FDA

FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]

Compliance Alert

OIG Calls on CMS to Recover Phlebotomy Travel Allowance Overpayments

If your lab bills Medicare for phlebotomy travel allowances, a Medicare Administrative Contractor (MAC) claims audit may be in your future. The threat stems from a new Office of Inspector General … [Read more...]

Reimbursement

Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

In a reminder of why politics and presidential elections matter so much, the Biden administration announced that it’s scrapping a Trump regulation that would have automatically provided initial … [Read more...]

Independent Labs

CMS Clarifies IDTF Billing, Coding and Coverage Rules

In September, the Centers for Medicare & Medicaid Services (CMS) issued new guidance making some important clarifications on Independent Diagnostic Testing Facility (IDTF) billing requirements. … [Read more...]

COVID-19

White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing

Much has changed since the spring when Abbott, LabCorp, Quest and other major COVID-19 testing labs were demobilizing their coronavirus infrastructure and pivoting to normal business. The surge of new … [Read more...]

Billing and Coding

Medicare to Reimburse 6 New CLIA-Waived Tests, Starting Oct. 1

The FDA recently approved a half a dozen assays as CLIA-waived tests that Medicare will reimburse when properly billed and coded by CLIA-certified labs. On Aug. 6, CMS sent out coding instructions to … [Read more...]

Compliance Alert

OSHA Orders Inspectors to Use the Hammer to Enforce New COVID-19 Protocols

On June 21, OSHA issued a new Emergency Temporary Standard (ETS) requiring labs, hospitals and other providers to take extensive measures to protect frontline workers against risk of COVID-19 … [Read more...]

FDA

FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On Aug. 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]

Enforcement Trends

Federal False Claims Act Recoveries Hit 5-Year High

For more than a decade, enforcement of the federal false claims act was a government cash cow. But in recent years, investment returns on the activity actually declined. That trend came to an end last … [Read more...]

Kickbacks

OIG Sheds Light on When Price Reductions Must Meet Discounts Safe Harbor

Labs that offer discounts of any kind to referring physicians run the risk of liability under the Anti-Kickback Statute (AKS) and other federal laws. However, new OIG Advisory Opinion No. 21-06 gives … [Read more...]


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