Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 46

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 46
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 action plans, and have often become subject to consent decrees or corporate integrity
agreements, restricting the manner in which they conduct their business.

The federal Health Insurance
Portability and Accountability Act of 1996, or HIPAA, created additional 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 third-party
payors; 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; and willfully obstructing a criminal
investigation of a healthcare offense. Like the federal Anti-Kickback Statute, the Affordable Care Act amended the intent standard for
certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to have actual knowledge of the statute or
specific intent to violate it in order to have committed a violation.

Given the significant size
of actual and potential settlements, we expect that the government will continue to devote substantial resources to investigating healthcare
providers’ and manufacturers’ compliance with applicable fraud and abuse laws. Also, many states have similar fraud and abuse
statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under
Medicaid and other state programs. Additionally, to the extent that our products, once commercialized, are sold in a foreign country,
we may be subject to similar foreign laws.

In addition, there has been
a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers. The Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, among
other things, imposed new reporting requirements on certain manufacturers of drugs, devices, biologics and medical supplies for which
payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, for payments
or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians
and their immediate family members. Covered manufacturers are required to collect and report detailed payment data and submit legal attestation
to the accuracy of such data to the government each year. Failure to submit required information may result in civil monetary penalties
of up to an aggregate of $150,000 per year (or up to an