HemoDoc, From Doctor to Patient

The DaVita Difference: The Transfusion King

By Peter Laird, MD

The major concern voiced about the renal bundle prior to implementation was withholding needed medications to maintain basic vital processes. The renal bundle is largely due to the abuse of EPO for the maintenance of hemoglobin levels in dialysis patients. Erythropoietin comes from health renal tissues that are absent in the majority of patients on hemodialysis with the exception of many with polycystic kidney disease. Under the renal bundle, EPO went from a separately billable income generator to a cost center for dialysis centers.

In the latest USRDS report noted by Gary Peterson on RenalWeb, blood transfusions increased throughout the industry, but the greatest increase is among patients at DaVita, a for-profit dialysis company.

"Since adoption of the bundled payment system, the number of transfusion events has increased, reaching 24 percent by September, 2011. Some providers are associated with a significant increase in transfusion rates over the one-year time period (the rate increased 46 percent in DaVita units), while others show minimal changes (4 and 7 percent in Fresenius and hospital-based units, respectively)."

Looking at further indicators of why DaVita has such an outrageous transfusion rate, one of the answers to that issue is not only in the 37% reduction of EPO use, but much more in their concomitant severe reduction of IV iron products by a factor of 42%.

Tracing the history of EPO abuse at DaVita leading to the moniker, the King of EPO, their gratuitous allegiance to profiteering, now evidenced by the 46% increased transfusion rate is nothing short of a shocking indictment of this company and their business plan. We all understood that the renal bundle would dramatically lower the usage of EPO, but the majority of practitioners expected an increased usage of IV iron products to maintain quality of life in dialysis patients.

Scott Rasgon at Kaiser Sunset maintained stable Hb levels with simple over the counter Vitamin D-3 supplementation while greatly reducing EPO usage. I have been fortunate to maintain my Hb levels with IV iron supplementation for nearly six years of dialysis to date. Patients understand well the quality of life issues associated with higher Hb levels. Sadly, there are absolutely no studies comparing the risk and benefits of EPO to the risk and benefits of transfusions.

Since transfusions are no longer allowed in many free standing dialysis units, hospitals and third party insurance companies pick up the tab on most of the transfusions that DaVita generated since implementing the bundle. This may make great business sense for DaVita generating further profits for their investors, but it makes no sense at all for the dialysis patients suffering with such severe anemia that they need such a large number of transfusions. As a practicing physician, I readily understood the risks of blood transfusions not the least of which is the risk of transmissible agents such as hepatitis and HIV. It was my goal to minimize the need for transfusions whenever possible.

Alan Nissenson has promoted the benefits of the DaVita model securing high quality of care as their model. In this instance, I must challenge their allegations of high quality care when they not only severely reduced EPO usage, but also withheld IV iron which is an effective and safe alternative and adjunctive therapy for renal associated anemia. I am sure that this has greatly increased DaVita profits, but at what expense to their patients.

Troubling Trends with Blood Transfusions in Renal Transplant Candidates

By Peter Laird, MD

Renal transplant is considered the gold standard renal replacement treatment for American ESRD patients. The longest living survivors of renal transplant such as Nancy Spaeth and Dr. Robin Eady defy the odds stacked against any person in with severe renal failure. The median survival once on dialysis is only 36-38 months depending on whether patients choose conventional in-center hemodialysis or peritoneal dialysis. (here) For those such as Nancy Spaeth and Dr. Eady, their survival since the original days of Dr. Scribner's Seattle program through today came about by a combination of hemodialysis, PD and renal transplantation. For long term survivors, multiple modalities and often successive transplants is common.

Renal transplantation is complicated in patients with high levels of antibodies most often accumulated from multiple blood transfusions. The USRDS notes troubling trends in blood transfusions even in candidates for renal transplant where the transfusions can delay the hoped for transplant. 

Blood transfusions in kidney transplant candidates are common and associated with adverse outcomes

Surprisingly, there are no data regarding transfusion frequency, factors associated with transfusion administration in patients on the kidney transplant waiting list, or transfusion impact on graft and recipient outcomes. We used United States Renal Data System data to identify 43,025 patients added to the waiting list in 1999-2004 and followed through 2006 to assess the relative risk of post-listing transfusions. In 69,991 patients who underwent transplants during the same time period, we assessed the association between pre-transplant transfusions and level of panel-reactive antibody (PRA) at the time of transplant, and associations between PRA and patient outcomes. The three-yr cumulative incidence of transfusions was 26% for patients added to the waiting list in 1999, rising to 30% in 2004. Post-listing transfusions were associated with a 28% decreased likelihood of undergoing transplant, and a more than fourfold increased risk of death. There was a graded association between percent PRA at the time of transplant and adjusted risk of death-censored graft failure, death with function, and the combined event of graft failure and death. These data demonstrate that transfusions remain common and confirm the adverse association between transfusions and PRA, and high PRA and inferior graft and patient outcomes.

