Now what?

[Desert Dancer]

My clinic emailed me to re-start my Epogen since my Hgb is at 11.3; however, Amgen has changed the prescribing guidelines and Epo is to be STOPPED when Hgb approaches or exceeds 11.0, due to risk of heart attack, stroke, etc. (thanks to okarol for posting the press release).

I emailed them back and pointed this out to them. Here's their response: "I am well aware of the AMGEN rule, but Davita has not adopted the changes yet. It is coming in the next 3 weeks or so. Until I have new orders/protocols I have to follow the orders I have. Are you willing to restart the Epogen and work with me on the order changes to come??"

In other words, am I willing to put my life at risk for the sake of satisfying some corporation's policy?

I so very much want to email them back and say, "Sure, if DaVita is willing to accept all liability should something happen to me" or "Sure, as long as you know Andy is going to sue the living shit out of DaVita if I have a stroke or heart attack". Really, I just want to say, "NO." But then there's that whole 'non-compliant' bullshit to contend with.

I mean, really? You're going to screw with patients' lives because DaVita hasn't gotten around to changing their POLICY yet? I don't give a sh*t about policy; this is my LIFE we're talking about.

What do you all think?

[MooseMom]

So, is your clinic saying that their corporate policy will be changing in 3 weeks, and then you won't have this problem any more?  Are they saying that in 3 weeks time, they'll be taking you off epo once their policy catches up with the new prescribing guidelines?  Because if that is what they are saying, I think I might "work with them" by accepting the script, filling it but not actually injecting yourself with it (that's assuming you administer it to yourself at home.)

Is this a feasible plan?  I'm a little surprised that Davita would risk a malpractice suit by insisting you take a drug when they know it could be dangerous for you.  There's a difference between being non-compliant because you just can't be arsed and being non-compliant in a bid to protect your own life.  If they made you take this drug despite the guidelines and you had a stroke, they'd be liable for willful negligence.  That seems an awfully big risk for Davita to take.

[Desert Dancer]

MooseMom, yes, that's pretty much what they're saying: "Yes, we're aware of the risks. Yes, we know Amgen had to end the clinical trials early because of all the adverse effects. Yes, we know the prescribing guidelines have changed. You have to take it anyway because that's our policy at the moment, even though we KNOW the policy is changing." That's EXACTLY what they're saying.

Believe me, I've thought about just saying yes and then not taking it. But I SHOULDN'T HAVE TO DO THAT. I shouldn't have to be dishonest, and I shouldn't have to be afraid to claim my RIGHT to refuse some aspect of treatment. I shouldn't have to sit here and agonize over what my response will be because I've got the stick of 'non-compliance' hanging over my head.

I'm also really failing to understand why it's so imperative for me to take the Epo right now anyway; I'm smack dab in the middle of the current acceptable range for Hgb, so what the hell is the big deal?

[MooseMom]

No matter what you decide, just be sure you have hard documentation of all of this correspondence between you and Davita in case you have to sue their pants off.  I am appalled that they would put their "policy" over patient health and safety.  I don't think this is legal, much less ethical, so I seriously advise you to keep immaculate records of Davita's intentions.

If you were to refuse treatment based on Amgen's recommendations, what is the worst that could happen to you?  I know you may be termed "non-compliant", but what exactly does that mean?  What are the ramifications of that? 

I agree that you shouldn't have to twist yourself into a pretzel over this.  None of us should have our lives made more difficult with yet more red tape.  But as far as I can see, you have an extremely valid reason to refuse epo.  It really irks me when medical people rail at us to educate ourselves and work hard to keep ourselves healthy, to follow the diet, do the treatments, take the meds, spend the money, lose the time, blah blah blah, but it is all just code for "Do what we say."

As for why they are in such a rush for you to take epo right here, right now, I'd bet the north forty that it has to do with profit margins.  They want to make as much money on EPO payments as they can before their policies change.

[Desert Dancer]

Oh yes, indeed - the entire conversation is via email, so I've got it all in writing.

The worst thing that could happen, I suppose, is that they pull me back in-center and don't let me dialyse at home anymore; that's my biggest fear. That would just be flat out vindictiveness, because I'd refuse the Epo no matter WHERE I dialysed.

I thought the new bundling went into effect January of this year? Wouldn't I be SAVING them money by taking less Epo?

[MooseMom]

I must be getting cranky and litigious in my old age because it seems to me that if they forced you to leave a treatment modality that gave good results (home nocturnal) and forced you onto a clinically inferior treatment modality (in clinic), again, that's willful negligence, and that's illegal.  Their epo policy is now NOT considered to be safest for the patient, and to force an unsafe treatment onto a patient is, again, willful negligence.

How about contacting your ESRD Network?  Many of our more politically active members refer others to their ESRD network for information on just this type of question, so that might be your first port of call.

I'm VERY eager to see how this plays out.  We need to get someone like Hemodoc or Bill Peckham or Meinuk in on this conversation!

