Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 65

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 65
---
 on any entity
that manufactures or imports specified branded prescription drugs and biologic agents; extended manufacturers’ Medicaid rebate
liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; expanded eligibility criteria
for Medicaid programs; expanded the entities eligible for discounts under the 340B drug pricing program; increased the statutory minimum
rebates a manufacturer must pay under the Medicaid Drug Rebate Program; established a new Patient-Centered Outcomes Research Institute
to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; and
establishes a Center for Medicare & Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare
and Medicaid spending.

Since
its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA, and on June 17, 2021,
the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling
on the constitutionality of the ACA. Prior to the Supreme Court’s decision, President Biden had issued an executive order to initiate
a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through
the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies
and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that
include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid
or the ACA. It is unclear how the healthcare reform measures will impact our business.

44

In
addition, other legislative changes have been proposed and adopted since the ACA was enacted. On March 11, 2021, the American Rescue
Plan Act of 2021 was signed into law, which eliminate the statutory cap on the Medicaid drug rebate, beginning January 1, 2024 at 100%
of a drug’s AMP. Further, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices
in light of the rising cost of prescription drugs. Such scrutiny has resulted in several recent congressional inquiries and proposed
and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship
between pricing and manufacturer patient assistance programs, and reform government program reimbursement methodologies for products.
Most recently, the Inflation Reduction Act of 2022, or IRA, included a number of significant drug pricing reforms, which