BILL NUMBER: SB 994 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 14, 2016
AMENDED IN SENATE MARCH 28, 2016
INTRODUCED BY Senator Hill
FEBRUARY 10, 2016
An act to amend the heading of Article 2.6 (commencing with
Section 1645) of Chapter 4 of Division 2 of, to amend the heading of
Article 10 (commencing with Section 2190) of Chapter 5 of Division 2
of, and to add Sections 1645.5, 2197, 2454.6, and 2496.5 to, the
Business and Professions Code, and to add Article 2.7 (commencing
with Section 1223) of Chapter 1 of Division 2 to the Health and
Safety Code, relating to antimicrobial stewardship.
LEGISLATIVE COUNSEL'S DIGEST
SB 994, as amended, Hill. Antimicrobial stewardship policies.
(1) Under the existing law, the
Dental Practice Act, the Dental Board of
California, among other things, establishes requirements pursuant to
which an California licenses and regulates the
practice of dentistry. The act provides that an applicant may
obtain an initial 2-year license to practice dentistry and a 2-year
renewal license, including that the board may require
successful completion of continuing education as a condition to
license renewal. license. The act also makes certain
conduct unprofessional conduct and authorizes the board to revoke or
suspend a license or reprimand or place on probation a dentist for
that unprofessional conduct.
Under the existing law, the Medical
Practice Act, the Medical Board of California, the Osteopathic
Medical Board of California, and the California Board of Podiatric
Medicine establish requirements pursuant to which an applicant may
obtain an initial 2-year license or subsequent 2-year renewal license
to practice medicine as a podiatrist, as a physician and surgeon,
osteopathic medicine as an osteopathic physician and surgeon, or
podiatric medicine as a podiatrist, respectively. Under existing law,
the Medical Board of California is required to adopt and administer
standards for the continuing education of physicians and surgeons and
each year audits a random sample of physicians and surgeons who have
reported compliance with those requirements and requires a
noncompliant licensee to make up the deficiency during the next
renewal period. Under existing law, a licensee who fails to so comply
is ineligible for a subsequent renewal license until he or she
documents compliance to the board. Existing law provides for similar
continuing education requirements as a condition of obtaining a
renewal license to practice osteopathic medicine and podiatric
medicine. The act authorizes these boards to discipline a
licensee for specified unprofessional conduct.
This bill would require a "covered licensee," defined as a
dentist, physician and surgeon, osteopathic physician and surgeon, or
person licensed to practice podiatric medicine, who practices in a
setting other than a clinic, general acute care hospital, or skilled
nursing facility, to adopt and implement an antimicrobial stewardship
policy consistent with specified guidelines or methods of
intervention, as defined, before applying for a renewal license and,
upon applying for a renewal license, to certify in writing, on a form
prescribed by the respective licensing board, that he or she has
both adopted an antimicrobial stewardship policy and is in compliance
with that policy. The bill would require those licensing boards to
audit, during each year, a random sample of covered licensees who
have certified compliance with these requirements and would limit the
audit of an individual covered licensee to once every 4 years. The
bill would require a covered licensee who is selected for audit to
submit to the board, on a form prescribed by the board, a copy of his
or her antimicrobial stewardship policy. The bill would require the
respective licensing board, that determines that its audited covered
licensee has failed to comply with these requirements, to require
that covered licensee to comply with these requirements during the
following renewal period. The bill would provide that the
failure of a covered licensee who fails to comply is
ineligible for license renewal until he or she has documented
compliance. to comply with those requirements during
the renewal period constitutes unprofessional conduct.
(2) Under existing law, health facilities, including, among
others, general acute care hospitals, skilled nursing facilities,
primary care clinics, and specialty clinics, are licensed and
regulated by the State Department of Public Health, and a violation
of those provisions is a crime. Existing law requires that each
general acute care hospital, on or before July 1, 2015, adopt and
implement an antimicrobial stewardship policy in accordance with
guidelines established by the federal government and professional
organizations that includes a process to evaluate the judicious use
of antibiotics, as specified. Existing law requires each skilled
nursing facility, on or before January 1, 2017, to adopt and
implement an antimicrobial stewardship policy consistent with
guidelines developed by the federal Centers for Disease Control and
Prevention and other specified entities.
This bill would, beginning January 1, 2018, require a clinic to
adopt and implement an antimicrobial stewardship policy consistent
with specified guidelines or methods of intervention, as defined.
