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”
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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
Regular Screening Finds Pancreatic Cancer at Earliest Stage
A recent study shows that the disease was detected sooner in high-risk individuals who underwent screening than those who did not.
Lab Companies Launch New Tests for Monkeypox
Centers for Disease Control and Prevention spearheads US effort to quickly increase lab testing capacity and access.
Prior Authorization and Benefits Verification Automation for Diagnostic Labs
In this Q&A, Tyler Wince of Myndshft discusses the key issues labs face when it comes to benefits and prior authorization, and how technology can help.
OIG Warns Providers to Steer Clear of Telehealth Scams
First Special Fraud Alert in nearly two years cites six red flags of suspect arrangements with telehealth companies.
Mitigating Biotin Interference in Lab Tests
Biotin interference can lead to erroneous lab results in certain IVDs, including some troponin tests.
Diagnostic Lab to Pay Nearly $10 Million to Settle FCA Allegations
BioReference Health LLC and its parent company have agreed to pay $9.85 million to resolve alleged violations of the False Claims Act.
NCCN Recommends Molecular Testing for Pediatric Cancer Treatment
The new guidelines will likely prove highly influential with oncologists and payors.
CDC, Major Laboratory Companies Launch New Tests for Monkeypox
As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.
Lesion Samples Are Best When It Comes to Monkeypox Testing
Recent FDA Safety Communication warns of the potential of false results from other sample types when testing for the monkeypox virus.
GAO to FDA: Create Emergency Powers Policy to Avoid COVID Mistakes
The agency needs a plan on use of EUA authority to get lab tests to market during the next public health emergency, says the GAO.