[Desert Dancer]

I'd thought of that, but I don't want to pull the ESRD network into it until I have to. I'm trying to keep this as low-key and non-antagonistic as possible, which is also why I've refrained from mentioning 'liability' or any other legal terms in my emails to them, as I don't want them to feel threatened or defensive.

But goddamit!

The worst part of all this is that I have to dialyse TONIGHT and that means they'll be expecting a flowsheet from me tomorrow morning. It's still going to show the Epo as 'held' and that'll be their answer right there, so I've got to compose an email saying 'No' before then. Every time I think about it my heart starts pounding. I HATE confrontation.

[MooseMom]

Would it be possible to contact your ESRD network just for some advice?  You don't have to "pull them into" anything, do you?  I don't know...I've never contacted mine, but it seems they could at least give you something to work with.

Does your neph go along with the clinic admin on this?

[cariad]

But... but... I was told about these dangers back in 2007. How could they only be getting round to changing their policy now? Most insurance won't reimburse for Aranesp if your HGB is over 11 because it is considered so dangerous.

I would just tell them no, DD, and see what their response is. This is national, common knowledge in the renal field. So far, neither side has threatened the other. Just write a very simple email saying that you are not willing to take the risk of injecting EPO until your starting HGB drops below 11. If they respond in an aggressive fashion and you don't want the confrontation, contact Plugger at dialysisethics and see if his organization can advise. I wish you the best of luck!

[tyefly]

I am sad that there are more problems with dosage with epo.....  I dont feel well when I am in the 10...but feel good when I am in the upper 11....  when I am in the 10 I want to sleep and dont feel motivated in doing to much .... I am not looking forward to feel bad again...  I was just starting to feel good for a change....

My clinic has not said anything about this yet..... but I am sure they will adopt this as a money saving measure...

I dont know how I am going to live life tired all the time.....

[rsudock]

DD I like your candidness and spunk! What is Davita's problem!!!?? How hard is it to put patients best interests first? Someone get Ken on the phone please!!!!

Good luck and tell them NO! I like the idea of saying "Are you willing to accept liability?"

xo,
R

[Ang]

apologies for  the ignorance, as an out of country person, does the corperation hold more sway than nephrologists?

ask the nephrologist the best course of action that will be safe for you.

[cariad]

apologies for  the ignorance, as an out of country person, does the corperation hold more sway than nephrologists?

ask the nephrologist the best course of action that will be safe for you.

I guess I assumed that the nephrologist is employed by DaVita and would follow their protocols, but you're right, Ang, if her nephrologist says DD should not have EPO, she won't get it. Theoretically tyefly's nephrologist could prescribe her EPO even when she is over 11 HGB, but it would be a rare doctor indeed willing to take on both the risk and the argument about the extra cost that that would involve, especially since it won't be the nephrologist dragging through each day.

[Desert Dancer]

Okay, here's the email I've composed; please tell me if you think the tone is all right:

Good morning, N-

If you are aware of the new guidelines, then you are also aware of the risk you're asking me to take. For Amgen to voluntarily end clinical trials early and lower the recommended target Hgb is a big deal; you are asking me to lay aside hard science in favor of a lagging corporate policy. This seems to me a poor basis for making a medical decision and so I'm afraid I have to exercise my prerogative to decline. I'm more than happy to reconsider once monthly lab results come back next week. Even if my Hgb drops another whole point I will still be within the current recommended range of 10-12, and will still be above the recommended point of initiation under the new guidelines. That is a risk I AM willing to take.

I've very sorry if you feel I'm being 'difficult' or 'non-compliant', but I gave this a great deal of consideration before making my decision and I feel it's the right one. Ultimately, I am the only one with skin in this game and I have to do what I feel is in my own best interest. Thank you for understanding.

[noahvale]

*

[jeannea]

Maybe you can put them off a few days to give you a chance to talk to the nephrologist. Ask for a retest of the hemoglobin level to be sure you need the epo since the levels are so variable. Then you'll have time to get a real policy out of the doctor. It helps you avoid confrontation while still getting what you want.

[Desert Dancer]

See, I don't know who this directive is coming from; I'm assuming it's just standing orders from the doc that are in line with DaVita procedure. The nephrologist I see is the one who came with the clinic and I just see her once a month for rounds. Other than that I really have no contact with her, though anytime I've ever raised an issue with her she's given me pretty much free rein to do what I like (adjusting my own BP med dose, adjusting my own heparin dose, etc). All my communications with my clinic/doctor in between rounds are through my dialysis nurse.

The only reason I feel compelled to respond to the clinic is because the nurse asked me a direct question: would I be willing to cooperate with policy? I feel common courtesy requires some response. It won't really do me any good to put it off, because all my documentation is going to show that I am NOT taking the Epo, and I can't just stop sending in my flowsheets to avoid the question.

Thank you for the feedback!

[noahvale]

^

[rsudock]

I thought the email was direct and to the point. I would send it!

xo,
R

[*kana*]

I think I would just forget to take my last dose and wait until they got their policy changed.