Because this bill would create new crimes, the bill would impose a
state-mandated local program.
(3) 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. The Legislature finds and declares all of the
following:
(a) The overuse and misuse of antibiotics can lead to the
development of antibiotic-resistant infections, a major public health
threat.
(b) The federal Centers for Disease Control and Prevention (CDC)
estimates that at least 2,000,000 Americans are infected with, and at
least 23,000 Americans die as a result of, antibiotic-resistant
infections every year, resulting in at least $20 billion in direct
health care costs and at least $35 billion in lost productivity in
the United States.
(c) Antibiotic resistance is a growing threat. A recent study
commissioned by the United Kingdom determined that by 2050,
worldwide, more people will die from antibiotic-resistant infections
than from cancer.
(d) The overuse and misuse of antibiotics in human medicine is a
significant factor driving the development of antibiotic resistance,
and a majority of antibiotics are prescribed in outpatient settings,
including primary care physician offices, outpatient settings where
physician assistants and nurse practitioners work, dentist offices,
and other specialty health care providers.
(e) According to the CDC, in one year, 262.5 million courses of
antibiotics are written in outpatient settings. This equates to more
than five prescriptions written each year for every six people in the
United States. The CDC estimates that over one-half of the
antibiotics prescribed in outpatient settings are unnecessary.
(f) More than 10 million courses of antibiotics are prescribed
each year for viral conditions that do not benefit from antibiotics.
(g) Antibiotic stewardship programs, which are already required in
general acute care hospitals and skilled nursing facilities in the
state, but not in outpatient settings, are an effective way to reduce
inappropriate antibiotic use and the prevalence of
antibiotic-resistant infections.
(h) The President's National Action Plan for Combating
Antibiotic-Resistant Bacteria calls for the establishment of
antibiotic stewardship activities in all health care delivery
settings, including outpatient settings, by 2020.
SEC. 2. The heading of Article 2.6 (commencing with Section 1645)
of Chapter 4 of Division 2 of the Business and Professions Code is
amended to read:
Article 2.6. Continuing Education and Antimicrobial
Stewardship
SEC. 3. Section 1645.5 is added to the Business and Professions
Code, to read:
1645.5. (a) For purposes of this section the following
definitions apply:
(1) "Antimicrobial stewardship policy" means efforts to promote
the appropriate and optimal selection, dosage, and duration
prescribing of antimicrobials for patients, with
the goal of reducing antimicrobial overuse and misuse and minimizing
the development of antimicrobial resistant infections, that is
consistent with one of the following parameters:
(A) Antimicrobial stewardship guidelines published by the federal
Centers for Disease Control and Prevention, the federal Centers for
Medicare and Medicaid Services, the Society for Healthcare
Epidemiology of America, the Infectious Diseases Society of America,
or similar recognized professional organizations.
(B) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven, evidence-based
methods should include more than one intervention or component.
(2) A "covered licensee" means a dentist who practices dentistry
in a setting other than a clinic licensed pursuant to Section 1204 of
the Health and Safety Code, a general acute care hospital as defined
in subdivision (a) of Section 1250 of the Health and Safety Code, or
a skilled nursing facility as defined in subdivision (c) of Section
1250 of the Health and Safety Code.
(3) "Evidence-based methods" means antimicrobial prescribing
intervention methods that have been proven effective through outcome
evaluations or studies, including, but not limited to, audit and
feedback, academic detailing, clinical decision support, delayed
prescribing practices, poster-based interventions, accountable
justification, and peer comparison.
(b) A covered licensee shall adopt and implement an antimicrobial
stewardship policy before applying for a renewal license.
(c) Upon filing an application with the board for a renewal
license, a covered licensee shall certify in writing, on a form
prescribed by the board, that he or she has both adopted an
antimicrobial stewardship policy pursuant to subdivision (b) and is
in compliance with that policy.
(d) (1) The board shall audit during each year a random sample of
covered licensees who have certified compliance pursuant to
subdivision (c). The board shall not audit an individual covered
licensee more than once every four years.
(2) A covered licensee who is selected for audit shall submit to
the board, on a form prescribed by the board, a copy of his or her
antimicrobial stewardship policy.
(e) If the board determines that an audited covered licensee has
failed to comply with subdivision (b), the board shall require that
covered licensee to comply with subdivision (b) during the following
renewal period. If the covered licensee fails to comply within that
renewal period, he or she is ineligible for a
subsequent license renewal until he or she has documented compliance.
that failure constitutes unprofessional conduct
subject to discipline pursuant to Section 1670.
