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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Balwani Loses Bid to Bar Incriminating Evidence from Fraud Trial
Even before the trial began, things got off to a rocky start for the ex-Theranos CEO, who faces charges of fraud and wire fraud.
NCI Program Expands Access to Key Diagnostic for Childhood Cancers
A new initiative launched by the National Institutes of Health’s National Cancer Institute (NCI) on March 21 will bring a state-of-the art diagnostic option to children, adolescents, and young adults who have recently been diagnosed with central nervous system...
What Will the Global Clinical Lab Services Market Be Worth in 2026?
Thanks to COVID-19, it’s no longer a secret to the general public just how important diagnostic testing services are to managing infectious disease outbreaks, as well as to many aspects of health care. A report released March 23 shows that the demand for testing...
Is Repeated SARS-CoV-2 Rapid Antigen Testing More Accurate?
While real-time reverse transcriptase–polymerase chain reaction (RT-qPCR) testing is the current gold standard for diagnostic testing for SARS-CoV-2, rapid antigen testing has emerged as an important alternative for screening asymptomatic people. Rapid antigen...
CMS Offers New Guidance on Medicare E-Signature Rules
Failure to comply with Medicare signature and authentication rules is a frequent cause of claims denials. In January, CMS revised its Medicare signature guidelines to incorporate new rules for electronic signatures. Acceptable signatures include handwritten...
Partnership to Accelerate SARS-CoV-2 Variant Identification in the US
On March 23, Thermo Fisher Scientific announced it is partnering with population genomics company Helix, bioinformatics company Rosalind, and the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Initiative to identify SARS-CoV-2 variants...
MedPAC to Congress: Don’t Raise Physician Medicare Pay in 2023
There’s no compelling reason to pay physicians more next year, concludes the 604-page report that the Medicare Payment Assessment Commission (MedPAC) submitted to Congress on March 15. “We expect volume and revenue to return to pre-pandemic levels (or higher) by...
FDA Releases Recommendations for Safe Use of At-Home COVID-19 Tests
On March 18, the U.S. Food and Drug Administration (FDA) released a Safety Communication about the dangers of improperly used FDA authorized at-home COVID-19 tests. The agency also reminded the public that these tests should be safely stored away from children and...
Labs in Court Weekly Roundup
Enforcement actions involving health care fraud were again dominant over the past two weeks, based on information from the U.S. Department of Justice (DOJ) and state agencies. Of the key court cases involving the lab and/or health care industry from March 10-21,...
