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The practice of oncology requires compliance with a gamut of laws (rules and regulations) relating to prescription and administration of drugs and treatment regimens. Given that the practice of medicine is highly regulated, it is not a surprise that there are laws that may impinge on a physician’s decision making when prescribing a drug or a treatment regimen. These laws, although seemingly burdensome to the everyday practice of oncology, are critical to what is in the best medical interest of patients and the overall health care system. These laws are meant to protect patients against undue influence of money in management of a disease or a condition while imparting the best medical treatment. This chapter provides a summary of four different laws, rules, and regulations—namely, the Anti Kickback Statute, the Physician Self-Referral law, the Right to Try Act, and Off-label Drug Use—that directly affect the act of prescribing a drug or a treatment regimen for a patient or making a referral regarding the same.


The Anti-Kickback Statute, commonly referred to as AKS, is a criminal statute that makes it illegal to solicit or receive remuneration in return for prescribing a drug or a service or making a referral regarding the same to a patient, where payment of such drug or service is covered by a federal health care program.1 The objective of AKS is to prevent undue influence of money or other favors on a physician’s or other health care practitioner’s ability to make sound clinical decisions that are in the best interest of a patient. Another objective of AKS is to prevent fraud and exploitation of federal health care programs by precluding claims for medically redundant or unnecessary services. Under the AKS, not only are some of the obvious acts, for example, bribes, prohibited, but even seemingly innocuous conduct, such as sponsored business dinners, paid speaking arrangements, or contributions to a physician’s favorite charity, is considered illegal if it meets all other elements of an AKS violation. Since AKS is a criminal statute, an action under the AKS must be brought by the government.

Elements of AKS

The AKS is implicated when a physician or an entity:

  • knowingly and willfully

  • solicits, receives, offers, or pays any remuneration

  • to induce or as an award for, referrals for or orders of, drugs or services

  • paid for, fully or partially, by a federal health care program.

Knowingly and willfully

Although it may appear that the requirement that a physician “knowingly and willfully” acted in violation of the AKS must mean that the physician knew that the AKS prohibited receiving renumeration in exchange for referrals, yet intended to break the law; that is not the case. Actual knowledge of the AKS or the specific intent to violate the AKS is not required ...

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