Medicare Bundling Q&A

[Bill Peckham]

- Training reimbursement for PD and home HD has been embarrassingly pitiful for years--just $12-20 a day (less than I made babysitting in 1978). The new proposed rule eliminates even that, rolling training into an already-overstuffed and underfunded bundle. This really has the potential to harm home treatments by discouraging training, and is the biggest challenge home dialysis faces in this new rule.

Dori doesn't it depend on if units can bill for five days a week of training? The way I'm reading it I think units can continue to bill with medical justification. So now instead of getting 5 old composite rate payments + $100 (5x20) a unit would get 5 new composite rates which would be like getting an extra $130.

Why $130? The difference in the old composite rate base payment and the new base rate is about $65 - in a month each dialyzor is expected to use ~$845 dollars worth of all the previously separately billables. They came to the expanded bundle based on 3 treatments a week. When you go beyond three times a week the extra part of the bundle is gravy or um ... a training fee.

And I would say the 2% haircut is not too bad when you consider that epo use is expected to decline by 10 to 15% (if not considerably more). Some of that savings will go to buy more iron but still it is hard to argue with Congress's logic that turning epo (and everything else) into expenses will result in less use. A 2% cut to the whole can be made up by a 10% reduction in epo use. (Except if Amgen raises its rates which is the wild card).

It could be a bigger bump if private payers case mix in the same way. I think rewarding retention would be very helpful.

The main concern I have is that there is not going to be a way to know what happens after 1/1/11. CrownWeb is a joke - even if it delivers some data in real time it won't be data that shows us what is going on in dialysis units across the country. We're going to do this blind so good outcomes will be due to the good will of renal administrators.

[Dori Schatell]

IF clinics are able to bill for 5 treatments/week, it would definitely help with the training concern. But, IMHO, that's a big if. Yes, it's in there, but requiring medical justification means a lot of overworked nephrologists (there aren't enough to go around) caring enough to write detailed letters. I also didn't see any criteria listed for medical justification, so this could be loose, or it could be so tight that almost no-one qualifies... I'd hate to rely on that to eliminate a disincentive for home training. Too risky.

As far as the 2% ding being offset by reduced EPO costs, it's important to remember that:
-- This bill purposely bundles in IV drugs to reduce their use. This means people will get less--whether or not that's medically appropriate. I hate to see the U.S. government in the role of practicing medicine (though I do believe they could do a good job of administering it. IMHO, doctors--not Medicare--should be prescribing drugs. Ordinary citizens can't practice medicine; why can CMS?

-- Vaccines are purposely left out of the bundle. Why? So they're not disincentivized, of course. Call me cynical, but part of me wants to call this the "pharmaceutical punishment bundle." Negotiating a lower price could have had the same budgetary impact without risking that people who do need higher doses of IV drugs (generally a rolling 10% or so--and not the same 10% from month to month) won't get them.

-- Since certain ORAL drugs are also included in the bundle, as above, I worry that some folks won't get their oral meds.

-- Finally, yes, lower EPO usage would be expected to lower costs. But leaving that $200 million IN the bundle would go a SMALL way toward correcting the historic treatment of the ESRD community. Taking it out adds insult to injury. In 1983, the first composite rate went into effect: $127 for non-hospital-based clinics. In 2007 dollars, that $127 = $261.15--ALMOST THE IDENTICAL AMOUNT THE RULE DRAFTERS STARTED WITH ($261.58)--until they had to ratchet down because Congress required it. Why not finally correct this inequity? Hospitals and nursing homes have had annual inflation adjustments all this time. Mortality rates on dialysis in the U.S. are lower than in any other industrialized nation.

I would argue that the low reimbursement is part of the reason. It creates a built-in disincentive for longer treatments and having enough staff to keep an eye on all of the parameters that matter. In a study by Rocco et al published in 2006 (abstract below), only 7% of patients had care that met all four standards for adequacy, anemia target, access (venous, not catheter), and albumin.. These are BASIC clinical measures the industry has been paying attention to since the first DOQI Guidelines came out in 1997. :-(

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Ann Intern Med. 2006 Oct 3;145(7):512-9.Links
Relationship between clinical performance measures and outcomes among patients receiving long-term hemodialysis.

