Category: Compliance

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 […]

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]

OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]

CMS Requests Information Regarding The Stark Law’s Potential Barriers to Coordinated Care

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a Request for Information (“RFI”) in the Federal Register regarding section 1877 of the Social Security Act, also known as the “physician self-referral law” or the “Stark Law”. The Stark Law is a strict liability statute that: […]

OIG Advisory Opinion Permits Limited Provision of Free Telemedicine Hardware and Services

On May 31, 2018, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-03 regarding an arrangement in which a not-for-profit Federally qualified health center look-alike (Provider) would provide, at no charge, certain information technology-related equipment and services to a County Department of Health health clinic (County Clinic) for […]

Two Enacted State Laws Permit Truthful Off-Label Promotion

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]

GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and integrity agreements (collectively, “Agreements”) entered into by the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”) with entities subject to HHS-OIG’s permissive exclusion authority. The […]