Tell it to CMS

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

and mine to Laurence Wilson, Director of Chronic Care Policy Group of CMS:

Dear Mr. Wilson,

Recently, I had the opportunity to talk with Dr. Barry Straube regarding the implications for home hemodialysis under the new “bundle” being designed for Medicare reimbursement of kidney dialysis services. I am a user of home hemodialysis and the founder of NxStageUsers, the largest organized group of dialyzors using the NxStage System One Home Dialysis machine. NxStageUsers is independent of any corporate entity, including NxStage Medical, Inc.

Home hemodialysis saved my life. I had a continual issue with fluid overload, and had a heart attack while driving home from dialysis. I believe the symptoms first were manifested during the long weekend. That’s the three days after which most instant heart attacks are suffered by those in-center patients doing Conventional Hemodialysis (CHD). It took a couple extra days for it to simmer to the point of an all out heart attack. My hospital bill for treating my heart attack, before any adjustments, was over $275,000. I believe it was all avoidable.

Fortunately I’m here to talk about it. That’s one of the reasons I started the Every Other Day Dialysis (eodD) Petition with several others that has garnered over 2,000 signatures. If we could only increase the number of day for those in-center to 3 ½ day per week, I am sure the savings would accrue, although I’m not sure how many would join an eodD program. However, I firmly believe dialyzors need as much dialysis as possible to live healthier and more purposeful lives. One of the pluses of doing Home Dialysis is that the dialyzor becomes more educated about the disease and process of dialysis itself, benefiting the patient as well as the overall health care system.

Fluid overload seems to be one of the consequences of Conventional Hemodialysis (CHD). CHD is three days per week and about four hours per treatment–the dialysis center basically plays games to get the dialyzor through her treatment. The primary culprit is sodium modeling, which ameliorates interdialytic symptoms such as blood pressure crashing and cramping, and general crashing after a treatment. Fluid is taken off much too quickly during an in-center treatment, so the dialyzor is forced to drink fluids to reverse the effects of sodium modeling. There simply is too much time between treatments for a CHD dialyzor.

This is one reason why home dialysis is proving to be the modality of choice for a growing number of people who can manage the process. By doing longer and more frequent dialysis the body isn’t jolted quite as much as doing CHD. There is less chance of having left ventricular hypertrophy, probably the greatest co-morbidity suffered by a dialyzor. More frequent dialysis means that fluid is better controlled since there is one fewer day between treatments.

In my discussion with Dr. Straube, I expressed my concern that home dialysis, although twice the treatments of CHD, saves money overall to the Medicare system, but the walls erected between Medicare Parts A, B and D prevent crediting home dialysis with the savings from hospitalizations and meds. We need to break those artificial walls. I understand what budget neutrality is all about. It’s not that I want more spent; I don’t even want the same spent; I want less spent to keep me living a better and more productive life. And for me, this means allowing adequate reimbursement for home dialysis now, and under the proposed new “bundle.” I also understand that breaking the “wall” is a process Congress must undertake and it’s not up to CMS to do that on their own. I just want to stress the savings are there to be had.

I truly do appreciate the fact that Congress has emphasized home dialysis several times; including the Social Security Act Section 1881 and MIPPA, and that CMS and the GAO has recognized it and is working toward a suitable solution. But with all due respect to the GAO, I am disappointed in its recently released report, “End Stage Renal Disease: CMS Should Monitor Effect of Bundled Payment on Home Dialysis Utilization Rates.” I believe we need to get the formula right from the get go, and not revisit the issue after the initial decisions are made. I am concerned that CMS believes the new bundled payment will encourage home dialysis, while there is no analysis that proves this, and my assessment is the opposite. Home hemodialysis has some up-front training costs, and some additional supply and case coordination costs. We need to guarantee that centers will want to offer home dialysis, even though it’s likely that only a small percentage of their patients would be agreeable at this time. The new bundle when applied to home dialysis needs to provide reimbursement for the cost of 4+ sessions per week.

Dr. Straube agreed to allow me to set up a webinar series where current dialyzors—like me–can speak directly to the CMS staff. I hope you would be present and allow others to gain the insight that only dialyzors could possibly have. We live it and can readily talk about the difference home dialysis has made in our lives. Please let me know when a convenient time would be for us to speak so I can finalize plans for such a series.

Sincerely,

Richard Berkowitz
Founder, NxStageUsers

I thought these two slides, which illustrate Bleyer’s work on the dangers of the 2-day standard HD “weekend” no-treatment gap could be useful to help folks see why it is so critical that everyone on hemodialysis have the option of longer and/or more frequent treatments.

On PD, deaths are distributed evenly over the 7 days of the week, because the treatment is continuous and doesn’t itself cause any additional cardiac stress. This is not true on standard HD, as Bleyer’s work illustrates. At the Annual Dialysis Conference, Dr. Carl Kjellstrand’s keynote address pointed out that an estimated 10,000 HD deaths in the U.S. each year are solely due to the 2-day “killer gap.”

If it is, as Dr. Straub said earlier, the goal of CMS to “to not authorize payment for treatments that aren’t proven to be necessary or safe,” then it would seem that the current system of three short treatments per week should be carefully examined–it doesn’t appear to be safe.

It’s not too late to sign the Every Other Day Dialysis Petition at http://www.PetitionOnline.com/eodD0903/. I know we haven’t been pushing it much lately and the signatures have slowed down, but as Dori points out with Bleyer’s slides, in-center dialyzers drastically need more frequent treatments.

When the petition first came out, many did not support it because they were afraid if successful it would create a new floor for the number of treatments and that home dialyzors would suffer. Well, I believe it’s perfectly clear that CMS is not sure whether the new dialysis policy encompassed in its forthcoming bundling proposal will create the incentives Congress has deemed as necessary. With the current thinking that no additional treatments be allowed for medical necessity to home dialyzors, it’s also clear that a new flooor would not have been created. It actually turns out a new floor of 3 1/2 treatments per week would have benefited home dialyzors.

So if you haven’t done so already, please sign the eodD Petition. It affects your life too. If that isn’t reason enough, I don’t know what is!

Wendy, I’m sorry, I forgot to reply to your question.

I did not wrote to Dr. Staube asking his advice, but have been consulting with others working on the issue. What has been decided is to write now, and later. The more dialyzors CMS hears from the better. In addition to Dr. Straube. Another person to send messages to is:

Laurence Wilson
Director of the Chronic Care Policy Group
laurence.wilson@cms.hhs.gov