Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 247

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 247
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 our diagnostic tests. Once the American Medical Association (AMA) establishes a CPT code, the Centers for Medicare & Medicaid Services (CMS) establishes payment levels and coverage rules under Medicare, while state Medicaid programs and commercial health plans establish rates and coverage rules independently in accordance with applicable rules. A Proprietary Laboratory Analyses (PLA) code is part of the CPT code set and may be assigned to tests that are not covered by standard CPT codes. We utilize a combination of established CPT codes and recently obtained PLA codes for billing and reimbursement of our tests. We use established CPT codes for certain tests, including our aneuploidy NIPT which CMS has a pricing rate of $759 per test. For other proprietary tests, we use PLA codes, including our carrier panel which CMS has a pricing rate of approximately $1,825 per test. We have also obtained PLA codes for our Northstar Select and Northstar Response tests, which CMS has pricing rates of approximately $2,920 per test and $1,644 per test, respectively. The transition from miscellaneous codes to specific PLA codes has enhanced our reimbursement clarity and is expected to continue to improve our ASPs as these codes are increasingly recognized by commercial third-party payors.

| 73 |     | In addition, our carrier screen test is not covered by Alabama, Michigan, or Nevada, and our aneuploidy test is not covered by Nebraska, Nevada or Utah. State Medicaid coverage for our RhD and fetal antigen tests is 
 currently uncommon. Our oncology test are covered at the federal level by Medicare. Medicaid coverage for our oncology tests is less relevant, as the vast majority of cancer patients do not have Medicaid coverage.   |

181

Despite favorable coding and high coverage rates for many of our tests, we face reimbursement challenges in certain scenarios. For example, for out-of-networkclaims with Managed Medicaid plans, we may receive no reimbursement. Even for commercial insurances with out-of-networkbenefits, the percentage of allowed amounts that are paid may be a small fraction of the CMS rate. Challenges related to reimbursements are more fully discussed in the section titled “Risk factors—Risks related to our reimbursements” included elsewhere in this prospectus. As a result of these challenges and rates negotiated with contracted payors, our Overall ASP is lower than the reimbursement amounts suggested by the codes. We maintain a systematic approach to appeals for denied claims, with variable success rates depending on the payor and reason for denial. Our appeals process is supported by