This is the time of year to reflect on the past 12 months, to be introspective and honestly assess where we have come and where we are going. As the themes of my blogs over the year have emphasized, patients with kidney disease are among the sickest of the sick, yet are embedded in a system of care that is largely dysfunctional. Uncoordinated care, inadequate focus on care transitions, lack of identification and management of co-morbid conditions, and too little preventive care all remain problems that must be overcome if we are to truly improve survival and quality of life for our patients.

Having said this, however, 2011 also showed us that there is clearly a growing momentum to do things differently, to restructure the way we think about and deliver care, and patients benefit. The one renal community initiative – PEAK, a program to lower incident patient mortality by 20% by the end of 2012 – is on track. The results of the CMS Global Capitation Demonstration Project are in and overall, with an intense focus on care coordination, survival improved, hospitalizations decreased and total costs of care were lower than in a matched group of Medicare fee-for-service population. Both DaVita and FMC identified the key drivers of poor outcomes and created customized programs including provision of nutritional supplements, use of biometric devices to control fluid overload, dramatic success with influenza and pneumococcal vaccination, and medication management therapy, among many others. These programs had one important characteristic in common – they were patient-centric, engaging patients in their own care and being sensitive to what each patient needed and wanted. Outside of the Demonstration, 2011 also saw a significant growth in home dialysis, particularly peritoneal dialysis, again demonstrating a sensitivity to patient needs and desires.

So why am I optimistic about 2012?  We now have a large number of approaches to improving outcomes that we know can work and are implementable. In addition, we are continuing discussions with the Center for Medicare and Medicaid Innovation (CMMI) and it looks more and more likely that a large-scale pilot program of integrated care management/care coordination will begin in the New Year. Finally, in mid-2011, a group of Chief Medical Officers from throughout the dialysis industry met together for the first time to discuss ways of substantially moving the quality needle for ESRD patients. This group is working closely with the KCP and KCC, ensuring alignment between business leaders and clinical leaders in the industry, along with policy makers. We have not seen this level of collaboration before and I am confident that 2012 will be just the beginning of new progress to improve the lives of patients with kidney disease. By working together, along with our patients, we can make this happen.

We would all do well to remember the words of Steve Jobs and try to live them as we start the new year:
“Everyone here has the sense that right now is one of those moments when we are influencing the future.”

I look forward to your comments, until next time.

Striving to bring quality to life,
Allen R. Nissenson, MD

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A recent editorial in the Clinical Journal of the American Society of Nephrology discusses the imperatives in the training of the future generation of nephrologists (1). In this insightful presentation Kohan notes five of the key forces that are driving what he calls a “perfect storm” in our discipline. The forces include increasing clinical workload, diminished interest in nephrology as a career choice, the changing nature of nephrology care, increased requirements for nephrology training programs from accreditation bodies and decreased funding for nephrology trainees and research. Mentioned as well is the excellent study by Berns published in 2010 demonstrating the dissatisfaction nephrologists had with the real-world preparation they received during their fellowship training (2).

Nearly seven years ago, we published a Special Article in Seminars in Dialysis following a preceptorship we organized for second-year nephrology fellows (3). This multi-day program, carried out by senior leaders in nephrology was attended by nearly 70 fellows, many from some of the most acclaimed nephrology training programs in the United States. As part of the experience we surveyed the participants to better understand the training programs from which they came. We were astonished by the responses, including:  50 percent of programs offered fewer than three months of experience in OP hemodialysis; 25 percent of programs offered no exposure to chronic peritoneal dialysis; 50 percent of programs offered fewer than three months of inpatient dialysis; and two-thirds of programs offered fewer than three months of transplantation. Faculty rounding during the OP dialysis rotation was “prn” in 25 percent of programs.

