Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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.
New PLA Codes Billable Under the Medicare CLFS to Be Aware Of
Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.
Federal Court Strikes Down No Surprises Act Dispute Resolution Rules
The rules unfairly favor insurers in out-of-network payment disputes, court says.
