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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Special Report: What Next for COVID-19 Tests?
An overview of what will happen to the COVID-19 tests issued via EUA once the public health emergency ends on May 11.
Weekly Enforcement Update: Inflated Claims Are a Key Theme
Though last week’s cases didn’t involve labs or lab testing, most were FCA-related issues including inflated claims.
Labs Partner with Pharma for New Companion Diagnostics Tests
Specially crafted lab tests speed up adoption of novel drug treatments.
Lab Companies See Mixed Bag of Financial Results in Q4 2022
Q4 2022 financial results released by three key lab companies over the past week mainly included losses, but there were positives as well.
No Routine Lipid Screening for Asymptomatic Children, Says USPSTF
Influential panel cites lack of evidence of tests’ harms and benefits.
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.