Tag: pharmaceutical manufacturers

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 […]

Revisions to New Jersey Prescriber Gift Ban Law Proposed – Comments Due October 5th

Revisions to the Limitations on and Obligations Associated with Prescriber Acceptance of Compensation from Pharmaceutical Manufacturers law, N.J.A.C. 13:45J-1.1 et seq. (NJ Gift Ban Law), have been proposed by the New Jersey Attorney General. The NJ Gift Ban Law, originally adopted effective January 16, 2018 and previously discussed on this blog, drew […]

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As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP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The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006.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 […]