Donald Trump Should Lead a Strong Federal Strategy to Improve Testing, Not Abdicate to the States

The Covid-19 curve in New York is slowly flattening but things are precarious. Without significant social distancing and containment, states that haven’t been touched yet, will be. They will have later peaks. Why? No human has natural immunity. We are flattening the curve not stopping it.

There is so much we don’t know about this virus, but at this point it’s safe to say that an invisible spec making its way into your nostril or throat can spread through many unknowing people. Eric Topol’s current best estimate is 40% never know they have it (without testing all of us). That spec, when it finds the right party, may be able to not only destroy lungs, but other organ systems — kidneys, heart, brain and gut.

I talked to a young doctor who has been wrestling with her own Covid-19 today. She describes feeling like her immune system was utterly befuddled at what to do. She cried from pain and confusion for first time since she was a child. (She is almost recovered now.)

If this were the flu, you get symptoms and you stay home. Even if it were deadly, it would be easier to manage. Since it’s not, if we want to open the economy, testing is the only way to get there. Deaths and confirmed case stats are all over the map, which we know is also a function of poor testing.

If having enough testing to contain new outbreaks is one metric that opening up the country is contingent on — and the WH said it is — we’re not ready to open the country. So today I’m looking into “why and what happens next.”

Prior to the Covid-19 outbreak, tests were not built for scale. It takes a lot of labor, supplies, some big machines — but measured in hundreds not thousands per day. If you had your cholesterol taken, you didn’t much care if it took a few days.

The FDA also approved things they thought worked best — the exact best swab with the exact right chemicals that fit the exact right machine was what the FDA approved. If Roche sold the razor it wanted to sell the razor blades (their cartridges and reagents).

We’ve ramped up testing quickly to about 1 million tests per week. And then we stopped increasing. I made some easy phone calls to discover the why:

1. Not understanding and overpromising from the White House
2. Overpromising from the major commercial labs
3. Load balancing (I’ll explain)
4. Limited number of the big machines need to make the tests
5. The uncertain reimbursement from insurers slowing down labs
6. Not allowing interchangeable parts
7. Two negative tests needed after a positive
8. Confusion on ordering — no public way of accessing tests
9. Testing swabs mostly from Italy
10. Some private labs catering to paying customers
11. Some tests are still being exported
12. New demand from the Department of Defense may be about to pull hundreds of thousands of tests
13. Processes to make the tests are labor intensive
14. Access and distribution points not set up + missing ordering process + lack of electronic health record integration
15. Many new tests from the Emergency Use Authorization are of dubious quality
16. Several governors/states haven’t figured out how to buy

The net of all of that is — after sitting down with a someone working on all this through a spreadsheet— if you iron out many these kinks we could produce 3.5 million per week (or so). I believe that’s good news. Because these are fixable issues.

They involve:

• Public design for swab
• Reconsidering swab specificity need
• DPA swabs (in process)
• FDA approving faster machines
• One price reimbursement by law all insurers — no bidding wars
• Interchangeable kits made by many breaking up the monopoly
• Selective repatriation
• Fix load balancing by putting supply lines behind the labs producing most and best tests
• Public clearinghouse for all test ordering with every lab in the country
• Medical records for every doctor all updated for ordering
• Require false negatives public on each test

That’s 3.5 million before we get creative on some of the big bets like; saliva tests, 15-minute tests, and new tests with no reagents.

If you look at those items, who can do them? The states or the federal government? I think only the federal government. And I think they are doing some. But they should be done robustly as part of a strategy in partnership with states — not clearing hurdles in the background. A government who believes in laissez faire policies and doesn’t want accountability will fall short of one that decides to take responsibility and set the strategy.

It’s not as if the states aren’t trying to do this on their own.

• California creating 5–7 hubs with UCSD and UC Davis
• Florida says it will enlist the National Guard to test nursing homes
• Georgia, Massachusetts, and Rhode Island are working with CVS on rapid tests
• Kentucky has a public private partnership with Kroger’s to test 20k people with a 48 hour turnaround
• are working with CVS on rapid tests
• Michigan is offering 13 new testing sites and partnering with Walmart
• Ohio is 3D printing 50k swabs
• Tennessee is creating 15 testing sites
• Texas is working with Walgreen’s on testing sites
• West Virginia ordered all nursing home residents and staff be tested

So governors can and are taking responsibility. But as long as they are bidding up costs on supplies, can’t get reimbursement, have no transparency, and don’t have resources behind best quality and fastest tests, there’s only so much they can do.

In that context, let’s turn to the Paycheck Protection Program: $450 billion, three-fourths for small businesses, $75B for hospitals, $25B for testing. In the end these things get done. They fight before the vote to get what they want, and then they will get to agreement.

But among the major issues is testing. No one I know has even seen the proposed language in the bill. Even the testing industry lobbyists! But one GOP Senator told me that there is a dispute over who is accountable — the states or the Federal Government with the Feds not wanting to own this. And in a perfect federated republic, in a non-crisis with abundant materials and commoditized low cost market where you could order a test on Amazon, I’m sure that could work out.

The bill will very likely get voted on in the Senate in the next couple days and then the House. I’m not sure how the kinks get worked out. And we probably won’t see the language until it’s out. Much will be left to regulations and guidance. But big picture money for testing and contact tracing is a good thing.

I have talked several times about the crisis in the disability community over Covid-19. I want to elaborate if you’ll allow me. Understand many of the deaths we are seeing in nursing homes, and not seeing from home, are people with disabilities. Those with disabilities living at home are also at great risk of being put in a nursing home. The people that care for them every day (largely women of color) are being impacted by Covid-19 and that care keeps them independent.

In nursing homes, neglect and abuse are rampant before infectious diseases are rampant. While many of us worry about Personal Protective Equipment, people with disabilities do too. Along with breathing devices, communication devices, medications, and access to transportation that they depend on.

All of the people at risk must become a priority for Congress. Particularly without testing, we have to protect our most at risk populations — not just so they survive but so they can survive with the life they want.

This story is pulled from my daily COVID-19 updates on Twitter