Point-of-Care Shipments on Track as One Device Maker Pulls Ahead — But SNFs Will Still Be ‘Tight on Tests’

The Department of Health and Human Services (HHS) reaffirmed Wednesday that the federal government is on track to ship point-of-care COVID-19 testing devices to all skilled nursing facilities with the proper waivers by the end of September — as one of two dedicated device manufacturers has emerged to shoulder more of the load.

“We are on schedule to meet that, and we’ll be having some announcements about that probably in the next 48 hours,” HHS assistant health secretary Admiral Brett Giroir said on a call with reporters.

The remarks reiterate comments Giroir made August 13, but he provided more details on the steps HHS is taking during the Wednesday update.

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Last month, HHS announced that it would be sending devices for point-of-care COVID-19 antigen testing to all SNFs in the U.S.

All SNFs in possession of a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver will receive a device, along with enough tests to provide checks for every SNF resident and staff member once a week for four weeks. After that initial tranche from HHS, SNFs can order new tests from Quidel and BD, the manufacturers of the testing devices, through a “concierge service” for roughly $25 apiece.

So far, HHS has shipped devices to 3,594 SNFs, for about 1.3 million point-of-care tests. The department is currently calculating estimates of how many tests nursing homes will need on a monthly basis, Giroir said, and the main focus now is to get instruments to all facilities to allow them to test their residents and staff; about 14,000 facilities across the country meet the CLIA requirements and should thus receive the units by next month.

“We are very aggressively working with BD and Quidel,” Giroir said on Wednesday. “BD will carry the primary load on this, and we’ll be getting more detail about that.”

Toward the end of July, some providers had said they were told that securing sufficient testing supplies could take six months, and immediately after the initiative was announced, Giroir had indicated that getting the supply chains in gear could take up until October. But on the Wednesday call, he stressed that HHS would not be undertaking the step if it did not believe supplies would eventually be sufficient.

He also noted that under the most recent round of CARES Act aid, providers can access up to $2.5 billion to help them secure testing supplies.

“Everybody’s going to be tight on tests through August and September,” he cautioned. “Our main issue is to get instruments to everybody.”

The news came as the federal government has announced several attempts to stem the newly burgeoning tide of cases in nursing homes, particularly across the Sun Belt states, as community cases spike and the Centers for Medicare & Medicaid Services (CMS) continues to identify persistent infection control problems as part of targeted surveys.