42 CFR 423.2032 - Issues before an ALJ.
(a) General rule. The issues before the ALJ include all the issues brought out in the coverage determination, redetermination, or reconsideration that were not decided entirely in an enrollee's favor. However, if evidence presented before the hearing causes the ALJ to question a favorable portion of the determination, he or she notifies the enrollee before the hearing and may consider it an issue at the hearing.
(b) New issues -
(2) Content of the new issues. The new issue may include issues resulting from the participation of CMS, the IRE, and/or the Part D plan sponsor at the ALJ level of adjudication and from any evidence and position papers submitted by CMS, the IRE, and/or the Part D plan sponsor for the first time to the ALJ.
(i) Could have a material impact on the issue or issues that are the subject of the request for hearing; and
(ii) Is permissible under the rules governing reopening of determinations and decisions as specified in § 423.1980.
(c) Adding issues to a pending appeal. An ALJ may not add any issue, including one that is related to an issue that is appropriately before an ALJ, to a pending appeal unless it has been adjudicated at the lower appeals levels and the enrollee is notified of the new issue(s) before the start of the hearing.