Navigation Links
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.


'/>"/>
SOURCE Food and Drug Law Institute
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. USP announces 11 new proposed monographs for dietary supplements
2. USP announces revised glycerin monograph
3. US Pharmacopeia announces revised heparin monographs and reference standards
4. ABC Releases Monograph on Scientific Research of POM Wonderful(R) Pomegranate Juice
5. MDMA Names New Director of Federal Affairs
6. Federal research plan to determine nanotech risks fails to deliver
7. Federal Employee Program Maintains Low Health Premiums In 2008
8. AMERIGROUP Contracts with Federal Government to Offer Medicare Advantage Health Plans in Seven States
9. SNM applauds NAS study showing need to restore federal nuclear medicine research funding
10. ACM Helps Medicaid Programs Comply With Federal Deficit Reduction Act Mandates
11. Boise(R) BEWARE(TM) Meets New Federal Guidelines Set Forth by Medicaid
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
(Date:5/26/2016)... Washington, D.C. (PRWEB) , ... May 26, 2016 , ... ... the men and women who lost their lives in military battle for the country. ... discount cards in 2015 to provide more programs that empower independence for disabled military ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people ... cancer survivors worldwide. On Sunday, June 5, 2016, communities around the world will gather ... Day®. , National Cancer Survivors Day® is an annual worldwide Celebration of Life ...
(Date:5/26/2016)... ... 2016 , ... Dr. James Maisel will present on “Macular ... on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public Library. The presentation ... of New York , is a Board Certified ophthalmologist who completed his fellowship ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... SAN FRANCISCO , May 27, 2016 ... biotechnology company focused on developing products for Regenerative Medicine, Neurology and ... Commissiong will be presenting at two upcoming investor conferences: ... Conference Center, 730 Third Avenue, New York City ... at 3:00pm Marcum MicroCap Conference   ...
(Date:5/26/2016)... May 26, 2016   Change Healthcare ... analytics, network solutions and technology-enabled services designed ... entered into a strategic channel partnership with ... software solutions and revenue cycle management services ... and rehabilitation clinics to optimize revenue, operational ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May 25, 2016 ... ; Frankfurt Prime Standard: QIA) today announced that the company ... Diagnostics GmbH to develop and commercialize predictive assays in oncology. ... as a marker to predict effectiveness of anthracycline treatment in ... "We are pleased to partner with Therawis, which developed the ...
Breaking Medicine Technology: