Clinical Laboratory Fee Schedule
Guidance for clinical laboratory fees for CDLT and CAH.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: December 13, 2019
IMPORTANT UPDATE: On September 26, 2024, Section 221 of the Continuing Appropriations and Extensions Act, 2025 was passed and delayed data reporting requirements for clinical diagnostic laboratory tests (CDLTs) that are not advanced diagnostic laboratory tests, and it also delayed the phase-in of payment reductions under the CLFS from private payor rate implementation. Please see below for the following changes:
- The next data reporting period will be from January 1, 2026 – March 31, 2026 and based on the original data collection period of January 1, 2019 through June 30, 2019.
- A 0% payment reduction will be applied for CY 2025 so that a CDLT that is not an ADLT may not be reduced compared to the payment amount for that test in CY 2024, and for CYs 2026-2028 payment may not be reduced by more than 15-percent per year compared to the payment amount established for a test the preceding year.
- After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs (that is 2029, 2032, etc.).
What’s the CLFS?
We pay for most clinical diagnostic laboratory tests (CDLTs) based off the weighted median of private payor rates (fee schedule). Typically, we update the payment rates using private payor rates every 3 years. This is based on The Protecting Access to Medicare Act (PAMA).
These amounts are based on information laboratories submit during a data collection period. There are 3 steps in the process:
- Collect data (data collection period): Laboratories submit applicable information.
- Analyze data (reviewing window): Laboratories and their reporting entities determine whether they meet the majority of Medicare revenues and low expenditure thresholds. Be sure to review and validate applicable information before you report it.
- Report data (data reporting period): Reporting entities report applicable information to us. The next data reporting period is January 1–March 31, 2026. Learn more about reporting data.
What’s a private payor?
These are private payors:
- A health insurance issuer
- A group health plan
- A Medicare Advantage Plan
- A Medicaid Managed Care Organization
What happens next?
After the next data reporting period, there’s a 3-year data reporting cycle for CDLT. We update the rates under the CLFS every 3 years.
When are the rates effective?
We’ve extended the statutory phase-in of payment reductions resulting from implementing the private payor rate.
| Year | Data Collection Period | Data Reporting Period | Reduction Cap |
|---|---|---|---|
| 2020 | January 1, 2016 – June 30, 2016 | January 1, 2017 – May 30, 2017 | 10% |
| 2021 | January 1, 2016 – June 30, 2016 | January 1, 2017 – May 30, 2017 | 0.0% |
| 2022 | January 1, 2016 – June 30, 2016 | January 1, 2017 – May 30, 2017 | 0.0% |
| 2023 | January 1, 2016 – June 30, 2016 | January 1, 2017 – May 30, 2017 | 0.0% |
| 2024 | January 1, 2016 – June 30, 2016 | January 1, 2017 – May 30, 2017 | 0.0% |
| 2025 | January 1, 2016 – June 30, 2016 | January 1, 2017- May 30, 2017 | 0.0% |
| 2026 | January 1, 2016-June 30, 2016 | January 1, 2017-May 30, 2017 | 15% |
| 2027 | January 1, 2019 – June 30, 2019 | January 1, 2026 – March 31, 2026 | 15% |
| 2028 | January 1, 2019 – June 30, 2019 | January 1, 2026 – March 31, 2026 | 15% |
Contact us
- Information on final rules: CLFS_Inquiries@cms.hhs.gov
- Information on the data collection system: clfshelpdesk@dcca.com
For more information
- View the CLFS files
- View the Summary of Private Payor Rate-Based Medicare Clinical Laboratory Fee Schedule (PDF)
- View the CLFS Applicable Raw Data File (from 2017 reporting)
- View the CLFS Applicable Information HCPCS Codes (ZIP)
- Visit the Clinical Labs Center for more clinical laboratory provider and supplier information
- Get Medicare Learning Network® (MLN) updates
HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.