US · guidance
CMS Pub. 100-16, ch. 21, § 50.6
Element VI: Effective System for Routine Monitoring, Auditing
and Identification of Compliance Risks
(Chapter 21 - Rev. 109, Issued: 07-27-12, Effective: 07-20-12; Implementation: 07- 20-12)
(Chapter 9 - Rev. 15, Issued: 07-27-12, Effective: 07-20-12; Implementation: 07-20- 12)
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 21 - Rev. 109, Issued: 07-27-12, Effective: 07-20-12; Implementation: 07- 20-12)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
211cd24645f6287158972143f50c43b4a585d3192d24cd8a34156774f8342053
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