Mehmet Oz, MD, MBA Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244
RE: Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028
Dear Administrator Oz:
The National Health Council (NHC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) draft guidance for the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028.
Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, equitable, and sustainable health care. Made up of more than 180 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.
This latest guidance reflects CMS’ continued efforts to operationalize the Inflation Reduction Act (IRA) through a negotiation framework that has expanded significantly in scope and complexity. As the program evolves, it is essential that cost-containment strategies are carefully balanced with safeguards that preserve timely, appropriate access to care. Ensuring that implementation remains transparent, predictable, and responsive to patient needs is critical to achieving these dual goals.
The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. We offer the following comments to help ensure that negotiated prices translate into meaningful affordability gains without undermining access to medically necessary treatments for people with chronic conditions and disabilities.
The NHC appreciates CMS’ continued efforts to refine implementation details in this draft guidance. At the same time, we emphasize that such refinements must not come at the expense of patient access. As the program expands to include Part B drugs, it is especially important to ensure that changes to reimbursement and program mechanics do not inadvertently disrupt access to clinically appropriate treatments. These developments present important opportunities to improve affordability and access— provided that the program is designed and implemented in a way that centers patient needs. Our comments are organized around key themes in the guidance, with emphasis on areas where additional clarity, patient engagement, or policy safeguards may be warranted. Across all sections, we prioritize the principles of meaningful patient input, clinical appropriateness, access preservation, and real-world transparency.
Inclusion of Part B Drugs: Scope, Challenges, and Opportunities
The addition of provider-administered therapies covered under Medicare Part B to the IPAY 2028 cycle introduces a fundamentally different reimbursement and care delivery context than that of pharmacy-dispensed Part D drugs. These therapies—often infused or injected biologics used to treat cancer, autoimmune conditions, and neurologic or rare diseases—are acquired by providers under the buy-and-bill model and reimbursed based on Average Sales Price (ASP) plus a percentage add-on. Applying the Maximum Fair Price (MFP) to these treatments will require significant adjustments to workflows related to drug acquisition, claims processing, and patient cost-sharing.1,2
If MFP-based reimbursement falls below actual acquisition costs—or introduces new uncertainties into revenue forecasting—providers, particularly those in smaller practices or rural areas, may face disincentives to administer these drugs. CMS should monitor for early disruptions to access and consider implementing temporary acquisition cost protections or transition payments. At the same time, the NHC recommends that CMS avoid incorporating the MFP into ASP calculations, as doing so could depress reimbursement rates across both Medicare and commercial markets, compounding access risks and straining provider viability.3
The NHC urges CMS to issue implementation guidance that accounts for the operational realities of Part B. A first priority is clarifying how providers should submit claims for drugs subject to the MFP. Because these therapies will no longer be reimbursed based on ASP + 6%, CMS must establish clear, practical billing instructions—including updated coding protocols, reconciliation pathways, and integration requirements for Medicare Administrative Contractors (MACs). These instructions should be released alongside a dedicated FAQ and include illustrative examples, edge-case scenarios, and transition considerations for off-cycle or multidose claims.4 CMS must also clearly articulate how the MFP will be operationalized at the point of sale, including through mechanisms such as the Medicare Transaction Facilitator (MTF). Without timely implementation guidance on effectuation systems— including claim-level reconciliation, data reporting standards, and real-time pricing updates—stakeholders across the supply chain, particularly community-based providers and pharmacies, face heightened risk of reimbursement errors, delays, and administrative burden. These disruptions could cascade into patient access barriers if not addressed before MFP-based pricing takes effect. Without such guidance, providers may face billing challenges that could delay reimbursement and patient care.
CMS must also clarify how overpayments—instances where provider reimbursement exceeds the MFP—will be reconciled. The draft guidance is vague on critical operational details, including the timeline for refunds, the responsible parties, and patient involvement in any refund process. Retroactive claims processing is common in Part B, so reconciliation mechanisms must be prompt and automated. CMS should specify whether coinsurance refunds to patients will be automatic or beneficiary-initiated and define the oversight mechanisms for ensuring consistency and timeliness.
Another area of concern is the potential impact of MFP reimbursement levels on provider participation, which in turn may create unintended consequences for patient access. If reimbursement under the MFP falls below the acquisition cost for a drug, or introduces new uncertainties into revenue forecasting, providers—particularly in smaller practices or rural areas—may opt not to stock or furnish these therapies.5 Past CMS experiences have demonstrated that even modest shortfalls between ASP and acquisition costs during periods of volatility or shortage have resulted in reduced provider uptake.6 CMS should monitor for such dynamics and consider whether temporary transition payments or acquisition cost safeguards are needed to preserve meaningful access for all patients, particularly during the early phases of implementation. As CMS explores reimbursement and refund mechanisms for Part B drugs subject to negotiation, it should also consider retrospective rebate models that do not depend on modifying ASP-based payment structures. For example, using a more stable benchmark—such as the difference between Wholesale Acquisition Cost (WAC) and the MFP—as the basis for a CMS-administered rebate could help preserve financial predictability for providers without distorting ASP. This approach may be particularly beneficial for community-based or rural providers that lack the margin flexibility to absorb discrepancies between acquisition cost and reimbursement.
CMS must further assess the downstream effects of MFP implementation on patient access. While lower coinsurance is a stated goal, it may be offset by service disruptions if providers reduce availability or shift patients to alternate sites of care.7 CMS should proactively identify high-risk access scenarios—such as high-cost therapies with limited provider margins or geographic areas with fewer providers—and implement safeguards including ombudsperson support, real-time appeals processes, and monitoring of site- of-care utilization trends. In particular, independent and community pharmacies may face significant cash flow challenges if they are reimbursed at the MFP but must continue purchasing products at higher pre-negotiation prices.8 CMS should evaluate whether advance payments, payment timing adjustments, or other interim protections are warranted to ensure that patients retain access to medications in these high-risk pharmacy settings during the transition period. Public reporting on provider participation rates and patient-reported access barriers would improve transparency and accountability.
To ensure a smoother transition, CMS should collaborate with patient and provider organizations to develop educational materials that explain the MFP’s implications for Part B therapies. These materials should be made available in multiple formats and languages and cover billing practices, coinsurance changes, and patient rights in plain language. CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. Even well-intentioned policies can create access disparities if communication and operational support are lacking.
Renegotiation of Previously Selected Drugs
The IRA anticipated that the clinical and economic value of a drug could evolve over time due to factors such as new FDA-approved indications, biosimilar entry, or shifts in real-world utilization. The IPAY 2028 guidance introduces a preliminary framework for addressing this evolution through potential renegotiation of MFPs. While the NHC acknowledges the rationale for establishing such a process, we emphasize that any renegotiation must be conducted with full transparency and careful monitoring of potential downstream effects on access. In particular, reductions in MFPs may have unintended consequences for formulary design, provider reimbursement, and patient cost-sharing, potentially deterring pharmacies or providers from offering affected therapies.9,10 It is critical that CMS weigh both clinical and access-related factors when considering renegotiation and take steps to mitigate any risks to timely and appropriate care.
CMS outlines four circumstances under which a drug may become eligible for renegotiation: the approval of a new FDA indication; a shift in exclusivity status; a material change in a statutory factor such as clinical benefit or unmet need; or a discretionary determination by CMS based on new evidence. While these triggers align with the statute’s intent, the operational details remain underdeveloped and warrant further clarification.
The process by which CMS will determine that a drug qualifies for renegotiation should be more transparent. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set. CMS should commit to issuing public notices of intent to renegotiate, followed by a defined comment period to allow patients, clinicians, and other affected parties to submit updated clinical data, real-world outcomes, and patient perspectives.11 The role of patient-centered evidence in the renegotiation process also requires greater definition. Although the statute references therapeutic benefit and unmet need, the draft guidance is silent on how CMS will gather and weigh patient-reported outcomes, registry data, or treatment experience narratives. Integrating these data sources would enable a more accurate reflection of a drug’s real-world impact, particularly for individuals with rare, complex, or poorly studied conditions.12
Another area of concern is the phrase “material change,” which appears throughout the guidance but is never defined. Stakeholders may interpret this threshold differently, leading to confusion or inconsistent application. CMS should develop and publish illustrative examples—drawn from clinical, economic, and operational contexts—to clarify the types of changes that would meet the threshold for triggering renegotiation.
The timing and cadence of renegotiation reviews is also unclear. The guidance references future IPAY cycles but does not specify whether CMS will review eligibility for renegotiation on a set schedule or only on an ad hoc basis. A regular review timeline—such as annual or biennial assessments—would promote consistency and allow stakeholders to anticipate upcoming changes, while still permitting expedited review in exceptional cases.
Renegotiation may also result in unintended consequences that extend beyond price. Changes in the MFP could influence formulary design, provider reimbursement, or patient cost-sharing. Without careful monitoring, a new price could prompt plans to reclassify a drug, alter utilization management policies, or introduce other access barriers. CMS should evaluate these downstream impacts and adopt safeguards to prevent disruptions in coverage or care continuity.13
Finally, CMS should ensure that the renegotiation process includes structured opportunities for stakeholder engagement beyond manufacturers. The current framework does not indicate whether public listening sessions, stakeholder briefings, or appeals pathways will be available to patient organizations, clinicians, or public health experts. Establishing a dedicated input process—separate from the manufacturer negotiation—would help ensure that decisions reflect not only cost data but also the lived experience of those affected by pricing changes.14
The inclusion of a renegotiation framework is an essential and forward-looking feature of IPAY 2028. However, to fully realize its promise, CMS must clarify its criteria, enhance transparency, and institutionalize patient engagement. A predictable, evidence-based, and participatory approach will ensure that the program remains responsive to evolving therapeutic landscapes while protecting uninterrupted patient access to care.
Inflation Rebate Integration with Negotiation
The IPAY 2028 draft guidance confirms that inflation-based rebates under the IRA will continue to apply to drugs selected for negotiation, even after the establishment of a MFP. This policy direction reflects Congress’s dual strategy to restrain drug price growth through complementary mechanisms: negotiated ceilings on drug prices for certain high-spend products and mandatory rebates for any drug—whether negotiated or not— that exceeds the inflation-adjusted price growth threshold.15
The continued application of the inflation rebate provision to drugs selected for negotiation reflects the IRA’s layered approach to managing costs within Medicare and the broader prescription drug market. While we recognize that this may introduce overlapping compliance requirements, the provisions serve complementary functions: the MFP sets a ceiling on Medicare reimbursement, while the inflation rebate provision is intended to promote long-term pricing stability. CMS should monitor the interaction of these mechanisms to ensure they do not inadvertently disrupt patient access or provider participation. In doing so, CMS must also remain attentive to the potential impact on future therapeutic development, particularly in areas of high unmet need or limited market competition. A balanced implementation approach—grounded in transparency, flexibility, and engagement—will be essential to advancing affordability while preserving incentives for continued innovation.
CMS should clarify how inflation rebate benchmarks will be maintained or recalculated when a drug transitions into or out of the negotiation program. For instance, if a previously rebated drug becomes subject to negotiation, it is unclear whether its inflation penalty benchmark would be frozen as of the MFP’s effective date or allowed to continue adjusting annually. Similarly, if a drug exits the negotiation program, it remains uncertain whether the benchmark would reset or revert to a prior methodology. Without clear parameters, stakeholders—including manufacturers, payers, and patient advocates—may be unable to anticipate the full pricing impact of program transitions.16
Further clarity is also needed on how CMS will reconcile violations involving both inflation rebate caps and MFP compliance. A manufacturer could, for example, fail to make the MFP available to dispensing entities while simultaneously triggering a rebate liability due to inflation-based price growth. The draft guidance does not specify whether such infractions are treated cumulatively, prioritized, or subject to adjustment. To minimize confusion and support consistent enforcement, CMS should publish a formal penalty reconciliation framework accompanied by practical examples.
The NHC also recommends that CMS enhance transparency around inflation rebate liabilities to support broader stakeholder understanding of the Inflation Reduction Act’s pricing provisions. Although the guidance outlines data collection and reporting obligations for MFP enforcement, it does not clarify whether manufacturers’ inflation rebate liabilities will be made publicly available or shared with non-manufacturer stakeholders. Greater visibility into these rebate trends could enable oversight of affordability trends, foster more informed public discourse, and allow patients and advocates to better anticipate the evolving cost burden on the Medicare program.
