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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.
Can Fee Cuts Be Delayed? Courts Are One Option
CEO SUMMARY: Some lab companies may be prepared to challenge in court the methodology CMS used in setting the requirements of the Protecting Access to Medicare Act of 2014 to conduct a study of private payer market prices for lab tests and use that data to propose new prices for the Part …
Positive Patient ID System Catches Patients Cheating on Toxicology Tests
CEO SUMMARY: The urine drug testing industry is challenged every day to detect the large number of patients trying to cheat on their drug tests. GenoTox Laboratories of Austin, Texas, developed a DNA-authentication method for urine samples that allows the lab to detect when patients have …
LabCorp, Quest Talk about Medicare Lab Price Cuts
CEO SUMMARY: In an effort to forestall CMS’ efforts to implement the PAMA final rule on market price reporting, Laboratory Corporation of America and Quest Diagnostics are meeting with members of Congress, officials in the administration, and the new leadership of CMS. During recent con…
Hospital Lab Data Essential For CMS Market Price Study
CEO SUMMARY: In five months, Medicare officials will implement a new Part B clinical laboratory fee schedule based on private payer lab price data submitted by certain medical laboratories required to report that data. At this year’s Executive War College, the CEO of XIFIN, Inc., reported o…
Is CMS Manipulating Data to Increase Medicare Fee Schedule Cuts?
This is an excerpt from a 2,150-word article in the April 3, 2017, 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: E…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Why Small Labs and Even Hospitals Are at Risk from PAMA Cuts
CEO SUMMARY: Clinical lab executives and experts who have studied the final rule for PAMA lab test market price reporting are seriously concerned that the design of this rule may put many of the nation’s smallest, but still essential, clinical labs at great risk of financial distress, i…
Should Labs File Court Challenge To PAMA Price Report Rule?
CEO SUMMARY: Just four weeks remain before CMS begins collecting private payer clinical laboratory test price data. Many lab industry executives have charged that Medicare officials are not following the language of the PAMA statute or the intent of Congress. At stake are $5.4 billion in …
Will Coming Medicare Fee Cuts Reduce Access to Laboratory Tests?
SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services. The American Clinical Laboratory A…
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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