The prospective payment system for dialysis services has been in effect since January 1, 2011. Included in the payment starting in 2012 is a 2% withhold to create a pool of money to fund a Quality Incentive Program (QIP). If facilities meet identified quality metrics related to hemoglobin (percent of patients with hemoglobin <10 g/dL; percent of patients with hemoglobin >12g/dL) and adequacy (percent of patients with URR≥65%) they may earn back the 2% withhold. There is no reward for outstanding or superior performance—the best performers get back the payment they would have received prior to the QIP being developed. While structurally this approach has been shown repeatedly to be a poor driver of improved outcomes, it is the one we have currently and the renal community has actively engaged CMS in trying to make it as effective and transparent a program as possible.

The playing field shifted drastically in June, however, when the FDA announced a new label for erythropoietic stimulating agents (ESAs) after a long negotiating process with Amgen. The new label was designed to stress safety—the black box now says that one should not target a hemoglobin >11g/dL (formerly 12g/dL), for example. On the low hemoglobin end, however, many clinicians and patients were surprised by the removal of any lower limit of hemoglobin target. The combination of these two changes essentially altered the entire paradigm of anemia management, with the elimination of any target hemoglobin range, and the recommendation that individualization of therapy was key—decisions to be made by clinicians and patients on a case-by-case basis.

CMS has quickly followed the FDA lead by announcing preliminary rules for QIP going forward, eliminating the hemoglobin <10g/dL metric to conform to the new label.  Many in the renal community, including patient groups and advocates, as well as provider group are concerned that we must all keep our eye on the low hemoglobin ball. Even though we can debate what the safe/appropriate lower hemoglobin level is, it is clear that a return to the days of severe anemia seen prior to 1989 and the introduction of EPO would be undesirable. So the renal community is trying to convince CMS to at least collect data on and report outcomes for low hemoglobin, until such time as sufficient data is amassed to allow return of a low hemoglobin metric for payment in the QIP.

Physician groups have been staunch supporters of this approach and have been strong advocates for focusing on patient safety at the extremes of hemoglobin levels. This is not only because the first and foremost responsibility of physicians is to do no harm, but it is the physicians who decide, after discussion with their patients, what hemoglobin to target, and how much EPO (and iron) is needed to achieve this hemoglobin. This puts some physicians in an awkward and uncomfortable position, trying to always maintain their role as patient advocates when evidence for benefit and harm is unclear or changing. In addition, they must be appropriate stewards of the public trust, in this case, largely Medicare resources when decisions involve costly treatments.

The challenge to practicing physicians is to be able to follow the lead of physician organizations and accept our role as the arbiter at the intersection of quality care and costs of care. The area of anemia management brings this right to the forefront, where costly therapy and a lack of clarity on the hard evidence of risk versus harm is front and center. A recent article by Bob Brook of Rand brings this issue front and center (Brook RH.  The role of physicians in controlling medical care costs and reducing waste.  JAMA 306:  650-651, 2011). Dr. Brook is one of the gurus of health outcomes research and has pioneered the use of medical evidence to determine how best to treat individual patients as well as populations. With our shrinking healthcare budget, can we justify treating all patients to a hemoglobin of 11 or higher? Would that be the best use of resources, some of which could be better spent on other more impactful care? Similarly, undertreating anemia is also wasteful—patients are more likely to require costly, and at times morbid, blood transfusions or to be hospitalized for complications of anemia. The human cost in terms of quality of life is also potentially huge.

It is clear that the way out of this conundrum is not a one-size-fits-all approach to patient care, but one that minimizes variation in care that is harmful and costly, while addressing the needs of each individual patient. Only a physician can do the latter, while collaboration between physician and provider, with use of protocols and algorithms, can achieve the former. We need to all be held accountable for the outcomes that derive from these approaches.

As the renowned lawyer Louis Nizer said, “When a man points a finger at someone else, he should remember that four of his fingers are pointing at himself.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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The question of relative mortality of incident patients commencing PD versus those starting conventional thrice-weekly in-center HD is one I am often asked. In the words of the great American philosopher, Yogi Berra,“I wish I had an answer for that, because I’m tired of answering that question.”

The 2010 USRDS report  shows an equal five-year survival in the Medicare population, with a higher survival on PD for the first two or three years. These results are confirmed by many other observational studies. The only randomized trial reported in 2003 from the Netherlands, showed a significantly better survival for patients on PD. However, of 773 eligible patients only 38 agreed to be randomized, so the results need to be interpreted with caution. The vast majority refused to be randomized because, after a full modality education, they wanted either in-center HD (52%) or PD (48%). The clearest outcome of this study is that a randomized prospective trial will never be done. I also attempted such a study –but abandoned it because over 90% of the patients refused randomization after modality education.

