Response to Comments: Frequency of Hemodialysis

The comment period for the Frequency of Hemodialysis DL37504 began on 10/05/2017 and ended on 12/15/2017. Comments were received from the provider community. The notice period begins on 01/03/2019 and ends 02/17/2019. The LCD becomes final on 02/18/2019. Noridian received numerous comments related to DL37504, Frequency of Hemodialysis. Noridian has an existing Local Coverage Article (A53826) for this subject and this present draft will replace that existing article. In this revision there is expansion of the coverage diagnoses, addition of the use of a modifier to identify those additional treatments needed, and establishment of an appropriate way for appeals should a denial occur for those diagnoses not in the list. As noted in the document, the draft addresses a narrow issue for the ESRD program and does not change the base payment process issued by The Centers for Medicare and Medicaid Services (CMS). CMS charged Local Contractors (Medicare Administrative Contractors [MACs]) to develop a list of clinical conditions appropriate for payment beyond the standard thrice weekly payment. This list (included in the draft) is felt to be appropriate for such payments should medical documentation be supportive. All payment policies for the ESRD program reside with CMS for other changes. MACs do not have the discretion to change any basic payment policies related to this issue and are only defining a list of clinical conditions that up front in the submission of a claim could be felt to be appropriate for additional payment should medical documentation support use, if reviewed. There may be other clinical situations that require additional treatments. These lines in the claims, even though they do not have a diagnosis listed, can be noted by an appended KX modifier (see A55676). Additional review following an initial denial would be available through the appeals process. Additional review may result in the addition of diagnosis codes to the Local Coverage Determination. In the comment review, all submitted published literature was reviewed. Noridian does not do research based on bibliographies that may have been submitted along with comments. Many of the issues were similar and gathering of like comments was done for a response. A large number of literature articles were submitted by industry that encompassed the requests from others who did not submit literature. In general, the comments address home dialysis and more frequent dialysis as a baseline for payment. This issue is outside the scope of the draft LCD and will need to be addressed to, and by CMS. MACs do not have discretion to change payment strategies for CMS. The comments can generally be divided into three comment categories: Patient, caretakers, those who work with these patients Providers Industry

_Hemodialysis is typically furnished three times per week in sessions of 3-5 hours in duration. If the ESRD facility bills any treatment in excess of this frequency, medical justification is required to be furnished to the A/B MAC (A) and must be based on the individual patient’s need. The A/B MAC reviews the medical justification for EACH ADDITIONAL treatment and is responsible for making the decision on the appropriateness for the extra treatment(s) and payment for these added treatments._ Inclusion in the Plan of Care a higher number of treatments per week is not medical justification for the allowance of additional payments. Medical documentation should be available to support the additional treatments. (See Documentation Requirements in the LCD.) By use of the modifier to signify additional treatments were needed (even with diagnoses not included in the LCD), the ESRD facilities will have an appeals process for submission of medical records to justify the use compared to just frequency based denials.