BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: SB 994 Hearing Date: April 11, 2016 ----------------------------------------------------------------- |Author: |Hill | |----------+------------------------------------------------------| |Version: |March 28, 2016 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Bill Gage | |: | | ----------------------------------------------------------------- Subject: Antimicrobial stewardship policies SUMMARY: Specifies that a covered licensee, as defined, that includes physicians and surgeons, osteopathic physicians and surgeons, podiatrists and dentists must adopt and implement an antimicrobial stewardship policy, as defined, before applying for a renewal license. Requires the covered licensee to certify in writing upon renewal of their license with the board that regulates and licenses the practitioner, that he or she has the adopted the policy as specified, and is in compliance with that policy. Requires the board to audit a random sample of covered licensees and for each audited licensee to provide a copy of his or her antimicrobial stewardship policy. If the covered licensee fails to provide a copy of their policy then they will have until their next renewal to comply or be ineligible to receive their license. Also requires a primary care clinic or specialty clinic, on or after January 1, 2018, to adopt and implement an antimicrobial stewardship policy. Existing law: 1)Specifies that the Department of Public Health (DPH) shall require that general acute care hospitals, as defined, develop a process for evaluating the judicious use of antibiotics, the results of which shall be monitored jointly by appropriate representatives and committees involved in quality improvement activities. SB 994 (Hill) Page 2 of ? (Health and Safety Code (HSC) § 1288.8) 2)Requires each general acute care hospital to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations and that this policy shall include a process to evaluate the judicious use of antibiotics in accordance with the requirements in Item #1), above. (HSC § 1288.85 (a)) 3)Requires the general acute care hospital to develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workshop and appoint to the entity at least one physician or pharmacist who is knowledgeable about the subject of antimicrobial stewardship, as specified, and to report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities. (HSC § 1288.85 (b), (c) and (d)) 4)Requires on or after January 1, 2017, each skilled nursing facility, as defined, to adopt and implement an antimicrobial stewardship policy that is consistent with antimicrobial guidelines developed by the federal Centers for Disease Control (CDC) and Prevention, the federal Centers for Medicare and Medicaid Services, the Society for the Healthcare Epidemiology of America, or similar recognized professional organizations. (HSC § 1275.4) 5)Restricts the use of medically important antimicrobial drugs in livestock for specified purposes beginning January 1, 2018, requires a veterinarian's prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs; requires the California Department of Food and Agriculture (CDFA) to, in coordination with federal programs and state agencies, to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria; requires CDFA to develop antimicrobial stewardship guidelines and best management practices on the proper use of these drugs; clarifies when SB 994 (Hill) Page 3 of ? medically important antimicrobial drugs may be used for preventative purposes; provides details regarding the CDFA antimicrobial monitoring program; and provides for penalties for those who violate the provisions of these new requirements as specified. (Food and Agriculture Code §§ 14400-14408) 6)Requires on or after January 1, 2018, a licensed veterinarian who renews his or her license to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every four years as part their continuing education requirements. (Business and Professions Code (BPC) § 4846.5) 7)Provides for the licensure and regulation of physicians and surgeons by the Medical Board of California (MBC), for osteopathic physicians and surgeons by the Osteopathic Medical Board (OMB), for podiatrists by the California Board of Podiatric Medicine (BPM) and for dentists by the Dental Board of California (DBC) under the Department of Consumer Affairs. 8)Provides that a "clinic" means an organized outpatient health facility that provides direct medical, surgical, dental, optometric, or podiatric advice, services, or treatment to patients who remain less than 24 hours, and that may also provide diagnostic or therapeutic services to patients in the home as incident to care provided at the clinic facility. (HSC § 1200) 9)Provides that a primary care clinics and specialty clinics, as defined, shall be eligible for licensure with the DPH. (HSC § 1204 (b)) 10)Defines a "general acute care hospital" generally as a facility having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary. (HSC § 1250 (a)) 11)Defines a "skilled nursing facility" as a health facility that provides skilled nursing care and supportive care to patients whose primary need is for the availability of skilled nursing care on an extended basis. (HSC § 1250 (c)) SB 994 (Hill) Page 4 of ? This bill: 1)Defines "antimicrobial stewardship policy" as 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 American, 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)Provides that a "covered license" means a physician and surgeon who practices medicine in a setting other that a clinic licensed pursuant to Section 1204 of the BPC, a general acute care hospital, as defined in Item # 10) above, or a skilled nursing facility , as defined in Item # 11) above. 