Delays while on the renal transplant list can be deadly, especially for those on conventional in-center hemodialysis or PD and not on daily home hemodialysis or nocturnal home hemodialysis which offers survival rivalling cadaveric transplant. (here and here) The issues of blood transfusions in dialysis patients is likely to become more prominent now that Hb parameters of dialysis patients has no minimum level. While the debate over the level of Hb needed for optimal quality of life remains unsettled except of course by patients themselves who know how they feel at each level, those with lower levels subject themselves to increased risks of transfusion under emergency blood loss. Dialysis patients have a high risk of bleeding from the stomach and intestines. The troubling trends that USRDS documents will continue.

Patients as in most matters medical must become their own best advocates. Dr. Scribner believed that dialysis patients should know more about their disease than their doctors.  The risks and benefits of EPO are well documented. Cardiovascular events and increased risk of cancer top the list. However, for someone contemplating renal transplant, the added burden of blood transfusions pushes the risk benefit analysis back into the direction of continued EPO use for those that need this support. I would hope that nephrologist would take these issues into consideration not only for those that have expressed interest in renal transplant, but also for those that may be a candidate in the future.

The Brave New World of the Renal Bundle

By Peter Laird, MD

We are now a year into the social experiment we call the renal bundle where payments for all dialysis services are bundled into a single payment with disease modifiers and QIP matrices for quality care tied to the final payment. There is no doubt that the abuses of EPO and other separately billable items under the old payment system suffered from an extreme profit motive pushing EPO dosages higher and higher with no clinical benefit and indeed, many would rightly argue, great clinical harm to those at the high dosage end with elevated Hb levels over 12.0. 

CMS.gov: ESRD Payment

Medicare payment to ESRD facilities for outpatient maintenance dialysis services furnished to Medicare beneficiaries with End-Stage Renal Disease (ESRD) is based on a prospective payment system known as the basic case-mix adjusted composite payment system.  The base composite rate covers the costs of the dialysis treatment and certain routine drugs, laboratory tests, and supplies furnished at home or in a facility.  Other items and services, particularly injectable drugs (for example, erythropoietin (EPO), iron sucrose, vitamin D), and non-routine laboratory tests are not included in the composite rate and are billed separately to Medicare.  Separately billable services represent about 40 percent of total Medicare payments per dialysis treatment.  The base composite rate is adjusted by a drug add-on payment to account for changes in the drug pricing methodology that occurred in 2005 and by case-mix factors, that is, age, body size, and a special adjustment for pediatric patients.

Since the implementation of the prospective payment system, several reports are sending a mixed message of this "brave new world" we now know as the bundle. EPO utilization is dropping dramatically as are patients average Hb levels. The biggest news of the renal bundle in 2011 was the decision by CMS to drop the lower Hb target level of 10.0 leaving the door open for providers to adopt the pre-EPO modality of iron supplementation and rescue transfusions. The literature is repleat with the dangers of patients having Hb levels lower than 10.0. PTH levels are rising and uncontrolled secondary hypoparathyroid disease will result in a net increase in the need for parathyroidectomies to control this new epidemic. DOPPS has published an interim report on the effects of the bundle and continue to monitor it effects.

DOPPS reports early trends in dialysis care after the implementation of the ESRD bundle

Anemia management

Trends in all patients: From Aug. 2010 to April 2011, average hemoglobin levels fell slightly (0.10 g/dL). The percentage of patients with hemoglobin >12 g/dL declined from 31.4% to 28.0%. The percentage with hemoglobin <10 g/dL rose from 8.5% to 10.0%, and the percentage with hemoglobin <9 g/dL was stable at ~2.7%. The average prescribed epoetin dose fell by ~3% and the average administered dose fell by 6%-7%, with a notable drop in the higher epoetin dose range. The percentage of patients prescribed injectable iron per month rose from 57% to 78%.

Mineral and bone disorder management 

Trends in all patients: Overall, the average PTH level rose sharply from 337 to 435 pg/mL from August 2010 to April 2011, an increase of 29%. No substantial changes were seen in serum phosphorus or calcium values. The reasons for the rise in PTH are being investigated; large changes in use of injectable vitamin D or oral medications are not yet apparent.

