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Fair or unfair, the general perception has been that the White House has been less than fully supportive of COVID-19 testing efforts during the pandemic. On Jan. 21, his first full day in office, President Biden released his plan to deal with the COVID-19 crisis. While vaccination takes center stage, the National Strategy for the COVID-19 Response and Pandemic Preparedness (National Strategy) emphasizes the importance of scaling and expanding testing by doing something the previous administration refused, namely, creating a centralized federal agency to “oversee implementation of a clear, unified approach to testing.” The 7 Objectives The National Strategy is organized around seven objectives: Restoring the trust of the American people; Mounting a safe, effective, and comprehensive vaccination campaign; Mitigating spread of the virus through the establishment of clear public… . . . read more
Getting Republicans and Democrats to agree on anything these days is a Herculean task, even during a global pandemic. One of the rare points of consensus is with regard to the notion that all Americans should be able to get free COVID-19 testing. Accordingly, the mandate that payors pick up the full costs of testing without charging copayments was baked into the bipartisan relief legislation that Congress adopted in response to the crisis last spring. Of course, things didn’t exactly go according to plan. Aided by CMS guidelines, payors were able to exploit an enormous loophole in the coverage policy to avoid paying for a crucial aspect of COVID-19 testing: screening of the asymptomatic. But now CMS has closed that loophole. Here’s a briefing of the new developments and their… . . . read more
Early detection and early intervention have the potential to improve the prospects of recovery and positive outcomes for a broad range of diseases, including coronavirus. And now researchers in Europe believe they have found a method that uses a COVID-19 patient’s blood count to guide treatment and improve case outcomes. Here is an overview: The Diagnostic Challenge COVID-19 spans a wide clinical spectrum ranging from asymptomatic to severe pneumonia with multiple organ failure, and death. Early identification of critical patients requiring more aggressive intervention could go a long way in reducing COVID-19 deaths. But from almost the moment the pandemic began, the paramount objective of COVID-19 diagnostics has been to determine whether a person does or does not have the virus. Collecting information to guide medical treatment and improve clinical… . . . read more
Case: Labs like LabCorp typically enter “pass-through” arrangements with physicians covering patients that lack insurance or are otherwise self-pay. The way it works: The lab bills the physician who ordered the results. The physician then pays the bill and seeks reimbursement from the patient. Thus, the charges “pass through” the physician to the patient. LabCorp contends that this was the case with a New Mexico physician liable for $117,210 of unpaid charges on a pair of accounts. But the physician disagreed, claiming that the accounts were set up solely to facilitate billing for insured patients and that he had never agreed to pay for any services rendered to uninsured patients. So, he asked the federal court to dismiss the claim. Significance: The court refused. Even though the agreement didn’t… . . . read more
Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for home collection of samples. On Nov. 17, the agency broke new ground by clearing Lucira Health’s COVID-19 All-in-One Test Kit, the first all-in-one COVID-19 diagnostic enabling people to test themselves in their own home to receive EUA. On Dec. 15, the agency went one step further by issuing EUA for a full at-home testing kit for the virus that does not require a prescription. The Ellume COVID-19 Home Test The distinction of being the first went to the Ellume COVID-19 Home Test, is a rapid antigen test capable of detecting fragments of the SARS-CoV-2 virus. Although the assay is… . . . read more
For years, Quest Diagnostics has been embroiled in a poignant lawsuit testing the liability of genetic labs for faulty DNA test results. In 2018, Quest struck a decisive blow by getting the South Carolina Supreme Court to toss the wrongful death claims on a technicality, namely, the fact that the case was filed after the statute of limitations had expired. On Nov. 4, the South Carolina federal court wrote the latest and perhaps last chapter in the drama by dismissing the remaining claims against Quest. What Happened Amy Williams was and is a sympathetic plaintiff with a highly compelling story. In 2007, the Myrtle Beach mother’s 2-year-old son Christian began experiencing regular seizures. Suspecting a mutation in the SCN1A gene, doctors sent Christian’s DNA for genetic testing to Athena Diagnostics… . . . read more