3)Defines "evidence-based methods" as 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. 4)Requires a covered licensee to adopt and implement an antimicrobial stewardship policy before applying for a renewal license. 5)Requires a covered licensee, upon filing an application with the MBC for a renewal license, to certify in writing, on a form prescribed by the MBC, that he or she has both adopted an antimicrobial stewardship policy as specified, and is in compliance with that policy. SB 994 (Hill) Page 5 of ? 6)Requires the MBC to audit each year a random sample of covered licensees who have certified compliance as specified, but that the MBC shall not audit an individual covered licensee more than once every four years. 7)Provides that a covered licensee who is selected for an audit shall submit to the MBC, on a form prescribed by the Board, a copy of his or her antimicrobial stewardship policy. 8)Provides that if the MBC determines that an audited covered licensee has failed to comply with the requirements to adopt and implement an antimicrobial stewardship policy, then the MBC shall require the covered licensee to comply during the following renewal period and 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. 9)Specifies that a covered licensee also includes osteopathic physicians and surgeons licensed and regulated by the OMB, podiatrists licensed and regulated by the BPM and dentists licensed and regulated by the DBC, and subjects these practitioners to the same requirements as those specified in Items #4) through # 8), above. 10)Requires a primary care clinic or specialty clinic, on or after January 1, 2018, to adopt and implement an antimicrobial stewardship policy, as defined, and meets that is consistent with one of the following parameters as specified in Items # 1) and # 3), above; published antimicrobial stewardship guidelines published by specified entities or evidence-based methods, as defined. FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative Counsel. COMMENTS: SB 994 (Hill) Page 6 of ? 1. Purpose. This measure is sponsored by the Author and is intended to promote the appropriate antibiotic prescribing for non-hospitalized patients in ambulatory healthcare settings. The Author indicates that according to the CDC at least 2 million 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 productivity loss nationwide. In California alone, the DPH estimates that antibiotic resistant infections are responsible for at least 3,000 deaths and 260,000 illnesses every year. Antibiotic resistance is a growing threat, as stated by the Author. "A recent study commissioned by the United Kingdom determined that by 2050, worldwide, more people will die from antibiotic resistant infections than from cancer. While not the only cause, the overuse and misuse of antibiotics in medicine is a significant contributing factor driving the development of antibiotic resistance and if we are to truly solve the problem, among other things, we need to focus on promoting more appropriate and judicious antibiotic prescribing." A majority of antibiotics are prescribed in non-hospital health care settings, as pointed out by the Author, such as medical offices where physicians, physician assistants and nurse practitioners work, dentist offices, and podiatric offices. Based on data from other countries, it can be estimated that up to 80% of all antibiotic prescriptions are written in the outpatient setting. For example, according to the CDC, across the country in 2013, healthcare providers prescribed 268.6 million courses of antibiotics in outpatient settings. Primary care physicians were responsible for 121.7 million prescriptions, physician assistants and nurse practitioners were responsible for 48.4 million prescriptions and dentists were responsible for 24.5 million prescriptions. The CDC estimates that 50% of these prescriptions are unnecessary and contributes to the development of antibiotic resistant infections. The Author further points out that worldwide antibiotic consumption is rising. Between 2000 and 2010, global SB 994 (Hill) Page 7 of ? consumption of antibiotics increased by 30%, according to the Center for Disease Dynamics, Economics, & Policy. The United States has the highest per capita consumption of antibiotics and consumes the third highest amount of antibiotics overall, preceded only by China and India. Inappropriate antibiotic use means using antibiotics when no benefit is possible (e.g. to treat a viral infection), or using the wrong antibiotic, or prescribing the wrong dosage. The Author believes that many different solutions are needed, but one of the most important actions that can be taken to slow the development of antibiotic resistance is to ensure that antibiotics are used judiciously and only when needed. To promote judicious use the CDC recommends the establishment of antibiotic stewardship programs, which represent a "commitment to always use antibiotics only when they are necessary to treat and in some cases prevent, disease; to choose the right antibiotics; and to administer them in the right way in every case. Effective stewardship ensures that every patient gets the maximum benefit from the antibiotics, avoids unnecessary harm from allergic reaction and side effects, and helps preserve the life-saving potential of these drugs for the future." Antibiotic stewardship programs in outpatient settings can help decrease inappropriate prescribing and decrease the development of antibiotic resistance. 