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
Is Your Lab Ready to Comply with the New Equity Standard?
You’ll need a healthcare equity plan to maintain Joint Commission accreditation after Jan. 1.
CMS Dishes Out First Penalties for Hospital Price Transparency Violations
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
Eight New CLIA-Waived Tests Your Lab Staff Need to Know About
CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.
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.
