Clinical Laboratory Fee Schedule

For more information regarding the CLFS Data and Reporting for CDLTs, please visit the CMS PAMA webpage.

IMPORTANT UPDATE: Next CLFS Data Reporting Period for Clinical Diagnostic Laboratory Tests - DELAYED 

• On December 10, 2021, the “Protecting Medicare and American Farmers from Sequester Cuts Act” (S. 610) was passed and delayed the reporting requirement under Section 1834A of the Act and also delayed the application of the 15% phase-in reduction.   
• Section 1834A of the Act, as established by Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under the CLFS. The CLFS final rule “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (CMS-1621-F) was published in the Federal Register on June 23, 2016. The CLFS final rule implemented section 1834A of the Act. Under the CLFS final rule, reporting entities must report to CMS certain private payer rate information (applicable information) for their component applicable laboratories. The data collection period (the period where applicable information for an applicable laboratory is obtained from claims for which the laboratory received final payment during the period) was from January 1, 2019 through June 30, 2019.
• The next data reporting period of January 1, 2023 through March 31, 2023, will be based on the original data collection period of January 1, 2019 through June 30, 2019.
• After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2026, 2029, etc.).
• The statutory phase-in of payment reductions resulting from private payor rate implementation is extended, that is, through CY 2024. There is a 0.0 percent reduction for CYs 2021 and 2022, and payment may not be reduced by more than 15 percent for CYs 2023 through 2025.
   

Effective January 1, 2018, CLFS rates will be based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014. For more details, visit PAMA Regulations. CMS held calls on the final rule and data reporting. For links to the slide presentations, audio recordings, and written transcripts, see CMS Sponsored Events.   

Fee Schedule Through December 31, 2017

Outpatient clinical laboratory services are paid based on a fee schedule in accordance with Section 1833(h) of the Social Security Act. Payment is the lesser of the amount billed, the local fee for a geographic area, or a national limit. In accordance with the statute, the national limits are set at a percent of the median of all local fee schedule amounts for each laboratory test code. Each year, fees are updated for inflation based on the percentage change in the Consumer Price Index. However, legislation by Congress can modify the update to the fees. Co-payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee schedule.

Each year, new laboratory test codes are added to the clinical laboratory fee schedule and corresponding fees are developed in response to a public comment process. Also, for a cervical or vaginal smear test (pap smear), the fee cannot be less than a national minimum payment amount, initially established at $14.60 and updated each year for inflation.

Critical Access Hospitals

Critical access hospitals are generally paid for outpatient laboratory tests on a reasonable cost basis, instead of by the fee schedule, as long as the lab service is provided to a CAH outpatient.

Clinical Laboratory Center

For a one-stop resource webpage for Medicare Fee-for-Service (FFS) clinical laboratory providers and suppliers, visit the Clinical Laboratory Center.