June 15, 2017
Health Care Environment Alert
Health Care Environment Alert
The Center for Medicare & Medicaid Services (CMS) recently distributed a memo to all State Survey Agency Directors directing them to begin surveying their certified health care facilities to ensure that they have done a Legionella-related risk assessment of their entire water system and used that as a basis of a facility-specific water management plan.
The Center for Medicare & Medicaid Services (CMS) recently distributed a memo to all State Survey Agency Directors entitled Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease (LD). The memo establishes a new requirement that certified health care facilities “must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of [L]egionella and other opportunistic pathogens in water.”
The memo was issued in response to multiple recent outbreaks of Legionnaires’ Disease in hospitals and long-term health care facilities that have triggered investigations by the CDC, state and local health departments or by State Survey Agencies under the Medicare/Medicate system. The memo instructs State Survey Agencies to take steps to verify that risk assessments and water management programs are in place at all certified health care facilities. It raises the specter that facilities that cannot document that they meet these requirements may be deemed to be non-compliant with their CMS Condition of Participation.
As explained in the CMS memo,
The bacterium Legionella can cause a serious type of pneumonia called [Legionnaires Disease] in persons at risk. …Outbreaks have been linked to poorly maintained water systems in buildings with large or complex water systems including hospitals and long-term care facilities. Transmission can occur via aerosols from devices such as showerheads, cooling towers, hot tubs, and decorative fountains.
Legionella are naturally occurring bacteria that can grow and multiply within many parts of a large or complex water system. According to the memo, the instances of such illnesses have increased 285% over a 14-year period and approximately 9% of reported legionellosis cases are fatal. The CMS memo notes that a review of recent Legionnaires’ Disease outbreaks in the United States indicated that health care facilities accounted for over 30% of the reported outbreaks during 2000–2014, 19% of which were associated with long-term care facilities and 15% with hospitals. Susceptible hosts include persons who are at least 50 years old, smokers and those with underlying medical conditions such as chronic lung disease or immunosuppression.
While most of the regulatory focus in recent years has been on vapors emitted by building cooling towers as a source of Legionella-related diseases, there are actually many possible places within a building or complex’s water system that can provide either growth or dispersal locations for these bacteria through potable water and other aspiration points. Some of the ones mentioned in the CMS memo include:
According to the CMS memo:
CMS expects Medicare certified healthcare facilities to have water management policies and procedures to reduce the risk of growth and spread of Legionella and other opportunistic pathogens in building water systems. An industry standard calling for the development and implementation of water management programs in large or complex building water systems to reduce the risk of legionellosis was published in 2015 by American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE). In 2016, the CDC and its partners developed a toolkit to facilitate implementation of this ASHRAE Standard. Environmental, clinical, and epidemiologic considerations for healthcare facilities are described in this toolkit
Potentially as soon as early July, State Surveyors will be focusing on covered facilities and will be reviewing the policies, procedures and reports documenting their water management plan implementation results to verify that facilities are (or shortly will be):
The memo states CMS’s expectation that health care facilities must take actions to protect the health and safety of their patients. The hammer it threatens is that those “facilities unable to demonstrate measures to minimize the risk of LD are at risk of citation for non-compliance with the CMS Conditions of Participation.” It concludes by stating that accrediting organizations will be surveying health care facilities deemed to participate in Medicare for compliance with the requirements listed in the CMS memo and will cite noncompliance accordingly.
The potential exposure to large or sensitive populations, the extremely high mortality rate due to Legionella related diseases, the lengthy hospitalizations and concomitant high health care costs and extreme reputational risks to covered health care facilities are all reasons why the CMS memo warrants attention quite apart from the threat of citation. Owners, operators, managers, architects, engineers and system designers of such facilities have all been targets of highly publicized lawsuits seeking substantial recoveries based on premises liability and allegedly negligent failure of duties to inspect, maintain, repair, operate and test the water and systems. The recent emergence of the ASHRAE standard as an “industry standard” and CMS’s use of it as the “expected” standard of care for compliance with Conditions of Participation may be admissible in such litigation as evidence of a failure to meet general/custom and usage in support of such claims.
Also, there remains controversy in the scientific community about the utility and ability of Legionella testing to predict illness, about the development and accuracy of new test methods and changing viewpoints on what constitutes reliable control measures. Therefore, it will be important to work with experienced counsel and consultants to effectively tailor the ASHRAE standards to specific health care facilities and their systems to avoid creating additional issues that can lead to compliance concerns, reporting and, potentially, claims. Also, although we expect that there will be an initial phase of compliance support from CMS, the abruptness with which this memo was issued suggests that there may be a fairly short interval before some publicized enforcement is taken against some visible targets.
The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.