CMS Finalizes 2024 DIR Guidance, Launches PDE & Formulary Rules for CY 2026 (Week of 4/14/25–4/18/25)

CMS continues its regulatory push toward greater transparency, drug pricing reform, and bid accuracy for Medicare Part D and Medicare Advantage. The April 14–18, 2025 updates provide critical directives for plan sponsors regarding Direct and Indirect Remuneration (DIR), Prescription Drug Event (PDE) data reporting, 2026 formulary submissions, and Medicare Star Ratings.

DIR Reporting Finalized for Contract Year 2024

CMS has issued final guidance for Part D plan sponsors regarding Direct and Indirect Remuneration (DIR) reporting for CY 2024. This update clarifies critical definitions and calculations in alignment with Section 1860D-15(f)(1)(A) of the Social Security Act.

• Two Required Reports:

   

  • Summary DIR Report: At the Plan Benefit Package (PBP) level.

     

  • Detailed DIR Report: At the National Drug Code (NDC) level (11-digit).

     

• Key Clarifications:

   

  • DIR #8 = ERPOSA (Estimated Remuneration at Point-of-Sale Amount).

     

  • DIR #9 = Difference between negotiated price and final reimbursement, reported as a negative value.

     

  • Actual Remuneration = DIR #8 + DIR #9.

     

📅 Deadline to Submit DIR Reports: June 30, 2025
📌 Operational Areas: Finance, Benefits, Compliance

New PDE Instructions for CY 2026 Implementation of IRA

Effective January 1, 2026, CMS will require updated Prescription Drug Event (PDE) record structures as part of the Inflation Reduction Act (IRA) implementation. These instructions are not retroactive and apply only to CY 2026 service dates.

• Covered Topics:

   

  1. Selected Drug Subsidy calculations

      

  2. Employer Group Waiver Plans (EGWPs) with non-calendar year alignment

      

  3. “Lesser of” logic for insulin pricing

      

This update aligns PDE reporting with the cost-sharing caps and manufacturer discounts introduced by the IRA.

📩 Questions: Email PDE-Operations@cms.hhs.gov
📌 Impacted Areas: Part D, Compliance, MA Departments

Call Center Timeliness Metrics Released for Q1 2025

To support oversight, CMS released Call Center Monitoring Performance Metrics for Quarter 1 of 2025. Plans can access both summary metrics and call-level raw data through the HPMS portal.

• Monitoring Period: January 6–31, 2025

   

• Data Access Path in HPMS:

   

  • Quality and Performance → Performance Metrics → Reports → Call Center Monitoring

     

📧 Issues? Email CallCenterMonitoring@cms.hhs.gov by April 29, 2025
📌 Operational Area: Member Services, Compliance

CY 2026 Formulary Submission Instructions & Review Phases

CMS published new guidance for CY 2026 Part D Formulary submissions, including timelines, file formats, and justification expectations.

Key Milestones:

• 📅 May 12, 2025 – Submission Module Opens

   

• ⏳ June 2, 2025 – Initial Submission Deadline

   

• 📩 June 6, 2025 – Supplemental File Deadline

   

New Requirement:

• Prior Authorization (PA) Field: Must indicate if prerequisite therapy is required.

   

🔍 CMS will also review formularies under Drug Price Negotiation provisions to ensure selected drugs are:

• Included

   

• Properly tiered

   

• Free from restrictive utilization management

   

📩 Questions: Email PartDFormularies@cms.hhs.gov