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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Lab Industry Advisor Subscriptions Include
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
Arrayit President Convicted in Massive Allergy and COVID-19 Testing Scam
Mark Schena was found guilty of defrauding investors, as well as running an illegal kickback and healthcare fraud scheme.
FDA to Issue EUA for Monkeypox Tests
The agency will also allow CLIA labs to use serology and antigen tests without EUA.
FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
Do Those on Medicare Advantage Receive Better Care?
Study shows that those enrolled in Medicare Advantage have lower rates of “low-value care” than those enrolled in traditional Medicare.
Medicare Part B to Cover New CLIA-Waived Tests on Oct. 1
Make sure your lab billing staff is aware of the changes to ensure full reimbursement.
First Diagnostic Test for Long COVID Receives CE-IVD Marking
Based on validation study data, the test offers 90 percent accuracy and is unaffected by the emergence of new COVID-19 variants.
Rebounds in Core Lab Services Offset Declines in COVID-19 Test Revenues
Second quarter diagnostics earnings were down, but not as much as predicted.
New Patient Guidelines Released for Breast Cancer Screening and Diagnosis
The new guidelines offer patients advice on when they should start their screening, and how often they should have it done.
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
Final Surprise Billing Rules Seek to Provide Fairer Price Dispute Resolution
Revised final rule essentially disarms the threat of insurers having the advantage in out-of-network price disputes.