Tag: exclusion

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

OIG Advisory Opinion Approves Ostomy Supply Distributor to Provide Free Product Samples

On Monday, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-02 regarding an arrangement in which the Requestor who distributes and sells, but does not manufacture, certain ostomy products (Products) provides a limited number of free Product samples to patients and contracts with a third party (Contractor) to […]

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed […]

OIG Releases Criteria for Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. This guidance replaces guidance previously released by the OIG in 1997. All of […]

21st Century Cures Passes House of Representatives; Ups the Ante for HHS Grant and Contracting Fraud

Earlier today H.R. 6, “21st Century Cures”, passed the House of Representatives by an overwhelming vote of 344-77.  Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent grants and contracting with the Department of Health of Human Services (HHS). According to a summary of the bill […]

OIG Announces New Special Litigation Team

The Office of Inspector General (OIG) announced this week that it will launch a special litigation team devoted solely to Civil Money Penalty (CMP) and Exclusion cases. The announcement was made by representatives of the Administrative and Civil Remedies Branch of the OIG in a presentation at the American Health Lawyer’s Association (AHLA) […]

OIG Releases Advisory Opinion Regarding the Effect of Exclusion

On February 13, 2015, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) posted an advisory opinion regarding the effect of exclusion from Medicare, Medicaid and other federal health care programs. Pursuant to a criminal plea and a civil False Claims Act settlement to resolve allegations of health […]