NHC Comments on the GUARD Model

NHC Comments on the GUARD Model

February 23, 2026

Mehmet Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard

Baltimore, MD 21244

RE: Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model [CMS-5546-P]

Submitted electronically via regulations.gov

Dear Administrator Oz:

The National Health Council (NHC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model issued through the Center for Medicare and Medicaid Innovation (CMMI).

Created by and for patient organizations more than 100 years ago, the NHC convenes organizations from across the health ecosystem to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, comprehensive, accessible, and sustainable health care. Made up of nearly 200 national health-related organizations and businesses, the NHC's core membership includes the nation's leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

The NHC appreciates CMS' efforts to examine approaches to addressing prescription drug costs in Medicare and recognizes the challenges inherent in designing models that balance fiscal sustainability with patient access. However, the NHC also acknowledges that certain model design choices may introduce risks for beneficiaries, particularly with respect to affordability and the predictability of out-of-pocket costs. These risks extend not only to beneficiaries themselves, but also to family caregivers who frequently coordinate care, manage treatment logistics, and absorb the practical and financial consequences of changes in coverage and access. After a review with these factors in mind, the NHC cannot support the GUARD Model as proposed.

Unlike some CMMI models that test delivery system reforms with more indirect or delayed effects on beneficiaries, the GUARD Model operates primarily through plan-level mechanisms that CMS acknowledges may affect premiums, cost-sharing, and benefit design. As a result, the Model has implications for beneficiaries that are more directly tied to plan behavior and coverage decisions. The concerns described below relate to the fundamental structure of the GUARD Model as proposed and are not amenable to resolution through technical refinement, supplemental safeguards, or post hoc monitoring once the Model is underway.

Possible Increases in Premiums and Cost-Sharing

CMS indicates that the GUARD Model is designed to generate savings for the Medicare program and acknowledges in the proposed rule that beneficiary premiums and cost-sharing may increase under the Model. However, CMS also notes that plan responses to the Model's financial structure may include adjustments to premiums, formularies, and other benefit features.

For beneficiaries, affordability is reflected in monthly premiums, predictable cost-sharing at the pharmacy counter, and stability in benefit design. While the GUARD Model is intended to reduce program spending, the proposed rule acknowledges that premiums and cost-sharing may increase for some beneficiaries and does not establish a mechanism to ensure that savings realized at the plan or program level translate into net affordability improvements for patients. Because plans retain broad discretion over benefit design, cost-sharing, and coverage policies, financial pressure introduced through the Model may be managed in ways that shift costs from plans or the Trust Fund onto beneficiaries. From a patient perspective, policies intended to address drug affordability should reduce out-of-pocket exposure and improve predictability, not redistribute financial risk in ways that leave some beneficiaries facing higher premiums or greater cost-sharing.

Foreseeable Disruptions of Sites of Care

CMS anticipates that the GUARD Model's rebate structure may result in shifts in drug utilization from Medicare Part D to Part B. For some beneficiaries, this shift would involve a transition from pharmacy-based access, including home administration, to clinic-based or provider-administered care.

For patients, changes in site of care can carry meaningful implications beyond the method of drug administration. Transitions from pharmacy-based access to clinic-based care may introduce additional logistical demands, including transportation challenges, scheduling constraints, delays in treatment, and new coordination responsibilities that often fall to family caregivers. These effects may be particularly consequential for beneficiaries with mobility limitations, caregiving responsibilities, or chronic conditions who rely on stable and predictable care arrangements.

The GUARD Model's anticipated shifts in site of care are a direct consequence of its rebate and coverage design and may disrupt continuity of treatment and patient experience in ways that are not readily addressed through supplemental assessment or mitigation strategies.

Coverage Design and Beneficiary Access

CMS acknowledges that plans participating in the GUARD Model may respond by altering formularies, benefit design, and other coverage features. CMS also acknowledges that beneficiary access and cost-sharing are outcomes that must be evaluated as part of the Model.

In the Medicare Advantage and Part D context, cost-containment pressures introduced at the plan level are often reflected in changes to coverage policies, including the use of prior authorization, step therapy, more restrictive coverage criteria, or narrower formularies. For patients, such changes can delay care, disrupt continuity of treatment, and increase administrative burden, even where nominal coverage remains in place.

The GUARD Model relies on plan-level coverage responses as a primary means of achieving savings, embedding access risk into the Model's core operating logic rather than treating it as a contingent or secondary outcome. CMS' reliance on monitoring and evaluation indicates a model design that anticipates access-related harms may occur as a potential consequence of participation, rather than solely as deviations from intended operation.

Implications for Clinical Decision-Making

The GUARD Model relies in part on international price benchmarking methodologies, including Method I, which references prices in economically comparable countries. CMS describes this approach as a means of identifying lower-cost benchmarks. However, reliance on external price references functions as a structural input into coverage decision-making, with downstream effects that are not closely aligned with individual patient needs or clinical circumstances. The reference countries used for benchmarking operate within health systems that apply different coverage mandates, access standards, and value-assessment frameworks than those established under Medicare statute. Importing price signals derived from those systems into the Medicare Part D benefit risks embedding policy judgments that were not adopted by Congress and that do not necessarily reflect the statutory protections and access expectations governing the Medicare program.

