BIODESIX INC
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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Sep 30, 2026 · Filed Nov 5, 2026
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Item 1A. Risk Factors
Except as set forth below, there have been no material changes to the risk factors as disclosed in “Item 1A. Risk Factors” of our Annual Report on Form 10-K as of and for the year ended December 31, 2025, filed February 26, 2026. These risk factors may not describe every risk facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial could materially and adversely affect our business, financial condition and results of operations.
Changes in payer reimbursement policies, claims review practices and broader healthcare policy and enforcement priorities may affect coverage, reimbursement rates, and the timing and amount of payment for our tests.
Changes in payer reimbursement policies, claims review practices and broader healthcare policy and enforcement priorities, including initiatives focused on fraud and abuse such as the Trump Administration’s CMS Request for Information for a potential forthcoming “CRUSH” rule focused on strengthening program integrity across federal healthcare programs, may affect coverage, reimbursement rates and the timing and amount of payment for our tests. Such changes may also increase administrative burdens and lead to additional denials, payment delays, recoupments or refund requests, any of which could adversely affect our revenue and results of operations. Because payer policies and enforcement priorities can change rapidly and vary across jurisdictions and payers, the ultimate impact of these developments on our business and financial performance remains uncertain.
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