Federal regulations · Through 2026-08-25 · Newer source version available

42 CFR 423.360: Reporting and returning of overpayments.

(a) Definitions. For the purposes of this section the following definitions are applicable:
Applicable reconciliation means the later of either the annual deadline for submitting—
(i) PDE data for the annual Part D payment reconciliations referred to in § 423.343(c) and (d); or
(ii) Direct and indirect remuneration data.
Funds for purposes of this section, means any payment that a Part D sponsor has received that is based on data submitted by the Part D sponsor to CMS for payment purposes, including data submitted under § 423.329(b)(3), § 423.336(c)(1), § 423.343, and data provided for purposes of supporting allowable costs as defined in § 423.308 which includes data submitted to CMS regarding direct or indirect remuneration.
Overpayment means funds that a Part D sponsor has received or retained under title XVIII of the Act to which the Part D sponsor, after applicable reconciliation, is not entitled under such title.
(b) General rule. If a Part D sponsor has identified that it has received an overpayment, the Part D sponsor must report and return that overpayment in the form and manner set forth in this section.
(c) Identified overpayment. The Part D sponsor has identified an overpayment when the Part D sponsor knowingly receives or retains an overpayment. The term “knowingly” has the meaning set forth in 31 U.S.C. 3729(b)(1)(A).
(d) Reporting and returning of an overpayment. A Part D sponsor must report and return any overpayment it received no later than 60 days after the date on which it identified it received an overpayment.
(1) Reporting. A Part D sponsor must notify CMS of the amount and reason for the overpayment, using the notification process determined by CMS.
(2) Returning. A Part D sponsor must return identified overpayments in a manner specified by CMS.
(e) Enforcement. Any overpayment retained by a Part D sponsor is an obligation under 31 U.S.C. 3729(b)(3) if not reported and returned in accordance with paragraph (d) of this section.
(f) Look-back period. A Part D sponsor must report and return any overpayment identified within the 6 most recent completed payment years.

Where this section sits in the code

Title 42—Public Health
CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B—MEDICARE PROGRAM
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart G—Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage

(a) Definitions. For the purposes of this section the following definitions are applicable:

Applicable reconciliation means the later of either the annual deadline for submitting—

(i) PDE data for the annual Part D payment reconciliations referred to in § 423.343(c) and (d); or

(ii) Direct and indirect remuneration data.

Funds for purposes of this section, means any payment that a Part D sponsor has received that is based on data submitted by the Part D sponsor to CMS for payment purposes, including data submitted under § 423.329(b)(3), § 423.336(c)(1), § 423.343, and data provided for purposes of supporting allowable costs as defined in § 423.308 which includes data submitted to CMS regarding direct or indirect remuneration.

Overpayment means funds that a Part D sponsor has received or retained under title XVIII of the Act to which the Part D sponsor, after applicable reconciliation, is not entitled under such title.

(b) General rule. If a Part D sponsor has identified that it has received an overpayment, the Part D sponsor must report and return that overpayment in the form and manner set forth in this section.

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

(d) Reporting and returning of an overpayment. A Part D sponsor must report and return any overpayment it received no later than 60 days after the date on which it identified it received an overpayment.

(1) Reporting. A Part D sponsor must notify CMS of the amount and reason for the overpayment, using the notification process determined by CMS.

(2) Returning. A Part D sponsor must return identified overpayments in a manner specified by CMS.

(e) Enforcement. Any overpayment retained by a Part D sponsor is an obligation under 31 U.S.C. 3729(b)(3) if not reported and returned in accordance with paragraph (d) of this section.

(f) Look-back period. A Part D sponsor must report and return any overpayment identified within the 6 most recent completed payment years.

Collected 2026-08-27T02:26:11Z. Source file · JSON

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