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
North American Leaders Commit to Better Pandemic Preparedness
The recent Declaration of North America makes updating the current North American Plan for Animal and Pandemic Influenza a priority.
No Surprises Act Payment Disputes Are Getting Out of Hand, CMS Says
Dispute resolution mechanism is being overwhelmed by unexpected case volume and complexity.
Weekly Enforcement Report: A Biotech Outlier
While most recent cases were the usual FCA and kickback-related issues, one involved the mischarging of federal grants by two biotech companies and their co-founder.
Tackling the Challenges of Early Cancer Detection
DNA sequencing technologies may revolutionize the early detection and prevention of the disease.
Hopes for Permanent PAMA Relief Dashed
Though the federal spending bill passed at the end of December offers another year’s reprieve from PAMA price cuts, SALSA was not included.
The 5 Most Significant Lab Company M&A Deals of 2022
Merger and acquisition deal volume and value were down last year, but deal impact was not.
Compliance Alert: Revised Medicare Part B Travel Allowance Rules
What labs need to know to maximize travel allowance reimbursements.
Eight New CLIA-Waived Tests Recognized by CMS
Labs will be able to bill their MACs for the newly recognized tests starting April 1, 2023.
Weekly Enforcement Report: Plenty of Kickbacks
Last week’s cases saw a major false claims-related settlement, as well as many kickback-related schemes.
New Medicare Part B Lab Specimen Collection Fee Rules Take Effect Jan. 1
What labs need to know to maximize specimen collection fee reimbursements.
