US · guidance

CMS Pub. 100-18, ch. 9, § 50.6

Element VI: Effective System for Routine Monitoring, Auditing and Identification of Compliance Risks

activein force · 2026-09-17 – presentas-observed

42 C.F.R. §§ 422.503(b)(4)(vi)(E), 423.504(b)(4)(vi)(E)

Sponsors must establish and implement an effective system for routine monitoring

and identification of compliance risks. The system should include internal

monitoring and audits and, as appropriate, external audits, to evaluate the

sponsor’s, including FDRs’, compliance with CMS requirements and the overall

effectiveness of the compliance program.

History

(Chapter 9 - Rev. 15, Issued: 07-27-12, Effective: 07-20-12; Implementation: 07-20 12)

Provenance

Source: cms.gov
Retrieved: 2026-09-17
Edition: iom-2026-09-17
Content hash: d94a95159e88da95b6c284115517f3291cac98f32096da0c140aa5f42834844d

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