indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under
federally funded healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation. In addition, the
government may assert that a claim that includes items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
Civil and Criminal False Claims Laws
the federal civil and criminal false claims laws, including the False
Claims Act, which can be enforced by private citizens through civil whistleblower and qui tam actions, prohibit, among other things, individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for
payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.
Health Insurance Portability and Accountability Act of 1996
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things,
individuals or entities from executing a scheme to defraud any healthcare benefit program or making any false statements relating to healthcare matters; as in the case of the Federal Anti-Kickback Statute, a person or entity does not need to have
actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation; additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their
respective implementing regulations, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate
authorization, on entities subject to the law, such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the creation, use, maintenance or
disclosure of, individually identifiable health information;
False Statements Statute
the federal
False Statements Statutes prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.
Stark Law
the federal ban on physician self-referrals prohibits, subject to certain exceptions,
physician referrals of Medicare or Medicaid patients to an entity providing certain designated health services if the physician or an immediate family member of the physician has any financial relationships, including compensation
arrangements or ownership interests, with that entity.
Sunshine Act
the federal transparency or
sunshine requirements of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, the ACA, requires certain manufacturers of drugs, devices, biologics
and medical supplies to annually report to the Department of Health and Human Services, or the DHHS, information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members.
Federal Food, Drug, and Cosmetic
Act
The Federal Food Drug and Cosmetic Act, or the FDCA, and the regulations promulgated pursuant to the FDCA by the FDA govern, among other things, the research, development, testing, manufacture, storage, recordkeeping,
approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products as well as so-called combination products, such as those
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