Model N Responds to Mounting Regulatory Pharma Pressures with Innovations that Ensure Compliance and Optimize Revenue

340B, Inflation Reduction Act, and global pricing innovations help leading life sciences companies manage regulatory, compliance, and discounting challenges

SAN MATEO, Calif.--(BUSINESS WIRE)--Model N (NYSE: MODN), the leader in revenue optimization and compliance today announced new product innovations geared towards the increasingly complex regulatory environment for global pharma manufacturers. Model N’s latest product enhancements relating to 340B, the Inflation Reduction Act (IRA), and global pricing help pharma manufacturers effectively manage duplicate discounts and maintain compliance with evolving U.S. and international regulations.

Continuously Supporting Pharma with the 340B Program

Model N has made further enhancements to 340B Vigilance, one of the company’s key products for pharma manufacturers to manage 340B rebates and compliance. New 340B Vigilance enhancements simplify compliance by working with leading industry partners to ensure manufacturers prevent duplicate discounts or help to resolve those that have been erroneously issued. With a new Ineligible Service Provider data integration, Model N’s continued investment in 340B Vigilance helps pharma manufacturers validate eligibility from covered entities up front, saving time and ensuring compliance.

“Pharma regulations are more challenging to navigate than ever before, both at the federal and state levels,” said Mike Townsend, Research Director, Life Sciences Commercial Strategies, IDC. “Manufacturers that prioritize technologies to ensure compliance and transparency, eliminate discounting errors, and monitor provider eligibility will better optimize revenue operations. Complexity will only increase as more medicines are added to the Medicare price negotiation and states adopt new rebate provisioning rules.”

Mastering Regulatory Changes in the Inflation Reduction Act

Model N’s 2023 State of Revenue Report showed that pharma executives found regulatory compliance, healthcare policy, and the IRA to be the areas of greatest concern for survey participants. Model N recently added IRA-specific master data attributes to its product master data, setting manufacturers up for success with regulatory compliance and Medicare price negotiation. The first 10 products selected for negotiation under the IRA directly impact many of Model N’s customers, creating a need for an immediate solution. This update will help companies adapt and adhere to the latest requirements from Centers for Medicare & Medicaid Services.

Strengthening Compliance on a Global Scale

Following the release of new tender functionality for the European market earlier this year, Model N further enhances its support for pharma customers’ global business by adding Country Rules as a Service to its Global Pricing Management product. Country Rules as a Service helps pharma companies comply with evolving regulations worldwide, as it allows customers to automatically load country reference rules to their system – a process that is typically manual and hard to control.

Furthering Model N’s data and analytics strategy, Country Rules as a Service leverages syndicated data from leading sources to help customers automate tedious tasks in managing global pricing and makes the process more seamless and efficient. This new capability also allows customers to configure the solution in meaningful ways through their own interpretation of country rules, enabling them to generate reference pricing and launch sequencing and perform “what-if” analyses.

“Successfully navigating regulatory complexities is critical for our pharma customers to release life-changing products into the world. Model N’s timely product innovations geared to the U.S. and the European market show our commitment and support for our customers and their needs in a fluid regulatory environment,” said Suresh Kannan, Chief Product Officer, Model N.

For more information about Model N's latest product innovations, please visit www.modeln.com.

About Model N

Model N is the leader in revenue optimization and compliance for pharmaceutical, medtech, and high-tech innovators. Our intelligent platform powers your digital transformation with integrated technology, data, analytics, and expert services that deliver deep insight and control.

Our integrated cloud solution is proven to automate pricing, incentive, and contract decisions to scale business profitably and grow revenue. Model N is trusted across more than 120 countries by the world’s leading pharmaceutical, medical technology, semiconductor, and high-tech companies, including Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom, and Microchip Technology. For more information, visit www.modeln.com.