DOJ DOJ Announces National Rapid Response Strike Force Thomas Sullivan Dec 15, 2020 0 Earlier this year, at the same time the United States Department of Justice (DOJ) announced the largest health care fraud and…
Drug Prices PhRMA Files Motion for Restraining Order and Preliminary Injunction in MFN… Thomas Sullivan Dec 14, 2020 0 On December 10, 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of Community Cancer…
ACCME ACCME Announces New Standards for Integrity and Independence for Accredited… Thomas Sullivan Dec 11, 2020 0 Yesterday, the Accreditation Council for Continuing Medical Education (ACCME) announced new Standards for Integrity and…
Medical Legal Lawsuit Filed Challenging the Legality of the Most Favored Nation Interim… Thomas Sullivan Dec 10, 2020 0 On December 4, 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA) – along with the Association of Community…
Government Agencies HHS Issues Policy Statements and RFI on Rulemaking and Transparency Thomas Sullivan Dec 9, 2020 0 On November 24, 2020, the Department of Health and Human Services (HHS) announced two policy statements and a request for…
Drug Prices PhRMA Files Suit to Stop Drug Importation from Canada Thomas Sullivan Dec 8, 2020 0 On Monday, November 23, 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA), along with the Partnership for…
Drug Prices Patient and Provider Groups Call on Congress to Stop CMS Policy Thomas Sullivan Dec 7, 2020 0 Recently, the All Copays Count Coalition (ACCC) sent a letter to House of Representatives Speaker Nancy Pelosi and Minority Leader…
FDA FDA Announces End of Unapproved Drugs Initiative Thomas Sullivan Dec 4, 2020 0 On Friday, November 20, 2020, the United States Food and Drug Administration (FDA) announced it would end the Unapproved Drugs…
Anti Kickback Final Rules Published on Stark Law and Anti-Kickback Statute Thomas Sullivan Dec 3, 2020 0 Along with the two other rules that we previously wrote about (the MFN rule and the AKS safe harbor rule), on November 20, 2020,…
FDA FDA Proposes Clarifying Intended Use Regulations Thomas Sullivan Dec 2, 2020 0 Earlier this year, the United States Food and Drug Administration (FDA) published a proposed rule that would amend its “intended…