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
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
High Billing by Labs Continues to Be Trigger for Audits
As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.
What’s New in ‘23 for Laboratory Coding & Billing
Get up to date on annual billing changes and critical developments currently facing laboratory medicine.
OIG Green Lights Free Hospital NP Services for Referring Physicians
A new OIG Advisory Opinion sheds some light on how to properly structure these arrangements in a hospital inpatient setting.
Why Mobile Phlebotomy Companies and Labs Should Be on Alert
Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
Weekly Enforcement Report: 23 People Charged in 2 Big Fraud Schemes
Last week saw the usual False Claims Act and kickback-related charges, with the biggest action involving urine drug testing.
End of Public Health Emergency Won’t End COVID-19 EUAs
FDA will still be able to issue EUAs for COVID-19 tests after May 11.
A Better Test for Early Detection of Multiple Cancers?
A new method of early, multi-cancer detection could prove more effective for non-invasive screening than other emerging options.
