On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
6/27/2024
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
HRSA ,
Interstate Commerce ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
5/15/2024
/ Affordable Care Act ,
Conflicts of Interest ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Prescription Drugs ,
Section 340B
US District Court for Southern District of Indiana granted plaintiffs Eli Lilly and Company and Lilly USA a preliminary injunction barring HRSA from implementing the final Administrative Dispute Resolution rule that was to...more
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
10/16/2020
/ Administrative Procedure Act ,
AIDS ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Drug Pricing ,
HIV ,
HRSA ,
New Regulations ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B