Amended in Senate March 28, 2016

Senate BillNo. 994


Introduced by Senator Hill

February 10, 2016


An actbegin delete relating to outpatient health facilities.end deletebegin insert to amend the heading of Article 2.6 (commencing with Section 1645) of Chapter 4 of Division 2 of, and 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.end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 994, as amended, Hill. begin deleteOutpatient health facilities: antimicrobial stewardship. end deletebegin insertAntimicrobial stewardship policies.end insert

begin insert

(1) Under existing law, the Dental Board of California, among other things, establishes requirements pursuant to which 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.

end insert
begin insert

Under 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.

end insert
begin insert

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 a covered licensee who fails to comply is ineligible for license renewal until he or she has documented compliance.

end insert
begin delete

Under

end delete

begin insert(2)end insertbegin insertend insertbegin insertUnderend insert 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 billbegin delete would state the intent of the Legislature to enact legislation that would promote the establishment of antimicrobial stewardship programs or policies in outpatient health facilities. The bill makes related findings and declarations.end deletebegin insert 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.end insert

begin insert

(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.

end insert
begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert

Vote: majority. Appropriation: no. Fiscal committee: begin deleteno end deletebegin insertyesend insert. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

The people of the State of California do enact as follows:

begin delete
P3    1

SECTION 1.  

It is the intent of the Legislature to enact
2legislation that would promote the establishment of antimicrobial
3stewardship programs or policies in outpatient health facilities.

end delete
4

begin deleteSEC. 2.end delete
5
begin insertSECTION 1.end insert  

The Legislature finds and declares all of the
6following:

7(a) The overuse and misuse of antibiotics can lead to the
8development of antibiotic-resistant infections, a major public health
9threat.

10(b) The federal Centers for Disease Control and Prevention
11 (CDC) estimates that at least 2,000,000 Americans are infected
12with, and at least 23,000 Americans die as a result of,
13antibiotic-resistant infections every year, resulting in at least $20
14billion in direct health care costs and at least $35 billion in lost
15productivity in the United States.

16(c) Antibiotic resistance is a growing threat. A recent study
17commissioned by the United Kingdom determined that by 2050,
P4    1worldwide, more people will die from antibiotic-resistant infections
2than from cancer.

3(d) The overuse and misuse of antibiotics in human medicine
4is a significant factor driving the development of antibiotic
5resistance, and a majority of antibiotics are prescribed in outpatient
6settings, including primary care physician offices, outpatient
7settings where physician assistants and nurse practitioners work,
8dentist offices, and other specialty health care providers.

9(e) According to the CDC, in one year, 262.5 million courses
10of antibiotics are written in outpatient settings. This equates to
11more than five prescriptions written each year for every six people
12in the United States. The CDC estimates that over one-half of the
13antibiotics prescribed in outpatient settings are unnecessary.

14(f) More than 10 million courses of antibiotics are prescribed
15each year for viral conditions that do not benefit from antibiotics.

16(g) Antibiotic stewardship programs, which are already required
17in general acute care hospitals and skilled nursing facilities in the
18state, but not in outpatient settings, are an effective way to reduce
19inappropriate antibiotic use and the prevalence of
20antibiotic-resistant infections.

21(h) The President’s National Action Plan for Combating
22Antibiotic-Resistant Bacteria calls for the establishment of
23antibiotic stewardship activities in all health care delivery settings,
24including outpatient settings, by 2020.

25begin insert

begin insertSEC. end insertbegin insert2.end insert  

end insert

begin insertThe heading of Article 2.6 (commencing with Section
261645) of Chapter 4 of Division 2 of the end insert
begin insertBusiness and Professions
27Code
end insert
begin insert is amended to read:end insert

28 

29Article 2.6.  Continuing Educationbegin insert and Antimicrobial
30Stewardshipend insert
31

 

32begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 1645.5 is added to the end insertbegin insertBusiness and Professions
33Code
end insert
begin insert, to read:end insert

begin insert
34

begin insert1645.5.end insert  

(a) For purposes of this section the following
35definitions apply:

36
(1) “Antimicrobial stewardship policy” means efforts to promote
37the appropriate and optimal selection, dosage, and duration of
38antimicrobials for patients, with the goal of reducing antimicrobial
39overuse and misuse and minimizing the development of
P5    1antimicrobial resistant infections, that is consistent with one of
2the following parameters:

3
(A) Antimicrobial stewardship guidelines published by the
4federal Centers for Disease Control and Prevention, the federal
5Centers for Medicare and Medicaid Services, the Society for
6Healthcare Epidemiology of America, the Infectious Diseases
7Society of America, or similar recognized professional
8organizations.

