Amended in Assembly September 1, 2015

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. 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 wouldbegin delete delete that review and countersignature requirement for a physician assistant’s Schedule II drug order, and, instead, require thatend deletebegin insert establish an alternative medical records end insertbegin insertreview mechanism, and would authorizeend insert the supervising physician and surgeonbegin delete use oneend deletebegin insert to use the alternative mechanism, or a sample review mechanism using a combinationend insert ofbegin insert theend insert 2 describedbegin delete mechanismsend deletebegin insert mechanisms, as specified,end insert 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:

P3    1(1) “Board” means the Physician Assistant Board.

2(2) “Approved program” means a program for the education of
3physician assistants that has been formally approved by the board.

4(3) “Trainee” means a person who is currently enrolled in an
5approved program.

6(4) “Physician assistant” means a person who meets the
7requirements of this chapter and is licensed by the board.

8(5) “Supervising physician” or “supervising physician and
9surgeon” means a physician and surgeon licensed by the Medical
10Board of California or by the Osteopathic Medical Board of
11California who supervises one or more physician assistants, who
12possesses a current valid license to practice medicine, and who is
13not currently on disciplinary probation for improper use of a
14physician assistant.

15(6) “Supervision” means that a licensed physician and surgeon
16oversees the activities of, and accepts responsibility for, the medical
17services rendered by a physician assistant.

18(7) “Regulations” means the rules and regulations as set forth
19in Chapter 13.8 (commencing with Section 1399.500) of Title 16
20of the California Code of Regulations.

21(8) “Routine visual screening” means uninvasive
22nonpharmacological simple testing for visual acuity, visual field
23defects, color blindness, and depth perception.

24(9) “Program manager” means the staff manager of the diversion
25program, as designated by the executive officer of the board. The
26program manager shall have background experience in dealing
27with substance abuse issues.

28(10) “Delegation of services agreement” means the writing that
29delegates to a physician assistant from a supervising physician the
30medical services the physician assistant is authorized to perform
31consistent with subdivision (a) of Section 1399.540 of Title 16 of
32the California Code of Regulations.

33(11) “Other specified medical services” means tests or
34examinations performed or ordered by a physician assistant
35practicing in compliance with this chapter or regulations of the
36Medical Board of California promulgated under this chapter.

37(12) “Medical records review meeting” means a meeting
38between the supervising physician and surgeon and the physician
39assistant during which medical records are reviewed to ensure
40adequate supervision of the physician assistant functioning under
P4    1protocols. Medical records review meetings may occur in person
2or by electronic communication.

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.

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 surgeon shall review,
18countersign, and date a sample consisting of, at a minimum, 5
19percent of the medical records of patients treated by the physician
20assistant functioning under the protocols within 30 days of the date
21of treatment by the physician assistant.

22(ii) The supervising physician and surgeon and physician
23assistant shall conduct a medical records reviewbegin delete meeting,end deletebegin insert meetingend insert
24 at least once a month during at least 10 months of the year. During
25any month in which a medical records review meeting occurs, the
26supervising physician and surgeon and physician assistant shall
27review an aggregate of at least 10 medical records of patients
28treated by the physician assistant functioning under protocols.
29Documentation of medical records reviewed during the month
30shall be jointly signed and dated by the supervising physician and
31surgeon and the physician assistant.

begin delete

32(iii) The supervising physician and surgeon shall supervise the
33care provided by the physician assistant through a review of cases
34involving treatment by the physician assistant functioning under
35protocols adopted by the supervising physician and surgeon. The
36review methods used shall be identified in the delegation of
37services agreement and shall include no less than an aggregate of
3810 cases per month for at least 10 months of the year.
39Documentation of the cases reviewed during the month shall be
P6    1jointly signed and dated by the supervising physician and surgeon
2and the physician assistant.

end delete
begin insert

3(iii) The supervising physician and surgeon shall review a
4sample of at least 10 medical records per month, at least 10 months
5during the year, using a combination of the countersignature
6mechanism described in clause (i) and the medical records review
7meeting mechanism described in clause (ii). During each month
8for which a sample is reviewed, at least one of the medical records
9in the sample shall be reviewed using the mechanism described in
10clause (i) and at least one of the medical records in the sample
11shall be reviewed using the mechanism described in clause (ii).

end insert

12(B) In complying with subparagraph (A), the supervising
13physician and surgeon shall select for review those cases that by
14diagnosis, problem, treatment, or procedure represent, in his or
15her judgment, the most significant risk to the patient.

16(3) Notwithstanding any other law, the Medical Board of
17California or the board may establish other alternative mechanisms
18for the adequate supervision of the physician assistant.

19(d) No medical services may be performed under this chapter
20in any of the following areas:

21(1) The determination of the refractive states of the human eye,
22or the fitting or adaptation of lenses or frames for the aid thereof.

23(2) The prescribing or directing the use of, or using, any optical
24device in connection with ocular exercises, visual training, or
25orthoptics.

26(3) The prescribing of contact lenses for, or the fitting or
27adaptation of contact lenses to, the human eye.

28(4) The practice of dentistry or dental hygiene or the work of a
29dental auxiliary as defined in Chapter 4 (commencing with Section
301600).

31(e) This section shall not be construed in a manner that shall
32preclude the performance of routine visual screening as defined
33in Section 3501.

34(f) Compliance by a physician assistant and supervising
35physician and surgeon with this section shall be deemed
36compliance with Section 1399.546 of Title 16 of the California
37Code of Regulations.

38

SEC. 3.  

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

P7    1

3502.1.  

(a) In addition to the services authorized in the
2regulations adopted by the Medical Board of California, and except
3as prohibited by Section 3502, while under the supervision of a
4licensed physician and surgeon or physicians and surgeons
5authorized by law to supervise a physician assistant, a physician
6assistant may administer or provide medication to a patient, or
7transmit orally, or in writing on a patient’s record or in a drug
8order, an order to a person who may lawfully furnish the
9medication or medical device pursuant to subdivisions (c) and (d).

10(1) A supervising physician and surgeon who delegates authority
11to issue a drug order to a physician assistant may limit this authority
12by specifying the manner in which the physician assistant may
13issue delegated prescriptions.

14(2) Each supervising physician and surgeon who delegates the
15authority to issue a drug order to a physician assistant shall first
16prepare and adopt, or adopt, a written, practice specific, formulary
17and protocols that specify all criteria for the use of a particular
18drug or device, and any contraindications for the selection.
19Protocols for Schedule II controlled substances shall address the
20diagnosis of illness, injury, or condition for which the Schedule II
21controlled substance is being administered, provided, or issued.
22The drugs listed in the protocols shall constitute the formulary and
23shall include only drugs that are appropriate for use in the type of
24practice engaged in by the supervising physician and surgeon.
25When issuing a drug order, the physician assistant is acting on
26behalf of and as an agent for a supervising physician and surgeon.

27(b) “Drug order,” for purposes of this section, means an order
28for medication that is dispensed to or for a patient, issued and
29signed by a physician assistant acting as an individual practitioner
30within the meaning of Section 1306.02 of Title 21 of the Code of
31Federal Regulations. Notwithstanding any other provision of law,
32(1) a drug order issued pursuant to this section shall be treated in
33the same manner as a prescription or order of the supervising
34physician, (2) all references to “prescription” in this code and the
35Health and Safety Code shall include drug orders issued by
36physician assistants pursuant to authority granted by their
37supervising physicians and surgeons, and (3) the signature of a
38physician assistant on a drug order shall be deemed to be the
39signature of a prescriber for purposes of this code and the Health
40and Safety Code.

P8    1(c) A drug order for any patient cared for by the physician
2assistant that is issued by the physician assistant shall either be
3based on the protocols described in subdivision (a) or shall be
4approved by the supervising physician and surgeon before it is
5filled or carried out.

6(1) A physician assistant shall not administer or provide a drug
7or issue a drug order for a drug other than for a drug listed in the
8formulary without advance approval from a supervising physician
9and surgeon for the particular patient. At the direction and under
10the supervision of a physician and surgeon, a physician assistant
11may hand to a patient of the supervising physician and surgeon a
12properly labeled prescription drug prepackaged by a physician and
13surgeon, manufacturer as defined in the Pharmacy Law, or a
14pharmacist.

