REDWOOD CITY, CA --(Marketwired - January 25, 2016) - Model N, Inc. (
"The Final AMP Rule will dramatically alter the landscape of Medicaid price reporting and manufacturer rebate obligations," said John Shakow, a government price reporting expert at King & Spalding. "Manufacturers need to quickly assess the impact of the changes and act to update their systems and processes to comply with elements of this new final rulemaking."
Under current Medicaid requirements, all participating drug manufacturers must report AMP (Average Manufacturer Price) data for covered outpatient drugs to the Centers for Medicare & Medicaid Services (CMS) each month and quarter. A revised set of Medicaid regulations affecting AMP calculation as well as other important program requirements has been cleared by the Office of Management and Budget and will be published by CMS shortly. The AMP Final Rule dramatically transforms government compliance requirements in the pharmaceutical industry, and will have highly significant implications for manufacturers and their operations.
Regulatory change introduces complexity and organizational plus reputational risk, where incorrect pricing calculations can cause over or underpayments to the government resulting in revenue leakage and / or fines for noncompliance.
"In recent years, the pharmaceutical industry has gone through massive regulatory changes. The AMP Final Rule presents the next regulatory compliance risk for drug manufacturers," said Jesse Mendelsohn, Head of Center of Excellence at Model N. "Model N is ready and able to ensure our customers will be in compliance with the new regulations."
Model N recommends all pharmaceutical companies take these Five Steps now that the AMP Rule is final:
- Identify scope of change by joining the webinar on February 2 at 10AM PT
- Determine financial and operational impacts
- Build response plan with contingencies
- Execute plan, communicating results
- Document new current processes
To enable customers to rapidly identify, develop, test and deliver product enhancements to address regulatory changes, Model N created its Regulatory Update Program. Every Model N government compliance solution customer is automatically enrolled at no extra charge. The program includes robust resources, timely notifications, webinars, networking events and benchmarking studies.
To register for the webinar with John Shakow, please visit: http://pages.modeln.com/AMP-is-here_LP_RSVP.html
For more information on the AMP final ruling, visit http://www.modeln.com/verticals/life-sciences.../amp-rule/
About John Shakow
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 for life science, technology and manufacturing companies. Driving mission critical business processes such as configure, price and quote (CPQ), contract management, rebates and regulatory compliance. Model N Cloud solutions transform 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 the world's leading brands in life science, technology and manufacturing companies across more than 100 countries.
Model N is a trusted partner to some of the world's largest brands, including Johnson & Johnson, AstraZeneca, Boston Scientific, Novartis, Ortho Clinical Diagnostics, Atmel, Fairchild and Marvell. Model N trades 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.
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Media Contact: Diandra Weldon Model N 650-610-4667 Dweldon@modeln.com
