Quality Improvement Organization Manual (Pub. 100-10), Ch. 5 § 5015
Organization of Chapter
5015 – Organization of Chapter
(Rev. 28, Issued: 10-21-16, Effective: 10-21-16, Implementation: 10-21-16)
The chapter is organized based on the two types of Quality of Care Reviews that QIOs conduct;
Beneficiary Complaint Reviews are addressed first (See §§5025-5065), followed by General
Quality of Care Reviews. (See §§5100-5125.)
NOTE: All references to a beneficiary in this chapter also include the beneficiary representative,
unless otherwise indicated.
Review Type and Description
1. Beneficiary Quality of Care Complaints – Reviews initiated because a beneficiary or the
beneficiary’s representative has complained (referred to as Beneficiary Complaint
Review) about the quality of care rendered to a Medicare beneficiary
2. General Quality of Care Reviews – Reviews conducted because the QIO has
independently identified a potential quality issue or has been referred a quality issue
from another entity (referred to as General Quality of Care Review)
Sources for Reviews
A. Beneficiary Complaint Review Sources
1. A written complaint filed by a beneficiary
2. A oral complaint by a beneficiary where the beneficiary agrees to participate in
Immediate Advocacy
B. General Quality of Care Reviews Sources
1. Concerns Identified during Other Review Activities: A Quality of Care review conducted
when a potential quality of care concern(s) is identified during the course of any other
review activity, such as medical necessity reviews, expedited discharge appeals,
Emergency Medical Treatment and Labor Act (EMTALA) reviews.
2. When a beneficiary raises a concern, but the beneficiary declines to submit a formal
written complaint, and the QIO makes a preliminary determination that the complaint
involves a potential gross and flagrant, substantial, or significant quality of care
concern, such complaint may be processed as a General Quality of Care Review. For
purposes of 42 CFR §476.120(a)(1) and this provision, an anonymous complaint, even if
received in writing, is not a “written complaint” sufficient to trigger the beneficiary
complaint procedures outlined in 42 CFR §476.130.
3. Referrals include a Quality of Care Review conducted in response to referrals from other
entities (e.g., Medicare Administrative Contractors, State-based organizations, the Office
of Inspector General, the Office for Civil Rights), including anonymous referrals.
4. Tracking and Trending is a Quality of Care review conducted as a result of tracking and
trending or other analysis of data.
Stages of Review by Type
Beneficiary Complaint Reviews
The process steps for this review are separated into four stages to facilitate identification of
roles and steps associated with various aspects of the process:
Stage 1: Intake Stage;
Stage 2: Quality of Care Review Stage;
Stage 3: Opportunity for Discussion Stage; and
Stage 4: Reconsideration Stage.
NOTE: The Social Security Act §1154(a)(14) requires that QIOs conduct an “appropriate
review of all written complaints” from Medicare beneficiaries alleging that the quality of
services they received did not meet professionally recognized standards of care. For Beneficiary
Complaints, the process instructions include a QIO’s authority to offer Immediate Advocacy (See
§5035) during the Intake Stage if a written complaint has not yet been received. QIOs may also
offer at their discretion a Post-Peer Review alternative dispute resolution process, called Post-
Review Advocacy (See §5065), for complaints submitted in writing that Peer Reviewers
determine contain no significant quality of care concerns.
General Quality of Care Reviews
The process steps for this review are separated into these three stages to facilitate identification
of roles and steps associated with various aspects of the process:
Stage 1: Intake Stage;
Stage 2: Quality of Care Review Stage; and
Stage 3: Reconsideration Stage.