Return to a Patient-Centered Model for Dialysis Care

DRAFT VERSION - 11/7/2010


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Introduction

We need to fix dialysis? Why is this needed? Isn’t dialysis saving hundreds of thousands of lives a year? Aren’t some of the most respected healthcare business leaders already doing this? Isn’t dialysis considered the ‘gold standard’ of artificial organ replacement? Why aren’t patients calling out for change?

Our approach to long-term replacement of the human kidney, so promising and patient-centered forty years ago, has evolved into a highly dysfunctional system. Some of the problems and long-term mistakes of dialysis care are now well-known and have begun to be addressed. Some have been rationalized, ignored, or denied. Others are just beginning to become understood, acknowledged, and defined.

This paper not only reviews problems and mistakes from the past, but also provides a new model of care that can address and correct them. It outlines a return to a patient-centered approach to care that most medical professionals would choose for themselves. It also recommends two small changes that could bring major improvements in dialysis care without increasing government costs.

 


 Paper Outline



Evident Problems and Mistakes

Survival

Despite improvements in technology and medications, the US has seen only a disappointing 2% decrease in the dialysis patient mortality rate over the last 26 years. Few other medical specialties can claim so little progress. It is presently a matter of debate whether this is due to the patients’ increasing age and comorbidities, or whether it is a failure of medicine, government policy, or financial factors.


Rehabilitation

A far greater percentage of working-age dialysis patients were employed in the 1970s. Debilitation and disability are now considered normal and acceptable outcomes. Unbelievably, patient employment and renal rehabilitation are NOT treatment goals of the two largest corporations that now treat the majority of the approximately dialysis 350,000 patients. Not surprisingly, depression is a widespread problem among dialysis patients. In terms of its original intent, this widespread acceptance and even fostering of patient disability has been one of the greatest failures of the Medicare dialysis program. Too many lives and livelihoods have been — and are being — needlessly lost. This is a human tragedy and a failure of purpose for this branch of medicine, as well as an economic disaster for families, local governments, and society.

Professional hypocrisy

Current professional and business models for dialysis care do not reflect the personal choices that informed and knowledgeable insiders would make. When asked what they would choose to stay active and employed, virtually all professionals say they would choose evening or night treatments and often insist on double or more dialysis therapy than their typical patient receives.

There is a growing hypocrisy among dialysis care professionals in that virtually none of them would accept the standard, thrice-weekly, day-time, in-center hemodialysis treatments that over 90% of their patients receive. Few of them fully disclose the mortality information and professional opinions they would use to make that choice for themselves. Until most nephrologists insist on providing their patients the kind of therapy that they would choose for themselves, it is evident that today's system of care is not patient-centered.

Kt/V (or its derivative URR) and 3-times-a-week hemodialysis

Using this value as a measure of dialysis adequacy was the biggest medical mistake of the last thirty years. While Kt/V and urea kinetics were based on complex mathematics and seemed to represent sophisticated medicine, they ignored the many benefits of longer and more frequent treatments. Only within the last two years have leading nephrologists begun to agree that the original premises on which both the concept and the mathematics are based are incorrect.

Despite the technological advances, hemodialysis is essentially the same as it was forty years ago. The process is primarily defined by the limitations of diffusion and osmosis within the human body and not by the properties of the artificial kidney or dialysis machines. If the process is rushed with high blood flow rates and treatments times under four hours, patients suffer from insufficient removal of middle molecules, cardiac stunning, and prolonged treatment recovery times.

Kt/V-based treatments goals are based on two outcomes: death and hospitalization for those patients receiving thrice-weekly hemodialysis treatments. Treatment based on this modality unnecessarily increases the medical complications the patients must bear. It ignores blood volume control issues, the leading cause of death today for dialysis patients. It has resulted in most patients being underdialyzed, feeling chronically poisoned or drugged, and unable to continue many of their normal life activities, especially employment.

As most nephrologists will acknowledge, when patients receive longer and more frequent hemodialysis treatments, many of their complications - and their need for medications - significantly decrease. Ironically, much of the nephrology's expertise in dialysis care has been focused on prescribing medications for the complications caused too little dialysis — usually prescribed by computerized Kt/V programs. Unfortunately for patients, Kt/V remains the standard of care for policymakers and the large dialysis provider corporations.

