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local coverage determination

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

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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Attorney Advises Labs to Track Genetic Test LCDs

CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…

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Payers Continue to Increase Coverage of Liquid Biopsies

SINCE THE FIRST BLOOD-BASED, circulating-tumor DNA (ctDNA) sequencing test for cancer became available in 2014, federal and private payer coverage of these so-called “liquid biopsy” tests has increased substantially. Now, clinical laboratory and pathology directors can expect additional coverage …

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California Lab Company Closes After Negative Medicare Decision

WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test. First, that…

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Medi-Cal to Cut Lab Pay on July 1 by 25% to 30%

CEO SUMMARY: Since 2011, state officials in California have aggressively cut laboratory testing fees for Medi-Cal, the state’s Medicaid program. Now state officials say they will implement a new methodology next month for determining lab testing fees. The new methodology is based…

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Medicare Ends Coverage for Genetic Drug-Sensitivity Tests

CEO SUMMARY: Medicare’s decision to cease covering many pharmacogenomic tests puts as many as 19 million Americans who have genetic variations affecting their response to medications at risk. These medications are commonly prescribed for patients with cardiovascular disease, pain…

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Are Clinical Labs and MACs Ready to Implement ICD-10?

ARE CLINICAL LABORATORIES and pathology groups prepared for ICD-10? Or, perhaps a better question to ask is this: Are Medicare administrative contractors prepared to switch to ICD-10 on October 1? A recent survey of clinical laboratories and pathology groups by McKesson Corporation showed th…

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Medicare Ends Coverage for Some Pharmacogenomic Testing

WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical labor…

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What Labs Need to Do as Payers Audit More Claims

CEO SUMMARY: Attorneys who advise pathologists and clinical laboratories on compliance issues say the number of audits from the government and third-party payers has increased sharply in recent years. In those audits, payers are looking for recoupment of overpayments. A lab’s fai…

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Medicare Special Stain LCD May Hinder Pathology Workflow

CEO SUMMARY: Under a proposed rule for Medicare region J-11, a pathologist will no longer be able to use “reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine H&E.” While the proposed LCD is designed to target a relatively small number…

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