TAG:
lab industry
More Medicare Price Cuts Coming in 2019, 2020
How many consecutive 10% and 15% cuts to the prices Medicare pays for clinical laboratory tests can smaller community labs absorb before they are forced to shut their doors and go out of business? This nation is about to…
Walgreens, LabCorp Announce Expansion of PSC Partnership
TWO NATIONAL COMPANIES just signed the lab industry’s largest agreement to put clinical laboratory patient service centers (PSCs) into retail stores. Earlier this month, Walgreens Boots Alliance and Laboratory Corporation of America announced plans to open 600 PSCs i…
ACLA Lawyer Says Judge’s PAMA Ruling Is Narrow
CEO SUMMARY: Many lab professionals were disappointed at the news that a federal judge dismissed the American Clinical Laboratory Association’s arguments in its lawsuit against the federal Department of Health and Human Services (HHS). In an interview, the ACLA’s lead lawyer on the ca…
Two Federal Court Decisions Are Bad News for Labs
Every pathologist and clinical lab administrator should pay attention to two federal court decisions made recently in two different legal cases. One decision is bad news for the entire clinical lab industry. The other is bad news for lab companies that push compliance with federal anti-kickback laws….
Court Dismisses ACLA Claims in PAMA Case
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
Defunct, Oft-Troubled Calloway Labs Hit with $1.4M Federal Judgement
HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for busine…
FDA Issues Response to Draft Legislation to Regulate LDTs
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…
CMS physician fee schedule: Will hospital labs be excluded again from PAMA price reporting?
CEO SUMMARY: Publication of the draft CMS Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to that perennial question: Should hospital lab outreach data be included in a PAMA market study? The federal Centers for Medicare and …
CMS Shows Its Hand in New Draft Rules for 2019
CEO SUMMARY: Publication of the draft Medicare Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to whether hospital lab outreach data should be included in the PAMA market study that the federal Centers for Medicare and Medica…
WSJ Reporter Tells All About Downfall of Troubled Theranos
CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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