Quality Improvement Organization Manual (Pub. 100-10), Ch. 5 § 5040.4
Beneficiary Complaint: Complaints Not Submitted in Writing (i.e. Oral
5040.4 – Beneficiary Complaint: Complaints Not Submitted in Writing (i.e. Oral
Complaints)
(Rev. 28, Issued: 10-21-16, Effective: 10-21-16, Implementation: 10-21-16)
In instances when a beneficiary contacts the QIO about a complaint but does not submit a signed
Complaint Form by calendar day thirty-one (31)or advises the QIO during the initial discussion
that he/she will not submit a written complaint, the QIO should:
1. Close the case as a “beneficiary complaint” in the CMS-designated case review system.
2. Identify if any Significant Quality of Care concern(s) is present, and if so, determine if a
General Quality of Care review is appropriate under 42 CFR §476.160 in accordance
with §1154(a)(1)(B) and the procedures in §5050, “Beneficiary Complaint: Quality of
Care Review Stage-One.”, A Significant Quality of Care Concern is defined as:
• A determination by a QIO that the quality of care provided to a Medicare beneficiary did
not meet the standard of care and, while not a gross and flagrant or substantial violation
of the standard, represents a noticeable departure from the standard that could
reasonably be expected to have a negative impact on the health of a beneficiary.
The following activities should occur where there exist Significant Quality of Care Concern(s)
arising out of an oral beneficiary complaint:
1. The QIO collects sufficient information to complete a General Quality of Care Review.
2. The QIO considers the concern(s) the beneficiary identified in an oral complaint to be at
least significant. Violations that are gross and flagrant or a substantial violation in a
substantial number of cases also meets this standard.
Should the QIO determine that the matter involves a significant concern and the QIO has
sufficient information to complete its review, the QIO may immediately request the medical
information and begin the quality of care review (See §42 CFR 476.130 for guidance, and
Manual §5050 for instruction).
NOTE: Because oral complaints are not processed as written beneficiary complaints, the
beneficiary shall not receive the results of the review. As such, the disclosure processes detailed
in §5060.2, “Beneficiary Complaint: Preparation of Reconsideration Disclosure Package,” and
§5060.3, “Beneficiary Complaint: QIO’s Final Decision, Preparing and Mailing Letter to
Beneficiary,” are not applicable. If the beneficiary nonetheless requests information, refer to 42
CFR §480.132.