On March 1, 2026, Chronic Care Policy Alliance (CCPA) submitted formal comments to the Centers for Medicare & Medicaid Services (CMS) on all 15 medications selected for negotiation under the Medicare Drug Price Negotiation Program’s Initial Price Applicability Year 2028 (IPAY 2028). This marks a significant milestone in the program – IPAY 2028 is the first negotiation cycle to include physician-administered Part B medications, in addition to Part D medications, broadening the program’s reach and the potential impact on patients with serious and chronic conditions.
In our comments, CCPA raised several patient-centered concerns about how the negotiation program may affect access, care continuity, and health equity, particularly as Maximum Fair Prices for IPAY 2026 medications are already taking effect. We urged CMS to ensure that the negotiation process incorporates meaningful patient input and carefully monitors downstream consequences, including changes to formulary placement, utilization management practices, and provider participation.
Read our full comments below:
The Chronic Care Policy Alliance (CCPA) is a coalition of patient advocates focused on issues affecting individuals living with chronic conditions. We appreciate the opportunity to provide comments regarding the medications selected for negotiation under IPAY 2028 and respectfully offer the following considerations to help ensure that the program remains focused on protecting patients.
Therapeutic Alternatives and Individualized Treatment
For patients living with chronic illness, treatment decisions are highly individualized and often refined over years of trial, adjustment, and collaboration with physicians. Medications grouped within the same therapeutic class may differ meaningfully in how they work for a given patient, including differences in side effects, administration, comorbidity management, and overall effectiveness.
For this reason, therapies identified as “alternatives” are not necessarily interchangeable in practice. A product that works well for many patients may be ineffective for others or poorly tolerated by specific patients. CMS should take care to avoid frameworks that treat medications as functionally uniform when patient experience demonstrates otherwise.
We encourage CMS to ensure that patient perspectives and real-world treatment variation are carefully weighed when assessing therapeutic alternatives. Incorporating this perspective will help safeguard against decisions that could unintentionally narrow meaningful treatment options for patients who depend on individualized care.
Physician-Administered Therapies and Care Delivery
Importantly, IPAY 2028 marks the first cycle in which physician-administered Part B drugs have been selected for negotiation. The inclusion of these therapies introduces additional considerations that warrant careful oversight.
The addition of Part B drugs to the negotiation program raises distinct concerns related to care delivery. Changes to reimbursement structures for these therapies may create unintended consequences for provider practices. If reimbursement adjustments meaningfully affect acquisition costs or margins, providers may face financial pressures that could detrimentally impact patient care and access.
For patients living with serious and chronic conditions, disruptions in care settings or treatment availability can have significant implications. CMS should carefully monitor how negotiation affects provider participation and treatment availability to avoid limiting options for patients who rely on these therapies.
Unmet Medical Need and Continued Innovation
CCPA urges CMS to consider how negotiation outcomes may influence future investment in therapies addressing areas of unmet need. Policies that inadvertently reduce incentives for continued research, supplemental indications, or next-generation treatments could limit progress for patients who still lack adequate therapeutic options.
Health Equity, Provider Stability, and Access to Care
Promoting equitable access to care remains a shared priority. However, the downstream effects of reimbursement changes must be carefully monitored to ensure that vulnerable communities do not experience unintended consequences.
Patients in rural areas and medically underserved communities already face limited access to specialists, infusion centers, and community pharmacies. Consolidation within the healthcare marketplace has further narrowed provider networks and pharmacy options in many regions.
If reimbursement adjustments meaningfully affect provider margins, there is a risk that certain medications may become more difficult to access in community settings. Over time, such pressures could lead some providers or pharmacies to limit services or discontinue offering specific therapies. These dynamics could disproportionately affect patients who already experience structural barriers to care.
We therefore encourage CMS to closely track the impact of negotiation on provider participation, pharmacy access, site-of-care shifts, and geographic disparities to ensure that implementation does not inadvertently restrict access to care.
Utilization Management and Continuity of Treatment
While improving affordability is an important objective, it is equally important that patients maintain reliable access to the therapies that are working for them.
CCPA remains concerned that plan sponsors may respond to negotiated pricing by modifying formulary placement or increasing utilization management requirements within affected therapeutic areas. Patients could face expanded prior authorization criteria, step therapy protocols, or other administrative requirements that delay or complicate access to clinically appropriate treatment.
For individuals managing chronic disease, delays in therapy can have significant health consequences. Administrative barriers often result in postponed care, additional provider visits, and increased burden on both patients and clinicians. Over time, such obstacles may contribute to disease progression, avoidable complications, and higher overall healthcare utilization.
With Maximum Fair Prices (MFPs) for IPAY 2026 medications now in effect, it is critical that CMS closely monitor how implementation is affecting coverage decisions, utilization management practices, provider participation, and patient access. Early policy outcomes should inform future negotiation cycles to ensure that program goals do not inadvertently compromise continuity of care or treatment choice for Medicare beneficiaries.
We urge CMS to monitor and, where appropriate, establish guardrails against the expansion of utilization management practices that could undermine patient access or disrupt stable treatment regimens.
Patient Engagement in the Negotiation Process
CCPA strongly supports a negotiation process that meaningfully incorporates patient input at every stage. As implementation progresses into IPAY 2028, alongside the real-world experience of IPAY 2026 MFP implementation, it is especially important that CMS gather robust feedback from patients regarding access, coverage changes, provider availability, and care continuity.