CMS Pub. 100-10, ch. 9, § 9020

The following are the three statutory obligations of practitioners and other persons that, if

not met, may form the basis for the initiation of a sanction action (see §1856(a) of the Act

and 42 CFR §1004.10):

1. Services or items ordered or furnished to Medicare patients are to be provided

economically and only when, and to the extent, medically necessary.

2. Services or items ordered or furnished are supported by evidence of medical

necessity and quality in the form and fashion (and at such time) that the QIO may

reasonably require for review (including copies) in exercising the QIO’s duties and

responsibilities.

3. Items or services ordered or furnished are to be of a quality that meets

professionally recognized standards of care.

After its final finding identifying a violation that is gross and flagrant or is a substantial

violation in three or more instances, the QIO must submit a report to OIG. (The

“reporting threshold” is when the practitioner or other person has either:

(a) failed substantially to comply with any obligation in a substantial number (three or

more) of admissions; or

(b) grossly and flagrantly violated any obligation in one or more instances.

See 42 CFR §1004.30 and §9010 of this Chapter 9 for the definition of Gross and Flagrant

and Substantial Violation in three or more instances.) When considering the sanction to

recommend as part of its report, the QIO must consider the degree that the practitioner’s

actions were inconsistent with the professional knowledge at the time care was provided

and the degree of harm that occurred to the patient.