The House Committee on Ways and Means Subcommittee on Health on Tuesday 6/26 held a Hearing on Ensuring Kidney Patients Receive Safe and Appropriate Anemia Management Care. Congressman Stark chaired the hearing to review Medicare's policies regarding anemia management. In general there is concern in Congress that Medicare (CMS) reimbursement policies may lead to clinically dangerous over use of medications used to treat dialysis patient anemia and there is concern that CMS is paying too much to manage dialysis patient anemia.

My previous diaries here and here present my view of the "bundling" solution to the perceived problem of anemia medication over use. My diaries here and here attempt to explain the current situation with regard to Epogen, the primary medication administered by dialysis providers to treat anemia in people on dialysis. I have an opinion piece posted here that reviews the unique way that dialysis is paid for in the United States; the opinion piece grew out of this diary which gives some history of the US dialysis entitlement.

The GAO and MedPAC are in favor of bundling but their evaluation criteria is financial, not clinical. More troubling was the testimony by the American Association of Kidney Patients (aakp) they present themselves as "the voice of all kidney patients" (count at least one person out. I'll speak for myself) testifying that they are dedicated to serving "the needs, interests, and welfare of all kidney patients and their families". That would be good, but the testimony that I heard could only be summarized as a case of cognitive dissonance.

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Here is an article I wrote for a dialysis patient advocates newsletter - a dialysis reimbursement primer.

How is dialysis paid for in the United States? That seems like a simple question but it's a complicated situation so there really is not a simple answer. In 2007 nearly 500,000 people have CKD5 (kidney disease so severe that to live a person needs either a kidney transplant or regular dialysis), over 350,000 individuals treat their CKD5 with dialysis. Medicare calls it End Stage Renal Disease (ESRD), while the FDA uses the term Chronic Renal Failure, no surprise I prefer the term CKD5 instead of End Stage or Chronic ... Failure.

With nearly 500,000 people needing treatment it should be no surprise that there is now a giant industry involved in providing care for all of those people. There are the manufacturers who make the equipment and supplies (from dialysis machines to the needles), there are drug makers (Amgen, Ortho Pharmaceutical) because in addition to dialysis or transplant treatment of CKD5 requires various medication therapies, and there are the providers who provide dialysis and transplantation (Davita, Fresenius and your local hospital transplant center). It is those providers of dialysis that we think of when we talk about how dialysis is paid for but we should remember that they are just a part of a very large industry.

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There is an interesting National Journal article online here that gives an overview of the epic lobbying battle going on right now in Congress over ESAs.

The pharma giants Amgen and Roche are fighting it out for control of the 2 billion dollar kidney dialysis anemia management market. I found the article very informative; it helps to explain the disjointed congressional interest in ESAs since the end of the 109th Congress, which continues today in the 110th.

The issue is not optimal patient care for dialysis patients. The issue is money - can Roche get a piece of the pie that for the last 16 years has been exclusively Amgen's. The article concludes saying "In this brawl, with so much at stake, vigilance doesn't come cheap." referencing the lobbying dollars spent by pharma. Vigilance may not be cheap for pharma but doing the right thing would allow moving money from ESA reimbursement to improving Medicare's dialysis program.

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Senator Grassley released a letter he wrote to CMS on 5/16 concerning the use of ESAs (mostly Epogen manufactured by Amgen) to treat anemia in dialysis patients. I'm tempted to go through the letter line by line but here is the meat:

"According to the GAO, bundling all ESRD drugs and services under a single rate would encourage more prudent use of ESAs. The Medicare Payment Advisory Commission (MedPAC) also recommends that payment be bundled to control costs and promote quality care. In addition, MedPAC has recommended implementation of a quality incentive payment policy for providers of outpatient dialysis services.

An overuse or inefficient use of ESAs is not only a financial concern to the Committee, but also a major patient safety concern. I am troubled by the findings in recent clinical studies of increased risks of death, blood clots, strokes, heart attacks, and tumor growths when ESAs are given in higher than recommended doses."

I think bundling medication reimbursement (basically those ESAs but other meds too and possibly other items) with dialysis reimbursement would be a mistake. I address why it is not a major patient safety concern here. After the fold I address the bundling strategy.

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Proponents of healthcare reform point to two buckets of money when discussing the potential savings that could be redirected to expanding access: insurance profits and provider profits. From the point of view of the US dialysis program I can't see how eliminating private payers and/or private providers saves money.

Dialysis is a useful lens to view the question of healthcare reform because it is free of some complicating issues, dialysis has fewer variables. The procedure is as close to a widget as the healthcare system gets making the business model of the dialysis unit fairly straightforward (at least as compared to a large city hospital or probably a busy medical practice or other specialty). And critically access to dialysis is nearly universal in the US (there are exceptions, varying with Medicaid rules i.e. undocumented dialyzors) giving it a status most people want for healthcare generally.

It could be that the US's thirty-five years of experience with its dialysis entitlement (formally known as Medicare's ESRD [End Stage Renal Disease] program) is not relevant but if I can adequately lay the situation bare I think it will be a productive tool with which to test a proposed fix treatment for a very sick system.

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