CLIENT CASE STUDIES

Top Pharmaceutical Manufacturer, IRA MFP Impact Assessment

As part of the 2022 Inflation Reduction Act (IRA) legislation, the Centers for Medicare and Medicaid Services (CMS) will negotiate and establish a “Maximum FairPrice” (MFP) with manufacturers for selected drugs to lower drug prices for Medicare beneficiaries. In 2024, one of the company’s Products was selected as one ofthe “top 10” drugs for negotiation, and the negotiated MFP would need to be effectuated by January 1, 2026.​

CHALLENGES

  • Similar to many other manufacturers, processing of IRA MFP rebates required the development of a new business process with additional resources to support the needed activities​
  • Current systems did not support the MFP effectuation processes, which meant a new system or solution was needed in order to process claims from pharmacies via the MTF and ensure payments could be processed within the allowed turnaround time​
  • Timing of IRA MFP effectuation deployment (based on CMS) did not align with major projects, including a large revenue management upgrade and the deployment of a new 340B rebate model solution​
  • Requirements for the IRA MFP processes and systems were highly dependent on 340B policies which were in flux due to the move to a rebate model​
  • Uncertainty in CMS schedules for the MTF and associated testing activities

SOLUTION

  • Conducted workshop sessions with impacted business teams and third-party vendors to determine business and technical requirements​
  • Reviewed policy documentation, business requirements, and technical designs across third party vendors to identify dependencies and updates needed​
  • Assessed “must have” requirements that were needed by the January 1, 2026, deadline versus “nice to have” requirements that could be deferred to a later implementation​
  • Worked with chosen IRA MFP vendor to understand upstream and downstream impacts between their solution and company systems including revenue management, ERP, reporting and other systems​
  • Developed timeline scenarios, risks, pros/cons, and other considerations in aligning timeline of the MFP effectuation solution with other company dependent projects​

RESULTS

  • Well defined release strategy to accommodate short term needs for 2026 balanced with additional functionality to be delivered in the future, considering company dependencies on other projects and business initiatives​
  • IRA MFP Roadmap (based on release strategy), project plan/timeline, budget, and risks for the solution and integrated systems​
  • Business and Technical Impacts for business teams to ensure clear understanding of organizational, business process, system, and change management impacts to master data, contracting, rebate, chargebacks, and Government Pricing processes​

As part of the 2022 Inflation Reduction Act (IRA) legislation, the Centers for Medicare and Medicaid Services (CMS) will negotiate and establish a “Maximum FairPrice” (MFP) with manufacturers for selected drugs to lower drug prices for Medicare beneficiaries. In 2024, one of the company’s Products was selected as one ofthe “top 10” drugs for negotiation, and the negotiated MFP would need to be effectuated by January 1, 2026.​

  • Well defined release strategy to accommodate short term needs for 2026 balanced with additional functionality to be delivered in the future, considering company dependencies on other projects and business initiatives​
  • IRA MFP Roadmap (based on release strategy), project plan/timeline, budget, and risks for the solution and integrated systems​
  • Business and Technical Impacts for business teams to ensure clear understanding of organizational, business process, system, and change management impacts to master data, contracting, rebate, chargebacks, and Government Pricing processes​
  • Conducted workshop sessions with impacted business teams and third-party vendors to determine business and technical requirements​
  • Reviewed policy documentation, business requirements, and technical designs across third party vendors to identify dependencies and updates needed​
  • Assessed “must have” requirements that were needed by the January 1, 2026, deadline versus “nice to have” requirements that could be deferred to a later implementation​
  • Worked with chosen IRA MFP vendor to understand upstream and downstream impacts between their solution and company systems including revenue management, ERP, reporting and other systems​
  • Developed timeline scenarios, risks, pros/cons, and other considerations in aligning timeline of the MFP effectuation solution with other company dependent projects​
  • Similar to many other manufacturers, processing of IRA MFP rebates required the development of a new business process with additional resources to support the needed activities​
  • Current systems did not support the MFP effectuation processes, which meant a new system or solution was needed in order to process claims from pharmacies via the MTF and ensure payments could be processed within the allowed turnaround time​
  • Timing of IRA MFP effectuation deployment (based on CMS) did not align with major projects, including a large revenue management upgrade and the deployment of a new 340B rebate model solution​
  • Requirements for the IRA MFP processes and systems were highly dependent on 340B policies which were in flux due to the move to a rebate model​
  • Uncertainty in CMS schedules for the MTF and associated testing activities