The pharmaceutical industry continues to navigate an increasingly complex government pricing and reimbursement landscape. This year’s discussions brought together manufacturers, legal experts, consultants, and industry partners to examine evolving requirements across government pricing, contracting, market access, and compliance.

One theme emerged across multiple sessions: government pricing can no longer be treated as a downstream reporting exercise. Decisions about fees, product launches, contracting, and distribution can have broader financial and compliance implications, making early coordination and ongoing oversight more important than ever.

Three topics stood out: the growing importance of bona fide service fee (“BFSF”) and fair market value (“FMV”) assessments, evolving Average Sales Price (“ASP”) compliance requirements, and the operational challenges surrounding product launches and the 340B program.

BFSF and FMV: Fee Arrangements Require Ongoing Monitoring

Bona fide service fees and fair market value assessments were heavily featured in this year’s discussions. As government scrutiny increases, manufacturers must reconsider how fees are structured, documented, and monitored over time.

Historically, fee assessments could occur after commercial arrangements were negotiated. With increased attention on ASP reporting and certifications, that sequence creates risk. Government Pricing, Legal, and Commercial teams need to evaluate potential implications earlier in the decision-making process.

Key considerations include:

• Reassess fee structures. Percentage-of-WAC arrangements should trigger greater attention. Manufacturers should understand the underlying dollar amounts and evaluate whether alternative structures, such as per-claim or per-member fees, are appropriate and supportable.
• Document the business rationale. Manufacturers should substantiate the need for each service, how it will be used, and whether the work delivered aligns with the contracted arrangement.
• Establish ongoing governance. Reassess arrangements when key assumptions change, including service volumes, methodologies, or regulatory requirements.

The broader takeaway is that BFSF and FMV are increasingly strategic business considerations. They should inform how arrangements are designed and approved, rather than simply validate decisions that have already been made.

ASP Compliance: Documentation is Increasingly Important

Discussions surrounding ASP reporting reinforced the importance of being able to explain not only the prices reported, but also the assumptions and decisions supporting those calculations. Reasonable Assumptions (“RAs”), fee certifications, and supporting documentation are playing an increasingly important role in the compliance process. Manufacturers need a repeatable approach for identifying where assumptions are necessary, documenting the rationale, and revisiting those assumptions as guidance and business practices evolve.

Practical priorities include:

• Keep RAs current. Review existing assumptions regularly to determine whether they still reflect current business practices and available guidance.
• Make documentation meaningful. Clearly build assumptions in areas where guidance is incomplete or interpretation is necessary, rather than repeating established requirements.
• Connect reporting with contracting decisions. Changes to fees, agreements, or commercial practices should trigger an assessment of potential government pricing implications before they are finalized in contracts.

Manufacturers should continue monitoring CMS guidance and future rulemaking. Questions remain about how certain requirements will be interpreted and implemented, particularly for fee arrangements, bundled transactions, and certifications involving third-party service providers.

340B: Program Growth and Policy Changes Create Continued Uncertainty

The 340B program remains an area of focus as manufacturers navigate legal challenges, and potential changes to program administration. Conference discussions highlighted the scale of the program, ongoing disputes over contract pharmacy access, and persistent questions surrounding patient definitions and duplicate discounts. 

The 340B Rebate Model Pilot was discussed alongside broader questions about program oversight and implementation. While the pilot represents a different approach to how 340B discounts may be administered, the pilot is limited in scope. Still, manufacturers may want to assess how a broader rebate model could affect their processes, data needs, and reconciliation activities.

Looking ahead

This year’s discussions reinforced that Government Pricing is increasingly interconnected with commercial strategy, market access, finance, legal, and broader compliance operations.

Manufacturers should prioritize three actions:

• Bring Government Pricing into decisions earlier. Evaluate the potential impact of fees, contracts, and commercial changes before arrangements are finalized.
• Strengthen documentation and governance. Establish clear decision rights, maintain support for key assumptions, and define when arrangements should be reassessed.
• Build adaptable processes. Monitor regulatory developments and ensure launch plans, reporting procedures, and cross-functional responsibilities can accommodate new requirements.

Want to discuss what these developments mean for your organization? Connect with our team to explore how evolving government pricing requirements may affect your processes, compliance priorities, and documentation needs.

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