The Inflation Reduction Act (IRA) makes significant changes to Part D’s benefit structure and coverage, which will require careful policy development and thoughtful implementation. On Monday, PhRMA submitted comments on the Calendar Year 2025 Part D Redesign changes, outlining key considerations for the Centers for Medicare and Medicaid Services (CMS) to help mitigate against potential disruptions to seniors’ access to medicines through Part D.
Here are key takeaways from our comments:
- Protect Access and Coverage: “The IRA requires Part D plans to assume greater financial risk while maintaining the program’s nondiscrimination rule and all patient protections. Therefore, CMS’ IRA implementation process should have as a key goal coverage, access and affordability that is as good as or better than what is in place today — rather than allowing beneficiary coverage, access and affordability to be eroded by more restrictions in coverage. It is important for CMS to clearly specify how it will enforce current protections as IRA’s changes are implemented.”
- Ensure Cost-Sharing Reflects Discounted Price: “Even if a Part D sponsor or its PBM has negotiated a rebate for the product, coinsurance is often based on a medicine’s undiscounted list price. A recent analysis found that 92 percent of Part D beneficiaries’ out-of-pocket spending is based on the list price rather than the discounted price their insurer gets. The drug price negotiation program will further distort patient access because the maximum fair price (MFP) of selected drugs will be equal to or lower than net price. … When a plan uses percentage-based coinsurance, cost sharing will differ significantly for selected versus non-selected drugs, exacerbating PBMs’ current failures to pass rebates to patients. PhRMA recommends that CMS move to equalize cost-sharing differentials for patients, by redefining Part D negotiated price to take into account all manufacturer price concessions.”
- Establish New Smoothing Provision that Benefits Patients: “The IRA includes several patient affordability improvements to the Medicare Part D program — including the creation of a program to spread out or ‘smooth’ beneficiary out-of-pocket costs over the course of the plan year. PhRMA is concerned about implementation of the new program as enrollment in smoothing is voluntary, the features of smoothing are only described with broad parameters in the law, and many key operational and effectuation details have yet to be determined. Proper implementation of the program will be critical in meeting its underlying goals and providing the intended affordability relief to enrollees, which will improve access to medicines and adherence, and likely will also reduce health disparities.”
- Solicit Feedback Through a More Public Platform: “Changes in the IRA related to redesign and associated policies in the Medicare Part D program are complex and have far reaching implications for all Part D stakeholders, including patients, caregivers, providers, health insurance plans, prescription drug manufacturers, and others. In order to ensure robust engagement from all Part D stakeholders, the Agency should not limit stakeholder feedback requests to the HPMS system, but instead employ more traditional methods of soliciting comment and feedback that coincide with publication in the Federal Register, which is the notice of public record.”
Read our full comments.