Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice (AHLA Members)

This brand new title provides a deep dive into drug and device development and distribution.

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Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice is a brand new publication that provides a uniquely comprehensive examination of the legal and business considerations relating to drug and device manufacturing and distribution, including market access, pricing, reimbursement, and promotion.

Each chapter provides a strong foundation for understanding medical product market access, as well as advanced topics for readers who have been practicing in the pharmaceutical and device industry for many years.

The treatise has been drafted with both new and experienced market access practitioners in mind. Although written through a lens of advising life sciences companies engaging in market access activities, Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice will also prove useful to stakeholders across the medical product supply chain—from manufacturers to distributors to payers to health care providers to government regulators—and the numerous additional entities that facilitate access to and distribution of medical products.

EDITORS: Rujul H. Desai, Stefanie A. Doebler, Kristie C. Gurley and Anna D. Kraus.

AUTHORS: Shruti C. Barker, Beth Braiterman, Elizabeth Brim, Tara Carrier, Andrew B. Do, Matthew F. Dunn, Daniel Grant, Alexander B. Hastings, Claire C. Jacob, Mingham Ji, Sanchi Khare, Caitlin E. Koury, Michael S. Labson, Kassandra Maldonado, Krysten Rosen Moller, Raymond Ngu, Jennifer L. Plitsch, Molly Ramsden, Kendra L. Roberson, Tiffany P. Rodriguez, Sarah M. Schuler, Chelsea Segal, Olivia Vega, and Allison Whelan.

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Published in March 2023.

 

Featured Authors

Table of contents

 Recent Titles from the American Health Law Association
About the Editors
About the Authors
About the American Health Law Association
Acknowledgements
Introduction
Editor's Note
Table of Acronyms

PART I  MECHANICS OF PRICING AND REIMBURSEMENT
Chapter 1:  U.S. Market Access Framework
Chapter 2:  Drugs and Biologics Pricing and Reimbursement
Chapter 3:  Medical Devices and Diagnostics Pricing and Reimbursement
Chapter 4:  Government Price Reporting
Chapter 5:  Commercial Channel
Chapter 6:  Government Purchaser Channel

PART II  COMPLIANCE AND PROMOTION
Chapter 7:  Fraud, Waste, and Abuse Issues
Chapter 8:  Communications with Payers
Chapter 9:  Support for Patients

PART III  EMERGING TRENDS
Chapter 10:  Measuring and Contracting for Value
Chapter 11:  State Market Access and Drug Pricing Laws

Table of Acronyms
Index