Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 48

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 48
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 case-by-case basis where pricing contracts or Medicare reimbursement is not in place. To the extent
laws or contracts require it to bill patient co-payments or co-insurance, PPLS must also comply with these requirements. PPLS may also
face increased risk in its collection efforts, including potential write-offs of doubtful accounts and long collection cycles, which could
adversely affect its business, results of operations, and financial condition.

Several factors make the billing process complex,
including:

| ● | the reimbursement rates of payors;                                                                                                                         |
| ● | compliance with complex federal and state regulations related to billing Medicare;                                                                         |
| ● | risk of government audits related to billing Medicare;                                                                                                     |
| ● | disputes among payors as to which party is responsible for payment;                                                                                        |
| ● | differences in coverage and in information and billing requirements among payors, including the need for prior authorization and/or advanced notification; |
| ● | the effect of patient co-payments or co-insurance;                                                                                                         |
| ● | changes to billing codes and/or coverage policies that apply to PPLS’ assays;                                                                              |
| ● | incorrect or missing billing information; and                                                                                                              |
| ● | the resources required to manage the billing and claims appeals process.                                                                                   |

PPLS uses standard industry billing codes, known as
Current Procedural Terminology (“CPT”) codes, to bill for its diagnostic assays. These codes can change over time. When codes
change, there is a risk of an error being made in the claim adjudication process. These errors can occur with claims submission, third-party
transmission, or in the processing of the claim by the payor. Claim adjudication errors may result in a delay in payment processing or
a reduction in the amount of the payment received. Coding changes, therefore, may have an adverse effect on PPLS’ revenues. There
can be no assurance that payors will recognize these codes in a timely manner or that the process of transitioning to such a code and
updating their billing systems will not result in errors, delays in payments, and a related increase in accounts receivable balances.

As PPLS introduces new assays, PPLS will need to add
new codes to its billing process as well as its financial reporting systems. Failure or delays in effecting these changes in external
billing and internal systems and processes could negatively affect its collection rates, revenue, and cost of collecting.

| 21 |

Additionally, PPLS’ billing