News & Analysis as of

Regulatory Oversight Section 340B

BakerHostetler

Healthcare Industry Team 2023 Year in Review

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As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

McDermott Will & Emery

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

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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

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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 & Emery

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

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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

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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

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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

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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

Parker Poe Adams & Bernstein LLP

340B Mega Guidance Withdrawn

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance). The guidance addressed a number of significant issues under...more

Akerman LLP - Health Law Rx

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

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