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Short answer: Under 42 CFR 401.305, a person who has received a Medicare overpayment must report and return it, generally by 60 days after the overpayment was identified. An overpayment is identified when the person knowingly receives or retains it. Some events suspend that clock, and an overpayment kept past the deadline becomes an obligation under the False Claims Act. This page is general regulatory information, not legal advice.
Definition and scope
Section 401.305 of Title 42 of the Code of Federal Regulations, titled “Requirements for reporting and returning of overpayments,” sets out the duty. Its first paragraph is direct: “A person that has received an overpayment must report and return the overpayment in the form and manner set forth in this section.” (42 CFR 401.305(a)(1).)
The section covers four things: when an overpayment counts as identified, the deadline to report and return it, how to report it, and how far back the duty reaches. It sets the timing and method. It does not decide whether a particular payment was an overpayment, which is a question about the claim, the coverage rules and the documentation.
How the rule works in practice
When is an overpayment “identified”?
Paragraph (a)(2) says a person has identified an overpayment “when the person knowingly receives or retains an overpayment.” The term “knowingly” has the meaning in 31 U.S.C. 3729(b)(1)(A), the False Claims Act definition. The 60-day period runs from that identification date.
How long is the deadline?
Under paragraph (b)(1), the report-and-return deadline is the later of two dates: 60 days after the date the overpayment was identified, or the date any corresponding cost report is due, if applicable.
How far back does the duty go?
Paragraph (f) sets a six-year lookback. An overpayment must be reported and returned if the person identifies it within 6 years of the date it was received.
How is it reported and returned?
Paragraph (d)(1) says to use “an applicable claims adjustment, credit balance, self-reported refund, or other reporting process set forth by the applicable Medicare contractor.” If the amount was calculated with statistical sampling, the report must describe the statistically valid sampling and extrapolation methodology. Paragraph (d)(2) adds that a disclosure under the OIG Self-Disclosure Protocol or the CMS Voluntary Self-Referral Disclosure Protocol that results in a settlement agreement satisfies the reporting obligation.
The clock map: what starts, extends or suspends the deadline
Every row below comes from 42 CFR 401.305.
| Event | Effect on the deadline | Paragraph |
|---|---|---|
| Person knowingly receives or retains an overpayment | Overpayment is “identified”; the 60 days start | (a)(2), (b)(1)(i) |
| A corresponding cost report is due later than day 60 | The later date is the deadline | (b)(1)(ii) |
| Timely, good-faith investigation into related overpayments from the same or similar cause | Deadline suspended until the investigation concludes and the total is calculated, or 180 days after the initial identification, whichever is earlier | (b)(3) |
| OIG acknowledges a Self-Disclosure Protocol submission | Suspended until settlement, withdrawal or removal from the protocol | (b)(2)(i) |
| CMS acknowledges a Voluntary Self-Referral Disclosure Protocol submission | Suspended until settlement, withdrawal or removal from the protocol | (b)(2)(ii) |
| Person requests an extended repayment schedule (as defined in 42 CFR 401.603) | Suspended until CMS or its contractor rejects the request, or the provider or supplier fails the schedule’s terms | (b)(2)(iii) |
| Overpayment retained after the deadline | Counts as an “obligation” for purposes of 31 U.S.C. 3729 (False Claims Act) | (e) |
Where it matters for labs, clinics and supply decisions
The practical question is which channel to use. This mapping follows the regulation and one contractor’s published instructions.
| Situation | Channel the sources point to | Source |
|---|---|---|
| An error affects a claim still in the Medicare system | Adjust the claim. One Medicare administrative contractor (Noridian, Jurisdiction E Part A) asks that claims be adjusted by the provider “whenever possible” and says checks for claims currently in the system should not be sent, only a claim correction made | Noridian voluntary refunds page; 42 CFR 401.305(d)(1) |
| Claim is no longer adjustable | Use the contractor’s voluntary refund process. Noridian says to complete its voluntary check form and mail it with the check and supporting documentation | Noridian voluntary refunds page |
| Amount was estimated by sampling | Describe the sampling and extrapolation methodology in the report | 42 CFR 401.305(d)(1) |
| Matter is in the OIG Self-Disclosure Protocol | Follow the protocol. Noridian says OIG participants should not make a voluntary refund to the Medicare office | Noridian page; 401.305(d)(2) |
Each contractor runs its own refund process, so use the one your Medicare contractor publishes. Noridian’s page also states that accepting a voluntary refund does not limit the government’s rights to pursue other remedies for the claims involved. For the disclosure route, see our guide to the OIG Self-Disclosure Protocol and clinical research billing overpayments. For recoupment that starts from a contractor’s own review, see Recovery Audit Contractor audits. The False Claims Act background is in False Claims Act exposure in clinical trial billing and the broader OIG compliance program guidance. Organizations that bill Medicare as equipment suppliers can also read the DMEPOS supplier standards.
Common misunderstandings
- “The clock starts when we first suspect a problem.” The current section text ties identification to knowingly receiving or retaining an overpayment, using the False Claims Act meaning of “knowingly.”
- “Sixty days is always the limit.” It is the later of 60 days or the cost report due date, and it can be suspended by an investigation (up to 180 days from identification), by an OIG or CMS protocol submission, or by an extended repayment schedule request.
- “Only recent payments count.” The lookback is six years from the date of receipt, measured against when the overpayment is identified.
- “A refund check is always the right method.” The regulation names claims adjustment, credit balance, self-reported refund and other contractor processes. For claims still in the system, a contractor may require a claim correction rather than a check.
- “Settling a disclosure and reporting are separate duties.” Under (d)(2), a protocol disclosure that results in a settlement agreement satisfies the reporting obligations of the section.
FAQ
What counts as identified?
Knowingly receiving or retaining an overpayment, with “knowingly” taken from 31 U.S.C. 3729(b)(1)(A) (42 CFR 401.305(a)(2)).
How long can Medicare look back?
Six years from the date the overpayment was received, if it is identified within that period (401.305(f)).
Does an investigation pause the clock?
Yes, if it is a timely, good-faith investigation into related overpayments from the same or similar cause. The suspension ends at the earlier of the investigation’s conclusion with the total calculated, or 180 days after the initial identification (401.305(b)(3)).
How do I return an overpayment?
Through the Medicare contractor’s claims adjustment, credit balance, self-reported refund or other reporting process (401.305(d)(1)). Contractor forms and steps differ, so use your contractor’s own instructions.
What if I am using the OIG Self-Disclosure Protocol?
The deadline is suspended once OIG acknowledges your submission, and a disclosure that ends in a settlement agreement satisfies the reporting obligation (401.305(b)(2)(i), (d)(2)).
Sources
- 42 CFR 401.305, “Requirements for reporting and returning of overpayments” (eCFR, amended at 89 FR 98553, Dec. 9, 2024), checked 31 October 2026: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-401/subpart-D/section-401.305.
- Noridian Healthcare Solutions, JE Part A, “Voluntary Refund” (page last updated Jun 6, 2025), checked 31 October 2026: https://med.noridianmedicare.com/web/jea/topics/overpayment-recoupment/voluntary-refunds.