2. Background. Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health. Antimicrobial resistance may develop for several reasons. One of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for "survival of the fittest" where only the strongest, most immune bacteria survive. These surviving, antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect SB 994 (Hill) Page 8 of ? other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance. According to a February 2013 joint letter from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of American (SHEA) to the National Quality Forum, ample data exist from both inpatient and outpatient settings demonstrating that antibiotics are often prescribed sub-optimally or inappropriately. Antibiotics are misused in a variety of ways. They are often administered when they are not needed, continued when they are no longer necessary, or prescribed at the wrong dose. Broad-spectrum agents may be used unnecessarily against bacteria that are very susceptible or the wrong antibiotic may be given to treat a particular infection. Over the past 30 years, bacteria that are extremely resistant to traditional treatments or resistant to multiple drugs have spread widely among patients in health care settings. In some cases these pathogens have been pan-resistant, meaning that they are resistant to all available antibiotics. The unique nature of antibiotics, in which the use of the drugs in one patient can impact the effectiveness of the drug in a different patient, make antibiotic overuse a serious patient safety issue and public health threat. The World Health Organization has characterized antibiotic resistance as "a crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even impossible to treat." Resistant infections not only result in increased morbidity and mortality, but increased economic burdens. For example, studies have shown that antibiotic-resistant infections are associated with longer lengths of stay and increased mortality, both in the hospital and in intensive care units. The Centers for Disease Control and Prevention (CDC) issued a report titled, Antibiotic Resistance Threats in the United States, 2013. The CDC estimates that in the United States more than 2 million people are sickened every year with antibiotic-resistant infections with at least 23,000 Americans who die as a result of antibiotic infections every year. In its report, the CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria SB 994 (Hill) Page 9 of ? from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria. The CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed. On September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that "the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections." Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals. California's program . In February 2010, the DPH Healthcare Associated Infection (HAI) Program developed a statewide antimicrobial stewardship program (ASP) initiative in order to strengthen and promote optimization of antimicrobial utilization in California health care facilities. According to DPH, the purpose of an antimicrobial stewardship program in a health care facility is to measure and promote the appropriate use of antimicrobials by selecting the appropriate agent, dose, duration and route of administration in order to improve patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. Although guidelines existed for developing ASPs, there was SB 994 (Hill) Page 10 of ? limited information on practical implementation of these guidelines, particularly in resource-limited settings. According to DPH, its partners in this statewide initiative included the Division of Healthcare Quality and Promotion at CDC, Infectious Disease Association of California, and SHEA. SB 1311 (Hill, Chapter 843, Statutes of 2014) more specifically required acute care hospitals to adopt and implement antimicrobial stewardship policy (ASP) in accordance with guidelines established by the federal government and professional organizations. Prior to SB 1311, only 50 percent of hospitals had actually established an ASP and only 22 percent said they were influenced by the current requirement to develop a stewardship program. 