Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 36

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 36
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, repealed, replaced, or further amended in the future, and
we cannot predict what effect further changes to the ACA would have on our business.

20 

Other
legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, in August 2011,
the Budget Control Act of 2011, among other things, included reductions of Medicare payments to providers of 2%, which went into
effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030 unless additional
Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other
things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers,
and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Moreover,
payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop
new payment and delivery models, including bundled payment models. In addition, recently there has been heightened governmental
scrutiny over the manner in which manufacturers set prices for their commercial products, which has resulted in numerous Congressional
inquiries and proposed and enacted state and federal legislation designed to, among other things, bring more transparency to product
pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement
methodologies for pharmaceutical products. At the federal level, former President Trump used several means to propose or implement
drug pricing reform, including through federal budget proposals, executive orders, and policy initiatives. It is unclear whether
the Biden administration will work to reverse those measures or pursue similar or other policy initiatives, for example related
to an independent review board or other mechanisms that would impact drug pricing and reimbursement. 

On
November 20, 2020, CMS and the HHS Office of the Inspector General issued two final rules implementing changes to the Physician
Self-Referral Law, or Stark Law, and the Anti-Kickback Statute. These new rules provide new value-based enterprise exceptions
and safe harbors to the Stark Law and the Anti-Kickback Statute, as well as offer additional clarification in the form of updated
definitions.

Compliance
with Other Federal and State Laws or Requirements; Changing Legal Requirements

If
any products that we may develop are made available to authorized users of the Federal Supply Schedule of the General