On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) published a Quality, Safety and Oversight Group (QSO) memorandum to all State Survey Agency Directors. In that memorandum, CMS notes that it plans to issue “a new requirement for [nursing] facilities to notify residents and their representatives to keep them up to date on the conditions inside the facility, such as when new cases of COVID-19 occur.” However, the CMS proposal has already garnered pushback from organizations such as LeadingAge which described the proposal as a “disaster.”
According to Betsy Wade, MPH, CHC, CNA, Chief Compliance and Ethics Officer at Signature HealthCARE, “Signature HealthCARE has taken a proactive approach and already notifies the family of residents who test positive for COVID and contacts them regarding any staff who also have tested positive.” Ms. Wade notes that “We support reporting, however, the proposal in the memorandum that was sent to state survey agencies is duplicative because facilities already are required to report positive results to designated government entities. We want to maintain transparency but don’t want to see this become overly burdensome to our facilities. Our number one goal is to make sure our families remain informed.”
Below, we explore some of the ramifications of the proposed requirements.
CMS notes that the Centers for Disease Control and Prevention’s (CDC) guidance already requires nursing facilities to notify State or local health departments concerning residents and/or personnel who have confirmed or suspected cases of COVID-19 as well as residents whose respiratory infection resulted in death or hospitalization. Additionally, whenever three or more residents or staff are observed to have “new-onset of respiratory symptoms within 72 hours of each other” a facility must notify the appropriate State or local health agencies. However, CMS is proposing an additional layer of mandatory reporting at the federal level.
CMS will “soon provide nursing homes with specific direction” concerning new reporting requirements regarding suspected or confirmed COVID-19 occurrences. That reporting will be made to the CDC’s National Health Safety Network (NHSN). At this time, such reporting to CDC is not required and is left up to each facility. CMS notes that its new requirements will mandate that nursing facilities inform residents and their representatives of even a single confirmed COVID-19 infection or whenever three or more staff or residents display “new onset of respiratory symptoms within 72 hours.” Such notification to residents and their representative must occur within 12 hours of the occurrence, according to CMS.
In addition to the above requirements, nursing facilities would have to notify residents and their representatives of updates on a weekly basis or every time another COVID-19 infection is confirmed as well as whenever three or more residents or staff develop new onset of respiratory symptoms. Further, facilities will be required, in the proposed rule, to provide information regarding mitigation efforts aimed at preventing and reducing the risk of transmission as well as whether facility operations may be affected.
CMS warns providers that a failure to comply with the proposed additional notification requirements could trigger a CMS-imposed enforcement action (e.g., civil money penalty) against the nursing facility.
Transparency in the era of COVID-19 is essential and no reasonable person objects to that. But, the proposed rule creates additional burdens for facilities at a time when they are already stretched thin, and it is worth considering whether these additional burdens are justified. Since nursing facilities already must notify State and/or local health agencies when there are confirmed or suspected cases of COVID-19 infections among residents or staff, such a rule seemingly creates an additional and duplicative layer of reporting requirements. All too often when there are multiple parallel systems of reporting the same data to different entities, there can be confusion and inadvertent inconsistency. At best, it will require a considerable labor-intensive effort on the part of staff at a time when nursing facilities are struggling to maintain adequate staffing. Query: Would it make more sense and be more efficient if instead of placing an additional burden on facilities, CMS required its partners at the state levels to forward the information? The same format for reporting that CMS plans to require providers to complete could theoretically be completed at the state and local levels.
While the goal of increased transparency is laudable, it should be balanced against other important interests, such as the ability of an already stretched and strained staff to meet additional time-consuming demands during the current crisis. As noted by Dr. Karl Steinberg, President-Elect of The Society for Post-Acute and Long-Term Care Medicine, AMDA, “Transparency is important, and I think the public, the medical community and first responders have a right to know where outbreaks are occurring.” However, Dr. Steinberg adds, “On the downside, this may unfairly target facilities with outbreaks that occur despite good infection control practices, and the actual data entry requirements are very time-consuming during a time when nursing home staff time is at a premium.”
There is a legal concept known as “void for vagueness” which essentially means that if a law or regulation is vague, it may be void. Well, what exactly does CMS’s phrase “new onset of respiratory symptoms within 72 hours” mean? Would a nursing facility have to file a mandatory report if two staff nurses started to cough and a third had a runny nose and was sneezing? All are respiratory symptoms. And, what if there was an unusually high pollen count and the staff’s symptoms were related solely to seasonal allergies, hay fever, or asthma? At a minimum, it would be helpful for CMS to provide specificity and define “new onset of respiratory symptoms” in any forthcoming rule.
Nursing facilities continue to be on the forefront of the battle against COVID-19 and are hit disproportionally hard given the aggressive nature of the novel coronavirus coupled with a highly susceptible population. However well-intentioned, adding additional reporting requirements may create more problems than it solves, particularly since the information would mostly be redundant. Sometimes the cure can be worse than the underlying disease.