We made a series of recommendations to improve the fellowship experience and align what fellows are taught with what they need to know when they enter practice. These include: continuity experience in outpatient dialysis (minimum of three months, preferably 12 months); exposure to all available forms of RRT including HD, PD, HDF, and CRRT; exposure to daily and nocturnal dialysis as well as HHD; exposure to interventional nephrology; regular multidisciplinary rounds with faculty and other care team members on a regular basis; and regular didactic lectures on relevant topics related to dialysis and the management of ESRD and CKD patients.

This list is now incomplete, as pointed out in the excellent study by Lane and Brown published in the same issue of CJASN as the Kohan editorial. These authors from Australia point out that in order to truly be a world class nephrologist, one must have the content knowledge, as outlined in our recommendations above, but also must be trained in delivering holistic care, in developing the necessary skills to apply the knowledge, the be sympathetic/empathetic and to be a superior communicator.

So the challenge goes to our nephrology training program directors – how can they adequately deal with the external forces outlined by Kohan, provide the content knowledge that grows every day and develop a new generation of compassionate communicators?  Not an easy task, but unless we all dedicate ourselves to helping making this possible, it will not happen and one of the last remaining great medical subspecialties will be struggling for survival.

Do the words of the late John F. Kennedy apply to nephrology of the future?

“We have the power to make this the best generation of mankind in the history of the world or to make it the last.”

I look forward to your comments, until next time.

Striving to bring quality to life,
Allen R. Nissenson, MD

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References:

1.    Kohan DE. Training the next generation of nephrologists. Clin J Am Soc Nephrol 6:  2564-2566, 2011.
2.    Berns JS. A survey-based evaluation of self-perceived competency after nephrology fellowship training. Clin J Am Soc Nephrol 5:  490-496, 2010.
3.    Nissenson AR, Agarwal R, Allon M, Cheung AK, Clark W, Depner T, Diaz-Buxo JA, Kjellstrand C, Kliger A, Martin MJ, Norris K, Ward W, Wish J. Improving outcomes in CKD and ESRD patients:  Carrying the torch from training to practice. Seminars in Dialysis 17:  380-397, 2004.

Ezekiel Emanuel is the oldest of three brothers, his younger brother Rahm is Mayor of Chicago and Ari is an agent in Hollywood.  Ezekiel is a physician, a bioethicist who has recently devoted his career to public policy.  He has been writing a series of editorials in the New York Times that outline his view of the current state of healthcare in the U.S. and approaches to addressing the disparities in access to care, the lack of health insurance for millions and, the real elephant in the room, the growing population of patients with multiple chronic conditions that is driving the overall expenditures on healthcare toward 18 percent of the gross domestic product (GDP).

It is this latter group that is most concerning. Representing 10percent of the population, these patients consume nearly two-thirds of all healthcare dollars.  One of the solutions suggested by Dr. Emanuel is to “bundle” payments to providers.  As he explains:  “…The idea is to force all of a patient’s care providers to work together.  They have a strong incentive to eliminate unnecessary tests and treatments and use less expensive implants, drugs and devices that don’t compromise quality, and to prevent infections and other complications that could land the patient back in the hospital…[This is] even more important…for patients with chronic illnesses…these conditions have clear, widely accepted clinical guidelines…that could form the basis for bundled payment…”

This should all sound familiar to nephrologists.  Patients with ESRD comprise less than one percent of all Medicare patients but account for nearly eight percent of all Medicare costs.  Payment for dialysis care has been bundled since nearly the inception of the program and recent changes in the reimbursement system have extended the bundle to include injectable medications, and an expanded list of laboratory tests.  If one closely examines the overall costs of dialysis patient care, however, it is clear that the current bundled payment does nothing to address the most important driver of overall costs- hospitalizations.  In fact, hospitalizations and rehospitalizations account for over 40% of the total costs of care for dialysis patients.  So does this mean that Dr. Emanuel’s concept is wrong – that bundled payments for the chronically ill are not effective in controlling costs and driving higher quality care?