Rocco MV, Frankenfield DL, Hopson SD, McClellan WM.
Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1053, USA. mrocco@wfubmc.edu

BACKGROUND: Patients receiving long-term hemodialysis have a yearly mortality rate of 15% to 20%. OBJECTIVE: To determine whether attaining clinical performance measures for hemodialysis care is associated with favorable 12-month mortality and hospitalization rates. DESIGN: Cohort study. SETTING: Outpatient hemodialysis centers in the United States. PATIENTS: 15 287 patients who were selected from a 5% random sample of patients receiving long-term hemodialysis. MEASUREMENTS: The authors used data from the Centers for Medicare & Medicaid Services End-Stage Renal Disease Clinical Performance Measures Project from 1999 and 2000. The clinical performance measure targets were hemoglobin value of 110 g/L or greater; serum albumin value of 40 g/L or greater or 37 g/L or greater (bromcresol green and bromcresol purple laboratory methods, respectively); use of a fistula for vascular access; and measured single-pool Kt/V urea value of 1.2 or greater. The outcome measures were death or hospitalization during 1-year follow-up. RESULTS: 8364 patients (54.7%) were hospitalized and 3062 (20.0%) died during the 12-month follow-up period. Six percent of patients did not meet any clinical measure targets, 24% met 1 target, 39% met 2 targets, 24% met 3 targets, and 7% met all 4 targets. The unadjusted 12-month hospitalization and mortality rates for these 5 groups were 60%, 60%, 56%, 49%, and 43% (P < 0.001) and 29%, 25%, 21%, 14%, and 7% (P < 0.001), respectively. The risk for death increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 4.6 (95% CI, 3.3 to 6.4), 3.5 (CI, 2.6 to 4.7), 2.6 (CI, 1.9 to 3.5), and 1.9 (CI, 1.4 to 2.6) for 0, 1, 2, or 3 targets met, respectively, compared with meeting 4 targets (referent). Similarly, the risk for hospitalization increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 1.6 (CI, 1.4 to 1.9), 1.5 (CI, 1.3 to 1.7), 1.3 (CI, 1.1 to 1.5), and 1.1 (CI, 0.98 to 1.3), respectively. LIMITATIONS: It was not possible to determine the roles of severity of illness, other patient factors, or suboptimal care in failure to meet performance measures. CONCLUSIONS: In patients receiving long-term hemodialysis, meeting multiple clinical measure targets is associated with a decrease in hospitalization and mortality rates.

[Dori Schatell]

Hi y'all,

I went to the CMS Town Hall meeting about the Bundled Payment System yesterday, and was one of 23 speakers, including 5 patients (Bill Peckham, Shad Ireland, Paul Conway, Kathe LeBeau, and Rich Berkowitz). From my notes, here's what the main focuses were:
-- Paying appropriately for home training. The concern is that including home training as "overhead" means that the 41% of clinics that offer PD training and the 14% or less who offer various types of home HD training will be penalized while the majority who don't will make more money. VERY BAD IDEA. Bill kicked off with this (he was the first speaker), and it was echoed by 6 other speakers, including one from the National Renal Administrator's Association, which I was very pleased about. I also asked the President of the American Society of Nephrology why he didn't include training in his comments, and he said it was because of a lack of time (each speaker only got 5 minutes). Their written comments will contain this. Interestingly, the Renal Physician's Association didn't have a speaker, so I don't know what they'll say in their comments. Four patient groups--American Association of Kidney Patients, National Kidney Foundation, Dialysis Patient CItizens, and the American Kidney Fund--did NOT mention home training in their spoken comments--I certainly hope they do in the written ones they submit. If you belong to these groups, please urge them to support home training!

