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
Hospitals Brace for, Seek to Stave Off Medicare Sequestration Cuts
Combined with rising labor costs, COVID-19, and other challenges, stakeholders say the cuts will negatively impact patient care.
Guidance for Healthcare Workers Treating Suspected Cases of Monkeypox
Experts offer advice in a recent commentary article on treating patients who may have monkeypox during the current COVID-19 pandemic.
CMS Issues First Penalties to Hospitals for Price Transparency Violations
Georgia health system hospitals are the first to be penalized for failing to update their websites or reply to agency warning letters.
New Company Formed to Help Improve Access to Diagnostics
The creation of Global Access Diagnostics aims to expand affordable access to quality tests around the world.
OIG: Did Labs Do Enough Non-COVID-19 Testing during Pandemic?
The number of non-COVID-19 tests billed to Medicare during the pandemic has decreased compared to the six-month period before COVID-19.
LabCorp Gets First FDA Greenlight for SARS-CoV-2 Differentiation Test
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Clinical Labs and Owner Charged in Alleged $2 Million UDT Scheme
Three labs, their owner, two lab marketing companies, a fourth lab, and a physician are accused of kickbacks, money laundering, and fraud.
Could AI Reduce CT Scans in Cancer Detection and Assessment?
A new AI method developed by the National Cancer Institute could produce results similar to regular CT scans, but without exposing patients to radiation.
FDA Resumes Pre-Submission Requests for Non-COVID-19 IVD Tests
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
New Laws Seek to Protect Healthcare Workers from Violence
With threats and attacks increasing, Congress has tabled a bill that would impose extra penalties on those seeking to harm healthcare staff.
