Nursing homes will be required to have Clinical Laboratory Improvement Amendments (CLIA) waivers to perform COVID-19 point-of-care tests. As a result, the Centers for Medicare & Medicaid Services is working to expedite the review of applications.
“Once a laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number is assigned and the laboratory can immediately begin testing as long as it meets applicable CLIA requirements to ensure the accuracy of patient test results,” the agency told McKnight’s Wednesday.
Most facilities already have the appropriate waiver, federal and association officials said.
Admiral Brett Giroir, assistant secretary of the Department of Health and Human Services, said during a call with nursing homes Wednesday that “Administrator Verma has assured me that the vast majority of nursing homes have a certificate of waiver that point-of-care testing could really be a solution for nursing homes.”
CMS data also indicates that 90% of skilled nursing facilities have CLIA waivers at the lowest level, according to the American Health Care Association/National Center for Assisted Living.
“The two POC tests that CMS is talking about using as part of this effort are allowed in healthcare settings with the lowest CLIA waiver,” AHCA/NCAL said in a statement. The organization also noted that CLIA has three levels.
Cynthia Morton, executive vice president of the National Association for the Support of Long Term Care, noted that some nursing facilities already have a CLIA waiver to perform blood sugar tests.
“Ideally, if an operator already has a CLIA waiver to do this test, they could add the COVID antigen test to their waiver. This could help expedite this for those who already have a CLIA waiver,” Morton told McKnight’s.
‘A turning point’
Meanwhile, the federal government’s plans to distribute point-of-care COVID-19 tests for providers could be “a turning point in the fight against the coronavirus and keeping our nursing home residents safe,” CMS Administrator Seema Verma proclaimed during the call with nursing homes Wednesday.
The goal of the initial distribution of the tests will be to have testing equipment shipped by the end of next week to 1,500 to 2,000 nursing homes. The federal government will prioritize nursing homes in hotspot areas, such as Florida, Texas and Arizona, nearby hospital capacity and those with three or more coronavirus cases for the initial distribution, she said Wednesday evening as officials provided more details about the federal government’s plan.
“That’s a real stretch goal for us but we’re working literally 24/7 to have that happen,” Giroir added.
He also said that while the operation to release point-of-care tests will start relatively modestly, there will be no issues with supplies by the fall.
“The situation is much too urgent to wait a few months so that we can put bows and lipstick on the program. We’re going to build this plane a little bit while we’re flying it,” he said.
The federal government will be supplying providers with either Quidel Sofia and Sofia 2 Instruments or BD Veritor Plus equipment to conduct antigen tests. They will also send about 400 tests to facilities.
Giroir added that officials have also called on the companies to provide special concierge service for nursing homes so they can resupply themselves. The tests for those systems cost under $25, he said.
“We thought this would really kill two birds with one stone by allowing you to have immediate testing capabilities and lower the cost,” Giroir said.