Category: Regulatory

Health Centers File 340B Dispute Resolution Petitions Against Drug Manufacturers

In Federal, Judicial, Pharma Industry, RegulatoryJanuary 14, 2021

The National Association of Community Health Centers (NACHC) last night on its members’ behalf asked a new federal 340B program administrative dispute resolution (ADR) panel to order drug manufacturers Eli Lilly and Co., Sanofi, and AstraZeneca to lift all “qualifications, …

Nevada ADAP Postpones Controversial 340B Policy Change

In Regulatory, StateJanuary 14, 2021

Tom Mirga

Nevada’s AIDS Drug Assistance Program (ADAP) on Tuesday postponed “through April 1, 2021, if not longer,” a 340B program policy change strongly opposed by the state’s Ryan White CARES Act grantees. The state health department’s Division of Public and Behavioral …

AstraZeneca, Lilly, and Sanofi Sue HHS to Block Requirement To Give 340B Discounts To Contract Pharmacies

In Federal, Judicial, Pharma Industry, RegulatoryJanuary 13, 2021

Tom Mirga

In a major escalation of the fight over 340B contract pharmacy, drug manufacturer AstraZeneca late yesterday asked a federal court to declare that it “is not required to offer 340B discounts to contract pharmacies.”

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

In Federal, RegulatoryJanuary 12, 2021

Tom Mirga

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.