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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.
Congress’ New SGR Law Has Mixed News for Labs
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
New Federal Law Changes How CMS Sets Lab Prices
CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…
Medicare OPPS Rule Has Pitfalls for Labs
CEO SUMMARY: On January 1, the new Medicare rule for requiring bundled or packaged reimbursement for certain services covered by the hospital Outpatient Prospective Payment System (OPPS) became effective. Just four days earlier (on December 27), Medicare officials issued instructions on h…
Study Reveals Medicare Already Pays Low Rates
CEO SUMMARY: Researchers studied a database containing laboratory test prices paid in 2012 on behalf of 56 million Americans covered by private health plans and determined that, for most tests, and in most regions, Medicare already pays less than private health insurers for clinical labor…
Tennessee BCBS Cuts Lab Fees to 52% of Medicare
CEO SUMMARY: Blue Cross Blue Shield of Tennessee has notified physicians that, starting January 1, it will reduce what it pays for lab testing to 52% of Medicare fees. Officials with the state medical association have been unable to get definitive answers to questions about what tests wou…
ACLA, CAP Comment on Final 2014 Medicare Rules
CEO SUMMARY: On November 27, as the nation prepared for the Thanksgiving holiday, the federal Centers for Medicare & Medicaid Services (CMS) announced the long-awaited final rules for 2014. Early analysis of the 1,300 pages of rules CMS released indicates that the agency moderated one…
Medicare Price Cuts Drive Labs to Sell or File BK
CEO SUMMARY: Professional investors are smart with their money. Thus, it is no surprise that clinical lab and pathology companies owned by private equity firms are the first to be sold or closed. These investors are acting in response to the cumulative negative financial impact of recent …
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
Medicare’s Latest Attack on Lab Test Prices
MANY OF YOU KNOW ABOUT THE PROPOSED NEW MEDICARE RULE by the Centers for Medicare & Medicaid Services (CMS) that it would use to initiate a review of the prices it pays for 1,250 clinical laboratory tests under the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). However…
CMS Proposes Yet More Cuts for 2014, Beyond
CEO SUMMARY: In July, CMS proposed rules to cut payments under the Hospital Outpatient Prospective Payment System, the Physician Fee Schedule, and the Clinical Laboratory Fee Schedule. Under each program, the proposed payment cuts could have a significant and negative effect on the amount…
CURRENT ISSUE
Volume XXXIII, No. 4 – March 23, 2026
A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.
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