By Christopher R. Blagg, MD, FRCP, and Robert S Lockridge, MD

Several government agencies-the Medicare Payment Advisory Commission, the Government Accountability Office, the Centers for Medicare & Medicaid Services-and Congress have all expressed interest in seeing more individuals with end-stage renal disease dialyzing at home in the future. As of 2007, 11 countries had a higher percentage of their dialysis patients on home hemodialysis (HHD) than the United States, and 41 countries had more patients on peritoneal dialysis (PD).
 
We have known for 45 years now that HHD is the best treatment for patients willing and able to do it. With the benefits found with daily and nightly HD-including survival that appears similar to that with a deceased donor transplant-and with the development of more patient-friendly equipment, we have seen a small but steady increase in the use of HHD.

The draft of the bundled ESRD Prospective Payment System (PPS), released on Sept. 15. proposes to include payment for a key element to the success of home dialysis-patient training-within the bundled composite rate instead of as a separate payment. We think this is a mistake.

In the proposed rule, the bundled rate for the first four months of Medicare eligibility for patients who select home hemodialysis will be: 1.473 (x) the standard bundled rate to account for the extra costs associated with stabilizing patients at home, administrative and labor costs associated with new patients, and "initial costs incurred to train patients and their caregivers to perform home dialysis." For PD, which is almost always selected as an initial therapy with training completed within a week or two once the patient is stable, such a policy makes sense for the dialysis provider. But the formula shows a lack of understanding of HHD.

According to the 2009 United States Renal Data System Report, 43% of new patients have not seen a nephrologist before starting dialysis, and so will almost certainly need vascular access surgery, time for a fistula to mature, and time to learn to needle their fistula before they can go into training for home HD. As a result, only about 10% of home HD patients start their actual training in the first four months of dialysis and a significant number of these are likely to have Medicare as a secondary payer. Other in-center patients may decide to change to home HD months or years after staring dialysis. In addition there are occasions when patients already being treated by home HD require one or more retraining dialyses on new equipment or for other reasons. Thus, the majority of home HD training will occur after the first four months
of entitlement.

Often times, patients who have been at home on PD may begin to have difficulties with their treatment after one to three years because of loss of residual renal function and will have to transfer to HD (the dropout rate for PD is about 30% per year). At least some of these patients, having experienced the advantages of self-dialysis at home, will welcome the opportunity to be trained for home HD.

CMS argues that it has included the cost of training based on cost reports in the bundled ESRD PPS. In general, data on the cost of home HD training from cost reports suffer from the fact that the details of what should be included in these costs have never been clearly defined, and costs reported to CMS (and the GAO) almost certainly are not comparable between different programs. Certainly, current payment of an extra $20 per treatment for three months is inadequate.

Based on USRDS 2007 data, if one assumes 425 patients a year train for home HD (based on 1,253 patients trained between 2005-2007) and if (for example) cost report data show an average additional cost of $250 per training of hemodialysis patients above the proposed bundled rate for 20 training dialyses (most patients can be trained with this or fewer dialyses once taught to use their blood access) for a total cost of $5,000 per patient trained, the total extra cost would be $2.125 million. If this is distributed across the 46,622,520 dialyses (based on 333,018 prevalent hemodialysis patients at the end of 2007 and an average 140 treatments per year per patient) this is slightly less than five cents per dialysis. If CMS uses estimates of home HD training costs based on the extra $20 per training dialysis 3 times weekly for 13 weeks, for a total cost of $780, and distributes these costs similarly, the result would be less than one cent per hemodialysis.

The first scenario, set at the appropriate level based on cost reports, would cover the cost of home HD training to the ESRD program. The second scenario (what we have been doing for many years), does not capture the cost of home HD training and is one of the factors that have discouraged the use of home HD in this country.

Thus, for patients trained for home HD after the first 4 months of Medicare eligibility (currently about 75% to 90% of home HD patients), it will take a year or more before the costs of training are recovered, even though the cost of hemodialysis at home is significantly less than the cost of in-center dialysis. It is also well recognized that when a new home HD program starts up it will need to train and send home some 12 to 15 patients before it completely recovers the initial start-up costs.

What would be a reasonable alternative for home HD training of patients in whom Medicare is primary and that occurs after the first four months of Medicare eligibility? One possibility would be to apply an appropriate adjustment per training dialysis, based on cost report data, for up to 25 training dialyses. This approach should incentivize providers to provide home HD training for more patients.

It behooves all of us, nephrologists, patients, dialysis staff and others interested in home HD to take a strong position against inclusion of home HD training costs in the expanded bundle as proposed by CMS. CMS has elected to describe home HD training costs as "renal dialysis services" but with only 0.8% of the 368,544 prevalent patients on home HD in 2007, it is hardly a routine service as yet.

Summary
While there should be strong support for continuing the one single payment for an individual hemodialysis treatment, whether in center or at home, and the equivalent for PD, inclusion of home HD training costs in the general bundle after the first four months of Medicare eligibility will hinder, not help, in encouraging use of the best forms of dialysis treatment, including nightly nocturnal home hemodialysis. The latter is overwhelmingly the choice of knowledgeable nephrologists when asked what treatment they would choose for themselves if they could not have a transplant.

Dr. Blagg is executive director emeritus at the Northwest Kidney Centers in Seattle. Dr. Lockridge is the medical director of the University of Virginia Lynchburg Home Hemodialysis Program, Lynchburg, Va.