---
kind: "section"
citation: "42 C.F.R. § 423.2046"
title: "42"
number: "423.2046"
heading: "Notice of an ALJ or attorney adjudicator decision."
url: "https://uscodex.org/cfr/42/423.2046"
---

# §423.2046. Notice of an ALJ or attorney adjudicator decision.

- (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.
    - (i) The decision must be based on evidence offered at the hearing or otherwise admitted into the record, and shall include independent findings and conclusions.
    - (ii) A copy of the decision should be mailed or otherwise transmitted to the enrollee at his or her last known address.
    - (iii) A copy of the written decision should also be provided to the IRE that issued the reconsideration determination, and to the Part D plan sponsor that issued the coverage determination or at-risk determination.
  - (2) **Content of the notice.** The decision must be provided in a manner calculated to be understood by an enrollee 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) The procedures for obtaining additional information concerning the decision; and
    - (iii) 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 the Part D drug 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 Part D plan sponsor 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 Part D plan sponsor for purposes of determining the amount of payment due. The amount of payment determined by the Part D plan sponsor in effectuating the ALJ's or attorney adjudicator's decision is a new coverage determination under [§ 423.566](/cfr/42/423.566.md).
- (b) **Decisions on requests for review of an IRE dismissal—**
  - (1) **General rule.** Unless the ALJ or attorney adjudicator dismisses the request for review of an IRE dismissal, or the dismissal is vacated and remanded, the ALJ or attorney adjudicator will issue a written decision affirming the IRE's dismissal. OMHA mails or otherwise transmits a copy of the decision to the enrollee.
  - (2) **Content of the notice.** The decision must be written in a manner calculated to be understood by an enrollee 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 the enrollee at his or her last known address.

## Notes

### Amendments

[82 FR 5134, Jan. 17, 2017, as amended at 83 FR 16754, Apr. 16, 2018]

### Source

Source: 74 FR 65363, Dec. 9, 2009, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.

### Source

Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.

### Amendments

[82 FR 5134, Jan. 17, 2017, as amended at 83 FR 16754, Apr. 16, 2018]