Glossary K-LA
Kickback - See Kickback Violation in this Glossary.
Kickback Violation - a violation of the Federal Anti-Kickback statute, which prohibits giving or receiving any kind of remuneration to promote goods or services. The Anti-Kickback Statute, 42 U.S.C. §1320 a-7b, makes it a criminal offense to knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce the referral of business covered by a Federal funded health care program. In other words, the statute prohibits payments made purposefully to induce referrals of business payable by a Federal health care program. The statute ascribes liability to both sides of a kickback transaction and has been interpreted to cover any arrangement where one purpose of the remuneration was to obtain money for the referral of services or to induce further referrals.
Labeling - in the context of FDA-regulated pharmaceuticals and devices, labeling means all labels and other written, printed, or graphic matters upon any article or any of its containers or wrappers, or accompanying such article. This typically involves package inserts and marketing materials for prescription drugs and devices, and the package labeling itself for over- the-counter-drugs.
Local Coverage Determination (LCD) - a decision by a fiscal intermediary or a carrier under Medicare Part A or Part B, regarding whether and how to cover a particular service. An LCD may provide that a service is not reasonable and necessary for certain diagnoses and/or for certain diagnosis codes. An LCD does not include a determination of which procedure code, if any, is assigned to a service, or a determination with respect to the amount of payment to be made for the service.