Clearly the devil is in the details.  The current bundled payment system for dialysis services, by focusing on what is “dialysis-related” is inadequate to test the Emanuel hypothesis.  In fact, the renal community has already proven that bundling payments can drive better outcomes and constrain costs of care.  The recently completed CMS Demonstration Project clearly showed that by fully bundling payment to the provider, enabling the provider to invest in holistic, integrated and coordinated care to improve patient health and avoid unnecessary hospitalizations, a true win-win is created.  Patients have better outcomes and the healthcare system costs are constrained.  The most recent movement in healthcare toward ACOs is an acknowledgment by policy makers and providers that bundling payment and creating aligned incentives make sense for patients and the overall system.  Unfortunately, efforts by the renal community to persuade CMS to allow ACOs with attribution of patients because of the presence with kidney disease did not prevail, and there is great concern that our patients will be lost in a general ACO.  We hope that the Centers for Medicare and Medicaid Innovation will be more willing to allow us to build on the great success we have shown in demonstration projects in order to benefit the lives of many more of our patients.

As Thomas Edison said:  “The doctor of the future will give no medicine but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease.”  Nearly a century later politicians and patients are demanding a true health care system rather than a sick care system, and for those with patients with kidney disease, it is time we stepped up and provided just such an approach.

I look forward to your comments, until next time.

Striving to bring quality to life,
Allen R. Nissenson, MD

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As an avid Kindle reader and someone who is often an early adopter of new technology, I was delighted to see the announcement recently that the Kindle Fire had arrived and would be an innovative addition to the growing field of e-readers and tablet electronic devices. Look out, iPad! New innovation drives more and better ideas, right? Innovative thinking results in more choices and a true push for value. This is the American way!

Nephrology has been left in the dust of innovation. Let’s take in-center hemodialysis and the technology to deliver it. Have there been substantive improvements in available equipment during the past decades, or have they been incremental? Is there competition among manufacturers sufficient to drive creativity, or is it just nibbling at the margins?

How about home dialysis therapy? Peritoneal dialysis (PD) is still performed the way it was developed more than 30 years ago with limited new approaches or technology. For home hemodialysis, equipment was created specifically to address this need. But wouldn’t it be even better if there were competitive products from which to choose that provided different features and pricing?

The lack of innovation spills over into the necessary pharmaceuticals that patients on dialysis need. Life-enhancing and clinically important medications — such as erythropoiesis-stimulating agents (ESAs), calcimimetics and others — have driven improvements in patient outcomes, but the lack of innovation and high development costs are particularly problematic in an age when publicly funded healthcare, not to mention the overall economy, is in serious trouble.

Innovation in medicine overall and nephrology in particular not only involves technology and medications but also care delivery models. Nephrologists are embedded in a fee-for-service reimbursement system that rewards individual care interactions and inhibits attempts to consider patient needs holistically. In addition, the ability to invest in proactive care that drives health rather than treating episodes of disease is severely constrained.

If at the end of the day we physicians must step up as true advocates for our patients and drive the best outcomes while stewarding the precious public funds (and trust), we need to advocate for:

     1.    Creating incentives for device and pharmaceutical manufacturers to want to innovate in the area of chronic
            kidney disease (CKD).

     2.    Easing the barriers that keep innovative equipment and medications that are widely used elsewhere in the world
            from being brought to the United States.

     3.    Aggressively pursuing creative care delivery models that include integrated and holistic care and an alignment
            of clinical and financial incentives.

     4.    Promoting collaboration with appropriate federal agencies to ensure that the comparative effectiveness of new
            delivery approaches, devices and pharmaceuticals is assessed, and when a new approach is demonstrated to
            add value, it is approved and appropriate reimbursement for its use is established.

As the innovator and philosopher Buckminster Fuller said, “You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete.”

I look forward to your comments, until next time.

