Amended in Assembly June 16, 2015

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, 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.begin delete 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.end delete 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” or “supervising physician and
6surgeon” 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 physicianbegin insert and surgeonend insert and the physician
36assistant during whichbegin delete a sample ofend delete medical recordsbegin delete isend deletebegin insert areend insert reviewed
37to ensure adequate supervision of the physician assistant
38functioning under protocols.begin delete The number of medical records and
39the specific issues to be reviewed shall be established in the
P4    1delegation of services agreement.end delete
begin insert Medical records review meetings
2may occur in person or by electronic communication.end insert

3(b) A physician assistant acts as an agent of the supervising
4physician when performing any activity authorized by this chapter
5or regulations adopted under this chapter.

6

SEC. 2.  

Section 3502 of the Business and Professions Code is
7amended to read:

8

3502.  

(a) Notwithstanding any other law, a physician assistant
9may perform those medical services as set forth by the regulations
10adopted under this chapter when the services are rendered under
11the supervision of a licensed physician and surgeon who is not
12subject to a disciplinary condition imposed by the Medical Board
13of California prohibiting that supervision or prohibiting the
14employment of a physician assistant. The medical record, for each
15episode of care for a patient, shall identify the physician and
16surgeon who is responsible for the supervision of the physician
17assistant.begin delete When a physician assistant transmits an oral order, he
18or she shall also identify the name of the supervising physician
19and surgeon responsible for the patient.end delete

20(b) (1) Notwithstanding any other law, a physician assistant
21performing medical services under the supervision of a physician
22and surgeon may assist a doctor of podiatric medicine who is a
23partner, shareholder, or employee in the same medical group as
24the supervising physician and surgeon. A physician assistant who
25assists a doctor of podiatric medicine pursuant to this subdivision
26shall do so only according to patient-specific orders from the
27supervising physician and surgeon.

28(2) The supervising physician and surgeon shall be physically
29available to the physician assistant for consultation when that
30assistance is rendered. A physician assistant assisting a doctor of
31podiatric medicine shall be limited to performing those duties
32included within the scope of practice of a doctor of podiatric
33medicine.

34(c) (1) A physician assistant and his or her supervising physician
35and surgeon shall establish written guidelines for the adequate
36supervision of the physician assistant. This requirement may be
37satisfied by the supervising physician and surgeon adopting
38protocols for some or all of the tasks performed by the physician
39assistant. The protocols adopted pursuant to this subdivision shall
40comply with the following requirements:

P5    1(A) A protocol governing diagnosis and management shall, at
2a minimum, include the presence or absence of symptoms, signs,
3and other data necessary to establish a diagnosis or assessment,
4any appropriate tests or studies to order, drugs to recommend to
5the patient, and education to be provided to the patient.

6(B) A protocol governing procedures shall set forth the
7information to be provided to the patient, the nature of the consent
8to be obtained from the patient, the preparation and technique of
9the procedure, and the followup care.

10(C) Protocols shall be developed by the supervising physician
11and surgeon or adopted from, or referenced to, texts or other
12sources.

13(D) Protocols shall be signed and dated by the supervising
14physician and surgeon and the physician assistant.

15(2) (A) The supervising physician and surgeon shall use one
16or more of the following mechanisms to ensure adequate
17supervision of the physician assistant functioning under the
18protocols:

19(i) The supervising physician and surgeon shall review,
20countersign, and date a sample consisting of, at a minimum, 5
21percent of the medical records of patients treated by the physician
22assistant functioning under the protocols within 30 days of the date
23of treatment by the physician assistant.

24(ii) The supervising physician and surgeon and physician
25assistant shall conductbegin delete at least 10 times annuallyend delete a medical records
26reviewbegin delete meeting, which may occur in person or by electronic
27communication.end delete
begin insert meeting, at least once a month during at least 10
28months of the year. During any month in which a medical records
29review meeting occurs, the supervising physician and surgeon and
30physician assistant shall review an aggregate of at least 10 medical
31records of patients treated by the physician assistant functioning
32under protocols. Documentation of medical records reviewed
33during the month shall be jointly signed and dated by the
34supervising physician and surgeon and the physician assistant.end insert

35(iii) The supervising physician and surgeon shall supervise the
36care provided by the physician assistant through a review ofbegin delete those
37cases or patients deemed appropriateend delete
begin insert cases involving treatment by
38the physician assistant functioning under protocols adoptedend insert
by
39the supervising physician and surgeon. The review methods used
40shall be identified in the delegation of servicesbegin delete agreement, and
P6    1review may occur in person or by electronic communication.end delete

2begin insert agreement and shall include no less than an aggregate of 10 cases
3per month for at least 10 months of the year. Documentation of
4the cases reviewed during the month shall be jointly signed and
5dated by the supervising physician and surgeon and the physician
6assistant.end insert

7(B) In complying with subparagraph (A), the supervising
8physician and surgeon shall select for review those cases that by
9diagnosis, problem, treatment, or procedure represent, in his or
10her judgment, the most significant risk to the patient.

