TAG:
Medicare Administrative Contractor
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…
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 …
What Labs Can Expect from PAMA in 2019
CEO SUMMARY: Attendees at the Executive War College learned that CMS has taken steps to expand the number of hospital labs required to report their private payer lab test price data under the Protecting Access to Medicare Act, but the unbundling of certain test panels could be problematic…
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…
August 7, 2017 Intelligence: Late Breaking Lab News
PAML of Spokane, Washington, was the subject of an unusual public disclosure recently made by Laboratory Corporation of America. The lab company sent a statement to the Spokane Journal of Business stating its plans to make PAML “its primary lab site in the western…
July 17, 2017 Intelligence: Late Breaking Lab News
Here’s an update on Theranos, the troubled lab company that is struggling to stay alive. Once again, reporter John Carreyrou of The Wall Street Journal scooped his peers by reporting that Theranos has listed its corporate offices for lease. For lab companies shopping for …
June 26, 2017 Intelligence: Late Breaking Lab News
Theranos is back in the news again. The Wall Street Journal reported earlier this month that the troubled lab company is close to negotiating a settlement with Walgreens after being sued for $140 million in a breach of contract lawsuit filed by the national pharmacy…
Medicare Demands Force PGx Lab into Bankruptcy
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx …
Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand
CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the…
$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab
CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These devel…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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