Where Is The CIA? – Recent Pharmaceutical and Hospital False Claims Act Settlements Raise The Question Of Whether A Presumption Against Corporate Integrity Agreements Exists For Certain Categories of Conduct

New Drug Pricing Settlement In the most recent of a long line of False Claims Act (FCA) whistleblower settlements involving allegations of shenanigans with government price reporting metrics, late last week Dava Pharmaceuticals, Inc. agreed to pay the United States $11 million to settle claims that it misreported …

[Read more...]

Top 10 Lessons From The Bradford Regional Case

If you have not done so already, you should read the court’s opinion in United States ex rel. Singh v. Bradford Regional Medical Center, No. 04-186 (W.D. Pa. Nov. 10, 2010). The case examined an arrangement between Bradford Regional Medical Center (Hospital) and Drs. Vaccaro and Saleh and their practice entity …

[Read more...]

OIG Uses New Exception to Beneficiary Inducement Prohibition

In its first Advisory Opinion of 2011, the Office of Inspector General (OIG) used its discretion and applied the general standards of a new exception to the federal Civil Monetary Penalties (CMP) law when approving a hospital system’s program to waive copayments and deductibles and provide free lodging and …

[Read more...]

Medical Device Manufacturer Exactech Enters DPA & Director of Sales Pleads Guilty

Last month, Florida-based Exactech, Inc., entered into a one-year deferred prosecution agreement (DPA) with the Department of Justice to resolve allegations that it paid kickbacks to orthopaedic surgeons in violation of the federal Anti-Kickback Statute. Under the DPA, a government-appointed monitor will review …

[Read more...]

Physician Fraud and Abuse Guidelines: Starting Young

According to an Office of Inspector General (OIG) study, less than half of all U.S. medical schools provide training on Medicare and Medicaid fraud and abuse laws. Further, the OIG study found that only two-thirds of residency and fellowship programs reported providing their residents or fellows with any …

[Read more...]

OIG Okays Charitable Contribution Program To Encourage Physicians to Meet with Drug and Device Manufacturers

In a new twist on pay to play, the Office of Inspector General of the Department of Health and Human Services (“OIG”) has concluded that a charitable contribution program designed to encourage physicians and other health care providers to meet with drug and device manufacturer representatives does not violate …

[Read more...]