Protecting Access to Medicare Act

Applicable laboratories

Certain laboratories that meet criteria established by the Centers for Medicare & Medicaid Services (see more below) are required to report Healthcare Common Procedure Coding System (HCPCS) laboratory codes, associated private payor rates, and volume data.

Find out if your lab is considered "applicable."

Importantly, labs that did not report in 2017 may now be required to report. Do not rely on whether your lab reported in 2017 or not.

Note: CMS is sending a letter by mail to entities that it believes are applicable laboratories. However, keep in mind that it may have outdated contact information and the letter may not reach the right person.

---

Data-collection period

In early 2026, when the Consolidated Appropriations Act was signed into law, the PAMA data-collection period changed. It is now from Jan. 1, 2025, through June 30, 2025.

---

Reporting period

Reports must be submitted between May 1 and July 31, 2026. Submitting early will allow CMS to review your data and contact you if there are issues.

---

What needs to be reported

• CLFS HCPCS code associated with the test (See HCPCS code list.)
• Each private payor rate for which final payment has been made during the data-collection period
• The associated volume of tests performed corresponding to each private payor rate
• NPI number

Note: See slides from AMP's March 2026 webinar for additional guidance.

---

How does a laboratory submit a report?

Use the CLFS Data Collection Module within the Fee-for-Service Data Collection System (FFSDCS) accessed via the CMS Enterprise Portal.

Download a guide for registering with the portal.

Make sure you understand which two employees should do the reporting.

• See guide for submitters.
• See guide for certifiers.

---

What happens if a lab does not report?

CMS has the authority to issue civil money penalties — up to $10,000 per day (adjusted for inflation) for each failure to report or each such misrepresentation or omission.

---

How will the reported data be used?

The weighted median will be the determined payment rate for 2027–2029.