9
(B) Evidence-based methods. To the extent practicable,
10antimicrobial stewardship policies based on proven,
11evidence-based methods should include more than one intervention
12or component.

13
(2) A “covered licensee” means a dentist who practices dentistry
14in a setting other than a clinic licensed pursuant to Section 1204
15of the Health and Safety Code, a general acute care hospital as
16defined in subdivision (a) of Section 1250 of the Health and Safety
17Code, or a skilled nursing facility as defined in subdivision (c) of
18Section 1250 of the Health and Safety Code.

19
(3) “Evidence-based methods” means antimicrobial prescribing
20intervention methods that have been proven effective through
21outcome evaluations or studies, including, but not limited to, audit
22and feedback, academic detailing, clinical decision support,
23delayed prescribing practices, poster-based interventions,
24accountable justification, and peer comparison.

25
(b) A covered licensee shall adopt and implement an
26antimicrobial stewardship policy before applying for a renewal
27license.

28
(c) Upon filing an application with the board for a renewal
29license, a covered licensee shall certify in writing, on a form
30prescribed by the board, that he or she has both adopted an
31antimicrobial stewardship policy pursuant to subdivision (b) and
32is in compliance with that policy.

33
(d) (1) The board shall audit during each year a random sample
34of covered licensees who have certified compliance pursuant to
35subdivision (c). The board shall not audit an individual covered
36licensee more than once every four years.

37
(2) A covered licensee who is selected for audit shall submit to
38the board, on a form prescribed by the board, a copy of his or her
39antimicrobial stewardship policy.

P6    1
(e) If the board determines that an audited covered licensee has
2failed to comply with subdivision (b), the board shall require that
3covered licensee to comply with subdivision (b) during the
4following renewal period. If the covered licensee fails to comply
5within that period, he or she is ineligible for a subsequent license
6renewal until he or she has documented compliance.

end insert
7begin insert

begin insertSEC. 4.end insert  

end insert

begin insertThe heading of Article 10 (commencing with Section
82190) of Chapter 5 of Division 2 of the end insert
begin insertBusiness and Professions
9Code
end insert
begin insert is amended to read:end insert

10 

11Article 10.  Continuing Medical Educationbegin insert and Antimicrobial
12Stewardshipend insert
13

 

14begin insert

begin insertSEC. 5.end insert  

end insert

begin insertSection 2197 is added to the end insertbegin insertBusiness and Professions
15Code
end insert
begin insert, to read:end insert

begin insert
16

begin insert2197.end insert  

(a) For purposes of this section the following definitions
17apply:

18
(1) “Antimicrobial stewardship policy” means efforts to promote
19the appropriate and optimal selection, dosage, and duration of
20antimicrobials for patients, with the goal of reducing antimicrobial
21overuse and misuse and minimizing the development of
22antimicrobial resistant infections, that is consistent with one of
23the following parameters:

24
(A) Antimicrobial stewardship guidelines published by the
25federal Centers for Disease Control and Prevention, the federal
26Centers for Medicare and Medicaid Services, the Society for
27Healthcare Epidemiology of America, the Infectious Diseases
28Society of America, or similar recognized professional
29organizations.

30
(B) Evidence-based methods. To the extent practicable,
31antimicrobial stewardship policies based on proven,
32evidence-based methods should include more than one intervention
33or component.

34
(2) A “covered licensee” means a physician and surgeon who
35practices medicine in a setting other than a clinic licensed pursuant
36to Section 1204 of the Health and Safety Code, a general acute
37care hospital as defined in subdivision (a) of Section 1250 of the
38Health and Safety Code, or a skilled nursing facility as defined in
39subdivision (c) of Section 1250 of the Health and Safety Code.

