Prescription Drugs

Office of Inspector General (“OIG”) Advisory Opinion 25-09[1] addresses an inquiry from a company that develops, manufactures and sells medical devices used in emergency stroke treatment and provides commentary

Continue Reading Strict Compliance with Safe Harbor Requirements is Key to Avoiding Anti-Kickback Violations
Medical needle“/ CC0 1.0

On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage

Continue Reading End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

Two landmark cases fraught with False Claim Act (“FCA”) allegations of fraudulent billing for prescription drugs against food and pharmacy chains are making their way from the Seventh Circuit to

Continue Reading Is it Really Fraud? The Supreme Court Will Decide

On the heels of the Supreme Court decision in Xiulu Ruan v. United States, wherein the Supreme Court held that the government must prove beyond a reasonable doubt that

Continue Reading Creation of New Opioid Strike Force, Following Decision in Xiulu Ruan v. US, Signals Investigations of Physicians Will Intensify

In the continued fight against opioid addiction, Pennsylvania enacted a new law, effective November 27, 2019, that requires prescribers in Pennsylvania to implement additional steps prior to treating a patient’s
Continue Reading PA Continues Fight Against Opioid Addiction with Opioid Treatment Agreements

In a severe act, Pennsylvania Gov. Wolf has ordered all health care providers, facilities, manufacturers, distributors and suppliers to report their inventory of personal protective equipment (PPE), certain pharmaceutical drugs
Continue Reading PA Gov. Orders All Health Care Providers to Report Inventory of PPE and Certain Drugs

Electronic Health RecordsBeginning on October 24, 2019, every licensed health care practitioner in Pennsylvania (excluding veterinarians) will be required to electronically prescribe controlled substances (regardless of the dosage) by sending the
Continue Reading Pennsylvania’s Electronic Prescription Requirement for Controlled Substances