hemoglobin protocall changed again?

[sullidog]

My nephs nurse was doing her rounds today and I heard her mention that the hg protocall has been changed yet again. This time it's between 10 and 12. When did this change occur? I thought it was between 9 and 11?

[jeannea]

Can you clarify? Do they want you to be at 10-12 or they'll give epo when you're at 10-12?

[Willis]

I talked with my PD nurse about this very subject Monday. The current protocol is 10.0-12.0...not 12.1 If it's 12.1 I'm over and they can't give me EPO. I think I function best at high 12s even low 13s...but the gov't dictates they know best and not what's best for me. As soon as I start feeling good I realize that next doctor's visit I'm going to get cut off again and feel like crap for the next 2 months. I would have a lot more energy if I my doctor had any say in the matter. Apparently, clinics getting paid under the Medicare "Bundle" get in serious trouble for violating this protocol. My nurse agreed that it's likely driven by the high cost of the EPO.

Now, even more depressing, she said she read a Technical Leaflet or something that said that Medicare was considering lowering the range to 9.5-11.5! Even my lab reports say for an adult male that the NORMAL range is 13-18. "Oh, but you're on dialysis so it different!" I say B.S. on that call. It's all about the money.

 

[sullidog]

She said that it's 10-12 before they cut it off. I feel good 11 or above.

[tyefly]

Well It doesnt get better after transplant either..... my insurance wants me to remain between 10 and 11..... and not higher.....   I am wondering what will happen if I go about 11.....   will they have been bleed out......LOL

[lmunchkin]

I totally agree with you Willis!  It all about the economics!

lmunchkin

[KarenInWA]

I am in-center hemo and I get an epo shot with every treatment excpet if I am over 12.  They want me at 11 or above, and even when I am at, say, 11.2, they still give me epo.

KarenInWA

[boswife]

this is one thing thats making me crazy.  Bo's hemo as always been between 11-12.  Wasnt taking iron but 2000 epo per week.  It all of a sudden plummeted to 8.6, he feels like crap!!!!  and though they are now pumping with iron and 9000 epo per week, im guessing he's still got a couple weeks before he feels better??  Then, when i mentioned the 'noodle' feeling, lack of energy etc,  i was told........  he's only a tad below the recomended protocal... and that it shouldnt have any effect on him..  ARE YOU KIDDING me... Sometimes im blown away by someone who i truly respect "most" of the time....

[sullidog]

One thing ya may wanna check for that big of drop is blood in the stool or any abnormal bleeding. Also if he had a fistulagram or any surgery lately that could cause it.

[paris]

Going from 11 to 8 is a really big drop.   At 8 you feel like you are in a fog and to put one foot in front of the other takes complete concentration and all your energy.    Post transplant I am steady at 10 and feel good.  No more epo or iron infusions.   When all of this started for me, if it was 11, I got a shot.   Then it all changed.    I do think that the clotting factor while on epo, arenesp was part of the range change. The risk of strokes increased while on epo.   And when Medicare changed their range, I believe the insurance companies followed quickly behind.  I am only a patient --- so what do I know?!!  LOL   

Meinuk would be the one to have all the information on this.  Or Bill Peckham.   Hope they answer this.   

[Marina]

Supposedly  this  change  came  about  after   Amgen   reported that  there's  a higher   risks of  stroke  and heart attacks  if hemoglobin is  in the  above  12. They  recommend  10-12.
How  about  those of  us  who  can't  function  below  11?        I  feel    my  best  at  12.        I  feel  okay in the  mid  to high  11's.         In the low  11's  I  can  manage.  But  in the  10's  it's  absolutely  difficult.     A  short  walk  wears  me  out.   My  legs  ache  so much  when   I  walk short  distances.

http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=1050110&highlight=

Amgen's presentation reviews data demonstrating that ESAs are safe when used appropriately and explains the critical role ESAs play in managing the debilitating effects of anemia in CRF patients. The company's presentation recognizes the potential risks observed in recent experimental trials targeting higher-than-recommended hemoglobin levels, lays out the need for an appropriate hemoglobin target of 10-12 g/dL to guide treatment and manage risk, and highlights the importance of the ongoing Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) to provide answers on the impact of anemia treatment in CRF patients. The company also identifies areas for future study and presents data that suggests that patient response is a stronger risk factor for poor outcomes than ESA dose.
"Generally patients with poor ESA responsiveness and who receive the highest ESA doses have very poor health status and suffer from multiple co-morbid illnesses," said Dr. Klassen. "It would be expected that these patients would have worse clinical outcomes."

