Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...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
Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more
The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more
On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more
Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more
On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more