Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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Laboratory Industry Report
Keeps You Up-to-Date on Lab Business and Competitive Strategy, Market Trends and Opportunities, and M&A and Investment Activity in Today’s Diagnostic Lab Industry
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Articles and Reports
FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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Dx Deals: Blackstone, TPG Take Hologic Private in $18.5 Billion Deal
Hologic has been on the vanguard of developing and distributing tests focusing on women’s health
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FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
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Dx Deals: Labcorp Continues Dealmaking with Incyte Asset Acquisition in Washington State
The majority of Labcorp’s revenue growth in the first quarter came from clinical lab acquisitions
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Why Revenue Cycle Management Systems Fall Behind—and How to Modernize Them
Clinical lab billing teams face an overwhelming number of challenges if revenue cycle strategies fall short
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Dx Deals: Labcorp and BioReference Health Agree on $225m Sale of Some Assets
Labcorp will acquire oncology-related clinical tests services from BioReference’s parent company, OPKO Health
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Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
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FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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Possible Job Description for a Diagnostic Health Consultant
The role at this point is theoretical, but our editors asked AI for help in drafting what the position might entail
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