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
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.
Weekly Enforcement Report: Lab Owner Gets Prison Time for UDT Fraud
In last week’s key cases, those involved in UDT fraud schemes face the music, and a doctor is convicted of stealing COVID relief money.
North American Leaders Commit to Better Pandemic Preparedness
The recent Declaration of North America makes updating the current North American Plan for Animal and Pandemic Influenza a priority.
No Surprises Act Payment Disputes Are Getting Out of Hand, CMS Says
Dispute resolution mechanism is being overwhelmed by unexpected case volume and complexity.
Massive Caseload Overwhelming No Surprises Act Payment Dispute Resolution System
According to a recent CMS report, the sheer volume of out-of-network payment disputes is overwhelming the system.
