By Peter Laird, MD
The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering. The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.
End Stage Renal Disease Program
In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973.
At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home.
On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients were on home dialysis including 59 PD patients at home.
The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program.
NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care
Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.
The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.
The politics of health cost containment: end-stage renal disease
Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival of home patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers."When we look at patient survival on home dialysis," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .
But the political damage had been done.
Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.
NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD patient was at least $4000.
The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)
Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.
This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere and at some time one who can make a difference inside our government will.
Why would you use $160 as the Medicare allowed cost? There is no situation under which Medicare pays $160. The base allowed rate is $230, the average is $250. The fact that Medicare now includes anemia management in with their routine payment (along with the other formerly separately billable services) doesn't change the math.
Additionally, to calculate the average per year per beneficiary allowed reimbursement you'd need to know the average number of treatments per year, per beneficiary. I think for beneficiaries who start and finish the year using dialysis, they average about 148 treatments a year. Thus, 148 x $250 x .8 gives the average per year, per beneficiary cost to Medicare for someone who uses dialysis.
The cost to Medicare is the same, whether the person dialyzes at home or incenter, whether the person dialyzes for 3 hours or 5. Medicare's dialysis cost increases only with frequency. However, Medicare can lower the cost of a beneficiary using dialysis by looking at the Part A side. And in fact there is a lot of money to be saved on hospitalizations. As much as Medicare spends on dialysis, it spends an equal amount on hospitalizations and skilled nursing.
D. Ishak, in your http://www.thekidneydoctor.org/2011/10/dialysis-unplugged-waiting-for-godot.html?showComment=1320817885323#c4408236234879080109 original comment to Dr. Singh's Waiting for Godot post you made the claim that, aside from a select group of dialyzors (represented improbably by myself and Rich B) higher dose dialysis would only benefit "The new Amgens and their agents!!"
You continue "There is a whole new industry for home dialysis and the more patients they have the more machines they will sell and the more treatments per patient the more supplies they will sell." (you point to the "home dialysis" industry but since PD has not been part of this discussion I will assume that you meant home hemodialysis). That is a false equivalency.
Prior to the expanded bundle the way to maximize EPO revenue (and profits) was to increase people's dose of EPO without increasing their hemoglobin. That is bad enough but combined with concerns about high EPO induced hemoglobins, or perhaps, with high doses of EPO, in and of themselves, there is reason to believe reimbursement led to medical harm. Tell me where the analogous dynamic is at work in home hemodialysis (HHD)?
Unlike EPO, HHD has a constraint built in: the dialyzor's willingness to preform the treatment. If someone feels well dialyzing every other day then that is the schedule they will freely select, leaving another dialyzor, another individual, to dialyze seven days a week, over night. Each person is perfectly able to identify their preferred dose, striking their own balance between pros and cons.
The other glaring difference betwen EPO and HHD, is that HHD, unlike EPO, evinces no evidence of harm. Indeed, as most recently spelled out in September by http://www.nejm.org/doi/full/10.1056/NEJMoa1103313 a paper in the New England Journal of Medicine, there is evidence of harm associated with the conventional three day a week schedule. If there had been evidence of harm associated with a 'Hgb less than 10' the situation would be analogous to HHD, instead the situation is exactly opposite.
If people want to dialyze at home they should be supported in that choice. If they want to dilayze more frequently than 3 times a week they should be supported in that choice as well. The FHN study was not powered to differentiate the benefit of HHD among various comorbidities, but it did demonstrate the absence of harm.
The question of what dialysis modality would nephrologist use is predicated on the assumption that transplant is not an option. In fact not being eligible for transplant is the only characteristic given: if you were among those who must use dialysis because a transplant is not being pursued, what modality would you choose? Nephrologist would choose to dialyze more frequently.
Since the not pursuing transplant group includes tens of thousands current Medicare beneficiaries, using a conventional incenter dialysis schedule, that are as healthy as an average nephrologists, how do you explain this dissonance?
The Nephrology Oral History project is a great resource. Dr Maddux interviews a nephrology luminary and reports their answer. On page 27 of the Gotch interview transcript (PDF linkhttp://www.voiceexpeditions.com/assets/media/noh/fag/gotch.pdf ), Dr. Maddux asks a great question. If you needed dialysis (a transplant not being an option) what would you choose?
I thought Gotch's answer was very revealing. He says he isn't sure he'd choose to dialyze at all but you can hear his approach to the question in his answer... that he'd want dialysis to take as little time as possible, that he'd want to feel well enough to still be able to do things that mattered to him, for example, going on a favorite hike, and that he'd want to evaluate the short daily dialysis option to see if it was a better choice in his case. He'd want to see how well he did, how well he felt and then decide.
It's a perfectly reasonable answer - find the best renal replacement to fit your life and then decide if it is worth the trouble. That's what we wish for everyone. The reason Gotch's answer stings, though, is that it is at odds with what he advocated during his long professional career boosting the importance of urea.
It is not enough to say Nephrologists wouldn't do what we routinely prescribe because nephrologists are special. It turns out that nephrologists are just like everyone else; everyone else deserves a nephrologist's level of informed consent.