PHYSICIAN OFFICE LAB
CLIA Update 2021 What recent CLIA changes mean for reps and their customers By Jim Poggi 2020 and 2021 (so far) have been years of great change for us and our customers, largely precipitated by the COVID-19
pandemic. But there have been other far-reaching impacts on the laboratory business and our customers for other reasons. In this month’s column, I will shed some light on CLIA changes and what they mean for reps and their customers.
CLIA lab certificate fees increased by 20% at the end of 2018 With so many other fundamental changes in our market, while this change did not exactly slip by without notice, it has not generated the level of noise I might have expected. Arguably, the reductions imposed by PAMA on payment for tests performed under the Clinical Lab Fee Schedule have had more discussion and more impact than the 20% increase in CLIA certificate fees. 4
May 2021
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What does the 20% increase look like? Taking the example of a customer performing 50,000 non-waived tests annually, their fee before the increase was $1,100 every two years. It is now $1,320. What is the net impact? Based on 50,000 tests, the cost of the CLIA certificate increases cost per test by less than one quarter of a cent. It went from $0.011 per test to $0.0132 per test. This analysis assumes 50,000 tests per year for the biennial period against the new fee structure.
