The Davita Difference: the King of EPO has no Clothes

By Peter Laird, MD

Davita made headline news in the Denver CO area recently over their business practices to include the use of higher than average EPO dosages that made their company millions of dollars. When I first started hemodialysis, even though I had a Hb level over 12, I was automatically started on EPO for a few weeks. I declined any further EPO after reviewing the medical literature on the risks and benefits of ESA use. This was back in 2007 prior to the release of the several studies which do show significant risks associated with ESA use including increased risk of MI, stroke, graft thrombosis not to speak of the increased cancer risks especially in patients with prior cancers who are now also on hemodialysis. Interestingly, my decision to stop EPO was not met with enthusiasm from my medical team. I was fortunate that within only a matter of weeks after stopping EPO, reports of adverse effects of this "wonder" drug stopped those criticisms of my decision short.

It turns out that my choice was prophetic. Nevertheless, despite several recent studies, the issues of increased cardiovascular events had already been duly noted even in the PDR prior to 2007 when the first of several reports arrived on the scene. In addition, I have survived cancer on two occasions fortunately by virtue of early detection at stages where surgery was completely curative, but for this reason, I have taken steps and precautions to avoid any further risks for cancer. My biggest reason for stopping EPO after about one month of therapy was the many articles showing worsening outcomes in the cancer patient population, a now confirmed link directly to EPO.

Davita stands today defending their documented practices of elevated dosages of EPO which earned their company millions of dollars under the old Medicare reimbursement practices for dialysis patients in the category called seperately billable items. At the height of their earnings Amgen's budget in the ESRD program accounted for nearly 40% of the total cost of the entire ESRD program and this fact alone led to the recently implemented Medicare Dialysis Bundle.  Davita of all the companies evaluated does stand alone in the amount of EPO prescribed to its patients despite the known dangers of these drugs prior to 2007. However, Dr Allen Nissenson calls Davita's response to their documented EPO over usage transparent, but in my opinion, that is only if you consider that Davita has no clothes.

The king of EPO in my opinion, stands before us today naked with their greed based prescribing habits fully exposed. Many leaders of industry in similar circumstances caught with dirty hands turn to complete admission of errors and come clean before the public scrutiny that they cannot escape anyway. Davita on the other hand chooses to deflect and attribute their practices to excuses of different times and changing protocols for anemia management:

Guest Commentary: DaVita CMO: We've been transparent

This is not a criticism of the team of reporters who worked hard on a complex, arcane subject that is a narrow part of the clinical care we provide. Your article suggested that we "continue to battle" controversies related to anemia management. In reality, those battles died a natural death in the media long ago.

I am the chief medical officer at DaVita, and prior to that was professor of medicine, director of the dialysis program and associate dean at the David Geffen School of Medicine at UCLA. Because the story could inappropriately alarm thousands of dialysis patients, and call into question the integrity of physicians across the country, we wanted to submit a few additional facts:

• Physicians make prescription decisions. Our affiliated physicians did what they felt was best for each patient every day. Every week. Period.

I would hope that all of the "loyal" Davita nephrologists realize that their CMO just sold them out and declares essentially that the dosages of EPO were simply as prescribed by the individual physicians involved and were not the result of corporate policies. Anyone who has followed the corporate policies of Davita against dissenting physicians who have left Davita understands the aggressive nature of this company against it's own who have left. Davita also continues the barbaric practice of re-use of artificial kidneys for purely monetary savings, any alleged benefits of re-use pales in comparison to the truth of it's dangers.

One of my favorite techs from my in-center days also worked at another privately owned dialysis clinic until shortly after they changed over to Davita leadership. Within a short period of time, the now Davita clinic reduced staffing levels to such dangerously low coverage that this tech quit her Davita job after in her opinion,  being unable to care for her patients in a safe manner. Further, according to the tech, the patients in this unit often suffered at the hands of their prescriptions of dialysis with short dialysis times and high ultrafiltration rates leaving them nauseous, passing out and feeling completely drained. On Monday, Wednesday and Friday in the shared unit that I was in, this same tech observed those symptoms in a well dialyzed population with 4 hours average dialysis times only on rare occasions. The business practices between the Davita unit and the well run unit in her words were night and day.  She no longer ethically could tolerate the Davita "difference" in that specific dialysis unit. She had called me in a bit of distress over the entire situation and left that employment at great financial cost to her family. The ProPublica series divulged dozens of stories equal to that and worse where staffing levels may have contributed to adverse outcomes, a shared trait especially among the for-profit dialysis chains.

