The Centers for Medicare and Medicaid Services has proposed changes in the Quality Incentive Program (QIP) for 2013. The changes specifically involve anemia. The QIP was created to assure that even though the costs of providing dialysis care are born exclusively by the dialysis provider, there are specific quality goals that if not met result in financial penalties. The quality goals currently place are:
- Percentage of Medicare patients with an average Hemoglobin < 10.0g/dL (Hemoglobin Less Than 10g/dL Measure)
- Percentage of Medicare patients with an average Hemoglobin > 12.0g/dL (Hemoglobin Greater Than 12g/dL Measure)
- Percentage of Medicare patients with an average Urea Reduction Ratio (URR) ≥ 65 percent (URR Hemodialysis Adequacy Measure).
Dialysis units that fail to hit the goals perscribed by the quality score receive a reduction in the Medicare payment by 0.5-2%. It should be apparent that the required hemoglobin targets ares problematic, especially given the recent action by the FDA (see my recent post Between a rock and a hard place). CMS is proposing the elimination of the floor on hemoglobin targets:
…Therefore, for the PY 2013 ESRD QIP, we propose to continue to use the following two measures previously adopted for the PY 2012 ESRD QIP:
- Hemoglobin Greater Than 12g/dL Measure.
- URR Hemodialysis Adequacy Measure.
This feels wrong to me. Creating an economic incentive that puts the cost of treating anemia on the provider but doesn’t provide any minimal goals may result in a race to the lowest hemoglobin. What’s to stop a rogue dialysis unit from removing ESAs from their formulary. We can all freely admit that ESAs have some previously under appreciated risks and that our enthusiasm for treating anemia was not entirely evidence-based, but our response to should not be to turn back the calendar to 1988.
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After the release of Epo, the transfusion rate plummets. It falls by two thirds in a year and continues to fall so that the current rate of 0.3% per quarter represents a 98% reduction in transfusions. Revolutionary. And this doesn’t even begin to address the quality of life brought to dialysis patients by higher hemoglobins.
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CMS states that they cannot add another unique quality indicator for 2013 and are looking toward 2014 to do this. In the absence of new quality guidelines they should keep the goal to maintain a hemoglobin over 10 g/dl but lower the target to 9 g/dL for 2013.
Patients deserve an incentive that keeps providers conscious of anemia. In study after study, low hemoglobins walk hand in hand with poor outcomes. The concern regarding anemia has been driven by attempts to normalize hemoglobin. It is clear that normalization is hazardous and without scientific support; however a failure of the experimental group does not mean we should abandon the therapy given to the control group. In every study the control group received ESA to maintain hemoglobins at least 9 g/dL. Removing the hemoglobin floor from the quality measures would be giving a de facto license to withhold an important medication from dialysis patients.
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| The TREAT trial is the best study every done on outcomes in CKD with an ESA. |
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| These dosing groups resulted in an effective separation in hgb with little profound anemia |
I have copied this post to Regulations.gov as my comment on the latest guidelines.
The deadline for comments is August 30th.
A science liaison at Amgen told me that Amgen was advocating for a hemoglobin floor of 10 g/dl. The Renal Physician Association is also supporting a hemoglobin of 10 g/dL. [This paragraph was updated 8/22/11, after a complaint that I mis-interpreted Amgen’s position. My apologies.]
I have heard that CMS has received few comments from physicians. Embarrassing. Anemia is important and nephrologists should care how the governments crafts incentives that will change how our patients are treated. Go now and comment. Tell CMS what you think.
"I was talking to a science liaison at Amgen and he said that Amgen was trying to explain to CMS that the proposed QIP guidelines are not safe and that physicians will hate them."
Would you expect Amgen to say anything different? Do you really think their opinion is what should count? Unfortunately, Amgen tentacles spread far and wide… They've infiltrated every major renal society, unfortunately.
Listen, if Amgen was REALLY concerned that people weren't going to use ESAs now because of the bundle & dropping the Hgb<10 measure, they could solve the problem very easily: Drop the price of ESAs. This could drastically reduce the financial incentive to withhold therapy to pre-bundle levels…then it's up to the physician and patient where they want the Hgb to be. CMS doesn't need to dictate it.
Amgen's fighting hard here by trying to get physicians to rally to be regulated — what nonsense! And shame on physicians for thinking that government-mandated hemoglobin targets are the only way to treat their patients "appropriately." The physician lobby should spin around and lobby the LDOs to maintain reasonable protocols and lobby Amgen to drop the price of their drug. Amgen has made BILLIONS over the years from ESAs; it's time for them to put their money where their mouth is. Patient safety's going to be a concern? Yeah, right. Their PROFIT is the concern.
"Removing the hemoglobin floor from the quality measures would be giving a de facto license to withhold an important medication from dialysis patients."
It would not. That would not be consistent with the FDA label, and frankly I think that patients would be able to sue their provider for negligence since withholding all ESAs to the point of "turning back the clock" to the transfusion era would not be considered standard of care. Although I won't deny that LDOs are interested in cutting back on ESA utilization now that the bundle is in place, I don't think anyone can show with certainty that cutting back is a bad thing…and it may even turn out to be a good thing.
Homer,
The point of the comment regarding Amgen is that physicians aren't commenting on this proposal, and I think this proposal is going to radically change hemoglobin management. I want physicians to have a word in how this plays put and the mechanism for that commenting on the proposed legislation.
It looks like you have some strong feelings about this issue and if that is the case you should comment at regulations.gov in addition to pbfluids.com (though, as a dead scientist, I'm not sure your constituency would have much weight).
In fact that was the point of the whole post, incentives matter, the incentives are being changed and doctors should take a seat at that table.
I've already commented at regulations.gov, and I completely support your call to physicians to weigh in.
Yes, I do have some opinions about this issue, and my comment here was simply to present another viewpoint that seems to counter yours a bit. Your blog is being re-tweeted by the ASN and probably others, which is fantastic publicity and I hope it encourages more physicians to comment on the rule, whether in support or in opposition.
En face, Amgen's pleading that dropping the Hgb<10 measure will hurt patients sounds like they're patient-centric. Some may read your post and believe that to be the case. While I'm not saying that Amgen's out to do harm intentionally, let's face it, they have one genuine constituency of interest: stockholders.
Some may have never considered that one way to "solve" this dilemma is for Amgen to drop the price of ESAs. I just want folks to at least consider various options before coming up with their own opinion.
nice post.