Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 144

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 144
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 or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable, in whole or
in part, under Medicare, Medicaid or other federal health care programs. Although there are a number of statutory exceptions and regulatory
safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Failure to meet all
of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal
under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a
cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that
if any one purpose of an arrangement involving remuneration is to induce referrals of federal health care covered business, the federal
Anti-Kickback Statute has been violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific
intent to violate it in order to have committed a violation. The majority of states also have anti-kickback laws which establish similar
prohibitions and in some cases may apply more broadly to items or services covered by any third-party payor, including commercial insurers
and self-pay patients.

The federal civil False Claims
Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim
for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or statement
material to a false or fraudulent claim to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery
Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition,
a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the federal civil False Claims Act. Private parties may initiate “qui tam” whistleblower lawsuits against
any person or entity under the federal civil False Claims Act in the name of the government and share in the proceeds of the lawsuit.

HIPAA also created additional
federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to
defraud any health care benefit program, including private third-party payors, knowingly and willfully embezzling or stealing