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.

From the National Journal article:
"Medicare actually pays one rate for routine dialysis services and a separate, per dose rate for dialysis drugs such as Epogen. To make matters worse, critics say, the repayment rate for dialysis services is not automatically adjusted for inflation, while the reimbursement rate for Epogen has generally exceeded its price, according to the GAO.

As a result, dialysis clinics often rely on the profit they make on the drugs to subsidize the hit they take on the reimbursement rate for dialysis services, which has not increased in two decades. A November 2006 GAO report said that the absence of market competition for Epogen "could be having a considerable effect on Medicare spending."

In 2003, Congress directed the Centers for Medicare and Medicaid Services to consider bundling dialysis services and drugs, including Epogen, under a single flat rate. But CMS is years behind schedule. Last November the GAO recommended that Congress "consider establishing a bundled payment system for all [dialysis] services, including drugs, as soon as possible." In March the independent Medicare Payment Advisory Commission, which advises Congress, also endorsed bundling.

CMS, which administers the Medicare program, agrees on the merits of bundled payments. But the agency cautions that bundling must account for the wide variation in doses given to patients based on their weight, the severity of their kidney disease, how frequently they receive dialysis, and other factors.

Yes MedPAC, the GAO and Medicare all agree that bundling ESAs with dialysis reimbursement would save money. The article even gives a dollar figure for the potential savings (the first time I've seen a figure):"former Congressional Budget Office Director Douglas Holtz-Eakin [was paid by Roche] to crunch numbers showing that bundling could save Medicare at least $700 million over five years." or $140 million per year.

But as I noted in my previous post the potential savings from administering ESAs subcutaneously (into the muscle as opposed to intravenously into the hemodialysis blood lines) saves over 20% or $180 million per year. If Congress enacted a bundled payment that anticipated the savings projected by Holtz-Eakin it would result in less ESA use but increased dialysis provider profits without even considering the impact of under dosing. And one could be sure that there will be under dosing.

The National Journal article also quotes Amgen VP Josh Offman who correctly notes " that the GAO and the Medicare Payment Advisory Commission's primary concern is fiscal policy, not science." It is bad policy to advocate reimbursement changes without looking at the clinical impact on patients.

The simple fix would be to offer Medicare reimbursement under current dosing guidelines for dialysis patients who agree to receive ESAs subcutaneously (a target hemoglobin of 10 to 12) and to offer reimbursement for intravenously administered ESAs to a target hemoglobin of 8 to 10. Whichever method the patient chose it would result in using less ESAs, which would result in Medicare Part B savings. Those savings should then be applied to improving Medicare's dialysis reimbursement by creating an continuous quality improvement inflation update framework, federal tech certification, CKD 4 services (HR1193/S635) and to expand the dose of dialysis available through Medicare by funding something like HR5321 from the 109th Congress.