However, this information should remain analytically distinct from the renegotiation process, which must continue to focus on clinical and statutory factors as defined under the law.
Publishing case-based illustrations would further enhance stakeholder understanding. Examples could include: a drug newly selected for negotiation after previously incurring inflation rebates; a renegotiated drug experiencing a midyear price spike; or a product that shifts formulations or market position while remaining subject to both rebate and negotiation requirements. Illustrative case studies would help demystify the interaction of these provisions for manufacturers, providers, and beneficiaries alike.
Regular publication of enforcement metrics would also benefit the advocacy community. Semiannual reports should disclose the number of drugs assessed inflation penalties, total rebate amounts collected, and the portion of those totals attributed to MFP- selected drugs. Such metrics would enhance oversight, facilitate research into policy effectiveness, and enable patient advocates to better anticipate the impact of enforcement on care access.17
Finally, CMS should assess whether certain therapeutic areas—such as oncology or rare diseases—may be disproportionately affected by the cumulative impact of rebates and price caps. In markets with limited competition or high variability in dosing, even well-intentioned policies could lead to distorted plan behavior or adverse formulary decisions. A proactive analysis of these potential effects is warranted to ensure safeguards are in place to preserve access and avoid disincentivizing innovation.18
The continued application of inflation rebates to negotiated drugs reflects a coherent cost-containment strategy. However, its success depends on operational clarity, consistent enforcement, and open communication with affected stakeholders. By refining its guidance and sharing actionable examples, CMS can align these mechanisms in a way that delivers on the IRA’s goals without introducing unnecessary barriers or uncertainty.
Effectuation of the MFP: Operational Mechanisms and Patient Communication
Among the most technically complex—and most consequential—aspects of the IPAY 2028 draft guidance is CMS’ expanded discussion of how the MFP will be implemented at the point of care. This includes leveraging systems such as the MTF to manage payment flows, enforce price ceilings, and process refunds across both Medicare Part D and Part B drugs. While these backend functions may receive less attention than drug selection criteria or negotiation methodologies, they are pivotal to determining whether patients actually experience the financial protections promised under the IRA.
The NHC supports CMS’ ongoing investment in these infrastructure systems and appreciates the additional operational details included in the draft guidance. However, several unresolved issues remain—particularly in the areas of transparency, accountability, and procedural safeguards when the MFP is incorrectly applied.
CMS should clearly articulate how beneficiaries will be notified if they are charged cost- sharing based on an amount that exceeds the applicable MFP. Although beneficiaries are not typically responsible for the full MFP amount, current guidance does not require plans or providers to notify them when cost-sharing exceeds what would be owed under the MFP. Nor are refund processes standardized or consistently communicated across payers and providers. For many Medicare beneficiaries—particularly those with limited health literacy, digital access, or language proficiency—relying on self-monitoring or post hoc claims review is not feasible. CMS should require that point-of-sale systems include standardized alerts when patient cost-sharing exceeds the MFP-based amount and mandate that refund notices be issued in plain language, through both mail and electronic formats, as appropriate.19
Greater specificity is also needed regarding the refund and reconciliation process. The draft guidance mentions the possibility of retrospective refunds but does not outline how such refunds are initiated, how patients will receive them (e.g., direct deposit, mailed check, or copay credit), or how long processing will take. Without defined timelines or error thresholds, the system risks delays and inconsistencies that could erode public trust and deter patients from accessing needed therapies. CMS should also consider the operational realities faced by providers in implementing MFP-related processes. For example, requiring providers to maintain dual inventories under a prospective pricing model would likely be infeasible in many clinical settings—particularly community-based practices—and could divert resources away from patient care. Clear, consistent guidance on timing and reconciliation processes will be critical to avoiding unintended disruptions in therapy availability.
CMS should also establish a patient-facing error correction and appeals process. This should include a centralized portal and toll-free hotline that allows beneficiaries to report discrepancies, obtain assistance, and navigate dispute resolution. To ensure meaningful access for all patients, support staff should be trained in health literacy and disability communication standards.20
The NHC further recommends that CMS require Medicare Advantage (MA) plans and Part D sponsors to distribute standardized educational materials explaining MFP protections and refund procedures. These materials should be provided at the point of care, included with each Explanation of Benefits (EOB), and made available in both print and digital formats. They should be written in plain language and tailored to meet the needs of patients receiving physician-administered Part B drugs as well as pharmacy-dispensed Part D prescriptions.21
From the patients’ perspective, the value of the MFP lies in its consistent and reliable application. CMS should ensure that systems are in place to minimize errors and simplify the correction process when discrepancies occur. CMS should minimize the burden on beneficiaries by ensuring that refund and correction processes are clearly communicated, accessible, and timely. This concern is particularly acute for low-income and medically complex patients who may lack the time, resources, or familiarity with Medicare processes to resolve such issues.22
To promote accountability and system-wide learning, CMS should regularly publish metrics on MFP implementation. These should include the frequency of overcharges, average refund timelines, number of beneficiary complaints, and compliance rates among plans and providers. Public reporting of these data will support transparency, identify operational bottlenecks, and guide future improvements to the MTF and related systems.
In designing these systems, CMS should draw on lessons from past implementation challenges in other Medicare programs. Persistent issues with inaccurate copay collection and delayed reimbursements in Medicare Part D—particularly for dual-eligible individuals and beneficiaries with limited English proficiency—demonstrate how implementation gaps can disproportionately harm vulnerable populations.23 Applying these lessons to the MFP rollout is essential to prevent similar disparities.
Ultimately, implementing the MFP is not a peripheral administrative task—it is central to fulfilling the law’s promise of improved affordability. CMS must ensure that operational systems are seamless, transparent, and firmly rooted in the patient experience. Only then can the negotiated prices under the IRA be translated into meaningful, real-world access for the millions of Medicare beneficiaries who depend on these therapies.
Patient Listening Sessions
The NHC commends CMS for continuing to convene patient-focused listening sessions as part of the Medicare Drug Price Negotiation Program. These forums are among the only formalized mechanisms for patients and caregivers to share their lived experiences with selected drugs directly with federal regulators. As such, they serve a unique and irreplaceable function in shaping negotiation decisions beyond what clinical trial data and cost models can reveal.
Patient listening sessions are especially critical in surfacing perspectives on treatment burden, adherence challenges, quality-of-life impacts, and other patient-centered outcomes that may not be reflected in the evidence submitted by manufacturers. These sessions provide insight into how drugs function in real-world conditions—information that is vital to determining whether a treatment’s price reflects its true value across various patient populations.24
To ensure that listening sessions yield actionable, patient-centered insights, the NHC recommends the following process improvements focused on accessibility, clarity, and broad participation of stakeholders:
CMS should provide a minimum of 30 days’ advance notice and allow scheduling flexibility for all listening sessions. This lead time enables patients, caregivers, and advocacy organizations to prepare comments, arrange time off work, and secure necessary support services such as transportation or caregiving. Many individuals managing complex conditions require advance logistical coordination to participate meaningfully.25
CMS should publish thematic guidance and clearly defined expectations in advance of each session. Publishing themes—such as “treatment burden,” “side effect management,” or “impact on caregiving”—will help participants prepare more tailored and relevant input. These prompts should also include examples of narratives that are particularly useful in informing negotiation-related 26
CMS should improve and expand asynchronous input opportunities to supplement live oral testimony. While CMS has provided written comment periods for listening sessions in the past, these opportunities have been limited in duration and hosted on platforms that are difficult to navigate. To increase accessibility, CMS should extend the length of written comment windows, improve the user interface of submission platforms, and conduct proactive outreach to encourage participation from a diverse range of Additionally, CMS should accept alternative formats such as audio and short video submissions to accommodate individuals who may be unable to submit traditional written input due to fatigue, speech limitations, or other barriers.27
CMS should provide accessibility and language services by default for all listening Sign language interpretation, closed captioning, multilingual translation, and accommodations for cognitive or sensory impairments should be standard features, not contingent upon special requests. Establishing these supports by default reflects CMS’ commitment to broad patient participation and minimizes the administrative burden on patients already navigating serious health challenges.28
CMS should provide private, de-identified submission options for patients who are not comfortable disclosing their identity. These options are particularly important for individuals with stigmatized conditions who may be reluctant to share personal stories in public Allowing anonymous or non- identifiable input ensures that privacy concerns do not prevent patients from contributing valuable insights.
Beyond participation mechanics, CMS must also improve transparency regarding how patient input is used. The current process lacks adequate public feedback loops. While CMS may state that patient insights are “considered,” this phrasing is insufficient to assure stakeholders that their contributions have influenced policy outcomes.
The NHC urges CMS to publish post-session summaries that include the following elements:
De-identified participant quotes organized by theme (e.g., barriers to access, treatment fatigue, adverse effects);
A high-level summary of key insights shared during the session;
A description of how these insights were incorporated into the negotiation process or where they influenced considerations about therapeutic alternatives, patient subgroups, or dosing variations;
A discussion of any themes that were noted but ultimately not acted upon, along with rationale for their exclusion.
Providing this level of transparency will build public trust, demonstrate procedural fairness, and reinforce that CMS is committed to evidence-informed, patient-centered decision-making—not just technical pricing models. Transparency in government engagement processes has been shown to increase both participation and perceived legitimacy, especially in high-stakes or politically sensitive programs.29
Furthermore, CMS should develop a centralized, publicly accessible archive of all patient listening session materials—including agendas, guidance prompts, anonymized summaries, and, where consent is granted, recordings. This will allow other stakeholders (e.g., academic researchers, patient organizations, and clinicians) to review patterns in patient-reported data and understand how those perspectives inform Medicare drug pricing decisions.30
Finally, we encourage CMS to formally invite participation from patient organizations, including those representing underserved and low-incidence populations who may otherwise be excluded from mainstream data collection. These groups can help identify unique patient experiences and ensure that less prevalent diseases and conditions are not overlooked during the negotiation process.
In sum, patient listening sessions represent one of the most tangible, high-impact ways that individuals and families can shape federal drug pricing decisions. CMS should continue to strengthen these forums as foundational elements of the program’s evidence base, ensuring that patient voices are meaningfully integrated into decision- making. By strengthening the format, ensuring meaningful access for all patients, and demonstrating a transparent link between testimony and policy action, CMS can uphold the spirit of the IRA and improve the health and financial well-being of Medicare beneficiaries nationwide.
Manufacturer Agreements and Compliance Requirements
The IPAY 2028 draft guidance builds on CMS’ authority under the IRA by outlining specific compliance expectations for manufacturers participating in the drug price negotiation program. These include timely execution of agreements, submission of required data, and accurate implementation of MFP across all Medicare Part B and Part D settings. While these measures are essential to program integrity, aspects of the compliance framework remain underdeveloped. Without greater procedural clarity and transparency, there is a risk that administrative errors—particularly those outside the control of the health care system’s end users, including patients—could lead to avoidable disruptions in access or affordability.
CMS states that manufacturers may face civil monetary penalties if the MFP is not made available to dispensing entities; however, the guidance does not specify whether enforcement actions will be automatic or discretionary, nor does it outline the severity thresholds that would trigger such penalties. This ambiguity may create uncertainty among manufacturers regarding the consequences of minor or unintentional errors, potentially discouraging timely participation or resulting in overly conservative implementation practices.31
In addition, the guidance does not explain how CMS will differentiate between systemic noncompliance and isolated, good-faith administrative mistakes—especially in cases where third parties (such as pharmacies, claims processors, or health systems) may have contributed to errors in MFP application. Patients should be protected from the downstream consequences of backend operational failures—including those stemming from third-party or manufacturer errors—that could result in delays, denials, or unexpected cost-sharing.
