As manufacturers with physician-administered drugs are aware, the Calendar Year (CY) 2026 Physician Fee Schedule (PFS) Final Rule introduced new requirements alongside the submission of Average Sales Price (ASP) data. These include the submission of Reasonable Assumptions and certification forms from recipients of any Bona Fide Service Fees (BFSF).

On April 8th, CMS issued updated FAQ guidance delaying these requirements: 

"Note about implementation: Due to delays in approval of the Paperwork Reduction Act (PRA) packaged to implement the requirement to submit reasonable assumptions and certification forms for BFSF, we are unable to collect this data for the first sales quarter of 2026. Therefore, new requirements as described in 42 CFR 414.804(a)(5)(ii) and (iii) are waived for the first sales quarter of 2026. We will provide updates regarding the availability of the forms and future reporting as they become available."

CMS FAQs (Updated 4/8/26)

CMS also postponed their ASP Data Collection System training webinar to July 7, 2026. (ASP Events)

While this gives manufacturers additional time to prepare, we anticipate these requirements will be in effect for the Q2 2026 ASP reporting cycle, with submissions due no later than July 30, 2026.

Lastly, CMS updated their package of templates and information: CMS PRA website. The revisions are open to a 30-day public comment period via the Federal Register Notice. Comments are due on May 7, 2026.

Woven will continue to monitor CMS updates and guidance. Please don't hesitate to reach out with any questions.