Navigation Links
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 (

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:
(Date:11/30/2015)... ... November 30, 2015 , ... ... dentistry out of Glen Ridge, NJ. He has both advanced training and ... mastication. He is also an expert in cosmetic dentistry. He is an ...
(Date:11/30/2015)... ... November 30, 2015 , ... ”Dying Words: The AIDS Reporting of Jeff Schmalz ... 2015, to coincide with World AIDS Day. The multi-media project will be in audio ... epidemic as he was dying of the disease. , A collaborative effort led by ...
(Date:11/30/2015)... Reading, PA (PRWEB) , ... November 30, 2015 ... ... Ashland Specialty Ingredients (ASI) as their exclusive channel partner for the Nutraceutical Specialties ... supplements markets in the US, effective immediately. , “We are pleased to ...
(Date:11/30/2015)... PA (PRWEB) , ... November 30, 2015 , ... An ... of life in the womb. "My last baby had high blood pressure due to ... for mothers to protect their babies from noise pollution as well as radio waves ...
(Date:11/30/2015)... ... November 30, 2015 , ... Since its inception, Seniors ... independent living, assisted living and all other retirement options. Support for issues surrounding ... research remains a top priority. , So it’s no surprise that every ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... 2015   Royal Philips  (NYSE: PHG ... Radiology Solutions, a fully integrated, consultative approach to ... data-driven practice management approaches that combine imaging systems, ... improve care delivery and reduce costs. Making its ... North America Annual Meeting (RSNA) in ...
(Date:11/30/2015)... SAN FRANCISCO , Nov. 30, 2015 ... and Designers of Things (DoT ) co-located events ... Printing and the Internet of Things, will draw more ... San Jose Convention Center. The events, combined ... their latest technologies. --> ...
(Date:11/30/2015)... , November 30, 2015 global cell ... of US$6.1 bn to US$11.3 bn by 2022 at a CAGR ... is expected to grow from its 2013 value of US$6.1 bn ... --> Transparency Market Research has announced the release of ... According to the report, titled ,Cell Culture Market - Global Industry ...
Breaking Medicine Technology: