BILL ANALYSIS Ó
SB 337
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Date of Hearing: June 23, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
SB 337(Pavley) - As Amended June 16, 2015
SENATE VOTE: 38-0
SUBJECT: Physician assistants.
SUMMARY: Authorizes a physician supervising a physician
assistant (PA) to use two additional mechanisms for the general
supervision of a PA, authorizes a physician to use one
additional mechanism for the supervision of a PA that
administers a Schedule II controlled substance, and requires a
PA's patient medical records to identify the PA's supervising
physician.
EXISTING LAW:
1)Establishes the Physician Assistant Board (PAB) within the
jurisdiction of the Medical Board of California (MBC) to
license and regulate PAs. (Business and Professions Code
(BPC) § 3504)
2)Requires a PA and the supervising physician to establish
written guidelines for the adequate supervision of the PA, and
the requirement may be satisfied by the supervising physician
adopting protocols for some or all of the tasks performed by
the PA. (BPC § 3502 (c)(1))
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3)Requires a supervising physician to be available in person or
by electronic communication at all times when the PA is caring
for patients. (Title 16, California Code of Regulations (CCR)
§ 1399.545 (a))
4)Requires a supervising physician to delegate to a PA only the
tasks and procedures consistent with the supervising
physician's specialty or usual and customary practice and with
the patient's health and condition, and requires the
supervising physician to observe or review evidence of the
PA's performance of all tasks and procedures to be delegated
to the PA until the physician is assured of the PA's
competency. (16 CCR § 1399.545 (b)(c))
5)Requires a supervising physician to review, countersign, and
date a sample consisting of, at a minimum, five percent of the
medical records of patients treated by the PA within 30 days
of the date of treatment. Requires the supervising physician
to select for review those cases that by diagnosis, problem,
treatment, or procedure represent, in his or her judgement,
the most significant risk to the patient. (BPC § 3502 (c)(2))
6)Authorizes the MBC or the PAB to establish other alternative
mechanisms for the adequate supervision of the PA. (BPC §
3502 (c)(3))
7)Requires a supervising physician who delegates the authority
to issue a drug order to a PA to first prepare and adopt a
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 must address the diagnosis of illness, injury, or
condition for which the Schedule II controlled substance is
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being administered, provided, or issued. (BPC § 3502.1(a)(2))
8)Requires a supervising physician to review and countersign
within seven days the record of any patient cared for by a PA
for whom the PA's Schedule II drug order has been issued or
carried out. (BPC § 3502.1 (e))
9)Allows a PA to administer Schedule II, III, IV and V drug
orders without advance approval from a supervising physician
if the PA has completed an education course that covers
controlled substances and that meets standards, including
pharmacological content, approved by the PAB. The education
course must be provided either by an accredited continuing
education provider or by an approved PA training program. For
Schedule II controlled substances, the course must contain a
minimum of three hours exclusively on Schedule II controlled
substances. (BPC § 3502.1 (c)(2))
10)Requires PAs who are authorized by their supervising
physician to issue drug orders for controlled substances to
register with the United States Drug Enforcement
Administration (DEA). (BPC § 3502.1 (f))
THIS BILL:
11)Revises the definition of "medical records review meeting" to
mean a meeting between the supervising physician and the PA
during which medical records are reviewed to ensure adequate
supervision of the PA functioning under protocols.
12)Authorizes the supervising physician and PA to hold medical
records review meetings in person or by electronic
communication.
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13)Requires the medical record, for each episode of care for a
patient, to identify the physician who is responsible for the
supervision of the PA.
14)Authorizes a physician to choose from two additional
mechanisms to supervise a PA, making a total of three
mechanisms:
a) Conduct a medical records review meeting at least once a
month during at least 10 months of the year-any month in
which a medical records review meeting occurs, the
supervising physician and PA must review an aggregate of at
least 10 medical records of patients treated by the PA.
Documentation of medical records reviewed during the month
must be jointly signed and dated by the supervising
physician and the PA.
b) Develop review methods for the review of cases involving
treatment by the PA. The review methods must be identified
in the delegation of services agreement and include at
least an aggregate of 10 cases per month for at least 10
months of the year. Documentation of the cases reviewed
during the month must be jointly signed and dated by the
physician and PA.
15)States that, in complying with the supervision requirements
above (number 4), the physician must select for review those
cases that by diagnosis, problem treatment, or procedure
represent, in the physician's judgment, the most significant
risk to the patient.
16)States that compliance with BPC § 3502 (numbers 3-5 above)
will be also considered compliance with § 1399.546 of Title 16
of the California Code of Regulations.
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17)Authorizes a physician to use an additional mechanism for the
supervision of a PA that prescribes a Schedule II controlled
substance. The physician may review, countersign, and date,
within seven days, a sample consisting of the medical records
of at least 20 percent of the patients with the PA's Schedule
II prescriptions if:
a) The PA has:
i) Completed a controlled substances education course
that meets the standards established in the PAB's
regulations and is provided either by an accredited
continuing education provider or by an approved physician
assistant training program; or,
ii)The PA has a certificate of completion of the course
described BPC § 3502.1(c)(2); and,
b) The supervision is verified and documented in the manner
established by the PAB's regulations.
18)Makes other minor technical and clarifying changes.
FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, this bill will result
in negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by the California Academy of
Physician Assistants . According to the author, "[This bill]
increases options for the physician/PA team to document
supervision. The options included in the bill will strengthen
the team-based approach by encouraging more active discussion
during the records review.
The Patient Protection and Affordable Care Act has resulted in
millions of additional people seeking health care services in
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California. This increase has created an even greater need for
high quality, efficient team-based care across all medical
settings.
This is especially true for the practice of physician
assistants, who are authorized to provide physician exams,
diagnose and treat illness, and prescribe medication, under the
supervision of a physician. [This bill] recognizes the growing
changes in medical practice settings and the use of electronic
medical records to update methods for documentation of the
supervision of PAs and encourages more interactive review of
patient cases."
Background. According to the PAB, a PA is a licensed health
care professional, trained to provide patient evaluation,
education, and health care services. A PA works with a physician
to provide medical care and guidance needed by a patient.
In order to become a PA, an applicant must attend a specialized
medical training program associated with a medical school that
includes classroom studies and clinical experience. Upon
graduation from the program, an academic degree or certificate
is awarded. Many PAs already have two or four year academic
degrees before entering a PA training program. Most PA training
programs require prior health care experience.
While a licensed PA is authorized to perform many of the same
health care services as a physician, the services the PA may
provide are limited to the services expressly authorized by the
PA's supervising physician. The physician's written
authorization is known as a delegation of services agreement.
In the agreement, the physician is allowed to authorize only the
services that the physician determines the PA competent to
perform, consistent with the PA's education, training, and
experience.
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As of June 2013, there were about 9,000 active PA licenses in
California.
General Supervision Requirements. Existing law requires each PA
to be supervised by at least one physician. The physician may
supervise the PA either when both are at the same location or by
telephone. Further, the physician must be physically or
electronically available to the PA at the time of treatment.
The PA and the supervising physician must also establish written
guidelines for the adequate supervision of the PA. The
requirement may be satisfied by adopting protocols for some or
all of the tasks performed by the PA.
In addition, the physician is responsible for following each
patient's progress and must review, countersign, and date a
sample of at least five percent of a PA's patient medical
records within 30 days of treatment. The physician decides to
review cases that represent the most significant risk to the
patient.
According to the author, the current five percent requirement
does not accommodate all care delivery models, which can lead to
less access to care and supervision issues. This bill seeks to
add two additional mechanisms to allow a supervising physician
more options to adequately supervise a PA:
1)Allow the physician to conduct a medical records review
meeting at least once a month during at least 10 months of the
year. In the months in which a medical records review meeting
occurs, the physician and PA must review at least 10 of the
PA's patient medical records. This option would allow a
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physician to spread the meetings out over the year rather than
as the treatments occur.
2)Allow the physician to develop the method for reviewing cases.
The review methods must be identified in the delegation of
services agreement and include at least an aggregate of 10
cases per month for at least 10 months of the year. This
option would allow the physician to combine several months of
review, for instance if the physician wants to physically
review the records but is only in the area six months out of
the year.
Supervision of Controlled Substances. Under the United States
Controlled Substances Act, the DEA classifies drugs into five
categories (schedules), depending upon the drug's acceptable
medical use and the drug's abuse or dependency potential. As
the schedule number decreases, the higher the concern for
potential abuse-Schedule V drugs present the least potential for
abuse, while Schedule II drugs are considered to have a high
potential. Schedule I drugs typically have no accepted medical
purpose.
Existing law allows a supervising physician to authorize a PA to
prescribe drugs classified as Schedule II, III, IV and V if:
3)The physician develops practice specific, written protocols
and formularies. The protocols for Schedule II controlled
substances must address diagnosis of illness, injury, or
condition for which the drug is being prescribed;
4)The PA registers with the DEA; and,
5)The PA obtains advanced approval from the physician.
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In addition, a PA may prescribe controlled substances without
advanced approval by the supervising physician if the PA has
completed a controlled substance education course that meets
standards approved by the PAB. For Schedule II controlled
substances, the course must spend at least three hours
exclusively on Schedule II controlled substances.
There is also an additional supervision requirement for Schedule
II controlled substances-the physician must reviews,
countersign, and date the medical record of all the PA's
patients within seven days of prescribing the drug. Schedule
III and IV drugs do not have a countersigning requirement, but
the physician is still required to review the medical records
of the PA's patients overall. The PAB is also required to
consult with the Medical Board of California and report during
sunset review the impacts of the exemption. The PAB is up for
sunset review in 2016.
According to the author, the 100% countersigning requirement is
also prohibitive to many new care delivery models. Because
existing law allows a physician to provide supervision
electronically, PA-lead clinics may be unable to provide
Schedule II drugs if the physician must be physically available
to countersign the medical records within seven days for every
prescription. Further, there are still the general supervision
requirements, which may create a duplicative or overlapping
signing requirement for Schedule II drugs.
The Reclassification of HCP to Schedule II. In August of 2014,
the DEA published a final rule, effective October 6, 2014,
following recommendations from the U.S. Food and Drug
Administration (FDA) to reclassify hydrocodone combination
products (HCP) from a Schedule III controlled substance to a
Schedule II. HCP products, such as Vicodin, are popular
alternatives to Oxycodone for pain management (due to risk of
addiction and side effects). According to the author, "the new
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ruling restricts the ability of a practice to fully utilize the
PAs they employee as there is no other profession with
prescribing privileges that has that level of mandate for
documentation."
Other States. The Schedule II countersigning requirements vary
from state-to-state. Some states have no countersigning
requirement and others do not permit PAs to administer Schedule
II drugs at all.
Prior Related Legislation. SB 1069 (Pavley), Chapter 512,
Statutes of 2010, authorized a PA, pursuant to a delegation of
services agreement, to order durable medical equipment, certify
unemployment insurance disability, and for individuals receiving
home health services or personal care services, after
consultation with the supervising physician, approve, sign,
modify, or add to a plan of treatment or plan of care. The bill
also authorized PAs to conduct specified medical examinations
and sign corresponding medical certificates for various
individuals.
AB 3 (Bass), Chapter 376, Statutes of 2007, created the
"California Team Practice Improvement Act" which deleted the
prohibition on the authority of a PA to issue a drug order for
specified classes of controlled substances if the PA has
completed a specified education course, required a PA and his or
her supervising physician to establish written supervisory
guidelines and protocols, increased to four the number of PAs a
physician may supervise, and specified that services provided by
a PA are included as covered benefits under the Medi-Cal
program.
AB 2626 (Plescia) Chapter 452, Statutes of 2004, removed the
requirement for the supervising physician to review, co-sign and
date each prescription written by a PA and limited the
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co-signature requirement to each Schedule II drug order written
by a PA.
ARGUMENTS IN SUPPORT:
The California Academy of Physician Assistants (sponsor) writes
in support, "Established over 30 years ago, existing law
stipulates supervision criteria between a supervising physician
and surgeon and the [PA]. It narrowly defines documentation of
this required supervision in the form of the supervising
physician co-signature on the medical record and prescriptions.
[This bill] increases the options for documenting supervision
between a supervising physician and PA would allow for
flexibility at the practice level to reflect current models of
team-based care. This bill will allow physicians and PA's to
spend more time with patients."
ARGUMENTS IN OPPOSITION:
The Medical Board of California writes in opposition, "[the MBC]
recognizes that the intent of this bill is to provide
flexibility and allow for a more team-based approach in PA
supervision, which the [MBC] believes is a laudable goal. The
recent amendments addressed concerns raised by the [MBC]?.
However, the [MBC] still has concerns related to the reduced
physician review of Schedule II drug orders from 100 percent to
20 percent, as this is a significant reduction of supervising
physician review for types of opioid medications that are
prevalent for abuse."
REGISTERED SUPPORT:
California Academy of Physician Assistance (sponsor)
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CAPG, the Voice of Accountable Physician Groups
Pacific Pain Medicine Consultants
Planned Parenthood
253 PAs
56 M.D.s and D.O.s
REGISTERED OPPOSITION:
Medical Board of California
California Pharmacists Association
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301