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
Texas Lab Settles Kickback Allegations for $5.9M
Last week saw three key settlements, including a lab accused of paying kickbacks for test referrals and billing for unnecessary drug tests.
DOJ Increases FCA Penalties
The U.S. Department of Justice recently announced inflationary increases to civil monetary penalties under the False Claims Act.
MedPAC Tells Congress Not to Hike Medicare Payments
Current provider pay rates are “adequate,” says influential committee in its recent report to Congress.
FDA to Keep COVID-19 EUA Pipeline Open for Now
U.S. Department of Health and Human Services secretary takes action to ensure continued access to COVID-19 EUA products.
Lab Owner Pleads Guilty to $89 Million Fraud Scheme
Last week saw two key lab-related cases, with the biggest involving a fraud scheme relating to cancer genetic testing.
No Surprises Act Independent Dispute Resolution Process Resumes
HHS orders arbitrators to go back to resolving payment disputes between providers and payors under the No Surprises Act.
Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
New Guidance Released for Cervical Cancer Detection
Recently released AACC document covers newly updated screening guidelines as well as information on surveillance and diagnosis.
Lab Business: It’s Back to Basics for LabCorp & Enzo Biochem
Enzo recently announced that it is selling its lab division to LabCorp for $146 million in cash.
Clinical Lab Services Market to Be Worth More than $125.6 Billion by 2030
A recently released report estimates that the US market will grow at a CAGR of 4.2 percent over the next seven years.
