BILL ANALYSIS Ó SB 361 Page 1 Date of Hearing: June 23, 2015 ASSEMBLY COMMITTEE ON HEALTH Rob Bonta, Chair SB 361 (Hill) - As Amended April 14, 2015 SENATE VOTE: 35-0 SUBJECT: Skilled nursing facilities: antimicrobial stewardship guidelines. SUMMARY: Requires skilled nursing facilities (SNFs) to adopt and implement an antimicrobial stewardship policy (ASP) by January 1, 2017, as specified. Requires SNFs to update their ASPs to be consistent with new guidelines established by the federal Centers for Disease Control and Prevention (CDC) or other professional organizations within three months of the publication of such new guidelines. Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment. EXISTING LAW: 1)Defines a SNF as health facility that provides skilled nursing care and supportive care to patients whose primary need is for the availability of long-term skilled nursing care. SB 361 Page 2 2)Establishes the Hospital Infectious Disease Control Program under the Department of Public Health (DPH) to determine best practices and policies related to the prevention of healthcare associated infections (HAIs). 3)Requires general acute care hospitals to adopt and implement an ASP, as specified, in accordance with existing state law and guidelines established by the federal government and professional organizations. FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. COMMENTS: 1)PURPOSE OF THIS BILL. According to the author, the overuse and misuse of antibiotics in nursing homes can lead to the development of antibiotic resistant infections, which is a national and worldwide public health threat. The author points to reports by the CDC which state that at least two million Americans are infected with antibiotic resistant infections annually, and are the cause of death to approximately 23,000 people each year. These reports also maintain that up to 50% of all antibiotics prescribed for patients are unnecessary or are not optimally effective as prescribed. The author contends that 70% of nursing home residents throughout the nation receive an antibiotic each year, and that 27,000 residents acquire antibiotic resistant infections, referring to research which suggests that 25-75% of antibiotic use in long-term care settings may be inappropriate and may contribute to the prevalence of SB 361 Page 3 antibiotic resistance. The author concludes that ASPs are an effective way to promote judicious antibiotic use and reduce antibiotic resistance, and that this bill is necessary to alleviate a deficiency in existing law by extending these programs to SNFs. 2)BACKGROUND. a) Antibiotics. Antimicrobial resistance is resistance of a microorganism to an antimicrobial drug that was originally effective for treatment of infections caused by it. Resistant microorganisms (including bacteria, fungi, viruses, and parasites) are able to withstand attack by antimicrobial drugs, such as antibacterial drugs (e.g. antibiotics), antifungals, antivirals, and antimalarials, so that standard treatments become ineffective and infections persist, increasing the risk of spread to others. The evolution of resistant strains is a natural phenomenon that occurs when microorganisms replicate themselves erroneously or when resistant traits are exchanged between them. The use and misuse of antimicrobial drugs accelerates the emergence of drug-resistant strains. Poor infection control practices, inadequate sanitary conditions, and inappropriate food-handling encourage the further spread of antimicrobial resistance. According to the World Health Organization, new resistance mechanisms currently continue to emerge and spread globally, threatening our ability to treat common infectious diseases, and are resulting in the death and disability of individuals who, prior to the emergence of these new resistance mechanisms, could continue a normal course of life. Without effective anti-infective treatment, many standard medical treatments will fail or turn into very high risk procedures. b) President's Executive Order. In September 2014, President Barack Obama signed an Executive Order directing SB 361 Page 4 federal departments and agencies to implement a national strategy for enhancing domestic and international capacity to manage antibiotics and antibiotic-resistant infections. Among other requirements, the Executive Order specifically requires the Departments of Health and Human Services, Defense, and Veterans Affairs to review existing regulations governing antibiotic stewardship in hospitals and other inpatient health care delivery facilities, and to propose new regulations and other actions to improve antibiotic stewardship programs in accordance with best practices in the country, including those defined by the CDC. The Executive Order also requires federal departments and agencies to lead the country by example by implementing stewardship programs in outpatient settings, emergency departments, and institutional and long-term care facilities such as nursing homes, pharmacies, and correctional facilities. c) The California Antimicrobial Stewardship Program. California is the