Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Congress Votes on CR, Health-Related Legislation. After reaching a deal over the weekend, both chambers passed a CR to avoid a government shutdown and fund the federal government through December 20, 2024. This tees up a push...more
House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more
This Week in Washington: 118th Congress begins, House finally chooses Speaker...more
The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The...more
On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule (Final Rule) that accelerates the effective and implementation date of the 340B Ceiling Price and Civil Monetary Penalties final rule...more
In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more
The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more
On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more
On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more
The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more