Here’s the letter that Mel Hodge wrote to Linda Kohn in responce to her GAO Report to CMS on Monitoring Home Dialysis re:the bundle.
Dear Ms. Kohn,
My purpose in writing is to express my grave concern that there will be serious unintended consequences of the “Recommendation for Executive Action” contained GAO’s report, “End Stage Renal Disease – CMS Should Monitor Effect of Bundled Payment on Home Dialysis Utilization Rates” – GAO-09-537, consequences which will result in a substantial, unnecessary loss of life. I will also suggest an alternative.
The fatal flaw in your recommendation, that CMS, “…implement a formal plan to monitor the expanded bundled payment plan on home dialysis rates,” is one of timing. If CMS implements expanded bundling and the recommended formal20monitoring plan in 2010, it is unlikely that the impact on home dialysis will stabilize and measurement completed in less than a year. If this impact is adverse, as experts anticipate, it is unlikely that a remedial plan could be designed and implemented in less than another year.
GAO’s analysis and conclusion are exactly right, “For these reasons we believe that the effect of the expanded bundled payment system on home dialysis utilization rates is uncertain…” You have accurately described how this uncertainty is shared by dialysis providers and is exacerbated by the stated intention of CMS to discontinue its present practice of reimbursement for a properly justified fourth weekly treatment after bundling is initiated.
Less than one percent of American dialysis patients benefit from home hemodialysis treatment, which is reported to reduce mortality by 50-80 percent and to provide a survival outlook comparable to kidney transplant; unfortunately, the NIH clinical trials referred to in your report are underpowered by an order of magnitude to be able to confirm this survival advantage. However, more and more favorable observational reports, small randomized trials and kinetic studies have given home hemodialysis modest, but growing momentum in the last several years.
Uncertainty about the impact of bundling is bound to have the consequence of destroying this momentum as prudent dialysis center managers delay initiating (or expanding) a home hemodialysis program until the final report from the formal monitoring program is known, together with resultant CMS remedial action.
The incentive to delay will be particularly strong because costs to design, organize and staff a home hemodialysis program are substantial, and together with patient training, are all front-end costs that must be amortized over time. If home dialysis in the presence of bundling proves unworkable, front-end costs will never be recovered.
The unfavorable consequences of this uncertainty will also affect a second important group not discussed in your report, the manufacturers of home hemodialysis machines. At present, only a single company, NxStage Medical, Inc., participates in this market, benefiting more than 3,000 patients. However, two large companies are known to have advanced R&D programs aimed at entering the market. If the market is frozen by the uncertainty of dialysis center managers indefinitely postponing home program initiation decis ions, then it is only prudent for manufacturers to also delay investment and market entry. The effect on the sole present machine provider, who has not yet achieved breakeven volume, could also be serious. The casualties will be home machines with better dialysis performance and lower costs, which can come only from a healthy, competitive market.
I urge GAO to withdraw its recommendation. As an alternative I offer a proposal I described in an editorial in the American Journal of Kidney Disease (Vol 52, No 3 September 2008) – “Practicable Frequent Hemodialysis: A Proposal to Meet the Needs of Patients and the Requirements of Medicare.” If this proposal, which resolves the front-end cost issue, is adopted, I believe CMS could proceed with expanded bundling without delay or adverse effect on home dialysis.
I hope you will communicate my deep concern and my alternative proposal to responsible policy makers who are considering your report. With rather abstract issues like payment bundling, it is easy to lose sight of the human consequences. Today – this single day –about 200 Americans will be forced to commence dialysis. If their only option is conventional thri ce-weekly, three hour treatment in a dialysis center, just 150 will be alive at the end of one year, and only 80 after five years. If we inadvertently freeze the home hemodialysis alternative for these 200 people until 2012 or 2013, you can estimate the human toll. It is a matter of life and death for many thousands.
In closing, let me say I have no interest in any aspect of dialysis, save one; I am the caregiver for my 80 year old wife who has been on daily nocturnal hemodialysis at home for the past seven years – without which, she would no longer be alive. My sole motivation is to do what I can so that my fellow Americans referred to above have the same opportunity for the quality and length of life that has been granted to Jane.
Melville Hodge