Strategic Comment Opportunities in CMS’s iPAY 2028 Draft Guidance
The Centers for Medicare & Medicaid Services (CMS) has released its draft guidance for the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (iPAY) 2028. This guidance sets the direction for how Medicare will negotiate the prices of selected prescription drugs, including, for the first time, certain drugs covered under Medicare Part B. Public comments are now open and will help shape the final policies that impact drug pricing, pharmacy operations, and patient access across the country. Comments on the iPAY 2028 draft guidance are due by June 26, 2025.
What Is New in iPAY 2028?
The iPAY 2028 guidance builds on the first two cycles of negotiations by introducing several significant updates:
Inclusion of Part B Drugs: For the first time, drugs paid under Medicare Part B are eligible for selection and negotiation.
Renegotiation Criteria: The draft sets parameters for when CMS will revisit Maximum Fair Prices (MFPs) for previously selected drugs.
Implementation and Transparency: New details are provided on how negotiated prices will be applied, communicated, and enforced across the health care system.
You can review the full CMS iPAY 2028 Draft Guidance and Fact Sheet for more background.
Why Pharmacy Voices Matter
Pharmacies play a pivotal role in medication access, adherence, and patient education. Every change to drug pricing, reimbursement, or regulatory requirements has a direct impact on pharmacy workflow, revenue, and most importantly, patients. By providing feedback on CMS’s draft guidance, pharmacy professionals and organizations can help ensure the final rules reflect the realities of pharmacy practice and support patient-centered care. Participating in the comment process gives pharmacies a seat at the table and helps shape policies that will last for years to come.
10 Strategic Comment Opportunities
Below are ten areas within the iPAY 2028 draft guidance where pharmacy stakeholders can provide valuable input. For each, we’ve included (1) what CMS is proposing, (2) why it matters for pharmacies, and (3) example points to consider when commenting.
1. Inclusion of Part B Drugs in Negotiations
What CMS is Proposing: For the first time, CMS will include certain drugs payable under Medicare Part B in the Medicare Drug Price Negotiation Program for iPAY 2028. CMS plans to identify eligible Part B drugs by ranking single-source drugs based on total expenditures under Part B. The agency will use claims data to calculate each drug's expenditures, apportioning costs among products that share a Healthcare Common Procedure Coding System (HCPCS) code using average sales price (ASP) sales-volume ratios. CMS is also expanding the small biotech exception policy to address drugs payable under Part B.
Why It Matters: Part B drugs often have different reimbursement pathways, billing processes, and inventory requirements than retail prescription drugs. Including these drugs in negotiation could mean significant changes in how pharmacies manage their Part B product lines, how they are reimbursed, and how they coordinate with providers and payers. If new negotiated prices reduce margins or increase administrative steps, it could affect pharmacy participation and access for patients who receive infusions or injectables in outpatient settings.
Points to Consider:
Ask CMS to provide detailed guidance for pharmacies on billing changes.
Recommend transition resources for pharmacies new to Part B negotiation requirements.
Suggest CMS clarify how negotiated prices will affect reimbursement and purchasing workflows for pharmacy-administered drugs.
2. Renegotiation Criteria for Previously Selected Drugs
What CMS is Proposing: CMS outlines criteria for renegotiating the MFP of drugs previously selected in earlier negotiation cycles. A drug may be eligible for renegotiation if:
It receives a new FDA-approved indication.
Its status changes to an extended-monopoly or long-monopoly drug.
There is a material change in negotiation factors, such as clinical effectiveness or market dynamics.
CMS will conduct a holistic review to determine if renegotiation is likely to result in a significant change (15% or more) in the MFP and whether such a change would significantly impact the Medicare program.
Why It Matters: Unexpected price shifts can disrupt pharmacy purchasing, contract negotiations, and reimbursement forecasting. If a high-use drug is renegotiated suddenly due to a material change in factors, pharmacies may need to adapt quickly, impacting inventory, pricing for patients, and financial planning. Clear, predictable renegotiation criteria will allow pharmacies to plan ahead, avoid mid-year disruptions, and maintain steady patient access.