[Meinuk]

There is a lot of government in this and it is a hot issue. I am going to write a VERY broad overview about hemoglobin.

Normal Hemoglobin Levels:  [for someone who is NOT living with CKD-5]

Hemoglobin is measured in grams per deciliter of blood. The normal levels are:

    Women: 12.1 to 15.1 gm/dl
    Men: 13.8 to 17.2 gm/dl

Now, how it is being measured, dosed and reimbursed for people living on dialysis with CKD-5:

Before 2009, there were many scandals and lawsuits about misuse and abuse of ESAs.  The government sought to correct that.  Medicare is the largest payor for dialysis treatments in the United States and they were being ripped off  (yeah, and maybe some people were dying too....)

Iin 2009, CMS (Medicare) proposed Pay for Performance measure along with the new Bundled payment system.  The change in hemoglobin would be that there would be a financial penalty if a dialysis facility's average hemoglobin levels were outside of a certain range:

Anemia Management: Controlled anemia, as shown in two measures:
o The Medicare percentage of patients at a facility whose hemoglobin levels were less than 10 grams per deciliter (g/dL)
o The percentage of Medicare patients at a facility whose hemoglobin levels were greater than 12 g/dL.

This rule was passed, and now is the "Final Rule" for dialysis payment reductions starting in 2012.

BUT...

In July 2011, the FDA changed their guidelines for use of ESA (Epo, procrit etc..)  The FDA issued warning: (Bolding my emphasis)

http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm

the FDA now recommends initiating ESA treatment when the hemoglobin level is less than 10 g/dL and reducing or interrupting the ESA dose if the hemoglobin level approaches or exceeds 11 g/dL.

What does this mean?

CMS has been reassessing if they should drop the low 10% target all together in the payment plan.  People have fought and lobbied for CMS to keep 10% as the minimum. (really, they want more, and more individualized care.  The way one person feels at 10 could be what another feels at 8)

Should CMS and the FDA be in line?  The warning says that providers should not start ESA until someone is below 10%. CMS is exploring dropping the 10% minimum all together.

These are the two government agencies that are dictating your dosage. 

There could be a change in CMS's Fianl Rule going forward, as there was a call for comments this summer for : Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule   [CY = Calendar Year, PY=Payment Year]

Many, many people advocated for change.   People have spoken and written, now we have to wait and see.

Here is Bill Peckham's  8/30/2011 comment regarding ESA

http://www.billpeckham.com/from_the_sharp_end_of_the/2011/08/my-comment-to-cms-on-the-proposed-2012-qip-for-esrd.html

My comment to CMS on the proposed 2012 QIP for ESRD

By Bill Peckham

The deadline to submit comments on: Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule is, I think, past not up, there is still time! Regulation.gov site indicates you have to 11:59PM EDT August 30. http://www.regulations.gov/#!submitComment;D=CMS-2011-0129-0002

As with my past public comments (here, here, here) I post them:

Re: CMS-1577-P: Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule

Dear Administrator Berwick:

Thank you for the opportunity to comment on the proposed changes to the End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014 (QIP). My name is Bill Peckham. I have been a Medicare beneficiary since 1988 and have used dialysis since 1990. My comment primarily concerns the proposal concerning anemia, so I note that I have used ESA therapy in the past though for the last  ten or so years with diminished frequency and as of today it has been nearly four years since my last dose; today I have a normal red blood cell count and thus do not, at this time, use ESA therapy.

I work as a sign maker, through the union, in the tradeshow and hospitality industry. I volunteer in various ways to promote the optimal health, quality of life and independence of people who use dialysis. I volunteer both with my provider, Northwest Kidney Centers, where I am immediate past trustee board chair and continue to serve in many ways, locally with the Kidney Research Institute, on the KRI Council, and nationally on the oversight committee of a federally sponsored comparative effectiveness research project, with DOPPS, on their steering committee and I volunteered to serve on the recent C-TEP looking for fluid management CPMs last year. Through my blog, Dialysis from the Sharp End of the Needle and participation in the CKD online community I've made many connections with people involved with the provision of dialysis, on both ends of the needle, and have had many discussions, over many years, about the details of Medicare reimbursement policy for those with severe kidney disease. The reimbursement details of CMS's ESRD program is my hobby; one I take seriously.

