for the Lab Diagnostics industry
We offer four monthly reports, each focused on the industry from a unique angle, covering science & technology, compliance, business, and legislation & regulations.
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MASTER GUIDE TO CLINICAL LAB COMPLIANCE
Navigating stepped-up investigations, audits, & enforcement actions
Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
New Guidance Released for Cervical Cancer Detection
Recently released AACC document covers newly updated screening guidelines as well as information on surveillance and diagnosis.
Lab Business: It’s Back to Basics for LabCorp & Enzo Biochem
Enzo recently announced that it is selling its lab division to LabCorp for $146 million in cash.
Clinical Lab Services Market to Be Worth More than $125.6 Billion by 2030
A recently released report estimates that the US market will grow at a CAGR of 4.2 percent over the next seven years.
Weekly Enforcement Report: Lab Owners Charged in 2 Fraud Schemes
The owners face fraud charges in two different schemes, one involving urine drug testing and one involving COVID-19 testing.
OIG Greenlights Pharma Patient Assistance Arrangement
New Advisory Opinion 23-01 is similar to other arrangements the OIG has approved in the past.
The End of COVID-19 PHE: Practical Implications for Clinical Labs
In this webinar, our expert speakers will share what the end of the COVID-19 PHE will mean for clinical labs and how they can best prepare.
FDA Says It’s Prepared to Impose LDT Regulations
If Congress won’t do it, we will, the FDA says of laboratory developed test reform.
No Surprises Act Controversy Takes Surprising Twist
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.
LDT Reform: If Congress Won’t Do It, We Will, Says FDA
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Labs Should Be Wary of Improper Billing of G0483 Testing
Recent OIG report says Medicare could have saved up to $215.8 million on at-risk payments for G0483 definitive drug tests.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.