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New FDLI Monograph on Federal Price Reporting Requirements Provides Essential Guidance on Commercial Strategy, Compliance Issues
Date:7/17/2009

WASHINGTON, July 17 /PRNewswire-USNewswire/ -- The Food and Drug Law Institute has published the first monograph in its landmark Monograph Series -- Price Reporting Basics under Medicaid, Medicare and the PHS340(b) Program: Planning for Both Compliance and Commercial Success.

Written by Alice Valder Curran, a partner at Hogan & Hartson, LLP, in Washington, D.C., and two associates at the firm, Emily S. Gebba and Sarah H. Zinn, the monograph concisely 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.

Pharmaceutical or biologics manufacturers who seek federal coverage of their products under the Medicaid and Medicare Part B programs must agree to participate in certain federal price reporting and discount programs. Those price reporting obligations often are misperceived as a back-room accounting function with perhaps some associated compliance obligations but still little relevance to daily commercial operations and strategy. That's not the case. These price reporting and discount programs instead have the potential to significantly affect the commercial pricing and discount strategy for almost any product, according to the monograph.

In addition, ongoing federal enforcement efforts and recent, comprehensive rulemaking should make federal price reporting obligations a central compliance and commercial strategic focus at manufacturers of all sizes. This monograph provides lawyers and business leaders with a user-friendly overview of each price point's calculation mechanics as well as how common commercial arrangements can affect those calculations.

Finally, the monograph includes two sample charts for manufacturers to use to start tracking important data and documenting their own price calculation methodologies.

FDLI's Monograph Series is designed to provide in-depth, practical analysis and guidance for attorneys on complex issues in food and drug law. New monographs are published every two months and are available for purchase, both as a part of a subscription product and individually. Monographs are available only as downloadable PDF files from FDLI's website (www.fdli.org).

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.


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SOURCE Food and Drug Law Institute
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