On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.
What key compliance issues must industry stakeholders consider as these provisions are put...more
IRA Provision: The Medicare Drug Price Negotiation Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
On November 5, 2014, the Department of Veterans Affairs (the “VA”) released its interim final rule (“Interim Final Rule”) regarding the Veterans Choice Program (the “Program”), allowing eligible veterans to elect to receive...more
On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more