To improve the clarity and effectiveness of the compliance framework, the NHC recommends the following enhancements:
CMS should establish a clear escalation and remediation pathway for enforcement. A tiered model should outline informal correction opportunities, formal notices, and civil penalties, with each step triggered by well-defined criteria. This structure, modeled after compliance regimes in other Medicare programs such as the Shared Savings Program, would promote early resolution of issues and reduce unnecessary punitive actions. CMS should also clarify whether internal dispute resolution or appeals processes will be available for manufacturers facing enforcement actions.32
CMS should implement patient-focused remediation measures when compliance failures occur. If patients experience higher out-of-pocket costs or treatment disruptions due to MFP misapplication, CMS should require retroactive refunds and a mechanism for expedited redress. Such failures should automatically trigger additional patient protections and targeted oversight of the responsible entities. It is critical that beneficiaries—especially those with life- threatening conditions—not be left to absorb consequences stemming from system-level lapses.33
CMS should consider publishing de-identified, aggregate compliance data to support continuous program improvement and foster stakeholder confidence. This could include summary statistics on the number and types of compliance issues, average resolution timelines, and corrective actions taken— disaggregated by program year and therapeutic area where appropriate. A regularly updated public dashboard or report would enhance transparency, help identify systemic challenges, and inform future policy refinements, while safeguarding proprietary and reputational interests.34
CMS should provide clear guidance on what constitutes “good faith” compliance While the draft references this term, it offers no detail on what behaviors qualify. CMS should clarify that good faith includes timely reporting of technical problems, cooperation with affected entities, proactive correction of known issues, and demonstrable attempts to comply despite extenuating circumstances. This clarity would reduce legal ambiguity and encourage open communication between manufacturers and the agency.
A well-calibrated compliance regime must balance firm oversight with fairness and operational realism. Enforcement approaches that lack transparency or patient-centered safeguards could unintentionally discourage participation or introduce legal uncertainty, ultimately reducing the availability of negotiated drugs. By contrast, a predictable, transparent framework that includes remediation for affected patients will promote both compliance and confidence in the negotiation process.35
The NHC remains committed to working with CMS to develop these guardrails and urges the agency to treat patients as central—not incidental—stakeholders in all phases of MFP enforcement and oversight.
Balancing Confidentiality and Transparency in Data Submission
The NHC supports CMS’ efforts to protect proprietary data while also ensuring that stakeholders have sufficient insight into the rationale behind pricing decisions. We believe that a balanced approach can foster both innovation and accountability. CMS’ reaffirmation of its confidentiality policies for manufacturer data submissions raises important questions about how the agency will balance the protection of proprietary information with the transparency needed to sustain public trust and stakeholder engagement. Under the IRA, CMS is authorized to collect sensitive data from manufacturers as part of the drug price negotiation process, including financial projections, cost structures, clinical benefit assessments, and research and development expenditures. The IPAY 2028 guidance reiterates CMS’ commitment to safeguarding trade secrets and proprietary commercial information, consistent with statutory obligations. The NHC supports the appropriate protection of confidential business information to encourage manufacturer participation and prevent anti- competitive misuse. However, we remain concerned that a confidentiality framework that is overly expansive or inconsistently applied could obstruct stakeholder engagement, limit public accountability, and weaken the legitimacy of MFP determinations. If transparency is the foundation of accountability, then CMS must ensure that stakeholders have sufficient visibility into the evidence and reasoning behind each pricing decision.
Several key concerns should be addressed to strike the appropriate balance:
Excessive confidentiality may obscure the rationale behind MFP determinations. Stakeholders—including clinicians, researchers, and patient organizations—need access to high-level summaries of the non-proprietary or confidential data and assumptions informing Without such transparency, it becomes difficult to evaluate whether pricing decisions reflect real-world value, policy objectives, and patient needs. Broad redactions can erode trust in the negotiation process and invite skepticism about CMS’ decision-making framework.36
Patient groups may be excluded from meaningful participation in the negotiation process. The ability of patient organizations to offer informed input depends on access to relevant information, including utilization patterns, cost- offset assumptions, and comparative effectiveness data. Without this, groups cannot speak to issues such as treatment adherence, financial toxicity, or unmet need. Transparency, when appropriately balanced with confidentiality, is essential to fostering trust and informed engagement across all stakeholder groups, including manufacturers, patients, and providers.37
Insufficient data disclosure may hinder program evaluation and iterative improvement. CMS has committed to refining the negotiation framework over time, but future adjustments require meaningful external If core data are withheld, oversight bodies and independent researchers will be unable to assess program effectiveness or recommend improvements, limiting the IRA’s long-term success.38
To ensure appropriate transparency without compromising proprietary interests, CMS should adopt the following procedural safeguards when it does not compromise confidential or proprietary data:
Ensure confidentiality claims are justified at the question level, consistent with the IPAY 2027 CMS should standardize the redaction process across all negotiation-related submissions by requiring justification of confidentiality claims at the question level, as outlined in the IPAY 2027 Information Collection Request (ICR). This approach balances transparency with administrative feasibility.
Publish aggregate or de-identified data summaries. CMS should release anonymized ranges or summaries of key non-confidential or proprietary data points—such as projected Medicare spending, estimated cost savings, or clinical assumptions—even when individual figures must remain This allows for meaningful oversight without exposing proprietary detail.
Create a petition process to reconsider redactions. CMS should allow recognized patient organizations to formally petition for the limited disclosure of redacted data categories, with the option to propose safeguards such as nondisclosure agreements. All petitions should be evaluated using consistent and transparent criteria.
Commercial confidentiality and public transparency are not mutually exclusive. Precedents from domestic and international programs demonstrate that drug pricing frameworks can protect sensitive business interests while maintaining enough transparency to foster public trust.39 International experience confirms that transparent decision-making is essential to the legitimacy, credibility, and durability of negotiation- based pricing systems.40
The NHC urges CMS to calibrate its confidentiality policies to reflect these dual imperatives. Drug price negotiation is not only a regulatory task—it is a public trust exercise. Without meaningful transparency, that trust cannot be earned or sustained.
Oversight of Part D Formulary Changes and Access Protections
The IPAY 2028 draft guidance provides a comprehensive update on the operational aspects of the Medicare Drug Price Negotiation Program across Parts B and D. However, it gives limited attention to how Part D plan sponsors might adapt to the implementation of MFPs, particularly with respect to formulary tiering, utilization management, and access protections. Additional clarity in these areas would be valuable, as plan decisions play a critical role in determining whether negotiated prices translate into meaningful improvements in patient access.
While lower list prices are designed to reduce out-of-pocket costs for beneficiaries, they may also result in unintended shifts in benefit design. Under current market dynamics, higher-cost therapies are often placed on non-preferred tiers because their elevated list prices enable larger manufacturer rebates. With the introduction of MFPs, the economic incentives surrounding these drugs may shift. As a result, some plans may reevaluate formulary placement or utilization management strategies based on updated cost structures. Without appropriate guardrails, such changes—though financially rational— may inadvertently limit access to clinically appropriate therapies.41
To support transparent and patient-centered implementation, CMS should reinforce expectations for plan behavior following MFP adoption. Specifically:
Plans remain accountable for ensuring timely and appropriate access to medically necessary therapies. CMS should reiterate that Part D sponsors are expected to maintain compliance with long-standing benefit design requirements, including therapeutic category representation and network adequacy, regardless of whether a drug is subject to an MFP.42
Utilization management changes should be clinically CMS should clarify that the introduction of an MFP alone does not warrant new prior authorization, step therapy, or tiering adjustments without appropriate clinical rationale. Promoting transparency around such changes will help ensure that utilization management tools remain aligned with patient needs.43
Beneficiary protections must remain in place. A reduced drug price does not diminish a patient’s right to appeal coverage CMS should reaffirm that beneficiaries continue to have access to existing grievance and appeals processes under 42 CFR § 423 Subpart M.44 In addition, CMS should take steps to ensure that these protections are clearly communicated to beneficiaries and that grievance and appeals processes are timely, accessible, and minimally burdensome to avoid unnecessary delays in access to needed medications.
In addition, CMS should consider establishing a proactive monitoring framework to assess plan responses to MFP implementation. Publicly reporting on changes to prior authorization policies, tier placement, and coverage decisions—particularly for drugs newly subject to MFPs—can help promote transparency and inform future policy adjustments.
Finally, CMS should acknowledge that price reductions, while critical, do not automatically resolve all access challenges. Administrative complexities, such as prior authorization or language barriers, may still delay or hinder treatment, especially among older adults or those with limited digital literacy.45 Ongoing monitoring and stakeholder engagement can help identify and mitigate these challenges.
To ensure that the program’s intended cost savings translate into real-world patient benefit, CMS should work collaboratively with plans and other stakeholders to prevent unintentional access barriers and uphold high standards of patient care.
Implementation of MFPs for Part B Drugs: Challenges and Safeguards
The IPAY 2028 cycle marks a significant expansion of the Medicare Drug Price Negotiation Program, encompassing—for the first time—drugs reimbursed under Medicare Part B. This extension introduces a fundamentally different implementation environment from that of Part D. Whereas Part D drugs are typically dispensed at retail pharmacies and managed by private plans, Part B drugs are primarily administered in clinical settings and reimbursed directly to providers through the buy-and-bill model.
This operational distinction is more than procedural—it has real implications for how negotiated prices will be implemented, how providers will be informed, and how patients will experience the benefits of price reductions.
However, the inclusion of Part B raises urgent operational questions that must be addressed to ensure the program functions as intended. Without targeted safeguards and implementation supports, both patient access and provider participation may be jeopardized.
First, CMS must establish a clear, structured process for communicating MFP implementation details to providers—especially those practicing outside of major health systems. While large hospitals may have dedicated reimbursement departments and billing vendors with direct access to CMS updates, smaller or rural practices often depend on Medicare Administrative Contractors (MACs) and third-party systems for claims processing guidance. The IPAY 2028 guidance does not yet clarify when or how MFP-related billing instructions will be issued, nor whether providers will receive advance access to revised payment files, new codes, or billing modifiers. Absent clear communication protocols and advance notice, providers risk billing at incorrect rates, resulting in reimbursement denials or overcharges for patients.
Second, CMS must put in place accessible remedies for patients who are billed incorrectly for MFP-covered drugs. Under Part B, patients often receive bills post- service and may have no way of knowing whether the MFP was applied. CMS should implement a formal correction and refund process that includes standardized patient notices, dispute instructions, and active outreach in cases of systemic overbilling.
Requiring patients to initiate corrections—particularly those with cognitive, language, or technological barriers—would place an unfair burden on those least able to navigate administrative complexity.
Third, CMS must anticipate and address the administrative burden on MACs and billing software vendors. These entities will play a pivotal role in implementing MFPs for Part B drugs, and their readiness will directly affect patient access. CMS should publish a detailed implementation calendar and an operational guidebook specific to Part B, including timelines for provider education, MAC coordination, software updates, and dispute escalation procedures. Clear delineation of responsibilities among CMS, MACs, providers, and plans is essential for effective implementation.
Additionally, CMS should ensure that technical assistance is available to smaller and rural practices, which are often under-resourced and more vulnerable to administrative disruption. These providers historically face greater difficulty adapting to major billing changes and may be at higher risk of withdrawing from Part B drug administration altogether if the MFP implementation proves overly complex.46
To monitor for downstream effects, CMS should collect and publish data on provider behavior following the implementation of Part B MFPs. This includes tracking whether physicians reduce or stop offering affected drugs, switch to alternative therapies, or shift care to different sites, such as hospital outpatient departments, which may impose higher burdens on patients. Site-of-care shifts can have significant implications for access, cost-sharing, and continuity of care.47
Finally, CMS should commit to regular public reporting on key metrics related to Part B MFP implementation, such as billing accuracy, refund frequency, provider uptake, and changes in beneficiary access. Transparent reporting will not only support stakeholder confidence but also provide actionable insights to inform future negotiation cycles.
The success of MFP implementation for Part B drugs will depend on CMS’ ability to operationalize the policy with clarity, fairness, and patient-focused safeguards. Structured communication, meaningful patient protections, and accountability for all implementation partners are essential to ensure that negotiated prices translate into real-world benefits for Medicare beneficiaries.
Considerations for Future Drug Selection and Renegotiation
The NHC acknowledges CMS’ decision to outline a process for the potential renegotiation of previously selected drugs, as changes in clinical evidence and market conditions may warrant future price adjustments. While such a process could help ensure that MFPs remain aligned with therapeutic value and real-world use, it must include strong safeguards to prevent unintended consequences for patient access.
