Compliance

• Assist Director of Institutional Contracts in managing the development and implementation of 340B as well as Inflation Reduction Act 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 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.
• Reports to the Director of Federal and Institutional Contracts.
• Also works closely and supports MDRP, Chargebacks and Master Data Management.
• Maintains relationships with the Finance, Pricing & Contracts, IT, Legal, Market Access and Field Sales.
• External relationships may include wholesalers, 340B entities, dispensing entities, vendors and other customers.
• Maintains a positive working relationship as an NNI representative to all stakeholders.
• 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 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 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.

Senior Manager, Inflation Reduction Act Program Analysis – Compliance

Specialist, Ethics & Compliance – Government Accountability

Regulatory Operations Specialist – Submissions

Manager – Contract Review and Compliance Reporting