One day after the federal government announced an ambitious plan to send point-of-care testing units for COVID-19 to all of the nation’s more than 15,000 nursing homes, leaders in the space expressed cautious optimism — while often emphasizing that they have more questions than firm answers.
Starting next week, the Department of Health and Human Services (HHS) will begin sending testing devices — the Quidel Sofia and Sofia 2, along with the BD Veritor Plus — directly to nursing facilities, starting with 2,000 buildings identified as high-risk based on levels of community spread.
Many of the program’s logistical details remain unclear, even after a late Wednesday phone call with operators that included commentary from Centers for Medicare & Medicaid Services (CMS) administrator Seema Verma and assistant HHS secretary Dr. Brett Giroir.
But until proven otherwise, the early consensus is that any attempt to boost the speed of COVID-19 testing at nursing homes is welcome news.
“I’m going to be positive. To me, there’s no reason to be negative,” Dr. Michael Wasserman, president of the California Association of Long-Term Care Medicine and former CEO of operator Rockport Healthcare Services, told SNN. “If the government’s saying it’s going to do what should have been done a couple months ago, I’m thrilled.”
By bringing tests directly to facilities’ doorsteps, the government hopes to alleviate the growing pile-ups at laboratories across the country, which have only worsened as case counts spike in the wake of economic reopening measures.
“As you know, the turnaround time is getting a bit longer,” HHS assistant health secretary Adm. Brett Giroir said Tuesday. “And it’s also very expensive. So what we’re talking about is a point-of-care, rapid, on-the-spot, 20 tests per hour, instrument — along with tests — to every single of the 15,400 nursing homes in this country.”
Asked for their reaction Wednesday, leaders and academics generally welcomed the news, with the caveat that details about the program remain scarce.
“The news coming out of CMS on point-of-care testing is welcomed and encouraging,” Derek Prince, president and CEO of The Woodlands, Texas-based operator HMG Healthcare, said in an e-mail. “Hearing about the availability and technology of rapid testing for all nursing facilities is something we look forward to hearing more about. For months nursing facilities have struggled with testing frequency, availability, accuracy and lag times in results. We cautiously wait for more information and direction on this new initiative.”
Erin Shvetzoff Hennessey, CEO of Health Dimensions Group in Minneapolis, echoed that sentiment.
“Knowing the devastating impact of the disease on the elderly, we hope this much appreciated support of our dedicated staff and the elderly they serve continues — from states, the federal government and the public,” Hennessey said. “We remain incredibly proud of the work of our profession and are thankful for more resources as we continue to fight COVID-19.”
But that doesn’t mean there aren’t pointed concerns. In particular, Wasserman focused on the on-the-ground logistics of regularly processing tests, which isn’t typically a part of an individual facility’s day-to-day operations.
“Reading what they said, they spent two months planning for this,” Wasserman said. “You would hope that their planning has included the ease of use and ability to integrate into a facility’s workflow.”
Christopher Laxton, the executive director of AMDA — The Society for Post-Acute and Long-Term Care Medicine, said that it can take up to a full day for staffers at a 100-bed nursing home to collect samples for testing, raising questions about whether the typical nursing home will be able to perform regular on-site tests with current — and often strained — staffing levels.
“You can’t take the clinical team away from bedside care for an entire day and expect the nursing home will continue to provide good care,” Laxton said.
For Shalom Friedland, vice president of operations at the Lakewood, N.J.-based Paramount Care Centers, any on-site testing will represent an improvement over the current system.
“Since we have been testing weekly in all facilities for the past six weeks or so, we know from trial and error what needs to be done, and we are fairly confident that the program will be significantly easier [than] what is in place currently, as the biggest challenge now has been timely results,” Friedland said via e-mail.
But then there’s the matter of the antigen-based testing units themselves. HHS allowed that these devices are “slightly more likely to have a false negative result” than their polymerase chain reaction (PCR) counterparts, generally considered to be the gold standard for effective COVID-19 diagnosis.
