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Federal Grand Jury Probes Major Dialysis Provider

DaVita, the country’s second-largest dialysis provider, announced in a financial filing that a U.S. Attorney’s Office investigation into the company’s business practices is “preliminary.”

The U.S. Attorney’s Office in Colorado has opened a grand jury investigation into the practices of DaVita Inc., the country’s second-largest dialysis chain.

As we’ve reported previously, Colorado-based DaVita operates more than 1,600 dialysis clinics nationwide and controls roughly one-third of the market for care relied on by about 400,000 Americans with kidney failure.

The company disclosed the investigation Wednesday in a filing with the Securities and Exchange Commission, describing it as “preliminary.”

It’s not yet clear exactly where the government’s attention is focused. The company said the probe appears to overlap with another Justice Department investigation into possible overuse of Epogen, a drug used to treat anemia, as well as the chain’s relationships with doctors.

Jeff Dorschner, the spokesman for the Colorado U.S. Attorney’s Office, declined to comment on the case.

In an earnings call with financial analysts on Wednesday, DaVita Chief Executive Kent Thiry said the company would cooperate with government investigators.

“We are eager to educate them,” he said. (The company also provided ProPublica with a longer statement.) “We are comfortable and confident with our business practices.”

The company appears to be facing scrutiny on multiple fronts.

A whistleblower lawsuit filed in 2007 and recently unsealed by a federal court in Atlanta alleges that DaVita systematically wasted certain medications to collect hundreds of millions of dollars in additional Medicare payments. The company has denied the allegations.

Last year, ProPublica published an investigation on U.S. dialysis care, finding that patients often received treatment in environments that were unsafe or unsanitary, though these problems were not specific to any particular provider.

Our analysis of government inspections turned up hundreds of instances in which facilities were cited for breaches in infection control, as well as egregious cases in which lapses in care may have led to patient injuries or deaths.


The full text of DaVita's statement to ProPublica is below:

DaVita learned from the US Attorney's Office for the District of Colorado that it opened a grand jury investigation that covers certain activities of the company. The investigation is at a very preliminary stage. While its precise scope is unclear, it appears to overlap, at least in part, with the OIG Dallas and the Eastern District of Missouri matters regarding physician relationships, which we have previously disclosed. We do thousands of transactions and work very hard to get every one right and are comfortable and confident with our business practices, which go through extensive internal and external review. Our strong record of compliance over the last eleven years is well-established in the healthcare industry. At this time, there is nothing more that we can say about this matter other than that the company intends to cooperate with the investigation.

roberta mikles dialysis patient advocate

Aug. 5, 2011, 7:52 a.m.

Why does this not surprise me. After reading Davita facility survey reports for over six years, and seeing the same type of deficiencies cited that affect day to day care, including some related to not following physician orders for Epogen administration, (from recall) or other related deficiencies in a few units, again, this not does surprise me. Perhaps, those at the top, e.g. Mr. Kent T, should ask himself “Is this the type of care that I would want to receive, or want a loved one to receive? If he read the surveys and if others in management read such and realized patients are not getting, in many Davita units, quality safe care. When facilities are cited for not following their own policies and procedures, as well as the Conditions, with some ‘not’ met, I ask, “Is this quality safe care?” I think not!

The California Davita surveys, through May 2011 from 2009, can be viewed at http://www.qualitysafepatientcare.com These surveys clearly show there is a problem. Aside from this horrendous situation with Epogen that Robin Fields has written about and the recent exposure of such, does the picture become more clear?

Davita needs to realize that the day to day care is important - and an easy fix
(1) Revisit your training/educational programs—Do these programs/inservices, etc clearly tell staff the rationale for why implementation of correct practices is necessary and why they MUST adhere to policies/procedures? Do staff understand the importance of such? The surveys show that staff either were unaware of the policies or just did not follow that which they knew. This is not okay. Dialysis Technicians can be reported to the oversight agency that certifies them if they implement an incorrect practice that results in harm to a patient, or death. Do they realize, as well as RNs, that their certification, and licensure, is at risk when they intentionally do not follow that which they have been taught?
(2) The unit-level supervision is suppose to be effective in ensuring that staff are following correct practices/policies, etc. However, when the RNs can not do a schedule that addresses delivery of care for HBV+ patients, or they can not implement correct infection control practices, then what is to be expected. Who is watching the units? Are things different when upper management is present? Probably. Therefore, Who is held responsible. When we see survey after survey and some revisit surveys with the same cited deficiencies, what can one expect. These surveys are not hidden and are public information. A good example to look at is the Davita Bakersfield survey—just one example. http://www.qualitysafepatientcare.com/resources/Davita bakerfield RV 0503112567.pdf This survey is the first revisit - the state returned as the recertification warranted such. Is this the care, you, Mr. KT would want to receive?

opinions of Roberta Mikles BA RN
Dialysis Patient Safety Advocate

Stan Nussbaum, MD

Aug. 5, 2011, 6:20 p.m.

