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Case: Former Theranos founder Elizabeth Holmes and former president Ramesh “Sunny” Balwani are facing federal criminal charges for wire fraud and conspiracy. But Balwani’s trial isn’t scheduled to start until Holmes’ trial ends. As a result, Balwani invoked his Fifth Amendment right against self-incrimination to avoid having to testify as a defense witness for Holmes. And since Balwani wasn’t available, Holmes’ lawyers asked the court to admit the statements he made to the US Securities Exchange Commission (SEC) about his role in the Theranos scheme during a deposition in 2017. The California federal court refused the request. Significance: The denial is based on a technical law governing when out-of-court statements made by a witness who’s not available to testify in a federal trial can be used as evidence in the… . . . read more
By Rachel Muenz For those who haven’t yet heard the news, we are pleased to welcome G2 Intelligence to LabX Media Group (LMG), a leading worldwide science publishing company that acquired G2 from Plain Language Media at the close of 2021. Though still early in the transition process, we’re already working hard to continue providing the great content G2 readers are familiar with as well as new and enhanced offerings for both paid and unpaid subscribers. Subscribers to G2’s Lab & Pathology Insider e-newsletters will note a change starting with our Jan. 21 Weekly Wrap Up edition as we unveil a new design, and subscribers to our National Lab Reporter, Diagnostic Testing & Emerging Technologies, Lab Compliance Advisor, and Laboratory Industry Report monthly briefings will also get a new design… . . . read more
Perhaps the biggest story in COVID-19 diagnostics in 2021 has been the emergence of rapid, point-of-care and at-home tests for use in screening asymptomatic populations. While test producers, policy makers and community health officials will continue to prioritize these tests in the months ahead, the modality of rapid COVID-19 testing is already beginning to evolve. Next year at this time, we may conclude that 2022 was the year that COVID-19 testing advanced beyond swabs to breathalyzers. The Rapid Testing Challenge Most of the current rapid assays on the market rely on antigen secreted by antibodies the body produces to fight SARS-CoV-2 in order to detect the virus. Serology tests detect SARS-CoV-2 antibodies directly. While suitable for screening purposes, antibody and antigen testing is relatively lacking in sensitivity and accuracy. The… . . . read more
What would you do if you discovered that your lab inadvertently received Medicare payments to which it wasn’t entitled? Almost as a reflex, the answer to that question should involve consideration of whether to seek more lenient treatment under the Provider Self-Disclosure Protocol (SDP). Just be aware that on Nov. 8, the OIG revised the SDP, which now has a new name, the Health Care Fraud Self-Disclosure Protocol. What the SDP Does First published in 1998, the SDP lays out a framework and process for labs and other providers to voluntarily disclose and resolve self-discovered overpayments, improper Anti-Kickback Statute (AKS) violations and other acts of potential fraud involving federal government health programs. According to the OIG, “self-disclosure gives persons the opportunity to avoid the costs and disruptions associated with a… . . . read more
Case: A pair of Texas physicians have agreed to pay $3.9 million to settle claims of billing Medicare, Medicaid and TRICARE for urine drug tests that they knew weren’t medically necessary out of their now defunct in-house pain clinic lab. The former lab employee who brought the whistleblower claim that got this case started will receive a share of $618,000. Significance: The feds claim that the physicians drafted the testing protocols that resulted in the performance of unnecessary tests knowing that the clinic needed the revenue from the tests to remain profitable. Even without whistleblower intervention, there’s a pretty good chance that the excessive number of urine drug tests generated by the clinic would have been spotted by the enforcement establishment’s radar [United States ex rel. Nuessner, et al. v…. . . . read more
Laboratories and health care providers should not use cycle threshold (CT) values to measure the performance of polymerase chain reaction (PCR) tests for SARS-CoV-2. That was the advice of the American Association of Clinical Chemistry (AACC) in a public statement issued on July 7. And the results of a new study reinforce that the AACC’s recommendation is a sound one. Use of CT Value for Managing COVID-19 Patients According to the Clinical and Laboratory Standards Institute (CLSI), the CT value is the “number of cycles needed for an amplicon to become detectable above background.” Stated differently, the CT value is the lowest PCR cycle number at which the fluorescent probe signal for the amplified target sequence is greater than the minimal detection level determined during validation by the user. Lower… . . . read more
