Nursing home leaders should document all attempts to test workers for COVID-19 under strict new rules, officials said this week, as the federal government looks to balance enforcement with the reality of continued hurdles on the ground.
“We want to ensure that we’re using enforcement discretion. We know that as we’re implementing this, there’s going to be some questions and concerns,” Centers for Medicare & Medicaid Services (CMS) administrator Seema Verma said late Tuesday during a call with nursing home stakeholders. “I think the most important thing, though, to emphasize is that we want you to be testing routinely, according to what’s going on in your county — and it’s important that you do that. Obviously, it may not be absolutely perfect, and we’ll work with you.”
With a Department of Health and Human Services (HHS) effort to send point-of-care testing units to most nursing homes in the country almost complete — and a second push to target facilities in hotspots with extra tests from manufacturer Abbott announced earlier this week — the federal government’s attention now shifts toward enforcing its stricter testing mandates.
Unveiled late last month, the new rules require operators to test all nursing home staffers on a regular basis, with the exact frequency based on the spread of COVID-19 in the surrounding county: twice weekly if the infection rate is above 10%, once weekly if it’s between 5% and 10%, and once monthly if it’s under 5%.
As of last week, about 800 counties had rates above 10%.
In addition, providers must test all residents that display symptoms of a COVID-19 infection, and in the event of an outbreak — defined as any new case confirmed in a facility — repeatedly test all negative residents until the virus is contained. CMS continues to affirm that regular testing of all residents is not necessary except for those who must routinely leave the building for doctors’ appointments, dialysis treatments, or other reasons.
The new rules also require facilities that have received point-of-care units to publicly report the results; operators can use existing channels established by state and local health departments, as well as state and regional health information exchanges (HIEs), according to CMS.
Failure to comply with the new testing regulations can result a denial of participation in Medicare and Medicaid, essentially sinking a provider financially, as well as per-instance fines that can exceed $8,000. The public reporting requirement was implemented with an initial $1,000 fine for non-compliance, followed by $500-per-day assessments; facilities have a three-week grace period, which started September 2, to begin submitting the information.
Operators in the space have generally known since early summer that the tighter rules were part of the bargain in the Trump administration’s plan to send point-of-care testing units from manufacturers Becton Dickinson and Quidel to all nursing facilities with a CLIA certificate of waiver, allowing them to perform COVID-19 tests on site.
HHS has so far sent out about 13,400 of the BD and Quidel testing units, along with 4.7 million kits, HHS assistant health secretary Brett Giroir said during the same Tuesday call. The remaining free units and tests will go out this week.
The Abbott tests — which use a nasal swab and a card-style testing medium that does not require a separate testing unit — will start rolling out to facilities in counties with infection rates of 5% or higher next week, with shipments continuing until November or December, according to Giroir.
Several audience members on the Tuesday call expressed concerns about the ongoing costs and logistical burdens of these testing requirements: After the initial distribution from the government, operators are on their own to purchase replenishment orders, with Giroir acknowledging early problems with high markups by distributors of the BD and Quidel testing kits.
In response, Verma pointed to the multiple distributions of CARES Act funding to nursing homes, including a $2.5 billion tranche specifically dedicated to covering testing and other day-to-day expenses released at the end of August; diagnostic testing in the wake of an outbreak at a facility also should be covered under Medicare, according to Giroir.
The BD units will also be available on the open marketplace “for a few hundred dollars” apiece.
“It’s a pretty dumb reader, so you’re more than welcome to purchase, with the money that’s been sent out, additional readers to increase your throughput,” Giroir said Tuesday. “Again, for this first phase, we bought every single machine that came off the line for both BD and Quidel. So after this, there are going to be literally thousands per month available in the marketplace.”
The officials on the Tuesday call acknowledged that Washington is still in active conversations with individual state survey agencies to iron out the specifics of enforcement. For instance, in response to a question about testing contractors who only visit a facility once per month, officials seemed to indicate that it would be sufficient to accept proof of a recent COVID-19 test in lieu of an on-site diagnostic.
Jean Moody-Williams, deputy director of CMS’s Center for Clinical Standards & Quality, emphasized the importance of documentation when navigating the new rules.
“Obviously, we are asking you to make every reasonable attempt; it is important that you document the attempts that you make, as this is falling under our Conditions of Participation … When we come out, the surveyors are going to look to see what have you done to comply with this regulation, and will take into consideration those things that you have documented,” Moody-Williams said.
That documentation can also include an effort to source more up-to-date community-spread data than the federal government can provide.
“If your state happens to have data that’s compiled that’s newer than the data from the CDC, then just document that you are testing based upon this data source, and we will accept that,” CMS chief medical officer Lee Fleisher said on the call. “But it really should be something that the state or county has specifically calculated — and it’s newer information, not older.”
As she has in the past, Verma repeatedly framed CMS’s role in the enforcement of these new COVID-era regulations as collaborative.
“We’re going to use enforcement discretion on this,” Verma said. “There’s a grace period, but we’re going to try to do everything we can to work with you. We know that there’s just going to be a few bumps, so you’ve got my commitment to work with nursing homes as we implement this.”
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