Points to Consider:
Ask CMS to publish detailed criteria in advance.
Recommend notification requirements for pharmacies and prescribers when renegotiations will impact MFPs.
Encourage CMS to consider the operational impact of mid-year or retroactive price changes on pharmacy contracts and patient access.
3. Effectuation of MFP at Pharmacies
What CMS is Proposing: CMS requires manufacturers to ensure that the negotiated MFPs are accessible to all Medicare beneficiaries through various dispensing entities, including pharmacies, mail-order services, hospitals, and physicians. This includes drugs covered under both Part D and, starting in 2028, Part B. Manufacturers must establish processes to provide access to the MFP for MFP-eligible individuals who are furnished or administered selected drugs.
Why It Matters: Operationalizing the MFP at the point of sale is complex, especially if manufacturers, PBMs, and payers are not aligned. Pharmacies need clarity on how to verify eligibility, ensure correct pricing for patients, and recoup reimbursements in real time. Without clear processes and support, pharmacies could face claim rejections, cash flow issues, or patient confusion at the counter.
Points to Consider:
Request that CMS provide clear, pharmacy-facing guidance and timelines for implementing MFP effectuation for Part B drugs.
Ask CMS to ensure the MTF system supports full claims reconciliation and payment tracking for all pharmacy types, including specialty and LTC pharmacies.
Recommend that CMS clarify how MFP processes will interact with existing pharmacy billing systems, including coordination with PBMs and wholesalers.
4. Transparency in MFP Calculations
What CMS is Proposing: CMS commits to publishing explanations for each MFP, detailing the factors considered during the negotiation process. This includes data on clinical benefit, unmet medical need, and manufacturer-specific information. CMS seeks feedback on how to enhance transparency in the negotiation process, including the data sources and calculation methods used.
Why It Matters: Without visibility into how MFPs are set, pharmacies may struggle to explain cost changes to patients, anticipate reimbursement shifts, or challenge errors. Transparency builds trust with patients, strengthens pharmacy-provider relationships, and helps pharmacies advocate effectively with manufacturers and plans.
Points to Consider:
Recommend that CMS publish the specific data sources and greater detail on the negotiation factors used for each drug’s MFP.
Suggest that summary explanations of MFP calculations be provided in plain language for pharmacy staff and patients.
5. Treatment of Fixed Combination Products
What CMS is Proposing: CMS addresses the treatment of fixed combination drugs—those containing multiple active ingredients—in the negotiation process. The agency proposes considering the distinct combination of active ingredients as a single qualifying single-source drug. CMS seeks public comment on how to handle fixed combination products, especially when one of the active ingredients is not biologically active against the disease state(s) the drug is indicated for.
Why It Matters: Pharmacies routinely dispense combination products. Misclassification or inconsistent pricing for these drugs could complicate billing, create compliance risks, and affect formulary status. If guidance isn’t clear, pharmacies could encounter discrepancies in reimbursement or patient copays and may have trouble navigating split codes or inventory management.
Points to Consider:
Urge CMS to clarify coding and reimbursement for combination products, especially when one component changes status.
Recommend guidance for pharmacies on inventory and dispensing when different MFPs might apply to single-ingredient and combo versions.
Request that CMS coordinate with PBMs and payers to minimize discrepancies in how combo products are adjudicated.
6. Administrative Burden and Compliance Requirements
What CMS is Proposing: CMS outlines various reporting, recordkeeping, and compliance responsibilities for manufacturers and other entities involved in the negotiation program. The agency seeks to reduce administrative burdens and is soliciting comments on ways to streamline processes while ensuring compliance. This includes considerations for manufacturer oversight, dispute resolution, and required documentation.
Why It Matters: New reporting or documentation requirements can divert staff from patient care, increase operational costs, and risk non-compliance penalties. Smaller or independent pharmacies, in particular, may lack resources to adapt quickly. Streamlined, pharmacy-friendly compliance policies can help maintain quality care and protect pharmacy viability.
