CMS Pub. 100-04, ch. 34, § 10.11.1

New and material evidence is one of the means for establishing good cause to reopen an

initial determination or redetermination. New and material evidence is evidence that:

1. Was not readily available or known to the person or entity requesting/initiating

the reopening at the time of the initial determination or redetermination; and

2. May result in a conclusion different from that reached in the initial determination

or redetermination.

For example, data analysis that identifies a high error rate or pattern of potential

overutilization on the part of a provider or supplier is one example of evidence that is not

readily available or known to a contractor at the time it made its initial determination, and

may cause the contractor to believe its initial determinations for the claims of the

provider or supplier were incorrect.

Evidence may include any record used in the provision of medical care that supports

whether or not the service was covered, medically necessary, and provided as billed.

This includes medical records, progress notes, orders, procedure reports, invoices, proofs

of delivery, or other documentation as required by CMS policy. However, as explained

further below, any such evidence submitted by a party must satisfy the good cause

standard set forth in §405.986 (i.e., that it is new and material evidence (as described

above), or demonstrates that the evidence considered in making the initial determination

or redetermination clearly shows on its face that an obvious error was made at the time of

the determination or decision).