You No Longer Need a Positive COVID Test to Receive Paxlovid

Person holding a positive COVID home rapid test

Basak Gurbuz Derman / Getty Images

Under new rules just issued by the Food and Drug Administration (FDA), you no longer need a positive COVID-19 test to get a prescription for Paxlovid, an antiviral drug that treats the virus.  

The FDA revised the emergency use authorization (EUA) for both Paxlovid and Lagevrio on Wednesday. Fact sheets regarding the updated EUA note a “removal of the requirement for SARS-CoV-2 viral testing.”

What Is Lagevrio?

Content callout: Lagevrio (molnupiravir) is an antiviral drug from Merck used to treat COVID-19. It is less effective than Paxlovid, but may be prescribed to someone if Paxlovid interferes with too many of their medications.

The reason why a test is no longer necessary is unclear. While removing this barrier to prescription may help to make antivirals more accessible to those who need them, experts say giving COVID medication to someone who may not really need it isn’t a great idea.

When Verywell asked for clarification, an FDA spokesperson said “the agency continues to recommend that providers use…viral testing to help diagnose COVID-19.”

Recommend, of course, is different than require.

Some physicians have voiced concern about the change because COVID symptoms can be similar to other viruses, like RSV. Certain viruses may need very different treatment approaches than Paxlovid or Lagevrio in order to prevent them from progressing to something more severe.

“It is impossible to distinguish COVID-19 clinically (without a test) from influenza, RSV, and a myriad of other respiratory viruses,” Amesh Adalja, MD, senior scholar at the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health, told Verywell. “Regardless of the EUA, best medical practice is to actually confirm COVID-19 before prescribing an antiviral. I don’t think the FDA should be dictating to physicians how to practice medicine, so I would advise my colleagues to ignore the change the FDA made and continue to practice sound, evidence-based medicine.”

Others believe the change eliminates an unnecessary barrier to getting people treatment when it’s clear they’re sick.

“Although it will still be at the provider’s discretion, we believe these EUA changes will make providers comfortable with prescribing Paxlovid in cases where a participant self-attests to a positive result but is not able to show proof of that result,” Home Test to Treat program director Andrew Weitz, PhD, told Verywell. Home Test to Treat is a new project from the National Institutes of Health (NIH) aimed at providing exclusively virtual COVID care for free, including rapid tests, telehealth sessions, treatments. “This is helpful because some participants may have tested positive but no longer have their test available; perhaps because it was thrown away.” 

The change may also be hedging against a future lack of tests. Easy access to free COVID tests will end in May when the COVID-19 public health emergency declaration is lifted, taking federal funding along with it.  

“If the delinking of tests and prescriptions had not happened, the uninsured could face cost barriers if and when they can’t find a free rapid home test or a center offering a PCR test when the public health emergency ends or when the federal supply of tests is depleted,” Jen Kates, PhD, senior vice president at nonprofit health policy group the Kaiser Family Foundation, told Verywell.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

By Fran Kritz
Fran Kritz is a freelance healthcare reporter with a focus on consumer health and health policy. She is a former staff writer for Forbes Magazine and U.S. News and World Report.