After receiving anonymous reports that lab results were being repeated and “gamed” to achieve the desired results, RenalWEB stopped reporting on the URR values on CMS’s Dialysis Facility Compare web site. This measure, derived from Kt/V, is typically only done on one of the thirteen hemodialysis treatments per month. Its validity as a marker of quality dialysis treatments is highly questionable.

Kt/V was supposed to provide optimal, individualized, hemodialysis treatment prescriptions. Instead, it brought a single-approach-fits-all standard to prescribing dialysis care. Instead of a whole-patient approach, many nephrologists relied almost completely on Kt/V and biochemical markers as a measure of patient well-being. Some nephrologists even stopped routinely seeing their dialysis patients, requiring a change in Medicare reimbursement policies in 2004. Instead of an individualized approach, Kt/V created a “fix the numbers” mentality in patient care that still drives unknowing patients to suboptimal care and life outcomes.

Standard Kt/V-based care provides a suboptimal quality of life. This was especially evident at the recent NxStage Users Conference in Las Vegas in October 2010. Patients on the NxStage system routinely receive far more therapy than the standard Kt/V or URR dose provided by standard, in-center care. This quote is from one of the attendees, Dr. Alan Hull, and it illustrates the point perfectly:

"A room full of people, 40 of which were patients & not being able to pick out the patients from helpers is something I have been seeking my whole nephrology life."

Medical problems identified at the 2009 Boston ESRD conference

In April 2009, a twenty-year follow-up meeting to the 1989 Dallas conference on reducing dialysis patient mortality was held in Boston. At this meeting (see course agenda), the course directors bluntly emphasized how little progress had been made in twenty years.

The conference (RenalWEB's coverage) finally did identify many problems with the Kt/V concept. These included its inappropriateness for smaller patients, that increasing "t" (time) but not Kt/V improves outcomes, and that the traditional renal diet associated with the Kt/V leaves many patients chronically undernourished. The conference also identified the need for euvolemia, decreased catheter use and lowering infection rates, addressing the high morbidity in the first 90 days of dialysis, preventing sodium overload, increasing rehabilitation, increasing immunization rates, and decreasing inflammation, and addressing sleep apnea.

In June 2009, the conference's steering committee sent an open letter that outlined their recommendations to Dr. Barry Straube, the Chief Medical Officer of the Centers for Medicare & Medicaid Services (CMS) and to Nancy-Ann DeParle, Counselor to the President (on healthcare reform). It should be noted that Ms. DeParle was once sat on the board of DaVita, a leading dialysis provider in the U.S., and she received significant compensation from them.

Dr. Straube responded in August. At best, it offers a long and complicated path to change.

To date, a few changes at CMS have resulted from the Boston conference. CMS has begun monitoring accessess and access infections, starting in July 2010. Partially in response to the Boston conference, in March 2010 CMS held Technical Expert Panel meetings on six measures:

  • Anemia Management (Target value for Serum Ferritin, Target value for Transferrin Saturation)
  • Mineral Metabolism (Target value for Calcium, Target value for Phosphorus)
  • Vascular Access Infection Rate (Catheter Infection Rate)
  • Pediatric Adequacy (Hemodialysis [HD], Peritoneal Dialysis [PD])
  • Pediatric Anemia (Anemia Management)
  • Fluid Weight Management
Note that none of these panel meetings are about patients' quality of life, rehabilitation, or patient-centered care.

The course directors state that they have had serious discussions with the large dialysis providers about engaging in a collaborative study to assess extracellular volume monitoring, rather than continuing to use subjective techniques of "dry weight." The American Society of Nephrology has invited the participants of the Boston conference to present at the 2010 meeting, at which Dr. Straube will participate. The conference chairs continue to publish and provide presentations of their findings in numerous formats.


Not-So-Evident Problems and Mistakes

These problems, mistakes, and issues are not routinely discussed at today's medical conferences, nor are they routinely addressed in medical journal articles on dialysis care. However, their impact on patient outcomes and patients' lives is undeniable.

Financial

Counterproductive financial incentives

The U.S. government now pays the majority of the $40 billion spent yearly on stage 5 chronic kidney disease (CKD5). The U.S. dialysis business is dominated by two for-profit corporations, Fresenius Medical Care and DaVita. Being publicly traded companies, their corporate officers must focus on maximizing profits from existing reimbursement policies while delivering an acceptable standard of patient care. Reimbursement policies set by Medicare and Congress drive nearly all of the patient care policies of these companies. Unfortunately, several of these reimbursement policies and practices now work against providing patient-centered care and against prolonging patients’ lives.