11(3) Notwithstanding any other law, the Medical Board of
12California or the board may establish other alternative mechanisms
13for the adequate supervision of the physician assistant.

14(d) No medical services may be performed under this chapter
15in any of the following areas:

16(1) The determination of the refractive states of the human eye,
17or the fitting or adaptation of lenses or frames for the aid thereof.

18(2) The prescribing or directing the use of, or using, any optical
19device in connection with ocular exercises, visual training, or
20orthoptics.

21(3) The prescribing of contact lenses for, or the fitting or
22adaptation of contact lenses to, the human eye.

23(4) The practice of dentistry or dental hygiene or the work of a
24dental auxiliary as defined in Chapter 4 (commencing with Section
251600).

26(e) This section shall not be construed in a manner that shall
27preclude the performance of routine visual screening as defined
28in Section 3501.

29(f) Compliance by a physician assistant and supervising
30physician and surgeon with this section shall be deemed
31compliance with Section 1399.546 of Title 16 of the California
32Code of Regulations.

33

SEC. 3.  

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

35

3502.1.  

(a) In addition to the services authorized in the
36regulations adopted by the Medical Board of California, and except
37as prohibited by Section 3502, while under the supervision of a
38licensed physician and surgeon or physicians and surgeons
39authorized by law to supervise a physician assistant, a physician
40assistant may administer or provide medication to a patient, or
P7    1transmit orally, or in writing on a patient’s record or in a drug
2order, an order to a person who may lawfully furnish the
3medication or medical device pursuant to subdivisions (c) and (d).

4(1) A supervising physician and surgeon who delegates authority
5to issue a drug order to a physician assistant may limit this authority
6by specifying the manner in which the physician assistant may
7issue delegated prescriptions.

8(2) Each supervising physician and surgeon who delegates the
9authority to issue a drug order to a physician assistant shall first
10prepare and adopt, or adopt, a written, practice specific, formulary
11and protocols that specify all criteria for the use of a particular
12drug or device, and any contraindications for the selection.
13Protocols for Schedule II controlled substances shall address the
14diagnosis of illness, injury, or condition for which the Schedule II
15controlled substance is being administered, provided, or issued.
16The drugs listed in the protocols shall constitute the formulary and
17shall include only drugs that are appropriate for use in the type of
18practice engaged in by the supervising physician and surgeon.
19When issuing a drug order, the physician assistant is acting on
20behalf of and as an agent for a supervising physician and surgeon.

21(b) “Drug order,” for purposes of this section, means an order
22for medication that is dispensed to or for a patient, issued and
23signed by a physician assistant acting as an individual practitioner
24within the meaning of Section 1306.02 of Title 21 of the Code of
25Federal Regulations. Notwithstanding any other provision of law,
26(1) a drug order issued pursuant to this section shall be treated in
27the same manner as a prescription or order of the supervising
28physician, (2) all references to “prescription” in this code and the
29Health and Safety Code shall include drug orders issued by
30physician assistants pursuant to authority granted by their
31supervising physicians and surgeons, and (3) the signature of a
32physician assistant on a drug order shall be deemed to be the
33signature of a prescriber for purposes of this code and the Health
34and Safety Code.

35(c) A drug order for any patient cared for by the physician
36assistant that is issued by the physician assistant shall either be
37based on the protocols described in subdivision (a) or shall be
38approved by the supervising physician and surgeon before it is
39filled or carried out.

P8    1(1) A physician assistant shall not administer or provide a drug
2or issue a drug order for a drug other than for a drug listed in the
3formulary without advance approval from a supervising physician
4and surgeon for the particular patient. At the direction and under
5the supervision of a physician and surgeon, a physician assistant
6may hand to a patient of the supervising physician and surgeon a
7properly labeled prescription drug prepackaged by a physician and
8surgeon, manufacturer as defined in the Pharmacy Law, or a
9pharmacist.