Striving to bring quality to life,
Allen R. Nissenson, MD

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I belong to a group of Chief Medical Officers that meets quarterly to discuss current and future challenges in the healthcare system.  The CMOs represent a wide variety of healthcare organizations, including integrated care systems, pharmaceutical companies, insurers, laboratory and pharmacy providers, and multispecialty physician groups.  I am the sole CMO from a chronic disease provider organization.  We recently met with Mike Leavitt, the former governor of Utah and former secretary of Health and Human Services under George W. Bush.  Mr. Leavitt is currently founder and chair of Leavitt Partners, a consulting firm in healthcare.  This was an intimate session with 10 or so CMOs participating with Governor Leavitt, and I was impressed with his view of the future of healthcare over the next four to six years.  The key points include the following — I have added what I see as the direct relevance for the future of kidney care:

1. Shift from compassion to dispassion. With the global economic crisis, including the serious economic downturn in the United States, dispassion (NOT the opposite of compassion) is becoming the decision driver rather than compassion.  Countries realize they cannot do everything for everyone.  In the United States this means that “good enough” will become an important part of the construct of healthcare delivery.
   Relevance for kidney care: We need to start being far more proactive in determining who is really going to benefit from dialysis, as well as when to work with families and patients when ongoing dialysis is just not improving a patient’s quality of life.  End-of-life care/palliative care need to be addressed much more openly and aggressively.
2. Networks. One only needs to look at the airline industry to see that networks have become an essential way of doing business in order to survive.  The future of healthcare will depend on robust networks, and in order to play providers have to form them or be part of them.
   Relevance for kidney care: It is likely that continued consolidation in the dialysis industry will occur, and will be required in the new healthcare world.  Survival as individual facilities or physicians will be increasingly difficult.  Should ACOs or other models of integrated care management continue to expand, nephrologists need to find their place in these networked organizations.
3. Buses, taxis and limos. Think of the city manager charged by the citizens to develop a public transportation system.  He decides taxis would be convenient and cost-efficient.  Over a few years, people in other cities hear about this, like it and move to the “taxi” city.  Soon the system is overloaded, more taxis are needed, taxes rise, and people start moving out or the wealthy stay but hire limos to continue to provide convenience.  The city decides, in order to provide transportation, it must switch to buses.  People complain, but the bus gets them where they are going.  In healthcare we are moving to getting from A to B, regardless of convenience — regionalized services, waiting periods and the like will all be necessary in a world of growing demand and increasingly limited resources, unless consumers pay for the level of convenience they want.  The question is can quality NOT be tiered despite tiering of convenience?
   Relevance to kidney care: Nephrologists are the gatekeepers of quality.  This responsibility cannot be delegated to other entities.  This will be increasingly important as more and more care will be “good enough”.  Nephrologists must be part of such discussions and always continue to advocate for what is best for their patients.
4. Three competitive entities. These are large multi-specialty groups, insurers and hospitals.  None of the three has all of the ingredients, and the real question is who is the “general contractor” for the healthcare delivery in a city or region.  General consensus is that of the three, hospitals have the least clue and have been the least innovative in preparing for the new world.
   Relevance to kidney care: Be wary of aggressive moves by hospitals to acquire practices or tie nephrologists into exclusive agreements.  This sector of the industry seems the most “dinosaur-like,” and maintaining agility in nephrology practice is one of the key ingredients to continued success.
5. Cinderella and the ball. Speed and timing will mean everything in determining winners and losers.  The smart players will be inching toward the door of the ballroom at about 11:50 p.m. so that they beat the stampede to the midnight pumpkins and get trampled in the process.  The movement toward integration of the care systems is moving more rapidly than most people think.
   Relevance to kidney care: It is essential that nephrologists stay educated on the moving playing field of healthcare in general and nephrology in particular.  Know who the leading players are, and be prepared to initiate a partnership/collaboration when the stars align — in this case, early in is likely to be the best approach, if you have the right partner.
6. Kodak moment. Kodak had the dilemma of basing its brand on film, even as the world of digital photography was developing.  It was promoting the latter while still basing its core business on the former.  The winners in the new care paradigm are those who have figured out what disruptive technology is coming and how to prepare for it.
   Relevance to kidney care: Nephrologists must be proactive in testing new approaches to delivering kidney care.  Such things as every-other-day dialysis, more frequent dialysis in-center and wearable devices are all talked about, and if they provide significant incremental clinical advantages, patients should have access to these.  The barriers of inadequate reimbursement, however, are real but starting slow, and demonstrating overall value (quality/cost) can push the curve substantially.
7. Leaven in the loaf. It is clear that the first target for realigning healthcare will occur at the state level with intense pressure on Medicaid programs to constrain costs for states that are in the midst of massive budget deficits.  This could be fertile ground for experimenting.  Insurance exchanges are likely to grow much more rapidly than initially thought, with employers moving employees into these systems to control costs and shift costs to the employee.
   Relevance to kidney care: Erosion of Medicaid programs will significantly wear down CKD and ESRD patient care.  Nephrologists must be proactive in their individual states to ensure that this vulnerable population is protected.  Similarly, insurance exchanges may significantly decrease fees paid to providers, threatening access of patients to care and the ability of nephrologists and dialysis providers to serve these patients.  An urgent threat is the omission of Medicare Secondary Payer (MSP) requirements for these exchanges, essentially resulting in patients with employer-based insurance being moved to Medicare immediately if they have ESRD rather than waiting the current 30 months.  As recently articulated by RPA/ASN/ASPN, “Patients with End Stage Renal Disease (ESRD) are among the most vulnerable of all Medicare patient populations. It is important to account for the needs of these patients by maintaining funding for ESRD care at current levels. The Medicare ESRD program was recently transitioned to a bundled payment system; the transition included an across-the-board payment reduction. Subjecting the program to further cuts would jeopardize patient access to readily available, high quality dialysis care. We urge you to consider applying the Medicare Secondary Payer (MSP) provision to the recently enacted health exchanges. This proposal not only will maintain current funding levels for ESRD care, but will also potentially achieve billions of dollars of savings for the Medicare program. ASN, ASPN, and RPA urge you to protect ESRD care by keeping dialysis reimbursements whole, and instead consider innovative solutions such as application of the MSP provisions to health exchanges.”*

