Short Daily HD Proves a Winner!

Hi all,

I’m actually ON a plane, flying home from the American Society of Nephrology meeting, where the late-breaking news session announced some of the big picture outcomes from the Frequent Hemodialysis Network trials. There were two studies:
1). One compared standard 3x/week in-center HD with short daily, 6x/week in-center HD
2). The other studied compared standard 3x/week home HD with 6x/week nocturnal home HD

Both studies had two outcomes that had to be met for the treatment option studied to be called a success:
1). Significant reduction in the size of the heart’s main pumping chamber, the left ventricle
2). Significantly better physical functioning scores on the SF-36 survey

Short daily HD resoundingly met both criteria! This is terrific news, in terms of finally proving to non-believers all over, and in CMS in particular, that more frequent HD truly is a life-saving option. We can only hope that this will translate ASAP into dropping the need for medical justification from a doctor to pay for a 4th treatment each week. The New England Journal of Medicine is releasing the results of this study today.

The nocturnal HD study trended in the same direction, but did not reach statistical significance. Dr. Rocco noted that this study was smaller (only 94 participants on nocturnal HD, if I recall without my notes in front of me). Also, more of the people who took part in this study had some residual kidney function left.

There is a LOT more data to be analyzed–researchers will surely be publishing papers on this data set for years to come. In the meantime, I’d like to congratulate all of the study investigators and participants for making this wonderful contribution to our knowledge of what really matters in dialysis.

p.s. You can read the full-length article here: http://www.nejm.org/doi/full/10.1056/NEJMoa1001593, and an editorial by Dr. Zbylut Twardowski here: http://www.nejm.org/doi/full/10.1056/NEJMe1012205

Dori,

Thanks for reporting. its good to hear the good news about daily dialysis. Can you explain more on the 2nd outcome that had to be met (Significantly better physical functioning scores on the SF-36 survey.) Not quite sure what this means…

Hopefuly this will bring about major change in the dialysis world for more frequent and longer dialysis…

///Miracleman

Hi Miracle Man. Physical functioning is a self-rating by someone, based on a paper-and-pencil survey. The survey asks questions like, “how often in the last 4 weeks were you able to…climb several flights of stairs, vacuum a room, etc.” Research with tens of thousands of people on dialysis has found that physical (and mental) functioning predict hospitalization and survival. So, they used it as an interim outcome, since the study was not big enough to study survival itself.

Thank you for the update Dori, the real question is what shall they do with this “new” information. Not really new since this was hypothesized in 1965. Will it change therapy in America? That is the real question. I see that some of the folks like Chertow are already stating it will be hard for the industry to go along with more frequent dialysis. Actually, going to every other day dialysis immediately would not add any burden on needing new facilities since it would utilize the Sunday now not utilized for two extra treatments a month.

Secondly, you wouldn’t need to build any new facilities to go to nocturnal in-center.

Lastly, you don’t need to build any new facilities to offer more home hemodialysis.

I won’t hold my breath on seeing this industry move quickly. It will still take a grass roots movement from the people themselves.

I absolutely don’t see a mass move toward 6x/week in-center HD. It’s just not practical. But minimally, CMS needs to step up to the plate and eliminate medical justification for a 4th treatment. They claimed to be waiting for the results of this study, and those results are now unequivocal. In the intervening 4 years that it took to get the incredibly obvious results, Dr. Carl Kjellstrand would estimate that 40,000 dialyzors died unnecessarily due to the 2-day no-treatment gap. This is the time for dialyzors to advocate for their own lives by removing the barriers to more effective life-saving treatment options.

Has any provider asked their FI/MAC if they’e need ongoing Medical Justification to bill for every other day dialysis? I don’t think so.

The FI/MACs are chartered to act on behalf of Medicare. The FI/MACs can act on evidence of harm under their own guidelines so the question of benefit isn’t even an issue. I agree that waiting for the FHN study gave a convenient excuse to not provide more than 3 treatments a week but it is the providers who have been stalling.

The 3x/week schedule benefits only the providers. The 3x/week schedule is only in the interest of the providers. The providers have it within their power to change the system, they could start offering EOD schedules tomorrow. It would be good medicine and good business.

