Final FDA Guidance on RUO, IUO Products Raises Compliance Concerns for Labs

Laboratories that market or sell laboratory-developed tests (LDTs) are facing new compliance challenges because of the Nov. 25 issuance of a final guidance document from the Food and Drug … [Read more...]

CareFusion Settles False Claims, Kickback Charges

CareFusion will pay $40.1 million under a settlement agreement with the United States and 31 individual states to resolve a whistleblower lawsuit alleging violations of state and federal False Claims … [Read more...]

When Should Labs Fight Overpayment Determinations Based on Extrapolation of Claims?

A recent district court decision on overpayments based on extrapolation of claims contains important lessons for health care providers, including clinical laboratories, on how and when to challenge … [Read more...]

Court Dismisses Lawsuit Against Millennium Laboratories; Compliance Officers Take Heed

A Massachusetts district court filed an order on Jan. 28 dismissing, for the final time, a 5-year-old whistleblower lawsuit against Millennium Laboratories (ML) in which an employee of a competitor, … [Read more...]

CMS Ignores Uniform Billing Committee, Creating Compliance Risks for Hospital Labs

In spite of concerns expressed by members of the National Uniform Billing Committee (NUBC) in a Jan. 21 letter to the Centers for Medicare and Medicaid Services (CMS), the agency went forward with its … [Read more...]

Government Health Care Budgets Include Increased Funding to Fight Fraud

Mandatory funding to fight health care fraud in the administration’s 2015 budget proposal is evidence that it remains a top priority among government agencies going forward, and compliance officers … [Read more...]

Compliance Perspective of the Doc Fix Law’s Section On Laboratory Payment Reform

Clinical laboratories may face substantial penalties for failure to submit complete and accurate data in the latest government move to revise the Clinical Laboratory Fee Schedule (CLFS). Section 216 … [Read more...]

OIG Again Demonstrates Its Prowess in Bringing Fraudsters to Justice

Government agencies this month announced a nationwide takedown by Medicare Fraud Strike Force operations that involved six cities and charges against 90 individuals for their alleged participation in … [Read more...]

LabMD vs. FTC Trial Delayed Amid Dramatic Twists and Turns

The highly anticipated trial of LabMD versus the Federal Trade Commission (FTC) has been interrupted by a related investigation by the House Committee on Oversight and Government Reform. The … [Read more...]

G2 Compliance Perspectives: Implications for Clinical Laboratories In the OIG’s Proposal to Expand CMP Authority

There are potentially significant implications for the clinical laboratory industry in a proposed rule published in the Federal Register on May 12 that amends and expands the authority of the Office … [Read more...]