HHS to Ramp Up Point-of-Care COVID Test Distribution in Hotspots, Launch New Cue Health Nursing Home Pilot

The federal government will increase shipments of point-of-care testing supplies to nursing homes in counties with high levels of COVID-19 community spread, while also launching a separate pilot program with yet another testing device in select states.

The Department of Health and Human Services (HHS) will now send enough rapid test kits to support twice-weekly testing of nursing home staffers in both “red” and “yellow” counties under the administration’s three-tiered coronavirus prevalence ranking system, assistant health secretary Brett Giroir said on a Monday media call. The lowest-level “green” counties will receive supplies to support once-monthly testing for workers.

“Please note that although these tests are predominantly meant for screening staff, so that an infected staff member can isolate and not expose highly vulnerable residents, they are also extremely valuable for diagnostic testing of a symptomatic resident,” Giroir said.

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HHS has sent point-of-care testing units from manufacturers Becton Dickinson and Quidel to most nursing facilities across the country, with frequent staff testing under the red-yellow-green system a requirement for participation in Medicare and Medicaid. Operators also face monetary fines for failure to comply with the rules.

That program has been beset with concerns over the potential for false positives, as well as confusion over frequency and reporting requirements. About 30% of operators that have received the machines have not used them at all, the Wall Street Journal reported this past weekend, and multiple states have expressed concerns over their use in determining cohorting and treatment decisions in nursing homes.

Massachusetts, the WSJ noted, does not allow operators to count point-of-care tests toward the state’s testing requirements, and many providers have been confirming rapid positive with follow-up tests.

The federal government has also supplemented the BD and Quidel program with shipments of Abbott Laboratories’ BinaxNOW tests, a card-based system that does not require the use of separate kits and processing units.

As he had in the past, Giroir on Monday defended the use of point-of-care tests in nursing homes. With the gold-standard polymerase chain reaction (PCR) tests still confined to independent laboratories that can take several days to process results, Giroir and HHS have argued that the ability to repeatedly test residents on point-of-care units provides the only currently workable safety net in institutional settings.

“There is concern about missing potentially infectious people on the early upswing of their virus with tests like Binax,” Giroir said Monday. “That is a concern, but it’s much less of a concern, because repeat testing — optimally twice or three times per week, like we’re doing in nursing homes — will catch those people when their viral loads get high enough to infect other people.”

Giroir on Monday also indicated that the federal government will soon begin sending molecular point-of-care units from manufacturer Cue Health to five states — Texas, Louisiana, Florida, New Jersey, and Alaska — as well as the Department of Veterans Affairs and the Department of Defense.

About 100 instrument readers and 7,600 tests will go out in the first shipment this week, with 7,000 readers and 24,000 tests set for distribution later in the week, according to Giroir.

“Priority will be to pilot as a point-of-care molecular test in support of the rapid antigen tests in nursing homes and in other venues, so that screening positives can be confirmed on the spot, and not referred out to a lab for testing,” he said.

Cue Health Inc. in late October received a $481 million investment from Washington to expand its production of the tests, which provide answers in about 25 minutes, according to Bloomberg News.

The devices received national attention for their use in the NBA’s “bubble” in Orlando, Fla., with Giroir last month referring to the game’s biggest star in promoting the government’s backing of Cue Health.

“If it’s good enough for LeBron, we want to democratize it and make sure it’s available to the American people,” Giroir told Bloomberg.