Overuse of epogen, just another example of the corrupting effects of money. I’m not saying this is the case in DaVita facilities.
I have, however, seen it regularly during my many years of practice in other venues.
Sad, but ultra expensive drugs unfortunately lead to way too many dollars flowing in a totally conflicted way!
And who suffers??  Our patients and those paying inflated insurance premiums.
Very sad!

roberta mikles dialysis patient advocate

Aug. 6, 2011, 7:26 a.m.

Several years ago, much was brought out into the open during a congressional hearing, to recall. If I remember, at the time, almost 1/4 of the providers revenue came from Epogen reimbursement. One problem as I see it is the lack of communication between the nephrologist (incenter) and the patient’s cardiologist. Many cardiologists have set limits on their patient’s hemoglobin, perhaps in the lower range. But, without such interactive communication to share this—- the provider administers the highest amount to maintain a level closest to 12. In my own situation, with my father, often I had to remind the staff that my loved one’s hemgolobin was either 12 or over and we wanted the Epogen lowered. (even though it was a rather small dose administered). At one point it became a major issue .... However, it is imperative for physicians to have open communication.

Perhaps, looking at the Davita data on CMS’ Dialysis Facility Compare to see how many facilities had numbers that were over the national and/or state average for hemoglobins over 12 would be interesting. With the new QIP and not looking at hemoglobins under 10, this is going to present an even greater problem for this vulnerable population. Why? With the new bundling, can we expect to see a change in the manner of which epogen is administered? The lower hemoglobins might require hospitalizations as a result of symptoms - shortness of breath, fatigue, etc… sending a dialysis patient to the hospital only exposes them, even more, to a preventable infection and other problems, maybe. We know that sub-q injections require less dosing then IV, but we don’t see subq given. Many providers, as well as advocacy groups, to recall, never addresses the fact that patients incenter could receive sub-q. Ofcourse, patients were, for the most part, not given that opportunity and/or educated. Surveys went out asking would you rather have an injection that stings, or would you want it IV when you feel nothing. I remember giving Epogen to my parents and if I rolled the bottle, after taking it out of the refrigerator and kept it at room temp for a few minutes, as instructed by a pharmacist and physician, there was no stinging. So, patients have not, in this area, been accurately educated. I wonder if providers now are educating patients in this respect

But again, I harp on the fact that no one continues to address the day to day care. And, speaking of Davita, many of their units, in California have had signficant delivery of care problems as can be seen at my website http://www.qualitysafepatientcare.com  These surveys will be updated and there are more for 2011 to come.

opinions of
Roberta Mikles, BA RN, Director
Advocates4QualitySafePatientCare
http://www.qualitysafepatientcare.com
San Diego, CA
858-675-1026
.(JavaScript must be enabled to view this email address)

roberta mikles dialysis patient advocate

Aug. 6, 2011, 11:26 a.m.

Ms. Loren,

First, please accept my deepest condolences for the loss of your husband, I understand that which you are going through. Did you get a copy of his medical records/dialysis records. Certainly, his hemoglobin was elevated over the range that facilities are suppose to keep within. One time my father was admitted to the hospital for a cardiac related event, his hemoglobin was elevated, to recall

I am seeing more and more where there is an anemia management nurse in the unit that calculates the epogen doses etc. I know in our clinic, they changed the protocol and had some problems, then went back to a prior protocol, as we wee told.

Although there are very good units out there, there are those that do not pay close attention to the medications patients are on and the needed adjustments that are required. It is very sad that there are so many preventable errors in the dialysis facilities. I am not saying that your husband’s death was a result of a preventable error just that many facilities do not do that which they are suppose to as evidenced in survey reports (inspections).

Additionally, often, there is not enough communication between physicians that are treating the patient

Perhaps you need to file a complaint with the state and let them investigate the entire situation.

above opinions of
Roberta Mikles BA RN Dialysis Patient Safety Advocate
.(JavaScript must be enabled to view this email address)

This article is part of an ongoing investigation:
Dialysis

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Nearly 40 years after Congress created a unique entitlement for patients with kidney failure, U.S. death rates and per-patient costs are among the world's highest while the biggest for-profit providers flourish.

The Story So Far

Dialysis holds a special place in U.S. medicine. In the 1960’s, it was the nation’s signature example of rationing, an expensive miracle therapy available only to a lucky few. A decade later, when Congress created a special entitlement to pay for it, dialysis became the country’s most ambitious experiment in universal care.

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