C.F.R. » Title 42 » 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

42 C.F.R. § 423.343

Retroactive adjustments and reconciliations

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(a) Application of enrollee adjustment. The provisions of § 422.308(f) of this chapter apply to payments to Part D sponsors under this section in the same manner as they apply to payments to MA organizations under section 1853(a) of the Act.

(b) Health status. CMS makes adjustments to payments made under § 423.329(a)(1) to account for updated health status risk adjustment data as provided under § 422.310(g)(2) of this chapter. CMS may recover payments associated with health status adjustments if the Part D sponsor fails to provide the information described in § 423.329(b)(3).

(c) Reinsurance. CMS makes final payment for reinsurance after a coverage year after obtaining all of the information necessary to determine the amount of payment.

(1) Submission of cost data. Within 6 months of the end of a coverage year, the Part D sponsor must provide the information that CMS requires.

(2) Payments. CMS at its discretion either makes lump-sum payments or adjusts monthly payments throughout the remainder of the payment year following the coverage year based on the difference between monthly reinsurance payments made during the coverage year and the amount payable in § 423.329(c) for the coverage year. CMS may recover payments made through a lump sum recovery or by adjusting monthly payments throughout the remainder of the coverage year if the monthly reinsurance payments made during the coverage year exceed the amount payable under § 423.329(c) or if the Part D sponsor does not provide the data in paragraph (c)(1) of this section.

(d) Low-income cost-sharing subsidy. CMS makes final payment for low-income cost-sharing subsidies after a coverage year after obtaining all of the information necessary to determine the amount of payment.

(1) Submission of cost data. Within 6 months of the end of a coverage year, the Part D sponsor must provide the information that CMS requires.

(2) Payments. CMS at its discretion either makes lump-sum payments or adjusts monthly payments throughout the remainder of the payment year following the coverage year based on the difference between interim low-income cost-sharing subsidy payments and total low-income cost-sharing subsidy costs eligible for subsidy under § 423.782 submitted by the plan for the coverage year. CMS may recover payments made through a lump sum recovery or by adjusting monthly payments throughout the remainder of the coverage year if interim low-income cost-sharing subsidy payments exceed the amount payable under § 423.782 or if the Part D sponsor does not provide the data in paragraph (d)(1) of this section.

(e) Selected drug subsidy. CMS makes final payment for selected drug subsidies after a coverage year after obtaining all of the information necessary to determine the amount of payment.

(1) Submission of cost data. Within 6 months of the end of a coverage year, the Part D sponsor must provide the information that CMS requires.

(2) Payments. CMS at its discretion either makes lump-sum payments or adjusts monthly payments throughout the remainder of the payment year following the coverage year based on the difference between interim selected drug subsidy payments and total selected drug subsidy costs eligible for subsidy under § 423.329(e) submitted by the plan for the coverage year. CMS may recover payments made through a lump sum recovery or by adjusting monthly payments throughout the remainder of the coverage year if the interim selected drug subsidy payments exceed the amount payable under § 423.329(e) of if the Part D sponsor does not provide the data in paragraph (e)(1) of this section.

[70 FR 4525, Jan. 28, 2005, as amended at 91 FR 17589, Apr. 6, 2026]
Notes of Decisions
Cited in 5 cases (1 in the last 5 years), 2008–2025 · leading case: United States Ex Rel. Spay v. CVS Caremark Corp., 875 F.3d 746 (3rd Cir. 2017).
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United States Ex Rel. Spay v. CVS Caremark Corp., 875 F.3d 746 (3rd Cir. 2017). “42 C.F.R. § 423.343 . 6 . Medicare Program; Medicare Prescription Drug Benefit, 70 Fed.”
Long Term Care Pharmacy All. v. Leavitt, 530 F. Supp. 2d 173 (D.D.C. 2008). · cites it 3× “§ 1395w-114(c)(2); 42 C.F.R. § 423.343 (d). After they receive updated data regarding cost-sharing eligibility, the PDPs are required to “reimburse subsidy eligible individuals, and organizations paying cost-sharing on behalf of such individuals, any excess premiums and…”
Fox Ins. Co., Inc. v. Centers for Medicare & Medic, 715 F.3d 1211 (9th Cir. 2013). · cites it 4× “See 42 C.F.R. § 423.343 . The plan “sponsors” or contractors have six months after the end of the year to provide CMS their relevant data, so the process is not completed until the following fall.”
Behnke v. Cvs Caremark Corp. (E.D. Pa. 2020). “’”) (citing 42 C.F.R. § 423.343 ).) Relator has failed to plausibly plead a clear obligation to pay the Government.”
Pharmaessentia USA Corp. v. United States Dep't of Health & Human Servs. (D.D.C. 2025). “” 42 C.F.R. § 423.343 (c); see 42 U.S.C. § 1395w- 115(d)(2)(A).”
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