If a facility issues an "addendum" or "comparison" report after the initial mammography report has already gone out, are these reports required to have an overall final assessment category?

Must the "addendum" or "comparison" report also be provided to the referring health care provider and the patient, even if there is no change in the final assessment category or recommended course of action?

Yes to both questions. The report issued after additional testing that is covered under MQSA (e.g., coned, repeat, magnification views) or following comparison with old films should reflect the final assessment category for the case following these additional tests or comparison studies. A report of this nature must be communicated to the referring health care provider or the self-referred patient, just as any other report would be. In addition, a lay summary of the “addendum” or “comparison” report sent to the health care provider (or self-referred patient) must be provided to all patients, even if there is no change in the final assessment category or recommended course of action. For the specific case where there is no significant change in the report, a simple statement that the comparison has been performed and that there is no overall change would satisfy the requirement. If the “addendum” merely stated that the referring health care provider had been notified of the results of the patient’s examination, the addendum lay summary could be a simple statement informing the patient of that fact.