Medicare Program Integrity Manual (Pub. 100-08), Ch. 4 § 4.10.2.1
Basis for Exclusion Under §1128(b)(6) of the Social Security
4.10.2.1 - Basis for Exclusion Under §1128(b)(6) of the Social Security
Act
(Rev. 11032; Issued: 09-30-21; Effective: 10-12-21; Implementation: 11-10-21)
Exclusions under §1128(b)(6) of the Act are effected upon a determination that a
provider has done one of the following:
• Submitted or caused to be submitted claims or requests for payment under
Medicare or a state health care program containing charges (or costs) for items or
services furnished substantially in excess of its usual charges (or costs).
• Furnished or caused to be furnished items or services to patients (whether or not
eligible for benefits under Medicare or under a state health care program)
substantially in excess of the needs of such patients or of a quality that does not
meet professionally recognized standards of health care.
For purposes of the exclusion procedures, “furnished” refers to items or services
provided or supplied, directly or indirectly, by any individual or entity. This includes
items or services manufactured, distributed or otherwise provided by individuals or
entities that do not directly submit claims to Medicare, Medicaid or other Federal health
care programs, but that supply items or services to providers, practitioners or suppliers
who submit claims to these programs for such items or services.