Associate Manager - Ira Program Analysis & Compliance
The position assists the Director of Institutional Contracts in managing the development and implementation of Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and implementation of Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations. Co-develop processes to validate MFP refund processes, oversee general management, and modifications in the event of regulatory changes. Supports analytics, good faith inquiries, complaints, and post payment audits. Supports master data management requirements for the IRA, as required. Supports special projects for all U.S. government programs to assist with compliance and implementation of new and existing regulations.
Reports to the Director of Federal and Institutional Contracts. Also works closely and supports MDRP, Chargebacks and Master Data Management. Also maintains relationships with the Finance, Pricing & Contracts, IT, Legal, Market Access and Field Sales. External relationships may include wholesalers, dispensing entities, vendors and other customers. Maintains a positive working relationship as an NNI representative to all stakeholders.
Essential functions include supporting review of MFP refund payments, coordinating maintenance of membership lists, overseeing and managing issuance of MFP refunds, assisting with developing policies and procedures for MFP refunds, independently and proactively managing outsourced activities related to administration of MFP tasks, managing responses to Good Faith Inquires ("GFI") from dispensing entities, providing support for SOX inquiries and ensuring adherence to SOX controls, ensuring timely receipt of claim-level data, transmission of payment elements, and submission of required information, proactively notifying the MTF Data Module ("MTF DM") Contractor of any system changes that may impact connectivity, updating CMS with any changes to the Manufacturer MTF Enrollment Information within 30 calendar days of such changes, accessing claim-level data elements through the MTF DM and maintaining functionality to receive and process this data, monitoring for inaccuracies in previously transmitted claim-level payment elements, regularly updating, correcting, maintaining, and re-certifying the completeness and accuracy of Manufacturer MTF Enrollment Information within the MTF DM, utilizing the MTF PM in alignment with the Manufacturer's MFP Effectuation Plan and updating the Plan as required by applicable guidance and regulations, providing accurate banking account information to the MTF Data Module Contractor in accordance with applicable guidance and regulations to facilitate MFP refund payments through the MTF PM, providing CMS with a minimum of 90 calendar days' advance notice if the Manufacturer elects to cease utilizing the MTF PM, reviewing and verifying credits and debits using Ledger System data provided through the MTF DM to ensure accuracy, ensuring that any outstanding credits are not treated as unclaimed funds and that related claims must be resolved directly with dispensing entities outside the formal dispute or complaint process, responsible for compiling, analyzing, creating and presenting MFP rebate reports and supports ad-hoc requests, supporting changes and updates to Government Contracts & Operations department MFP administration work instructions and procedures when external changes in process occurs, providing MFP subject matter expertise in the form of advice and recommendations to internal stakeholders, supporting the analysis and implementation of pending and new regulatory requirements for IRA programs, and supporting the analysis and implementation of MFP-related business initiatives.
Qualifications include a Bachelor's degree required; relevant experience may be substituted for degree when appropriate, a minimum of five years of progressively responsible, relevant experience with any or all the following : rebate adjudication, government programs and the IRA, pharmaceutical experience preferred, working knowledge of U.S. Government program requirements, working knowledge of the 340B / PHS Program, entity types, CE relationships, 340B ecosystem and related stakeholders and other program requirements, advanced proficiency in Microsoft Excel skills required, Microsoft Access and SQL Management Studio skills preferred but not required, experience with Master Data Management and Model N Revenue Management Suite preferred, excellent verbal and written communication skills, may co-lead a project in the development and implementation of processes and programs, experience with recognizing trends, establishing a way forward, and focusing on the big picture as well as key details, self-motivator who consistently seeks to improve accuracy and efficiency of analytical work and business, attention to detail and ability to multi-task required, and effective personal time management and organization skills.
Compliance Program Manager • Plainsboro, NJ, US