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 »

Feds in Mediation with Tenn. Health System that Allegedly Paid for Referrals to Boost 340B Profits

Methodist Le Bonheur Healthcare building
Methodist Le Bonheur Healthcare and the federal government have settled a 340B-related False Claims Act suit against the system.

The federal government and a Tennessee health system are meeting with a mediator in connection with a whistleblower lawsuit that alleges that the system paid Memphis-area cancer physicians for referrals that generated $50 million in profits in one year alone

Read More »

Breaking News

In Key Hearing, Appeals Court Panel Seems to Lean in Favor of Some Drug Manufacturer Conditions on 340B Pricing

CADC courtroom
A federal appeals court in Washington, D.C., heard arguments this morning in Novartis and United Therapeutics' consolidated 340B contract pharmacy cases.

Two of three judges on a federal appeals court panel strongly indicated this morning that they reject the federal government’s position that nothing in the 340B statute gives drug manufacturers the right to put any conditions on offers of 340B

Read More »

Breaking News

HRSA Refers Merck to HHS Inspector General Over its 340B Contract Pharmacy Policy

Merck flag with U.S. flag
Merck did not immediately comment on the governnment's referral yesterday to the HHS Inspector General for possible imposition of civil fines over the company's 340B contract pharmacy restrictions.

The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.

Public Health Services Lt.

Read More »

CMS Says Steps to End Medicare Drug Payment Cut for 340B Hospitals Are in Progress

CMS building
CMS says it is making computer file changes to restore hospitals’ Part B payments for 340B-purchased drugs to average sales price plus 6% for the rest of 2022 after paying them almost 30% less since 2018.

The U.S. Centers for Medicare & Medicaid Services is making computer file changes to restore hospitals’ Part B payments for 340B-purchased drugs to average sales price plus 6% for the rest of 2022 after paying them almost 30% less since

Read More »

340B COVID-19 Flexibilities Will Continue Through Mid-January

Screenshot of HRSA COVID-19, 340B program resources page
HHS extended the COVID-19 public health emergency (PHE) to mid-January, which keeps in place 340B program flexibilities that started in March 2020.

The U.S. Department of Health and Human Services (HHS) late last week extended the COVID-19 public health emergency (PHE) to mid-January, giving some 340B-eligible entities more time for immediate enrollment in the program without having to wait for the next

Read More »

NACHC Seeks Meeting with Becerra About 340B Contract Pharmacy Restrictions After “Inexplicable” ADR Decision

NACHC wordmark
NACHC told HHS Secretary Becerra it has “little choice” but to turn to Congress after an HHS panel dismissed NACHC’s 340B overcharging claims against AstraZeneca and Sanofi.

The National Association of Community Health Centers is asking to meet with U.S. Health and Human Services Secretary Xavier Becerra to discuss drug companies’ “unlawful restrictions” on 340B drug shipments to contract pharmacies.

NACHC told Becerra in an Oct. 14

Read More »

HRSA Tells AbbVie and Amgen Their 340B Contract Pharmacy Restrictions Are Illegal

HHS HRSA building entrance and signage
HRSA sent AbbVie and Amgen letters yesterday telling the companies their restrictions on 340B pricing when providers use contract pharmacies are illegal and must stop or the companies could face stiff civil monetary penalties.

Federal health officials told drug manufacturers AbbVie and Amgen late yesterday their restrictions on 340B pricing when providers use contract pharmacies are illegal and must end or the companies could be fined.

The Health Resources and Services Administration’s last 340B

Read More »

Breaking News

Effort Launched to Create 340C—a Separate Drug Discount Program for Health Centers and Possibly Other Entities

Advocates for Community Health wordmark
The health center advocacy group behind a proposed 340B program alternative recently slammed the 340B ACCESS Act, saying the newly introduced drug discount program overhaul bill would make it harder for members to leverage the 340B program and care for patients.

A national community health center association founded last year is launching a campaign to urge Congress to create a separate drug discount program called 340C open to health centers and perhaps rural hospitals and federal grantees.

According to a description

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