42 CFR 426.450 - Mandatory provisions of an ALJ's decision.
(a)Findings. An ALJ's decision must include one of the following:
(1) A determination that the provision of the LCD is valid under the reasonableness standard.
(2) A determination that the provision of the LCD is not valid under the reasonableness standard.
(3) A statement dismissing the complaint regarding the LCD and a rationale for the dismissal.
(4) A determination that the LCD record is complete and adequate to support the validity of the LCD provisions under the reasonableness standard.
(b)Other information. An ALJ's decision must include all of the following:
(1) The date of issuance.
(2) The docket number of the LCD review.
(3) A statement as to whether the aggrieved party has filed a claim for the service(s) named in the complaint, the date(s)-of-service, and the disposition, if known.
(i) Findings of fact.
(ii) Interpretations of law.
(iii) Applications of fact to law.
(5) A summary of the evidence reviewed. If proprietary or privileged data were submitted under seal, the decision must state whether the data were material and what role they played in the determination, but without disclosing the substance or contents of the evidence under seal. A separate statement of the rationale for the ALJ's treatment of the sealed evidence must be prepared and kept under seal itself. If the ALJ decision is appealed to the Board, this statement must be provided to the Board under seal.
(6) A statement regarding appeal rights.