H.R 3096, Kidney Patient More Frequent Dialysis Quality Act of 2005, updates bills submitted unsuccessfully in prior years calling for CMS to fund more frequent dialysis – both in-center and home. I am concerned this most recent bill perpetuates a paradox which will again prevent its passage into law. The paradox stems from the fact that the most compelling argument in favor of passage – the substantial patient benefits resulting from more frequent dialysis – is also the most compelling argument against its passage – that the benefits are so substantial that the percentage of present thrice-weekly patients who would elect the more frequent in-center mode if it were available is also substantial.
Given that in-center labor, supplies and facility related costs are roughly proportional to number of treatments delivered, the cost impact for CMS is likely to be seen as very high by the Congressional Budget Office (CBO) – even if only a few percent of in-center patients elect more frequent treatment. I understand that last year CBO assumed 30 percent would so elect – probably not an unreasonable assumption. H.R 3096’s authors have attempted to address the cost issue by limiting the definition of more frequent dialysis to four or five treatments per week. While this reduces the potential cost by up to one-third, it does so by limiting clinical efficacy from a sixth treatment and may also create a scheduling dilemma for centers striving for a high level of capacity utilization. It also seems unlikely that this cost reduction will be sufficient for the bill to survive much beyond the CBO scoring process.
While high cost alone cannot justify denial under the Medicare “reasonable and necessary” standard, as a practical matter is seems almost certain that what is likely to be viewed as the “budget busting” cost of H.R. 3096 will cause CBO, Congress and CMS to continue to hide behind the need for the results of the planned NIH study of more frequent dialysis – a three year study to decide if a subsequent five year study is warranted!
If this pessimism about the likelihood of enactment of H.R. 3096 is well-founded an alternative strategy to secure CMS funding of more frequent dialysis is needed. I believe such a strategy exists through an amended bill:
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Limit the new bill to more frequent dialysis at home only – setting aside in-center (but see below)
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Provide new funding only for upfront one-time training and machine purchase for home patients bill while limiting the monthly coverage for these patients to the existing coverage for all dialysis patients. Given the small number of home patients, the likely pace at which new home centers and patients would be added and most important – that only one-time capital funding – not continuing operating funding – is required, it is likely that CBO funding projections would be quite modest. To account for patients terminating home dialysis for various reasons a “high water mark” rule could be followed under which CMS would be billed for a machine purchase only when there is an increase to a new high in the net number of a center’s home patients.
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Require such funding to be provided under CMS’s new [i]Coverage with Evidence Development /i policy which implies a more relaxed standard for coverage of new technology. One application of this policy is where, ”… there may remain questions about the comparative effectiveness of new items and services compared to existing alternatives or to usual care.” (Draft Guidance for the Public, Industry, and CMS Staff: Factors CMS Considers in Making a Determination of Coverage with Evidence Development – Centers for Medicare and Medicaid Services, April 7, 2005) This would also provide “cover” for modifying the prior Congressional and CMS decision to defer funding for frequent dialysis pending results of the previously called-for NIH studies. While perhaps not likely it is conceivable that the costs may be seen as low enough that CMS might even adopt this proposal without legislation under its CED policy. Since the benefits of more frequent dialysis are so important – quite literally a matter of life and death – application of the CED policy for coverage now in contrast to an eight year study delay before a coverage decision is made seems entirely justified.
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With the upfront cost barrier removed it is likely that many centers would initiate home programs – one consequence would be that benefits data under CED would accumulate rapidly – much more rapidly than could be expected from the NIH studies, and in-center patients would become aware much sooner of the benefits of frequent dialysis they are being denied.
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Home dialysis equipment vendors would benefit not only from a more rapidly growing, subsidized market, but also through no longer being required to finance their sales. While some vendors presently do not offer their machines for outright sale it seems likely that all vendors would promptly adjust their pricing and contract policies to best exploit this new legislation.
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As more frequent dialysis benefits data under CED data collection requirements accumulated demonstrating that more frequent dialysis was “reasonable and necessary” and patient awareness increased it would be increasingly difficult for Congress and CMS to deny more frequent dialysis to everyone – in-center as well as home – even at higher direct cost. (There is little doubt that net cost to Medicare will decrease with more frequent dialysis when Part A (hospital) and Part D (prescription drugs – blood pressure medications, etc.) savings are considered.) As a result the goal of more frequent dialysis for all would likely be fulfilled in a far shorter time than the eight years plus required by the present CMS policy trajectory.
On its surface this amendment appears more modest than H.R. 3096. I believe, however, that it exceeds H.R. 3096 as introduced in the House of Representatives in probability of enactment into law. Therefore, the amended version is likely to achieve the goal of H.R. 3096 – frequent dialysis for all who would benefit – much sooner than annually resubmitting the same legislation in the hope that opposition might be ultimately worn down.
The sponsors and advocates who have worked so tirelessly on H.R. 3096 and its predecessors deserve the gratitude of the entire dialysis community. I hope they will give careful consideration to this suggested amendment as a means for achieving their goal.
In closing I should note that I have no financial interest of any kind in any aspect of dialysis. My wife, Jane, has been getting nocturnal dialysis six time per week at home for nearly three years. My sole interest is in seeing the striking benefits she has received made available to every dialysis patient.
Mel