Nursing homes will be required to test staffers for COVID-19 as often as twice weekly depending on the prevalence of the virus in the surrounding community, and a top federal official emphasized that repeat testing for negative antigen results may not be necessarily required in all cases.
“Testing will occur twice a week, weekly, or monthly, depending on local factors such as an individual facility’s risk for COVID-19 transmission,” the Trump administration announced.
The Centers for Medicare & Medicaid Services (CMS) confirmed that frequency in a memo issued to State Survey Agencies on Wednesday, linking the cadence with the overall rate of positive COVID-19 tests in the county over the preceding week.
In counties with “low” community spread of less than 5%, staff must be tested once monthly. Between 5% and 10%, the frequency increases to once per week, topping out at twice weekly in counties with a rate higher than 10%.
That said, the weekly and twice-weekly edicts presume that facilities either have on-site point-of-care testing units, or can receive third-party results in less than 48 hours.
Both the White House and CMS indicated that resident testing will be required for all who display symptoms, as well as in the event of outbreaks — but general asymptomatic resident testing will not be mandatory in most cases.
“Routine testing of asymptomatic residents is not recommended unless prompted by a change in circumstances, such as the identification of a confirmed COVID-19 case in the facility,” CMS wrote in the memo. “Facilities may consider testing asymptomatic residents who leave the facility frequently, such as for dialysis or chemotherapy.”
Fines for failure to comply with the new regulations can run in excess of $400 per day or $8,000 per instance, CMS announced on Tuesday. Routine staff testing will also be added to the government’s baseline requirements for nursing homes to participate in Medicare and Medicaid, effectively threatening non-compliant facilities with closure by removing the sector’s two primary income streams.
“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 new rules.
Both CMS and the administration pointed to a Department of Health and Human Services (HHS) effort to send point-of-care antigen testing units to most of the nation’s 15,000 nursing homes as a primary resource for facilities to meet the new requirements — though operators will also need to report antigen results or face recurring fines of $500 per day on top of an initial $1,000 penalty.
CMS provided further details about the reporting requirements in a separate memo sent to SSAs, also released Wednesday.
HHS has so far shipped 5,670 antigen devices to nearly as many nursing homes across the country, assistant secretary for health Adm. Brett Giroir said on a Wednesday press call, and the program remains on track to complete the distribution by the end of September.
Both nursing home leaders and health officials have expressed concerns over the relatively lower sensitivity of the antigen units as compared to the more accurate polymerase chain reaction (PCR) test, primarily performed by third-party labs.
Early guidance around antigen testing emphasized the importance of following up negative results with a PCR test to confirm the lack of infection — given the relatively higher risk of false negatives — and treating antigen negatives as presumptive until PCR could rule out the presence of the virus.
But Giroir on Wednesday said that the Food and Drug Administration (FDA) has signed off on the use of serial point-of-care antigen testing without the need for follow-ups in all situations.
The new FDA guidance, released late last week, still emphasizes that health providers should consider a negative antigen result to be presumptive — but allows that the decision to require a second test depends on context.
A negative antigen result collected during an ongoing outbreak at a nursing home or other congregate living facility, for instance, would necessitate a PCR follow-up, according to the FDA. But if a facility without any cases is using the machines to monitor residents as part of a routine plan, that may not be the case.
“It is not necessary to perform confirmatory high sensitivity molecular tests on individuals with negative antigen test or other point-of-care test results if they are obtained during routine screening or surveillance,” the FDA noted.
Giroir hammered that point on the call Wednesday.
“It is absolutely not necessary to repeat negative tests during routine screening or surveillance,” Giroir said.
In fact, the FDA indicated that routine antigen tests may be preferable to PCR tests if they can be performed frequently enough.
“For congregate care settings, like nursing homes or similar settings, repeated use of rapid point of care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times,” the FDA observed.
Verma supported that thinking in comments made to the Wall Street Journal, recommending follow-up PCR tests in the case of outbreaks but telling the publication that “from where we sit, using the point-of-care test would be appropriate” for general surveillance.
Nursing home leaders raised the specter of extended wait times for PCR results from third-party laboratories in expressing concerns about the new CMS testing requirements and associated fines.
“When CMS clarifies the frequency of testing required, it must factor in the delays that continue to be a reality,” American Health Care Association president and CEO Mark Parkinson said in a Tuesday 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.”
But Giroir on pointed to general improvements in those PCR processing times: As of Wednesday morning, 91.3% of tests were processed within three days, and 96.4% were completed within five days. The average turnaround time so far in August sits at 2.43 days, according to Giroir, with the number declining each week.
“The turnaround-time issue is essentially solved,” Giroir said.