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
Routine, PreoOp Testing Costlier for Medicare Than Previously Thought
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OIG Work Plan Monthly Review: January 2018
From - G2 Compliance Advisor
Opioid drug-related issues continue to command the lion's share of OIG Work Plan attention, including two of this month's six new items. While none of the new…
Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
From - Laboratory Industry Report
Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of …
Older Adults Undertested, Underdiagnosed with the Flu
From - Diagnostic Testing & Emerging Technologies
Hospitals around the nation are seeing high volumes of patients with the flu this season. A new study, published online Jan. 17 in the Journal of the American Geriatrics Society, shows that…
Innovation: AMP Issues New Guidelines for NGS Pipeline Validation
From - National Intelligence Report
Molecular next-generation sequencing (NGS) tests have spurred tremendous growth in the lab industry. But as often happens with innovation, NGS technology may be…
Case of Month: Judge Takes Back Ruling that Labs Must Independently Verify Medical Necessity
From - National Intelligence Report
Thanks for clearing that up. As if the lab industry doesn't already have enough legal agita to deal with, last June a federal D.C. District Court upheld a…
Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
Venture Capital Investment in Diagnostic Companies Strong in 2017
From - Diagnostic Testing & Emerging Technologies
Venture capital investments in health care innovation reached an all time high in 2017, including in diagnostics/tools (Dx/Tools) companies, according to…
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…
FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy
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