P7    1
(3) “Evidence-based methods” means antimicrobial prescribing
2intervention methods that have been proven effective through
3outcome evaluations or studies, including, but not limited to, audit
4and feedback, academic detailing, clinical decision support,
5delayed prescribing practices, poster-based interventions,
6accountable justification, and peer comparison.

7
(b) A covered licensee shall adopt and implement an
8antimicrobial stewardship policy before applying for a renewal
9license.

10
(c) Upon filing an application with the board for a renewal
11license, a covered licensee shall certify in writing, on a form
12prescribed by the board, that he or she has both adopted an
13antimicrobial stewardship policy pursuant to subdivision (b) and
14is in compliance with that policy.

15
(d) (1) The board shall audit during each year a random sample
16of covered licensees who have certified compliance pursuant to
17subdivision (c). The board shall not audit an individual covered
18licensee more than once every four years.

19
(2) A covered licensee who is selected for audit shall submit to
20the board, on a form prescribed by the board, a copy of his or her
21antimicrobial stewardship policy.

22
(e) If the board determines that an audited covered licensee has
23failed to comply with subdivision (b), the board shall require that
24covered licensee to comply with subdivision (b) during the
25following renewal period. If the covered licensee fails to comply
26within that period, he or she is ineligible for a subsequent license
27renewal until he or she has documented compliance.

end insert
28begin insert

begin insertSEC. 6.end insert  

end insert

begin insertSection 2454.6 is added to the end insertbegin insertBusiness and Professions
29Code
end insert
begin insert, to read:end insert

begin insert
30

begin insert2454.6.end insert  

(a) For purposes of this section the following
31definitions apply:

32
(1) “Antimicrobial stewardship policy” means efforts to promote
33the appropriate and optimal selection, dosage, and duration of
34antimicrobials for patients, with the goal of reducing antimicrobial
35overuse and misuse and minimizing the development of
36antimicrobial resistant infections, that is consistent with one of
37the following parameters:

38
(A) Antimicrobial stewardship guidelines published by the
39federal Centers for Disease Control and Prevention, the federal
40Centers for Medicare and Medicaid Services, the Society for
P8    1Healthcare Epidemiology of America, the Infectious Diseases
2Society of America, or similar recognized professional
3organizations.

4
(B) Evidence-based methods. To the extent practicable,
5antimicrobial stewardship policies based on proven, evidence
6based methods should include more than one intervention or
7component.

8
(2) A “covered licensee” means an osteopathic physician and
9surgeon who practices osteopathic medicine in a setting other than
10a clinic licenced pursuant to Section 1204 of the Health and Safety
11Code, a general acute care hospital as defined in subdivision (a)
12of Section 1250 of the Health and Safety Code, or a skilled nursing
13facility as defined in subdivision (c) of Section 1250 of the Health
14and Safety Code.

15
(3) “Evidence-based methods” has the same meaning as in
16paragraph (3) of subdivision (a) of Section 2197.

17
(b) A covered licensee shall adopt and implement an
18antimicrobial stewardship policy before applying for a renewal
19license.

20
(c) Upon filing an application with the board for a renewal
21license, a covered licensee shall certify in writing, on a form
22prescribed by the board, that he or she has both adopted an
23antimicrobial stewardship policy pursuant to subdivision (b) and
24is in compliance with that policy.

25
(d) (1) The board shall audit during each year a random sample
26of covered licensees who have certified compliance pursuant to
27subdivision (c). The board shall not audit an individual covered
28licensee more than once every four years.

29
(2) A covered licensee who is selected for audit shall submit to
30the board, on a form prescribed by the board, a copy of his or her
31antimicrobial stewardship policy.

