibiting the
12employment of a physician assistant. The medical record, for each
13episode of care for a patient, shall identify the physician and
14surgeon who is responsible for the supervision of the physician
15assistant. When a physician assistant transmits an oral order, he
16or she shall also identify the name of the supervising physician
17and surgeon responsible for the patient.

18(b) (1) Notwithstanding any other law, a physician assistant
19performing medical services under the supervision of a physician
20and surgeon may assist a doctor of podiatric medicine who is a
21partner, shareholder, or employee in the same medical group as
22the supervising physician and surgeon. A physician assistant who
23assists a doctor of podiatric medicine pursuant to this subdivision
24shall do so only according to patient-specific orders from the
25supervising physician and surgeon.

26(2) The supervising physician and surgeon shall be physically
27available to the physician assistant for consultation when that
28assistance is rendered. A physician assistant assisting a doctor of
29podiatric medicine shall be limited to performing those duties
30included within the scope of practice of a doctor of podiatric
31medicine.

32(c) (1) A physician assistant and his or her supervising physician
33and surgeon shall establish written guidelines for the adequate
34supervision of the physician assistant. This requirement may be
35satisfied by the supervising physician and surgeon adopting
36protocols for some or all of the tasks performed by the physician
37assistant. The protocols adopted pursuant to this subdivision shall
38comply with the following requirements:

39(A) A protocol governing diagnosis and management shall, at
40a minimum, include the presence or absence of symptoms, signs,
P5    1and other data necessary to establish a diagnosis or assessment,
2any appropriate tests or studies to order, drugs to recommend to
3the patient, and education to be provided to the patient.

4(B) A protocol governing procedures shall set forth the
5information to be provided to the patient, the nature of the consent
6to be obtained from the patient, the preparation and technique of
7the procedure, and the followup care.

8(C) Protocols shall be developed by the supervising physician
9and surgeon or adopted from, or referenced to, texts or other
10sources.

11(D) Protocols shall be signed and dated by the supervising
12physician and surgeon and the physician assistant.

13(2) (A) The supervising physician and surgeon shall use one
14or more of the following mechanisms to ensure adequate
15supervision of the physician assistant functioning under the
16protocols:

17(i) The supervising physician and surgeonbegin delete reviews, countersigns,
18and datesend delete
begin insert shall review, countersign, and dateend insert a sample consisting
19of, at a minimum, 5 percent of the medical records of patients
20treated by the physician assistant functioning under the protocols
21within 30 days of the date of treatment by the physician assistant.

22(ii) The supervising physician and surgeon and physician
23assistantbegin insert shallend insert conductbegin delete and documentend deletebegin insert at least 10 times annuallyend insert a
24medical records reviewbegin delete meeting at least once each quarter during
25the calendar year.end delete
begin insert meeting, which may occur in person or by
26electronic communication.end insert

27(iii) The supervising physician and surgeonbegin delete supervisesend deletebegin insert shall
28superviseend insert
the care provided by the physician assistant through a
29review of those cases or patients deemed appropriate by the
30supervisingbegin delete physician.end deletebegin insert physician and surgeon.end insert The review methods
31used shall be identified in the delegation of services agreement,
32andbegin insert reviewend insert may occur inbegin delete person, by telephone,end deletebegin insert end insertbegin insertperson orend insert by
33electronicbegin delete messaging, or using video conferencing technology.end delete
34begin insert communication.end insert

35(B) In complying with subparagraph (A), the supervising
36physician and surgeon shall select for review those cases that by
37diagnosis, problem, treatment, or procedure represent, in his or
38her judgment, the most significant risk to the patient.

P6    1(3) Notwithstanding any other law, the Medical Board of
2California or the board may establish other alternative mechanisms
3for the adequate supervision of the physician assistant.

4(d) No medical services may be performed under this chapter
5in any of the following areas:

6(1) The determination of the refractive states of the human eye,
7or the fitting or adaptation of lenses or frames for the aid thereof.

8(2) The prescribing or directing the use of, or using, any optical
9device in connection with ocular exercises, visual training, or
10orthoptics.

