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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.

Useful Lessons for Labs That Report PAMA Data

CEO SUMMARY: Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017? One major difference is that the definition of applicable laboratories now includes most hospital labs. This creates the opportunity for a la…

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Senator Asks: Are Lab Test Payments Too High?

CEO SUMMARY: It is ironic that, after the federal Centers for Medicare and Medicaid Services (CMS) enacted the deepest price cuts to the Part B Clinical Laboratory Fee Schedule in more than 50 years, a U.S. Senator now asks CMS why it will pay billions more for lab testing. The question f…

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Is There a Future for Hospital Lab Outreach Programs?

CEO SUMMARY: This will be one of the most challenging years facing the clinical lab industry since the early 1990s. The CMS scheme to collect private payer lab test prices and use that data to set Medicare clinical laboratory test pric…

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Do Community Labs Have a Future in the U.S.?

It may be timely to ask a provocative question that touches everyone in the profession of laboratory medicine. Is there a future for community laboratories and hospital lab outreach programs in the United States, given the different forces acting upon the clinical laboratory industry today? In this …

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Why PAMA May Be Poised to Disrupt Lab Industry

CEO SUMMARY: This will be one of the most challenging years facing the clinical lab industry since the early 1990s, when closed panel HMOs were the disruptive force that generated deep cuts in lab test prices. However, unlike HMOs of that era, the CMS scheme to collect private payer lab t…

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CEO Offers Lab Strategies for a Post-PAMA World

CEO SUMMARY: With so many market forces working against the economic interests of clinical laboratories, it is essential that all labs develop appropriate strategies designed to sustain the quality of laboratory testing services and the financial integrity of the laboratory organization. …

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2019 Outlook: Lab Industry Future Looks Dire, From Reactions to Recent Medicare Fraud Cases to PAMA Reporting and Other Stress Factors

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…

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Several Big Surprises in 2018’s Top 10 Lab Stories

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…

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If 2019 Is a Tough Year, Blame Government, Payers

Traditionally, the new year is a time of optimism. People make resolutions such as exercising more and losing weight. Companies get to start the year with a fresh budget and the new opportunity to achieve their goals. Unfortunately, events of the last 90 days of this year are not auspicious for clin…

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CMS Adjustments for Medicare Fee Schedule Might Be Too Late

This is a summary of two articles in the Nov. 13, 2018 issue of THE DARK REPORT. The complete articles are available only to paid members of the Dark Intelligence Group. CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee S…

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