-- Including lab tests in the bundle. The concerns are that folks on Medicare weren't paying for labs before, but now as part of the bundle, you would be. Plus, the amount put in isn't enough, and travel could be difficult (which clinic will pay for "extra" labs?). And what about labs needed for transplant evaluations? No specific labs are even mentioned, which leaves things very murky. Bill spoke to this, too, and so did 11 other speakers--nearly half.

-- Overall complexity of the case-mix adjustment. A case-mix adjustment means that the payment per treatment will vary depending on things like folks' age, gender, and number of other illnesses. The concerns are that it's so complex that this will put a huge burden on small providers (and may even take away from patient care time), and that race isn't included--which could penalize clinics that have lots of African American patients, since there are good data showing that they tend to need more costly ESAs to reach the same hemoglobin levels. 8 speakers talked about this.

-- Including oral drugs in the bundle. Lots of concerns about this--the amount allowed isn't nearly enough. Folks would pay co-pays on the bundle (essentially paying for these drugs whether or not you use them). Part D protections would be gone--like extra payment help, and checking for drug interactions. Pharma won't bother to do R&D in this area, with no chance of making any money, so no new drugs will be developed. Another BAD IDEA. A total of 13 speakers (more than half) talked about this.

Those were the major points, and others were also brought up, like:
-- Potentially higher patient co-pays, since the bundle would include things (like labs) that you didn't have to pay for before.
-- Problems with underpaying for treatment in rural areas.
-- Losing Method II as a way to pay for home dialysis (or staff-assisted home dialysis).
-- Inequities--why should ONLY folks on dialysis on Medicare have to pay for labs or only be able to get dialysis meds through the clinic?
-- No quality measures to ensure that folks will even get phosphate binders and Vitamin D once the clinic is required to provide them.

The key to all of this is avoiding unintended consequences. I hope that everyone reading this message board will comment on the proposed rule. This month's Topic of the Month article tells you how: http://www.homedialysis.org/resources/tom/200910/, or feel free to read MEI's draft of our full-length comments: http://www.homedialysis.org/files/pd...raft_mippa.pdf. (We'll update those before we submit them).

Right now, the deadline for sending in comments is November 16. There was some talk at the meeting about extending that deadline, and if CMS does that, we'll let you know.

[Dori Schatell]

Hi y'all,

Here are the comments I made at yesterday's meeting.

"Thank you for the opportunity to speak, and for all of the countless hours you must have put in compiling this proposed bundled. I’m sure it wasn’t fun. Like many others today, we agree with the concerns that have been expressed about including oral medications and lab tests, the overall complexity of the bundle, and the impact of both on patient co-pays. But that’s not where I’ll be addressing my remarks today.

At the Medical Education Institute, we don’t work day-in and day-out in dialysis centers. So, that gives us the luxury to step back and observe the renal community from a bit of a distance. We take a long-term, strategic view. And one observation that we’ve made is that it’s very important to periodically challenge our assumptions. They are not gospel.

For example, the case-mix adjustment is based on completely unvalidated 2728 data—which means we are building a structure that can affect patient care on top of a house of cards. We strongly recommend that those data be validated—that a sample of them each year be checked for accuracy. Maybe you’ll find that they’re 100% accurate. But I don’t think so.

We also need to challenge the assumption that it’s okay to do dialysis just three times per week. We were very pleased to see that CMS included the possibility of more frequent hemodialysis treatments in the proposed bundle, with medical justification—but I think you need to go one step further, and eliminate medical justification. Here’s why. Each year in the U.S., about 110,000 people start dialysis—and about 87,000 people die, a rate that has only improved by about 2% over the past decade, and which is worse than any other industrialized nation.

Now, you might think that all of those deaths are evenly distributed among the seven days of the week. And, for peritoneal dialysis, they are. But for standard hemodialysis, that’s not true: Bleyer’s studies, compiled from USRDS data, found that the risk of death, of sudden cardiac death, is 50% higher than expected on the day after the 2-day dialysis weekend. And, in fact, it’s three times higher—triple—in the 12 hours before the next treatment after that 2-day gap. In a keynote address at the Annual Dialysis Conference last February, Dr. Carl Kjellstrand, a nephrologist from the Netherlands, estimated that more than 10,000 dialysis deaths per year in the U.S.—10,500—could be attributed solely to what he calls the 2-day “killer gap.”

