Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 98

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 98
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ificantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible
that the Affordable Care Act will be subject to judicial or Congressional challenges in the future. It is unclear how any such
challenges and any potential future healthcare reform measures of the Trump administration will impact the Affordable Care Act and
the combined company’s business.

Other legislative changes
have been proposed and adopted in the United States since the Affordable Care Act was enacted. These changes include, among others,
aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in 2013 and, due to subsequent
legislative amendments to the statute, will remain in effect until 2032 unless additional Congressional action is taken. Congress is considering
additional health reform measures.

Further, there has been particular
and increasing legislative and enforcement interest in the United States with respect to drug pricing practices in recent years,
particularly with respect to drugs that have been subject to relatively large price increases over relatively short time periods. There
have been several recent U. S. Presidential executive orders, Congressional inquiries and proposed bills designed to, among other
things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between
pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

For example, in July 2021,
the Biden administration released an executive order, “ Promoting Competition in the American Economy,” with multiple provisions
aimed at prescription drugs. In response to President Biden’s executive order, on September 9, 2021, the Department of Health
and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform
and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can
take to advance these principles. Further, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure,
single-source drugs and biologics covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D
to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023. On August 29,
2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation
program is currently subject to legal challenges. On January 17, 2025,