The safety net of the bundle is an ongoing and developing quality indicator payment reduction system for failing to reach the minimum quality standards. Many are now decrying the fact that just measuring the indicators is enough to qualify for payment without actually addressing some of the measured indicators. 

What to Expect from the ESRD Quality Incentive Program

By Steven Fishbane, MD

The Centers for Medicare & Medicaid Services (CMS) published the final rule for the End-Stage Renal Disease Prospective Payment System and Quality Incentive Program (QIP) on Nov. 1. This follows the proposed rule that had been published in the Federal Register on July 8, 2011.

In this article, the focus will be on the ESRD QIP. There were 88 public comments received on the QIP, and the final QIP rule reflects important changes relative to the proposed rule. The greatest changes in the QIP will be for payment year 2014. It is critically important for providers to understand the 2014 QIP because, 1) it contains major changes from previous years and 2) the performance period begins very soon: Jan. 1, 2012. This posting is a summary of the major components of the final QIP rule, with changes from the proposed rule highlighted in italics.

Despite the alleged oversight through the QIP, a distressing essay written by a leading dietitian and posted by Gary Peterson in RenalWeb today depicts the desperate plight that the ESRD bundle is having on the dietitian profession who are admittedly one of the most important clinical partners in preventing complications of dialysis care. It is not only a call to arms for dietitians, but for all concerned about the care of dialysis patients in America. It is most importantly, a call to arms so to speak for all dialysis patients here in this nation as we see many of the improvements of the last three decades in pharmaceutical care slip through the bottomless pit of the ESRD bundle with QIP indices for Hb for instance with no minimum safety zone. Instead, for Hb, the patient is now at the mercy of their provider to consider what is their "healthiest" Hb levels without any guideline to say when low is too low.

Call to Arms

MY FELLOW RENAL dietitian, if ever there was a time to stand up, make noise, and be heard, it is now. We as renal healthcare professionals can no longer sit by in the wings as Medicare and dialysis units make policies that negatively impact our patients’ lives and outcomes. I am outraged by the changes that I have seen in the past year. I am disappointed that policies are made and implemented without thinking about how they will affect those that we serve. I am disheartened that one day, I, a family member, or a friend will have to submit to the suboptimal care that these policies have created. We, as a profession, knew that there would be changes in how we treat our patients when the bundled reimbursement plan came into effect last year. I could never imagine the turn that it would take. . .

Finally, this summer, Medicare released its proposed QIP measures for 2013, which addresses bone mineral management. With the inclusion of phosphate binders into the bundled rate beginning in 2014, Medicare is proposing that units attest whether or not they are following disease markers. There is no proposal at this time on whether the unit is treating the disease. There is no mention of disease marker goal ranges, either minimums or maximums. There is no mention of accountability that medications to treat the disease are being used. I concede that we do not yet know the “ideal” ranges for calcium, phosphorus, and parathyroid hormone, but there is enough evidence to determine levels that we should not exceed without increasing morbidity and mortality in our patients.

Yes, we are entering a brave new world we call the ESRD bundle and to date, the data is not comforting. Prior to the final ESRD bundle rule, CMS had many open meetings and vast input from patients, physicians, health care providers and dialysis patient groups. The QIP was the safety net proposed by CMS to address the concerns of all involved and as congress sat idly by aloof to the outcry by many to intervene for patient safety, instead we entered quietly into this brave new world. If the latest report by the renal dietitians is any indication of where we are heading, then this brave new world may in fact be nothing more than a return to the dark ages of dialysis prior to when advances in pharmaceuticals ended many patients suffering. There is a dark cloud hanging over this nation in our dialysis centers and the QIP blindly measures the faltering indices but has no power to evoke change. A call to arms is our only choice at this point in time. It is no longer a time for complacency among dialysis patients or allied health care professionals. 

EPO: Lighting the Fires of Cancer

By Peter Laird, MD

Erythropoietin (EPO) is a natural hormone that mediates the production of red blood cells (RBC's) that is primarily produced in the renal cortex and small amounts in the liver. Studies over the last decade evaluated the effects of  EPO in diverse populations at risk of anemia outside of the renal dialysis patients, especially in patients undergoing chemotherapy for a variety of cancers. Unfortunately, these studies revealed adverse survival with more rapidly progressive cancers and shortened survival. In addition, in the CKD population, patients were more likely to experience cardiovascular events and death bringing the CHOIR study to an early close as well.  The TREAT trial followed shortly with a higher risk of stroke for patients treated with EPO for CKD related anemia.

Many patients sustained with EPO for years on dialysis vocally protested the new FDA labelling changes and the removal of minimum Hb levels in the QIP. Despite the increased risk of cardiovascular outcomes with EPO and the suspected increased cancer risk for chemotherapy trials, the correction of anemia for many patients overcame the potential risks. However, a new study highlighed by Gary Peterson of RenalWEB sheds light on the role of EPO not only in promoting cancer, but it is actually involved in the development of cancers as well:

PDGF-BB modulates hematopoiesis and tumor angiogenesis by inducing erythropoietin production in stromal cells

At the molecular level, we show that the PDGF-BB–PDGFR-bβ signaling system activates the EPO promoter, acting in part through transcriptional regulation by the transcription factor Atf3, possibly through its association with two additional transcription factors, c-Jun and Sp1. Our findings suggest that PDGF-BB–induced EPO promotes tumor growth through two mechanisms: first, paracrine stimulation of tumor angiogenesis by direct induction of endothelial cell proliferation, migration, sprouting and tube formation, and second, endocrine stimulation of extramedullary hematopoiesis leading to increased oxygen perfusion and protection against tumor-associated anemia.

Blood protein EPO involved in origin and spread of cancer

Angiogenesis is the formation of new blood vessels from pre-existing ones, and is one of the most important research fields in the treatment of such diverse conditions as cancer, metastases, obesity, heart disease, stroke, diabetes and chronic inflammation. The process is also important in healthy individuals for wound healing, the menstrual cycle and other normal processes. Professor Yihai Cao and his team are researching into angiogenesis and its links to cancer and other diseases, and in the present study show the significant role played by a growth factor, PDGF-BB.

"It's a member of the PDGF family and significantly contributes to blood vessel development, which is one of the characteristic signs of cancer, says Professor Yihai Cao. Our preclinical findings suggest that PDGF-BB causes systemic effects in the body, which is to say that rather than being active locally it goes into the blood and interferes with the function of several organs so that the entire body is affected."

As a cancer survivor in addition to my IgA nephropathy and dialysis, I have been very leery of EPO right from the time I first started on dialysis in 2007. My first confrontation with my health care team at dialysis came about when I refused to continue EPO shortly after beginning dialysis. In retrospect of current guidelines, I never needed EPO with a Hb over 12.0 with only iron infusions alone. The issue of adverse cardiovascular outcomes and now this new basic science information that EPO is involved in cancer formation leaves dialysis patients with hard choices. EPO prevents the need for blood transfusions and their associated complications, but at what price?

The for-profit dialysis industry made billions of dollars pushing higher and higher dosages of EPO to their patients prior to the bundle. The cardinal duty of physicians is to first do no harm. As we evaluate each and every aspect of dialysis care in America, it keeps coming up short every time.  The irony is that we are spending billions of dollars for a genetically engineered medicine that is supposed to reduce pain, suffering and enhance our lives. Instead, the evidence is mounting on the dangers of EPO. The debate will continue especially since many dialysis patients fail to respond to iron supplementation alone. Blood transfusions for many are an unacceptable rescue method.  In an era of uncertainty, EPO may be too risky to justify it's continued use. Adding the risks of cardiovascular disease and cancer  together may render the issue of informed consent between doctor and patient on whether to use EPO instead in the hands of the FDA and further black box warnings.

 

The FInal CMS ESRD QIP Rule Weakens Anemia Goals

By Peter Laird, MD

CMS issued it's final rule of the 2012 ESRD Quality Incentive Program (QIP) with a controversial decision to eliminate the minimum hemoglobin (Hb)  standard in place for years. Anemia management with erythropoiesis stimulating agents (ESA) came under scrutiny  prior to implementing the Dialysis Bundle due to over-utilization of this medication which for two decades provided huge profits to its manufacturers and to nephrologists and dialysis centers that pushed patients to the maximum doses for pure financial gain. However, it appears that CMS may have swung the pendulum too far in making a needed correction.

CMS ANNOUNCES STRONGER INCENTIVES TO IMPROVE ESRD TREATMENT OUTCOMES

The final rule changes the QIP performance measures for PY 2013 by retiring the anemia management measure of hemoglobin level less than 10 grams per deciliter measure from the initial measure set.

This decision is consistent with new medical evidence regarding the safety of a common treatment for anemia in dialysis patients – administration of erythropoiesis-stimulating agents (ESAs).  In addition, this change is consistent with the recent labeling for ESAs approved by the U.S Food and Drug Administration (FDA).   For PY 2013, CMS will give equal weight to the two finalized measures: (1) an anemia management measure of hemoglobin levels greater than 12 grams per deciliter and (2) a hemodialysis adequacy measure as measured by a Urea Reduction Ratio (URR) of at least 65 percent. 