However, the draft guidance leaves several important questions unresolved— particularly around the transparency of the process, criteria for triggering review, and mechanisms for stakeholder input.
To promote predictability, legitimacy, and meaningful patient engagement, the NHC recommends the following enhancements:
CMS should formalize patient participation in all renegotiation proceedings and trigger assessments. This is particularly important for therapies with high treatment burden or evolving real-world impacts. Direct patient input can illuminate changes in adherence, side effects, or comparative outcomes not captured in published literature.48
CMS should define clear and objective criteria for initiating renegotiation. While the draft guidance lists potential triggers, it does not establish thresholds for determining when a “material” change has occurred. CMS should identify specific metrics—such as defined utilization changes, the introduction of new indications, or emerging comparative data—to guide consistent decision-making.
CMS should institute a public comment period before finalizing any new MFP. A minimum 60-day window for public input should be established, with outreach to affected patient groups. This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions.
CMS should provide advance notice and detailed justification for any downward adjustment in the MFP. Renegotiation must not become a mechanism for retroactive cost-cutting absent due Notifications should include the basis for the change, supporting data, and an assessment of likely effects on patient access and cost-sharing.49
CMS should evaluate the access implications of revised MFPs for therapies used across multiple populations. Drugs that serve as last-line treatments or are indicated for multiple conditions must remain accessible regardless of pricing adjustments. CMS should issue guidance to mitigate unintended consequences such as formulary exclusion or site-of-care restrictions.
CMS should publish anonymized summaries and aggregate statistics on renegotiation outcomes. This should include the number of renegotiations initiated, reasons for each, and summaries of the resulting decisions. Public transparency is essential to building trust in the integrity of the renegotiation process.
While renegotiation is a critical mechanism for ensuring pricing reflects evolving evidence, it must be structured to reinforce—not undermine—trust in the Medicare Drug Price Negotiation Program. Clear criteria, transparent processes, and robust stakeholder involvement are essential to preserving access and legitimacy as the program matures.
Cross-Cutting Concerns: Transparency, Predictability, and Patient Trust
Despite the technical detail included in the IPAY 2028 draft guidance, many aspects of the Medicare Drug Price Negotiation Program remain opaque to patients, providers, and other external stakeholders. Implementation decisions—ranging from data confidentiality to enforcement priorities—often rely on internal processes that lack clear avenues for public insight or input. This lack of transparency poses a risk to the program’s credibility, particularly as the scope of negotiation expands and the number of affected drugs, beneficiaries, and provider types grows.
The long-term success of the program depends not only on generating cost savings for Medicare, but also on fostering trust with the public and ensuring that affected communities understand how the program works, why certain decisions are made, and how their input is used. Without a consistent structure for stakeholder engagement and public accountability, CMS may inadvertently undermine support for a program that is otherwise designed to promote patient affordability.
A continuing area of concern raised in the NHC’s previous comments relates to how CMS defines a potentially qualifying single source drug (QSSD).50,51 Specifically, CMS is considering whether to group together drugs that share “at least one active ingredient” when determining QSSD status for the purposes of negotiation. While intended to prevent gaming or patent extension strategies, this approach could inadvertently aggregate products that serve distinct therapeutic purposes or are used in different clinical contexts. Such grouping could limit transparency into how MFPs are derived and obscure distinctions that are highly relevant to patients.
The NHC is particularly concerned that overly broad grouping could discourage the development of new indications, forms of administration, or combination products that are meaningful to patients. For example, long-acting formulations, less painful injection methods, and fixed-dose combination therapies have each played a critical role in improving adherence and outcomes in conditions such as diabetes, autoimmune diseases, and HIV. These innovations often stem from incremental advances that would not be reflected in a grouping methodology focused narrowly on shared ingredients.
Therefore, the NHC urges CMS to engage patients directly to understand whether such advances constitute meaningful therapeutic improvements. Patient perspectives can help distinguish between clinically relevant innovation and superficial reformulations, guiding a more transparent and patient-centered application of QSSD criteria.
While CMS currently publishes MFP updates and related policy guidance, the NHC recommends that CMS further strengthen transparency by producing an annual summary report that includes plain-language explanations of negotiation methodology, incorporation of stakeholder feedback—particularly from patients—and data on downstream effects such as access and adherence trends.
CMS should also host public debriefing sessions following the close of each IPAY cycle. These sessions would offer an opportunity for beneficiaries, clinicians, manufacturers, and advocates to provide feedback on the negotiation process, including the effectiveness of communication materials, clarity of guidance, and any operational issues experienced during implementation. Feedback from these sessions should be incorporated into future guidance and shared through public summaries.
Finally, CMS should consider establishing a standing Patient Advisory Council to provide structured, ongoing input into the Medicare Drug Price Negotiation Program. This Council should reflect the diversity of the patient community and offer insights on proposed policy changes, listening session formats, educational materials, and implementation challenges. A formal advisory mechanism would help ensure that patient perspectives are consistently and meaningfully integrated into program development and refinement.
Programs that succeed in balancing regulatory rigor with stakeholder collaboration tend to enjoy stronger public legitimacy and compliance. When affected communities— especially patients and caregivers—can see how their insights shape outcomes, they are more likely to support program goals, adhere to new rules, and serve as trusted messengers to others in their networks. Conversely, when policy decisions appear opaque or unresponsive, skepticism and disengagement increase. Transparency and accountability are therefore not just governance principles—they are necessities for durable, patient-centered implementation of the negotiation program. 52,53
Conclusion
The IPAY 2028 draft guidance reflects an important evolution in the Medicare Drug Price Negotiation Program. The NHC acknowledges CMS’ efforts to expand the program to encompass physician-administered drugs under Part B, to clarify enforcement and compliance expectations, and to formalize criteria for renegotiating previously selected drugs. We also value the agency’s sustained focus on incorporating patient input and real-world evidence into the negotiation framework.
While commendable, we urge CMS to take further steps to embed the patient perspective in all facets of implementation. Whether through clearer operational protocols, transparent communication with beneficiaries, or access safeguards, the program’s long-term credibility will depend on how well it delivers not only fiscal savings, but also tangible improvements in care, access, and outcomes.
The NHC remains committed to supporting CMS in the successful implementation of this historic program and stands ready to work together to ensure that people with chronic diseases and disabilities are at the center of every decision the program affects. Thank you again for the opportunity to provide input on this draft guidance. Please do not hesitate to contact Kimberly Beer, Senior Vice President, Policy & External Affairs at kbeer@nhcouncil.org or Shion Chang, Senior Director, Policy & Regulatory Affairs at schang@nhcouncil.org, if you or your staff would like to discuss these comments in greater detail.
Sincerely,
Randall L. Rutta Chief Executive Officer
1 Centers for Medicare & Medicaid Services, “Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request,” Federal Register 90, no. 95 (May 15, 2025): 20674, https://www.federalregister.gov/d/2025-08607.
2 Congressional Budget Office, Estimated Budgetary Effects of H.R. 5376, the Inflation Reduction Act of 2022: As Amended in the Nature of a Substitute (ERN22335) and Posted on the Website of the Senate Majority Leader on July 27, 2022, August 3, 2022, https://www.cbo.gov/system/files/2022- 08/hr5376_IR_Act_8-3-22.pdf.
5 T. Joseph Mattingly II, Anthony A. Esterly, and Anna Kaltenboeck, “Implementing Maximum Fair Price Without Hurting Pharmacies,” JAMA Health Forum 5, no. 5 (May 10, 2024): e240921, https://doi.org/10.1001/jamahealthforum.2024.0921.
6 Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Health Care Delivery System, Chapter 2, “Medicare Part B Drug Payment Policy Issues” (Washington, DC: MedPAC, June 2017), https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default- source/reports/jun17_ch2.pdf.
7 Gabriella M. McLoughlin et al., “Mending the Gap: Measurement Needs to Address Policy Implementation Through a Health Equity Lens,” Translational Behavioral Medicine 14, no. 4 (February 25, 2024): 207–14, https://doi.org/10.1093/tbm/ibae004.
8 Three Axis Advisors, Unpacking the Financial Impacts of Medicare Drug Price Negotiation: Analysis on Pharmacy Cash Flows, prepared for the National Community Pharmacists Association, January 2025, https://ncpa.org/sites/default/files/2025-01/January2025-ThreeAxisAdvisors-Unpacking-the-Financial- Impacts-of-Medicare-Drug-Price-Negotiation.pdf.
9 National Community Pharmacists Association, “NCPA to CMS: A Third of Independent Pharmacies Won’t Carry Drugs Subject to Government Price Controls,” NCPA Newsroom, January 27, 2025, https://ncpa.org/newsroom/news-releases/2025/01/27/ncpa-cms-third-independent-pharmacies-wont- carry-drugs-negotiated.
10 Julie A. Patterson, Hanke Zheng, and Jon D. Campbell, “Impacts of the Inflation Reduction Act on 2025 Formulary Coverage in Medicare Part D Plans,” Value in Health 28, no. S1 (May 2025): ISPOR 2025, Montréal, Quebec, Canada, National Pharmaceutical Council, https://www.ispor.org/heor- resources/presentations-database/presentation-cti/ispor-2025/poster-session-2/impacts-of-the-inflation- reduction-act-on-2025-formulary-coverage-in-medicare-part-d-plans.
11 National Health Council, Policy Recommendations for Reducing Health Care Costs, September 2021, https://nationalhealthcouncil.org/additional-resources/policy-recommendations-for-reducing-health-care- costs/#:~:text=The%20NHC%20strongly%20opposes%20policies,as%20defined%20by%20the%20patie nt.
12 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making, March 21, 2025, https://www.fda.gov/drugs/development-approval-process-drugs/fda- patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical.
13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care, April 2, 2025, https://www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage.
14 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement, March 2024, https://nationalhealthcouncil.org/wp- content/uploads/2025/05/Amplifying-the-Patient-Voice-Roundtable-and-Recommendations-on-CMS- Patient-Engagement-new-1.pdf.
16 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
17 John (Xuefeng) Jiang, Max Jiang, and Ge Bai, “Enforcing Hospital Price Transparency: Lessons From CMS Actions,” Health Affairs Forefront, December 3, 2024, https://doi.org/10.1377/forefront.20241202.645014.
18 Hanke Zheng, Julie A. Patterson, and Jonathan D. Campbell, “The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials,” Therapeutic Innovation & Regulatory Science, published April 22, 2025, https://doi.org/10.1007/s43441-025-00634-7.
21 Centers for Medicare & Medicaid Services, Marketing Models, Standard Documents, and Educational Material, November 5, 2024, PDF file, https://www.cms.gov/medicare/health-drug-plans/managed-care- marketing/models-standard-documents-educational-materials.
22 Rahul Aggarwal, Suhas Gondi, and Rishi K. Wadhera, “Comparison of Medicare Advantage vs Traditional Medicare for Health Care Access, Affordability, and Use of Preventive Services Among Adults With Low Income,” JAMA Network Open 5, no. 6 (June 2022): e2215227.
24 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
25 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
26 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series, March 21, 2025.
27 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
28 Centers for Medicare & Medicaid Services. CMS Framework for Healthy Communities. U.S. Department of Health and Human Services. February 28, 2025. https://www.cms.gov/priorities/health- equity/minority-health/equity-programs/framework.
29 Lisa Ann Baumann, Anna Katharina Reinhold, and Anna Levke Brütt, “Public and Patient Involvement in Health Policy Decision-Making on the Health System Level: A Scoping Review,” Health Policy 126, no. 11 (November 2022): 1156–1171, https://doi.org/10.1016/j.healthpol.2022.07.007.
30 U.S. Food and Drug Administration, FDA-Led Patient-Focused Drug Development (PFDD) Public
34 Centers for Medicare & Medicaid Services, Compliance Program Policy and Guidance.
35 David N. Bernstein and Jonathan R. Crowe, “Price Transparency in United States’ Health Care: A Narrative Policy Review of the Current State and Way Forward,” Inquiry 61 (May 26, 2024): 00469580241255823, https://doi.org/10.1177/00469580241255823.
