Medicare Bundling Q&A

Discussions for Patients, Family, and Friends HD For Patients
1

If you’ve been to the HDC or NxStageUsers homesites or read DSEN, you’d be aware that a Medicare Bundling Q&A has been published to educate others about the upcoming CMS decisions regarding dialysis bundling. CMS will be releasing its proposal sometime this summer. After its release there will be an open comment period in which we will ask people to submit their comments.

So far some people have written messages to Dr. Barry Straube and Laurence Wilson of CMS. The responses have been very interesting. There’s still time to write them before the release to tell them your story about how home dialysis has affected you. It doesn’t particularly make sense to criticize what you think may be in the bundling proposal – we just don’t know although we can guess.

Watch this spot for what happens next. If you have any questions, you can also post them here.

2

Hi y’all,

Dialysis Patient Citizens has a really good letter that they wrote to Dr. Barry Straub at CMS about the MIPPA law, and the need to protect home options. You can read it here: http://www.dialysispatients.org/site/DocServer/090513_Bundle_and_MFD_Straube.pdf?docID=3421

If you didn’t see our Q&A and cover letter about the Medicare bundle (perhaps you’ve bookmarked the message boards and don’t check the home page…) here’s the link: http://www.homedialysis.org/files/pdf/resources/tom/200907.pdf.

3

Bundling sounds like an excellent idea! This brings back memories of how epo was being misused. The clinics were making a bundle off it and as I recall some were bouncing a person’s hemocrit levels all over the place in order to use more epo. There was a big lawsuit about it and even Investor’s Business Daily reported on it.

4

That’s true, but with epo bundled there may be the danger of shorting was a dialyzor needs if that the way the for-profits can squeeze more out of it. But as the Medicare Q&A points out, there are issues that can affect our home treatments if the rules comes out wrong. The issue of unit of payment can also affect those in-center regarding travel or being in the hospital. If the unit of payment is weekly or monthly and the clinic receives a lump sum, how does the other center or hospital get paid? From the dialyzor’s center? WHat a mess that would be.

5

Never easy is it! I could see going to the other extreme when administrating epo, however maybe an anemic dialyzor might be easier to spot than one being overdosed on epo? I’m just wondering here.

Not sure what to think about who gets paid and how.

6

I did look up the symptoms of too much epo and too little:

“High doses of Epogen and similar drugs can lead to increased risk for death, strokes and heart attacks in kidney dialysis patients, which is why the FDA following the study issued a black box warning to advise doctors that they should use only the lowest dose necessary.”
http://whatifpost.com/dialysis-treatment-a-punch-in-the-kidneys.htm

“Most commonly, people with anemia report non-specific symptoms of a feeling of weakness, or fatigue, general malaise and sometimes poor concentration. They may also report shortness of breath, dyspnea, on exertion. In very severe anemia, the body may compensate for the lack of oxygen carrying capability of the blood by increasing cardiac output. The patient may have symptoms related to this, such as palpitations, angina (if preexisting heart disease is present), intermittent claudication of the legs, and symptoms of heart failure.”

7

I had a great meeting today with the Legislative Heath Aide to one of the co-chairs of the Congressional Kidney Caucus today. She had made a trip back to the district from DC and we had her come to our Wellbound clinic. Whereas I only had about 30 minutes with her when I went to DC. She was at the clinic for more than an hour and a half. We were able to get into great detail about bundling and other issues. Regarding bundling, we went through the major issues talked about in the Medicare Bundling Q&A.

When she gets back to DC she’s going to find out what the buzz is on the different issues. But what I said was that she can expect to hear from me when the Notification of Proposed Rulemaking comes out from CMS. I’m going to tell her what my likes and dislikes are and if she agrees she’ll also write a letter from the Congressman’s office during the open comment period. Also, I told her that if CMS ends up with bundling rules which are not beneficial for home dialyzors that we would be back talking about new legislation that would correct the flaws that are part of the rules.

