Month: March 2021

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For-Profit Hospitals Make Major Pitch for Keeping Medicare’s 340B Hospital Cuts

In Breaking, Federal, Judicial, RegulatoryMarch 31, 2021144 Views

United Therapeutics says that, starting May 13, entities must upload their 340B contract pharmacy claims data to its vendor 340B ESP twice monthly to "be eligible to place Bill To / Ship To replenishment orders for United Therapeutics products dispensed through a contract pharmacy.”

The association for U.S. for-profit hospitals submitted a brief to the U.S. Supreme Court and released a study today arguing against reversing the nearly 30 percent cut in what Medicare pays many public and private nonprofit hospitals for

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

In Federal, JudicialMarch 30, 2021133 Views

Tom Mirga

The federal government has asked three more federal judges to not let hospital groups intervene in drug manufacturers' lawsuits challenging HHS's 340B contract pharmacy requirements. | Shutterstock

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

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

In Regulatory, StateMarch 30, 2021161 Views

Ron Shinkman

The Colorado General Assembly is one of nine state legislatures considering bills to create state drug affordability boards.

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 bills’ implications for the 340B program have not

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Q2 340B Registration Period Starts April 1

In Federal, RegulatoryMarch 30, 202168 Views

Tom Mirga

A screen capture from HRSA's user guide for providers wishing to register to participate in the 340B program.

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

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Origin Biosciences Posts Limited Distribution Notice on 340B Program Site

In Federal, Pharma Industry, RegulatoryMarch 30, 2021118 Views

Tom Mirga

The maker of Nulibry, a new, first-of-its-kind drug whose supply is limited, notified providers about how they can buy it at its 340B price.

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

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HRSA Takes Step Forward on 340B Dispute Resolution Petitions

In Federal, Judicial, RegulatoryMarch 25, 2021133 Views

Tom Mirga

HRSA this week notified 340B covered entities that it had finished reviewing their administrative dispute resolution petitions for completeness, and determined that they were complete. | Shutterstock

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

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

In Pharma IndustryMarch 25, 2021326 Views

Tom Mirga

Merck said in letters to 340B covered entities this week that its approach to solving problems with 340B contract pharmacy transactions "is more streamlined—and less burdensome on covered entities, HRSA, and Merck—than undertaking individual manufacturer audits" of entities and their pharmacy partners.

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

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

In Federal, JudicialMarch 25, 2021154 Views

Tom Mirga

The federal government said this week that hospital groups should not be allowed to participate as third parties in Novo Nordisk's lawsuit against the government over enforcement of its 340B contract pharmacy requirements.

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.

The government’s March 22 brief in opposition the

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

In Federal, LegislativeMarch 25, 2021168 Views

Ron Shinkman

Harvard Medical School professor Dr. Aaron Kesselheim told a Senate subcommittee yesterday, “There’s no doubt the fact that 340B pricing is among the best prices we offer for certain high-cost drugs.”

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

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340B Dispute Resolution Injunction Is Having Ripple Effects

In Federal, JudicialMarch 23, 2021153 Views

Tom Mirga

The federal judge considering drug manufacturer Sanofi’s motion for protection from 340B dispute resolution proceedings wants to hear more about a different court's recent decision to grant Eli Lilly such protection.

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

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