The dialysis community is still digesting the changes that have come with the bundle. The data I have seen through DOPPS and the reports I have heard through email and online communities, is that ESA use has declined since the final rule was announced a year ago. And that this has resulted in generally lower hemoglobins, which the effected dialyzors report, limits their energy and thus diminishes their quality of life.

Given this developing trend it is a particularly risky time to make the changes proposed in CMS-1577-P. Specifically, the proposal to eliminate the performance measure (CPM) "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)" will magnify this trend to the detriment of your beneficiary's quality of life.

A close reading of the FDA label change suggests that a Hgb=10 is a valid treatment threshold (link: http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm ):

    For patients with CKD on dialysis:Initiate ESA treatment when the hemoglobin level is less than 10 g/dL.If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA.

This guidance suggests that a threshold of 10 g/dL is appropriate and complies with MIPPA's language that “measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management”.

I propose that CMS continue the QIP's support of the FDA label's treatment threshold of Hgb=10 for payment year 2013 and 2014.

However, to improve the QIP and allow for care that is tailored for each beneficiary the QIP should move away from both the Hgb=10 and the Hgb=12 CPMs, to an anemia CPM that reinforces best practices and gives your beneficiaries a voice in their anemia management. 

I propose that CMS institute a new QIP CPM:  "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target hemoglobin for that beneficiary" (%+/-Hgb Target).

In this year's final QIP final rule, CMS should propose using 2012 outcomes of a %+/-Hgb Target CPM as a benchmark to implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgment into practice. The NQF did not evaluate anemia CPMs based on the MCP physician prescription but I believe the Secretary has the discretion to take this approach under the exception clause of MIPPA Sec 153(c)(2)(A)(i).

I like this approach because the beneficiary can be included in the discussion as to where to set their personal Hgb target allowing the MCP physician to take their patient's view on the trade offs between a Hgb=11 vs a Hgb=9 into consideration when setting an individualized goal. Basing the goal on the MCP physician's judgment allows individualization in the framework of existing rules. Requiring MCP physicians to set and monitor the target should not be a burden since it is very nearly what is required today. This could be implemented by 2012.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement to note ESA Route of Administration. Starting this January providers will be required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012. Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it would be a simple math equation to determine the unit's performance.

This approach to the anemia question would help to reinforce the role of the MCP physician as the medical professional in charge of the individual treatment details of each of your beneficiaries who use dialysis. The dialysis unit is being paid to implement a care plan that they jointly develop with the patient and the doctor, the proposed CPM would reinforce these separate roles.

Taking this approach forward the MCP physician's prescription could form the benchmark for other CPMs from the dialysis unit to the hospital. Meaningful CPMs related to bone health and Kt/v are very difficult to develop if they are meant to apply to every person using dialysis. I think a better approach would be CPMs based on the MCP physician's prescription for each beneficiary. The beneficiary's personal calcium, PTH, Kt/v and phosphorus targets would make useful CPMs. By showing confidence in the judgment of the doctors you employ to manage our care the QIP can implement CPMs that have much more meaning to the lives of your beneficiaries.

Sincerely,
Bill Peckham
Seattle WA

[paris]

Thanks Meinuk.   I knew you would have the correct info.  And thanks to Bill also.  You are both such great advocates for all of us.  Bill fights for our rights and we appreciate all his work.   

Thanks for giving us the correct information         

[boswife]

had a stool check and no blood loss that can be found.  Did some scans and have found nothing.  Hoping that it was from a long time of them thinking (each thought the had perscribed iron) that he was getting iron.  getting pumped up now,,, sooooooo, how long should it take if he just needed iron/epo..

[Meinuk]

Boswife, EPO does not work without Iron.  They need to both be in line for your HGB to go up.  If someone gets EPO and there is no Iron in their system for it to work with, then all EPO will do is wipe out their iron stores and they'll feel terrible.

It all depends on how depleted he was.  Talk to your Dr. bluntly about it.  Ask what to expect.  Review labs for six months ago and a year ago, and look to see how gradual the decline was.  This isn't a magic elixir that works overnight, but you should be seeing some progress. It all depends on the body's ability to adapt.

[CebuShan]

Personally, I think we have. Obamacare to thank for the change. The quicker they can get rid of the "undesirables" the better. We will simply be chalked up to statistics.

