Applicable laboratories are required to report information to CMS for each clinical diagnostic laboratory test that the laboratory furnishes.
The Centers for Medicare & Medicaid Services (CMS) has launched the Clinical Lab Fee Schedule (CLFS) Module within its Fee-for-Service Data Collection System to begin collecting private payor rate data.
The data collection period, which follows the passage of the Consolidated Appropriations Act in February 2026, requires applicable laboratories to report information based on data from Jan 1, 2025, through June 30, 2025. The reporting period began May 1, 2026, and submissions must be completed by July 31, 2026.
Determining Applicable Laboratory Status
Because CMS cannot verify all information to determine laboratory status, the agency has issued guidance to help hospital outreach laboratories evaluate whether they qualify as applicable laboratories required to report.
According to the guide, laboratories that bill Part B under a hospital’s national provider identifier and determine status based on Medicare revenues from the 14x type of bill will likely meet the majority of Medicare revenues threshold. This is because these revenues are primarily or entirely derived from the CLFS or the physician fee schedule.
The reporting requirements are mandated by the Protecting Access to Medicare Act of 2014 (PAMA), which requires applicable laboratories to report information for each clinical diagnostic laboratory test they furnish.
Submission Resources and Registration
Laboratories must complete a registration process to access the module before gathering and submitting data. CMS has provided several resources to assist facilities, including a frequently asked questions document on PAMA reporting, a guide for hospital outreach laboratories, and a booklet containing reporting scenarios and examples.
Final data submissions must be completed through the module by the July 31 deadline. Inquiries can be directed to [email protected].
