Virus Outbreak Testing Decline

A BinaxNOW rapid COVID-19 test made by Abbott Laboratories, in Tacoma, Wash. 

A $53 million plan to deliver rapid, at-home coronavirus tests to Colorado educators and frontline workers is in collapse, with the company the state hired to partner on the program accusing state officials of bungling the distribution rollout and placing nearly 1.86 million tests in danger of expiring.

The company suspended testing services for the program on Sunday and is in a protracted dispute with state officials.

Polis has said robust testing is a critical policy goal for the state. He pledged last year, early on in the pandemic, an “all-hands on deck” approach to expand testing. That approach has seen some successes, but also a recent setback related to an effort to expand surveillance testing in Colorado nursing homes.

The at-home testing dispute is the second controversy to hit Polis’ testing initiatives this month — and this one involves threats of litigation made outside the view of the public.

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Dr. Patrice Harris, the chief executive officer of Miami-based eMed, in a scathing April 26 letter she sent to Gov. Jared Polis, said the state has not fixed “the unnecessary constraints it has placed on distribution of these tests.” As a result, she warned, the state only has used 7% of the rapid at-home tests it agreed to purchase from eMed.

Other states that partnered with the company have had a much more robust distribution plan, Harris said in the letter, adding that the Colorado Department of Public Health and Environment’s inability to deliver the tests is unique. Ohio and Massachusetts also hired eMed and have successfully generated widespread use, a company representative said in an interview. In contrast, Colorado has relied on a cumbersome and bureaucratic approach that requires those who want the tests to register and then fill out surveys to get them, Harris, a former president of the American Medical Association, said in her letter.

The company’s lawyers say Colorado breached its contract with eMed and will have to pay the full $53 million amount for the tests, even if tests expire, though state officials dispute that the state is on the hook to pay the full amount of the money.

“To date, CDPHE has delivered less than 140,000 of the 2 million tests to Colorado residents, and CDPHE does not have a distribution plan to deliver these tests to Colorado residents before the tests expire,” Harris wrote to Polis, saying he had not responded to two earlier efforts from her seeking a meeting with him to craft a solution.

Harris said 1.86 million of the tests “remain in a warehouse mere months before they expire.” A company official said the test have a remaining shelf-life of eight months.

CDPHE officials, in a prepared statement, said the state shouldn’t be blamed if the tests are unpopular and noted that the state now offers the free test kits to virtually all Coloradans, expanding the reach well beyond the original target of teachers, other school staff and frontline workers. CDPHE officials did not respond to requests for an interview.

Polis hand-delivered tests to a teacher at his home during the initial rollout of the at-home testing program in February to emphasize the tests' importance and drive up usage. He has worked hard to promote the tests and touted them during press conferences, CDPHE said in the statement.

“Despite these efforts, and the state’s due diligence, the demand for the tests is low,” the statement from CDPHE reads.

But Dr. Harris in her letter said state officials are very much to blame for lagging distribution.

“Even in the first weeks of the program, CDPHE’s data demonstrated that its extremely narrow distribution model could only deliver a small fraction of the state’s 2 million tests,” she wrote in her letter to Polis. “The problem is at the foundation of CDPHE’s distribution model: Shipping one individual test kit at a time, after a person completes a multi-day registration process that is individually approved by CDPHE, could never support the distribution of 2 million tests. CDPHE has had data showing these facts but has refused to open distribution channels to deliver the state’s tests before they expire.”

The dispute with eMed follows reports that the state paid nearly $90 million to another firm, San Dimas, Calif.-based Curative Labs, to provide mass screening for coronavirus for Colorado nursing home residents and staff. Nursing home administrators criticized the use of Curative Labs' coronavirus tests as flawed, and in late January, state officials stopped using the tests after federal regulators warned that they were allowing them to be used beyond their limited use authorization.

In January, Colorado also reached a deal with eMed for the at-home testing program, which was primarily aimed at teachers and school staff, frontline workers and other vulnerable populations, according to documents. The contract included a telehealth component through which eMed agreed to coach those taking the at-home tests. The company also agreed to verify and validate the results and pass the results onto state health officials.

“It’s not just about the test,” said eMed’s chief operating officer, Dr. Mitch Morris. "What we do is a full process, and, for whatever reason, the state really never took advantage of that even though they had an agreement to purchase 2 million tests.”

He said additional documents that he couldn’t discuss beyond the contract prompted eMed to purchase 2 million BinaxNOW tests for use in Colorado. “Based on what the governor announced, we purchased 2 million tests and put together an infrastructure, and then it just didn’t happen,” Morris said.

Morris said the company expected the 2 million order for tests was the first of what would be additional shipments for Colorado, with hopes that the partnership would eventually deliver up to 10 million coronavirus tests for use in Colorado.

Michael O’Donnell and Marissa Ronk, Denver lawyers hired by eMed, informed Colorado officials in letters that they believe the state breached its contract with the company. O’Donnell in an interview said the state is on the hook for the full $53 million cost of the test kits. The company on Sunday suspended testing services for Colorado. CDPHE officials in a mass email encouraged people who ordered the test kits to administer them on their own without eMed's telehealth service because "we feel confident you can administer the test yourself."

W. Eric Kuhn, a senior assistant Colorado attorney general, has fired back in a letter to eMed's lawyers, stating that Colorado has not breached the contract, and that the company’s refusal to provide testing services amounts to a breach of the contract.

He said that the state contract with eMed only authorized the purchase of a “maximum” of $53 million in tests. “At no point has CDPHE ordered 2 million tests as you assert,” Kuhn wrote. He continued: “As CDPHE has repeatedly indicated, it has valued eMed as a partner. However, eMed’s tests have been less useful in Colorado than other tests.”

Harris, the company’s CEO, suggested in her letter to Polis other approaches to boost testing in Colorado other than CDPHE’s current system that requires an individual to register for the tests and then requires them to fill out a survey before delivery of the tests. She said the state’s health officials have “either ignored these solutions or rebuffed eMed for inserting itself in distribution management, communicating that eMed has no role in the state’s test distribution of the state’s 2 million tests.”

She suggested delivering the tests to local governments, all school districts in the state and targeted hot spots, such as summer tourism destinations and airports in the state. She also suggested that Colorado officials explore delivering a free test to every Colorado household in the state through a “one click” Amazon ordering partnership.

“In sum, eMed believes that there are numerous viable solutions that would result in distributing and administering Colorado’s tests before they expire, but each solution requires CDPHE to commit to an additional delivery channel very soon,” Harris added.

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