340B Report Page 3

Feds Oppose Hospitals’ Intervention in Three More Pharma 340B Lawsuits

In Federal, JudicialMarch 30, 2021

The federal government has asked federal district judges in Indianapolis, Delaware, and New Jersey to deny hospital groups’ requests for active roles in drug manufacturers’ Eli Lilly’s, AstraZeneca’s, and Sanofi’s lawsuits against the government over its 340B contract pharmacy requirements. …

340B Entities Keeping Watch on Bills to Create State Drug Affordability Boards

In Regulatory, StateMarch 30, 2021

Ron Shinkman

Nine states are considering legislation to create boards to review prescription drug prices and intervene to lower them if drugs become too expensive or if their prices spike. Although the board’s implications for the 340B program have not been fully …

Q2 340B Registration Period Starts April 1

In Federal, RegulatoryMarch 30, 2021

Tom Mirga

The second of four opportunities this year for covered entities to register themselves, their sites, and their contract pharmacies in the 340B program starts this Thursday, April 1 and ends on Thursday, April 15. New registrants can begin buying discounted …

Origin Biosciences Posts Limited Distribution Notice on 340B Program Site

In Federal, Pharma Industry, RegulatoryMarch 30, 2021

Tom Mirga

The manufacturer of Nulibry, a recently approved, first-of-its-kind injectable treatment for a very rare, often fatal genetic disorder that typically appears soon after birth, has posted details about the limited distribution network for the drug on the U.S. Health Resources …

Women in 340B – March 30th at 3PM ET – Webinar Sponsored by Community Voices for 340B

In UncategorizedMarch 25, 2021

HRSA Takes Step Forward on 340B Dispute Resolution Petitions

In Federal, Judicial, RegulatoryMarch 25, 2021

Tom Mirga

The federal government on Tuesday declared 340B administrative dispute resolution (ADR) petitions by covered entities against drug manufacturers AstraZeneca, Eli Lilly, and Sanofi to be “complete,” a sign that claims against two of the three companies—AstraZeneca and Sanofi—are ready for …

Merck Pitches Its Voluntary 340B Integrity Initiative to Providers as a Better Option than Audits

In Pharma IndustryMarch 25, 2021

Tom Mirga

Drug manufacturer Merck sent letters to 340B covered entities by email on Tuesday to provide background and answer questions about its request that entities voluntarily upload their contract pharmacy claims to a vendor’s software platform so they can be checked …

Feds Oppose Hospitals’ Motion to Intervene in Novo Nordisk’s 340B Lawsuit

In Federal, JudicialMarch 25, 2021

Tom Mirga

The federal government on Monday strongly objected to letting six hospital groups participate as third parties in drug manufacturer Novo Nordisk’s lawsuit challenging the government’s 340B contract pharmacy requirements.

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340B Gets Cameo Role in Senate Hearing on Government Drug Price Negotiation

In Federal, LegislativeMarch 25, 2021

Ron Shinkman

The Senate committee with direct jurisdiction over the 340B program held its first drug pricing hearing of the 117th Congress Tuesday. It held the session amid signs that House Democrats want to add language to let Medicare negotiate drug prices …

340B Dispute Resolution Injunction Is Having Ripple Effects

In Federal, JudicialMarch 23, 2021

Tom Mirga

The federal judge considering drug manufacturer Sanofi’s motion for protection from 340B dispute resolution proceedings asked the company and the federal government last Wednesday to brief her on a different federal judge’s order the day before granting drug company Eli …

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