Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 152

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 152
---
and continue to be, proposals by the federal government, state governments, regulators, and third-party payors to control or manage the
increased costs of healthcare and, more generally, to reform the U.S. healthcare system. Certain of these proposals could limit the prices
we are able to charge for our products or the coverage and reimbursement available for our products and could limit the acceptance and
availability of our products. The adoption of proposals to control prices could have a material adverse effect on our business, financial
condition, results of operations, and prospects.

In the United
States, there have been, and continue to be a, number of legislative initiatives to contain healthcare costs. For example, in March 2010,
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the ACA)
was enacted in the United States, which made a number of substantial changes in the way healthcare is financed by both governmental and
private insurers. Among other ways in which it may affect our business, the ACA established a new Patient-Centered Outcomes Research Institute
to oversee and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such research;
implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other
healthcare providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models;
implemented the federal Physician Payment Sunshine Act; and expanded the eligibility criteria and rebates for Medicaid programs.

| 65 |

The ACA and certain
of its provisions have been subject to judicial challenges as well as legislative and regulatory efforts to repeal or replace them or
to alter their interpretation or implementation. For example, the Tax Cuts and Jobs Act (TCJA), among other things, included a provision
repealing, effective January 1, 2019, the tax-based shared responsibility payment, or penalty, imposed by the ACA on certain individuals
who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.”
Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA, effective January 1, 2019, to increase from 50% to 70%
the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap
in most Medicare drug plans, commonly referred to as the “donut hole.” Additionally, the Further Consolidated Appropriations
Act of