Should the Medicare ESRD program fund daily and nocturnal hemodialysis?

A recently published paper concluded that funding for conventional hemodialysis (CHD) should be maintained and that the newer methods of short daily (sDHD) and nocturnal home hemodialysis (NHHD) be denied funding through Medicare until a randomized control trial (RCT) on the benefits of sDHD and/or NHHD are complete. This conclusion is irrespective of the fact that RCT methodology has never been required of CHD itself and irrespective that a host of observational studies (OS) have already confirmed comparative outcome and cost benefit from these novel regimens. It begs the question: How can any RCT of dialysis modality, frequency, duration, location, and lifestyle impact ever be fairly (or ethically) completed? It also invokes a classic Catch-22 funding argument--funding should not be accorded without a fair and ethical RCT, yet a fair and ethical RCT of widely disparate lifestyle-impacting dialysis modalities is effectively impossible. Meanwhile, the better observational outcomes and cost-efficiencies of sDHD and NHHD remain tantalizingly attainable. It is time to recognize that a RCT may not be the best way to evaluate complex dialysis modalities and that available data is adequate to developing funding models.