Know we have discussed this before, but I have forgotten. My clinic now wants Hgb at 10-12. Is this CMS mandated or is there a physical reason why Hgb should not be higher than 12? Believe I read an article once that stated Hgb of over 12 can have detrimental effects for dialysis patients.
Used search and found the old threads on this topic dating back to 06’-07’. My clinic has allowed my Hgb to be in the 12’s for many months. Were clinics forced to observe the 10-12 goal or not get paid, or was it merely recommended that they do so? Since my clinic wasn’t keeping me within this goal all this time, but have just now gone to this goal, have there been any new regs or warnings re EPO?
There are many reasons why the standard put on the level of your hbg in dialysis patients.
One reason is that many for profit dialysis clinics were allowing the hbg levels to reach the high side in order to bill Medicare. In 2005, For many centers, more than 20% of their revenues come from the administration of Epogen and other similar drugs. Therefor the more they push out, the more they make…People were experiencing more adverse effects due to this.
This is one reason why there was a black box warning placed on the drug.
CMS and the FDA have placed certain standards that centers must follow when administering this type of drug.
It was determined that centers must keep the hbg within a certain level in order for them to pay for the drug.
Read more at Epogen Reimbursements
///MM
///MM,
Thanks for this article as this was my general understanding of the issue. And I have heard my dialysis professionals discuss how the financial incentive was taken away. Looks like this occurred back in 07’. So, what I am trying to figure out is, what are the possible reasons why my Hgb has been allowed to stay in the 12’s for so many months yet only now are they enforcing the 10-12 goal? If my Hgb exceeded 12 did my clinic gain anything monetarily even if not as much as before, did they lose anything, or is this just an oversight in my care that didn’t cost them anything one way or the other?
My guess would be the latter. Your clinic probably focused on in-center patients first, and is just now getting around to folks at home.
What does it say when a clinic is many months behind thus giving a wrong scrip for medications that go in a patient’s body? Is this a violation or are they permitted to get a patient’s scrip up to date many months past due? I believe I read that home patients are allowed to go past 12 on their Hgb without any penalties. Also, can a neph overide the regs if he wants a higher Hgb for his patients? And, I was just now given my care plan to sign from 6 months ago. I know nurses are stretched to the limit, but are these issues violations or not?
It’s likely that this is occurring because of at least 4 reasons:
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Research found risks of stroke and other adverse events were higher when Hgb levels were higher leading the FDA to require Amgen to put a “black box warning” on EPO.
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CMS changed its reimbursement policies in 2006 and again in 2008 to require dialysis facilities to reduce EPO dose 25% (and later 50% if Hgb levels stay up) for in-center patients when Hgb rises above 13 g/dL and stays there for 3 months or longer. Also, CMS set 400,000 units a month as the level for “medically unbelievable edit” where it believes there may be a typographical error. NOTE: This policy applies to in-center patients only. Their labs are drawn more regularly than home patients and their physicians can take action faster to reduce the dose 25%. With home patients, they may not get labs drawn as often so doctors can’t tell them to reduce their dose as quickly.
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Because of the FDA black box warning, the Medicare Claims Processing manual encourages dialysis facilities to reduce the dose of EPO to try to keep Hgb in the range of 10-12 g/dL. CMS encourages dialysis facilities to look for causes of low Hgb (<10 g/dL) when large doses of EPO don’t get Hgb into the target range.
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ESRD surveyors have been advised to use 10-12 g/dL as the target range for all patients (not just in-center) when doing their survey and to check to see if clinics are following CMS’ recommendation to reduce the dose when Hgb rises above 12 g/dL.
Beth,
From what you have posted, since I had a Hgb of 12-13 for most of 09’, sounds like someone was not doing their job. We do labs 1x/mo. just like in-center patients and the home nurse has the delegated authority to adjust epo doses.