Volunteers with the Medical Reserve Corps in Philadelphia administer COVID-19 tests in 2020. (Photo: HHS)

This is an excerpt from Medically Necessary, a health care supply chain newsletterSubscribe here.

The plan: Last week, the White House released an ambitious plan to reduce the spread of COVID-19. Diagnostic testing will play an enormous role in achieving the plan’s goals. 

The plan will require large employers to get workers vaccinated or tested weekly and encourages entertainment venues and schools to require frequent testing. 

It’s difficult to predict how the plan will affect demand for testing or whether manufacturers can produce enough tests to meet the federal government’s goals. The impact will depend on the final details of the policies, responses from business owners and workers and the overall vaccination rate. 

Despite those uncertainties, some experts say the testing ecosystem will probably hold up in the short term and there are steps that could stabilize testing supply over the long term.

The details: Soumi Saha, who oversees supply chain issues related to government policy for the group purchasing organization Premier, said she expects the requirement that employers vaccinate or test all workers to come in the form of an interim rule from the Occupational Safety and Health Administration. 

OSHA hasn’t published any specific language to clarify exactly how this rule would work and Saha said there are a lot of open questions. It’s not clear what type of testing will be required, who will perform the testing and who will pay for it.

“That’s the big, outstanding question. Is that onus on the employer? Is the onus on the administration to set up that type of testing availability?” she told FreightWaves. “A lot [of] that is unknown. We’re awaiting further detail.”

In addition to the requirement that large employers will have to either vaccinate or test workers, the federal government wants to take several additional steps to expand testing. The plan calls for:

  • Directly purchasing and distributing 280 million rapid point-of-care and over-the-counter at-home COVID-19 tests.
  • Sending 25 million free at-home rapid tests to community health centers and food banks.
  • Adding 10,000 pharmacies to the Department of Health and Human Services free testing program.

Background: Last summer, demand for diagnostic testing, along with COVID-19 case numbers, fell sharply. That led some manufacturers to scale back.

Test maker Abbott Laboratories reduced production, closed factories and let go workers starting in May due to falling demand. In August, Medical device company Becton, Dickinson and Co. (BD) reported that excess and obsolete COVID-19 testing inventory cut into profits. 

Where are we now? Currently, manufacturers aren’t saying much about their production capacity or how they expect the White House’s plan to affect demand. 

BD didn’t respond to questions. A representative from Abbott simply said the company is “very focused on production of tests right now.” Device maker Quidel noted it’s still too early to predict the effect of the new White House  plan.    

“We at Quidel are currently reviewing the president’s announced plans and how we can best respond to the challenge for COVID-19 testing,” a spokesperson for the test maker wrote in an email. “We continue to dedicate significant resources to further expand our manufacturing capability as we have been doing now for some time.”

Amy Smith, who monitors COVID-19 testing supplies for the group purchasing organization Vizient, said some antigen tests are currently on allocation, meaning testing companies can’t fulfill all orders. 

However, over the last several weeks, rising case numbers and the more contagious delta variant have pushed manufacturers to increase production once again, according to Smith.

“It’s a different story than what it was three weeks ago,” Smith told FreightWaves. “It really sped up, and today testing is more available, but suppliers are indicating they are on allocation.”

There are other indications that the supply of rapid COVID-19 tests are tight. Walgreens and CVS currently limit the number of at-home COVID-19 tests that customers can purchase online, according to a report in The Wall Street Journal. The CVS website currently limits customers to six at-home tests per order.

The recent White House plan places a big emphasis on rapid, antigen tests. However, Smith said the supply chain for PCR tests — the slower and more accurate molecular tests conducted at a lab — is in better shape. Instruments and reagents needed for PCR testing are more readily available.

In some cases, commercial labs could pick up some of the slack with PCR tests, according to Akiva Faerber, who works on lab, blood and dialysis solutions for Vizient. But they would be slower, less convenient and more expensive. 

“Except for staffing, which they’ll have to work on … the skids are sort of greased for them to accept more tests,” he told FreightWaves.

Overall, Faerber said he believes the testing ecosystem will hold up as the federal government pushes for more aggressive testing.

“For the short term, the best that I can predict is that the manufacturers will hold up. … I don’t think we’re in trouble,” he said. “With flu season kicking in … that’s going to add more pressure. ” 

The impact: Without more detail, any prediction about the impact of the White House’s COVID-19 policy is basically an exercise in crystal ball gazing. But there are few variables that will influence the outcome. 

The White House COVID-19 plan includes a big push to get more Americans vaccinated. If that effort works, then employers may not have to test quite as much. However, Saha said it’s difficult to predict how employers and workers will respond to the policy. 

“This is more of a stick versus a carrot,” she said. “In January, we put together a suite of recommendations to increase vaccination. … We had suggested looking at incentives to employers who have higher than average vaccination rates, for example. We didn’t go as far as suggesting a mandate.”

Mandates have worked in some cases. The food processor Tyson, which has suffered severe COVID-19 outbreaks at meat processing facilities, has vaccinated more than 30,000 workers since announcing a vaccine requirement in August.  

What’s next? Over the long term, one challenge will be maintaining consistent demand for testing even when case numbers drop, according to Ravi Anupindi, a supply chain researcher at Michigan University who has studied strategies for increasing COVID-19 testing.

“It’s one thing for Biden or somebody else to say we need 200 million tests. But those announcements don’t have teeth unless somebody makes a commitment,” Anupindi told FreightWaves. “With that certainty, people can build capacity.

The White House committed to purchasing 280 million rapid tests. The federal government doesn’t track antigen tests, so it’s not totally clear how far that commitment goes. 

Some states do track those tests, which offers a useful but incomplete picture of current demand for antigen testing. (An analysis from the COVID Tracking Project suggests states may be undercounting antigen tests.)

During the first week of September, antigen tests represented about 37% of total tests in Missouri. Last week, antigen tests made up about 41% of total tests in Utah. Antigen tests accounted for about 30% of total tests in Arkansas over the last two weeks.

An average of 1.4 million PCR tests were conducted in the U.S. each day during the first week of September, according to data from the Centers for Disease Control and Prevention

If the few states reporting antigen test data roughly approximate the situation in the U.S. as a whole, then the country could be using somewhere between 600,000 and 930,000 tests each day.

Timeline: While the details still aren’t clear, Saha said she expects testing manufacturers and employers will have some time to adjust.

“They have to provide some time for people to actually get vaccinated,” she said. 

The federal government is giving federal workers 75 days to comply with a vaccine mandate. Saha expects the OSHA rule would have a similar timeline.

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