“What does ‘slightly higher’ mean?” R. Tamara Konetzka, a researcher at the University of Chicago, said in an e-mail to SNN. “While a tradeoff between timeliness and reliability is unfortunately part of the science of testing right now, if the rate of false negatives is high enough, this whole effort could backfire. It could similarly backfire if no training is available.”
Laxton echoed those questions, noting that the false-positive rate for antigen testing systems can run as high as 20%. Some facilities that used early versions of antigen units “found they’re catching all kinds of things, and they’re not necessarily COVID.”
“Truthfully, the biggest question and concern we have is the false positive rate, and the reliability and sensitivity — especially sensitivity — on the antigen test,” he said. “Do they actually pick up COVID, or are they picking up anything — any kind of coronavirus, or corona-like virus?”
For that reason, Laxton advised that nursing homes use the antigen tests as part of an overarching surveillance strategy, calling them just one tool in a kit that should also include PCR testing to confirm suspected cases.
Wasserman, meanwhile, acknowledged the potential for false positives, but noted that the ability for repeated on-site testing could mitigate that issue.
“Even if the rate of false negatives is a little higher, that’ll almost end up being taken care of itself, ultimately, by increased frequency of testing, increased availability of testing, decreased turnaround time,” he said.
Dr. Richard Feifer, chief medical officer of nursing home giant Genesis HealthCare (NYSE: GEN), concurred on both the upsides and downsides of antigen testing.
“It remains possible, even likely, that we will need to still have PCR tests available to us, in addition to antigen tests, especially for negative antigen test results for symptomatic cases,” Feifer said in an e-mail. “For screening of asymptomatic residents, antigen testing may suffice if it is run more often, to make up for the lesser sensitivity.”
Wasserman and Konetzka both raised the issue of who will ultimately pay for the supplies required to perform ongoing tests; Giroir’s statement seemed to indicate that facilities would receive both the units and associated testing supplies.
“Who will pay for them? And is there a supply chain accessible to nursing homes for the testing supplies?” Konetzka said. “Are the supplies device-specific? I fear this will be similar to the previous federal shipments of PPE to nursing homes — inadequate and of low quality, with no thought to longer run needs.”
Some confusion also reigned Wednesday after HHS indicated that facilities that did not have a CLIA waiver — which allows non-laboratory health facilities to perform certain diagnostic tests — will not receive the units. All 50 states have some properties that do not currently qualify, an HHS spokesperson said, also pointing to Washington, Alaska, Hawaii, and West Virginia as states that “did not have any facilities that met the criteria for receiving an instrument while also having a CLIA waiver.”
Nursing home leaders in Washington state pushed back on that assessment, citing a federal exemption that gives the state health department the power to approve or deny facilities’ ability to perform certain tests on site.
But the lack of immediate clarity around that issue, in Laxton’s view, illustrated the overall gaps between federal and state responses to COVID-19 in nursing facilities; to stay on top of the latest guidance and best practices, Laxton advised long-term care leaders to work with their local health departments.
“I think it just shows you that there’s a whole lot of people that are firing from the hip, and not really thinking strategically or working in coordination with the states,” he said.
At least for Wasserman, until the first shipments appear at the nation’s nursing homes next week, cautious optimism remains the order of the day.
“Based on the history of CMS’s engagement with nursing homes, I must admit that I am incredibly skeptical. However, I will give them the benefit of the doubt,” he said. “They’ve given us a one-week timeline, that they’re going to have 2,000 of these out there in one week, and in a week, I will then see what they’ve done, and I’ll see how it’s working, and then I will start giving my next level of response.”
Maggie Flynn contributed reporting.
Companies featured in this article:
AMDA – The Society for Post-Acute and Long-Term Care Medicine, California Association of Long Term Care Medicine, Department of Health and Human Services, Genesis HealthCare, Health Dimensions Group, HMG Healthcare, Paramount Care Centers, Rockport Healthcare Services