Breaking News

CMS Says It Will Announce Sometime Next Year How it Will Repay 340B Hospitals for Five Years of Illegal Drug Reimbursement Cuts

CMS building
CMS said late this afternoon it will put off until next year its decision on how it will comply with a U.S. Supreme Court decision striking down five years of drug reimbursement cuts for 340B hospitals.

The U.S. Centers for Medicare & Medicaid Services said late this afternoon that it will address how it will remedy five years of illegal Medicare Part B underpayments to hospitals for 340B purchased drugs “in future rulemaking,” rather than in

Read More »

HRSA for Now Will Not Seek More Info from 340B Providers About Ownership of Onsite Pharmacies

Screenshot of HRSA search result for Shipping address
HRSA for now has set aside a proposed change to its 340B program forms that RWC-340B warned might lead to covered entities losing access to 340B pricing under some drug manufacturers’ contract pharmacy restrictions.

The U.S. Health Resources and Services Administration, for now at least, is setting aside a proposed change to 340B program forms that a provider group warned might lead to covered entities losing access to 340B pricing under some drug manufacturers’

Read More »

Feds and S.C. Health Center Spar Over Center’s Access to Government Info in its 340B Patient Definition Case

Genesis Health Care building and signage
Genesis Health Care's proposed 340B patient definition would remove all limits on dispensing 340B drugs, HHS and HRSA told a federal district judge.

A South Carolina health center and the federal government are sparring over whether the center should have access to more information from the government than it already possesses in its fight to clarify the 340B patient definition.

Oct. 26 court

Read More »

HHS Official Under Trump Calls for “Honest Conversation” About 340B at it Reaches Age 30

John O'Brien headshot
John O'Brien, architect of ex-President Trump's drug pricing blueprint, calls for more 340B transparency in a commentary for STAT.

Getting 340B pharmacy data to study trends and public health impacts “is like trying to catch a will-o’-the-wisp,” a former senior Trump administration health care official said in a commentary last week in the life sciences news publication STAT.

“The

Read More »

Breaking News

Appeals Court Questions Yet Again if it Has Jurisdiction Over Lilly’s 340B Contract Pharmacy Case

Screenshot of 7th Circuit Court Chief Judge Frank Easterbrook on C-SPAN2
Federal appeals court Judge Frank Easterbrook is pictured during an appearance on C-SPAN in 2013. Easterbrook during a court hearing today questioned whether a closely watched 340B contract pharmacy case was ripe for appellate review.

A federal appeals court judge in Chicago expressed doubt during a hearing this morning that the court can review a lower court decision in drug manufacturer Eli Lilly’s 340B contract pharmacy lawsuit.

Judge Frank Easterbrook, the senior judge on the

Read More »

Second of Three U.S. Appeals Court Hearings on 340B Contract Pharmacy Is Set for Monday

US Appeals Court Seventh Circuit court room
Oral arguments are scheduled for this Monday at the federal appeals court in Chicago over Lilly's 340B contract pharmacy restrictions.

Now that a federal appeals court in Washington, D.C., has heard arguments in Novartis and United Therapeutics’ 340B contract pharmacy lawsuits, the scene shifts to Chicago, where an appeals court will hear arguments Monday morning in Eli Lilly’s companion case.

Read More »

AIDS Advocates Holding Weeklong Protest Over Gilead’s 340B Contract Pharmacy Restrictions and Changes In Patient Assistance Program

AIDS advocates with placards protesting Gilead policy
AIDS advocates are holding a week long series of protests outside Gilead's California headquarters.

AIDS Healthcare Foundation (AHF) members are staging a weeklong, twice-daily series of protests at drug maker Gilead Science’s Northern California headquarters to protest the company’s policy to impose conditions on 340B providers that use contract pharmacies to dispense 340B-priced drugs.  

Read More »

HRSA Cites Almaject for 340B Price Data Lapse, No Sanctions Imposed 

Screenshot of HRSA manufacturer audit results page
New Jersey-based generic manufacturer Almaject was cited for an infraction by HRSA during a recent audit. However, the company will not be sanctioned.

The U.S. Health Resources and Services Administration (HRSA) has cited Almaject, a New Jersey-based maker of generic injectables, with failing to submit quarterly pricing data into the 340B Office of Pharmacy Affairs Information System, although the agency did not impose

Read More »

News Alert

Federal Appellate Judges Ask Lawyers, What is a Bona Fide Offer of 340B Pricing?

Screenshot of Judge Gregory Katsas speaking on C-SPAN
Judge Gregory Katsas is on a three-judge panel that will decide the legality of HRSA's 340B program violation letters to Novartis and United Therapeutics. He is shown here speaking at an October 2021 symposium on U.S. Supreme Court Justice Clarence Thomas, for whom he clerked. | C-SPAN

Two of three judges on a federal appeals court panel yesterday repeatedly asked lawyers during a highly anticipated hearing in Washington, D.C., what standard the court should use to decide whether drug manufacturers’ 340B contract pharmacy conditions are legal.

The

Read More »

As Interest in Legislation Grows, Congressional Research Service Issues Back-to-Back Reports on 340B Program

Congressional Research Service wordmark and logo
The Congressional Research Service issued a summary of the range of policy actions affecting 340B contract pharmacy use in recent years

Congress’ nonpartisan research office has issued a four-page backgrounder on litigation over the 340B contract pharmacy program and a two-pager on the entire drug discount program. They could be a sign that 340B hearings and/or bills are coming.

The Congressional

Read More »
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
×

*Sign up for news summaries and alerts from 340B Report

Site Footer Live