Points to Consider:
Suggest that CMS conduct burden assessments with input from independent and rural pharmacies.
Request that compliance and reporting requirements be harmonized with existing pharmacy workflow and electronic systems.
Recommend simplified documentation or “safe harbor” processes for pharmacies acting in good faith.
7. Data Sharing and Confidentiality
What CMS is Proposing: CMS plans to collect and share certain data elements as part of the negotiation program, with confidentiality protections in place. The agency will implement a confidentiality policy respecting certain categories of data submitted by manufacturers, treating non-publicly available information as proprietary. CMS seeks feedback on data sharing protocols and additional safeguards needed to protect sensitive information.
Why It Matters: Sharing sensitive business or patient data raises privacy and security risks. Pharmacies must ensure compliance with HIPAA and state laws, safeguard competitive information, and maintain patient trust. Weak data protections could expose pharmacies to legal liability and reputational harm.
Points to Consider:
Urge CMS to specify exactly what pharmacy or patient data will be collected, how it will be stored, and who will have access.
Request that any data sharing requirements are HIPAA-compliant and that data minimization principles are used.
Suggest regular audits or reviews of CMS data security practices, with a channel for pharmacies to report concerns.
8. Integration with Pharmacy Systems
What CMS is Proposing: CMS acknowledges that implementing MFPs may require changes to pharmacy billing and dispensing systems. The agency is considering modifications to facilitate access to the MFP for individuals enrolled in Medicare Advantage plans and seeks comments on data or policy clarifications to support system integration.
Why It Matters: IT changes can be costly, time-consuming, and disruptive, especially when coordination with multiple vendors is needed. Poor integration could cause claim rejections, delayed payments, or errors in price adjudication. Pharmacies need support and clear standards to avoid operational headaches and ensure patients receive the correct price at the counter.
Points to Consider:
Recommend that CMS provide technical specifications and implementation guides well ahead of any changes.
Ask for funding or technical assistance for pharmacies needing to upgrade their billing or dispensing software.
Suggest a pilot period to test new integration requirements with diverse pharmacy settings before full rollout.
9. Education and Training for Pharmacy Staff
What CMS is Proposing: While not specified in detail, CMS recognizes that effective implementation of the negotiation program will necessitate training for pharmacy personnel. The agency is committed to providing accessible educational materials to Medicare beneficiaries and the pharmacies, mail-order services, and other dispensing entities that serve them. CMS seeks suggestions on strategies for education and resource allocation to ensure staff are prepared for the changes.
Why It Matters: If pharmacy staff aren’t adequately trained, errors may occur in pricing, eligibility determination, or claims processing. Knowledge gaps could also lead to patient dissatisfaction or compliance problems. Robust training and easy-to-access resources help staff stay current, support patients confidently, and ensure smooth implementation of new policies.
Points to Consider:
Request that CMS develop and distribute user-friendly training modules for pharmacy staff at all levels.
Recommend a centralized resource hub with up-to-date FAQs, video tutorials, and job aids on iPAY 2028 changes.
Suggest CMS engage pharmacy associations in outreach and feedback on educational needs.
Final Thought: Why Stakeholder Input Matters
Public comment periods are one of the few times stakeholders across the healthcare system can help shape how federal policy is implemented. CMS is explicitly seeking practical, operational feedback, and the insights of those closest to drug dispensing, pricing, and reimbursement are especially important.
Whether your organization is navigating Medicare Part B billing, managing specialty drug inventories, or working across policy and pricing functions, iPAY 2028 will likely introduce new complexities. Clear, constructive input from stakeholders with real-world experience can help CMS build a more workable and transparent implementation framework.
For Additional Context or Strategic Support
Coral Health Advisors provides regulatory insight and policy guidance for life sciences, pharmacy, and healthcare delivery organizations. We specialize in translating evolving federal policy into clear, actionable implications.
If you need help interpreting the draft guidance or developing comments tailored to your experience and needs, we’re available to support your process, without overcomplication. Let’s connect: Contact — Coral Health Advisors.