Hurdles Continue When Labs Request Genetic Test Coverage

By Virchow | From the Volume XXXI, No. 13 – September 23, 2024 Issue

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Labs, Payers Don’t Like Prior Authorization for Genetic Tests

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

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July 22, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

Some hospitals failing to comply with the federal price transparency regulation have been fined. The website of CMS.gov lists 15 hospitals and the amount each was fined. On June 6, 2022, the first fines were levied against Northside Hospital of Atlanta ($883,130) and Northsid…

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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Lab’s Innovation Center Encourages Staff Ideas

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and ph…

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Payer Contracts with Labs: Getting the Contract Is Just the Start

By Virchow | From the Volume XXXI, No. 6 – April 29, 2024 Issue

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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CMS Issues AI Guidance for Medicare Advantage

By Mary Van Doren | From the Volume XXXI, No. 3 – February 26, 2024 Issue

CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…

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FDA & CMS Issue Letter, Agree on LDT Oversight

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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Published Data Show Claim Denials on the Rise, But Why?

By Virchow | From the Volume XXXI, No. 2 – February 5, 2024 Issue

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