Kathe LeBeau said, “If we get this wrong, patients pay with their lives.” I would argue that they already have.

We don’t close ICU’s on Sundays. We don’t give insulin to diabetics just three days per week. We don’t use heart-lung machines three times per week. It makes no physiological sense to replace a continuous body function with an intermittent therapy. If any practice in U.S. nephrology requires medical justification, it should be short, three times per week dialysis treatments!

Perhaps you noticed that all of the patients who spoke today were getting home dialysis, or had a transplant. At the Medical Education Institute, our mission is to help people with chronic disease learn to manage and improve their lives, and our goal is to create expert patients who can self-manage at a high level. The best way to do that is to have more home dialysis. So, it is vital to not threaten more frequent dialysis by rewarding clinics that don’t train and punishing the minority who do.

You have an opportunity to improve dialysis patient care. I hope you’ll take it.

[Bill Peckham]

From my blog:


To adapt a phrase from London's subway - Mend the Gap.

The 2 day "killer gap" underlies the entire proposed rule - the payment is based on 13 payments a month, so it was an apt topic to bring up but more important than bringing these points to Medicare's attention was bringing these points to the renal community's attention. I'm not sure CMS's reimbursement is the barrier to every other day dialysis, so much as it is dialysis providers that have shown no appetite to challenge the status quo. (note that this is a world wide phenomenon. Every other day incenter dialysis is not offered anywhere in Europe or Oz either, AFAIK).

The Town Hall was a unique opportunity to talk to the whole renal community - Schatell made the most of it. Mend the Gap.

ETA: HDC should make "Mend the Gap" coffee mugs and t-shirts. I'd buy a couple coffee mugs (so long as they were the larger 15oz more frequent dialysis style).

[Dori Schatell]

Hey, Bill. It's good that they at least have medical justification--but that requires a 1-hour upfront time commitment per dialyzer for a doc to write an initial letter (there are ~350K people on dialysis in the U.S., so LOTS of hours writing letters), PLUS 10 minutes per dialyzer every month to resubmit the letter. And then, if the original reason for medical justification was, say, fluid overload, and the more frequent treatments have resolved it--there's no justification.

So, yes, it's technically possible for providers to offer every other day dialysis now using the medical justification angle, but, IMHO, it's not very practical. If I were a provider thinking of running a clinic based on every other day treatments, and sending medical justifications in for every dialyzer, I would worry about being accused of Medicare fraud.

And requiring medical justification means that CMS is giving tacit approval for a standard of care that has been shown to result in poor outcomes. I want them to acknowledge that more is better!

[Bill Peckham]

Hey, Bill. It's good that they at least have medical justification--but that requires a 1-hour upfront time commitment per dialyzer for a doc to write an initial letter (there are ~350K people on dialysis in the U.S., so LOTS of hours writing letters), PLUS 10 minutes per dialyzer every month to resubmit the letter. And then, if the original reason for medical justification was, say, fluid overload, and the more frequent treatments have resolved it--there's no justification.

So, yes, it's technically possible for providers to offer every other day dialysis now using the medical justification angle, but, IMHO, it's not very practical. If I were a provider thinking of running a clinic based on every other day treatments, and sending medical justifications in for every dialyzer, I would worry about being accused of Medicare fraud.

And requiring medical justification means that CMS is giving tacit approval for a standard of care that has been shown to result in poor outcomes. I want them to acknowledge that more is better!

I totally agree that medical justification should be abandoned for at least home dialysis training and 4 treatments a week but there is something blocking every other day dialysis besides reimbursement.

What is the excuse of European or Australian units? Why are all dialysis clinics in the world closed one day a week? I think patients, providers and payers are all swimming in inertia. Do we really expect CMS to be out in front of patients and providers? At some point a provider will first have to challenge this status quo for CMS to take it seriously. This is unfortunate.

