Pharmacy and health organizations see problems with ‘Test to Treat’ program

By: - March 16, 2022 5:47 am

The Test to Treat program includes two oral antivirals, which came on the market in December. (George Frey | Getty Images)

Citing the need to get time-sensitive antiviral medication to COVID-19-positive people quickly, the Biden administration recently announced it will allow anyone with symptoms to be tested and given the medication in a single trip to a pharmacy – without seeing their medical provider for a prescription.

Much of New Hampshire, however, won’t have access to the new “Test to Treat” initiative because the only qualifying pharmacies here are the six CVS Minute Clinics, according to the Department of Health and Human Services. None are north of Concord. 

Those who can’t get to a Minute Clinic can still get a prescription through their health care provider, as has been the case, and fill it at a pharmacy.

At least for now.

As federal officials finalize the program’s details, pharmacy and health organizations are asking them to rethink key components to expand access and involve primary care providers. Advocates say success would not only give more people access to this new initiative but also transform the way medicine is practiced. 

The Test to Treat program includes two oral antivirals, which came on the market in December, that have shown to be effective at reducing hospitalizations and deaths in people with mild to moderate COVID-19 symptoms. Pfizer’s paxlovid (for adults and children age 12 and up who weigh at least 88 pounds) can reduce those outcomes by 88 percent, and Merck’s molnupiravir (for adults 18 and older) by 30 percent. 

But to work, they must be taken within five days of symptoms. Test to Treat’s one-stop option is intended to reduce delays. 

Health care leaders say they support the concept but not the piece that bypasses primary care providers who best know their patients’ health risks. Both drugs come with considerable considerations for prescribing and follow-up care.

Paxlovid can reduce HIV-1 drug resistance, pose increased risks for people with kidney and liver disease, and carries special considerations for people who’ve been on anti-cancer and anti-coagulant drugs, among others. Molnupiravir is not recommended for pregnant women, and women and men of child-bearing age are advised to use reliable birth control during treatment and after. 

“You’re really not getting a true diagnosis through this, and coming up with a cookie-cutter treatment plan that doesn’t take into account diagnosing the symptoms … can be risky,” said Jim Potter, executive vice president of the New Hampshire Medical Society. ​​“Pharmacists are not trained to do that kind of medical diagnosis and physiological evaluation. They’re just not.”

He added: “We don’t want to throw cold water on it. We just want to make sure it’s done well, and that does include making sure that your primary care provider is involved.”

Pharmacist organizations said they don’t oppose working with primary care providers but do reject arguments they are not sufficiently trained. They want the program expanded to all pharmacies. Otherwise, they say, equitable access is impossible. 

“This leaves out the independent pharmacies and the non-clinic pharmacies – the pharmacies that are available all across the country in all kinds of neighborhoods,” said Dr. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. The group last week asked the Biden Administration to lift the program’s limits on pharmacies with clinics. “And there is no better medical professional who is more qualified to navigate the drug-drug interactions that are a concern.”

Limiting the program to select pharmacies caught his association by surprise. 

In September, the federal Department of Health and Human Services amended federal rules to add pharmacists to the list of medical professionals authorized to prescribe COVID-19 “therapeutics,” including oral medications. In making the announcement, the agency said it anticipated “a need to increase the available pool of providers able to order and administer COVID-19 therapeutics to address rising COVID-19 cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible.”

Test to Treat, however, is a project of the Food and Drug Administration, not Health and Human Services, and it did not include pharmacists. 

“We met with the FDA,” Ganio said. “We talked with them about being able to talk with a patient about their medical history. I felt we had addressed their concerns.”

Ganio noted that emergency care sites are treating people for a wide variety of non-COVID-19 illnesses that need immediate attention without first consulting with the person’s primary care provider. And for many people, those emergency settings are their only medical provider. “There is no difference,” he said. 

Rick Newman, lobbyist for the New Hampshire Independent Pharmacy Association, has talked with a couple of state lawmakers about the possibility of amending a current bill to bring all pharmacists into the program. That seems unlikely at this point in the session, he said, especially given that the details of Test to Treat seem to be developing almost daily. 

His members believe they are as qualified as Minute Clinic providers to prescribe antivirals.  

“We’re not talking about Mr. Gower in ‘It’s a Wonderful Life,’” Newman said. “We’re talking about medical professionals.” He said 10 to 15 years ago there were similar arguments against allowing pharmacists to administer vaccines. 

Both Newman and Ganio said pharmacists are open to including primary care providers, at a minimum by informing them after they’ve prescribed and dispensed the medication.

“There is no part of this process that has to be going it alone,” Ganio said. “It can still be an interprofessional program or process. And in many cases it may have to be. Some of the drug-drug interactions can be quite severe. Some can be managed easily.”

There’s an additional barrier: The Centers for Medicaid and Medicare Services does not require that pharmacists be reimbursed for their time testing for COVID-19, ordering and prescribing the antivirals, and consulting with a patient. (Additionally, the state Insurance Department recommends people who use the Test to Treat program choose a pharmacy covered by their plan and contact their carrier about potential co-pays.) 

Eliminating the access and reimbursement barriers could revolutionize the management of chronic disease, Ganio said, because pharmacies are more easily accessible than health care offices for many. The role pharmacies played in COVID-19 testing and vaccinations are prime examples.

Bruce Berke, lobbyist for the Coalition of New Hampshire Chain Drug Stores, is also watching the development of Test to Treat. His members, which does not include CVS, see the same opportunity. 

“Efforts in these areas will be beneficial for the consumer and our communities,” he said. “The more health care providers, of which pharmacists are certainly a part of, know and treat patients in the most effective and efficient manner, the better for everyone.” 

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Annmarie Timmins
Annmarie Timmins

Senior reporter Annmarie Timmins is a New Hampshire native who covered state government, courts, and social justice issues for the Concord Monitor for 25 years. During her time with the Monitor, she won a Nieman Fellowship to study journalism and mental health courts at Harvard for a year. She has taught journalism at the University of New Hampshire and writing at the Nackey S. Loeb School of Communications.