“CMS believes that new concerns about the safety of ESAs for dialysis patients strongly argue for providers to work more closely with their patients to develop anemia management strategies that respond the patient’s unique medical issues, rather than adopting a one-size fits all approach to care,” said Patrick Conway, M.D., CMS chief medical officer and director of the Agency’s Office of Clinical Standards & Quality.  “This patient-centered approach should result in better treatment outcomes. We plan to monitor hemoglobin levels by facility and to transparently share this information with consumers.”

Since EPO is such an expensive medication, many nephrologists and dialysis centers will likely eliminate ESA therapy for the majority of their patients and reserve its use only in those patients who are transplant candidates since blood transfusions cause difficulties with antibody development. The dialysis industry has a failed record when it comes to informed consent counseling. When faced with treatment options that have inherent risks, the physician's duty is to inform the patient of the risks, benefits and alternative treatments, assess that the patient has understood these risks and then offer the treatment that the patient and his family prefers. Many advocates of continued minimum standards for anemia management spoke out against eliminating the minimum Hb level:

AAKP Comment to CMS on the 2012 ESRD QIP Final Rule

To not have a minimal Quality Incentive Program (QIP) for anemia management is dangerous given the intensive struggle dialysis centers are going through to control costs. Not since the establishment of the composite rate in 1983 has there been such pressure on dialysis companies to meet the demands of providing accessible and efficient dialysis. The hard question is whether or not history will repeat itself. Will we enter another dark era of health delivery like that following the initiation of the composite rate?  

Given our current environment, it is necessary to minimize dosing of ESAs. Having no minimum standards for anemia management will drive down hemoglobin levels to the point patients will become weak and fatigued, require blood transfusions, have increased hospitalizations, and may request early retirement or disability. While the economic strain on dialysis providers should promote comparative effectiveness and the selection of a least costly alternative to care, minimal standards for all to abide by must remain in place as a safeguard to patients, and to assure that their quality of life is not interrupted.  

With a "black box" warning for all ESA prescriptions and the excessive costs of these medications, it is not hard to predict how many in the dialysis industry will respond to eliminating the minimum Hb levels. It is also easy to predict that we shall soon step back in time to the difficulties associated with frequent blood transfusions. Patients may suffer needlessly despite the example of Europe and Asia-Pacific nations which have long had lower utilization of EPO coupled with better outcomes than America. Swinging the pendulum too far is as much of a mistake as letting the dialysis industry use this medication to augment their profits for the last two decades. Perhaps someday, America will place patient outcomes and quality of life before their own financial outcomes, but I wont' hold my breath. 

How Often Should We Sample Hb Levels In Dialysis Patients?

By Peter Laird, MD

It is interesting to understand that many of our practices in medicine are not based on clinical evidence, but instead on financial factors.  However, with the advent of the bundled payment for renal dialysis services, the issue of lab tests which were previously separately billable, those related to routine dialysis evaluation are included in the bundle which shall put several tests at risk of reduced frequency.  An interesting study quite timely from Louisville, Kentucky looked at the question of what is the optimal sampling frequency for Hb measurements:

Determining Optimimum Hemoglobin Sampling for Anemia Managemet from Every-Treatment Data:

Results: The most accurate Hb estimation is achieved when monitoring 8× per month (Hb_err = 0.23 ± 0.05 g/dl), but it exceeds the accuracy of the measurement device. The estimation error increases to 0.34 ± 0.07 g/dl when monitoring 4× per month, 0.39 ± 0.08 g/dl when monitoring 2× a month, and 0.45 ± 0.09 g/dl when monitoring 1× per month. Estimation error comparable to instrument error information is as follows: 8× per month, 15 patients; 4× per month, 22 patients; 2× per month, 6 patients; 1× per a month, 6 patients.

Conclusions: Four times a month is the clinically optimal Hb monitoring frequency for anemia management.

The accuracy of Hb measurements and adjustment of Iron and EPO requirements is an important adjunct to dialysis therapy tied directly to mortality based on high or low values. I suspect many dialysis units will be tempted to monitor Hb no more than twice a month in otherwise stable patients with the pressure of standard labs included in only one monthly payment for all dialysis services. This is one laboratory of great clinical importance that in my opinion is at risk of the financial managers making decisions based on what is best for the dialysis company instead of what the clinical evidence from this one study suggests is best for the patient.   Follow up studies of the impact of the bundle are needed to see how the majority of units respond on Hb management as well as the many other clinical interventions subject to the values of monthly labs.