TAG:
clia 1988
Why Theranos Is a Big Test for CMS and CLIA
By R. Lewis Dark | From the Volume XXIII No. 8 – June 13, 2016 Issue
OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc.,…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
By Robert Michel | From the Volume XXIII No. 7 – May 23, 2016 Issue
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
Top 10 2014 Biggest News Stories
By Robert Michel | From the Volume XXI No. 17 – December 15, 2014 Issue
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
FDA Notifies Congress that It Will Regulate LDTs
By Joseph Burns | From the Volume XXI No. 11 – August 11, 2014 Issue
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
PAMA’s New Rules Affect Lab Test Pricing, Coverage
By Joseph Burns | From the Volume XXI No. 8 – June 9, 2014 Issue
CEO SUMMARY: For several reasons, the “Protecting Access to Medicare Act” (PAMA) has the potential to be the most disruptive federal legislation directed at the clinical lab industry since the enactment of CLIA 1988. Following passage of the law, some lab industry groups have taken di…
Speakers in New Orleans Offer Important Insights
By Robert Michel | From the Volume XXI No. 7 – May 19, 2014 Issue
CEO SUMMARY: In coming years, there will be multiple challenges and opportunities for the nation’s clinical laboratories and pathology groups. That was one common theme heard from the 90 speakers and panelists at the 19th annual Executive War College on Laboratory and Pathology Manageme…
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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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