Laboratory providers should be preparing for the next round of Clinical Laboratory Fee Schedule (CLFS) data reporting, with the window open May 1 through July 31, 2026. Applicable laboratories should be confirming reporting status and validating data now. Advis recommends:
- Confirming applicable laboratory status at the TIN level
- Identifying and registering individuals for the submitter and certifier roles within the Identity Management (IDM) system
- Validating applicable data from January 1, 2025 through June 30, 2025 for reporting
- Preparing and completing submissions within the above-noted window
Under the Protecting Access to Medicare Act of 2014, as updated by the Consolidated Appropriations Act of 2026, applicable laboratories must report private payor data used by CMS to establish future CLFS rates.
Applicable laboratories include independent labs billing Medicare Part B under their own NPI and receiving a majority of their Medicare revenues from the CLFS and MPFS, as well as most hospital outreach laboratories billing non-patient specimen services to Medicare under TOB 14X.
For this round of reporting, CMS requires granular data. Applicable labs must report:
- HCPCS Codes: Report each HCPCS code that each lab performed that is listed on the CLFS.
- Private Payor Rates: Report every individual private payor rate for which final payment was made. (As an example, if a single HCPCS code has five different contracted rates, each rate must be listed as a distinct entry.)
- Volume: Report the associated volume of tests performed for each specific rate.
CMS has increased outreach ahead of the reporting cycle, including notices to potentially applicable laboratories and a national webinar last week. CMS received a high volume of stakeholder questions and expects to release additional guidance, including compiled Q&A, in the near term.
Reporting is completed through the CMS Enterprise Portal at the TIN level, with a designated submitter and certifier for each TIN. Both individuals will need to register through the Identity Management (IDM) system using personal rather than business credentials. While an organization may report for multiple TINs, an individual should only be associated with one TIN within the system.
Advis is available to assist your organization in preparing and submitting these CLFS PAMA reports. Please reach out to your Advis contact with any questions or for support.
Published April 22, 2026
