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. § 405.1046

Notice of an ALJ or attorney adjudicator decision

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(a) Decisions on requests for hearing—(1) General rule. Unless the ALJ or attorney adjudicator dismisses or remands the request for hearing, the ALJ or attorney adjudicator will issue a written decision that gives the findings of fact, conclusions of law, and the reasons for the decision. The decision must be based on evidence offered at the hearing or otherwise admitted into the record, and shall include independent findings and conclusions. OMHA mails or otherwise transmits a copy of the decision to all the parties at their last known address and the QIC that issued the reconsideration or from which the appeal was escalated. For overpayment cases involving multiple beneficiaries, where there is no beneficiary liability, the ALJ or attorney adjudicator may choose to send written notice only to the appellant. In the event a payment will be made to a provider or supplier in conjunction with the ALJ's or attorney adjudicator's decision, the contractor must also issue a revised electronic or paper remittance advice to that provider or supplier.

(2) Content of the notice. The decision must be written in a manner calculated to be understood by a beneficiary and must include—

(i) The specific reasons for the determination, including, to the extent appropriate, a summary of any clinical or scientific evidence used in making the determination;

(ii) For any new evidence that was submitted for the first time at the OMHA level and subject to a good cause determination pursuant to § 405.1028, a discussion of the new evidence and the good cause determination that was made;

(iii) The procedures for obtaining additional information concerning the decision; and

(iv) Notification of the right to appeal the decision to the Council, including instructions on how to initiate an appeal under this section.

(3) Limitation on decision. When the amount of payment for an item or service is an issue before the ALJ or attorney adjudicator, the ALJ or attorney adjudicator may make a finding as to the amount of payment due. If the ALJ or attorney adjudicator makes a finding concerning payment when the amount of payment was not an issue before the ALJ or attorney adjudicator, the contractor may independently determine the payment amount. In either of the aforementioned situations, an ALJ's or attorney adjudicator's decision is not binding on the contractor for purposes of determining the amount of payment due. The amount of payment determined by the contractor in effectuating the ALJ's or attorney adjudicator's decision is a new initial determination under § 405.924.

(b) Decisions on requests for review of a QIC dismissal—(1) General rule. Unless the ALJ or attorney adjudicator dismisses the request for review of a QIC dismissal, or the QIC's dismissal is vacated and remanded, the ALJ or attorney adjudicator will issue a written decision affirming the QIC's dismissal. OMHA mails or otherwise transmits a copy of the decision to all the parties that received a copy of the QIC's dismissal.

(2) Content of the notice. The decision must be written in a manner calculated to be understood by a beneficiary and must include—

(i) The specific reasons for the determination, including a summary of the evidence considered and applicable authorities;

(ii) The procedures for obtaining additional information concerning the decision; and

(iii) Notification that the decision is binding and is not subject to further review, unless reopened and revised by the ALJ or attorney adjudicator.

(c) Recommended decision. An ALJ or attorney adjudicator issues a recommended decision if he or she is directed to do so in the Council's remand order. An ALJ or attorney adjudicator may not issue a recommended decision on his or her own motion. The ALJ or attorney adjudicator mails a copy of the recommended decision to all the parties at their last known address.

[82 FR 5119, Jan. 17, 2017, as amended at 84 FR 19871, May 7, 2019]
Notes of Decisions
Cited in 9 cases (6 in the last 5 years), 2010–2026 · leading case: Randall D. Wolcott, Md, Pa v. Sebelius, 635 F.3d 757 (5th Cir. 2011).
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Randall D. Wolcott, Md, Pa v. Sebelius, 635 F.3d 757 (5th Cir. 2011). · cites it 2× “See 42 C.F.R. § 405.1046 (c). Alternatively, they argue that Wolcott could have requested a “reopening,” which is a remedial action taken to change a binding determination or decision that resulted in underpayment.”
Almy v. Sebelius, 749 F. Supp. 2d 315 (D. Maryland 2010). “42 C.F.R. § 405.1046 . Finally, the ALJ’s decision may be appealed to the Medicare Appeals Council (“MAC”), which is a division of the Department of Health and Human Services.”
Calvary Hosp., Inc. v. Becerra (S.D.N.Y. 2025). · cites it 4× “42 C.F.R. § 405.1046 (a)(1). (4) Medicare Appeals Council.”
Pac. Surgical Inst. of Pain Mgmt., Inc. v. Becerra (S.D. Cal. 2025). · cites it 4× “92 payment to Pacific Surgical, thereby creating a new initial 4 determination under 42 C.F.R. § 405.1046 (a)(3) that requires Pacific Surgical to first 5 exhaust its administrative remedies.”
Pinnacle Peak Neurology, LLC v. Noridian Healthcare Solutions (9th Cir. 2019). “42 C.F.R. § 405.1046 (a)(3) (emphasis added).”
Goose Creek Physical Med., LLC v. Becerra (D.S.C. 2024). “(quoting 42 C.F.R. § 405.1046 (a)(3)). Thus, the Secretary concludes that “any challenge to the effectuation must be presented to the agency through the appeal process.”
Dubus v. Soc. Sec. (W.D. La. 2024). “(citing 42 C.F.R. § 405.1046 (c)). They additionally argued that the plaintiff could have requested a “reopening” which is a remedial action taken to change a binding determination or decision that resulted in underpayment.”
Ashli Healthcare, Inc. v. Kennedy (E.D. Cal. 2025). “2019) (amount of payment 25 determined by contractor after ALJ decision “is a new initial determination” under 42 C.F.R. § 405.1046 (a)(3) and claim 26 regarding such determination must be presented and exhausted) 27 (emphasis omitted).”
MacOmb Foot, Ankle & Wound Care v. Becerra (D.D.C. 2026). “Plaintiffs also argue that the Appeals Council’s finding that the ALJ failed to evaluate the literature in the record was a mischaracterization of 42 C.F.R. § 405.1046 (a)(2)(i), which requires the agency to include a “summary of any clinical or scientific evidence used in…”
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