Tag: diagnostic laboratories

Use of ‘1099 Marketers’ and Lab Compliance Risk

CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements. David Gee, an experienced lab industry attorney at Davis Wright Tremaine, said lab

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What’s in the cards for ACLA’s PAMA-CMS lawsuit?

This is an excerpt from a 2,580-word article in the January 2, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: This expert analysis shows that laboratories may face an uphill fight

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ACLA Suit Challenges HHS’ Data-Collection Efforts

CEO SUMMARY: In a lawsuit filed last month, the American Clinical Laboratory Association charged that HHS failed to comply with the statutory requirements of the Protecting Access to Medicare Act of 2014 when setting the 2018 Clinical Laboratory Fee Schedule. In the lawsuit, ACLA said HHS disregarded the law’s requirement that all applicable laboratories would

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$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab

CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These developments should be a concern to all labs offering pharmacogenomic testing to Medicare patients.

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