32
(e) If the board determines that an audited covered licensee has
33failed to comply with subdivision (b), the board shall require that
34licensee to comply with subdivision (b) during the following
35renewal period. If the covered licensee fails to comply within that
36period, he or she is ineligible for a subsequent license renewal
37until he or she has documented compliance.

end insert
38begin insert

begin insertSEC. 7.end insert  

end insert

begin insertSection 2496.5 is added to the end insertbegin insertBusiness and Professions
39Code
end insert
begin insert, to read:end insert

begin insert
P9    1

begin insert2496.5.end insert  

(a) For purposes of this section the following
2definitions apply:

3
(1) “Antimicrobial stewardship policy” means efforts to promote
4the appropriate and optimal selection, dosage, and duration of
5antimicrobials for patients, with the goal of reducing antimicrobial
6overuse and misuse and minimizing the development of
7antimicrobial resistant infections, that is consistent with one of
8the following parameters:

9
(A) Antimicrobial stewardship guidelines published by the
10federal Centers for Disease Control and Prevention, the federal
11Centers for Medicare and Medicaid Services, the Society for
12Healthcare Epidemiology of America, the Infectious Diseases
13Society of America, or similar recognized professional
14organizations.

15
(B) Evidence-based methods. To the extent practicable,
16antimicrobial stewardship policies based on proven, evidence
17based methods should include more than one intervention or
18component.

19
(2) A “covered licensee” means a podiatrist who practices
20podiatric medicine in a setting other than a clinic licenced pursuant
21to Section 1204 of the Health and Safety Code, a general acute
22care hospital as defined in subdivision (a) of Section 1250 of the
23Health and Safety Code, or a skilled nursing facility as defined in
24subdivision (c) of Section 1250 of the Health and Safety Code.

25
(3) “Evidence-based methods” has the same meaning as in
26 paragraph (3) of subdivision (a) of Section 2197.

27
(b) A covered licensee shall adopt and implement an
28antimicrobial stewardship policy before applying for a renewal
29license.

30
(c) Upon filing an application with the board for a renewal
31license, a covered licensee shall certify in writing, on a form
32prescribed by the board, that he or she has both adopted an
33antimicrobial stewardship policy pursuant to subdivision (b) and
34is in compliance with that policy.

35
(d) (1) The board shall audit during each year a random sample
36of covered licensees who have certified compliance pursuant to
37subdivision (c). The board shall not audit an individual covered
38licensee more than once every four years.

P10   1
(2) A covered licensee who is selected for audit shall submit to
2the board, on a form prescribed by the board, a copy of his or her
3antimicrobial stewardship policy.

4
(e) If the board determines that an audited covered licensee has
5failed to comply with subdivision (b), the board shall require that
6licensee to comply with subdivision (b) during the following
7renewal period. If the covered licensee fails to comply within that
8period, he or she is ineligible for a subsequent license renewal
9until he or she has documented compliance.

end insert
10begin insert

begin insertSEC. 8.end insert  

end insert

begin insertArticle 2.7 (commencing with Section 1223) is added
11to Chapter 1 of Division 2 of the end insert
begin insertHealth and Safety Codeend insertbegin insert, to read:end insert

begin insert

12 

13Article begin insert2.7.end insert  Antimicrobial Stewardship Guidelines
14

 

15

begin insert1223.end insert  

(a) For purposes of this article the following definitions
16apply.

17
(1) “Antimicrobial stewardship policy” means efforts to promote
18the appropriate and optimal selection, dosage, and duration of
19antimicrobials for patients, with the goal of reducing antimicrobial
20overuse and misuse and minimizing the development of
21antimicrobial resistant infections.

22
(2) “Evidence-based methods” means antimicrobial prescribing
23intervention methods that have been proven effective through
24outcome evaluations or studies, including, but not limited to, audit
25and feedback, academic detailing, clinical decision support,
26delayed prescribing practices, poster-based interventions,
27accountable justification, and peer comparison.

28
(b) On or before January 1, 2018, a primary care clinic or
29specialty clinic shall adopt and implement an antimicrobial
30stewardship policy that is consistent with one of the following
31parameters:

32
(1) Antimicrobial stewardship guidelines published by the
33federal Centers for Disease Control and Prevention, the federal
34Centers for Medicare and Medicaid Services, the Society for
35Healthcare Epidemiology of America, the Infectious Diseases
36Society of America, or similar recognized professional
37organizations.

38
(2) Evidence-based methods. To the extent practicable,
39antimicrobial stewardship policies based on proven,
P11   1evidence-based methods should include more than one intervention
2or component.

end insert
3begin insert

begin insertSEC. 9.end insert  

end insert
begin insert

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.

end insert


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