So to all out there, I think this is the time to write to the Legislative Health Aides for your Congressperson and Senators and prepare them for the time you’ll contact then after the Proposed Rules come out. It’s all about building relationships. The email doesn’t have to be long. Introduce yourself, tell them a little about yourself being a home dialyzor and remind them that CMS will be coming out with the bundling proposed rules soon and that you’ll be contacting them again. That will make it easier for the next time you write. You can find the name of the Aide here. Find your rep and look under Staff. Please blind copy me at rjberkowitz@nxstageusers.com. We want to keep track of which offices have been contacted.

8

Hi y’all,

I thought this article from this month’s Nephrology News & Issues, by some folks whose names may be familiar to you, was a great summary of recommendations to protect home therapies (especially longer and/or more frequent home HD) when the MIPPA bundle comes out. Good background, because rumor has it that the notice of proposed rulemaking–the start of the public comment period–will be at the end of this month.

NN&I Editor’s note: The following position statement was prepared by the Home Hemodialysis Workgroup, an informal coalition of patients, providers, physicians, technology suppliers, and others convened to discuss and summarize priorities on issues impacting access to home dialysis modalities, and, in particular, more frequent home hemodialysis. The group has organized to proactively discuss and create a voice “so that this important patient option may be supported, and not inadvertently discouraged, in this time of major legislative and payment system change,” the group said in submitting the position paper to NN&I.

Background
Home dialysis enables individuals with failed kidneys to receive ongoing life-sustaining dialysis in settings and at times minimally disruptive to their personal, family, and work lives, and is an important option for rural beneficiaries who otherwise must travel significant distances for care in a dialysis center three times a week. Home dialysis includes various modalities of peritoneal dialysis (PD) and home hemodialysis (HHD). PD is a well-recognized treatment currently used by some 7% of U.S. patients, although much more widely used in Canada, Australia, New Zealand and elsewhere.

Research has shown that frequent (4 to 6 times a week) and/or longer (6 to 8 hours per session) HHD are more effective than in-center hemodialysis in improving patients’ health, well-being, and energy; help to significantly reduce costly cardiovascular complications and hospitalizations; and allow maintained employment and rehabilitation.1,2 Even so, only 1% of dialysis patients utilize home HD, despite clinician preference for this modality3 and its appropriateness for at least an estimated 12%-16% percent of dialysis patients.4 Limited utilization has resulted in large part from Medicare payment policies that have discouraged HHD and economically favored delivery of in-center hemodialysis.

Issue
The Medicare Improvements for Patients and Providers Act (MIPPA) calls for significant dialysis payment changes. MIPPA directs CMS to implement, beginning in 2011, a bundled payment for routine dialysis service that incorporates items and services in the current composite payment rate and also certain drugs and laboratory tests that heretofore are separately billable.

Current law and documented proceedings clearly express Congress’ support for policies to ensure beneficiary access to home dialysis, including more frequent HHD and PD.5 Congress wants payment policy to encourage home dialysis so that patient preferences and physician clinical judgment, not economics, are the primary determinants in choosing the best setting for care.

CMS anticipates that the bundling process will inherently encourage home dialysis;6 however the extremely low number of HHD patients today and the declining numbers of PD patients suggest economic disincentives to home therapy will exacerbate with bundling cost pressures. More frequent HHD costs for supplies and equipment are higher than for thrice-weekly in-center, and staffing costs for all forms of home dialysis are significant due to intensive up-front patient self-training and new Conditions for Coverage requirements. Unfortunately, Medicare sources do not fully capture current cost data necessary to ensure that by 2011 the bundle will appropriately reflect adequate payment for home dialysis services, especially more frequent HHD services.

