340B Drug Pricing Program Compliance
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the...more
A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more
On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more
For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more
On August 27, 2014, the United States District Court for the District of Columbia rejected Plaintiff Pharmaceutical Research and Manufacturers of America’s (PhRMA) request to invalidate HHS’s recent interpretive rule...more
A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance...more
Polsinelli Podcast Explores Upcoming Webinar Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June....more
On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more
The Department of Health and Human Services (HHS) through its Office of Health Resources and Services Administration (HRSA) announced last week that, although a court recently struck down its regulation addressing application...more
In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the “Mega-Reg” ...more