Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 33

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 33
---
 practices, including but not limited to, research, distribution, sales and
    marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor,
    including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s
    voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise
    restricts payments that may be made to healthcare providers and other potential referral sources; state laws that require
    drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting
    of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; state
    and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the
    privacy and security of health information in certain circumstances, many of which differ from each other in significant ways
    and may not have the same effect, thus complicating compliance efforts.

The
scope and enforcement of each of these laws is uncertain and subject to rapid change in the current regulatory and healthcare
environment, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have
recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number
of investigations, prosecutions, convictions and settlements in the healthcare industry.

Insurance
Coverage and Reimbursement

In
the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing
healthcare services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Thus, even
if a compound is approved, sales of the product will depend, in part, on the extent to which third-party payors, including government
healthcare programs in the United States such as Medicare and Medicaid, private health insurers, managed care organizations and
other third-party payors, provide coverage, and establish adequate reimbursement levels for, the product. In the United States,
principal decisions about Medicare reimbursement for new products are typically made by CMS and regional contractors responsible
for administering the Medicare program. CMS and these contractors decide whether and to what extent a new product will be covered
and reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement
to a substantial degree.

Reimbursement
by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination
that use