3. Prior Related Legislation . SB 27 (Hill, Chapter 758, Statutes of 2015) restricts the use of antimicrobial drugs in livestock, requires a veterinarian's prescription or feed directive for use, eliminate the over-the-counter availability of these drugs, requires the CDFA to develop antimicrobial stewardship guidelines and best management practices for veterinarians, as well as livestock owners and their employees on the proper use of antimicrobial drugs, and to develop a program to track antimicrobial drug use in livestock. SB 361 (Hill, Chapter 764, Statutes of 2015) requires, on or after January 1, 2017, each skilled nursing facility, as defined, to adopt and implement an antimicrobial stewardship policy consistent with guidelines development by federal or professional organizations, as specified. Requires a veterinarian upon renewal of their license to have completed a continuing education course in the judicious use of medically important antimicrobial drugs, as specified. SB 1311 (Hill, Chapter 843, Statutes of 2014) requires each general acute care hospital, as defined, to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations and that this policy shall include a process to evaluate the judicious use of antibiotics, as specified. SB 158 (Florez, Chapter 294, Statutes of 2008) established an infection surveillance, prevention, and control program SB 994 (Hill) Page 11 of ? within DPH to provide oversight of hospital prevention and reporting of general acute care hospital-associated infections, expanded the responsibilities of DPH's Healthcare Associated Infection (HAI) Advisory Committee, and requires all hospitals to institute a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. SB 1058 (Alquist, Chapter 296, Statutes of 2008) established the Medical Facility Infection Control and Prevention Act, which requires hospitals to implement specified procedures for screening, prevention, and reporting specified health care associated infections also known as HAIs. Requires hospitals to report positive MRSA and other HAI test results to DPH and requires DPH to make specified information public on its Internet Web site. 4. Arguments in Support. The California Hospital Association (CHA) is in support of this bill and indicates that "the overuse and misuse of antibiotics in medicine is a significant contributing factor driving the development of antibiotic resistance and if we are to truly solve the problem, among other things, we need to focus on promoting more appropriate and judicious antibiotic prescribing. The CHA goes on to state that a majority of antibiotics are prescribed in non-hospital health care settings, such as medical offices where physicians, physician assistants and nurse practitioners work, dentist offices, and podiatric offices. CDC estimates at least 50 percent of the antibiotic prescribing in outpatient settings is unnecessary or inappropriate. The CHA believes this measure is important because it will require ambulatory health care settings that serve non-hospitalized patients to establish an antibiotic stewardship policy that is similar to the requirements for hospitals and nursing homes. The Society of Infectious Diseases Pharmacists (SIDP) is also in support of this measure. SIDP indicates that growing bacterial resistance is contributing to increased morbidity and mortality of patients across California and the county as a whole. Overuse and inappropriate use of antibiotics is common, and contributing to this increasing resistance, therefore expanding the reach of microbial stewardship to reduce unnecessary and inappropriate use in primary clinics SB 994 (Hill) Page 12 of ? is important. SIDP believes that directing primary care clinics to initiate antimicrobial stewardship efforts can help to educate the public and prescribers regarding the appropriate antibiotic use and thus have meaningful impacts on society. 5. Policy Issue . Should the "Covered Licensee" be ineligible for a subsequent license renewal until he or she has documented compliance with adopting the antimicrobial policy? The Author may want to consider rather than subjecting the practitioner to possible loss of their license for non-compliance with adopting the antimicrobial policy, that instead provide that it would be unprofessional conduct on the part of the licensee if they did not adopt the policy. This would allow some latitude with the individual licensing board as to what appropriate action to take to assure compliance with the requirement to have an antimicrobial stewardship policy in place. The board could determine that they could do anything from cite and fine the licensee for non-compliance to more formal disciplinary action if determined necessary. 6. Suggested Technical Amendment. On page 10, line 29, after "specialty clinic" insert the following: ,licensed pursuant to Section 1204, 7. Author's Amendment. The Author would like to clarify the definition of antimicrobial stewardship policy by making the following change: On Page 6, line 19, strike the following,and optimal selection, dosage, and duration ofand insert prescribing of The definition would then read as follows: "Antimicrobial stewardship policy" as efforts to promote the appropriate prescribing of 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 SB 994 (Hill) Page 13 of ? Epidemiology of America, the Infectious Diseases Society of American, 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. NOTE : Double-referral to Health Committee. SUPPORT AND OPPOSITION: Support: California Hospital Association Society of Infectious Diseases Pharmacists Opposition: None on file as of April 5, 2016. -- END --