11(3) The prescribing of contact lenses for, or the fitting or
12adaptation of contact lenses to, the human eye.

13(4) The practice of dentistry or dental hygiene or the work of a
14dental auxiliary as defined in Chapter 4 (commencing with Section
151600).

16(e) This section shall not be construed in a manner that shall
17preclude the performance of routine visual screening as defined
18in Section 3501.

19(f) Compliance by a physician assistant and supervising
20physician and surgeon with this section shall be deemed
21compliance with Section 1399.546 of Title 16 of the California
22Code of Regulations.

23

SEC. 3.  

Section 3502.1 of the Business and Professions Code
24 is amended to read:

25

3502.1.  

(a) In addition to the services authorized in the
26regulations adopted by the Medical Board of California, and except
27as prohibited by Section 3502, while under the supervision of a
28licensed physician and surgeon or physicians and surgeons
29authorized by law to supervise a physician assistant, a physician
30assistant may administer or provide medication to a patient, or
31transmit orally, or in writing on a patient’s record or in a drug
32order, an order to a person who may lawfully furnish the
33medication or medical device pursuant to subdivisions (c) and (d).

34(1) A supervising physician and surgeon who delegates authority
35to issue a drug order to a physician assistant may limit this authority
36by specifying the manner in which the physician assistant may
37issue delegated prescriptions.

38(2) Each supervising physician and surgeon who delegates the
39authority to issue a drug order to a physician assistant shall first
40prepare and adopt, or adopt, a written, practice specific, formulary
P7    1and protocols that specify all criteria for the use of a particular
2drug or device, and any contraindications for the selection.
3Protocols for Schedule II controlled substances shall address the
4diagnosis of illness, injury, or condition for which the Schedule II
5controlled substance is being administered, provided, or issued.
6The drugs listed in the protocols shall constitute the formulary and
7shall include only drugs that are appropriate for use in the type of
8practice engaged in by the supervising physician and surgeon.
9When issuing a drug order, the physician assistant is acting on
10behalf of and as an agent for a supervising physician and surgeon.

11(b) “Drug order,” for purposes of this section, means an order
12for medication that is dispensed to or for a patient, issued and
13signed by a physician assistant acting as an individual practitioner
14within the meaning of Section 1306.02 of Title 21 of the Code of
15Federal Regulations. Notwithstanding any other provision of law,
16(1) a drug order issued pursuant to this section shall be treated in
17the same manner as a prescription or order of the supervising
18physician, (2) all references to “prescription” in this code and the
19Health and Safety Code shall include drug orders issued by
20physician assistants pursuant to authority granted by their
21supervising physicians and surgeons, and (3) the signature of a
22physician assistant on a drug order shall be deemed to be the
23signature of a prescriber for purposes of this code and the Health
24and Safety Code.

25(c) A drug order for any patient cared for by the physician
26assistant that is issued by the physician assistant shall either be
27based on the protocols described in subdivision (a) or shall be
28approved by the supervising physician and surgeon before it is
29filled or carried out.

30(1) A physician assistant shall not administer or provide a drug
31or issue a drug order for a drug other than for a drug listed in the
32formulary without advance approval from a supervising physician
33and surgeon for the particular patient. At the direction and under
34the supervision of a physician and surgeon, a physician assistant
35may hand to a patient of the supervising physician and surgeon a
36properly labeled prescription drug prepackaged by a physician and
37surgeon, manufacturer as defined in the Pharmacy Law, or a
38pharmacist.

39(2) A physician assistant shall not administer, provide, or issue
40a drug order to a patient for Schedule II through Schedule V
P8    1controlled substances without advance approval by a supervising
2physician and surgeon for that particular patient unless the
3physician assistant has completed an education course that covers
4controlled substances and that meets standards, including
5pharmacological content, approved by the board. The education
6course shall be provided either by an accredited continuing
7education provider or by an approved physician assistant training
8program. If the physician assistant will administer, provide, or
9issue a drug order for Schedule II controlled substances, the course
10shall contain a minimum of three hours exclusively on Schedule
11II controlled substances. Completion of the requirements set forth
12in this paragraph shall be verified and documented in the manner
13established by the board prior to the physician assistant’s use of a
14registration number issued by the United States Drug Enforcement
15Administration to the physician assistant to administer, provide,
16or issue a drug order to a patient for a controlled substance without
17advance approval by a supervising physician and surgeon for that
18particular patient.

