By Kayla Webster and Gale Scott, Health Payer Specialists
Three government agencies have been tasked with providing guidance by the end of this week on President Biden's at-home testing mandate, and health insurers are eagerly awaiting answers to a myriad of questions the new policy has generated/Getty
As payers await details on Biden administration policies aimed at increasing at-home testing for Covid-19, the unanswered questions pile up.
At a news briefing last week, the president again said payers will have to reimburse their members for the cost of self-administered tests. He also again pledged the federal government will set up a website, by the end of the month, where anyone can order a free at-home test. The administration has ordered 500 million tests for the U.S.’s approximately 332 million residents, according to the White House.
“The ultimate cost of this policy change relies on if there’s any constraint on the volume payers will have to reimburse,” Julie Utterback, senior analyst for Morningstar, told Health Payer Specialist. “There could be potential cost savings for payers if it means less in-clinic testing, unless people start testing more frequently. The devil is in the details.”
In December, Biden tasked the Departments of Health and Human Services, Labor and Treasury to issue guidelines by this Saturday for the mandate for payers to cover at-home testing.
Among the questions yet to be resolved:
- Which at-home tests will payers have to cover? There are rapid at-home antigen tests, such as Abbott’s BinaxNow, which retail for about $12 each and are sold in packages of two tests. But there are also at-home PCR tests, ones administered under the supervision of a clinician on a Zoom call then sent to a lab for processing. They cost about $100.
- When will the government’s 500 million free tests start to be available and which tests will they be? An Abbott spokesman says the company is “working 24/7 to produce the tests” which are made at its plants in Greater Portland, Maine and Guernee, Illinois. Abbott is producing 70 million tests a month, he said, and is the market leader in making the at-home antigen tests.
- Will there be price controls on the tests payers must cover? AHIP raised concerns about potential pharma profiteering weeks ago and Walmart and Kroger have already increased their prices for the BinaxNOW kits by about 10%, NBC news reports.
- Will there be enough tests to meet demand? As of the end of last week the tests were not available at major pharmacy chains or online. Abbott says that situation should soon change.
- Are the at-home tests accurate? A study cited in The New York Times Wednesday found the Abbott BinaxNOW and Quidel QuickVue tests may give more false results than scientists thought originally. A U.S. Food and Drug Administration study last month found the tests are not foolproof. “Early data suggests that antigen tests do detect the Omicron variant [of the Covid-19 virus] but may have reduced sensitivity,” the FDA wrote. Responding to those reports, the Abbott spokesman says “in all cases, our studies confirm that BinaxNOW continues to detect the Omicron variant at comparable viral load levels as all other variants and the original SARS-CoV-2 strain.”
Apart from questions about the design of the federal program there are also unanswered questions about just what it is meant to achieve, says Daniel Rhoads, M.D. a Cleveland Clinic pathologist who also serves as vice chair of the College of American Pathologists microbiology committee.
“It’s good to start with the goal,” of any testing program, Rhoads tells Health Payer Specialist. “Whether its surveillance, screening, or checking to see if you might be infected.”
But in terms of slowing the spread of the pandemic, he’s not sure how effective the Biden plan will be. “It’s reasonable to say this effort should have been made earlier,” Rhoads says. “I believe in testing– it has been my whole career–but there are a lot of ways to perform it and many different uses, it’s not one size fits all,” he adds.
Pressed for details on his testing proposals at the news briefing last week, Biden waved off questions. In his remarks he suggested that people should search online for available at-home tests, or to find testing sites.
The president also said several states are giving away at-home tests. Those include the mail-in Covid-19 PCR tests which are more accurate than the at-home antigen tests. As reported there are at least nine states doing that, including programs in California. But on Thursday Los Angeles County halted its program temporarily, citing an unmanageable backlog of tests. New Jersey is also among those states offering free PCR tests. The program began last month and was popular, but it soon developed test shortages and longer-than-promised turnaround on getting results to those who ordered the PCR kits.
Critics of the testing programs in general have sometimes dismissed the testing effort as “Covid-19 theater” meaning an attempt to dramatize government efforts to quell people’s fears and frustrations even though those efforts are not likely to make a big difference.
Covid testing can be useful but has many limits, scientists have pointed out
Covid testing can be useful but has many limits, scientists have pointed out. Rhoads says a person who tests negative can become positive shortly afterwards. A PCR test result can take days to arrive and by then the person tested can be negative again, particularly if that person is fully vaccinated.
Meanwhile, the pharma companies making the tests have likely enjoyed a windfall.
On Abbott’s website in a Dec. 16 posting the company urged readers to become “serial testers” and buy up dozens of its test kits, saying they made a “perfect gift” for the holidays.
“Serial testing, self-testing frequently on a routine basis though the holidays can be especially useful for those who attend multiple celebrations like work parties, an in-laws’ Christmas, secret Santa functions and even New Year’s parties,” the Abbott posting read in text below a photo of a jolly Santa Claus. A few days later the tests were in short supply, testing sites were overwhelmed, and people were left with no way of knowing whether they had been exposed to the virus even as holiday events picked up–or had to be cancelled.
Facing test shortages even as the virus surges, the government and the test manufacturers now face questions of how many tests to produce and how soon that can happen.
To meet demand manufacturers might have to make more tests than they can sell. The government may have to purchase more that they can use. “Somebody is going to have to take a financial risk,” says Rhoads.