Breaking News

Federal Judge Rebukes HRSA on 340B Patient Definition

Genesis
Genesis Health Care successfully challenged HRSA's 340B patient definition in the U.S. District Court for the District of South Carolina.
A federal district judge in South Carolina late today struck down the 340B program’s patient definition, as federal regulators described [...]

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Breaking News

CMS Proposes $9 Billion in Lump Sum Payments to Reimburse Hospitals for Past 340B Part B Drug Payment Cuts

CMS proposed rule
CMS late this afternoon proposed how it will repay 340B hospitals for $10.5 billion in illegal Medicare Part B drug payment cuts.
The U.S. Centers for Medicare & Medicaid Services plans to provide lump sum Medicare Part B drug payments to 340B [...]

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Breaking News

House E&C Committee Passes Two Bills That Would Create 340B Entity Reporting Requirements

Energy & Commerce Committee
The House E&C Committee passed a bill to impose reporting requirements on 340B DSH hospitals and potentially other entities. The committee passed another bill that could expose all types of 340B covered entities to separate reporting requirements.

The House Energy & Commerce Committee passed two bills today to impose 340B program reporting requirements on hospitals and other health care providers.

They were among 19 health care, telecommunications, and energy bills that the committee marked up today.

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Breaking News

House Subcommittee Votes on Party Lines to Impose Reporting Requirements on 340B DSH Hospitals & Potentially Other Covered Entities

Bucshon
Rep. Larry Bucshon (R-Ind.), who has led high-profile 340B-related legislation, will retire at the end of this Congress.

In a significant development, a GOP-led U.S. House health subcommittee this afternoon voted 16 to 12 along party lines to pass and send to the full committee legislation to impose significant new reporting requirements on 340B disproportionate share hospitals.

The

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Breaking News

HRSA and Prime Vendor Yank FAQs About 340B Use in Hospital Child Sites, and GAO Issues a New 340B Study

FAQ excerpt
Excerpts from 340B FAQs that HRSA (top) and the 340B prime vendor Apexus (bottom) have removed from their websites.

The U.S. Health Resources and Services Administration midday yesterday and the 340B prime vendor Apexus this morning, in connection with the end of the COVID-19 public health emergency late last night, withdrew mostly identical 340B program FAQs about use of

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Breaking News

GSK Extends 340B Pricing Conditions to all Covered Entities and all Products

GlaxoSmithKline wordmark and GSK logo on a building
GlaxoSmithKline and Pfizer announced updates to their 340B contract pharmacy policies to comply with new state laws that will take effect in July.

UPDATE Friday, March 31, 2023, 6:45 p.m. EDT—Story updated with comment from the National Association of Community Health Centers.


Drug manufacturer GlaxoSmithKline this afternoon announced a major expansion of its conditions on 340B pricing in the contract

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Breaking News

Major Drug Industry and Health Center Groups Unite to Reform 340B for Patients and “True” Safety-Net Providers

ASAP 340B wordmark
PhRMA, NACHC, and and the National Hispanic Medical Association created a new group, ASAP 340B, and issued a 10-point plan to ensure that the 340B program “benefits patients and true safety-net providers, including rural hospitals.”

Pharmaceutical Research and Manufacturers of America, the National Association of Community Health Centers, and the National Hispanic Medical Association this morning jointly issued a 10-point plan and created a nonprofit group to ensure that the 340B program “benefits patients and

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Breaking News

EMD Serono Is the Second Drug Maker Today to Impose Conditions on 340B Contract Pharmacy, and the 21st Overall

EMD Serono wordmark on building
Beginning Oct. 1, EMD Serono will extend its contract pharmacy restrictions to all 340B covered entities.

EMD Serono today became the 21st pharmaceutical manufacturer to impose conditions on 340B pricing involving drug shipments to contract pharmacies.

Bayer announced conditions on 340B sales involving contract pharmacies earlier today. The companies’ announcements came two days after

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Breaking News

Bayer Is the 20th Drug Maker to Impose Conditions on 340B Contract Pharmacy

Bayer wordmark on side of building
Bayer will no longer exempt federal grantees from its 340B contract pharmacy policy as of Oct. 1.

Bayer Healthcare Pharmaceuticals starting March 1 is imposing limits on hospitals’ replenishment orders of 340B-priced drugs shipped to contract pharmacies. It said it is voluntarily letting 340B grantee covered entities continue to use multiple contract pharmacies to dispense 340B drugs.

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Breaking News

Third Circuit Court Rules for Drugmakers in 340B Contract Pharmacy Cases

Interior of Third Circuit Court courtroom
A federal appeals court ruled today that the 340B statute does not compel drug manufacturers to deliver 340B-purchased drugs "wherever and to whomever a buyer demands."

A federal appeals court in Philadelphia ruled 3-0 this morning that “Congress never said that drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies.”

“By trying to enforce that supposed requirement, the government overstepped

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