The Clock Has Struck — Amplify Your Knowledge
REDWOOD CITY, Calif., August 12, 2015 – Model N, Inc. (NYSE: MODN), the leading provider of cloud-based Revenue Management solutions to life science and technology industry leaders, today announced it will host a discussion this week to help U.S. pharmaceutical manufacturers prepare for significant pending changes in regulatory compliance requirements. This timely Webinar, titled ‘The AMP Rule is with OMB – What is the impact?’, will be presented on Thursday, August 13 at 10 a.m. PT/1 p.m. ET.
The informative webinar, featuring John Shakow, Partner at Washington, D.C. law firm King & Spalding, shares insights on what the OMB submission could mean to you and walks through different scenarios. Model N has also assembled comprehensive content enabling pharmaceutical manufacturers to gain insight into the potential AMP Final Rule, as well as strategies to mitigate them.
“The pending AMP Final Rule will include dozens of significant CMS interpretations of the Affordable Care Act that will very likely change how pharmaceutical manufacturers calculate reportable prices, pay Medicaid rebates and set 340B ceiling prices,” said John Shakow. “Manufacturers will need to quickly assess – and act to update – their current systems and processes to comply with elements of the new rule before its effective date. In this Webinar, we’ll discuss practical insights on what OMB’s receipt of the AMP final rule means to pharmaceutical businesses, and walk through how they can best address different scenarios.”
“In recent years, the pharmaceutical industry has gone through massive regulatory changes. The new AMP rule presents the next regulatory compliance risk for drug manufacturers,” said Shail Khiyara, SVP & Chief Marketing Officer at Model N. “Model N will enable our customers to comply with each and every regulatory change, and is taking immediate action to ensure our customers will be in compliance.”
Under current AMP requirements, all U.S. drug manufacturers must report AMP (Average Manufacturer Price) data for Medicaid-covered drugs to the Centers for Medicare & Medicaid Services (CMS) each month and quarter. A revised set of Medicaid regulations, in the form of the “AMP Final Rule,” has been sent into final reviews with the U.S. OMB (Office of Management and Budget). When published, this ruling could dramatically transform government compliance requirements in the pharmaceutical industry, and has massive implications for manufacturers and their operations. Regulatory change introduces complexity and organizational plus reputational risk, where one wrong price calculation can cost millions of dollars in leaked revenue and, potentially, fines for noncompliance.
Model N created its Regulatory Update Program to enable customers to rapidly identify, develop, test and deliver product enhancements to address regulatory changes. Every Model N government compliance solution customer is automatically enrolled at no extra charge.
Model N gathers input on additional tools and solutions manufacturers need to respond to changes, and provides customers with timely and robust resources, events and information.
Key components and benefits include:
- 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
About the Speaker
John Shakow is a partner in the FDA & Life Sciences Practice in the Washington, D.C. office of King & Spalding. His practice focuses on complex regulatory, commercial and litigation issues related to all aspects of drug pricing and price reporting. He counsels a diverse group of pharmaceutical and biotechnology manufacturer clients on all pricing-related rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and TRICARE programs.
About Model N
Model N is the leader in Revenue Management Cloud solutions. Model N helps its customers maximize their revenues by maximizing sell time, revenues per opportunity and number of opportunities. Model N Cloud solutions manage every dollar that impacts the customer’s top line and transforms the revenue lifecycle from a series of disjointed operations into a strategic end-to-end process. With deep industry expertise, Model N supports the unique business needs of life science and technology companies across more than 100 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: 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.
Connect with Model N