• Referring suspected, detected or reported cases of illegal drug activity, including
drug diversion, to the NBI MEDIC and/or law enforcement and conducting case
development and support activities for NBI MEDIC and law enforcement
investigations; and
• Assisting law enforcement by providing information needed to develop successful
prosecutions.
SIUs must be accessible through multiple channels such as via phone, email, Internet
message submission, and mail. Sponsors must ensure that suspicions of FWA can be
reported anonymously to the SIU.
Sponsors must ensure that the SIU and compliance department communicate and
coordinate closely to ensure that the Medicare Parts C and D benefits are protected from
fraudulent, abusive and wasteful schemes throughout the administration and delivery of
benefits, both at the sponsor and FDR levels.
50.6.11 – Auditing by CMS or its Designee
(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)(F), 423.504(b)(4)(vi)(F), 422.504(e)(2), 423.505(e)(2)
CMS has the discretionary authority to perform audits under 42 C.F.R. 44 422.504(e)(2)
and 423.505(e)(2), which specify the right to audit, evaluate, or inspect any books,
contracts, medical records, patient care documentation, and other records of sponsors or
FDRs that pertain to any aspect of services performed, reconciliation of benefit liabilities,
and determination of amounts payable under the contract or as the Secretary of Health
and Human Services may deem necessary to enforce the contract.
Sponsors must allow access to any auditor acting on behalf of the federal government or
CMS to conduct an on-site audit. On-site audits require a thorough review of required
documentation. Such reviews include any information needed to determine compliance
with the Medicare Parts C and D regulations and contracts, such as copies of
prescriptions, invoices, provider and pharmacy licenses, claims records, signature logs,
records documenting delivery status by postal carrier, long-term care delivery notice to
nursing staff, other forms of documentation of medication delivery, purchase records,
contracts, rebate and discount agreements, as well as interviews of the staff. The
interviews gauge whether control activities are practiced as dictated by the company’s
policy and applicable Parts C and D requirements are being followed. On-site audits are
based on sampling or results of desk audits. In most cases, CMS or its designee will
provide reasonable notice to the sponsor of the time and content of the audit.
The OIG has independent authority to conduct audits and evaluations necessary to ensure
accurate and correct payment and to otherwise oversee Medicare reimbursement.