SEC. 4. The heading of Article 10 (commencing with Section 2190)
of Chapter 5 of Division 2 of the Business and Professions Code is
amended to read:
Article 10. Continuing Medical Education and Antimicrobial
Stewardship
SEC. 5. Section 2197 is added to the Business and Professions
Code, to read:
2197. (a) For purposes of this section the following definitions
apply:
(1) "Antimicrobial stewardship policy" means efforts to promote
the appropriate and optimal selection, dosage, and duration
prescribing of antimicrobials for patients, with
the goal of reducing antimicrobial overuse and misuse and minimizing
the development of antimicrobial resistant infections, that is
consistent with one of the following parameters:
(A) Antimicrobial stewardship guidelines published by the federal
Centers for Disease Control and Prevention, the federal Centers for
Medicare and Medicaid Services, the Society for Healthcare
Epidemiology of America, the Infectious Diseases Society of America,
or similar recognized professional organizations.
(B) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven, evidence-based
methods should include more than one intervention or component.
(2) A "covered licensee" means a physician and surgeon who
practices medicine in a setting other than a clinic licensed pursuant
to Section 1204 of the Health and Safety Code, a general acute care
hospital as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, or a skilled nursing facility as defined in
subdivision (c) of Section 1250 of the Health and Safety Code.
(3) "Evidence-based methods" means antimicrobial prescribing
intervention methods that have been proven effective through outcome
evaluations or studies, including, but not limited to, audit and
feedback, academic detailing, clinical decision support, delayed
prescribing practices, poster-based interventions, accountable
justification, and peer comparison.
(b) A covered licensee shall adopt and implement an antimicrobial
stewardship policy before applying for a renewal license.
(c) Upon filing an application with the board for a renewal
license, a covered licensee shall certify in writing, on a form
prescribed by the board, that he or she has both adopted an
antimicrobial stewardship policy pursuant to subdivision (b) and is
in compliance with that policy.
(d) (1) The board shall audit during each year a random sample of
covered licensees who have certified compliance pursuant to
subdivision (c). The board shall not audit an individual covered
licensee more than once every four years.
(2) A covered licensee who is selected for audit shall submit to
the board, on a form prescribed by the board, a copy of his or her
antimicrobial stewardship policy.
(e) If the board determines that an audited covered licensee has
failed to comply with subdivision (b), the board shall require that
covered licensee to comply with subdivision (b) during the following
renewal period. If the covered licensee fails to comply within that
renewal period, he or she is ineligible for a
subsequent license renewal until he or she has documented compliance.
that failure constitutes unprofessional conduct
subject to discipline pursuant to Section 2234.
SEC. 6. Section 2454.6 is added to the Business and Professions
Code, to read:
2454.6. (a) For purposes of this section the following
definitions apply:
(1) "Antimicrobial stewardship policy" means efforts to promote
the appropriate and optimal selection, dosage, and duration
prescribing of antimicrobials for patients, with
the goal of reducing antimicrobial overuse and misuse and minimizing
the development of antimicrobial resistant infections, that is
consistent with one of the following parameters:
(A) Antimicrobial stewardship guidelines published by the federal
Centers for Disease Control and Prevention, the federal Centers for
Medicare and Medicaid Services, the Society for Healthcare
Epidemiology of America, the Infectious Diseases Society of America,
or similar recognized professional organizations.
(B) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven, evidence-based
methods should include more than one intervention or component.
(2) A "covered licensee" means an osteopathic physician and
surgeon who practices osteopathic medicine in a setting other than a
clinic licensed pursuant to Section 1204 of the Health and Safety
Code, a general acute care hospital as defined in subdivision (a) of
Section 1250 of the Health and Safety Code, or a skilled nursing
facility as defined in subdivision (c) of Section 1250 of the Health
and Safety Code.
(3) "Evidence-based methods" has the same meaning as in paragraph
(3) of subdivision (a) of Section 2197.
(b) A covered licensee shall adopt and implement an antimicrobial
stewardship policy before applying for a renewal license.
(c) Upon filing an application with the board for a renewal
license, a covered licensee shall certify in writing, on a form
prescribed by the board, that he or she has both adopted an
antimicrobial stewardship policy pursuant to subdivision (b) and is
in compliance with that policy.
