Category: Federal

Lilly Asks Court to Shield it From “Crippling” 340B Sanctions

January 14, 2021 Tom Mirga, Editor at Large Views

Drug manufacturer Eli Lilly and Co. told a court this week that HHS has placed it in the "untenable position of offering 340B discounts that are not required by the statute or else facing crippling financial sanctions." | Source: Shutterstock

340B program stakeholders are still digesting drug manufacturers AstraZeneca, Eli Lilly and Co., and Sanofi’s Jan. 12 lawsuits to block federal sanctions over their decisions to stop or impose conditions on 340B discounts on drugs dispensed by contract pharmacies.

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

January 13, 2021 Tom Mirga, Editor at Large Views

AstraZeneca, Eli Lilly and Co., and Sanofi sued HHS in defense of their 340B contract actions just hours before covered entities could begin challenging those actions in a new 340B administrative dispute resolution process. | Source: Shutterstock

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.”

As we went to press, we

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

January 12, 2021 Tom Mirga, Editor at Large Views

The U.S. Health Resources and Services Administration (HRSA) headquarters building in Rockville, Md.

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

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

January 12, 2021 Tom Mirga, Editor at Large Views

340B covered entities are scrambling to respond to the fallout from Bausch Health's surprise announcement that it ended its relationship with AmerisourceBergen to distribute its 340B-priced branded products. | Source: Shutterstock

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

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

January 12, 2021 Tom Mirga, Editor at Large Views

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

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