The Department of Health and Human Services (HHS) announced Monday that it is extending coverage for prescribing or administering point-of-care COVID-19 tests to screen for the illness in congregate settings such as skilled nursing facilities. The move overrules state directives that restrict or ban outright the use of such tests.
The extension of coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) is designed to expand the use of rapid point-of-care antigen tests for COVID-19, assistant secretary for health Admiral Brett Giroir said in the release announcing the guidance.
HHS announced last month that it would send point-of-care antigen test devices and an initial round of tests to every SNF in the U.S. The tests will go to every SNF with a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver, but some states did not allow SNFs to use point-of-care antigen testing, as the nursing home trade group American Health Care Association (AHCA) noted at the end of July.
“Due to the lower sensitivity and specificity of these test devices, not all state public health departments allow for their use, and many have certain requirements in place for using these tests appropriately,” AHCA said in a memo to its members dated August 20.
The new guidance from HHS overrules this, allowing SNFs to use point-of-care antigen tests for COVID-19 even in states that enacted laws otherwise banning the test, a spokeswoman for HHS confirmed to Skilled Nursing News.
“This PREP Act coverage preempts any State or local provision of law or legal requirement that prohibits or effectively prohibits such licensed health-care practitioners from administering or prescribing FDA-authorized COVID-19 tests to symptomatic or asymptomatic individuals at congregate facilities,” the guidance said.
The HHS spokeswoman specifically said the department is aware of state actions taken by Florida, South Carolina and California.
The guidance issued by HHS on Monday also focused on the issue of using the point-of-care tests for individuals without symptoms. Providers had raised concerns about the use of the antigen tests, which are not as reliable as the polymerase chain reaction (PCR) tests for COVID-19, for testing staff and residents without any symptoms of the virus.
The two companies whose devices form the backbone of the testing push, BD and Quidel, have indicated the point-of-care antigen tests should be used to test patients within five days of displaying symptoms, Kaiser Health News reported on August 24.
Still, Giroir emphasized in July that a positive result from the tests is reliable, and the August 31 guidance emphasized that the the PREP Act coverage includes licensed health-care practitioners prescribing or administering Food and Drug Administration (FDA)-authorized COVID-19 tests, including for “off-label,” or outside the original authorization, use to screen asymptomatic people in congregate settings.
The HHS guidance pointed to part of the FDA’s general frequently asked questions, specifically the question on the off-label use of COVID-19 diagnostic tests. The FDA indicated that while there is limited data on the virus level of individuals without symptoms, less sensitive tests can be considered if more sensitive tests are not feasible, or “turnaround times are prolonged.”
“For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times,” the FDA said in an FAQ updated August 24.
The Centers for Medicare & Medicaid Services, for its part, is going to “temporarily exercise enforcement discretion for the duration of of the COVID-19 public health emergency under CLIA for the use of SARS-CoV-2 POC antigen tests on asymptomatic individuals,” according to a CMS/CLIA action.
That particular action was issued on August 28, according to the HHS spokeswoman.
In terms of progress on the point-of-care testing initiative, the government has shipped 10,637 instruments and 2,952,850 tests to 9,894 facilities as of August 31, the HHS spokeswoman told SNN, with 3,570 instruments and 1,226,790 tests to ship out to 3,527 facilities this coming week.
Providers had positive reactions to the guidance overall, though some noted that the variance in guidance from the FDA, the Centers for Disease Control and Prevention (CDC) and CMS is concerning.
“We appreciate HHS taking this step toward helping nursing homes meet the federal testing requirements issued last week,” AHCA said in a statement provided to SNN via email on Monday. “Everything we can do to support long term care providers with resources for testing residents and staff is valuable.”
Dr. Michael Wasserman, president of the California Association of Long-Term Care Medicine, told SNN on Monday that the coverage is a positive step.
“There’s no question, as best we can tell right now, that there’s an opportunity to use point-of-care antigen testing on asymptomatic individuals to decrease the likelihood of someone with the virus entering a facility,” he said. “Even though a single test may not pick up someone with the virus to a high degree of certainty, if we’re testing people regularly, frequently, you will improve your accuracy.”
And in practical terms, any reduction of people entering the SNF setting with the virus is a good thing, Wasserman told SNN. For him, false negatives are less of a concern than false positives, given the existing staffing shortages in skilled nursing.
“While I appreciate that they’re finally letting the clinicians on the front lines, make some decisions and stating that that’s the case, we still could use the full weight of the federal government to help us figure out how effective these tests are,” Wasserman told SNN.
But he also noted the fact that the CDC’s guidance on antigen testing for asymptomatic people doesn’t appear to match how the FDA and CMS are approaching the issue. According to the CDC guidance, “there are limited data to guide the use of rapid antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19.”
That issue was also flagged by Dr. Christian Bergman, an assistant professor at Virginia Commonwealth University who has worked with AMDA – The Society for Post-Acute and Long-Term Care Medicine on antigen testing.
“The recommendations from the CDC – when you look at the interim guidance for antigen testing, [it] makes it fear fairly clear that there is not guidance to strongly suggest using the antigen tests as screening methods,” Bergman told SNN on Monday. “However CMS has said that they want to use these antigen tests for screening asymptomatic individuals, and it’s concerning that the two federal guidelines don’t seem to speak the same language. They don’t seem to correlate with each other.”
However, as Bergman noted, the question for providers becomes whether there are any other options.
“Without any better tests and potentially long turnaround tests for the more invasive nasal pharyngeal PCR-based tests, we are left with trying to tackle how to use this most appropriately,” he told SNN. “I do believe that the PREP Act is a way to allow coverage, financial coverage costs for these tests to be done. So if we decide as a scientific community that we have no better alternative, we have to have assistance financially to be able to test 1.3 million residents across long term care facilities and anywhere between one to 1.5 million staff.”