It has been an especially active period for federal rule making, and, this year, that extended to the Calendar Year (CY) 2026 Physician Fee Schedule (PFS) Final Rule for “buy and bill” drugs. The rule was finalized in early November of 2025 and became effective on January 1, 2026. The first set of new requirements will apply to the Q1 2026 Average Sales Price (ASP) reporting and must be submitted no later than April 30, 2026.

Among other updates, CMS will now require manufacturers that report ASP to submit additional documentation via the FFSDCS / ASP - Modernization application, where pricing is certified. Specifically, manufacturers must provide:

1. Reasonable Assumptions in Reporting of Manufacturer’s ASP
2. Bona Fide Service Fee Certification Form

While any new reporting requirement needs thoughtful implementation, the compressed timeline for the first submission, combined with the potential need to coordinate with commercial partners for the certification form, has made this process particularly challenging for manufacturers.

Notably, this month CMS published a "Frequently Asked Questions", which outlines their position on many of the questions we at Woven have been hearing from manufacturers. The FAQ also includes links to the current templates and related materials (download link). 

This package is still under comment period until March 2nd. Any additional changes would be finalized after.

Please reach out with any questions!

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