CY 2026 Physician Fee Schedule Final Rule Update: Preliminary ASP Reasonable Assumption and BFSF Certification Forms Available

Background on the PRA and Timing of the Issuance

Under the PRA, at 42 U.S.C. § 3506, agencies are expected to provide 60-day notice in the Federal Register for each proposed information collection or form, with an opportunity for the public and affected agencies to comment, regarding the necessity of the information collection, the accuracy of the agency’s burden estimate, how to enhance the “quality, utility, and clarity” of the information to be collected, and how to minimize burden on those that will be required to respond. After this initial notice and comment period, and after the agency has updated the form as appropriate, the form is submitted to the Office of Information and Regulatory Affairs at OMB for review in parallel with a second public-facing 30-day notice and comment period under 42 U.S.C. § 3507.

The above-linked template forms have been published under CMS’s PRA listing for form CMS-10110 (an existing form that also includes several older average sales price (ASP)-related documents). For various reasons, it is not fully clear when the forms in their current iteration were initially published. However, CMS does not appear to be accepting comments. That said, as noted above, we expect there may be updated versions of the forms published and that there would be at least a 30-day comment process once that happens, consistent with the PRA process.

Contents of the Proposed Template Forms

As noted above, CMS has published what appears to be preliminary template forms for reasonable assumptions and for BFSF pass-through prohibition compliance certifications. In the Final Rule, CMS stated that it would issue such forms to be submitted with quarterly ASP pricing data beginning with the Q1 2026 submission, due 30 days after the end of each calendar quarter though the ASP Data Collection System:

1. A template reasonable assumption submission; and
2. A template certification form regarding the pass-through prohibition prong of the BFSF test.

Regarding the reasonable assumption template, CMS states in the template form that it will allow manufacturers to upload an “Assumption File” to the ASP Data Collection System using the specified form, which can be supplemented as needed with an attached cover letter, with each reasonable assumption category subject to a 7,666-character limit. However, in contrast, the ASP Submitter User Guide indicates that the information is to be copied into text boxes for each reasonable assumption category with a 1,000-character limit, which can be supplemented with an upload in the “other” reasonable assumptions category. Both the current draft of the form and the ASP Submitter User Guide include the following topic categories:

• “Overview of contractual arrangements that the submitting manufacturer has with entities for which it pays a [BFSF] as well as the fair market value analysis for service arrangements each time an arrangement is issued or renewed.”
• “Overview of bundled sales arrangements” and each arrangement’s “discount reallocation.”
• “List and [provide an] overview of price concessions and discounts for products or transactions,” including whether they are lagged or not, stacked, or prompt pay.
• Confirmation of “how [the manufacturer] will report products with zero, negative, or false positive ASPs.”
• Confirmation of how “[the manufacturer] will report sales excluded from Medicaid Best Price.”
• Confirmation of “how [the manufacturer] factor[s] the time value of money in the ASP calculation.”
• A “[r]eview of any free goods not contingent on a purchase requirement,” including coupon, copay assistance, voucher, free good, and patient assistance programs.
• Confirmation of how manufacturer accounts “for any value-based purchasing arrangements in the ASP calculation.”
• Confirmation of “how sales to 340B covered entities are considered in the ASP calculation.”
• Confirmation of “how returned goods will be treated in the ASP calculation.”
• Confirmation of “how [the manufacturer] process[es] transactional issues that may require a credit or rebill.”
• Any other reasonable assumptions.

Regarding the BFSF pass-through compliance prohibition certification form, the current draft of the form would require manufacturers to submit, for each BFSF:

• “[A]ll drug and manufacturer information associated” with that fee;
• Details on the recipient of the fee, including the certifying individual’s name and title, organization and entity name and address, bona fide service, and BFSF amount, including a description about how the fee varies based on “certain metrics” to the extent applicable; and
• A certification signed by the manufacturer and certifier, which states “I certify that the fee is not passed on in whole or in part to an affiliate, client, or customer of an entity” (emphasis added).

Notably, CMS specified in the Final Rule that the certification statement should only apply with respect to whether a fee is passed on in whole or in part to a client or customer of an entity, not an affiliate. Thus, the current template appears to be based on the Proposed Rule and not the Final Rule. At minimum, this provision of the form should be changed, but as noted above, as of the date of this alert, we have not seen updated version of these forms posted at OMB for further comment. We will continue to monitor this space for further developments, including updated forms, as applicable.

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As always, it is important that you carefully review the forms in light of considerations that may be relevant to your organization and specific drugs. Please feel free to contact the Hogan Lovells Health Team if you have any questions or concerns.

Authored by Alice Valder Curran, Maura Calsyn, Kathleen Peterson, Samantha D. Marshall, Mahmud Brifkani, Viraj Paul, and Sydney Fay.