FDLI Publications - Monograph Volume 1, Number 1

FDLI Monograph Series
Volume 1, Number 1

Price-Reporting Basics under Medicaid, Medicare and the PHS 340B Program: Planning for Both Compliance and Commercial Success
Alice Valder Curran, Partner, Hogan & Hartson LLP
Emily S. Gebbia, Associate, Hogan & Hartson LLP
Sarah H. Zinn, Associate, Hogan & Hartson LLP

Preview Volume 1, Number 1

Included in the preview:
Table of Contents, About this Monograph, About the Authors, Introduction, Part of Chapter 2 and About the Monograph Series

About This Monograph

Are you evaluating whether to pay a fee to a GPO, PBM, wholesaler
or other purchaser for administrative services or data?
Are you considering a patient coupon arrangement or the creation
of a Patient Assistance Program?
Are you providing free goods to any entity that otherwise would
or still does purchase your product?
Are you preparing for a product launch and considering launch discount strategies?
Are you involved in a managed care or group purchasing organization (GPO)
contract that has more than one product and has performance conditions?
Do you have a drug going off patent soon such that you are considering
launching an authorized generic?

If you answered “yes” to any of these questions, this monograph will help you plan an effective compliance and business strategy.

The Monograph’s Value Proposition (MVP)

This monograph summarizes the price calculation and reporting obligations under the Medicaid Drug Rebate Program, the Public Health Service (PHS) Drug Pricing Program,
and the Medicare Average Sales Price reporting requirement.

Here’s the MVP:

This monograph is the first and only publication that specifically addresses the price calculation and reporting obligations of the Medicaid rebate, Medicare ASP, and PHS/340B drug pricing programs.
This monograph will provide attorneys and business decision-makers with a user-friendly overview of each price point’s calculation mechanics as well as how common commercial arrangements can affect those calculations under Medicare, Medicaid and PHS/340B.
This monograph provides two sample charts specifically designed for manufacturers to use to start tracking important data and documenting their own price calculation methodologies under the three pricing programs.

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