Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 100

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 100
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 | the federal government may bring a lawsuit under the False Claims Act (FCA), against any party whom it believes has                                                                                                                                       
 knowingly or recklessly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim for payment approved. The federal government 
 and a number of courts have taken the position that claims presented in violation of certain other statutes, including the AKS or the Stark Law, can also be                                                                                              |

60

| considered a violation of the FCA based on the theory that a provider impliedly certifies compliance with all applicable laws, regulations, and other rules when submitting claims for 
 reimbursement;                                                                                                                                                                         |

| • |     | the HIPAA fraud and abuse provisions, which created federal criminal statutes that prohibit, among other things, knowingly                                                                                                                              
 and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private insurers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal   
 investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare 
 benefits, items or services;                                                                                                                                                                                                                            |

| • |     | federal and state laws related to, among other things, unlawful schemes to defraud, excessive fees for services, unlawful                                                                              
 trade practices, insurance fraud, kickbacks, patient inducement and statutory or common law fraud restrict the provision of products, services or items for free or at reduced charge to government or 
 non-government healthcare program beneficiaries;                                                                                                                                                       |

| • |     | other federal and state fraud and abuse laws, such as state anti-kickback, self-referrals, false claims and anti-markup 
 laws, any of which may extend to services reimbursable by any payor, including private insurers; and                    |

| • |     | state laws that prohibit other specified practices, such as: billing physicians for tests that they order; providing tests                                             
 at no or discounted cost to induce adoption; waiving co-insurance, co-payments, deductibles or other amounts owed by patients; billing a state healthcare program at a 
 price that is higher than what is charged to other payors; or employing, exercising control over or splitting fees with licensed medical professionals.                |

Because of the breadth of these