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Capitol Correspondence - 04.28.20

National Governors Association Offers Roadmap to COVID Recovery

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As reported by Politico Pro:

“A new road map from the nation’s governors for reopening the economy urges a cautious approach, saying the White House must dramatically ramp up testing and help states bolster other public health measures before social distancing can be safely pulled back.

The plan from the National Governors Association and state health officials suggests a wide-scale reopening of the country isn’t imminent, even as President Donald Trump roots on southern states that are dialing down restrictions despite warnings from health experts.

The 10-point governors’ road map insists there aren’t enough coronavirus tests and said the federal government needs to better distribute testing supplies to the states. The report echoes concerns from health experts that moving too quickly could reignite the spread of the virus in communities and undo the health benefits gained by weeks of social distancing.”

Separate reporting by Politico Pro, copied below, regarding the challenges surrounding testing helps underscore why this is of particular concern for governors.

Commercial labs say they need billions of dollars to expand testing

Vice President Mike Pence and other members of the White House coronavirus task force members argue that the U.S. can double the number of tests it’s performing to 2 million per week by taking full advantage of existing lab capacity. But commercial labs, which perform the vast majority of coronavirus testing, say that doubling won’t be possible without purchasing expensive new equipment, including high-volume testing machines, and training more staff.

The labs have asked Congress for billions to expand their capacity. A coronavirus aid bill, H.R. 266 (116), passed by the Senate on Tuesday includes $25 billion for testing, with much of that going to states, territories and localities that are likely to enlist help from commercial labs to increase the number of people they are screening.

Some of that money might go toward adding more high-volume testing platforms in U.S. labs. Right now the country has relatively few of these systems, including 33 Roche Cobas 8800 machines — which can test up to 2,880 samples daily — and 180 Abbott M2000 machines, which can do 470 tests daily, according to a presentation Monday by White House coronavirus coordinator Deborah Birx.

There are also 18,000 machines that can analyze Abbott’s 15-minute rapid test — each capable of processing 96 tests a day, for a theoretical daily maximum of 1.7 million. But Abbott can only make 50,000 test cartridges per day, although it is working to expand daily production to 65,000.

To increase their capacity, labs “are willing to take on almost any [testing] platform they can get,” said Doug Schenkel, a health care managing director at Cowen.

The supply chain for basic equipment is global — and everyone’s buying

The White House has directed states to compete against each other on the global market for testing supplies, including swabs and chemicals needed to prepare patient samples for analysis — creating a bottleneck that has hindered testing capacity across the country. […]

Some frustrated governors have taken extreme measures to solve the problem. Maryland Gov. Larry Hogan circumvented supply chain issues over the weekend by using his wife’s connections to obtain supplies for 500,000 tests from South Korea.

Reagents, the chemicals used to prepare patient samples for testing, are also scarce, said Mike Fraser, executive director for the Association of State and Territorial Health Officials. Qiagen, one of the largest manufacturers of chemicals used to automate extraction of the virus’ genetic material from patient samples, produces the majority of its stock in Spain and Germany. Although the company also produces some in Maryland, the global nature of its manufacturing makes it harder for the administration to use tools like the Defense Production Act to pump up the reagent supply.

Ohio Gov. Mike DeWine is trying a different approach to the problem: asking the federal government to approve new types of reagents to help expand testing. DeWine said Tuesday on Twitter that he is also working with private companies to obtain more reagent kits.

Other basic materials in short supply nationally include protective gear for workers collecting patient samples and processing tests, Fraser said.

There are many brands of tests and they aren’t interchangeable

There are more than 40 different coronavirus tests on the market — and often, test kits made by one company can’t be analyzed using a machine made by one of their competitors. In other words, a lab that has a Roche machine can’t process patient samples with a Thermo Fisher test kit. So mismatches between available test kits and a lab’s equipment can slow down screening.

HHS testing czar Brett Giroir told reporters Monday that there are supplies to test more than 40 million people ‘in the marketplace’ but acknowledged that number does not paint the full picture.

‘You can have a lot of tests in the market, and those are correct numbers, but if the machines aren’t utilizing them and they’re not organized at that level, then they’re not being utilized to its fullest,’ Giroir said.

Fixing one bottleneck often creates another

Testing supply shortages can feel like a game of whack-a-mole. As labs have expanded their testing capacity, shortages of the swabs and tubes used to collect and transport patient samples have become more pronounced.

And even if those supply problems are fixed, labs say they don’t have enough workers to achieve the level of testing needed to safely reopen the country.

The Trump administration has tried to plug those gaps by allowing the use of different types of swabs and invoking the Defense Production Act to compel an unnamed U.S. company to produce 20 million more swabs each month. The administration also recently doubled reimbursement for commercial labs conducting high-volume testing from around $51 per test to $100 to help make hiring more workers economically feasible.

But those steps alone are unlikely to lead to a significant uptick in coronavirus testing over the next several weeks, according to former FDA Commissioner Scott Gottlieb. Access ‘is still limited by supply chain constraints, like reagents, personal protective equipment for providers, and personnel to run tests,’ he tweeted Sunday.

Coordination between hospitals, labs and government officials is lacking

A lack of coordination across the health care system has prevented the U.S. from reaching its full testing capacity. Academic, hospital, public health and private labs are all testing for coronavirus, but they aren’t necessarily talking to each other — and that has left some labs with capacity to spare.

The commercial labs represented by the American Clinical Laboratory Association analyzed 56,000 samples on Monday, down from a high of 108,000 on April 5. Many of these labs say they’re eager to take on a bigger workload. Quest, one of the largest commercial labs, can perform up to 50,000 tests per day; another, LabCorp, says it can now analyze up to 65,000 samples per day.

And an investigation by Nature found that university labs retrofitted to conduct coronavirus tests still aren’t operating at full capacity because of regulatory and logistical problems — such as the fact that most of these labs aren’t hooked into the health record software used by hospitals.

A government document obtained by POLITICO shows that the federal government is developing a dashboard to track stocks of testing supplies for HHS and public labs. According to the document, the Trump administration is working with the tech company Palantir, co-founded by Silicon Valley billionaire and prominent Trump supporter Peter Thiel, to help with data for the dashboard.”