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Variability in Reimbursed Amounts for Biomarker-Based IVD Tests

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We’ve been continuing to analyze the CMS reimbursement data that we received via our FOIA request, and for this post I analyzed the variability in the amounts at which tests were reimbursed by CMS during 2014. The net conclusion is that variability appears to be quite high.

For the four common cancer biomarkers that I analyzed (BRAF, EGFR, HER2, and KRAS), the testing was reimbursed at 25 or more different amounts. HER2 stands out dramatically in that it was reimbursed at 677 different amounts.

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The table above lists the counts of the different amounts at which each biomarker-based test was reimbursed by CMS, along with the average allowed amount, and the maximum allowed amount. Minimum allowed amount was excluded because a sizable percentage of all tests (>25%) were reimbursed at $0.

The average amounts reimbursed across all tests were less than $250, which shows that price definitely shouldn’t be a barrier to testing before prescribing personalized medicines. HER2 did stand out again though in terms of being the most costly test on average, and also by the fact that tests for this biomarker appreciated significantly the highest maximum reimbursement amount.

Please contact me if you have any specific questions that you are interested in having answered about CMS reimbursement of IVD tests, as we have a wealth of information to draw upon to help answer your questions.