TAG:
Centers for Medicare and Medicaid Services
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…
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…
How Private Health Insurers May Respond to FDA LDT Regulation
By Virchow | From the Volume XXXI, No. 8 – June 10, 2024 Issue
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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…
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…
Read the Tea Leaves… FDA Will Require LDT Review
By R. Lewis Dark | From the Volume XXXI, No. 2 – February 5, 2024 Issue
PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…
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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