I would urge Davita to own up to its aggressive prescribing habits and admit their mistakes instead of trying to offer platitudes of changing times and practices as their excuse in an attempt at transparency. The truth is that their practices netted them millions of dollars for their corporation in the separately billable portion of the old medicare payment system for dialysis but the real story I would like to know is how many thousands of patients might have suffered by these corporate practices at Davita. I would hope that the the Denver Post investigation does not end  only in a series of investigational reports, it is time that the authorities question these practices as well. All just my own opinion on these investigational reports and Davita's responses to date.

 

Comments

[Jtopf]

this tech quite her Davita job

typo: quite should be quit

[Peter Laird, MD]

Thank you Joel, skipping the spell check is hazardous to a blog.

[Denise Eilers]

NOOOOO !!! Physicians should only "write" the prescriptions. The "decision" to use a medication should be a shared one between the the physician and a fully informed patient.

[Rich Berkowitz]

The King of EPO has no Clothes is an appropriate title. Although I never dialyzed at a DaVita center, I have dialyzed with other LDO's and found the treatment lacking in many ways. I was personally offended when reading the Denser Post articles and also the DaVita 10K for the 2011 1st Quarter.

I could not believe the audacity displayed of saying it was the docs who over-prescribed Epo, and all of a sudden just before the implementation of Bundling they changed prescriptions seeminly overnight to reduce the dosage. We're talking thousands of patients. How convenient!

Hopefully, the government will investigate further and sting DaVita and recoup the millions of dollars DaVita took in quite fraudulently from Medicare. Of course, DaVita's plethora of attorneys will argue it wasn't fraud since it was the nephrologists that ordered the drug, but a look at how DaVita controls the docs is in order too.

Obviously, we want as much money to be in the system for dialysis as possible, but not to overuse the system to the point cuts are made for legitimate care.

[roberta mikles]

It is all very interesting. Giving large doses of Epogen prior to bundling, then cutting back. That, alone, says it all. I have to laugh when I see that Davita professes any type of transparency (or other companies, for that matter). They refuse to state the truth, admit errors when they occur, display their own surveys for patients and continue to deny when they are in the wrong. I also have to shake my head on another topic. Having worked with many patients who have experienced intimidation, retaliation, etc in Davita units, then mentioning such to a physician at the corporate level, then having this person just be totally shocked at what I stated, I have to wonder if those at the top truly understand what patients experience. Nothing will change in the units until there is a culture change. Patients need to be included in the team and fully educated as to what staff will be doing, including what the doctor orders, e.g. medications, staff need to be educated to respect patients.. there is a double standard, our organization believes, that follow the rule that if a patient does something that a staff does not like, they are labeled disruptive, etc and many times given warning that they will be discharged, regardless of regulations, however, if a staff intimidates a patient, it can go on forever.
Roberta Mikles
Advocates 4 Quality Safe Patient Care
www.qualitysafepatientcare.com

[Suzette Fish]

My husband will be starting Peritoneal Dialysis within the next 10 days. In reference to the training we will be getting we were told that I would be taught to give my husband his EPO shots once a week. My husband currently gets an EPO shot about once every 3-4 weeks when his Hg is about 10. How severe does ones anemia get on PD, are weekly EPO shots routinely ordered for all PD patients? In view of the FDA recent warning about the danger of EPO shots should one just refuse them if Hg is above a certain level?

[Peter Laird, MD]

Anemia management is dependent on many factors. Most PD patients have a fair amount of residual urinary function and are often switched to Hemodialysis when that function declines over time. PKD patients often have a high degree of residual EPO production and have less problems with anemia. Other factors to consider are history of cancers since they might recur or worsen in the face of EPO supplementation.

The precise recommendations for EPO are in many ways in a state of flux at present because of the recent studies showing adverse outcomes at higher dosages. For myself, I keep my iron levels above the minimum thresholds and I do not at present need any EPO to maintain my Hb over 11.0. In addition, I have needed only one iron infusion in the last 2.5 years as well. This may not be the case in the future, but if you can manage anemia without EPO at acceptable levels, who would argue with that outcome?

A remote article prior to EPO suggested exercise as one modality to modestly increase Hb levels. Recently, some studies have shown that Vit D3 supplementation will raise Hb levels by one point as well, but caution is needed to keep PO4 levels under control if you plan to take Vit D3.

These are issues you may wish to discuss with your medical team to see what may help in your own case. The bottom line in my opinion is that if you can avoid EPO, do avoid it. If you need to use it, keep it at the lowest possible dose. Once again, these are issues to discuss with you medical team to see what applies to your specific situation.