In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
4/25/2024
/ Arbitration ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Section 340B
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more
11/7/2023
/ Drug Pricing ,
FQHC ,
Health Care Providers ,
Healthcare ,
HRSA ,
Life Sciences ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more
10/30/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
HRSA ,
Life Sciences ,
Medicare ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Outpatient Services ,
Patients ,
Pharmaceutical Industry ,
Registration Requirement ,
Section 340B
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration's (HRSA) underlying enforcement...more
2/9/2023
/ Anti-Discrimination Policies ,
Healthcare ,
HRSA ,
Insurance Industry ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In...more