15(2) A physician assistant shall not administer, provide, or issue
16a drug order to a patient for Schedule II through Schedule V
17controlled substances without advance approval by a supervising
18physician and surgeon for that particular patient unless the
19physician assistant has completed an education course that covers
20controlled substances and that meets standards, including
21pharmacological content, approved by the board. The education
22course shall be provided either by an accredited continuing
23education provider or by an approved physician assistant training
24program. If the physician assistant will administer, provide, or
25issue a drug order for Schedule II controlled substances, the course
26shall contain a minimum of three hours exclusively on Schedule
27II controlled substances. Completion of the requirements set forth
28in this paragraph shall be verified and documented in the manner
29established by the board prior to the physician assistant’s use of a
30registration number issued by the United States Drug Enforcement
31Administration to the physician assistant to administer, provide,
32or issue a drug order to a patient for a controlled substance without
33advance approval by a supervising physician and surgeon for that
34particular patient.

35(3) Any drug order issued by a physician assistant shall be
36subject to a reasonable quantitative limitation consistent with
37customary medical practice in the supervising physician and
38surgeon’s practice.

39(d) A written drug order issued pursuant to subdivision (a),
40except a written drug order in a patient’s medical record in a health
P9    1facility or medical practice, shall contain the printed name, address,
2and telephone number of the supervising physician and surgeon,
3the printed or stamped name and license number of the physician
4assistant, and the signature of the physician assistant. Further, a
5written drug order for a controlled substance, except a written drug
6order in a patient’s medical record in a health facility or a medical
7practice, shall include the federal controlled substances registration
8number of the physician assistant and shall otherwise comply with
9Section 11162.1 of the Health and Safety Code. Except as
10otherwise required for written drug orders for controlled substances
11under Section 11162.1 of the Health and Safety Code, the
12requirements of this subdivision may be met through stamping or
13otherwise imprinting on the supervising physician and surgeon’s
14prescription blank to show the name, license number, and if
15applicable, the federal controlled substances registration number
16of the physician assistant, and shall be signed by the physician
17assistant. When using a drug order, the physician assistant is acting
18on behalf of and as the agent of a supervising physician and
19surgeon.

20(e) The supervising physician and surgeon shall use either of
21the following mechanisms to ensure adequate supervision of the
22administration, provision, or issuance by a physician assistant of
23a drug order to a patient for Schedule II controlled substances:

24(1) The medical record of any patient cared for by a physician
25assistant for whom the physician assistant’s Schedule II drug order
26has been issued or carried out shall be reviewed, countersigned,
27and dated by a supervising physician and surgeon within seven
28days.

29(2) If the physician assistant has documentation evidencing the
30successful completion of an education course that covers controlled
31 substances, and that controlled substance education course (A)
32meets the standards, including pharmacological content, established
33in Sections 1399.610 and 1399.612 of Title 16 of the California
34Code of Regulations, and (B) is provided either by an accredited
35continuing education provider or by an approved physician assistant
36training program, the supervising physician and surgeon shall
37review, countersign, and date, within seven days, a sample
38consisting of the medical records of at least 20 percent of the
39patients cared for by the physician assistant for whom the physician
40assistant’s Schedule II drug order has been issued or carried out.
P10   1Completion of the requirements set forth in this paragraph shall
2be verified and documented in the manner established in Section
31399.612 of Title 16 of the California Code of Regulations.
4Physician assistants who have a certificate of completion of the
5course described in paragraph (2) of subdivision (c) shall be
6deemed to have met the education course requirement of this
7subdivision.

8(f) All physician assistants who are authorized by their
9supervising physicians to issue drug orders for controlled
10substances shall register with the United States Drug Enforcement
11Administration (DEA).

12(g) The board shall consult with the Medical Board of California
13and report during its sunset review required by Article 7.5
14(commencing with Section 9147.7) of Chapter 1.5 of Part 1 of
15Division 2 of Title 2 of the Government Code the impacts of
16exempting Schedule III and Schedule IV drug orders from the
17requirement for a physician and surgeon to review and countersign
18the affected medical record of a patient.

19

SEC. 4.  

No reimbursement is required by this act pursuant to
20Section 6 of Article XIII B of the California Constitution because
21the only costs that may be incurred by a local agency or school
22district will be incurred because this act creates a new crime or
23infraction, eliminates a crime or infraction, or changes the penalty
24for a crime or infraction, within the meaning of Section 17556 of
25the Government Code, or changes the definition of a crime within
26the meaning of Section 6 of Article XIII B of the California
27Constitution.



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