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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.
PAMA Final Rule a Threat To Community Lab Survival
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
Palmetto GBA Issues Guidance On Billing NGS Test Panels
CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…
Labs React with Criticism to Proposed ADLT Rule
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
New ADLT Payment Rate May Force Lab to Close
CEO SUMMARY: Four Medicare Administrative Contractors currently pay $2,821 for CareDx’s AlloMap test. But under the proposal that CMS issued last month to overhaul the clinical lab fee schedule, CareDx would get only $644. Such a steep price cut would put the lab out of business because…
Protecting Access to Medicare Act of 2014: Will price reporting rule drive small labs out of business?
This first assessment of the PAMA (Protecting Access to Medicare Act of 2014) proposed rule on market reporting of lab prices gives pathologists and lab executives insights about the good, the bad, and the…
CMS Releases Draft of PAMA Market Price Rule
CEO SUMMARY: CMS’ proposed rule details how it will collect private market data, then use that data to establish prices for the Medicare Part B Clinical Laboratory Fee Schedule beginning in 2017. The proposed rule will limit data reporting to les…
Labs Have Questions for CMS on Proposed Rule
CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…
Are Labs Facing a Collapse in Test Prices?
IS IT REASONABLE, AT THIS TIME, TO ASK IF THE LAB INDUSTRY IS FACING a potential collapse in lab testing pricing? Were I to have asked that question several years ago, most of you would probably have responded with skepticism. But how the times have changed! Take the Protecting Access to Medicare Ac…
Beware Ides of March! Lawmakers Are in Session
CEO SUMMARY: Few pathologists and lab administrators know that, when the Protecting Access to Medicare Act of 2014 (PAMA) became law last April 1, language in the bill was scored to reduce Part B clinical laboratory test fees by $2.5 billion over 10 years. Congress used those lab…
Protecting Access to Medicare Act of 2014 Could Harm Independent Community Labs
In the Protecting Access to Medicare Act of 2014 (PAMA), the Center for Medicare and Medicaid Services (CMA) is directed to collect market price data and use the data to establish prices for the Medicare Part B Clinical Laborato…
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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