36 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
37 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
38 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
39 Sarosh Nagar, Leah Z. Rand, and Aaron S. Kesselheim, “What Should US Policymakers Learn From International Drug Pricing Transparency Strategies?” AMA Journal of Ethics 24, no. 11 (2022): 1083– 1090, https://doi.org/10.1001/amajethics.2022.1083.
40 Eliana Barrenho and Ruth Lopert, Exploring the Consequences of Greater Price Transparency on the Dynamics of Pharmaceutical Markets, OECD Health Working Papers No. 146 (Paris: OECD Publishing, 2022), https://dx.doi.org/10.1787/c9250e17-en.
41 Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System, June 2020. Washington, DC: MedPAC.
42 Centers for Medicare & Medicaid Services, Medicare Prescription Drug Benefit Manual, Chapter 6 – Part D Drugs and Formulary Requirements (Baltimore, MD: U.S. Department of Health and Human Services), https://www.cms.gov/Medicare/Prescription-Drug- Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefit-Manual-Chapter-6.pdf.
43 Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System. Chapter 6, “Provider Networks and Prior Authorization in Medicare Advantage.” Washington, DC: MedPAC, June 2024. https://www.medpac.gov/document/june-2024-report-to-the- congress-medicare-and-the-health-care-delivery-system/.
44 U.S. Code of Federal Regulations, Title 42, § 423 Subpart M (2024), https://www.ecfr.gov/current/title- 42/part-423/subpart-M.
45 Ariel D. Stern, Michael E. Chernew, Adam L. Beckman, and J. Michael McWilliams, “Patient, Provider, and Health Plan Perspectives on Prior Authorization,” JAMA Network Open 5, no. 6 (2022): e2219943, https://doi.org/10.1001/jamanetworkopen.2022.19943.
47 Dana P. Goldman, Geoffrey F. Joyce, and Yuhui Zheng, “Prescription Drug Cost Sharing: Associations with Medication and Medical Utilization and Spending and Health,” JAMA 298, no. 1 (July 4, 2007): 61– 69, https://doi.org/10.1001/jama.298.1.61.
48 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series, March 21, 2025.
49 Barrenho and Lopert, Exploring the Consequences of Greater Price Transparency.
50 National Health Council. NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191–1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027. July 2, 2024. https://nationalhealthcouncil.org/wp-content/uploads/2024/07/NHC-Comments-RE-IPAY- 2027_07.02.24.pdf.
51 National Health Council. “NHC Comments on IRA Guidance Response.” April 14, 2023. https://nationalhealthcouncil.org/letters-comments/nhc-comments-on-ira-guidance-response/.
52 Caelesta Braun and Madalina Busuioc, “Stakeholder Engagement as a Conduit for Regulatory Legitimacy?” Journal of European Public Policy 27, no. 11 (2020): 1599–1611, https://doi.org/10.1080/13501763.2020.1817133.
53 Laura Esmail, Emily Moore, and Alison Rein, “Evaluating Patient and Stakeholder Engagement in Research: Moving from Theory to Practice,” Journal of Comparative Effectiveness Research 4, no. 2 (2015): 133–145, https://doi.org/10.2217/cer.14.79.
NHC Submits Comments on CMS Draft Guidance for IPAY 2028 (PDF)
June 26, 2025
Mehmet Oz, MD, MBA Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244
RE: Draft Guidance for the Medicare Drug Price Negotiation Program: Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028
Dear Administrator Oz:
The National Health Council (NHC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) draft guidance for the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028.
Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, equitable, and sustainable health care. Made up of more than 180 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.
This latest guidance reflects CMS’ continued efforts to operationalize the Inflation Reduction Act (IRA) through a negotiation framework that has expanded significantly in scope and complexity. As the program evolves, it is essential that cost-containment strategies are carefully balanced with safeguards that preserve timely, appropriate access to care. Ensuring that implementation remains transparent, predictable, and responsive to patient needs is critical to achieving these dual goals.
The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. We offer the following comments to help ensure that negotiated prices translate into meaningful affordability gains without undermining access to medically necessary treatments for people with chronic conditions and disabilities.
The NHC appreciates CMS’ continued efforts to refine implementation details in this draft guidance. At the same time, we emphasize that such refinements must not come at the expense of patient access. As the program expands to include Part B drugs, it is especially important to ensure that changes to reimbursement and program mechanics do not inadvertently disrupt access to clinically appropriate treatments. These developments present important opportunities to improve affordability and access— provided that the program is designed and implemented in a way that centers patient needs. Our comments are organized around key themes in the guidance, with emphasis on areas where additional clarity, patient engagement, or policy safeguards may be warranted. Across all sections, we prioritize the principles of meaningful patient input, clinical appropriateness, access preservation, and real-world transparency.
Inclusion of Part B Drugs: Scope, Challenges, and Opportunities
The addition of provider-administered therapies covered under Medicare Part B to the IPAY 2028 cycle introduces a fundamentally different reimbursement and care delivery context than that of pharmacy-dispensed Part D drugs. These therapies—often infused or injected biologics used to treat cancer, autoimmune conditions, and neurologic or rare diseases—are acquired by providers under the buy-and-bill model and reimbursed based on Average Sales Price (ASP) plus a percentage add-on. Applying the Maximum Fair Price (MFP) to these treatments will require significant adjustments to workflows related to drug acquisition, claims processing, and patient cost-sharing.1,2
If MFP-based reimbursement falls below actual acquisition costs—or introduces new uncertainties into revenue forecasting—providers, particularly those in smaller practices or rural areas, may face disincentives to administer these drugs. CMS should monitor for early disruptions to access and consider implementing temporary acquisition cost protections or transition payments. At the same time, the NHC recommends that CMS avoid incorporating the MFP into ASP calculations, as doing so could depress reimbursement rates across both Medicare and commercial markets, compounding access risks and straining provider viability.3
The NHC urges CMS to issue implementation guidance that accounts for the operational realities of Part B. A first priority is clarifying how providers should submit claims for drugs subject to the MFP. Because these therapies will no longer be reimbursed based on ASP + 6%, CMS must establish clear, practical billing instructions—including updated coding protocols, reconciliation pathways, and integration requirements for Medicare Administrative Contractors (MACs). These instructions should be released alongside a dedicated FAQ and include illustrative examples, edge-case scenarios, and transition considerations for off-cycle or multidose claims.4 CMS must also clearly articulate how the MFP will be operationalized at the point of sale, including through mechanisms such as the Medicare Transaction Facilitator (MTF). Without timely implementation guidance on effectuation systems— including claim-level reconciliation, data reporting standards, and real-time pricing updates—stakeholders across the supply chain, particularly community-based providers and pharmacies, face heightened risk of reimbursement errors, delays, and administrative burden. These disruptions could cascade into patient access barriers if not addressed before MFP-based pricing takes effect. Without such guidance, providers may face billing challenges that could delay reimbursement and patient care.
CMS must also clarify how overpayments—instances where provider reimbursement exceeds the MFP—will be reconciled. The draft guidance is vague on critical operational details, including the timeline for refunds, the responsible parties, and patient involvement in any refund process. Retroactive claims processing is common in Part B, so reconciliation mechanisms must be prompt and automated. CMS should specify whether coinsurance refunds to patients will be automatic or beneficiary-initiated and define the oversight mechanisms for ensuring consistency and timeliness.
Another area of concern is the potential impact of MFP reimbursement levels on provider participation, which in turn may create unintended consequences for patient access. If reimbursement under the MFP falls below the acquisition cost for a drug, or introduces new uncertainties into revenue forecasting, providers—particularly in smaller practices or rural areas—may opt not to stock or furnish these therapies.5 Past CMS experiences have demonstrated that even modest shortfalls between ASP and acquisition costs during periods of volatility or shortage have resulted in reduced provider uptake.6 CMS should monitor for such dynamics and consider whether temporary transition payments or acquisition cost safeguards are needed to preserve meaningful access for all patients, particularly during the early phases of implementation. As CMS explores reimbursement and refund mechanisms for Part B drugs subject to negotiation, it should also consider retrospective rebate models that do not depend on modifying ASP-based payment structures. For example, using a more stable benchmark—such as the difference between Wholesale Acquisition Cost (WAC) and the MFP—as the basis for a CMS-administered rebate could help preserve financial predictability for providers without distorting ASP. This approach may be particularly beneficial for community-based or rural providers that lack the margin flexibility to absorb discrepancies between acquisition cost and reimbursement.
CMS must further assess the downstream effects of MFP implementation on patient access. While lower coinsurance is a stated goal, it may be offset by service disruptions if providers reduce availability or shift patients to alternate sites of care.7 CMS should proactively identify high-risk access scenarios—such as high-cost therapies with limited provider margins or geographic areas with fewer providers—and implement safeguards including ombudsperson support, real-time appeals processes, and monitoring of site- of-care utilization trends. In particular, independent and community pharmacies may face significant cash flow challenges if they are reimbursed at the MFP but must continue purchasing products at higher pre-negotiation prices.8 CMS should evaluate whether advance payments, payment timing adjustments, or other interim protections are warranted to ensure that patients retain access to medications in these high-risk pharmacy settings during the transition period. Public reporting on provider participation rates and patient-reported access barriers would improve transparency and accountability.
To ensure a smoother transition, CMS should collaborate with patient and provider organizations to develop educational materials that explain the MFP’s implications for Part B therapies. These materials should be made available in multiple formats and languages and cover billing practices, coinsurance changes, and patient rights in plain language. CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. Even well-intentioned policies can create access disparities if communication and operational support are lacking.
Renegotiation of Previously Selected Drugs
The IRA anticipated that the clinical and economic value of a drug could evolve over time due to factors such as new FDA-approved indications, biosimilar entry, or shifts in real-world utilization. The IPAY 2028 guidance introduces a preliminary framework for addressing this evolution through potential renegotiation of MFPs. While the NHC acknowledges the rationale for establishing such a process, we emphasize that any renegotiation must be conducted with full transparency and careful monitoring of potential downstream effects on access. In particular, reductions in MFPs may have unintended consequences for formulary design, provider reimbursement, and patient cost-sharing, potentially deterring pharmacies or providers from offering affected therapies.9,10 It is critical that CMS weigh both clinical and access-related factors when considering renegotiation and take steps to mitigate any risks to timely and appropriate care.
CMS outlines four circumstances under which a drug may become eligible for renegotiation: the approval of a new FDA indication; a shift in exclusivity status; a material change in a statutory factor such as clinical benefit or unmet need; or a discretionary determination by CMS based on new evidence. While these triggers align with the statute’s intent, the operational details remain underdeveloped and warrant further clarification.
The process by which CMS will determine that a drug qualifies for renegotiation should be more transparent. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set. CMS should commit to issuing public notices of intent to renegotiate, followed by a defined comment period to allow patients, clinicians, and other affected parties to submit updated clinical data, real-world outcomes, and patient perspectives.11 The role of patient-centered evidence in the renegotiation process also requires greater definition. Although the statute references therapeutic benefit and unmet need, the draft guidance is silent on how CMS will gather and weigh patient-reported outcomes, registry data, or treatment experience narratives. Integrating these data sources would enable a more accurate reflection of a drug’s real-world impact, particularly for individuals with rare, complex, or poorly studied conditions.12
Another area of concern is the phrase “material change,” which appears throughout the guidance but is never defined. Stakeholders may interpret this threshold differently, leading to confusion or inconsistent application. CMS should develop and publish illustrative examples—drawn from clinical, economic, and operational contexts—to clarify the types of changes that would meet the threshold for triggering renegotiation.
The timing and cadence of renegotiation reviews is also unclear. The guidance references future IPAY cycles but does not specify whether CMS will review eligibility for renegotiation on a set schedule or only on an ad hoc basis. A regular review timeline—such as annual or biennial assessments—would promote consistency and allow stakeholders to anticipate upcoming changes, while still permitting expedited review in exceptional cases.
