Tag: Office of Inspector General

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 […]

LITIGATION ROUND-UP: SOME RECENT DRUG & DEVICE SETTLEMENTS, INVESTIGATIONS, INQUIRIES

Settlements Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies, promoted its antidepressants for unapproved uses, and misrepresented its drug prices to state Medicaid programs.  The settlement resolved two False Claims Act […]

OIG Releases Proposed Rule re: Beneficiary Inducements and Gainsharing Revisions

The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing.  The 94-page proposed rule is expected to be published tomorrow in the […]

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Earlier this week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled, Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs (Report).  Copayment coupons are offered by pharmaceutical manufacturers in many […]

LITIGATION ROUND-UP

Settlements & Resolutions GlaxoSmithKline (GSK) agreed to pay $105 million to resolve allegations that it illegally marketed its asthma drug Advair and its antidepressants Paxil and Wellbutrin for uses not approved by the US Food and Drug Administration (FDA) in violation of state consumer protection laws.  The multi-state settlement included 44 states […]

Subcommittee on Oversight and Investigations Holds “Medicare Program Integrity: Screening Out Errors, Fraud and Abuse” Hearing

On June 25, 2014, the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse.” During the hearing, subcommittee members heard testimony from administration officials from the Centers for Medicare and Medicaid Services (“CMS”), the Office of Inspector […]

Cooley Client Alert: HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

The following Cooley Client Alert was released today.  The PDF version is available here.    On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (“Supplemental Bulletin”) to […]