CMS opens new resources ahead of 2026 PAMA reporting window

Clinical laboratories should begin preparing now for the next round of Medicare Clinical Laboratory Fee Schedule (CLFS) private payor data reporting under PAMA. The Centers for Medicare & Medicaid Services (CMS) has confirmed that the next reporting period will run from May 1, 2026, through July 31, 2026, and that applicable laboratories will report private payor data collected from January 1, 2025, through June 30, 2025. CMS has also indicated that under the Consolidated Appropriations Act, 2026, there will be no CLFS payment reductions in 2026, with payment reductions set to resume on January 1, 2027.

To help laboratories prepare, CMS has updated its CLFS/PAMA reporting webpage with several operational resources, including new FAQs, the applicable HCPCS code list, the CLFS Submitter and Certifier user guides, and the CLFS data reporting template. These materials provide important guidance for laboratories that may be subject to reporting and should be reviewed well before the May 1 opening of the reporting window.

Laboratories should focus on these immediate steps:

• Complete CLFS Submitter and Certifier registration as soon as possible. CMS’s submitter guide explains that reporting entities must register within the CLFS module and associate their TIN and NPI information before they can move forward in the system. The guide also states that only one CLFS Submitter and one CLFS Certifier per TIN and NPI is allowed, underscoring the need to identify and approve the right personnel in advance.
• Review whether your organization meets the applicable laboratory definition and reporting thresholds. CMS explains that applicable laboratories generally must meet both the majority of Medicare revenues threshold and the low expenditure threshold, including receiving at least $12,500 in Medicare CLFS revenues during the data collection period. The agency also reiterates that reporting is conducted by the TIN-level reporting entity, which reports applicable information for component applicable laboratories.
• Validate the data that must be reported. CMS states that “applicable information” includes the specific HCPCS code associated with the test, each private payor rate for which final payment has been made during the data collection period, and the associated volume of tests performed corresponding to each private payor rate. Laboratories should also review the CMS code list and organize private payor rate and volume data well ahead of the reporting deadline.

With the reporting window approaching, laboratories should use the coming weeks to confirm whether they are applicable laboratories, complete registration, review CMS’s materials, and validate the data they will need to report. While Congress delayed the next scheduled round of PAMA cuts until 2027, the 2026 reporting cycle is moving forward, and timely preparation will be critical to compliance.

ADLM will continue to keep members informed as implementation moves forward and is actively working alongside allied stakeholders to fix longstanding flaws in PAMA and advocate for reforms that better support patient access and the clinical laboratory community.