Section 1834A of the Social Security Act, as established by the Protecting Access to Medicare Act of 2014 (PAMA) and most recently updated by section 6226 of the Consolidated Appropriations Act, requires applicable laboratories to report specific data to the Centers for Medicare and Medicaid Services (CMS). For this cycle, applicable laboratories must report data collected from January 1, 2025, through June 30, 2025, during the reporting period of May 1, 2026, through July 31, 2026.
CMS launched the data collection system on May 1, 2026. Laboratories that fail to submit required data by 11:59 p.m. EST on July 31, 2026, may be subject to civil monetary penalties.
CMS is reaching out to potential applicable hospital outreach laboratories to provide updates on the data collection initiative supporting improvements to Medicare’s payment methodology. Action is required of hospital laboratories to verify their laboratory’s participation in this round of data collection. Applicable laboratories that fail to submit data may be subject to civil monetary penalties.
What are hospital laboratories asked to do?
Hospital laboratories will need access to the following information for the collection period to verify their applicable status:
- Clinical Laboratory Fee Schedule (CLFS), Medicare Physician Fee Schedule (PFS), and total Medicare revenues from the hospital lab’s own NPI or from the 14X TOB (if sharing NPI with the hospital) to confirm applicable status
- Final paid private payor rates and test volumes to report to CMS, if applicable
Hospitals that bill Part B under the hospital’s NPI will determine applicable laboratory status based on Medicare revenues from the 14x TOB and will likely meet the Medicare revenue threshold, requiring them to report.
Please carefully review this letter from CMS with detailed information on how to verify your lab, register in the CLFS module, and prepare and submit your data
What resources are available to hospital laboratories?
User guides, FAQs, quick reference guides, and a recording of an April webinar are available on the CLFS and PAMA Reporting Resources website.
Data collected through this initiative will inform Original Medicare laboratory payment rates for CYs 2027–2029. Broader participation leads to more representative data, helping CMS set payment rates that better reflect market rates as intended by PAMA.
Should you have any technical issues with registration or access to the CLFS Module, please contact CLFSHelpDesk@dcca.com. For all other policy-related questions, contact CLFS_Inquiries@cms.hhs.gov.
