The federal government on Wednesday revealed more details about its ambitious effort to send point-of-care COVID-19 testing units and kits to every nursing home in the country, indicating that each facility will receive 400 tests to start with — and thereafter be able to secure subsequent tests for under $25 apiece through a “special concierge service.”
Production capacity for the tests and associated supplies will likely not be fully up and running until October, Department of Health and Human Services (HHS) assistant health secretary Dr. Brett Giroir said on a late afternoon phone call with nursing home leaders.
But starting shipments to the current hotspot areas by the end of this week remains a “stretch goal” for HHS, Giroir said, with specific prioritization based on case counts, hospital capacity, and other factors as identified by the Centers for Medicare & Medicaid Services (CMS).
“The shipping of the available instruments [that] will be coming over the next many weeks — probably six to eight weeks — will get us most of the nursing homes, not all of them,” Giroir said.
That 400 figure also remains an estimate; depending on the size of the facility, the number may be greater, Giroir noted, with a target of six weeks’ supply. By September, the government hopes to have 15 million to 20 million tests available each month, backed in part with federal investment, according to Giroir.
“The situation is much too urgent to wait a few months so we can put bows and lipstick on the program,” he said. “So we’re going to build this plane a little bit while we’re flying it.”
CMS administrator Seema Verma provided more detail on the federal government’s calculus in determining the targets for the first shipments.
“We are focusing on the hotspot areas, so obviously those are some of the nursing homes in Florida and in Texas and in Arizona,” Verma said. “We’ve also been using the data that you all have been turning into the CDC, and that’s really been critical to our efforts.”
The prioritized facilities will also include nursing homes with three or more COVID-19 cases, Verma said.
Giroir and HHS are currently working with the two companies that sell the devices included in the shipments — Quidel and BD — to set up a special nursing home ordering portal that will allow operators to receive ordering priority.
“We’ve asked them to establish a special concierge service for nursing homes so that you have a single-stop shopping — that you can call one number, make one e-mail, and really get the gold-plated service, because you are those who protect the most vulnerable,” Giroir said.
Though the assistant secretary acknowledged that the price point remains in flux, he characterized the antigen tests as the most cost-effective available on the market, contrasting them with the $100 to $150 cost of laboratory tests.
As HHS indicated Tuesday night, Giroir also pointed to the higher risk for false negatives with the antigen tests as compared with the gold-standard polymerase chain reaction (PCR) tests performed by third-party labs. PCR tests should still be used to confirm negatives, with Giroir advising nursing homes to treat negative antigen results for residents with a suspected case as presumptive until a PCR test can back it up.
But while stopping short of guaranteeing 100% accuracy, he expressed serious confidence in the positives that the machines will generate.
“If you get a positive, these are essentially 100% specific. If you have a positive it is positive: You can bet the farm on it. Never 100%, but literally they are operating at about 99-plus percent specificity. If you get a positive, it’s real,” he said.
Speaking to SNN prior to the press call, Christopher Laxton, the executive director of AMDA — The Society for Post-Acute and Long-Term Care Medicine, indicated that he was aware of cases where facilities that used early antigen test units saw positives for a variety of non-COVID viruses.
“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 recommended that nursing homes use the antigen tests as one tool in a larger kit that also includes PCR testing to confirm cases.
In response to a question indicating that Michigan does not allow the use of antigen tests in nursing facilities, Giroir also asserted that the technology is the best point-of-care system that nursing homes can expect during the COVID-19 pandemic.
“There will not be another solution, by technology, that is going to be available,” he said. “I am happy to speak with anyone in Michigan, but it would be a death blow to nursing home residents to not be able to use this technology.”
Verma also took pains to thank Mark Parkinson, president and CEO of the American Health Care Association, for his group’s work in bringing the depth of the testing issue — particularly long turnaround times — to the government’s attention.
“This is so huge,” Parkinson said of the testing initiative on the call.