Gold Cards Offer Labs Limited Relief for Prior Auth Woes

By Virchow | From the Volume XXXI, No. 17 – December 16, 2024 Issue

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129,624 Genetic Tests in the United States

By R. Lewis Dark | From the Volume XXXI, No. 16 – November 25, 2024 Issue

REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…

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Federal Prosecution of Lab Test Fraud & Abuse

By R. Lewis Dark | From the Volume XXXI, No. 14 – October 14, 2024 Issue

SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty…

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Hurdles Continue When Labs Request Genetic Test Coverage

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

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September 23, 2024, Intelligence: Late-Breaking Lab News

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

One sign of the financial turmoil associated with the market for genetic tests is the news that all seven independent directors of 23andMe’s board resigned at the same time on Sept. 18. The reason given was that these directors opposed the plan of CEO and co-founder Anne Wojcicki t…

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Lab News Briefs

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

New York Times Reviews DNA Testing Kits for Its Readers It’s a sign of the times when The New York Times considers it useful to conduct and publish a review of DNA ancestry testing kits to guide readers. AncestryDNA of Lehi, Utah, was picked as “the most eff…

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OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’

By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue

CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…

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Stressful Weeks Ahead for Labs Thanks to Z-codes

By R. Lewis Dark | From the Volume XXX, No. 10 – July 10, 2023 Issue

We are not alone in recognizing that UnitedHealthcare’s…

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Alert! Changes to CLIA Accreditation, CLIA Revisions

By R. Lewis Dark | From the Volume XXX No. 2 – January 23, 2023 Issue

MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing statu…

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How Genomic Testing Labs Can Improve Their Relationships with Payers

By Robert Michel | From the Volume XXIX, No. 14 – October 10, 2022 Issue

CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …

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