Recommendations
A single, bundled payment for all dialysis modalities paid on a weekly or monthly basis (which assumes a conventional three times a week treatment schedule and ignores training costs) will exacerbate current disincentives toward all forms of home dialysis. Fewer, rather than more, beneficiaries will have access to home dialysis. To avoid this adverse outcome, CMS is encouraged to:

[b]1. Retain the “treatment” as the unit of payment for home hemodialysis under the expanded bundle, and maintain existing provisions for Medicare payment for all prescribed, medically justified treatments.7

  1. Maintain home training payment separate from the routine dialysis bundle and update the payment level based on resource use associated with delivery of training services.*

  2. Modify CMS claims coding and cost report instructions so that CMS can better track home dialysis utilization and costs. Over time CMS can then consider payment modifications to achieve Congress’ intent with respect to beneficiaries’ access to home therapy. [/b]

References

  1. The renaissance of home hemodialysis: Lessons from the world over. Christopher Blagg, Todd ING, Peter Kerr, and Claudio Ronco , eds. Hemodialysis International, 2008 Jul; 12 Suppl1: S1-SS65

  2. Contemporary trends in home dialysis, Christopher T. Chan, MD, Charmaine E. Lok, MD, eds. Advances in Chronic Kidney Disease, 2009 May; 16(3): 156-220

  3. Ledebo I. The best dialysis therapy? Results from an international survey among nephrology professionals. Nephrol Dial Transplant, 2008

  4. Mendelssohn DC et al. What do American nephrologists think about dialysis modality selection? Am J Kidney Dis, 37(1), 2001

  5. Sec. 1881 ©(6) of the Social Security Act; Chairman Stark comments in Congressional Record-House, June 24, 2008, p. H5908

  6. GAO-090-537 CMS should monitor effect of bundled payment on home dialysis utilization rates, May 2009, p.15

  7. Medicare Benefit Policy Manual, Ch. 11, ß 30.1(A); Medicare Provider Reimbursement Manual, Part 1, Chapter 27 ß 2709

  • Provider payments for self-dialysis training have not been updated since 1983, and do not reflect current processes or resource requirements.

This position paper was prepared/approved by:

Christopher R. Blagg MD, FRCP
Professor Emeritus of Medicine, University of Washington
Executive Director Emeritus,
Northwest Kidney Centers, Seattle

Robert Blaser
Director of Public Policy
Renal Physicians Association

Mark Burke
Chief Executive Officer
Satellite Healthcare

Michelle Carver, RN, BSN, CNN
Director of Clinical Services -
Home Programs
Renal Advantage Inc.

Dolph Chianchiano
Senior Vice President, Health Policy
and Research
National Kidney Foundation

Larry Emerson, FACHE
Chief Executive Officer
Dialysis Center of Lincoln

Wayne A. Evancoe
CEO/Renal Administrator
Hortense and Louis Rubin Dialysis
Center, Inc.

Lori Hartwell
President/Founder
Renal Support Network

Joyce Jackson
President & CEO
Northwest Kidney Centers

Stan Langhofer
Chief Executive/Administrator
Kansas Dialysis Services

Kathe LeBeau
weKAN Program Manager
Renal Support Network
Home Hemodialyzor

Robert Lockridge, Jr., MD
Lynchburg Nephrology

Bill Peckham
Home Hemodialyzor and Founder, “Dialysis from the Sharp End of
the Needle”

Linda Upchurch
Director of Public Policy
NxStage Medical

9

Hi y’all,

The Notice of Proposed Rulemaking is Out. You can download the 500+ page document here: http://www.federalregister.gov/OFRUpload/OFRData/2009-22486_PI.pdf, if you want to read it yourself. Otherwise, folks will be reading and “digesting” it to figure out what the implications are for home dialyzors and let you know what topics will be most helpful for letter-writing (and where to send them) during the public comment period which has now begun.

