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Our Take: Insufficient COVID-19 testing persists, despite more tests being available

Apr 20, 2020
The roster of businesses and organizations that have received Emergency Use Authorization (EUA) for their COVID-19 tests continues to grow.

For instance, on Wednesday, Abbott launched its third COVID-19 test, an IgG antibody test that can tell if a person has been previously infected with the coronavirus. Theoretically, testing positive for the antibody could indicate immunity — though in reality that remains to be seen.

Abbott said in a press release that it anticipates shipping close to 1 million of the new tests right away and a total of 4 million by the end of the month. By June, if all goes as planned, the company will be able to produce 20 million of the tests per month.

Unfortunately, even though the FDA is authorizing new diagnostic tests virtually every week, and companies like Abbott are scaling up their manufacturing efforts as quickly as they can, it’s not nearly enough.

Our Take: The consensus among public health officials is that the U.S. needs to dramatically increase its testing capacity (as well as its contact tracing capabilities) before attempts are made to reopen the economy.

We need to have testing capacity of at least 750,000 tests per week, and that’s after there are no more regional outbreaks, according to a recent report co-authored by health experts that include former FDA commissioners Mark McClellan and Scott Gottlieb. In the meantime, Dr. Gottlieb suggested in an interview that we should be testing 3.8 million people per week — essentially every time someone has a doctor’s visit. Economist Paul Romer said capacity would need to reach 22 million tests a day in order to screen the entire U.S. population.

The good news, as we stated earlier, is that more and more tests are becoming available.

Of particular note, the Associated Press reported last Monday that the first saliva test for diagnosing COVID-29, developed by researchers at Rutgers University, has been cleared for use. Paired with a genetic testing service that also was developed at Rutgers, the saliva tests could be another pathway to large-scale testing. Currently, the lab at Rutgers can process 10,000 patient samples daily.

Abbott has already shipped more than 1 million of its first test, a “high throughput” molecular test that received EUA in mid-March. That test is designed for use on an Abbott system that can run up to 470 tests in a 24-hour period. The company has already shipped at least 1 million of those tests to labs and hospitals throughout the country, but MedtechDive reported that more than 90% of them haven’t been used because labs don’t have the resources they need to run Abbott’s high throughput systems. Abbott said the problem lies with the labs’ lack of trained staffing and supplies (i.e., swabs, reagents, and personal protective equipment), not with the company’s systems.

Meanwhile, as an incentive for labs to increase their testing capacity, CMS said last Wednesday that it was raising the reimbursement rate to $100 per test for high-throughput tests like Abbott’s. That’s almost twice the amount the agency is paying for other types of COVID-19 tests.

CMS also issued guidance last week requiring private health plans and employer group health plans to cover COVID-19 testing, including antibody testing, with no out-of-pocket costs to members.

Yet Quest Diagnostics, one of the nation’s largest testing labs, has furloughed more than 4,000 employees, or 9% of its workforce. In an email sent to employees last week, CEO Steve Rusckowski said that even though Quest has performed about 40% of all COVID-19 testing done by commercial labs, it hasn’t been enough to offset decreases in the company’s overall testing volumes. Those volumes declined more than 40% during the last two weeks of March, he said.
Never one to sit on the sidelines, Amazon has started to develop its own testing capacity for employees. The company wrote in a blog post that a diverse team, “from research scientists and program managers to procurement specialists and software engineers” is working on the initiative. Equipment is being assembled to build the first Amazon testing lab, and the company hopes to start testing “small numbers of … front line employees soon.”

“Unfortunately, today we live in a world of scarcity where COVID-19 testing is heavily rationed. … Until we have an effective vaccine available in billions of doses, high-volume testing capacity would be of great help, but getting that done will take collective action by NGOs, companies, and governments,” the Amazon blog post stated.

The bad news? On average, all of the country’s public and commercial labs combined processed fewer than 150,000 tests per day last week, according to the COVID Tracking Project. Although that’s far better than where we were in early March, it’s a far cry from where we need to be.

And maybe that’s where tests like Abbott’s point-of-care test, the company’s second COVID-19 test to be authorized by the FDA, will help turn the tide. That test can be used in doctor’s offices and urgent care clinics and can deliver results in 5 to 13 minutes.

What else you need to know
Altais signed a definitive agreement with Brown & Toland Physicians, under which Brown & Toland’s network of more than 2,700 physicians in the Bay Area will joint Altais’ clinical services unit. Altais is a health care services company that Blue Shield of California launched last year with the goal of “helping doctors focus on patient care that’s sustainably affordable and professionally gratifying.” Brown & Toland will retain its brand and will continue to service all payers, the organizations said in a press release. The transaction, which has been approved by the boards of both organizations, will give Brown & Toland access to additional capital and broader support for physicians to operate independent practices. It is still subject to Brown & Toland shareholder approval and customary regulatory reviews.

Kaiser Permanente, the American Hospital Association, Microsoft, UPS, Merit Solutions, and consulting firm Kearney have launched an initiative called Protecting People Everywhere to match donations of personal protective equipment (PPE) with recipients. Anyone with PPE to donate can use the HealthEquip app to add their PPE to a central database. Hospitals can sign up on the app to request PPE they need. The app matches donated PPE to recipients based on critical need factors to ensure “an unbiased distribution” of the equipment. Details are available at www.health-equip.com.
Apple and Google are partnering on contact tracing technology to stem the spread of COVID-19. Their goal is to use Bluetooth technology to notify people on their smartphones if they’ve had contact with someone who’s infected. People who opt in will be able to report receiving a COVID-19 diagnosis. Then, using extensive data compiled with the aid of anonymous identifier beacons, the system will then alert others who’ve opted in and have been in close contact with the infected person. In a press release, the two tech mammoths said the plan is to roll out the system in two steps. In the first phase, expected to begin next month, users will need to download an app from a public health authority to participate. Eventually, though, the tracing functionality will be built into the underlying operating systems so that anyone using an iPhone or Android phone can participate without downloading a separate app.

More than half of the risk-based ACOs in the Medicare Shared Savings Program (MSSP) are considering dropping out, according to a recent survey by the National Association of ACOs (NAACOS), citing fears they’ll have to pay huge pandemic-related losses. Specifically, 21% said they are “very likely” to leave the MSSP, 14% said they are “likely,” and 21% said they are “somewhat likely.” In all, 77% of the ACOs surveyed said they are “very concerned” about the impact of COVID-19 on their 2020 performance. The survey was conducted online earlier this month. ACOs can quit the program by May 31 without penalty.

Molina Healthcare will not be acquiring NextLevel Health Partners, a Medicaid managed care organization based in Illinois. The insurer entered into a definitive agreement in January to acquire all of NextLevel’s capital stock for an estimated $50 million, but in a filing with the Securities and Exchange Commission last Tuesday Molina said it had terminated the agreement because of “the seller’s stated unwillingness to close pursuant to the terms of the acquisition agreement.” The deal would have increased Molina’s membership by about 50,000.

AstraZeneca and Merck’s Koselugo (selumetinib) gained FDA approval, making it the first treatment ever to be approved for neurofibromatosis type 1 (NF1), a rare, debilitating genetic disorder of the nervous system that typically begins in early childhood and can cause tumors to grow inside the patient’s nerve sheaths. Koselugo, a kinase inhibitor, is approved for patients aged 2 years or older with NF1 who have symptomatic, inoperable plexiform neurofibromas. Citing an AstraZeneca senior executive, FiercePharma reported that the drug’s wholesale acquisition cost will average about $12,500 per month.

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