As the hockey great Wayne Gretzky said, “You miss 100% of the shots you don’t take”.

This approach, and the urgency we and our patients face, is described in an African proverb:  “If you want to go quickly, go alone, if you want to go far, go together.” We have to go far, quickly, and that means we have to quickly find a way to change the world’s consciousness about exactly what we are facing and how we have to work to solve it.

Nephrologists need to look into the future, identify partners whose vision they share, and then together shape the opportunities for delivering even better care and better outcomes despite shrinking resources.

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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*ASN, RSPN, RPA letter to Congress, October 13, 2011.

The New York Times published an article recently about the increasing trend of nurses getting advanced degrees. “[In 2010] 153 nursing schools gave doctor of nursing practice degrees to 7,037 nurses, compared with four schools that gave the degrees to 170 nurses in 2004, when the association of nursing schools voted to embrace the new degree. In 2008, there were 375,794 nurses with master’s degrees and 28,369 with doctorates.”(1)   The concerns expressed by a variety of groups in organized medicine was over the use of the title “doctor” for the nurses who had earned a PhD, with possible confusion of patients over who was a “real” doctor. Clearly this is a smokescreen and the real concern is over control and concern over the slow “intrusion” of nurses into medical practice. This concern is curious since it is clear that there continues to be a significant workforce deficit in primary care and in medical subspecialties such as nephrology.

Recent data from the Renal Physicians Association confirms what all practicing nephrologists already know: The patient population with ESRD and CKD is growing and is increasingly medically complex; the ability to recruit new nephrologists into practices is decreasing, with stagnant training programs and large numbers of IMGs not remaining in practice in the U.S. following training; there is increasing demand on time for administrative activities, including fulfilling the requirements of the Conditions for Coverage to carry out Medical Director activities appropriately; continued pressure from hospitals and other organized care systems to become salaried physicians; and constant downward pressure on reimbursement for physician services. All in all, working harder for less. It is time we applied the age-old adage, work smarter, not harder, and embraced ways of doing this, like working in teams and expanding the use of our advanced nurse colleagues.