Advocates of home hemodialysis who live in or would be willing to travel to Baltimore (at their own expense, I’m afraid, unless one of the companies wants to sponsor people, and I don’t know that anyone has gotten that far in their thinking yet) may want to register for the CMS Town Hall meeting on 10/23 and sign up to speak (you get 5 minutes if they accept you). Last I looked, there were 468 spots left. You can register here: http://www.cms.hhs.gov/apps/events/event.asp?id=589&Kw=&Mh=NoMonth&cboOrder=date&Yr=NoYear&type=2. Please sign up only if you really will go, or you’ll prevent other advocates from having a chance.

10

The first salvo has been fired in the fight to maintain the training benefit for home hemodialysis in the newly proposed Medicare rules. Dr. Christopher Blagg has gotten himself quoted in USA Today (which is proving itself to be quite a friend to people with kidney failure, I have to say). Here’s the article:

Doctor: Medicare rule may discourage home dialysis
Medicare’s just-released proposed rule for revamping how it pays for treating chronic kidney failure could discourage dialysis centers from training patients to dialyze at home, a University of Washington kidney doctor said Wednesday.
As expected, the rule “bundles” the reimbursement for dialysis into a single payment, with a base rate of $198.64 per treatment. Patient and location factors, such as the local wage index, could raise the payment. Currently, dialysis centers receive a payment per treatment, but they bill Medicare separately for costly injectable drugs and some lab tests. Added together, that averages to about $261 per treatment, Medicare estimates.

DIALYSIS IN USA: High costs, high death rates
Medicare also has been paying an extra $12 or $20 for treatments during which centers train patients to dialyze at home, but the proposed rule, released late Tuesday, eliminates that.

Only 8% of the more than 350,000 U.S. dialysis patients treat themselves at home, where they can dialyze longer or more frequently than in a center — which, research suggests, results in greater survival.

“The thing that disturbs me about what I’ve seen so far (of the bundling details) is the idea that they’re going to put the training costs in the bundle,” says Christopher Blagg, professor emeritus of medicine at the University of Washington. Without an extra payment for training, Blagg says, dialysis centers won’t make up the cost until a patient has been dialyzing at home — which is less expensive than in-center — for a year or two.

The Centers for Medicare & Medicaid Services will accept comments on the proposed rule through November and issue a final rule in 2010. The new system is to go into effect Jan. 1, 2011.

The proposed rule DOES:
– Keep the per-payment reimbursement (this is good for people who do more frequent HD or who travel)
– Allow up to 20 HD treatments/month, with medical justification

– There is a 47.3% INCREASE in payment per treatment during the first 4 months–IF someone is on Medicare. This means that either people are already disabled or over 65, or they choose a home treatment option. This could create an incentive for PD, but, IMHO, the learning curve to start home HD is such that it may see only a small bump from this. I’m also concerned that clinics will push to train but not do anything to retain people who go home (providing appropriate support and such.

Those are the pretty clear pluses, IMHO.

Here are the points that are concerning:
– Overall reimbursement starts out LOW (just $198/treatment). An additional $200 million is being taken away from the ESRD community, which is extremely dismaying, given the historical lack of annual updates for inflation. Congress tied Medicare’s hands, here, very unfortunately.

– Some Medicare Part B and Part D oral drugs (binders & calcimimetics) and all IV drugs are included in the bundle. Will this help encourage better dialysis–so people need fewer binders–or will folks with ESRD become “second class” Medicare citizens who can’t get these drugs because the clinics won’t pay for/approve them? This could go either way. I hope it becomes an incentive to give more dialysis–for example, to go to a 2-week rotating schedule for all in-center treatments (standard and nocturnal) and eliminate the 2-day “killer gap”.

– 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.

That’s my first analysis. Comments welcome from others who’ve read the proposed rule, or reactions to the article and what I have here.

11
  • 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.

12

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. :frowning:

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.

13

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/pdf/mei_draft_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.

14

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.

15

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).

16

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!

17

[QUOTE=Dori Schatell;18695]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![/QUOTE]

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.

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

19

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.

20

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?

B it will cost up front dollars[/B]

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 …

B it will cost up-front dollars[/B]

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