The Price Point

Welcome to The Price Point, where we share our insights on the complicated world of Government Pricing and the pharmaceutical industry. Whether you’re curious about the latest regulatory changes or just looking to expand your GP knowledge, you’ll find discerning analyses and thought-provoking discussions here. Want to receive updates like these straight to your inbox? Sign up for our emails here.

CMS Issues Long-Awaited Final Rule

On September 20, 2024, CMS issued the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program Final Rule (Final Rule) that is related to the Proposed Rule issued May 24, 2023.

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Audit vs. Assessment: Which is right for your company?

Unsure if you’re ready for a Government Pricing audit? An assessment might be a better fit for your company. Read the differences below, and let us know if you have any additional questions. We’d be happy to point you in the right direction!

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Final Rule re. 340B Administrative Dispute Resolution Process

On April 19, 2024, the Health Resources and Services Administration (HRSA) issued a Final Rule with regards to the administrative dispute resolution process (ADR) between manufacturers and Covered Entities (CEs) who participate in the 340B Program.

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OIG Compliance Program and Guidance re. Line Extensions

It’s a busy time in Government Pricing! Late last week, we had the decision from the United States Court of Appeals for the Fourth Circuit regarding the Patient definition for purposes of the 340B Program.

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