BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 361| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: SB 361 Author: Hill (D) Amended: 4/14/15 Vote: 27 - Urgency SENATE HEALTH COMMITTEE: 9-0, 4/8/15 AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8 SUBJECT: Skilled nursing facilities: antimicrobial stewardship guidelines SOURCE: Author DIGEST: This bill requires skilled nursing facilities to adopt and implement an antimicrobial stewardship policy by January 1, 2017. ANALYSIS: Existing law: 1)Provides for the licensure and regulation of health facilities by the Department of Public Health (DPH), including skilled nursing facilities (SNFs), which are defined as health facilities that provide skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis. SB 361 Page 2 2)Requires general acute care hospitals, by July 1, 2015, to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations; develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup; and report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities. This bill: 1)Requires SNFs, by January 1, 2017, to adopt and implement an antimicrobial stewardship policy. 2)Requires SNFs, within three months of the establishment of antimicrobial stewardship guidelines specific to SNFs by the federal Centers for Disease Control and Prevention or by professional organizations, including the Society for Healthcare Epidemiology of America, to amend their antimicrobial stewardship policies to be consistent with those newly established guidelines. 3)Specifies that failure to comply with the provisions of this bill may subject the SNF to citation and civil penalty provisions in existing law. 4)Contains an urgency clause that will make this bill effective upon enactment. Comments 1)Author's statement. The overuse and misuse of antibiotics in nursing homes can lead to the development of antibiotic resistant infections. Antibiotic resistance is a national and worldwide public health threat. The Centers for Disease Control and Prevention (CDC) estimates that each year at least 2 million Americans are infected with - and at least 23,000 Americans die from - antibiotic resistant infections. Each year, antibiotic resistant infections result in at least $20 billion in direct health care costs and at least $35 billion in lost productivity in the United States. A recent study SB 361 Page 3 commissioned by the United Kingdom determined that by 2050, worldwide, more people will die from antibiotic resistant infections than from cancer. The overuse and misuse of antibiotics in human medicine is a major driver of antibiotic resistance. The CDC reports that "up to 50 percent of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed." For example, antibiotics are sometimes prescribed when no infection is present or the wrong antibiotic may be given to treat a certain infection. Nationwide, up to 70 percent of nursing home residents receive an antibiotic every year and 27,000 acquire antibiotic resistant infections. Studies suggest that between 25 and 75 percent of antibiotic use in long-term care settings may be inappropriate, contributing to the prevalence of antibiotic resistance. Antibiotic stewardship programs are an effective way to promote judicious antibiotic use and reduce antibiotic resistance. Last year, SB 1311 (Hill), Chapter 843, Statutes of 2014 was signed into law, requiring antibiotic stewardship programs at all California hospitals. However, this requirement does not extend to SNFs. 2)Background. According to the CDC, antibiotic resistance is a quickly growing, extremely dangerous problem. World health leaders have described antibiotic-resistant bacteria as "nightmare bacteria" that "pose a catastrophic threat" to people in every country in the world. Most infections occur in the community, like skin infections with Methicillin-resistant Staphylococcus aureus (MRSA) and sexually transmitted diseases. However, most deaths related to antibiotic resistance occur from drug-resistant infections picked up in healthcare settings, such as hospitals and nursing homes. According to a February 2013 joint letter from the Infectious Diseases Society of America (IDSA) and the Society for Health Epidemiology of America (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 SB 361 Page 4 to multiple drugs have spread widely among patients in healthcare 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. 3)Presidential Executive Order. In September of 2014, President Obama issued an executive order, titled "Combating Antibiotic-Resistant Bacteria." Among other things, this executive order requires the Health and Human Services Agency, by the end of calendar year 2016, to review existing regulations and propose new regulations or other actions, as appropriate, that require hospitals and other inpatient healthcare delivery facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those identified by the CDC. The executive order also established a federal task force that is required to, as appropriate, define, promulgate, and implement stewardship programs in other healthcare settings, including office-based practices, outpatient settings, emergency departments, and institutional and long-term care facilities, such as nursing homes, pharmacies, and correctional facilities. 4)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 healthcare 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 SB 361 Page 5 patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. Although guidelines exist for developing ASPs, there is limited information on practical implementation of these guidelines, particularly in resource-limited settings. According to DPH, its partners in this statewide initiative include the Division of Healthcare Quality and Promotion at CDC, Infectious Disease Association of California, and SHEA. According to the DPH website, current program activities include: a) The HAI Program has launched a statewide Antimicrobial Stewardship Program Collaborative, with the goal of ensuring that all California hospitals have a functional and robust ASP to promote patient safety and to decrease antimicrobial resistance. The Collaborative will extend for one year from January through December 2015; b) Spotlight on ASP Project, which helps define antimicrobial stewardship programs and activities, and spotlights volunteer hospitals that want to highlight and share with others their ASP progress; c) Utilization of a statewide assessment of ASPs present in California healthcare facilities (May 2010 - March 2011) to develop evidence-based recommendations on how to implement or strengthen ASPs given available resources and facility attributes; d) Developing recommendations with the Antimicrobial Stewardship Subcommittee of the California HAI Advisory Committee; e) Defining activities that comprise ASPs in California hospitals; and, f) The California Antibiogram Project, which collects information on specific antimicrobial-organism combinations across California general acute care hospitals. Prior Legislation SB 1311 (Hill, Chapter 843, Statutes of 2014) required general acute care hospitals, by July 1, 2015, to adopt and implement an antimicrobial stewardship policy, as specified; develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup; appoint at least one physician or pharmacist who has attended training specifically on antimicrobial stewardship to the committee, subcommittee, or workgroup, as specified; and, report antimicrobial stewardship SB 361 Page 6 program activities to appropriate hospital committees, as specified. SB 158 (Florez, Chapter 294, Statutes of 2008) established an infection surveillance, prevention, and control program within DPH to provide oversight of hospital prevention and reporting of general acute care hospital-associated infections, expanded 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 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 website. SB 739 (Speier, Chapter 526, Statutes of 2006) created 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. Required, 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. Required 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. SB 1487 (Speier 2004) would have required specified hospitals to have written infection control plans and report to Office of Statewide Health Planning and Development (OSHPD) data, including the rate of HAIs and risk-adjusted infection rate data SB 361 Page 7 according to the risk-adjustment methodology determined by CDC. SB 1487 was vetoed by then Governor Schwarzenegger, who's veto message suggested that it was unnecessary because of other national efforts, which could call into question the quality and validity of the data without proper auditing, and because it would impose significant costs to hospitals and OSHPD. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: Yes SUPPORT: (Verified4/28/15) Blue Shield of California California Optometric Association California Long-Term Care Ombudsman Association CALPIRG OPPOSITION: (Verified4/28/15) None received ARGUMENTS IN SUPPORT: This bill is supported by CALPIRG, which states that 70 percent of nursing home residents nationwide receive an antibiotic every year, and 27,000 residents acquire antibiotic resistant infections. According to CALPIRG, studies suggest that between 25 and 75 percent of antibiotics prescribed in long-term care facilities may be inappropriate. CALPIRG states that it is hopeful that the development and enforcement of these guidelines will reduce the unnecessary use of antibiotics in nursing homes, helping to prevent the spread of antibiotic resistant bacteria. Blue Shield of California states in support that it has been well document by the CDC that antibiotics are being grossly overused in nursing homes. Blue Shield notes that antibiotic resistant infections require prolonged and costlier treatments, extend hospital stays, necessitate additional doctor visits and healthcare use, and result in greater disability and death compared with infections that are easily treatable with SB 361 Page 8 antibiotics. The California Long-Term Care Ombudsman Association states that the current practice of giving residents medications prior to confirmation or test results recommending such medications puts residents at risk due to an increase in antimicrobial resistant infections, and this bill is an appropriate solution to this problem. Prepared by:Vince Marchand / HEALTH / 4/29/15 16:07:31 **** END ****