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CMS

CLIA Accreditation Market: More Competitive Now?

CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…

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Interesting New Surprises for Lab Leaders

Unexpected and surprising things continue to happen in the clinical laboratory industry. You might consider that to be one unifying theme to the intelligence briefings we present in this issue of The Dark Report.  For example, a…

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Genesis Lab Lawsuit Pursues UnitedHealth Over Unpaid Test Claims

This is an excerpt of a 1,946-word article in the July 6, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outc…

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NJ Lab Sues UnitedHealth Over Unpaid Test Claims

CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outcome if a New Jersey lab company were to prevail in a federal lawsuit it filed against UnitedHealthcare alleging non-payment of COVID-19 test claims. An interesting fact me…

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CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’

CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…

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Understanding Key Parts of New AKS, Stark Law Rules

CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…

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OIG Says Medicare Spending On Testing Increased in 2019

CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…

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New Federal Rule: Non-Physician Providers Can Supervise Testing

SUMMARY: It’s the latest example of how interim rules issued earlier this year in response to the pandemic are being made permanent by the federal Centers for Medicare and Medicaid Services. Issued on Dec. 2, this new final rule allows certain non-physician practitioners—includi…

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One Genetic Test CPT Code Earns ‘Fraudomatic’ Title

CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…

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CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates

CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS).  The first letters were sent on Aug. 12 and le…

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