Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
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,...
Fraud Trial of Theranos CEO Is Back on Track
After several delays, the trial of former Theranos CEO Ramesh "Sunny" Balwani on charges of fraud and wire fraud resumes today. The prosecution evidence includes records showing that Theranos voided lab test results to cure CLIA deficiencies cited in January 2016....
MRI Innovation Makes Cancerous Tissue Light Up and Easier to See
A new form of magnetic resonance imaging (MRI) that makes cancerous tissue glow in medical images could help doctors more accurately detect and track the progression of cancer over time. The innovation, developed by researchers at the University of Waterloo,...
