HHS Taps Defense Production Act to Bolster Point-of-Care Testing Shipments to Nursing Homes

The Department of Health and Human Services (HHS) on Thursday announced the use of the Defense Production Act to bolster orders of point-of-care coronavirus testing units and supplies for the nation’s nursing homes.

HHS applied “priority rated contracts” for devices and related assays with Becton Dickinson (BD) and the Quidel Corporation, the two manufacturers tasked with spearheading the federal testing effort.

“These acquisitions will fulfill a large-volume purchase of diagnostic systems and assays for COVID-19 testing and will expedite shipments of these systems and assays to every nursing home certified by the Centers for Medicare & Medicaid services (CMS) with a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver — approximately 14,000 nursing homes — in the United States,” the agency announced.

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The move boosted the government’s order of testing devices from manufacturer BD from 2,000 to 9,000, company spokesperson Troy Kirkpatrick told SNN.

“BD pledged our support to our country’s most vulnerable nursing home residents through this important nursing home initiative from our initial discussions with HHS leaders, and we are steadfast in following through with our commitment,” Kirkpatrick said in an e-mail.

The federal government announced the aggressive antigen testing program in mid-July, triaging the distribution to focus on facilities in known hotspots as well as those without access to third-party laboratory testing.

“The federal efforts to supply nursing homes with rapid point-of-care antigen instruments and tests is our highest priority to save lives and the U.S. government will exert its full authority to complete this mission,” HHS assistant health secretary Adm. Brett Giroir said in a Thursday statement.

The initiative remains on track to reach those 14,000 approved facilities by next month, with more than 3,500 already distributed along with 1.3 million tests, Giroir said Wednesday during a conference call with reporters.

But Giroir also acknowledged that access to the required testing supplies will be “tight” through September, as BD and Quidel ramp up their production to meet the ongoing demand for point-of-care tests.

The Defense Production Act grants the executive branch broad powers to direct domestic manufacturing of goods deemed vital to national security; historically invoked for military purposes, President Trump has used his authority under the DPA to coordinate the federal government’s response to the COVID-19 pandemic.

“Rated orders” take priority over other contracts or requisitions submitted to private companies by the federal government, according to the Federal Emergency Management Agency (FEMA).

“A rated order is placed to ensure on-time delivery of items and services, in accordance with the delivery requirements specified in the order,” FEMA states.

The announcement comes a day after a story in Talking Points Memo described widespread confusion over reporting requirements for antigen tests results among nursing home operators, as well as some concerns over facilities’ capacity to accurately collect and process the tests.

The Centers for Disease Control & Prevention (CDC) this week released updated guidance for using the antigen tests — which are generally less sensitive than the “gold standard” polymerase chain reaction (PCR) tests — in nursing homes and other congregate living settings.

Giroir and HHS have been largely upfront about the federal government’s decision to prioritize expediency over perfection in rolling out the antigen testing equipment.

“The situation is much too urgent to wait a few months so we can put bows and lipstick on the program,” Giroir said last month. “So we’re going to build this plane a little bit while we’re flying it.”

While the government is furnishing the devices and first round of supplies free of charge, providers will be on the hook for all future refills, at a cost of about $25 per test; BD and Quidel were tasked with setting up “concierge service” ordering portals for nursing homes to receive expedited deliveries, Giroir said in July.

Facilities will receive a unit from either BD or Quidel, with the assays not cross-compatible across platforms; the former company has emerged as the primary supplier, Giroir said Wednesday.

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

The Franklin Lakes, N.J.-based BD has received a committed HHS order for 3 million tests alongside the 9,000 Veritor Plus antigen testing units, Kirkpatrick said; that’s an increase from the previous order of 2,000 units and 750,000 tests.

The total of 11,000 devices means that BD will serve more than 70% of the nursing homes in the country, which Kirkpatrick attributed to BD’s “ability to rapidly ramp up manufacturing of both devices and tests.”

Maggie Flynn contributed reporting.

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