Federal Government Will Send Point-of-Care COVID-19 Testing Units, Kits to All Nursing Homes in U.S. [Updated]

UPDATE, July 15: CMS and HHS on Wednesday provided more information about the initial roll-out of this program. Click here for the latest.

The federal government on Tuesday announced that it would send point-of-care testing supplies for COVID-19 to all skilled nursing facilities in the country, starting next week, according to Admiral Brett Giroir, Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) and a member of the White House Coronavirus Task Force.

“In order to protect them, we recommend that staff be tested once a week in order to make sure that they don’t bring unintentionally … the virus into the nursing homes,” Giroir said at a press conference in Baton Rouge, La., on Tuesday. “That means four to five million tests per month. And as you know, the turnaround time is getting a bit longer. 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.”

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“With the recent FDA [U.S. Food and Drug Administration] Emergency Use Authorization of the BD Veritor system, combined with the earlier authorization of the Quidel Sofia and Sofia 2 systems, we now have the ability to provide more testing faster,” Giroir said in a release sent to SNN late Tuesday.

The initiative will begin next week with 2,000 nursing homes, ranked by the Centers for Medicare & Medicaid Services (CMS) as being at risk because of community spread of COVID-19. The other SNFs in the U.S. will receive tests in the following weeks.

Each nursing home will receive one diagnostic test instrument and associated tests, and can directly procure additional tests from the respective manufacturers, according to the press release. Nursing homes must have the ability to screen and test residents, while testing staff on a weekly basis or according to state and local health department guidance; the procurement could also allow for testing of nursing home visitors, HHS indicated.

The Quidel Sofia and Sofia 2 Instruments and BD Veritor Plus Systems make use of antigen tests, which detect fragments of proteins on or within the virus by testing samples collected from the nasal cavity via swab, according to HHS.

The tests are “slightly more likely to have a false negative result than molecular PCR [polymerase chain reaction] COVID tests,” HHS noted. The assays are approved for detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (both devices) and nasopharyngeal (Sofia SARS Antigen FIA only) swab specimens, and authorized for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA).

“This is not an acquisition, it is not just writing a check and doing it,” Giroir said at the press conference. “This has been the culmination of about two months of work to develop the technology, to increase the sensitivity of the test, of investments of manufacturing, in regulatory flexibility with the FDA to bring it all together.”

He argued that the testing would save thousands of lives.

Testing for COVID-19 has emerged as a major challenge across the U.S. but nursing homes have faced challenges securing timely results, even though knowing who is infected is a critical component of slowing a COVID-19 outbreak. As SNFs work to cohort patients and prevent asymptomatic workers from coming to work, getting quick results is a priority for operators.

CMS administrator Seema Verma on Tuesday focused on the importance of being able to test workers weekly and isolate patients as part of the path toward to resuming visitations at SNFs; the agency put out a set of guidelines for reopening nursing homes in May that emphasized the importance of securing testing for both residents and staff, including recommending the weekly testing of staff.

“Once we know a facility is free of the coronavirus, it allows visitors to come back in,” she said at the press conference.

CMS had previously emphasized the role that states play in testing strategies for nursing homes, with Verma and Centers for Disease Control & Prevention (CDC) director Robert Redfield telling states at the start of June to take the lead on testing strategies for nursing homes.

Long-term care researchers argued, on the other hand, for the federal government taking a stronger role testing. David Grabowski, a professor of health care policy at Harvard Medical School and a member of the Medicare Payment Advisory Commission (MedPAC), argued that without resources, the CMS guidance would not be much help.

“CMS should be doing two things. First, they should be providing facilities with testing and personal protective equipment. Second, they should be looking to provide education and guidance to facilities on best infection control practices,” Grabowski wrote in an e-mail to SNN on June 2.

The American Health Care Association (AHCA), which represents more than 14,000 nursing homes and long term care facilities across the U.S., emphasized the need for on-site testing with reliable, rapid results in order to keep residents and staff safe in its statement on the testing initiative issued Tuesday.

“The facilities that will receive these machines will be able to conduct on-site testing and receive timely results,” Mark Parkinson, president and CEO of AHCA, said in the statement. “Recently, 87% of nursing homes and assisted living communities said obtaining test results back from lab companies is taking multiple days or more to process … We look forward to working with HHS and Administrator Verma to expand this program and make rapid testing widely available for more providers in the coming months.”

LeadingAge — which represents non-profit senior housing and skilled nursing providers and has been a pointed critic of the federal response to the COVID-19 emergency in nursing homes and senior living — pointed out that numerous questions still remain about this initiative.

“Given the federal government’s many announcements that sounded big but delivered less, we look forward to learning more details about the plans,” Katie Smith Sloan, the president and CEO of LeadingAge said in a statement issued Tuesday. “For example, how will providers be trained? Will supplies be provided on an ongoing basis? Our members will be basing significant infection control decisions based on the tests results, so what guidance will CMS provide regarding reliability?”

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