Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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”
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
Proposed 2019 Medicare PFS: The 5 Things Labs Need to Know
From - G2 Compliance Advisor
On July 12, CMS issued the proposed 2019 Medicare physician fee schedule (PFS), with comments scheduled to end on Sept. 10. Takeaways…
New Test Aids Lung Cancer Risk Assessment, But Survival Benefit of Comprehensive Sequencing Questioned
From - Diagnostic Testing & Emerging Technologies
Lung cancer-related testing is receiving a lot of attention, but recent results appear to show mixed benefits for these emerging tests…
AAB and NILA comments allege unlawful implementation of PAMA by CMS
From - National Intelligence Report
The National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB) has formally commented to the…
Kickback Settlement Costs Pennsylvania Hospital $13.1 Million
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Strategic Alliances, Partnerships & Collaborations Analysis – September 2018
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Mergers, Acquisitions & Asset Sales Analysis – September 2018
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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
OIG Monthly Work Plan Review: August 2018
From - G2 Compliance Advisor
Of the 12 new Work Plan items, four have direct implications for labs and billing of lab tests…
The Safety Interpretation
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of injuries that occur on the job…
Hidden Blood in Stool May Indicate Higher All-Cause Death Risk
From - Diagnostic Testing & Emerging Technologies
"Invisible" blood in stool may predict death from a wide range of causes, not just colorectal cancer, according to a study published July 16 in…
