Definitions.

For purposes of this subpart— Abuse is defined as in § 455.2 of this chapter. Adverse medical result means a clinically significant undesirable effect, experienced by a patient, due to a course of drug therapy. Appropriate and medically necessary means drug prescribing and dispensing that is in conformity with the predetermined standards established in accordance with § 456.703. Criteria is defined as in § 466.1 of this chapter. Fraud is defined as in § 455.2 of this chapter. Gross overuse means repetitive overutilization without therapeutic benefit. Inappropriate and medically unnecessary means drug prescribing and dispensing not in conformity with the definition of appropriate and medically necessary. Overutilization means use of a drug in a quantity, strength, or duration that is greater than necessary to achieve a desired therapeutic goal or that puts the beneficiary at risk of a clinically significant undesirable effect, or both. Predetermined standards means criteria and standards that have been established in accordance with the requirements of § 456.703. Standards is defined as in § 466.1 of this chapter. Underutilization means use of a drug by a beneficiary in insufficient quantity, strength, or duration to achieve a desired therapeutic goal or that puts the beneficiary at risk of a clinically significant undesired effect, or both. [57 FR 49408, Nov. 2, 1992, as amended at 59 FR 48824, Sept. 23, 1994]