C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL PROVISIONS › PART 401—GENERAL ADMINISTRATIVE REQUIREMENTS › Subpart D—Reporting and Returning of Overpayments

42 C.F.R. § 401.305

Requirements for reporting and returning of overpayments

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(a) General. (1) A person that has received an overpayment must report and return the overpayment in the form and manner set forth in this section.

(2) A person has identified an overpayment when the person knowingly receives or retains an overpayment. The term “knowingly” has the meaning set forth in 31 U.S.C. 3729(b)(1)(A).

(b) Deadline for reporting and returning overpayments. (1) Except as provided in paragraphs (b)(2) and (3) of this section, a person who has received an overpayment must report and return the overpayment by the later of either of the following:

(i) The date which is 60 days after the date on which the overpayment was identified.

(ii) The date any corresponding cost report is due, if applicable.

(2) The deadline for returning overpayments will be suspended (or will continue to be suspended following the completion of a timely, good faith investigation in accordance with paragraph (b)(3) of this section) when any of the following occurs:

(i) OIG acknowledges receipt of a submission to the OIG Self-Disclosure Protocol and will remain suspended until such time as a settlement agreement is entered, the person withdraws from the OIG Self-Disclosure Protocol, or the person is removed from the OIG Self-Disclosure Protocol.

(ii) CMS acknowledges receipt of a submission to the CMS Voluntary Self-Referral Disclosure Protocol and will remain suspended until such time as a settlement agreement is entered, the person withdraws from the CMS Voluntary Self-Referral Disclosure Protocol, or the person is removed from the CMS Voluntary Self-Referral Disclosure Protocol.

(iii) A person requests an extended repayment schedule as defined in § 401.603 and will remain suspended until such time as CMS or one of its contractors rejects the extended repayment schedule request or the provider or supplier fails to comply with the terms of the extended repayment schedule.

(3)(i) The deadline for reporting and returning overpayments will be suspended when both of the following occurs:

(A) A person has identified an overpayment but has not yet completed a good-faith investigation to determine the existence of related overpayments that may arise from the same or similar cause or reason as the initially identified overpayment; and

(B) The person conducts a timely, good-faith investigation to determine whether related overpayments exist.

(ii) If the conditions of paragraph (b)(3)(i) of this section are satisfied, the deadline for reporting and returning the initially identified overpayment and related overpayments that arise from the same or similar cause or reason as the initially identified overpayment will remain suspended until the earlier of:

(A) The date that the investigation of related overpayments has concluded and the aggregate amount of the initially identified overpayments and related overpayments is calculated; or

(B) The date that is 180 days after the date on which the initial identified overpayment was identified.

(c) Applicable reconciliation. (1) The applicable reconciliation occurs when a cost report is filed; and

(2) In instances when the provider—

(i) Receives more recent CMS information on the SSI ratio, the provider is not required to return any overpayment resulting from the updated information until the final reconciliation of the provider's cost report occurs; or

(ii) Knows that an outlier reconciliation will be performed, the provider is not required to estimate the change in reimbursement and return the estimated overpayment until the final reconciliation of that cost report.

(d) Reporting. (1) A person must use an applicable claims adjustment, credit balance, self-reported refund, or other reporting process set forth by the applicable Medicare contractor to report an overpayment, except as provided in paragraph (d)(2) of this section. If the person calculates the overpayment amount using a statistical sampling methodology, the person must describe the statistically valid sampling and extrapolation methodology in the report.

(2) A person satisfies the reporting obligations of this section by making a disclosure under the OIG's Self-Disclosure Protocol or the CMS Voluntary Self-Referral Disclosure Protocol resulting in a settlement agreement using the process described in the respective protocol.

(e) Enforcement. Any overpayment retained by a person after the deadline for reporting and returning the overpayment specified in paragraph (b) of this section is an obligation for purposes of 31 U.S.C. 3729.

(f) Lookback period. An overpayment must be reported and returned in accordance with this section if a person identifies the overpayment, as defined in paragraph (a)(2) of this section, within 6 years of the date the overpayment was received.

[81 FR 7683, Feb. 12, 2016, as amended at 89 FR 98553, Dec. 9, 2024]
Notes of Decisions
Cited in 9 cases (6 in the last 5 years), 2017–2026 · leading case: United States v. Dental Dreams, LLC, 307 F. Supp. 3d 1224 (D.N.M. 2018).
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United States v. Dental Dreams, LLC, 307 F. Supp. 3d 1224 (D.N.M. 2018). · cites it 3× “42 C.F.R. § 401.305 (a)(1). A person who has received an overpayment must report and return it to the Health and Human Services Secretary, the State, or other appropriate entity within "60 days after the date on which the overpayment was identified.”
Hill v. Bd. of Regents of the Univ. Sys. of Georgia Et Al., 829 S.E.2d 193 (Ga. Ct. App. 2019). “15 , which provides that "[a] State plan must provide that the Medicaid agency must limit participation in the Medicaid program to providers who accept, as payment in full, the amounts paid by the agency plus any deductible, coinsurance or copayment required by the plan to be…”
United States ex rel. Salters v. Am. Fam. Care, Inc., 262 F. Supp. 3d 1266 (N.D. Ala. 2017). “Further, Salters does not provide evidence of any other legal duty AFC may have had ■to report these overpayments.”
La Frontera Ctr., Inc. v. United Behavioral Health, Inc. (D.N.M. 2025). · cites it 2× “§ 1320a-7k(d)(1)–(2) (Medicare and Medicaid program integrity provisions); see also 42 C.F.R. § 401.305 (e) (2024) (Any overpayment retained by a person after the deadline for reporting and returning the overpayment .”
La Frontera Ctr., Inc. v. United Behavioral Health, Inc. (D.N.M. 2025). · cites it 2× “An “overpayment” includes “any funds that a person receives or retains under . . . to which the person . . . is not entitled.”
United States of Am. v. Nw. Mem'l Healthcare (N.D. Ill. 2023). “” See 42 C.F.R. § 401.305 . But Plaintiff’s reverse false claim fails for the same reasons as its presentment and records claims—it has not alleged any false claim that needed to be repaid.”
United States of Am. v. Curo Health Servs. Holdings, Inc. (M.D. Tenn. 2022). “42 C.F.R. § 401.305 (a)(2). The defendants suggest that CMS’s definition is likely to be set aside as inconsistent with the statutory text, because the D.”
Post v. Amerisourcebergen Corp. (N.D.W. Va. 2023). “§ 1320a-7k(d)(1); 42 C.F.R. § 401.305 (a). If an overpayment is not returned, the statute and regulation provide that is to be enforced through the FCA.”
Emery Soos v. Mehmet Oz (D. Md. 2026). “The Rooker- Feldman doctrine thus squarely applies to Plaintiff’s claims, and this Court is without subject matter jurisdiction to review them. Plaintiff may challenge the judgment through the appropriate appellate procedures in the California court.”
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