Tag: drugs

Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain […]

Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model  (Part B Demo).  The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in […]

No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”).  Currently, although manufacturers often voluntarily make their product PIs available electronically, they are […]

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain […]

OIG Blesses Tiered Rebate Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently determined that a proposed tiered rebate program would not constitute grounds for sanctions under the federal health care program anti-kickback statute (42 U.S.C. § 1320a-7b(b)(7)), or the civil monetary penalty provision of the Social Security Act […]