ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
The Top 10 Clinical Lab Acquisitions of 2023
Seven months into the year, there were already four reported deals valued at over $1 billion in 2023, as many as in all of 2022.
Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Medicare Reimbursement: CMS Proposes to Cut Part B Payments to Physicians
The proposed PFS rule also includes other changes that will affect physician, lab, and other reimbursements in 2024 and beyond.
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Buy or Lease: Seven Things to Consider When You Need a New Instrument
Deciding whether to purchase or lease laboratory instrumentation involves a variety of factors.
Dx Deals: Exact Sciences Makes Big Moves to Maintain Leadership of Cancer DNA Testing Market
Release of second-generation Cologuard test data and recently announced partnerships aim to position company well for the future.
M&A and Strategic Deals: Thermo Fisher, BD, and Quest Use M&A to Advance Post-COVID-19 Strategies
Diagnostics companies that invested heavily in COVID-19 products are relying on M&A transactions to restructure and transition.