Renegotiation may also result in unintended consequences that extend beyond price. Changes in the MFP could influence formulary design, provider reimbursement, or patient cost-sharing. Without careful monitoring, a new price could prompt plans to reclassify a drug, alter utilization management policies, or introduce other access barriers. CMS should evaluate these downstream impacts and adopt safeguards to prevent disruptions in coverage or care continuity.13
Finally, CMS should ensure that the renegotiation process includes structured opportunities for stakeholder engagement beyond manufacturers. The current framework does not indicate whether public listening sessions, stakeholder briefings, or appeals pathways will be available to patient organizations, clinicians, or public health experts. Establishing a dedicated input process—separate from the manufacturer negotiation—would help ensure that decisions reflect not only cost data but also the lived experience of those affected by pricing changes.14
The inclusion of a renegotiation framework is an essential and forward-looking feature of IPAY 2028. However, to fully realize its promise, CMS must clarify its criteria, enhance transparency, and institutionalize patient engagement. A predictable, evidence-based, and participatory approach will ensure that the program remains responsive to evolving therapeutic landscapes while protecting uninterrupted patient access to care.
Inflation Rebate Integration with Negotiation
The IPAY 2028 draft guidance confirms that inflation-based rebates under the IRA will continue to apply to drugs selected for negotiation, even after the establishment of a MFP. This policy direction reflects Congress’s dual strategy to restrain drug price growth through complementary mechanisms: negotiated ceilings on drug prices for certain high-spend products and mandatory rebates for any drug—whether negotiated or not— that exceeds the inflation-adjusted price growth threshold.15
The continued application of the inflation rebate provision to drugs selected for negotiation reflects the IRA’s layered approach to managing costs within Medicare and the broader prescription drug market. While we recognize that this may introduce overlapping compliance requirements, the provisions serve complementary functions: the MFP sets a ceiling on Medicare reimbursement, while the inflation rebate provision is intended to promote long-term pricing stability. CMS should monitor the interaction of these mechanisms to ensure they do not inadvertently disrupt patient access or provider participation. In doing so, CMS must also remain attentive to the potential impact on future therapeutic development, particularly in areas of high unmet need or limited market competition. A balanced implementation approach—grounded in transparency, flexibility, and engagement—will be essential to advancing affordability while preserving incentives for continued innovation.
CMS should clarify how inflation rebate benchmarks will be maintained or recalculated when a drug transitions into or out of the negotiation program. For instance, if a previously rebated drug becomes subject to negotiation, it is unclear whether its inflation penalty benchmark would be frozen as of the MFP’s effective date or allowed to continue adjusting annually. Similarly, if a drug exits the negotiation program, it remains uncertain whether the benchmark would reset or revert to a prior methodology. Without clear parameters, stakeholders—including manufacturers, payers, and patient advocates—may be unable to anticipate the full pricing impact of program transitions.16
Further clarity is also needed on how CMS will reconcile violations involving both inflation rebate caps and MFP compliance. A manufacturer could, for example, fail to make the MFP available to dispensing entities while simultaneously triggering a rebate liability due to inflation-based price growth. The draft guidance does not specify whether such infractions are treated cumulatively, prioritized, or subject to adjustment. To minimize confusion and support consistent enforcement, CMS should publish a formal penalty reconciliation framework accompanied by practical examples.
The NHC also recommends that CMS enhance transparency around inflation rebate liabilities to support broader stakeholder understanding of the Inflation Reduction Act’s pricing provisions. Although the guidance outlines data collection and reporting obligations for MFP enforcement, it does not clarify whether manufacturers’ inflation rebate liabilities will be made publicly available or shared with non-manufacturer stakeholders. Greater visibility into these rebate trends could enable oversight of affordability trends, foster more informed public discourse, and allow patients and advocates to better anticipate the evolving cost burden on the Medicare program.
However, this information should remain analytically distinct from the renegotiation process, which must continue to focus on clinical and statutory factors as defined under the law.
Publishing case-based illustrations would further enhance stakeholder understanding. Examples could include: a drug newly selected for negotiation after previously incurring inflation rebates; a renegotiated drug experiencing a midyear price spike; or a product that shifts formulations or market position while remaining subject to both rebate and negotiation requirements. Illustrative case studies would help demystify the interaction of these provisions for manufacturers, providers, and beneficiaries alike.
Regular publication of enforcement metrics would also benefit the advocacy community. Semiannual reports should disclose the number of drugs assessed inflation penalties, total rebate amounts collected, and the portion of those totals attributed to MFP- selected drugs. Such metrics would enhance oversight, facilitate research into policy effectiveness, and enable patient advocates to better anticipate the impact of enforcement on care access.17
Finally, CMS should assess whether certain therapeutic areas—such as oncology or rare diseases—may be disproportionately affected by the cumulative impact of rebates and price caps. In markets with limited competition or high variability in dosing, even well-intentioned policies could lead to distorted plan behavior or adverse formulary decisions. A proactive analysis of these potential effects is warranted to ensure safeguards are in place to preserve access and avoid disincentivizing innovation.18
The continued application of inflation rebates to negotiated drugs reflects a coherent cost-containment strategy. However, its success depends on operational clarity, consistent enforcement, and open communication with affected stakeholders. By refining its guidance and sharing actionable examples, CMS can align these mechanisms in a way that delivers on the IRA’s goals without introducing unnecessary barriers or uncertainty.
Effectuation of the MFP: Operational Mechanisms and Patient Communication
Among the most technically complex—and most consequential—aspects of the IPAY 2028 draft guidance is CMS’ expanded discussion of how the MFP will be implemented at the point of care. This includes leveraging systems such as the MTF to manage payment flows, enforce price ceilings, and process refunds across both Medicare Part D and Part B drugs. While these backend functions may receive less attention than drug selection criteria or negotiation methodologies, they are pivotal to determining whether patients actually experience the financial protections promised under the IRA.
The NHC supports CMS’ ongoing investment in these infrastructure systems and appreciates the additional operational details included in the draft guidance. However, several unresolved issues remain—particularly in the areas of transparency, accountability, and procedural safeguards when the MFP is incorrectly applied.
CMS should clearly articulate how beneficiaries will be notified if they are charged cost- sharing based on an amount that exceeds the applicable MFP. Although beneficiaries are not typically responsible for the full MFP amount, current guidance does not require plans or providers to notify them when cost-sharing exceeds what would be owed under the MFP. Nor are refund processes standardized or consistently communicated across payers and providers. For many Medicare beneficiaries—particularly those with limited health literacy, digital access, or language proficiency—relying on self-monitoring or post hoc claims review is not feasible. CMS should require that point-of-sale systems include standardized alerts when patient cost-sharing exceeds the MFP-based amount and mandate that refund notices be issued in plain language, through both mail and electronic formats, as appropriate.19
Greater specificity is also needed regarding the refund and reconciliation process. The draft guidance mentions the possibility of retrospective refunds but does not outline how such refunds are initiated, how patients will receive them (e.g., direct deposit, mailed check, or copay credit), or how long processing will take. Without defined timelines or error thresholds, the system risks delays and inconsistencies that could erode public trust and deter patients from accessing needed therapies. CMS should also consider the operational realities faced by providers in implementing MFP-related processes. For example, requiring providers to maintain dual inventories under a prospective pricing model would likely be infeasible in many clinical settings—particularly community-based practices—and could divert resources away from patient care. Clear, consistent guidance on timing and reconciliation processes will be critical to avoiding unintended disruptions in therapy availability.
CMS should also establish a patient-facing error correction and appeals process. This should include a centralized portal and toll-free hotline that allows beneficiaries to report discrepancies, obtain assistance, and navigate dispute resolution. To ensure meaningful access for all patients, support staff should be trained in health literacy and disability communication standards.20
The NHC further recommends that CMS require Medicare Advantage (MA) plans and Part D sponsors to distribute standardized educational materials explaining MFP protections and refund procedures. These materials should be provided at the point of care, included with each Explanation of Benefits (EOB), and made available in both print and digital formats. They should be written in plain language and tailored to meet the needs of patients receiving physician-administered Part B drugs as well as pharmacy-dispensed Part D prescriptions.21
From the patients’ perspective, the value of the MFP lies in its consistent and reliable application. CMS should ensure that systems are in place to minimize errors and simplify the correction process when discrepancies occur. CMS should minimize the burden on beneficiaries by ensuring that refund and correction processes are clearly communicated, accessible, and timely. This concern is particularly acute for low-income and medically complex patients who may lack the time, resources, or familiarity with Medicare processes to resolve such issues.22
To promote accountability and system-wide learning, CMS should regularly publish metrics on MFP implementation. These should include the frequency of overcharges, average refund timelines, number of beneficiary complaints, and compliance rates among plans and providers. Public reporting of these data will support transparency, identify operational bottlenecks, and guide future improvements to the MTF and related systems.
In designing these systems, CMS should draw on lessons from past implementation challenges in other Medicare programs. Persistent issues with inaccurate copay collection and delayed reimbursements in Medicare Part D—particularly for dual-eligible individuals and beneficiaries with limited English proficiency—demonstrate how implementation gaps can disproportionately harm vulnerable populations.23 Applying these lessons to the MFP rollout is essential to prevent similar disparities.
Ultimately, implementing the MFP is not a peripheral administrative task—it is central to fulfilling the law’s promise of improved affordability. CMS must ensure that operational systems are seamless, transparent, and firmly rooted in the patient experience. Only then can the negotiated prices under the IRA be translated into meaningful, real-world access for the millions of Medicare beneficiaries who depend on these therapies.
Patient Listening Sessions
The NHC commends CMS for continuing to convene patient-focused listening sessions as part of the Medicare Drug Price Negotiation Program. These forums are among the only formalized mechanisms for patients and caregivers to share their lived experiences with selected drugs directly with federal regulators. As such, they serve a unique and irreplaceable function in shaping negotiation decisions beyond what clinical trial data and cost models can reveal.
Patient listening sessions are especially critical in surfacing perspectives on treatment burden, adherence challenges, quality-of-life impacts, and other patient-centered outcomes that may not be reflected in the evidence submitted by manufacturers. These sessions provide insight into how drugs function in real-world conditions—information that is vital to determining whether a treatment’s price reflects its true value across various patient populations.24
To ensure that listening sessions yield actionable, patient-centered insights, the NHC recommends the following process improvements focused on accessibility, clarity, and broad participation of stakeholders:
Beyond participation mechanics, CMS must also improve transparency regarding how patient input is used. The current process lacks adequate public feedback loops. While CMS may state that patient insights are “considered,” this phrasing is insufficient to assure stakeholders that their contributions have influenced policy outcomes.
The NHC urges CMS to publish post-session summaries that include the following elements:
Providing this level of transparency will build public trust, demonstrate procedural fairness, and reinforce that CMS is committed to evidence-informed, patient-centered decision-making—not just technical pricing models. Transparency in government engagement processes has been shown to increase both participation and perceived legitimacy, especially in high-stakes or politically sensitive programs.29
Furthermore, CMS should develop a centralized, publicly accessible archive of all patient listening session materials—including agendas, guidance prompts, anonymized summaries, and, where consent is granted, recordings. This will allow other stakeholders (e.g., academic researchers, patient organizations, and clinicians) to review patterns in patient-reported data and understand how those perspectives inform Medicare drug pricing decisions.30
Finally, we encourage CMS to formally invite participation from patient organizations, including those representing underserved and low-incidence populations who may otherwise be excluded from mainstream data collection. These groups can help identify unique patient experiences and ensure that less prevalent diseases and conditions are not overlooked during the negotiation process.
In sum, patient listening sessions represent one of the most tangible, high-impact ways that individuals and families can shape federal drug pricing decisions. CMS should continue to strengthen these forums as foundational elements of the program’s evidence base, ensuring that patient voices are meaningfully integrated into decision- making. By strengthening the format, ensuring meaningful access for all patients, and demonstrating a transparent link between testimony and policy action, CMS can uphold the spirit of the IRA and improve the health and financial well-being of Medicare beneficiaries nationwide.
Manufacturer Agreements and Compliance Requirements
The IPAY 2028 draft guidance builds on CMS’ authority under the IRA by outlining specific compliance expectations for manufacturers participating in the drug price negotiation program. These include timely execution of agreements, submission of required data, and accurate implementation of MFP across all Medicare Part B and Part D settings. While these measures are essential to program integrity, aspects of the compliance framework remain underdeveloped. Without greater procedural clarity and transparency, there is a risk that administrative errors—particularly those outside the control of the health care system’s end users, including patients—could lead to avoidable disruptions in access or affordability.
