New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became effective last week. These Regulations provide the rules under which prescribers may receive anything of value from pharmaceutical and biologics manufacturers. ‘Prescribers’ is defined […]

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As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP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 […]

FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies.  By clarifying what is – and what is not – subject to regulation, this set of guidance could create significant opportunities for […]

OIG Releases December Work Plan Items; Focus on Opioid Prescribing Continues

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The December updates include 6 new Work Plan items: Status Update on States’ Efforts on Medicaid-Provider Enrollment. OIG will follow-up on a previous review to determine the extent to […]

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The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006.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 […]

OIG Releases November Work Plan Items; Focus on Opioid Prescribing and Telemedicine

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The November updates include 4 new Work Plan items: Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States. Focusing on the opioid public health […]

White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration, while acknowledging the scope and tragic costs of opioid abuse, falls short of a “national emergency” declaration […]