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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
CMS to Crack Down on False Billing of COVID-19 Add-on Tests
Some labs took advantage of COVID coverage rules to bill Medicare for medically unnecessary RPPs, allergy, and genetic tests.
New Cancer Diagnostic Tests Stand Out
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
Clinical Laboratory Enforcement Update
Get an overview of trending areas of enforcement and steps labs and pathology practices can consider to protect their businesses.
The Promise of Mobile Photoacoustic Imaging
The flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.
COVID-19, Genetic Tests Wipe Out Medicare Part B Lab Test Savings
Even though PAMA has slashed reimbursement rates for many tests, overall Medicare Part B spending on lab tests continues to increase.
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
Lab Owner Convicted for $463 Million Genetic Testing Fraud
Case is a recent example of the trend toward Medicare schemes involving telehealth, cancer genetic testing, and kickbacks.
Five Key Changes Affecting Labs in the New Spending Bill
While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.
Congress Delays Part B Price Cuts but Nixes Long-Term SALSA Solution
Legislation offering permanent relief from both PAMA price cuts and reporting didn’t make it into the federal spending bill passed Dec. 23.
ACMG Recommends NIPS for Common Fetal Trisomies
The new practice guideline also recommends NIPS to screen for fetal sex chromosome aneuploidy.