CMS states that manufacturers may face civil monetary penalties if the MFP is not made available to dispensing entities; however, the guidance does not specify whether enforcement actions will be automatic or discretionary, nor does it outline the severity thresholds that would trigger such penalties. This ambiguity may create uncertainty among manufacturers regarding the consequences of minor or unintentional errors, potentially discouraging timely participation or resulting in overly conservative implementation practices.31
In addition, the guidance does not explain how CMS will differentiate between systemic noncompliance and isolated, good-faith administrative mistakes—especially in cases where third parties (such as pharmacies, claims processors, or health systems) may have contributed to errors in MFP application. Patients should be protected from the downstream consequences of backend operational failures—including those stemming from third-party or manufacturer errors—that could result in delays, denials, or unexpected cost-sharing.
To improve the clarity and effectiveness of the compliance framework, the NHC recommends the following enhancements:
A well-calibrated compliance regime must balance firm oversight with fairness and operational realism. Enforcement approaches that lack transparency or patient-centered safeguards could unintentionally discourage participation or introduce legal uncertainty, ultimately reducing the availability of negotiated drugs. By contrast, a predictable, transparent framework that includes remediation for affected patients will promote both compliance and confidence in the negotiation process.35
The NHC remains committed to working with CMS to develop these guardrails and urges the agency to treat patients as central—not incidental—stakeholders in all phases of MFP enforcement and oversight.
Balancing Confidentiality and Transparency in Data Submission
The NHC supports CMS’ efforts to protect proprietary data while also ensuring that stakeholders have sufficient insight into the rationale behind pricing decisions. We believe that a balanced approach can foster both innovation and accountability. CMS’ reaffirmation of its confidentiality policies for manufacturer data submissions raises important questions about how the agency will balance the protection of proprietary information with the transparency needed to sustain public trust and stakeholder engagement. Under the IRA, CMS is authorized to collect sensitive data from manufacturers as part of the drug price negotiation process, including financial projections, cost structures, clinical benefit assessments, and research and development expenditures. The IPAY 2028 guidance reiterates CMS’ commitment to safeguarding trade secrets and proprietary commercial information, consistent with statutory obligations. The NHC supports the appropriate protection of confidential business information to encourage manufacturer participation and prevent anti- competitive misuse. However, we remain concerned that a confidentiality framework that is overly expansive or inconsistently applied could obstruct stakeholder engagement, limit public accountability, and weaken the legitimacy of MFP determinations. If transparency is the foundation of accountability, then CMS must ensure that stakeholders have sufficient visibility into the evidence and reasoning behind each pricing decision.
Several key concerns should be addressed to strike the appropriate balance:
To ensure appropriate transparency without compromising proprietary interests, CMS should adopt the following procedural safeguards when it does not compromise confidential or proprietary data:
Commercial confidentiality and public transparency are not mutually exclusive. Precedents from domestic and international programs demonstrate that drug pricing frameworks can protect sensitive business interests while maintaining enough transparency to foster public trust.39 International experience confirms that transparent decision-making is essential to the legitimacy, credibility, and durability of negotiation- based pricing systems.40
The NHC urges CMS to calibrate its confidentiality policies to reflect these dual imperatives. Drug price negotiation is not only a regulatory task—it is a public trust exercise. Without meaningful transparency, that trust cannot be earned or sustained.
Oversight of Part D Formulary Changes and Access Protections
The IPAY 2028 draft guidance provides a comprehensive update on the operational aspects of the Medicare Drug Price Negotiation Program across Parts B and D. However, it gives limited attention to how Part D plan sponsors might adapt to the implementation of MFPs, particularly with respect to formulary tiering, utilization management, and access protections. Additional clarity in these areas would be valuable, as plan decisions play a critical role in determining whether negotiated prices translate into meaningful improvements in patient access.
While lower list prices are designed to reduce out-of-pocket costs for beneficiaries, they may also result in unintended shifts in benefit design. Under current market dynamics, higher-cost therapies are often placed on non-preferred tiers because their elevated list prices enable larger manufacturer rebates. With the introduction of MFPs, the economic incentives surrounding these drugs may shift. As a result, some plans may reevaluate formulary placement or utilization management strategies based on updated cost structures. Without appropriate guardrails, such changes—though financially rational— may inadvertently limit access to clinically appropriate therapies.41
To support transparent and patient-centered implementation, CMS should reinforce expectations for plan behavior following MFP adoption. Specifically:
In addition, CMS should consider establishing a proactive monitoring framework to assess plan responses to MFP implementation. Publicly reporting on changes to prior authorization policies, tier placement, and coverage decisions—particularly for drugs newly subject to MFPs—can help promote transparency and inform future policy adjustments.
Finally, CMS should acknowledge that price reductions, while critical, do not automatically resolve all access challenges. Administrative complexities, such as prior authorization or language barriers, may still delay or hinder treatment, especially among older adults or those with limited digital literacy.45 Ongoing monitoring and stakeholder engagement can help identify and mitigate these challenges.
To ensure that the program’s intended cost savings translate into real-world patient benefit, CMS should work collaboratively with plans and other stakeholders to prevent unintentional access barriers and uphold high standards of patient care.
Implementation of MFPs for Part B Drugs: Challenges and Safeguards
The IPAY 2028 cycle marks a significant expansion of the Medicare Drug Price Negotiation Program, encompassing—for the first time—drugs reimbursed under Medicare Part B. This extension introduces a fundamentally different implementation environment from that of Part D. Whereas Part D drugs are typically dispensed at retail pharmacies and managed by private plans, Part B drugs are primarily administered in clinical settings and reimbursed directly to providers through the buy-and-bill model.
This operational distinction is more than procedural—it has real implications for how negotiated prices will be implemented, how providers will be informed, and how patients will experience the benefits of price reductions.
However, the inclusion of Part B raises urgent operational questions that must be addressed to ensure the program functions as intended. Without targeted safeguards and implementation supports, both patient access and provider participation may be jeopardized.
First, CMS must establish a clear, structured process for communicating MFP implementation details to providers—especially those practicing outside of major health systems. While large hospitals may have dedicated reimbursement departments and billing vendors with direct access to CMS updates, smaller or rural practices often depend on Medicare Administrative Contractors (MACs) and third-party systems for claims processing guidance. The IPAY 2028 guidance does not yet clarify when or how MFP-related billing instructions will be issued, nor whether providers will receive advance access to revised payment files, new codes, or billing modifiers. Absent clear communication protocols and advance notice, providers risk billing at incorrect rates, resulting in reimbursement denials or overcharges for patients.
Second, CMS must put in place accessible remedies for patients who are billed incorrectly for MFP-covered drugs. Under Part B, patients often receive bills post- service and may have no way of knowing whether the MFP was applied. CMS should implement a formal correction and refund process that includes standardized patient notices, dispute instructions, and active outreach in cases of systemic overbilling.
Requiring patients to initiate corrections—particularly those with cognitive, language, or technological barriers—would place an unfair burden on those least able to navigate administrative complexity.
Third, CMS must anticipate and address the administrative burden on MACs and billing software vendors. These entities will play a pivotal role in implementing MFPs for Part B drugs, and their readiness will directly affect patient access. CMS should publish a detailed implementation calendar and an operational guidebook specific to Part B, including timelines for provider education, MAC coordination, software updates, and dispute escalation procedures. Clear delineation of responsibilities among CMS, MACs, providers, and plans is essential for effective implementation.
Additionally, CMS should ensure that technical assistance is available to smaller and rural practices, which are often under-resourced and more vulnerable to administrative disruption. These providers historically face greater difficulty adapting to major billing changes and may be at higher risk of withdrawing from Part B drug administration altogether if the MFP implementation proves overly complex.46
To monitor for downstream effects, CMS should collect and publish data on provider behavior following the implementation of Part B MFPs. This includes tracking whether physicians reduce or stop offering affected drugs, switch to alternative therapies, or shift care to different sites, such as hospital outpatient departments, which may impose higher burdens on patients. Site-of-care shifts can have significant implications for access, cost-sharing, and continuity of care.47
Finally, CMS should commit to regular public reporting on key metrics related to Part B MFP implementation, such as billing accuracy, refund frequency, provider uptake, and changes in beneficiary access. Transparent reporting will not only support stakeholder confidence but also provide actionable insights to inform future negotiation cycles.
The success of MFP implementation for Part B drugs will depend on CMS’ ability to operationalize the policy with clarity, fairness, and patient-focused safeguards. Structured communication, meaningful patient protections, and accountability for all implementation partners are essential to ensure that negotiated prices translate into real-world benefits for Medicare beneficiaries.
Considerations for Future Drug Selection and Renegotiation
The NHC acknowledges CMS’ decision to outline a process for the potential renegotiation of previously selected drugs, as changes in clinical evidence and market conditions may warrant future price adjustments. While such a process could help ensure that MFPs remain aligned with therapeutic value and real-world use, it must include strong safeguards to prevent unintended consequences for patient access.
However, the draft guidance leaves several important questions unresolved— particularly around the transparency of the process, criteria for triggering review, and mechanisms for stakeholder input.
To promote predictability, legitimacy, and meaningful patient engagement, the NHC recommends the following enhancements:
While renegotiation is a critical mechanism for ensuring pricing reflects evolving evidence, it must be structured to reinforce—not undermine—trust in the Medicare Drug Price Negotiation Program. Clear criteria, transparent processes, and robust stakeholder involvement are essential to preserving access and legitimacy as the program matures.
Cross-Cutting Concerns: Transparency, Predictability, and Patient Trust
Despite the technical detail included in the IPAY 2028 draft guidance, many aspects of the Medicare Drug Price Negotiation Program remain opaque to patients, providers, and other external stakeholders. Implementation decisions—ranging from data confidentiality to enforcement priorities—often rely on internal processes that lack clear avenues for public insight or input. This lack of transparency poses a risk to the program’s credibility, particularly as the scope of negotiation expands and the number of affected drugs, beneficiaries, and provider types grows.
The long-term success of the program depends not only on generating cost savings for Medicare, but also on fostering trust with the public and ensuring that affected communities understand how the program works, why certain decisions are made, and how their input is used. Without a consistent structure for stakeholder engagement and public accountability, CMS may inadvertently undermine support for a program that is otherwise designed to promote patient affordability.
A continuing area of concern raised in the NHC’s previous comments relates to how CMS defines a potentially qualifying single source drug (QSSD).50,51 Specifically, CMS is considering whether to group together drugs that share “at least one active ingredient” when determining QSSD status for the purposes of negotiation. While intended to prevent gaming or patent extension strategies, this approach could inadvertently aggregate products that serve distinct therapeutic purposes or are used in different clinical contexts. Such grouping could limit transparency into how MFPs are derived and obscure distinctions that are highly relevant to patients.
The NHC is particularly concerned that overly broad grouping could discourage the development of new indications, forms of administration, or combination products that are meaningful to patients. For example, long-acting formulations, less painful injection methods, and fixed-dose combination therapies have each played a critical role in improving adherence and outcomes in conditions such as diabetes, autoimmune diseases, and HIV. These innovations often stem from incremental advances that would not be reflected in a grouping methodology focused narrowly on shared ingredients.
Therefore, the NHC urges CMS to engage patients directly to understand whether such advances constitute meaningful therapeutic improvements. Patient perspectives can help distinguish between clinically relevant innovation and superficial reformulations, guiding a more transparent and patient-centered application of QSSD criteria.
While CMS currently publishes MFP updates and related policy guidance, the NHC recommends that CMS further strengthen transparency by producing an annual summary report that includes plain-language explanations of negotiation methodology, incorporation of stakeholder feedback—particularly from patients—and data on downstream effects such as access and adherence trends.
CMS should also host public debriefing sessions following the close of each IPAY cycle. These sessions would offer an opportunity for beneficiaries, clinicians, manufacturers, and advocates to provide feedback on the negotiation process, including the effectiveness of communication materials, clarity of guidance, and any operational issues experienced during implementation. Feedback from these sessions should be incorporated into future guidance and shared through public summaries.
