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
Arrayit President Convicted of Silicon Valley Blood Testing Scam
Mark Schena was convicted of swindling investors and running a $77 million kickback scheme involving COVID-19 and allergy tests.
US Government Suspends Free At-Home COVID-19 Antigen Test Program
Biden administration blames the decision on Congress’ failure to provide the additional funding necessary to keep the program going.
Final Surprise Billing Regulations Cut Insurer Control—Sort Of
It remains far from clear whether the new surprise billing rule goes far enough to fix the problem of insurers having too much power in disputes.
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.
