TAG:

clia 1988

Why Theranos Is a Big Test for CMS and CLIA

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.,…

Read More



Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

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 …

Read More



Top 10 2014 Biggest News Stories

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…

Read More



FDA Notifies Congress that It Will Regulate LDTs

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…

Read More



PAMA’s New Rules Affect Lab Test Pricing, Coverage

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…

Read More



Speakers in New Orleans Offer Important Insights

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…

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.