[boswife]

hi MEinuk,,, ya know, im pretty sure what happened is that we had  been on home hemo for 8 months when, all of a sudden, (and this was before the drop) i was asked how much iron he was getting and did i need more.  I answered with,  "IRON"?    Not getting at all.  You should have seen the looks flashing when i said that and no one wanted to take the blame and at the time, i didnt feel anything much about it as his hemoglob was still up.  Well, they got him on iron, and wam,,,, hemoglobin droped.  Now, hes getting 2 vials every other week, and his epo up to 9000 once a week.  They are going to give an extra test now to see if he's making it or whats up next.  He feels soooo awful and it's been 2 1/2 weeks now and barly comming up.  but at least it is.  I just couldnt believe that dr woud say.....  "oh, that wouldnt make him feel bad"  WHAT???  are we from another planet?   

[sullidog]

My center cut my epo off when it was at 13. It seems though is that from this thread that people are feeling differently at different ranges.

[Meinuk]

Yes Boswife, they wiped out his iron stores, no wonder he was feeling terrible.  It happened to me you know, and I worked on the EPO study in 1987.  I was at the MGH, and we were amazed at how well it was doing in human studies.  We even had a patient fly it in from Japan.  But we always knew about needing iron to bind with.

Cut to 20 years later, I was on dialysis. I had been on EPO and iron, and when I started dialysis, we stopped all meds.  Then they started giving me epo in my lines.  Three weeks later, my hair started falling out. I had totally forgotten about the iron, and when my hair started failing out, I yelled at them to take a ferritin level. Of course I had no iron stores.  I was more embarrassed that it happened to me, and I knew better.

I figured that if I could fall victim to factory dialysis, anyone could.  I am glad that you have a handle on what happened. I really hope that he starts feeling better soon.

  At one point, I actually sat down and read the minutes from the congressional testimony in the mid 2000's about epo dosing. I am sure that I have posts about it here somewhere.  The upshot is, it isn't Obamacare.  The system was broken long before he took office.  I don't want to turn this into a political thread, because I don't really care about politics.  People will be working the system from both sides as long as we are alive.  To me, the important thing is to be alive, and to try and do well no matter what governance we have in place. 

I don't care about our politicians.  I care about finding a way to make US feel better.  My life does not have a long run, and I don't care about future generations, they can take care of themselves.  If I can post about EPO, and make sure that people understand why things are happening, then they will be better prepared to advocate for themselves on a level playing field. If your clinic says that they won't dose you if your Hgb is 10, tell them that they need to practice medicine and not business.  if you are not a Medicare beneficiary, then it does not matter, your lab values don't count in the Medicare Pay for Performance Schedule.  If you are on Medicare, tell them that it is the AVERAGE that the payment scheme is based on and one person should not change their payment averages.  Let your provider know that you know when they are being cheap.

Providers are being handed an excuse to save money.  Do not let them save money at the cost of your (or someone you love's) health. Remember though that too much epo can be worse than too little.  The warnings are there for a reason, and those studies are not financially motivated - people have had strokes and died from ESA abuse.  Ask your medical team if they would treat their family this way.  Do not accept feeling crappy as a by-product of dialysis.  Not everyone feels that way, and you should be able to do everything within your power to get the best treatment that you can.

If your provider does something stupid, remember that you have to work with them, but make your point, just like BosWife did.  You have rights. 

Ok, I am off my soapbox now.

[Meinuk]

Boswife, two weeks isn't a long time as far as his body is concerned.  The important thing is that he have the right therapy (combination) to make him feel better.  Have you considered seeing an outside hemotologist?  When I was pre-dialysis, I saw a hemotologist/oncologist to deal with my baseline anemia. When I went back to him after I was on dialysis, my labs had stabilized, and I was ok once we managed my iron/epo. (post transplant, that is a whole other bag of worms.)

I know that the dialysis center is running tests to see if he is bleeding anywhere else in his body, but the nature of dialysis is that it destroys platelets (especially at high pump speeds). This is why anemia is so common.  (along with diet and co-morbidities)

If he is not showing sign of improvement in the next week or so, I would seek a second opinion.  And don't take "He's in Kidney Failure" as an answer - that is just being lazy.  You want to know WHY his health is faltering.  Either you can do something about it or why you can't.  Kidney failure is a symptom - not the disease.

[Meinuk]

In all of this, I started looking for educational handouts on anemia.  Here is one from DPC attached.  It is pretty good.  I have to say, as angry as DPC makes me with their lobbying for DaVita's profits, they have produced some good materials for our education.

The text from the handout:

What You Need to Know about Anemia and Kidney Disease

Anemia and Kidney Disease
Anemia can make you feel weak, tired, and short of breath.  You may also have headaches and trouble sleeping.  You may also experience a loss of appetite and a more rapid heart rate.

