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CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from the market. Also, the FDA says 45 …
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail Read More »
CEO SUMMARY: Under new federal laws, health insurers are required to pay for testing for the novel coronavirus without cost-sharing, prior authorization, or medical management limits, but insurers are questioning these COVID-19 lab test bills and denying many of the claims, a healthcare attorney said. Payers are challenging the medical necessity of COVID-19 tests, such as for patients needing surgery and …
Health Insurers Push Back On COVID-19 Test Claims Read More »
This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun …
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs Read More »
It is easy to say that the current COVID-19 pandemic is a global event without precedent in human history. After all, what other event has caused airline travel to drop by 95%, ended all professional and amateur sports events worldwide, shuttered Broadway theaters and movie cinemas, closed all non-essential businesses, and required nearly all citizens to “shelter in place”? …
CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being missed by the national news media is the steady deterioration of the finances of the clinical laboratory organizations that are …
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs Read More »
CEO SUMMARY: When it announced its new antibody test for the novel coronavirus SARS-CoV-2 on May 3, Roche Holdings explained that its sensitivity level after 14 days was 100%, which is an important point to understand about the test. When assessing Roche’s claims, two experts agreed that the test performs exceptionally well. Abbott Laboratories also reported high performance levels for its …
ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March. That’s when patients stopped visiting their doctors and …
CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the lack of oversight under the March 16 rules, the market was flooded with tests, including some …
CLINICAL LABORATORIES have a new revenue-generating opportunity, as some states relax stay-at-home rules: Many employers are likely to seek COVID-19 screening tests for employees returning to work to detect the presence of the new coronavirus. This new source of lab specimens and revenue gives clinical labs an opportunity to replace some revenue lost since early March. That is when routine daily specimen volume began to …
New Lab Revenue Source: COVID-19 Worker Screening Read More »
JUST WEEKS AFTER THE FIRST CASES OF SARS-CoV-2 appeared in the United States, federal prosecutors filed criminal charges in a COVID-19 lab test fraud scheme. Erik Santos, 49, of Braselton, Ga., was charged with conspiracy to defraud federal and private healthcare programs by submitting fraudulent testing claims for COVID-19 and genetic cancer screenings. This may be a sign that federal healthcare investigators will …
DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests Read More »
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