California Senate Bill SB994 Amended / Bill

 BILL NUMBER: SB 994AMENDED BILL TEXT AMENDED IN SENATE MARCH 28, 2016 INTRODUCED BY Senator Hill FEBRUARY 10, 2016 An act  relating to outpatient health facilities.   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 B   usiness 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.  Outpatient health facilities: antimicrobial stewardship.   Antimicrobial stewardship policies.   (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.   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.   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.   Under   (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 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.   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:  no   yes  . State-mandated local program:  no   yes  . THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:  SECTION 1.   It is the intent of the Legislature to enact legislation that would promote the establishment of antimicrobial stewardship programs or policies in outpatient health facilities.   SEC. 2.   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 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 period, he or she is ineligible for a subsequent license renewal until he or she has documented compliance.   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 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 period, he or she is ineligible for a subsequent license renewal until he or she has documented compliance.  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 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 licenced 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 period, he or she is ineligible for a subsequent license renewal until he or she has documented compliance.   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 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 licenced 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 period, he or she is ineligible for a subsequent license renewal until he or she has documented compliance.   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 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 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.