C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED › Subpart I—Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and Part B)

42 C.F.R. § 405.921

Notice of initial determination

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(a) Notice of initial determination sent to the beneficiary. (1) The notice must be written in a manner calculated to be understood by the beneficiary, and sent to the last known address of the beneficiary.

(2) Content of the notice. The notice of initial determination must contain all of the following:

(i) The reasons for the determination, including whether a local medical review policy, a local coverage determination, or national coverage determination was applied.

(ii) The procedures for obtaining additional information concerning the contractor's determination, such as a specific provision of the policy, manual, law or regulation used in making the determination.

(iii) Information on the right to a redetermination if the beneficiary is dissatisfied with the outcome of the initial determination and instructions on how to request a redetermination.

(iv) Any other requirements specified by CMS.

(b) Notice of initial determination sent to providers and suppliers. (1) An electronic or paper remittance advice (RA) notice is the notice of initial determination sent to providers and suppliers that accept assignment.

(i) The electronic RA must comply with the format and content requirements of the standard adopted for national use by covered entities under the Health Insurance Portability and Accountability Act (HIPAA) and related CMS manual instructions.

(ii) When a paper RA is mailed, it must comply with CMS manual instructions that parallel the HIPAA data content and coding requirements.

(2) The notice of initial determination must contain all of the following:

(i) The basis for any full or partial denial determination of services or items on the claim.

(ii) Information on the right to a redetermination if the provider or supplier is dissatisfied with the outcome of the initial determination.

(iii) All applicable claim adjustment reason and remark codes to explain the determination.

(iv) The source of the RA and who may be contacted if the provider or supplier requires further information.

(v) All content requirements of the standard adopted for national use by covered entities under HIPAA.

(vi) Any other requirements specified by CMS.

(c) Notice of initial determination sent to an applicable plan—(1) Content of the notice. The notice of initial determination under § 405.924(b)(16) must contain all of the following:

(i) The reasons for the determination.

(ii) The procedures for obtaining additional information concerning the contractor's determination, such as a specific provision of the policy, manual, law or regulation used in making the determination.

(iii) Information on the right to a redetermination if the liability insurance (including self-insurance), no-fault insurance, or workers' compensation law or plan is dissatisfied with the outcome of the initial determination and instructions on how to request a redetermination.

(iv) Any other requirements specified by CMS.

(2) [Reserved]

[70 FR 11472, Mar. 8, 2005, as amended at 80 FR 10617, Feb. 27, 2015]
Notes of Decisions
Cited in 8 cases (5 in the last 5 years), 2017–2026 · leading case: Arriva Med. LLC v. United States Dep't of Health & Human Servs., 239 F. Supp. 3d 266 (D.D.C. 2017).
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Arriva Med. LLC v. United States Dep't of Health & Human Servs., 239 F. Supp. 3d 266 (D.D.C. 2017). · cites it 2× “11 (citing 42 C.F.R. § 405.921 (b)). This is apparently completed “in the ordinary course of Medicare claim processing,” id.”
Cypress Home Care, Inc. v. Azar, 326 F. Supp. 3d 307 (E.D. Tex. 2018). “001302-001306; see also 42 C.F.R. 405.921(b). Cypress filed a request for redetermination and, subsequently, a request for reconsideration with the responsible CMS contractors.”
Compass Lab'y Servs., LLC v. Becerra (W.D. Tenn. 2024). · cites it 2× “See 42 C.F.R. § 405.921 (b). The remittance advice that providers receive outlines how one can pursue an appeal for a denied payment.”
Gen. Med., P.C. v. Sec'y of the U.S. Dep't of Health & Human Servs. (E.D. Mich. 2026). · cites it 2× “First, General Medicine contended that production of the worksheets was required under 42 C.F.R. § 405.921 (b)(2)(i) (“Section 921”).”
D&G Holdings, L.L.C. v. Alex Azar, II, Sec'y (5th Cir. 2019). “§ 1395ff(a)(2)(A), (a)(4); 42 C.F.R. § 405.921 . No party contends that Novitas sent a written notice to D&G regarding its repayment decision.”
Consultants in Pain Med., PLLC & David Blanton v. Ellen Boyle Duncan, PLLC & Ellen Boyle Duncan, M.D. (Tex. App. 2024). “at *3 (citing 42 C.F.R. §§ 405.921 , 405.371; Medicare Program Integrity Manual § 8.”
Integrity Soc. Work Servs., LCSW, LLC v. AZAR (E.D.N.Y 2021). “; see also 42 C.F.R. §§ 405.921 , 405.371. The MAC must explain its reasons for seeking recoupment or future offset and provide an opportunity for rebuttal.”
Ashli Healthcare, Inc. v. Kennedy (E.D. Cal. 2025). “§ 1395ff(a)(3)); see also Compass Lab’y, 4 2024 WL 1289696 , at *6 (citing 42 C.F.R. § 405.921 (b)) (same). 5 After receiving a claim, Medicare sends notice of a claim’s 6 initial determination to Ashli, and it must contain “the basis 7 for any full or partial denial…”
— 42 C.F.R. § 405.921(b) — 1 case
Cypress Home Care, Inc. v. Azar, 326 F. Supp. 3d 307 (E.D. Tex. 2018). “001302-001306; see also 42 C.F.R. 405.921(b). Cypress filed a request for redetermination and, subsequently, a request for reconsideration with the responsible CMS contractors.”
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