10(2) A physician assistant shall not administer, provide, or issue
11a drug order to a patient for Schedule II through Schedule V
12controlled substances without advance approval by a supervising
13physician and surgeon for that particular patient unless the
14physician assistant has completed an education course that covers
15controlled substances and that meets standards, including
16pharmacological content, approved by the board. The education
17course shall be provided either by an accredited continuing
18education provider or by an approved physician assistant training
19program. If the physician assistant will administer, provide, or
20issue a drug order for Schedule II controlled substances, the course
21shall contain a minimum of three hours exclusively on Schedule
22II controlled substances. Completion of the requirements set forth
23in this paragraph shall be verified and documented in the manner
24established by the board prior to the physician assistant’s use of a
25registration number issued by the United States Drug Enforcement
26Administration to the physician assistant to administer, provide,
27or issue a drug order to a patient for a controlled substance without
28advance approval by a supervising physician and surgeon for that
29particular patient.

30(3) Any drug order issued by a physician assistant shall be
31subject to a reasonable quantitative limitation consistent with
32customary medical practice in the supervising physician and
33surgeon’s practice.

34(d) A written drug order issued pursuant to subdivision (a),
35except a written drug order in a patient’s medical record in a health
36facility or medical practice, shall contain the printed name, address,
37and telephone number of the supervising physician and surgeon,
38the printed or stamped name and license number of the physician
39assistant, and the signature of the physician assistant. Further, a
40written drug order for a controlled substance, except a written drug
P9    1order in a patient’s medical record in a health facility or a medical
2practice, shall include the federal controlled substances registration
3number of the physician assistant and shall otherwise comply with
4Section 11162.1 of the Health and Safety Code. Except as
5otherwise required for written drug orders for controlled substances
6under Section 11162.1 of the Health and Safety Code, the
7requirements of this subdivision may be met through stamping or
8otherwise imprinting on the supervising physician and surgeon’s
9prescription blank to show the name, license number, and if
10applicable, the federal controlled substances registration number
11of the physician assistant, and shall be signed by the physician
12assistant. When using a drug order, the physician assistant is acting
13on behalf of and as the agent of a supervising physician and
14surgeon.

15(e) The supervising physician and surgeon shall use either of
16the following mechanisms to ensure adequate supervision of the
17administration, provision, or issuance by a physician assistant of
18a drug order to a patient for Schedule II controlled substances:

19(1) The medical record of any patient cared for by a physician
20assistant for whom the physician assistant’s Schedule II drug order
21has been issued or carried out shall be reviewed, countersigned,
22and dated by a supervising physician and surgeon within seven
23days.

24(2) If the physician assistant has documentation evidencing the
25successful completion of an education course that covers controlled
26 substances, and that controlled substance education course (A)
27meets the standards, including pharmacological content,begin delete approved
28by the board,end delete
begin insert established in Sections 1399.610 and 1399.612 of
29Title 16 of the California Code of Regulations, andend insert
(B) is provided
30either by an accredited continuing education provider or by an
31approved physician assistant training program,begin delete and (C) satisfies
32Sections 1399.610 and 1399.612 of Title 16 of the California Code
33of Regulations,end delete
the supervising physician and surgeon shall review,
34countersign, and date, within seven days, a sample consisting of
35the medical records of at least 20 percent of the patients cared for
36by the physician assistant for whom the physician assistant’s
37Schedule II drug order has been issued or carried out. Completion
38of the requirements set forth in this paragraph shall be verified and
39documented in the manner established in Section 1399.612 of Title
4016 of the California Code of Regulations. Physician assistants who
P10   1have a certificate of completion of the course described in
2paragraph (2) of subdivision (c) shall be deemed to have met the
3education course requirement of this subdivision.

4(f) All physician assistants who are authorized by their
5supervising physicians to issue drug orders for controlled
6substances shall register with the United States Drug Enforcement
7Administration (DEA).

8(g) The board shall consult with the Medical Board of California
9and report during its sunset review required by Article 7.5
10(commencing with Section 9147.7) of Chapter 1.5 of Part 1 of
11Division 2 of Title 2 of the Government Code the impacts of
12exempting Schedule III and Schedule IV drug orders from the
13requirement for a physician and surgeon to review and countersign
14the affected medical record of a patient.

15

SEC. 4.  

No reimbursement is required by this act pursuant to
16Section 6 of Article XIII B of the California Constitution because
17the only costs that may be incurred by a local agency or school
18district will be incurred because this act creates a new crime or
19infraction, eliminates a crime or infraction, or changes the penalty
20for a crime or infraction, within the meaning of Section 17556 of
21the Government Code, or changes the definition of a crime within
22the meaning of Section 6 of Article XIII B of the California
23Constitution.



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