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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.
ACLA Suit Challenges HHS’ Data-Collection Efforts
CEO SUMMARY: In a lawsuit filed last month, the American Clinical Laboratory Association charged that HHS failed to comply with the statutory requirements of the Protecting Access to Medicare Act of 2014 when setting the 2018 Clinical Laboratory Fee Schedule. In the lawsuit, ACLA said HHS…
Helping You Plan Your Lab’s Financial Future
WE ARE NOW IN THE NEW YEAR and the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS) is a reality. The dramatic price cuts that the federal Centers for Medicare and Medicaid Services has enacted is the single most disruptive financial event the clinical laboratory industry has fa…
ACLA hits Medicare fee schedule cuts with lawsuit
This is an article from the Dec. 11, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers. This article plus a full analysis of 2017 developments in the PAMA process are available at all times to paid members of the Dark Int…
ACLA Sues HHS over Market Price Study, Fee Cuts
IT’S A LONG-AWAITED DEVELOPMENT! Today, a federal lawsuit was filed against the Department of Health and Human Services (HHS) by the American Clinical Laboratory Association (ACLA). The lab association is asking a federal judge to review specific actions taken by …
CMS Publishes Final CLFS Rates, Labs Prepare to Cut Staff or Close
MEDICARE OFFICIALS PUBLISHED the final Part B Clinical Laboratory Fee Schedule for 2018 last Friday. Some changes clinical labs will welcome. The rates remain deeply flawed, however, and will cause many labs to lay off staff and others to close, experts said Saturday. How CMS set the rates remains p…
Fla. Lab Sells to Labcorp, But Keeps Nursing Homes
CEO SUMMARY: Vista Clinical Diagnostics of Clermont, Fla., is betting big on the nursing home sector just when many labs serving nursing homes are worried about steep Medicare cuts coming Jan. 1. After selling its physician office referral testing, 35 patient service centers, and a mobile…
Surprisingly Low Price Paid for Miraca’s AP Lab Is a Warning
EVEN INTO THE MID 1980s, coal miners used canaries as an early-detection system for the presence of carbon monoxide and other toxic gases. In this way, canaries served as a sentinel species to save miners’ lives. Clinical laboratories and pathology groups don’t have a sentinel species to warn th…
Some Labs Performing ADLTs May See Increased Medicare Fees
MIXED IN THE BAD NEWS concerning the proposed Clinical Laboratory Fee Schedule for 2018, there is some good news regarding what the federal Centers for Medicare and Medicaid Services proposes to pay for certain advanced diagnostic tests. After analyzing the proposed fee schedule, …
XIFIN CEO WHITE ANALYZES MEDICARE 2018 FEE CUTS
CEO SUMMARY: If the draft lab rates that CMS published Sept. 22 for the Clinical Laboratory Fee Schedule for 2018 go into effect Jan. 1 as proposed, the…
Looming CMS lab fee schedule cuts unite AMA, AHA and labs in opposition
This is an excerpt from a 1,237-word article in the Oct. 8, 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: In what m…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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