first, and remains the only state, to enact an antimicrobial stewardship program. DPH states the major objectives of antimicrobial stewardship are to optimize clinical outcomes for patients while minimizing toxicity and other adverse events associated with antimicrobial use. Since 2008, California has required general acute care hospitals to develop a process for monitoring the judicious use of antibiotics, and has mandated that the results are monitored by quality improvement committees. Studies have shown that ASPs are particularly active in community settings. DPH currently offers an ASP toolkit to the public, to provide hospital leadership and support staff with guidelines, resources, and practical examples of how best to implement ASP practices. SB 361 Page 5 3)SUPPORT. The Health Officers Association of California supports this bill stating it is imperative for SNFs to adopt policies that reduce the consequences of antibiotic resistance because residents are often elderly or disabled patients with underlying health conditions that make them more vulnerable to contracting disease. Blue Shield of California supports, contending that it has been well documented by the CDC that antibiotics are grossly overused in nursing homes and can lead to the development of antibiotic resistant infections. Blue Shield also contends antibiotic resistant infections add considerable and avoidable costs to the already overburdened healthcare system, as these infections require prolonged and costlier treatments. The California Optometric Association and CALPIRG support, stating that each year at least two million Americans are infected with - and at least 23,000 Americans die from - antibiotic resistant infections. The California Long-Term Care Ombudsman Association also supported a previous version of this bill, asserting that the current practice of giving SNF residents antimicrobial medications prior to confirmation or test results recommending such medications puts residents at risk. 4)PREVIOUS LEGISLATION. a) SB 1311 (Hill), Chapter 843, Statutes of 2014, requires all general acute care hospitals to adopt and implement, by July 1, 2015, an ASP, that includes a process to evaluate the judicious use of antibiotics. b) SB 158 (Florez), Chapter 294, Statutes of 2008, establishes an infection surveillance, prevention, and control program within DPH to provide oversight of hospital prevention and reporting of general acute care HAIs, expands the responsibilities of DPH's 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 SB 361 Page 6 safety events. c) SB 1058 (Alquist), Chapter 296, Statutes of 2008, establishes the Medical Facility Infection Control and Prevention Act, which requires hospitals to implement specified procedures for screening, prevention, and reporting specified HAIs. Requires hospitals to report positive Methicillin-resistant Staphylococcus aureus and other HAI test results to DPH and requires DPH to make specified information public on its website. d) SB 739 (Speier), Chapter 526, Statutes of 2006, creates a state HAI Advisory Committee to make recommendations regarding reporting cases of HAI in hospitals. Requires each general acute care hospital, after January 1, 2008, to implement and annually report to DPH its implementation of infection surveillance and infection prevention process measures that have been recommended by CDC Healthcare Infection Control Practices Advisory Committee, as suitable for a mandatory public reporting program. Requires, initially, these process measures to include the CDC guidelines for central line insertion practices, surgical antimicrobial prophylaxis, and influenza vaccination of patients and healthcare personnel. Requires DPH, in consultation with the HAI Advisory Committee, to make this information public no later than six months after receiving the data. Requires that general acute care hospitals 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. 5)POLICY COMMENT. This bill requires SNFs to establish and implement an ASP. Existing law requires each general acute care hospital to establish and implement an ASP; in addition, the hospitals are required to develop a physician-supervised multidisciplinary antimicrobial stewardship committee, SB 361 Page 7 subcommittee, or workgroup, and to appoint at least one physician or pharmacist to the committee who is knowledgeable about antimicrobial stewardship through specified training. This bill's language is currently silent as to how the policy must be implemented within each SNF and does not specifically require SNFs to form an antimicrobial stewardship committee. The author may wish to consider amending this bill's provisions to be consistent with existing statutory requirements regarding ASPs for general acute care hospitals. REGISTERED SUPPORT / OPPOSITION: Support Blue Shield of California California Long-Term Care Ombudsman Association (prior version) California Optometric Association CALPIRG (prior version) Health Officers Association of California Opposition None on file. Analysis Prepared by:An-Chi Tsou / HEALTH / (916) 319-2097 SB 361 Page 8