Anemia (uh-NEE-me-eh) comes from the Greek work that means “without blood”.  Anemia is common in people with chronic kidney disease (CKD) 

When kidneys are healthy, they make a hormone called erythropoietin, or EPO.  This hormone helps the bone marrow to produce the amount of red blood cells (RBC) that the body needs to carry oxygen to vital organs. When the kidneys are damaged, they often do not make enough EPO.  As a result, the bone marrow makes too few red blood cells.

Anemia often develops in the early stages of kidney disease and gets worse as kidney disease progresses.

Hemoglobin
Hemoglobin (Hgb) is the protein in red blood cells that carries oxygen from the lungs to the cells of the body. 
The test for Hgb is usually part of a blood test called a Complete Blood Count or CBC.  Hgb volume in the blood is measured in grams (gm) per deciliter (dL).  Ranges for healthy individuals who do not have CKD can vary by age and gender, for an adult male the range is 14-18 gm/dL, an adult woman 12-16 gm/dL. 

The Food and Drug Administration has recommended that a person with chronic kidney disease who has a low Hgb, most likely has anemia caused by decreased EPO production. Hgb levels can also be affected by the amount of iron in the body. 

Treating Anemia
For individuals with CKD it is important to treat anemia because there are many risks to having low hemoglobin levels.  Treating anemia can also ease many of the common symptoms so that you feel better.  The most common treatment for anemia in people with CKD is Erythropoiesis Stimulating Agents (ESAs).  These are often prescribed for patients with CKD if your anemia is caused by not having enough EPO in the body.  ESAs are usually injected under the skin or given intravenously during hemodialysis.

These medications work by stimulating bone marrow to product RBC’s, but some studies have indicated there may also increased risks for heart attack or failure, blood clots, and strokes.

Studies have also shown that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products.  This is why the Food and Drug Administration recommends that ESAs only be used to achieve Hgb levels between 10g/dl and 12g/dl. People who are receiving treatment with ESAs should have regular lab testing done to help you and your doctor make informed decisions  about the appropriate hemoglobin range for you and lower the risks of using these drugs.  You should keep track of and tell your doctor how you feel at different hemoglobin levels.  If you have concerns about your anemia and ESAs, you should make a list of these concerns and questions and discuss them with your doctor.

Iron
For many people with kidney disease, iron supplements have an important role in improving your anemia. If a person’s iron levels are too low, ESAs may not help and you may continue to experience the effects of anemia. A lab test for the ferritin level will measure how much iron is stored in the body. The ferritin score should be no less than 100 or more than 800 micrograms per liter (mcg/L).  Another test called TSAT, or transferrin saturation, shows how much iron is available to make red blood cells. The TSAT score should be between 20 and 50 percent.  Some people can take an iron pill, but people with kidney failure may need to get iron through an injection or their hemodialysis tubing.

Other causes of anemia in kidney disease
It is important to know that other factors can also be causing your anemia.  There are tests that your doctor should run to determine what is causing your anemia.

For some people, supplements of vitamin B12 and folic acid may be needed.  Other causes such as inflammatory conditions or sickle cell will need to be investigated if anemia is not caused by lack of EPO, low iron, B12 or folic acid levels.   

What can I do to improve my anemia?
Eating a healthy diet can help treat and even prevent anemia. Your body absorbs iron best from meats such as beef and fish. Eating certain vegetables can help you get even more iron out of these foods. Foods high in vitamin C can help your body absorb iron better.

Some foods including coffee, tea, egg whites, and milk block the absorption of iron. Foods high in fiber and proteins made from soy can also affect how well we can absorb iron.  Try to avoid these when eating foods rich in iron.

Be your own advocate
People who have both anemia and kidney disease are at higher risk for stroke, heart failure, and even death. Diabetes raises the risk of this risk even higher.  While your kidney care team is responsible for providing you with the care you need, it is up to you to follow through with treatments, take medicines as they are ordered and eat a balanced diet.  You are the only one who knows how you feel and what questions you have.  Ask questions, share any concerns you may have and make sure that you understand all of the care you are receiving.  Know what your lab results mean and how often you should have them, what foods you should eat, understand all of your medicines including side effects, and ask questions about anything that doesn’t seem right. 

[MooseMom]

Thanks so much for that, Meinuk.  You are so right...we have to advocate for ourselves.  And we have to try to work with our carers as a team, not as adversaries.

Thank you for all of the information you have provided us over the years.  I've learned so much from you, as have all of us, and I am grateful.