Be Prepared for Medicare NPE Validation Visits – Part 3: Complaint Procedures
By: Kris Ravotti, RRT, RCP
Clinical Compliance Educator
Posted: June 3, 2025
To continue discussing preparation for Medicare National Provider Enrollment (NPE) site visits, let’s turn to the section of the site investigation document dealing with complaints.
DME suppliers must have a complaint policy and a written or electronic document to log complaints received and the supplier’s response. ACHC Standards DRX2-4A through C addressing policies for and handling of complaints and align with CMS quality and supplier standards, but NPE site inspectors will reference DMEPOS supplier standards 13, 19, and 20 (42 CFR 424.57(c)(13), (19), (20)) directly.
Defining a Complaint
No one likes dealing with complaints, and CMS does not give a definitive definition. Organizations must decide for themselves what constitutes a complaint and train their personnel on when to implement the relevant policy and procedure.
Given this flexibility, it may be tempting to reduce the volume of documentation by limiting complaints to a narrow definition. When considering this approach, keep in mind that sometimes it’s the recurrence of small things that add up to a big issue. You may decide it’s better to be informed as early as possible to track trends as they emerge.
Another approach is a process that starts broad rather than narrow, documenting any concern or negative feedback as it comes in. This would include voiced feedback about service delays, inadequate service, or untimely repairs/replacements. It would encompass billing issues such as unexpected fees, incorrect submission of claims, or when a beneficiary feels that their product should have been covered but wasn’t. And it would equally apply when a customer was upset that a blue wheelchair was delivered instead of a red one. After initial intake, your organization would apply a screening process to determine if the issue met your policy requirements for a complaint.
The decision about how to define a complaint is yours, but it must be clear and applied consistently.
Maintaining Compliance
However you define a complaint, your policy must meet CMS requirements. Supplier standard 42 CFR 424.57(c)(13) requires that suppliers document contacts with beneficiaries to answer questions and respond to complaints about Medicare-covered items that were sold or rented. To meet 42 CFR 424.57(c)(19), suppliers must have a complaint resolution protocol, again with documentation of the complaint and notes on actions taken in response. And 42 CFR 424.57(c)(20) details that the documentation must include:
- The name, address, telephone number, and health insurance claim number of the beneficiary.
- A summary of the complaint; the date it was received; the name of the person receiving the complaint, and a summary of actions taken to resolve the complaint.
- If an investigation was not conducted, the name of the person making the decision and the reason for the decision.
This information must be kept at the organization’s physical facility and made available to CMS, upon request.
Prepare your personnel to provide your definition of a complaint and your policy and procedure for handling complaints, including reporting and logging information.
We’ve written previously about how to prepare for Medicare National Provider Enrollment (NPE) validation or revalidation visits. Read: Part 1 and Part 2 of this series.
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