Two recent papers address this question again. The first, from Canada, (J Am Soc Nephrol 22: 1113–1121, 2011) examines an interesting idea –that the early higher mortality in incident HD patients may be due to the use of central venous catheter (CVC) as vascular access. The data supports this, compared with the 7,412 PD patients, one-year mortality was similar for the 6,663 HD-AVF/AVG patients but was 80% higher for the 24,437 HD-CVC patients (adjusted HR, 1.8; 95% CI, 1.6 to 1.9). Of course this result does not rule out patient selection as an explanation for these results, and indeed the HD-CVC patients were older and had more documented comorbidities than the PD patients.

The second paper, also from Canada (J Am Soc Nephrol 22: 1534–1542, 2011) examines a different potential explanation for the observed differences in mortality between PD and HD. They hypothesize that the difference is seen because patients with emergent starts on maintenance dialysis are usually treated with HD. They analyzed the survival in patients who commence dialysis electively as outpatients and who also have at least four months of predialysis care. In this group there was no difference in survival between PD and HD.

So how do I translate all the literature into practice? First, home should be the default option. Second, for the individual patient, the one sitting across the desk in the office, the choice between PD and in-center HD is one that should be very largely based on lifestyle. PD offers simplicity, ease of travel, freedom from facility schedules, and at least equivalent outcomes to HD. I believe the only absolute contraindication to PD is not having a peritoneal membrane! Third, while all patients need to be educated on all options, my experience is that patients new to dialysis almost all choose PD rather than home HD as the home modality.

John Moran, MD FRACP FACP
VP, Clinical Affairs – Home Modalities

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The ESRD Networks have been an integral part of the quality oversight of the ESRD program for decades now. Originally 44 such organizations, now officially 18, cover the country and have a contractual relationship with CMS based on specific performance and deliverables. The most recent iteration of Network contracts holds these organizations accountable for some specific clinical outcomes of dialysis facilities, in particular the fraction of patients with AVFs.  This focus for CMS and the Networks is part of the Fistula First Initiative, an outstanding national quality improvement program designed  to increase the number of AVFs in U.S. hemodialysis patients—an area where we lagged significantly behind other parts of the world. And who could argue with this focus? Everyone knows that AVFs are associated with fewer infections and episodes of clotting than grafts or catheters and the latter in particular lead directly to increased hospitalizations, mortality and significant increases in the costs of care.

An intense focus on AVFs, however, has some unintended consequences, including multiple surgical procedures.  Poorly constructed AVFs do not function and may lead to significant morbidity. Until permanent access is functional, catheters are required for carrying out dialysis with all of the attendant risks these convey. Judicious use of grafts is a far better alternative. Ah, but there is the rub—dialysis facilities and now Networks are not “graded” on how few catheters their patients have, but only on how many fistulas, no matter what the cost.

The misalignment this state of affairs causes was clearly illustrated to me in a recent call I had with an ESRD Network MRB chair and Executive Director. They were very concerned because their Network was getting intense pressure from CMS because the facilities in their region had among the lowest AVF rates in the country.  As it turns out, however, this Network has the lowest catheter rate. As we have been able to show in DaVita facilities, the facility can clearly impact catheter rates after patients enter the facility, with clear process approaches that drive permanent access placement and catheter removal.  It is less clear, however, how facilities impact, and can be held accountable for, whether a patient gets an AVF or a graft.  That is the domain of the attending nephrologist and the vascular surgeon, who are the ones who should be held accountable.

So, should the Network in question be viewed by CMS as a poorly functioning one because of somewhat low AVF rates or one of the best because of great catheter rates? If we return to the old adage, Do No Harm, forcing placement of AVFs where surgeons are not skilled in their construction or patients may not be suitable, seems to be far less important than focusing on minimizing the use of catheters. In the ideal circumstance, there would be great surgical support and both goals—more AVFs and fewer catheters—would be possible, few real life situations fit that description. Making tough choices is a part of the Art of Medicine, and for me, intense focus on catheter removal should clearly take priority. Penalizing Networks and facilities focusing only on AVFs, Fistula First, rather than Catheter Last is the wrong policy approach.  It creates unproductive friction between components of the care system that should be working closely together.

As articulated in Wikipedia:  “The law of unintended consequences is an…idiomatic warning that an intervention in a complex system always creates unanticipated and often undesirable outcomes.  Akin to Murphy’s law, it is commonly used as a…humorous warning against the hubristic belief that humans can fully control the world around them.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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