Model N Tackles Life Sciences Regulations changes Head On With Regulatory Update Program
Trusted partner in navigating regulatory change ensures customers stay on top of fast-changing regulations
REDWOOD CITY, CA – July 1st , 2014 – Model N, Inc. (NYSE: MODN), the leading revenue management provider to the life sciences and technology industries, today announced the expansion of the Model N Regulatory Update Program — a program that every Model N Government Compliance customer is automatically enrolled in at no extra charge.
On June 18, CMS announced changes of new fields and features in the Drug Data Reporting for the Medicaid (DDR) system, which will be effective starting July 19 and will impact most manufacturer’s June and Q2 2014 filings due by July 30th. Next on the horizon, the AMP Final Rule will significantly affect manufacturers contracting with the government. The Model N Regulatory Update Program addresses both of these issues.
Over 60 percent of pharmaceutical executives perceive regulatory and legislative issues to be the “most significant barrier to their company’s growth,” according to a study conducted by KPMG that surveyed 107 senior pharmaceutical executives, with 45 percent of respondents working at companies with annual revenues over $10 billion.
Regulatory change introduces complexity and organizational plus reputational risk, where one wrong price calculation can cost you millions of dollars in leaked revenue and enormous fines.
Key Components and Benefits:
- Swiftly receive Regulatory Update Packs to ensure systems, calculations, and reporting are up-to-date
- Engage in webinars and events with industry experts to delve into best practices, the impact of the Affordable Care Act (ACA), and how to prepare for upcoming changes
- Receive regulatory update emails to ensure notification of late-breaking regulation changes
- Compare and learn from other manufacturers by participating in industry benchmark surveys
- Influence product direction by providing feedback regarding what additional tools and solutions are needed to effectively and efficiently respond to regulatory changes
- Access rich resources and videos to better understand vital aspects of regulation changes and their impact.
“Model N is committed to keeping our customers current on required calculations and reporting in the Model N Government Compliance solution and informed of the latest developments in regulations and requirements,” said Dr. Scott Medberry, director of product management at Model N.
Since enactment of the ACA in 2010, Model N has delivered the following solution updates through Regulatory Update Packs:
- Authorized business user configuration of Medicaid minimum rates
- Unit Rebate Amount (URA) changes for:
- New formulations
- Clotting factor/Pediatric drugs
- Cap at 100 percent of AMP
- Line extensions
- PHS price calculation update
- 5i Drug Filtering in price type calculations
- AMP Unit reporting
- NFAMP/FCP changes for newly launched products
- Medicaid Record ID and ROSI/PQAS updates
- ASP Addendum A and DDR product file changes
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About Model N
Model N is the leader in Revenue Management solutions. Model N helps its customers maximize their revenue and reduce revenue compliance risk by managing every dollar that impacts their top line encompassing contracting, pricing, incentives, and rebates. Model N leverages its deep industry expertise to support the unique business needs of Life Sciences and Technology companies in more than 50 countries. Global Customers include: Actavis, Allergan, Atmel, Bristol-Myers Squibb, Dell, Johnson & Johnson, Linear Technology, Merck, Marvell, Maxim, Micron, Nokia, Novartis, Novo Nordisk, ON Semiconductor, and STMicroelectronics. Learn more at:http://www.modeln.com. Model N is traded on the New York Stock Exchange under the symbol MODN.
Model N® is the registered trademark of Model N, Inc. Any other company names mentioned are the property of their respective owners and are mentioned for identification purposes only.