The federal government on Tuesday issued stricter requirements for COVID-19 testing in nursing homes, making routine staff testing a requirement for participation in Medicare and Medicaid and rolling out fines as high as $8,000 per instance of non-compliance.
The Centers for Medicare & Medicaid Services (CMS) established the new rules as part of a larger package of data reporting requirements for hospitals and laboratories.
“These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19,” CMS administrator Seema Verma said in a statement announcing the requirements. “Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it.”
The exact frequency of the required employee testing will depend on the level of COVID-19 infections in a facility’s surrounding community, according to CMS.
“CMS recommendations for the frequency of staff testing will be based on the degree of community spread, to be announced shortly through guidance, that indicate the facility may be at increased risk for COVID-19 transmission,” the agency noted.
Nursing homes must now also provide tests to residents during all outbreaks, as well as when residents show any symptoms of the viral infection.
CMS has directed state surveyors to perform inspections ensuring that providers comply with the new regulations, with fines exceeding $400 per day or $8,000 per individual infraction.
Finally, all nursing facilities that receive a point-of-care testing unit from the Department of Health and Human Services (HHS) will be required to report diagnostic results as mandated under the CARES Act, CMS announced.
The rule, which will also apply to hospital labs and other sites that perform COVID-19 tests, will be enforced with fines of $1,000 per day for the initial infraction, with $500-per-day fines thereafter.
Nursing homes and other lab sites will be given a one-time grace period, lasting three weeks, to begin reporting the data.
“This requirement complements existing HHS guidance requiring laboratories to report test results and additional information, such as demographic data,” CMS noted. “This change allows CMS to take enforcement action against laboratories that fail to provide the required data, which is needed by federal, state, and local officials to conduct effective surveillance of the COVID-19 pandemic.”
CMS explicitly framed the rulemaking decision as a directive from President Trump.
“The provisions in today’s rule on nursing homes represent his expectation that CMS pull every available regulatory lever to maximize nursing home residents’ safety and quality of life,” Verma said in the statement. “These Americans and their families, who have already gone through so much, deserve nothing less.”
The move to beef up rules and enforcement around testing was largely expected in the wake of the HHS program, under which most of the nation’s 15,000 nursing facilities are slated to receive a point-of-care antigen testing unit by the end of September.
The antigen testing units are generally less sensitive than the gold-standard polymerase chain reaction (PCR) tests, with a higher chance of false negatives, though industry leaders and health care experts have largely welcomed the ability for quicker test results in a landscape marked by overwhelmed third-party labs and long turnaround times.
The federal government will provide an initial shipment of testing assays as part of those device deliveries, but facilities will be on their own to cover the costs of subsequent tests — as well as any follow-up PCR tests, which are typically recommended to confirm negative antigen results.
CMS pointed to the most recent round of $5 billion in federal CARES Act relief set aside for nursing homes — on top of billions in other aid available to post-acute and long-term care providers — as a key source of funding to cover testing expenses under the new rules.
The new requirements will take effect under an interim final rule with comment period, published in the Federal Register for inspection.
Previous federal testing requirements have largely taken the form of recommendations, such as specific benchmarks included in CMS’s guidelines for reopening nursing homes to visitors; CMS in July also announced its intention to require weekly staff testing in states with an overall infection rate of 5% or higher.
The American Health Care Association, which represents primarily for-profit nursing facilities, expressed general support for wider mandatory testing rules, while also raising concerns about how third-party testing delays could potentially result in fines.
“When CMS clarifies the frequency of testing required, it must factor in the delays that continue to be a reality,” AHCA president and CEO Mark Parkinson said in a statement. “Otherwise facilities could face fines for circumstances beyond their control and be conducting tests that are so delayed that they have little clinical value. CMS can solve these concerns by being reasonable in its implementation of the rule.”
LeadingAge, a trade organization of non-profit senior care and housing providers, called for more direct assistance on top of the requirements, noting that some providers have serious questions about the logistics of using the point-of-care machines.
“The fight against this virus is far from over, and our members need continued support,” CEO Katie Smith Sloan said in a statement. “The antigen testing machines HHS is delivering to nursing homes will help, but members who already have the machines report that they are still waiting for instructions and test kits to make them usable. What’s more, this HHS program addresses just one segment of the care continuum, and even nursing homes still face high costs for testing supplies and staff resources.”