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NIH Takes COVID-19/Flu Test-to-Treat Program Nationwide


NEW YORK – Following a limited pilot project, the federal government is taking its Home Test to Treat program nationwide, making available free home COVID-19/Flu testing along with telemedicine consultations and antiviral medication as needed.

The effort, a collaboration among the National Institutes of Health, the Administration for Strategic Preparedness and Response, and the Centers for Disease Control and Prevention, aims to gauge public demand for such home-based interventions and to better understand how to deliver them effectively, said Andrew Weitz, program director at the National Institute of Biomedical Imaging and Bioengineering and leader of the program's implementation.

Under the program, individuals who are either uninsured or insured through a federal insurance program like Medicare or Medicaid, can register at the Home Test to Treat website to receive free Pfizer Lucira molecular COVID-19 & Flu Home tests. If a person tests positive for either virus, they can receive a telehealth evaluation provided by telehealth firm eMed and then have antiviral medication mailed to them if needed.

Individuals with commercial insurance are not eligible to receive free Lucira tests but they can obtain free telehealth services and antiviral medicine through the program if they test positive with tests they have obtained outside the program, Weitz said.

He noted that the decision to restrict distribution of free tests to uninsured individuals and those with government-based insurance stemmed from the observation during the program's limited pilot stage that many people were using it to stockpile free tests. Program administrators were concerned that this could make it difficult to get tests to the intended medically underserved populations.

NIH launched the pilot program in January in Berks County, Pennsylvania, and then expanded it to the Atlanta and Houston metro areas over the summer. The program enrolled between 1,000 and 2,000 people during the Berks County phase and has enrolled around 21,600 individuals total to date, roughly 1,700 of whom have reported a positive test result and 1,400 of whom have gotten prescriptions for antiviral medication. Weitz said the program aims to enroll around 100,000 people before its end, which is scheduled for some time this spring.

Weitz said that enrollment levels have largely tracked with COVID-19 levels and the public's interest in the topic.

"Part of what we've learned is that it's really difficult to get people interested in COVID-related things at times when COVID isn't really prevalent," he said.

He added that while COVID wasn't at the forefront of many minds when the project launched in Berks County at the beginning of the year, flu was.

"There was a huge flu surge in January 2023, and we kept getting asked, 'Can you guys do this for flu?'" Weitz said.

At the time, there were no US Food and Drug Administration-authorized home tests for both COVID-19 and flu, but in February, Lucira Health received Emergency Use Authorization for its Lucira COVID-19 & Flu Home Test, a loop-mediated isothermal amplification-based test for detecting RNA from the three viruses. Lucira had announced two days prior to receiving the EUA that it was filing for bankruptcy. In April, Pfizer bought Lucira in a bankruptcy auction for $36.4 million. Pfizer is also the maker of Paxlovid, one of the most commonly used COVID-19 antiviral medications, giving the drugmaker a prominent role in both the "test" and "treat" parts of the program. Tamiflu, the antiviral most commonly used for treating flu, is made by Roche.

One of the program's main goals is reaching and learning how to better reach individuals in medically underserved areas where telehealth programs could have a significant impact in improving access, Weitz said.

"We want to understand, are we actually being effective in reaching people in rural areas, people with more limited access to healthcare? What types of messaging is most effective in reaching those populations?" he said.

Weitz noted that initially the program primarily used online and social media advertising to reach potential participants but found that this was not a very effective approach.

"We made a major pivot and brought in a community engagement team who has years of experience doing enrollment for studies and recruitment for clinical trials with a focus on these types of more underserved populations," he said.

The effort also aims to evaluate whether a home testing and telemedicine approach is able to speed up the time to treatment compared to a traditional care pathway. This could be particularly relevant for flu patients as it is generally recommended people start Tamiflu treatment within 48 hours of the start of symptoms.

Weitz said he and his colleagues are also interested in determining the level of public interest in home-based testing approaches and what aspects of the program users appear to value most.

"Maybe we find that a lot of people are coming for the free tests but never report the results or participate in telehealth. Or maybe people use the telehealth part but then decide they don't want to take the medication after speaking to the provider," he said. "Ultimately, what we want to know is if a program like this is attractive to the public. Is this the type of program that the government could and should continue to offer in the future, not just for COVID but for other types of diseases and conditions?"

Weitz said the program reflects interest across a number of federal government organizations in exploring the potential of telehealth initiatives.

"I think everyone's eyes opened when we saw telehealth grow by a factor of around 40 during the pandemic," he said.

Weitz said, however, that any continuation and/or expansion of the program will contend with the issue of funding, which he noted could be particularly challenging given the rollback of federal COVID-19 programs as the pandemic has wound down.

"The scale of this program is only on the order of tens of thousands," he said. "If we look at how a program like this can provide services to tens of millions of people, the costs balloon."

He suggested, though, that if the project demonstrates demand and utility for such a program, it could spur activity on the part of commercial payors and providers.

"We'll be publishing all of the findings from this, and if it's something that we see there is a lot of demand and interest for and it can speed up the time for people to get treatment and provid[e] benefits, then we could see the commercial sector run with this in the future," he said.