Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 70

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 70
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 negatively affect the quality of test results,
or that it will be successful in responding to the growing complexity of testing operations.

In
addition, PPLS’ growth may place a significant strain on its management, operating and financial systems, and its sales, marketing,
and administrative resources. As a result of its growth, PPLS’ operating costs may escalate even faster than planned, and some
of its internal systems may need to be enhanced or replaced. If we cannot effectively manage PPLS’ expanding operations and its
costs, we may not be able to grow effectively or we may grow at a slower pace, and our business could be adversely affected.

Billing
for PPLS’ services is complex, and PPLS must dedicate substantial time and resources to the billing process to be paid.

Billing
for clinical laboratory services is complex, time consuming and expensive. Depending on the billing arrangement and applicable law, PPLS
bills various payors, including Medicare, insurance companies, and patients, all of which have different billing requirements. It generally
bills third-party payors for its diagnostic assays and pursues reimbursement on a 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.

 36 

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