New FDLI Monograph on Federal Price Reporting Requirements Provides Essential Guidance on Commercial Strategy, Compliance Issues
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.
Media: To obtain a copy of the monograph, contact Michael
Levin-Epstein,
Editor-in-Chief, FDLI, 222-0897; mdl@fdli.org
First Call Analyst:
FCMN Contact:
Source: Food and Drug Law Institute
CONTACT: Michael Levin-Epstein, Editor-in-Chief, FDLI,
+1-202-222-0897,
mdl@fdli.org
Web Site: http://www.fdli.org
Posted: July 2009
