All posts by Robert A. Paster

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 […]

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 Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory Opinion Rescission

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP failed to fully, completely and accurately disclose all relevant and material facts to the OIG and failed […]

OIG Revokes Patient Assistance Program Advisory Opinion Protection

The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006. Opinion 06-04 had been modified by the OIG on December 23, 2015. Issued to a nonprofit, tax-exempt, charitable patient assistance program that provides aid […]

Pharmaceutical and Biotechnology Industry Representatives File Lawsuit Over Nevada’s Prescription Drug Transparency Bill

On September 1, 2017, Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization (collectively “Plaintiffs”) filed a complaint (the “Lawsuit”) in the United States District Court for the District of Nevada, against Brian Sandoval, in his official capacity as the Governor of the State of Nevada, and Richard Whitley […]