19(3) Any drug order issued by a physician assistant shall be
20subject to a reasonable quantitative limitation consistent with
21customary medical practice in the supervising physician and
22surgeon’s practice.

23(d) A written drug order issued pursuant to subdivision (a),
24except a written drug order in a patient’s medical record in a health
25facility or medical practice, shall contain the printed name, address,
26and telephone number of the supervising physician and surgeon,
27the printed or stamped name and license number of the physician
28assistant, and the signature of the physician assistant. Further, a
29written drug order for a controlled substance, except a written drug
30order in a patient’s medical record in a health facility or a medical
31practice, shall include the federal controlled substances registration
32number of the physician assistant and shall otherwise comply with
33Section 11162.1 of the Health and Safety Code. Except as
34otherwise required for written drug orders for controlled substances
35under Section 11162.1 of the Health and Safety Code, the
36requirements of this subdivision may be met through stamping or
37otherwise imprinting on the supervising physician and surgeon’s
38prescription blank to show the name, license number, and if
39applicable, the federal controlled substances registration number
40of the physician assistant, and shall be signed by the physician
P9    1assistant. When using a drug order, the physician assistant is acting
2on behalf of and as the agent of a supervising physician and
3surgeon.

4(e) The supervising physician and surgeon shall use either of
5the following mechanisms to ensure adequate supervision of the
6administration, provision, or issuance by a physician assistant of
7a drug order to a patient for Schedule II controlled substances:

8(1) The medical record of any patient cared for by a physician
9assistant for whom the physician assistant’s Schedule II drug order
10has been issued or carried out shall be reviewed, countersigned,
11and dated by a supervising physician and surgeon within seven
12days.

13(2) If the physician assistant has documentation evidencing the
14successful completion of an education course that covers controlled
15 substances, and that controlled substance education course (A)
16meets the standards, including pharmacological content, approved
17by the board, (B) is provided either by an accredited continuing
18education provider or by an approved physician assistant training
19program, and (C) satisfies Sections 1399.610 and 1399.612 of Title
2016 of the California Code of Regulations, the supervising physician
21and surgeon shall review, countersign, and date, within seven days,
22a sample consisting of the medical records of at least 20 percent
23of the patients cared for by the physician assistant for whom the
24physician assistant’s Schedule II drug order has been issued or
25carried out. Completion of the requirements set forth in this
26paragraph shall be verified and documented in the manner
27established in Section 1399.612 of Title 16 of the California Code
28of Regulations. Physician assistants who have a certificate of
29completion of the course described in paragraph (2) of subdivision
30(c) shall be deemed to have met the education course requirement
31of this subdivision.

32(f) All physician assistants who are authorized by their
33supervising physicians to issue drug orders for controlled
34substances shall register with the United States Drug Enforcement
35Administration (DEA).

36(g) The board shall consult with the Medical Board of California
37and report during its sunset review required by Article 7.5
38(commencing with Section 9147.7) of Chapter 1.5 of Part 1 of
39Division 2 of Title 2 of the Government Code the impacts of
40exempting Schedule III and Schedule IV drug orders from the
P10   1requirement for a physician and surgeon to review and countersign
2the affected medical record of a patient.

3

SEC. 4.  

No reimbursement is required by this act pursuant to
4Section 6 of Article XIII B of the California Constitution because
5the only costs that may be incurred by a local agency or school
6district will be incurred because this act creates a new crime or
7infraction, eliminates a crime or infraction, or changes the penalty
8for a crime or infraction, within the meaning of Section 17556 of
9the Government Code, or changes the definition of a crime within
10the meaning of Section 6 of Article XIII B of the California
11Constitution.



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