(d) (1) The board shall audit during each year a random sample of
covered licensees who have certified compliance pursuant to
subdivision (c). The board shall not audit an individual covered
licensee more than once every four years.
(2) A covered licensee who is selected for audit shall submit to
the board, on a form prescribed by the board, a copy of his or her
antimicrobial stewardship policy.
(e) If the board determines that an audited covered licensee has
failed to comply with subdivision (b), the board shall require that
licensee to comply with subdivision (b) during the following renewal
period. If the covered licensee fails to comply within that
renewal period, he or she is ineligible for a
subsequent license renewal until he or she has documented compliance.
that failure constitutes unprofessional conduct
subject to discipline pursuant to Section 2234.
SEC. 7. Section 2496.5 is added to the Business and Professions
Code, to read:
2496.5. (a) For purposes of this section the following
definitions apply:
(1) "Antimicrobial stewardship policy" means efforts to promote
the appropriate and optimal selection, dosage, and duration
prescribing of antimicrobials for patients, with
the goal of reducing antimicrobial overuse and misuse and minimizing
the development of antimicrobial resistant infections, that is
consistent with one of the following parameters:
(A) Antimicrobial stewardship guidelines published by the federal
Centers for Disease Control and Prevention, the federal Centers for
Medicare and Medicaid Services, the Society for Healthcare
Epidemiology of America, the Infectious Diseases Society of America,
or similar recognized professional organizations.
(B) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven, evidence-based
methods should include more than one intervention or component.
(2) A "covered licensee" means a podiatrist who practices
podiatric medicine in a setting other than a clinic licensed pursuant
to Section 1204 of the Health and Safety Code, a general acute care
hospital as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, or a skilled nursing facility as defined in
subdivision (c) of Section 1250 of the Health and Safety Code.
(3) "Evidence-based methods" has the same meaning as in paragraph
(3) of subdivision (a) of Section 2197.
(b) A covered licensee shall adopt and implement an antimicrobial
stewardship policy before applying for a renewal license.
(c) Upon filing an application with the board for a renewal
license, a covered licensee shall certify in writing, on a form
prescribed by the board, that he or she has both adopted an
antimicrobial stewardship policy pursuant to subdivision (b) and is
in compliance with that policy.
(d) (1) The board shall audit during each year a random sample of
covered licensees who have certified compliance pursuant to
subdivision (c). The board shall not audit an individual covered
licensee more than once every four years.
(2) A covered licensee who is selected for audit shall submit to
the board, on a form prescribed by the board, a copy of his or her
antimicrobial stewardship policy.
(e) If the board determines that an audited covered licensee has
failed to comply with subdivision (b), the board shall require that
licensee to comply with subdivision (b) during the following renewal
period. If the covered licensee fails to comply within that
renewal period, he or she is ineligible for a
subsequent license renewal until he or she has documented compliance.
that failure constitutes unprofessional conduct
subject to discipline pursuant to Section 2234.
SEC. 8. Article 2.7 (commencing with Section 1223) is added to
Chapter 1 of Division 2 of the Health and Safety Code, to read:
Article 2.7. Antimicrobial Stewardship Guidelines
1223. (a) For purposes of this article the following definitions
apply.
(1) "Antimicrobial stewardship policy" means efforts to promote
the appropriate and optimal selection, dosage, and duration
prescribing of antimicrobials for patients, with
the goal of reducing antimicrobial overuse and misuse and minimizing
the development of antimicrobial resistant infections.
(2) "Evidence-based methods" means antimicrobial prescribing
intervention methods that have been proven effective through outcome
evaluations or studies, including, but not limited to, audit and
feedback, academic detailing, clinical decision support, delayed
prescribing practices, poster-based interventions, accountable
justification, and peer comparison.
(b) On or before January 1, 2018, a primary care clinic or
specialty clinic clinic, licensed pursuant to
Section 1204, shall adopt and implement an antimicrobial
stewardship policy that is consistent with one of the following
parameters:
(1) Antimicrobial stewardship guidelines published by the federal
Centers for Disease Control and Prevention, the federal Centers for
Medicare and Medicaid Services, the Society for Healthcare
Epidemiology of America, the Infectious Diseases Society of America,
or similar recognized professional organizations.
(2) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven, evidence-based
methods should include more than one intervention or component.
SEC. 9. 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.