I still want my Mend the Gap coffee mug.

[Rich Berkowitz]

I've already talked to Satellite Health about doing an eodD pilot. I will follow up and see where they are with it.

[Bill Peckham]

I've already talked to Satellite Health about doing an eodD pilot. I will follow up and see where they are with it.

I think much of the problem is that it is hard to be a little bit pregnant and it would be hard to run a few dialyzors EOD while having the rest of a unit's census going 3x/week.

You'd need to have at least four shifts doing EOD - two shifts each day. Which means about 2/3s of the unit.That's a big pilot.

[nocturnaldialysis]

Bill

We (the land of OZ) dont have one! ... an 'excuse', I mean.

Yes, you are right. Our (OZ) facility-based patients do (almost all) do 3 x week though, in my unit ... which, a couple of years ago had >1/2 of the national total of 6 x weekers ..., some facility-based patients do do 6 x week.

I try to push our national envelope. It isnt easy, but it's good to try!

But, pretty much all our national 1000/7500 home vs facility patients do a MINIMUM of alternate nights. Few now do only 3 nights and, those that do, do so by their own choice and not by applied funding pressure. Our home patients are funded to effectively between 4 - 4.5 x week in most states.

We pay, in Victoria, 1200/year (pro-rata) for utilites (water and power) and, in addition, in all states, all dialysis expenses, machines, machine installation, servicing, dialysis consumables, any building at home to accomodate the machines or the plumbing, all water treatment equipment and all medical and nursing costs are covered by government. We have dialysis for all. And ... for any who want or wish it. There is no age 'cut-off', as I read, in shock, one of your ill-informed readers suggested might be so. What rubbish. No, we offer to all who wish and want ... though, perhaps with a modicum of pride in my countrymen and women, not all seek dialysis - and, in my view, rightly so.

I believe that the key changes needed to bring US dialysis up to the standard of that in other countries are:

1. Pay for 15 treatments a month

This allows alternate day at home or in-centre and allows long overnight at either site at the patient's choice.

This abolishes the greatest single cause of death and hospitalization: the 'long break'.

2. Either 'unbundle' or otherwise allocate additional reimbursement for training

This allows 6-8 weeks x 4 sessions/week = 24-32 training sessions in all (for most, in our experience ... though I do have awesome staff ... this is more than enough)

This equates to two EXTRA months at the routine in-centre monthly rate if (#1 ... above) is adopted as a pre-requiste

OK ... the truth?

(1) it will cost up front dollars

No question ... and there is nothing a pollie dislikes more than being told to spend upfront dollars for a down-stream 'gain' .... they never beleive it will happen!

... but, somehow you need to convince them (we did) that the reduction in morbidity, hospitalization and mortality will more than offset the additional up-front reimbursement costs ... far more, way more, beyond expectations more

... have they read the Australian (and other country literature? Our experience? ... No! Blindly, as ever, the US looks only to its own ... and its own, in a word, is 'fatally flawed' ... oops, two! So, how CAN you ever step out of your box. Maybe you can't. But, unitl you do, you remain behind, lagging, and falling ever in others wake.

next ...

(2) it will cost up-front dollars

But ... it will lead to more home dialysis = cheaper dialysis.

12-14 months at home offsets the additional up-front reimbursement costs

Beyond 12-14 months at home, the initial up-front costs will progressively diminishing costs to system.

Transplant listed patients are an issue ... the cost of installing them at home to have them transplanted at 8 months is not cost-effective.

Maybe those with a REALISTIC EXPECTATION of a graft in under 15 months should stay facility-based. Contentious? Yes. Realistic? Very.

My suggestion?

Stop carping the negatives. Provide them positives. Give them light at the end of the tunnel. Opposition at every turn is wearing. Maybe, just maybe, suggest a visit here (OZ) to see how its done somewhere else. Or, to British Columbia ... even better! With due respect, anywhere would be better to consult than those (except the enlightened few) in the US. Tell the pollies to look OUTSIDE the US for ideas.

Well ... thats my humble two penneth worth!

John Agar