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:5/23/2017)... ... May 23, 2017 , ... New England Journal Of Medicine Confirms ... a Policy Response”, -The Rory Staunton Foundation Calls on Health & Human Services, Tom ... of Sepsis ( http://www.rorystauntonfoundation.org ) today reported on a new study released on May ...
(Date:5/23/2017)... ... May 23, 2017 , ... By all indications, and due to ... While officials call for diligence, asking homeowners to scout for any open water sources ... Along with the annoying buzz of mosquitos is the buzz associated with potential infections ...
(Date:5/23/2017)... ... May 23, 2017 , ... Orbita’s Nathan Treloar will discuss the ... in San Francisco. Titled Connected Health and IoT: Technology Innovators and Disruption , ... by Parks Associates, a market research and consulting firm specializing in emerging consumer technology ...
(Date:5/22/2017)... ... May 22, 2017 , ... The American Academy ... development, healthcare training and clinical application of medical infrared imaging, has announced two ... medical thermal imaging services. , The first new educational offering is an online ...
(Date:5/22/2017)... ... May 22, 2017 , ... “Homeostasis: The Journey of a Manic-Depressive” tells ... Bipolar 1. Donald Rodriguez takes readers on a rollercoaster ride that includes a midnight ... winter and to a dark place where Donald considers suicide. Readers learn how ...
Breaking Medicine News(10 mins):
(Date:5/4/2017)... , May 4, 2017 Clarius Mobile ... wireless, handheld ultrasound scanners this week at the ... Meeting (ACOG) in San Diego, CA ... "Clarius is the perfect tool for clinicians ... heart rate, and evaluate pregnancy-related complications like ectopic ...
(Date:5/4/2017)... 2017  A new tight-tolerance microextrusion medical tubing ... materials, is being launched by Natvar, a Tekni-Plex ... in recent years to service a wide variety ... More expensive materials such as glass and fluoropolymers ... to their ability to consistently hold tolerances. This ...
(Date:5/3/2017)... , May 3, 2017  Kalorama Information notes ... nine percent next year and this is projected ... hematopoietic stem cell (HSCT) or bone marrow transplants ... technologies are well-suited for this task. This according ... publisher Kalorama Information. The various PCR-based methodologies, Sanger ...
Breaking Medicine Technology: