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
'/>"/>

SOURCE Food and Drug Law Institute
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:8/1/2014)... Cannabis use among young people has spiked, with ... used marijuana at least once and 17 percent admitting to ... Drugs, Say ‘Yes to Life,’ volunteers from the Church of ... with factual information about drugs, to help reverse this alarming ... to Drugs, Say ‘Yes’ to Life,” volunteers have distributed 40,000 ...
(Date:8/1/2014)... School of Medicine in St. Louis helps explain why ... are more harmful than similar tumors in females. For ... diagnosed twice as often in males, who suffer greater ... long. , The researchers found that retinoblastoma protein (RB), ... less active in male brain cells than in female ...
(Date:8/1/2014)... Barbara Bronson Gray HealthDay Reporter ... obese and work in manufacturing jobs may have significantly less endurance ... a study of 32 people -- half were obese, half were ... times that were about 60 percent longer. Obesity also was ... Being older -- 50 to 65 years of ...
(Date:8/1/2014)... 1, 2014 (HealthDay News) -- Almost 140 people ... transportation in the United States. But there ... catastrophes, Dawne Gardner, injury prevention coordinator at Cincinnati ... said in a medical center news release. ... to school, it,s important for parents and children ...
(Date:8/1/2014)... MN (PRWEB) August 01, 2014 Summer is ... are most active during the summer, and they can be ... Minnesota is ready to help all their customers get rid ... between 3,000 and 6,000 eggs in the summer, which is ... to live in tall grass and woodland areas and carry ...
Breaking Medicine News(10 mins):Health News:Addressing a Serious Issue Affecting German Teens 2Health News:Study reveals one reason brain tumors are more common in men 2Health News:Obesity Might Slow You Down at Work 2Health News:Obesity Might Slow You Down at Work 3Health News:Expert Offers School Bus Safety Tips 2Health News:Tis the Season for Tick Prevention 2
... was honored for ecommerce expertise when President Michael Del Chiaro was ... the highly respected Entrepreneur magazine. , ... Fort Scott, ... for the interview based on his proven success in building a ...
... Feature ,Leave It To Beaver, Star Jerry MathersJACKSON, Miss., ... Express, bus tour will be stopping in Mississippi the ... state in order to help uninsured and financially-struggling Mississippians ... free or nearly free. With the unemployment rate in ...
... March 5 Ranbaxy Pharmaceuticals Inc. (RPI), a ... announced today that RLL has received approval from ... and market Quinapril Hydrochloride & Hydrochlorothiazide (Quinapril + ... The Application for the drug was submitted by ...
... every day for six months were able to increase the ... their erectile function by up to 36%, according to an ... BJU International . , Researchers from San Giovanni Battista Hospital ... this treatment could provide a viable alternative to surgery, as ...
... March 4, 2009Overweight children and adolescents, with the active ... weight by following the Seven Steps to Success described ... a journal published by Mary Ann Liebert, Inc. ... , A team of experts that includes ...
... BioFortis wins another award for its Labmatrix(TM) ... institutional clients worldwide for translational research, biomarker ... 5 /PRNewswire/ -- BioFortis, Inc., ... used by pharmaceutical and institutional clients, today ...
Cached Medicine News:Health News:My1Stop.com President Michael Del Chiaro Interviewed by Entrepreneur.com for ecommerce Expertise 2Health News:Partnership for Prescription Assistance Prepared to Help Mississippi Workers Hurt by Recession 2Health News:Partnership for Prescription Assistance Prepared to Help Mississippi Workers Hurt by Recession 3Health News:Partnership for Prescription Assistance Prepared to Help Mississippi Workers Hurt by Recession 4Health News:Ranbaxy Secures Final FDA Approval for Quinapril Hydrochloride + Hydrochlorothiazide Tablets 2Health News:Penile extender increased flaccid length by almost a third says independent clinical study 2Health News:7 steps to successful child and adolescent weight loss 2Health News:BioFortis Wins Best Product Award in Discovery Informatics at the 2009 Molecular Medicine Tri-Conference 2
(Date:7/31/2014)... 31, 2014  According to data released today by ... average monthly Medicare Part D premium is expected to ... was originally projected, the Pharmaceutical Care Management Association (PCMA) ... to be a bright spot in American health care. ... region and using cutting edge, cost-saving tools like pharmacy ...
(Date:7/31/2014)... -- IRIDEX Corporation (Nasdaq: IRIX ) today reported ... June 28, 2014.  , Revenues were $10.6 million ... million in the 2013 second quarter and up sequentially from ... the first six months of 2014 were $20.9 million, up ... last year. , Gross margin for the quarter was ...
(Date:7/31/2014)... Xencor Inc. (NASDAQ: XNCR ), a ... the treatment of autoimmune diseases, asthma and allergic ... the second quarter ended June 30, 2014 and provided ... "In the second quarter, we presented preclinical data ... (ATS) demonstrating three novel mechanisms of action of ...
Breaking Medicine Technology:IRIDEX Reports 2014 Second Quarter, Six-Month Results 2IRIDEX Reports 2014 Second Quarter, Six-Month Results 3IRIDEX Reports 2014 Second Quarter, Six-Month Results 4IRIDEX Reports 2014 Second Quarter, Six-Month Results 5IRIDEX Reports 2014 Second Quarter, Six-Month Results 6IRIDEX Reports 2014 Second Quarter, Six-Month Results 7Xencor Reports Second Quarter 2014 Financial Results 2Xencor Reports Second Quarter 2014 Financial Results 3Xencor Reports Second Quarter 2014 Financial Results 4Xencor Reports Second Quarter 2014 Financial Results 5Xencor Reports Second Quarter 2014 Financial Results 6Xencor Reports Second Quarter 2014 Financial Results 7Xencor Reports Second Quarter 2014 Financial Results 8
... on Monday, December 10, 2007, NEW HAVEN, Conn., ... today announced that preliminary data,from its pivotal Phase II ... acute myelogenous leukemia (AML) would be presented,in a poster ... in,Atlanta, Georgia on Saturday, December 8, 2007., The ...
... 5 Replidyne, Inc.,(Nasdaq: RDYN ) announced today ... participate on the New and Powerful Anti-infectives,panel at the ... take place at 11:00 am ET on Thursday, December ... City., A live audio webcast of the panel ...
Cached Medicine Technology:Vion Pharmaceuticals To Present Preliminary Data on its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) at the American Society of Hematology Meeting 2Vion Pharmaceuticals To Present Preliminary Data on its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) at the American Society of Hematology Meeting 3
... ready-to-use solutions ideal for a wide range ... prepared with 18 megOhm water, filtered using ... sterile bottles., Reliable - Manufactured according ... lot-to-lot consistency. , High Quality - ...
12% Tryptone, 24% Yeast Extract, 4.0% Glycerol. Supplied with 1 liter of 10x phosphate buffer (0190-1L)....
1.2% Tryptone, 2.4% Yeast Extract, 0.4% Glycerol, with 100ml of 10x Phosphate buffer supplement (0190-01)....
10% Casein digest (NZ amine), 5.0% Sodium Chloride, 5.0% Yeast Extract....
Medicine Products: