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
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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
Just How User-Friendly Are Current Rapid At-Home COVID-19 Test Kits?
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One-Step HCV RNA Tests Help Encourage Hepatitis C Screening
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Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
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New Blood Test Enables Early Cancer Detection in “Low-Risk, but Not No-Risk” Patients
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COVID-19 Testing Drives Increase in Part B Medicare Lab Spending
Here’s a look at the key takeaways from the Dec. 30 OIG report on Medicare Part B spending on lab testing.
Theranos Wunderkind Elizabeth Holmes Convicted on Federal Fraud Charges
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Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
Labs that bill federal health care programs for these tests need to pay especially close attention to ensure compliance.
The Sun Is About to Set on the Controversial Trump Era “SUNSET” Rule
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Omicron Forces FDA to Temporarily Shut Down Inspections
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