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Part D Operational Implications of the Inflation Reduction Act (IRA) of 2022

By December 1, 2022IRA, November 2022

On August 16th, the Inflation Reduction Act of 2022 (IRA) was signed into law.  The text of the bill is located here and includes changes that, among other things, would allow the government to negotiate drug prices and reform the Medicare Part D benefit.  BluePeak has released several articles on the IRA provisions and advises all Plan Sponsors validate operational areas are fully compliant with all regulations.  CMS has already noted that they will be performing monitoring and oversight next year to ensure plan compliance.

BluePeak has received numerous questions concerning how the IRA provisions will impact Part D operations next year and what steps could be taken to ensure they are better prepared for these changes.  Outlined below are the provisions impacting vaccines and insulins, what operational areas would be impacted, and how plans can proactively take steps to ensure their systems are configured appropriately.  Having a plan in place will allow enrollees affordable access to their Vaccines and Insulins in 2023.


  • Description: Effective 1/1/2023, plans must charge a $0 cost-share for Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) vaccines.
  • Operational Impacts:
    • Adjudication Drug list:
      • Plans should not expect CMS to provide a national drug code (NDC) list of ACIP vaccines that are expected to have a $0 cost-share. Instead, plans and their clinical staff should collaborate with their pharmacy benefit manager (PBM) to review and approve an adjudication list of ACIP vaccines.
    • Annual Testing:
      • Claim Adjudication – All vaccines (ACIP and non-ACIP) should be evaluated to validate the cost-sharing amount. Testing should include formulary and non-formulary ACIP vaccine products, claims processing inside and outside of transition, and within in-network and out-of-network (OON) pharmacies.   The Inflation Reduction Act Subsidy Amount (IRASA) calculation should be validated for accuracy as well as for inclusion within the enrollee’s true out-of-pocket (TrOOP) accumulator.
      • Prescription Drug Event (PDE) – A test PDE file should be able to add additional testing around vaccine claims to validate the IRASA amounts are reporting in the correct field with the appropriate PDE indicators.
      • Explanation of Benefits (EOB) –Test EOBs should be created for test claims to validate the IRASA amounts are being captured and reported appropriately.
    • Monitoring and Oversight:
      • Claim Adjudication
        • All ACIP vaccine claims should reviewed daily to validate no cost-sharing is being applied, the IRASA amount is calculating appropriately, and the IRASA is being applied towards the enrollee’s TrOOP accumulator.
      • PDE
        • CMS indicated they will reject any PDE records that apply a cost-share on an ACIP vaccine. A standardized process should be created to report any PDE rejections of this type to the clinical area to ensure those NDCs get reviewed and likely added to the ACIP vaccine list.  CMS would likely expect enrollee refunds to be issued within 30 days of the date of identification.
      • EOB
        • Plans should pull EOBs for enrollee with paid ACIP vaccine claims and validate cost-sharing and IRASA amounts are reporting appropriately.


  • Description: Starting in 2023, plans cannot charge more than a $35 copay for a one-month supply of insulins. This provision applies to all plans including individual plans and employer group waiver plans (EGWPs).  The provisions will also wrap around the Part D Senior Savings (PDSS) model requirements.  CMS is allowing plans a grace period to implement these changes by April 1, 2023, but requires any overpayments to be refunded to the enrollee within 30 days of the claim.
  • Operational Impact:
    • Annual Testing:
      • All covered Part D insulin products should be included in testing. This includes formulary and non-formulary products, extended day supplies, out-of-network (OON) pharmacies, inside and outside of transition, and through all four Part D benefit phases.  Additionally, testing should also be extended to PDSS model plans as well as EGWPs.  Non-formulary exceptions are not typically included in annual testing but need to be evaluated to validate cost-sharing does not exceed the IRA maximum limits.  Annual testing should also include a validation that the IRASA is being calculated correctly and is being applied towards the enrollee’s TrOOP accumulator.
    • Enrollment and Eligibility:
      • Enrollees will be afforded a special enrollment period (SEP) to add, drop, or change their Part D coverage if they find a better option. The SEP will be available for all enrollees who use a covered insulin product and begins on December 8th, 2022, and ends on December 31, 2023.  Plan Sponsor should ensure their enrollment and eligibility department is educated and aware of this requirement.
    • Monitoring and Oversight:
      • Claim Adjudication
        • All insulin claims should be reviewed daily to validate the enrollee cost-sharing does not exceed $35 for a one-month supply, $70 for a two-month supply, and $105 for a three-month supply. CMS noted that they will be reviewing PDEs for compliance with this requirement.
      • PDE
        • CMS will not reject insulins that exceed $35 and will provide an informational/soft PDE edit after April 1, 2023. Plans should carefully monitor their PDE response files for this edit and take immediate action to remediate the overpayment issue.
      • EOB – Plans should pull EOBs for enrollees with paid insulin claims and validate cost-sharing and IRASA amounts are reporting appropriately.
    • Reprocessing: Any enrollee overpayments must be issued within 30 days of the claim being processed.  Plans should ensure these refunds are issued timely and any requests are effectively managed.

BluePeak can help!

To assist plans during this time, BluePeak Advisors has a trained staff of seasoned Medicare analysts to perform year-end testing and to offer continued monitoring and oversight.  We collaborate with our internal auditors on CMS audit trends and ensure our testing and monitoring approach captures any high-risk areas and will mitigate compliance risk during a CMS program audit.  Please CONTACT US  if you have any further questions or would like our assistance with year-end testing and/or monitoring and oversight.

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