How new CMS rules reshape ASP reporting and pricing operations

The Medicare Part B pricing landscape is shifting again. The Centers for Medicare & Medicaid Services (CMS) latest proposed updates raise the bar for how pharmaceutical manufacturers calculate and justify the average sales price (ASP). As part of the CY 2026 Medicare Physician Fee Schedule, the agency is moving toward tighter oversight and greater transparency, reshaping assumptions about price concession and ASP calculations. 

These changes will influence far more than reporting and compliance; they will affect pricing models, contracting structures, operational readiness and the financial dynamics that drive reimbursement. If you prepare now, you will be better positioned to adapt, reduce reclassification risk and build a more resilient pricing foundation. 

What is ASP? Why does it still matter?

ASP remains one of the most consequential pricing benchmarks in the U.S. healthcare system. Calculated as the weighted average of commercial prices after allowable concessions, ASP determines Medicare Part B  reimbursement at ASP + 6%. 

Even small shifts in definitions, documentation, or reporting practices can have meaningful downstream effects on you, providers and patients. CMS’s proposed updates aim to align reported prices more closely with actual market activity, reinforcing the need for accuracy, consistency and traceability. Much of the alignment rigor comes from integrating pricing, contracting and government reporting into a single, governed environment where assumptions, classifications and calculations are automated and transparent. Solutions like Vistex help support this level of operational discipline. 

Charting the changes: What CMS’s proposal means for ASP

CMS’s proposal introduces 2 major updates that will reshape how pharma manufacturers calculate and report average sales price. Each update focuses on:

• Tightening transparency
• Strengthening documentation
• Reducing variability in how price concessions are defined and reported

To understand the full impact of these shifts, let’s look at each update.

1. Clarifying the rules around bona fide service fees (BFSFs)

CMS is narrowing what qualifies as a BFSF, allowing exclusions from ASP only when a fee reflects a legitimate, itemized service rather than an indirect discount. This change places greater emphasis on documentation integrity and fee precision. 

Tighter standards for service legitimacy
You will now need to demonstrate that each BFSF corresponds to an actual, non-duplicative service. Itemized fee descriptions must align directly with the work performed, requiring a more structured approach to contracting, fee justification and validation.

Stronger documentation expectations
CMS expects formal documentation that substantiates fair market value, certifications confirming that fees are not passed to patients, and clear evidence that service arrangements are not functioning through disguised price concessions. A workflow-driven solution ensures classifications are consistent, evidence-based and audit-ready.

Greater reclassification risk
Fees lacking clear support may be recategorized by CMS as price concessions, lowering ASP and Medicare reimbursement. This makes bona fide service fee validation cycles, service definitions, and contract structures critical. Standardized approval logic and centralized documentation control, such as Vistex enterprise software, can reduce risk and ensure accuracy. 

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2. Expanding the requirements governing ASP calculation and reporting

CMS’s second major update broadens the scope of what pharmaceutical manufacturers must document, justify, and report in the ASP calculation. These changes affect every element that contributes to ASP, including assumptions, methodologies, price concessions and now Fair Market Value (FMV) documentation. 

Heightened documentation across ASP submission
CMS expects ASP submissions to be tied to clear, auditable processes, making centralized data and consistent governance essential. Pharma manufacturers leveraging an integrated enterprise software platform have an advantage: connecting pricing, contracting and government reporting inside a single source of truth. 

Mandatory fair market value (FMV) documentation
A key component of this ASP update is CMS’s requirement that FMV justification be provided for all service fees that may influence ASP. You must be prepared to:

• Provide FMV support for new, existing and renewed contracts
• Maintain ongoing FMV documentation
• Align with CMS’s forthcoming FMV template
• Supply FMV rationale for new, existing and renewed contracts

This elevates FMV from recommended practice to regulatory expectation. Centralizing FMV logic, documentation and approvals reduces manual efforts and supports stronger compliance.

Transparent reporting of “reasonable assumptions”
You will now be required to disclose the assumptions behind ASP calculations. This includes the methodologies used to classify fees, interpret concessions and handle incomplete data — the goal: greater consistency and fewer discrepancies in reporting approaches.  

Integrated maximum fair prices (MFP)
Under the Inflation Reduction Act (IRA), designated drugs will now have MFPs that must be incorporated into ASP calculations when applicable. This shift may lower ASP values and materially affect reimbursement, requiring updated financial models and closer coordination between government pricing, commercial pricing and finance. 

Navigating the impact: What the new ASP updates mean for your pharmaceutical company
Navigating changes will require more disciplined workflows, more structured documentation and closer alignment across commercial pricing, contracting, government pricing and finance. Pharma manufacturers using an integrated revenue, pricing and contract management solution like Vistex are better positioned to manage the increased complexity with full transparency. 

Understanding the ripple effect: How the proposed ASP rules may influence reimbursement
he combined impact of these updates may lower the ASP value through:

• Reclassification of certain fees as price concessions
• Inclusion of Maximum Fair Prices (MFPs)
• More conservative reporting practices driven by transparency requirements

Modeling these shifts early, supported by reliable data and automated scenario analysis, enables you to anticipate financial exposure and plan strategically.  

Looking ahead strategically: How pricing and contracting approaches must evolve
The proposed ASP updates may reshape how you structure contracts, negotiate service arrangements, and design pricing strategies. It’s essential to reassess:

• Bundled arrangements
• Complex service agreements
• Unbundling practices
• Alignment of commercial terms with regulatory expectations

Using an integrated enterprise software platform that connects commercial strategy to government pricing calculations and ASP reporting will allow you to navigate these changes more efficiently. 

Setting your course: Steps to get ready for the new ASP environment
To prepare for the new ASP environment, pharma manufacturers should:

• Audit all BFSF agreements for FMV compliance
• Reevaluate ASP methodologies
• Strengthen controls for classifications and assumptions
• Monitor CMS guidance as templates and protocols evolve
• Improve coordination between pricing, legal and government pricing teams

Investing early in an end-to-end solution, structured workflows and controlled documentation will help you prepare for the next era of ASP oversight.