Category: Regulatory

HRSA Releases Details and FAQs About New 340B Dispute Resolution System

In Federal, RegulatoryJanuary 12, 2021

The U.S. Health Resources and Services Administration (HRSA) Tuesday afternoon posted a new webpage describing the steps health care providers and drug manufacturers must follow to invoke the 340B program’s new administrative dispute resolution (ADR) process. It simultaneously posted 11 …

340B Providers Blindsided by Bausch Health’s Decision to Drop AmerisourceBergen as Distributor

In Federal, Other Industry, Pharma Industry, RegulatoryJanuary 12, 2021

Tom Mirga

Drug manufacturer Bausch Health blindsided 340B covered entities on New Year’s Eve, announcing that starting the very next day, Jan. 1, more than 200 of its branded products and future branded products would no longer be available through distributor AmerisourceBergen …

Senate Democratic Chairs-in-Waiting Waste No Time Going to Bat for 340B Providers

In Federal, Legislative, Pharma Industry, RegulatoryJanuary 12, 2021

Tom Mirga

The incoming Democratic chairs of two key U.S. Senate committees want the federal agency in charge of the 340B program “to take immediate action to clarify that implementation of a rebate model by [drug] manufacturers would violate a material condition …

Nevada Ryan White Clinics Furious About State ADAP’s 340B Policy Change

In Regulatory, StateJanuary 12, 2021

Tom Mirga

Nevada Ryan White CARES Act grantees enrolled in 340B are strongly protesting a state AIDS Drug Assistance Program (ADAP) policy change that the clinics say will deprive them of 340B savings on drugs that pay for housing, transportation, and

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BREAKING: HHS’s Top Lawyer Says Pharma’s 340B Contract Pharmacy Actions Are at Odds with the Law

In Breaking, Federal, Judicial, RegulatoryDecember 31, 2020

Tom Mirga

The U.S. Health and Human Services Department’s (HHS) top lawyer today rejected drug manufacturers’ legal arguments for either ending or imposing conditions on 340B pricing on covered outpatient drugs shipped to contract pharmacies.

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BREAKING: HHS Says 340B Discounts Apply to Contract Pharmacies

In Breaking, Federal, Judicial, RegulatoryDecember 30, 2020

Tom Mirga

HRSA Releases 340B Insulin Final Rule Over Health Centers’ Strong Objections

In Federal, Regulatory, Trade AssociationDecember 22, 2020

Tom Mirga

White House Clears 340B Insulin Final Rule for Publication

In Federal, RegulatoryDecember 18, 2020

Tom Mirga

340B Report will be available exclusively to paying subscribers starting Jan. 1. Don’t miss out on our Early Bird 20% discount (available until Dec. 31, 2020). We’ve kept 340B Report free for

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