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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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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While looking into the documentation regarding the FDA "Black Box Warning" on the use of drugs to treat anemia I came across what I consider incorrect word usage. I think this sloppy use of language has added a layer of confusion to an already complex issue.

The FDA document Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) uses the terms: Chronic Kidney/Renal Failure and Chronic Kidney/Renal Disease interchangeably. They are not the same thing.

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Matt Stroller's post on 4/28 points to recent reports regarding the drug Epogen manufactured by Amgen. Matt's take is pretty well summed up by the post's title "Killing Patients and Bilking Taxpayers" ... I take Epogen - I'm not dead and I do not think I'm ripping off the tax payers.

Matt quotes a study that showed that patients at for profit dialysis providers (80% of all US dialysis treatments are provided by for profit companies) "are given the highest doses" of Epogen, as compared to not for profits. This could indicate the for profits are "gaming" the system or it could indicate that patients at not for profit clinics are getting more/better dialysis. However, Matt links the quote to HR 1193 which does not address Epogen use or reimbursement. One thing at a time ... but the rampant conflating is instructive.

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