Senior Manager, Inflation Reduction Act Program Analysis & Compliance

Novo Nordisk•Plainsboro, NJ

27d

About The Position

Assist Director of Institutional Contracts in managing the development and implementation of 340B as well as Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and implementation of 340B requirements as well as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations. Co-develop processes to validate 340B Program processes as well as 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.

Requirements

A Bachelor's degree required; relevant experience may be substituted for degree when appropriate
A minimum of seven (7) years of progressively responsible, relevant experience with any or all the following: financial reporting, rebate adjudication, government programs and the IRA
Excellent verbal and written communication skills
Experience co-leading 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
Demonstrated ability to be a self-motivator who consistently seeks to improve accuracy and efficiency of analytical work and business
Attention to detail and ability to multi-task required
Effective personal time management and organization skills

Nice To Haves

Pharmaceutical experience preferred
Working knowledge of U.S. Government program related financial impacts and requirements preferred
Working financial reporting knowledge of the 340B/PHS Program, entity types, CE relationships, 340B ecosystem and related stakeholders and other program requirements preferred
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

Responsibilities

Supports resolution of government contract issues and compliance with 340B regulations and review of MFP refund payments within the 14-day payment window to confirm accuracy of refund calculation and adherence with NNI policies and procedures
Coordinates maintenance of membership lists with Membership Team and supports onboarding new customers into Model N
Oversees and manages issuance of 340B refunds to covered entities and MFP refunds to dispensing entities
Assists with developing policies and procedures for 340B and MFP refunds
Independently and proactively manages outsourced activities related to administration of 340B and MFP tasks
Manage inquiries from 340B entities as well as responses to Good Faith Inquires ("GFI") from dispensing entities
Provide support for SOX inquiries and ensure adherence to SOX controls. Performs post audit reviews and analysis of 340B PHS chargebacks and MFP rebates
Ensure timely receipt of claim-level data, transmission of payment elements, and submission of required information such as audit, complaint, and dispute data
Proactively notify the MTF Data Module ("MTF DM") Contractor of any system changes that may impact connectivity
Update CMS with any changes to the Manufacturer MTF Enrollment Information within 30 calendar days of such changes
Access claim-level data elements through the MTF DM and maintain functionality to receive and process this data
Monitor for inaccuracies in previously transmitted claim-level payment elements
Regularly update, correct, maintain, and re-certify the completeness and accuracy of Manufacturer MTF Enrollment Information within the MTF DM
Utilize the MTF PM in alignment with the Manufacturer's MFP Effectuation Plan and update the Plan as required by applicable guidance and regulations
Provide 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
Provide CMS with a minimum of 90 calendar days' advance notice if the Manufacturer elects to cease utilizing the MTF PM
Review and verify credits and debits using Ledger System data provided through the MTF DM to ensure accuracy
Ensure 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 340B chargeback and MFP rebate reports and supports ad- hoc requests
Supports changes and updates to Government Contracts & Operations department 340B and MFP administration work instructions and procedures when external changes in process occurs
Provides 340B and MFP subject matter expertise in the form of advice and recommendations to internal stakeholders
Supports the analysis and implementation of pending and new regulatory requirements for U.S. government programs
Supports the analysis and implementation of 340B and MFP-related business initiatives