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Regulatory Oversight Prescription Drugs Section 340B

McDermott Will & Schulte

This Week in 340B: February 4 – 10, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

McDermott Will & Schulte

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

Bricker Graydon LLP

CMS finalizes site-neutral payment for clinic visits but declines to finalize clinical families payment limitation

Bricker Graydon LLP on

In its final Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule released November 2, 2018 (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to make payments for...more

Bricker Graydon LLP

CMS expands reimbursement cuts on 340B drugs

Bricker Graydon LLP on

On November 2, 2018, CMS issued the CY 2019 OPPS/ASC Final Rule, further cutting reimbursement for 340B Program purchased drugs. CMS finalized its proposed rule and expanded the reimbursement reductions for separately-payable...more

Bricker Graydon LLP

340B litigation update: Both Ceiling Price Rule delay and 340B rate cuts face legal challenges

Bricker Graydon LLP on

On September 11, 2018, the American Hospital Association (AHA) and other major health care industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of...more

Bricker Graydon LLP

340B Drug Pricing Program spawns two antitrust lawsuits

Bricker Graydon LLP on

The 340B Drug Pricing Program has spawned two antitrust lawsuits related to CVS’s acquisition of Wellpartner, a 340B administrator. 340B administrators contract with 340B covered entities (e.g., hospitals) to provide a...more

Hogan Lovells

Administration presents plans to lower drug prices

Hogan Lovells on

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

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