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News Alert: Becerra Signs off on HRSA Reorganization that Elevates 340B Program’s Status

HHS Secretary Xavier Becerra has signed off on a reorganization of HRSA that elevates decision making about the 340B program closer to the top of the department.

The 340B drug pricing program has a new, higher profile home within the U.S. Health Resources and Services Administration (HRSA), and likely is getting a new director due to its current director’s promotion.

U.S. Health and Human Services (HHS) Secretary

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Health Centers Plan to Resubmit 340B Dispute Resolution Petitions

The National Association of Community Health Centers says it intends to resubmit 340B ADR claims against three drug companies. An injunction against ADR proceedings involving one of the companies has kept proceedings against the other two from moving ahead, the federal government said.

The U.S. Health Resources and Service Administration (HRSA) early this month invited community health centers to “resubmit a new” 340B administrative dispute resolution (ADR) petition against drug companies that deny or restrict 340B drug discounts when contract pharmacies are involved,

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As Frustration Mounts Over 340B Contract Pharmacy Impasse, Arguments in Highly Anticipated AstraZeneca Lawsuit Postponed to Mid-October

Oral arguments previously scheduled for Sept. 14 in drugmaker AstraZeneca’s closely watched 340B contract pharmacy lawsuit against HHS and HRSA have been rescheduled for Oct. 18.

Oral arguments previously scheduled for Sept. 14 in drugmaker AstraZeneca’s 340B contract pharmacy lawsuit against HHS and HRSA have been rescheduled for Oct. 18. The U.S. District Court for the District of Delaware announced the new date for arguments on

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Hospital Groups Back Feds in United Therapeutics 340B Contract Pharmacy Case

United Therapeutics’ denials of and restrictions on 340B pricing involving contract pharmacies are illegal and jeopardize patient care, six hospital groups have told a federal district judge.

Drug manufacturer United Therapeutics’ (UT) denials of and restrictions on 340B drug discounts when covered entities use contract pharmacies are illegal and jeopardize patient care, six hospital groups have told a federal district judge in Washington, D.C.

The groups—American Hospital

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House Passes Framework for $3.5T Budget Bill That Will Include Key Drug Pricing Measures

The U.S. House this week passed a budget blueprint that will pave the way for a vote on a number of drug pricing measures. 340B providers hope to be spared from Medicaid pharmacy cuts.

The House of Representatives passed a $3.5 trillion budget framework bill on Tuesday that potentially clears the path for Democrats to make extensive changes to U.S. health care delivery, although the impact on the 340B program remains to be seen.

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As Biden and House Dems Prepare to Unveil Drug Pricing Plans, 340B Providers Fret Over About Lost Savings

HHS Secretary Xavier Becerra's plan to fight excessive drug prices will be published publicly in the coming weeks, a White House official said yesterday.

As President Biden and House Democrats prepare to unveil their drug pricing game plans, 340B stakeholders eagerly await word on key provisions that could either be helpful or result in significant lost revenue.  While the proposals are going to be

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Key House Democrats Keep Up Pressure on Insulin Manufacturers

U.S. House Energy & Commerce Committee Democratic leaders Frank Pallone (N.J.) and Diana DeGette (Colo.) have asked insulin manufacturers Lilly, Novo Nordisk, and Sanofi for information about their prices, revenues, and expenses.

U.S. House Energy & Commerce Committee Democratic leaders have sent letters to three major drug manufacturers demanding an explanation for the skyrocketing price of insulin. The E&C Committee has jurisdiction over the 340B program and plays an instrumental role on

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340B Entities Left Out of BMS’s $75 Million Settlement; Whistleblower Pursues Case Against Lilly

340B covered entities will get none of the $75 million Bristol Myers Squibb is paying to settle claims it underreported its average manufacturer prices (AMPs) in order to underpay Medicaid drug rebates. A whistleblower is pursuing a similar case against Lilly.

340B covered entities will get none of the $75 million Bristol Myers Squibb is paying California, 27 other states, and the federal government to settle claims it underreported its average manufacturer prices (AMPs) in order to underpay Medicaid drug rebates.

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Recent Supreme Court Ruling Could Affect 340B Dispute Resolution Lawsuits

A recent U.S. Supreme Court decision involving medical device manufacturer Arthrex could influence lawsuits over the 340B program’s administrative dispute resolution (ADR) process.

A U.S. Supreme Court decision in late June about the appointment of federal administrative patent judges (APJs) could influence the outcome of several ongoing lawsuits over the 340B program’s administrative dispute resolution (ADR) process.

On June 21, the high court

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In Strongly Worded Brief in United Therapeutics Case, Feds Defend 340B Contract Pharmacy Actions

Federal officials relied “on sound statutory interpretation and sufficient evidence” when it concluded in May that United Therapeutics (UT) broke the law when it conditioned access to 340B pricing on its products, government lawyers told a federal district judge yesterday.

Federal officials relied “on sound statutory interpretation and sufficient evidence” when it concluded in May that United Therapeutics (UT) broke the law when it conditioned access to 340B pricing on its products, government lawyers told a federal district judge in

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