CMS Proposed Rule – Exploring the Potential Impact to Manufacturers

August 11, 2020 | 1:00 pm ET

On June 17, 2020, The Centers for Medicare & Medicaid Services (CMS) posted a proposed rule that could impact manufacturers’ Medicaid and 340B liabilities, commercial strategies, and patient assistance programs. At a high level, this proposed rule may:

  • Introduce new ways of evaluating Value Based Pricing (VBP) agreements when determining Best Price
  • Expand the products to which the “alternative URA” applies by broadening the definition of line extensions, new formulations and oral solid drugs
  • Codify the previously provided guidance (“Health Extenders Act” in 2019) on treatment of Authorized Generics in MDRP calculations
  • Raise the possibility of certain copay and patient assistance programs that provide value to patients facing payer-implemented “accumulator” programs being eligible in Best Price
  • Cause supplemental rebates that are paid on Medicaid Managed Care utilization to not meet the exclusion criteria for AMP and BP.

In this webinar, we will attempt to demystify the potential impact the proposed rule may have on a participating manufacturer’s business. We will share insights and perspectives from the multitude of discussions we have had with manufacturers since the proposed rule was released and highlight some of the key questions that the proposed rule raises. We will also walk through several “real world” examples of how some of these proposed changes may impact a manufacturer’s business to explore the potential application of the more impactful aspects of the proposed rule.

Please join Rupal Patel, Director, Advisory Services and Carmela Crimeni, Director, Advisory Services.




    Rupal Patel     Carmela Crimeni


    Register now!

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