For patients, access to appropriate therapy depends on individualized clinical decision-making with their providers. When pricing benchmarks inform coverage restrictions, formulary exclusions, or coverage conditions, patients may face barriers to therapies selected based on clinical characteristics, disease progression, or prior treatment response. From a patient perspective, treatment value is reflected in clinical outcomes, continuity of care, and the ability to maintain effective therapy, rather than in prices established in health systems structured around different coverage priorities and tradeoffs.

Protected Classes and Continuity of Care

Patients who rely on drugs within Medicare's protected classes often do so because they have serious, complex, or chronic conditions for which therapeutic stability is essential. Protected class policies are intended to preserve access and continuity of care for these patients, recognizing that disruptions in therapy can have significant clinical consequences.

The GUARD Model introduces financial and operational pressures that may affect plan coverage behavior, yet the proposed rule does not clearly explain how continuity of care for patients relying on protected classes will be preserved. While CMS does not propose to eliminate protected class requirements, increased reliance on coverage management tools within these classes would alter how those protections function in practice, without formally changing protected class policy. From a patient perspective, this raises concerns that safeguards designed to support stable access may be weakened through administrative or coverage-related changes rather than through formal policy modification.

In addition, the Model's use of a $69 million spend threshold for drug inclusion creates the possibility of abrupt changes in coverage dynamics once a product crosses that threshold. For patients who have been clinically stable on a particular therapy, a shift in a drug's status under the Model may introduce new administrative requirements, formulary reassessment, or coverage conditions. Such changes can disrupt established treatment regimens and place continuity of care at risk, particularly for patients managing complex or progressive conditions. The proposed rule does not provide a structural approach to preserving continuity of care for patients who are clinically stable, leaving those patients exposed to abrupt coverage changes once model thresholds are crossed.

Geographic Participation Design and Patient Impact

CMS proposes to require participation in the GUARD Model for a defined percentage of beneficiaries based on ZIP code, rather than on patient need, disease burden, or affordability risk. The proposed rule does not demonstrate that the selected geographic areas correspond to populations most likely to benefit from the Model or most affected by high out-of-pocket costs.

For patients, geographic selection can translate into uneven exposure to changes in premiums, cost-sharing, and coverage conditions. Beneficiaries with similar clinical profiles may experience different coverage outcomes based solely on place of residence, rather than on health status or treatment needs.

The absence of a beneficiary opt-out mechanism further compounds these concerns. Mandatory participation based on geography embeds uneven exposure to Model effects into the design of the Model itself, including circumstances where participation results in higher costs or new barriers to access.

Interaction with the Inflation Reduction Act

Congress recently enacted the Inflation Reduction Act (IRA), establishing a comprehensive framework for addressing drug affordability in Medicare. That framework reflects deliberate policy choices regarding how savings are generated, how patient protections are maintained, and how incentives for innovation, including in rare disease research, are preserved.

The NHC has previously raised concerns that layering additional pricing models onto the IRA framework may introduce unintended consequences for patients. In particular, the NHC has emphasized the importance of maintaining incentives for rare disease research and avoiding policy changes that could reduce investment in areas of unmet medical need.

The GUARD Model introduces a parallel pricing and participation structure that was not contemplated as part of the IRA framework and that may alter how those statutory policy choices operate in practice, effectively revisiting policy tradeoffs that Congress resolved through the IRA framework. From a patient perspective, the concern is not simply policy overlap, but the cumulative effect of multiple, rapidly implemented reforms that interact in complex ways and may contribute to uncertainty in coverage, access, and continuity of care.

Conclusion

The NHC supports efforts to improve prescription drug affordability for Medicare beneficiaries and recognizes CMS' role in testing models intended to reduce program spending. However, CMS' own discussion of the GUARD Model indicates that beneficiary premiums and cost-sharing may increase, that plans may alter benefit design and coverage behavior, and that unintended consequences for access are plausible and require evaluation.

These concerns arise from the core structure of the GUARD Model as proposed and are not amenable to resolution through monitoring, evaluation, supplemental safeguards, or incremental adjustment once the Model is underway. For patients, particularly those with serious, chronic, and rare conditions, the risks associated with increased utilization management, higher costs, and disrupted continuity of care are substantial.

For these reasons, the NHC cannot support the GUARD Model as proposed. The NHC appreciates the opportunity to provide these comments and remains committed to engaging with CMS on approaches that more directly and transparently improve patient affordability while preserving access, continuity of care, and the protections Congress has recently established. Please do not hesitate to contact Kimberly Beer, Senior Vice President, Policy & External Affairs at [email protected] or Shion Chang, Senior Director, Policy & Regulatory Affairs at [email protected], if you or your staff would like to discuss these comments in greater detail.

Sincerely,

Randall L. Rutta
Chief Executive Officer