TAG:
lab risk & compliance
CAP Introduces Features to Aid CLIA Inspections
CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospit…
MedPAC Reports to Congress on Issues in Lab Test Price Survey
IN THE HALLS OF CONGRESS, A GOOD NEWS/BAD NEWS STORY is unfolding around the multi-year cuts to the prices Medicare pays for clinical laboratory tests. First the good news. In its latest semi-annual report to Congress, the Medicare Payment …
Comment Period Closing on Federal Surprise Billing Rule
PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….
Insurers Get Aggressive with Years-Old Audits
CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…
CLIA Accreditation Market: More Competitive Now?
CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…
CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’
CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…
Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit
IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…
Ransomware Attackers Target Health Providers
CEO SUMMARY: Both malware and ransomware have been around for a number of years. But the attacks launched today against healthcare providers are more sophisticated and better at achieving the total shutdown of targeted hospitals, doctor groups, and clinical laboratories. For this re…
Federal Judges: Paying Commissions Violates AKS
CEO SUMMARY: Health Diagnostic Laboratory and its marketing partner, BlueWave Consultants, were back in the news recently after a three-judge panel of a federal appeals court denied a challenge from the former principals of those companies to an earlier court ruli…
Restitution and Guilty Plea in Two Lab Fraud Cases
CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…
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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