The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
8/5/2025
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
HRSA ,
Johnson & Johnson ,
Manufacturers ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
New Guidance ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Pilot Programs ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more
12/31/2024
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Section 340B
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
As detailed further in our article on the current state of the 340B Program and what to expect in 2023, a growing list of manufacturers have taken the step of significantly restricting 340B pricing for fills completed by...more
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more