The rock would be Amgen with their newest prescribing information for Epogen and Aranesp. The recommendations for dialysis patients can be summarized as:
Specifically, for patients on dialysis, the label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL. So target a hemoglobin higher than needed to prevent transfusions and no higher than 11 g/dL.
The hard place would be the federal government whose Quality Improvement Plan (QIP) for dialysis units states:
The intent is to control anemia and maintain optimum hemoglobin levels within the range of 10-12 g/dL (grams per deciliter). Anemia management will be assessed by two separate measures:
- CMS will assess the percentage of patients whose hemoglobin levels dipped under 10 g/dL. The program assigns this measure the greatest weight in facility performance calculation, because numbers under 10 g/dL are highly undesirable. (Weight = 50%)
- CMS will assess the percentage of patients whose hemoglobin levels exceeded 12 g/dL. Numbers greater than 12 g/dL could suggest unnecessary or excessive administration of certain drugs. (Weight = 25%)
There is little air to breathe between 10 and 11 g/dL. Something has got to change and my guess is by the end of the year QIP will be suggesting hemoglobins between 9 and 10.
UPDATE: CMS has proposed new rules that remove the lower limit for hemoglobin as a quality measure. Here is some news coverage and here is the PDF.
I think its crazy to remove the lower hemoglobin limit. When CMS introduced the bundled payment system they turned anemia management from a profit center to a cost center for dialysis units. The Quality Incentive Plan was designed to prevent dialysis units from minimizing costs by denying patients adequate treatment. It seems that with the 2013 proposal, a Machiavellian dialysis unit could eliminate anemia management completely and reap financial rewards without penalty.
This can’t be right, at the least CMS should add minimizing transfusions as a quality measure, that would reconcile the prescribing information and the quality goals.
Hat tip to the anonymous first poster.
The situation gets even more interesting with Friday's release of the proposed rule for changes to the QIP. The less than 10 g/dL has been removed and only the higher than 12 g/dL will now be judged.
From the CMS press release:
"The proposed rule proposes to change the performance measures for PY 2013 by retiring the hemoglobin level less than 10g/dL measure from the measure set, and equally weighting the two remaining measures (hemoglobin levels greater than 12g/dL and hemodialysis adequacy, as measured by Urea Reduction Ratio (URR) levels of at least 65). "
Hey Anonymous, Thanks for the tip. You should register with Google and gain fame and fortune as a professional blog poster.
Why crazy re: the QIP? Doctors should be able to police their own quality care…are you suggesting nephrologists are so money hungry that they'll hurt patients because Medicare gave them wiggle room to individualize therapy? That suggestion, and the thought that you find the QIP change "crazy" speaks poorly for your profession.
Since the financial burden of treating anemia rests entirely on the dialysis provider, there is an implicit incentive to minimize treatment/cost. There needs to be something on the other end of scale to balance that incentive, this is the role of the QIP.
If you feel that incentives don't matter and that people will always do the honorable and noble ideal, well I think you should open your eyes.
Of course incentives affect practice, but you imply that the QIP is critical to nephrologists practicing appropriate care. Bundled payment structures have been around for years (DRGs) yet the QIP is the first quality-incentive program in the US, correct?
I guess I'm just playing devil's advocate to your statement that dropping the less than 10 measure is "crazy." You correctly outlined that keeping that measure would effectively invoke a 10-11 range, which would be near possible to hit, and frankly I don't think we know where the lower level should be to maximize outcome. So while I think that it's entirely appropriate to suggest a lower limit (like 9) in opinion-based clinical guidelines, putting an opinion-based lower limit into a pay-for-performance measure is another matter entirely.
which is why I didn't suggest 9, but rather a target based on transfusions. There is a strong evidence base that EPO reduces transfusions.
And by the way, clever pseudonym Mr Fish2Philosopher
My guess, and it's only a guess, is that given the proximity of the FDA label change and the CMS proposed rule, they didn't have time to operationalize a new measure. We'll see what (or if) they come up with. Perhaps we should brainstorm and then write in during the comment period. 🙂