Finally, CMS should consider establishing a standing Patient Advisory Council to provide structured, ongoing input into the Medicare Drug Price Negotiation Program. This Council should reflect the diversity of the patient community and offer insights on proposed policy changes, listening session formats, educational materials, and implementation challenges. A formal advisory mechanism would help ensure that patient perspectives are consistently and meaningfully integrated into program development and refinement.
Programs that succeed in balancing regulatory rigor with stakeholder collaboration tend to enjoy stronger public legitimacy and compliance. When affected communities— especially patients and caregivers—can see how their insights shape outcomes, they are more likely to support program goals, adhere to new rules, and serve as trusted messengers to others in their networks. Conversely, when policy decisions appear opaque or unresponsive, skepticism and disengagement increase. Transparency and accountability are therefore not just governance principles—they are necessities for durable, patient-centered implementation of the negotiation program. 52,53
Conclusion
The IPAY 2028 draft guidance reflects an important evolution in the Medicare Drug Price Negotiation Program. The NHC acknowledges CMS’ efforts to expand the program to encompass physician-administered drugs under Part B, to clarify enforcement and compliance expectations, and to formalize criteria for renegotiating previously selected drugs. We also value the agency’s sustained focus on incorporating patient input and real-world evidence into the negotiation framework.
While commendable, we urge CMS to take further steps to embed the patient perspective in all facets of implementation. Whether through clearer operational protocols, transparent communication with beneficiaries, or access safeguards, the program’s long-term credibility will depend on how well it delivers not only fiscal savings, but also tangible improvements in care, access, and outcomes.
The NHC remains committed to supporting CMS in the successful implementation of this historic program and stands ready to work together to ensure that people with chronic diseases and disabilities are at the center of every decision the program affects. Thank you again for the opportunity to provide input on this draft guidance. Please do not hesitate to contact Kimberly Beer, Senior Vice President, Policy & External Affairs at kbeer@nhcouncil.org or Shion Chang, Senior Director, Policy & Regulatory Affairs at schang@nhcouncil.org, if you or your staff would like to discuss these comments in greater detail.
Sincerely,
Randall L. Rutta
Chief Executive Officer
1 Centers for Medicare & Medicaid Services, “Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request,” Federal Register 90, no. 95 (May 15, 2025): 20674, https://www.federalregister.gov/d/2025-08607.
2 Congressional Budget Office, Estimated Budgetary Effects of H.R. 5376, the Inflation Reduction Act of 2022: As Amended in the Nature of a Substitute (ERN22335) and Posted on the Website of the Senate Majority Leader on July 27, 2022, August 3, 2022, https://www.cbo.gov/system/files/2022- 08/hr5376_IR_Act_8-3-22.pdf.
3 Centers for Medicare & Medicaid Services, Medicare Part B Drug Average Sales Price, March 12, 2025, https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price.
4 Centers for Medicare & Medicaid Services, National Provider Communication Standards, April 15, 2025, https://www.cms.gov/files/document/national-provider-communication-standards.pdf.
5 T. Joseph Mattingly II, Anthony A. Esterly, and Anna Kaltenboeck, “Implementing Maximum Fair Price Without Hurting Pharmacies,” JAMA Health Forum 5, no. 5 (May 10, 2024): e240921, https://doi.org/10.1001/jamahealthforum.2024.0921.
6 Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Health Care Delivery System, Chapter 2, “Medicare Part B Drug Payment Policy Issues” (Washington, DC: MedPAC, June 2017), https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default- source/reports/jun17_ch2.pdf.
7 Gabriella M. McLoughlin et al., “Mending the Gap: Measurement Needs to Address Policy Implementation Through a Health Equity Lens,” Translational Behavioral Medicine 14, no. 4 (February 25, 2024): 207–14, https://doi.org/10.1093/tbm/ibae004.
8 Three Axis Advisors, Unpacking the Financial Impacts of Medicare Drug Price Negotiation: Analysis on Pharmacy Cash Flows, prepared for the National Community Pharmacists Association, January 2025, https://ncpa.org/sites/default/files/2025-01/January2025-ThreeAxisAdvisors-Unpacking-the-Financial- Impacts-of-Medicare-Drug-Price-Negotiation.pdf.
9 National Community Pharmacists Association, “NCPA to CMS: A Third of Independent Pharmacies Won’t Carry Drugs Subject to Government Price Controls,” NCPA Newsroom, January 27, 2025, https://ncpa.org/newsroom/news-releases/2025/01/27/ncpa-cms-third-independent-pharmacies-wont- carry-drugs-negotiated.
10 Julie A. Patterson, Hanke Zheng, and Jon D. Campbell, “Impacts of the Inflation Reduction Act on 2025 Formulary Coverage in Medicare Part D Plans,” Value in Health 28, no. S1 (May 2025): ISPOR 2025, Montréal, Quebec, Canada, National Pharmaceutical Council, https://www.ispor.org/heor- resources/presentations-database/presentation-cti/ispor-2025/poster-session-2/impacts-of-the-inflation- reduction-act-on-2025-formulary-coverage-in-medicare-part-d-plans.
11 National Health Council, Policy Recommendations for Reducing Health Care Costs, September 2021, https://nationalhealthcouncil.org/additional-resources/policy-recommendations-for-reducing-health-care- costs/#:~:text=The%20NHC%20strongly%20opposes%20policies,as%20defined%20by%20the%20patie nt.
12 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making, March 21, 2025, https://www.fda.gov/drugs/development-approval-process-drugs/fda- patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical.
13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care, April 2, 2025, https://www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage.
14 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement, March 2024, https://nationalhealthcouncil.org/wp- content/uploads/2025/05/Amplifying-the-Patient-Voice-Roundtable-and-Recommendations-on-CMS- Patient-Engagement-new-1.pdf.
15 Inflation Reduction Act of 2022, Pub. L. No. 117–169, 136 Stat. 1818 (2022). https://www.congress.gov/bill/117th-congress/house-bill/5376.
16 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
17 John (Xuefeng) Jiang, Max Jiang, and Ge Bai, “Enforcing Hospital Price Transparency: Lessons From CMS Actions,” Health Affairs Forefront, December 3, 2024, https://doi.org/10.1377/forefront.20241202.645014.
18 Hanke Zheng, Julie A. Patterson, and Jonathan D. Campbell, “The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials,” Therapeutic Innovation & Regulatory Science, published April 22, 2025, https://doi.org/10.1007/s43441-025-00634-7.
19 Centers for Medicare & Medicaid Services, Medicare Communications and Marketing Guidelines (MCMG), February 9, 2022, https://www.cms.gov/files/document/medicare-communications-and- marketing-guidelines-3-16-2022.pdf.
20 “CMS.gov Accessibility and Compliance with Section 508,” Centers for Medicare & Medicaid Services, September 10, 2024, https://www.cms.gov/about-cms/web-policies-important-links/accessibility- compliance.
21 Centers for Medicare & Medicaid Services, Marketing Models, Standard Documents, and Educational Material, November 5, 2024, PDF file, https://www.cms.gov/medicare/health-drug-plans/managed-care- marketing/models-standard-documents-educational-materials.
22 Rahul Aggarwal, Suhas Gondi, and Rishi K. Wadhera, “Comparison of Medicare Advantage vs Traditional Medicare for Health Care Access, Affordability, and Use of Preventive Services Among Adults With Low Income,” JAMA Network Open 5, no. 6 (June 2022): e2215227.
23 Medicare Part B Drug Average Sales Price, Centers for Medicare & Medicaid Services, March 12, 2025, https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales- price.
24 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
25 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
26 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series, March 21, 2025.
27 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
28 Centers for Medicare & Medicaid Services. CMS Framework for Healthy Communities. U.S. Department of Health and Human Services. February 28, 2025. https://www.cms.gov/priorities/health- equity/minority-health/equity-programs/framework.
29 Lisa Ann Baumann, Anna Katharina Reinhold, and Anna Levke Brütt, “Public and Patient Involvement in Health Policy Decision-Making on the Health System Level: A Scoping Review,” Health Policy 126, no. 11 (November 2022): 1156–1171, https://doi.org/10.1016/j.healthpol.2022.07.007.
30 U.S. Food and Drug Administration, FDA-Led Patient-Focused Drug Development (PFDD) Public
Meetings, March 21, 2025, https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led- patient-focused-drug-development-pfdd-public-meetings.
31 Centers for Medicare & Medicaid Services, Compliance Program Policy and Guidance, September 10, 2024, https://www.cms.gov/medicare/audits-compliance/part-c-d/compliance-program-policy-and- guidance.
32 Centers for Medicare & Medicaid Services, Compliance Program Policy and Guidance.
33 Centers for Medicare & Medicaid Services, Medicare Managed Care Appeals & Grievances, September 10, 2024, https://www.cms.gov/medicare/appeals-grievances/managed-care/grievances.
34 Centers for Medicare & Medicaid Services, Compliance Program Policy and Guidance.
35 David N. Bernstein and Jonathan R. Crowe, “Price Transparency in United States’ Health Care: A Narrative Policy Review of the Current State and Way Forward,” Inquiry 61 (May 26, 2024): 00469580241255823, https://doi.org/10.1177/00469580241255823.
36 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
37 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
38 National Health Council, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement.
39 Sarosh Nagar, Leah Z. Rand, and Aaron S. Kesselheim, “What Should US Policymakers Learn From International Drug Pricing Transparency Strategies?” AMA Journal of Ethics 24, no. 11 (2022): 1083– 1090, https://doi.org/10.1001/amajethics.2022.1083.
40 Eliana Barrenho and Ruth Lopert, Exploring the Consequences of Greater Price Transparency on the Dynamics of Pharmaceutical Markets, OECD Health Working Papers No. 146 (Paris: OECD Publishing, 2022), https://dx.doi.org/10.1787/c9250e17-en.
41 Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System, June 2020. Washington, DC: MedPAC.
42 Centers for Medicare & Medicaid Services, Medicare Prescription Drug Benefit Manual, Chapter 6 – Part D Drugs and Formulary Requirements (Baltimore, MD: U.S. Department of Health and Human Services), https://www.cms.gov/Medicare/Prescription-Drug- Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefit-Manual-Chapter-6.pdf.
43 Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System. Chapter 6, “Provider Networks and Prior Authorization in Medicare Advantage.” Washington, DC: MedPAC, June 2024. https://www.medpac.gov/document/june-2024-report-to-the- congress-medicare-and-the-health-care-delivery-system/.
44 U.S. Code of Federal Regulations, Title 42, § 423 Subpart M (2024), https://www.ecfr.gov/current/title- 42/part-423/subpart-M.
45 Ariel D. Stern, Michael E. Chernew, Adam L. Beckman, and J. Michael McWilliams, “Patient, Provider, and Health Plan Perspectives on Prior Authorization,” JAMA Network Open 5, no. 6 (2022): e2219943, https://doi.org/10.1001/jamanetworkopen.2022.19943.
47 Dana P. Goldman, Geoffrey F. Joyce, and Yuhui Zheng, “Prescription Drug Cost Sharing: Associations with Medication and Medical Utilization and Spending and Health,” JAMA 298, no. 1 (July 4, 2007): 61– 69, https://doi.org/10.1001/jama.298.1.61.
48 U.S. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series, March 21, 2025.
49 Barrenho and Lopert, Exploring the Consequences of Greater Price Transparency.
50 National Health Council. NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191–1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027. July 2, 2024. https://nationalhealthcouncil.org/wp-content/uploads/2024/07/NHC-Comments-RE-IPAY- 2027_07.02.24.pdf.
51 National Health Council. “NHC Comments on IRA Guidance Response.” April 14, 2023. https://nationalhealthcouncil.org/letters-comments/nhc-comments-on-ira-guidance-response/.
52 Caelesta Braun and Madalina Busuioc, “Stakeholder Engagement as a Conduit for Regulatory Legitimacy?” Journal of European Public Policy 27, no. 11 (2020): 1599–1611, https://doi.org/10.1080/13501763.2020.1817133.
53 Laura Esmail, Emily Moore, and Alison Rein, “Evaluating Patient and Stakeholder Engagement in Research: Moving from Theory to Practice,” Journal of Comparative Effectiveness Research 4, no. 2 (2015): 133–145, https://doi.org/10.2217/cer.14.79.