I suspect that providers would LOVE to charge for a 4th treatment–but that this is much more likely at home. The logistics of switching people to an every-other-day in-center schedule (and hiring folks to work on Sundays) are daunting for in-center care. So, I still think that advocating for CMS to get rid of medical justification is important, because this is a barrier for some nephrologists. But it can’t hurt to also speak up to providers! :slight_smile:

I don’t understand this explanation - you wouldn’t have to have an entire unit on an EOD schedule. You could do it by shift - everyone on the evening shift goes EOD, the rest of the shifts stay 3x/week. Then on Sunday you run two shifts of dialyzors, that would be the only odd day. You could also think of it in terms of stations, maybe out of 9 chairs and four daily shifts, three are used for EOD. On Sunday you’d need to provide 12 treatments so you could set up two shifts running 6 stations.

But why would units do this? Because the bundle provides a $90 bonus for every treatment provided above the standard 3/week.

The way I’d say it is, the Bundle has two components: the current composite rate and 1/156th of the total yearly amount spent on formerly separately billable items. As we know some of the separately billable items are routinely given monthly, like iron maybe or routine labs, and some each treatment, like Epo (assuming the three day a week schedule) and some quarterly or semi annually, for instance other labs e.g. PTH, Hep B. So to get the whole payment for the care a unit historically provided a patient over the course of a year the unit will need people to be in their chair every treatment.

Medicare did not create any sort of fractional payment scheme so if you get medically justified additional payments you’ll get the 1/156th of the total yearly amount spent on formerly separately billable items as a sort of bonus. that’s about $90. That’s a big bonus and it would more than cover whatever additional labor costs come with opening on Sundays. So for those treatments you provide on Sunday you get a reimbursement premium , you spread the fixed costs of bricks and mortar over seven days instead of six (effectively lowering the cost of every treatment the unit provides) and with higher doses you can anticipate lower med costs - particularly post 2014 when oral drugs are included.

In general a conservative analysis of the impact of more dialysis would assume the total yearly amount spent on formerly separately billable items doesn’t change much with frequency - if you dialyze more than 3x week you don’t get more or fewer labs or more or less frequent doses of medications. This sets up a dynamic where the per treatment revenue is the same for each treatment over three a week but the cost of each treatment over three a week drops dramatically - the cost of the forth fifth sixth seventh treatment is much less because the weekly cost of all the formerly separately billable items have been paid by the first three treatments.

The other side of the of the “less medications need with more dialysis” coin, is that if people skip or vacation at units that skimp on medications or, importantly if people are frequently hospitalized, those separately billables not provided will have to be provided once the person is back in the chair. ANd if they’ve been getting less dialysis they’ll need additional formerly separately billables. One concern I have is that people won’t be readmitted after a long hospital stay, and/or if they like to take frequent vacations, and/or skipping may be seen as costing the unit even more money and result in involuntary dismissals.

So in light of this dynamic I think it is time units started expecting 3.5 payments a week.

It is a good business decision and from a clinical point of view it would be much better so I don’t know what would stop it. In a business the obvious thing to do is upsell existing customers. If you switched someone from 3x week to EOD you would be increasing sales from 156 a year, to 182/183 a year. The per treatment revenue is the same for each EOD treatment but the cost of the 157th to 183th treatment is much less because the cost of all the formerly separately billable items have been paid by the first 156 treatments.

Importantly an EOD schedule would cushion units from the cost of skipping, hospitalizations and travel. So long as people on an EOD schedule dialyzed 156 times in the year the unit would be fully paid for the cost of the formerly separately billable items in the bundle, and every treatment delivered above 156 would be much more profitable. The other nice thing is that this infusion of resources into the industry can be manifested entirely through the actions of providers. It can occur outside the rules of budget neutrality and the machinations of congressional action.

Bill, as I often find myself in agreement with your statements, once again I fully agree. The issue of offering more treatments put forth by many of the pundits opposing more frequent dialysis state they need to build more facilities. but in fact, if you look at Sunday and the night shifts, most dialysis units in America are underutilized, so more facilities is not the issue.

Secondly, from the perspectice of CMS, more frequent dialysis results in fewer hospitalizations which in the end analysis of providing only two more sessions/month with EOD, the offset in hospital cost reduction more than pays for itself in addition to being the right thing to do.

Lastly, it is simply time to act upon the information we have known for decades. What really matters is that people are dying and suffering needlessly while those in charge argue about what to do. That is simply not right.