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Clinical Laboratory Fee Schedule
Outpatient clinical laboratory services are paid based on the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) 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 are paid for outpatient laboratory services on a reasonable cost basis, instead of by the fee schedule. Hospitals with fewer than 50 beds in qualified rural areas—those with population densities in the lowest quartile of all rural areas—are paid based on a reasonable cost basis for outpatient clinical laboratory tests for cost reporting periods between July 2004 and July 2006.
The Protecting Access to Medicare Act of 2014 (PAMA) that became law on April 1, 2014, required labs to report such data and the test volumes associated with that data, beginning on Jan. 1, 2016.
On Jan. 1, 2017, CMS will use the market data to set prices for the Part B Clinical Laboratory Fee Schedule. As currently written, PAMA specifies that CMS cannot cut the price of a specific lab test by more than 10% in each of 2017, 2018, and 2019, nor by more than 15% in each of 2020, 2021, and 2022. There is no limit on price reductions outlined in the law for years following 2022.
Test price data shows major difference between Medicare lab fee schedule and private payers
This is an excerpt from a 1,500-word article in the November 7 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: THE DA…
10% PAMA Fee Cut Would Lower Medicare Pay to Laboratories by $400 Million
CEO SUMMARY: Just eight weeks remain before certain clinical laboratories must begin submitting private payer lab test price data to the federal Centers for Medicare & Medicaid Services. A new report …
Labs Have Heavy Burden to Report Lab Price Data
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
XIFIN Analysis of Its Real Price Data Shows Hospital Lab Price Effect
CEO SUMMARY: In a new analysis of data its lab clients will use to report market prices to CMS, XIFIN Inc., reports private payers paid independent labs a weighted average price that was 19.6% less than what Medicare pays for 20 of its highest-volume tests. By contrast, private payers pa…
Can Clinical Laboratories Adjust To ‘New’ Healthcare System?
CEO SUMMARY: Month by month, there is increased clarity in the path the American healthcare system will follow as hospitals, health systems, and physicians integrate clinical care, manage populations, and practice personalized and precision medicine. While these changes play out, clinical…
Cepheid, Sequenom Acquisitions Further Consolidate Lab Testing
TWO ACQUISITIONS FURTHER consolidated the clinical laboratory testing industry in recent weeks. The acquired companies were Sequenom and Cepheid. Sequenom went first. On July 27, Laboratory Corporation of America announced an agreement to acquire …
Reference Pricing’s New Lab Winners and Losers
CEO SUMMARY: Expanded use of reference pricing by employers in coming years could trigger a cycle of cuts to lab test prices that would put the most pressure on the lab companies with the highest prices. Many hospital labs are viewed as having high prices. But because they run outreach sp…
ADLT Final Rule Creates Tough Questions for Labs
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
Is CMS about to Create New Lab Winners, Losers?
FROM ITS INCEPTION IN 1966, THE MEDICARE PROGRAM WAS DESIGNED to give beneficiaries easy access to healthcare services while allowing any qualified provider to provide those clinical services. That is about to change for…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
CURRENT ISSUE
Volume XXXII, No. 13 – September 15, 2025
The Dark Report examines a new bill that would reform PAMA and avoid reimbursement rate cuts scheduled for January 2026. Clinical laboratory leaders are urged to make their voices heard in Congress. Also, an expert describes how labs can fix pre-analytical errors and avoid disaster.
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