There is no area in medicine where the interdisciplinary team (IDT) is as critical to optimizing clinical outcomes as it is in ESRD. Most people, however, narrowly define the IDT as the physician and various teammates in the facility (nurse, technician, dietitian and social worker). This narrow paradigm is critical for driving outcomes, as we showed in a recent publication. (2) When we looked at process measures that significantly correlated with survival at a facility level, IDT meetings were critical, particularly following sentinel events like hospitalizations. That is fine as far as it goes, but it is now apparent that this is necessary, but not sufficient to get the best outcomes.

Focusing on the holistic needs of the ESRD patient is essential, as demonstrated in the recently completed CMS ESRD Demonstration project.(3)  Attention to preventative care, including immunizations, control of diabetes, fluid overload and aggressive medication management all lead to better overall outcomes. But who is going to relentless pursue these things? The nephrologist?  The dialysis facility core team? We need to expand the definition of the IDT to include additional members, such as advanced practice nurses who cannot replace the nephrologist, but can enhance the team by addressing these key areas of care. If we do, we will truly be walking the walk of team, and our patients will be far better off— withbetter clinical outcomes and higher satisfaction with their care.

If we as nephrologists are to fulfill our responsibilities as leaders of dialysis facilities and clinical care for our vulnerable patients we should remember what the organizations guru Peter Drucker said:

“The leaders who work most effectively, it seems to me, never say ‘I.’ And that’s not because they have trained themselves not to say ‘I.’ They don’t think ‘I.’ They think ‘we’; they think ‘team.’ They understand their job to be to make the team function. They accept responsibility and don’t sidestep it, but ‘we’ gets the credit…. This is what creates trust, what enables you to get the task done.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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I was at the Hollywood Bowl recently—a magnificent outdoor concert facility built in 1919, featuring incredibly diverse music from jazz to pop to classical to Broadway. Small boxes are available for seating and my wife Charna and I have a series—four seats in a box. We invite another couple, and Charna, who is an amazing cook, prepares an incredible meal, and life is good. This evening we were going to experience an all-Beethoven concert—two romances, then Symphony no. 8 and ending with Symphony no. 5.  The guest artist and conductor was Itzhak Perlman. Perlman was born in 1945 in Israel to parents of very modest means—his father was a barber. At age four Perlman contracted polio and has had no movement in his legs since that time. He became a violin virtuoso in high school and has never looked back. He is truly one of the great musicians of his generation.

When Itzhak Perlman came out on the stage that evening, walking slowly with his ever-present crutches, the audience was first quiet then burst into applause. As he made his way across the stage and up a three-step platform, however, the applause stopped then began again—as if this was a major accomplishment—Perlman waved his hand to indicate that the acknowledgement was not necessary. He didn’t consider what he did to be remarkable in any way, just a normal part of his life and his job.

While listening to the first of the two romances I could not help but reflect about the lives our patients lead, and the way we all, as caregivers, often forget the courage they exhibit every day, whether it is a day coming to dialysis or a day recovering.  Each day these folks get out of bed with the same desires, hopes, dreams that healthy people have. But, in addition, they have the concerns and worries about their health, that day and in the future, about how long they will live and be able to provide for and be with their families, how they will be able to continue to be productive members of society.

How many of us, however, when we make rounds in the dialysis facility, think about these issues and what our patients are really going through and thinking? What is the balance of conversation between discussing lab tests and the need for being compliant with instructions compared with how things are really going in the patient’s life? We have become very complacent about the patients we treat—we oversee an incredibly complex technical procedure, carried out in seriously ill patients, generally safely and effectively. But is that really the best we can do? Next time you make rounds think about what each patient is going through—not just when on dialysis, but holistically, and think about how you can really make each patient’s life better. If our discipline can learn to do this effectively not only will patients be better off, but so will we!

As Hippocrates said almost 2500 years ago: “Some patients, though conscious that their condition is perilous, recover their health simply through their contentment with the goodness of the physician.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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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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