For more than 25 years, the Medicare composite rate – essentially a flat fee for providing a dialysis treatment – has been stagnant. It has forced dialysis providers to lower their dialysis treatment costs and reduce patient services. This led to shortened treatment times, increased patient-to-staff ratios, and widespread consolidation of dialysis providers. It has also decimated the professional staff in dialysis centers, with large reductions in professional nursing staff, psychological services, social workers, and dieticians. In terms of renal rehabilitation and patient employment, virtually no professional expertise remains in the entire industry. Instead of assisting patients to stay employed, many providers routinely encourage patients to apply for disability status.

When Congress and Medicare officials created the composite rate system, they did not create financial incentives that would also maintain patient employment rates, increase rehabilitation, and improve health-related quality-of-life. MedPAC, the Medicare Payment Advisory Commission that recommended composite payment rates, never considered patient life outcomes in its payment recommendations. Today, most dialysis centers that provide standard, in-center treatments have essentially become factories that produce debilitated, disabled, and depressed patients. Unfortunately for patients, the new PPS or “bundle,” which replaces the composite rate system, only continues these perverse financial disincentives.

Another significant reimbursement policy, the Medicare Secondary Payer (MSP) time period, has evolved over many years in terms of its intent, purpose, and effects. What started as a small cost-saving measure for Medicare has now become the economic backbone of the dialysis industry. Almost unnoticed, it also now has the unintended effect of discouraging corporate investments in extending patient lifespans beyond 30 months on dialysis. (What follows is a simplified, but conceptually correct, explanation of MSP policy and policy changes.)

The MSP period was first intended to lower Medicare spending on dialysis treatments. It began by having the patients’ private insurance pay for the first 12 months of dialysis treatments. Then in one evolutionary change, dialysis corporations began charging the private insurance companies fees that far exceeded – sometimes now by enormous amounts – the standard Medicare reimbursement. In another change, the MSP time period has been gradually extended from 12 months to thirty months. In yet another change, its financial purpose evolved into subsidizing the stagnant Medicare composite rate. Today, the MSP period has become the economic foundation of all dialysis centers and the primary source of profits of the two large corporations. Almost every dialysis center requires a few MSP-period patients to stay solvent and subsidize their Medicare patients. Obviously, all dialysis providers want more MSP-period, “private-pay” patients.

In an unintended evolutionary change, the MSP period now functions to discourage corporate investment in the development of products and services that would extend patients’ lives beyond the MSP time period. When MSP-period patients reach 31 months on dialysis, they become Medicare patients and are no longer the source of significant profits, if any at all. From the viewpoint of corporate shareholders and business managers, the perfect patient is one that has private insurance and then is transplanted, dies, or is discharged from their facility 31 months after starting dialysis.

Interestingly, the dialysis industry recently announced a voluntary program (PEAK) that is focused on improving the mortality rate for some patients during their first year on dialysis. There has been no announcement of a similar concerted effort to try to improve the survival rate of longer-term patients. While the 2009 Boston ESRD conference did focus on the lack of improvement in long-term patient survival, its two course directors were two nephrologists outside the two major corporations.

A final financial disincentive for better care is the separation between Medicare Part A and Part B, which does not exist in commercial insurance. It makes it impossible for savings in Part A (inpatient) to offset the higher costs in Part B (outpatient) that are often necessary to achieve improved outcomes and overall savings in the care of dialysis patients. In the future, both the the medical home concept and the accountable care organizations have the potential to address this problem.

Professional conflicts of interest

The influence of money can no longer be understated in the dialysis business. It has changed the way patients are seen by many, as they have become commodities rather than individuals requiring excellent medical care. When physician-owned clinics are acquired by large for-profit corporations, the sales are usually based on a "per head” amount. Many of these nephrologists reap fortunes based on the amount of profit the corporation believes it will make from treating people with kidney failure.

Medicare and Congress always have and still do expect nephrologists to look out for the best interests of the patients. Some nephrologists continue to function in that role. Unfortunately, CMS and Congress did not foresee the consolidation and expansion of corporate power and that many nephrologists would align their financial interests with these corporations. Nephrologists now receive tens of millions of dollars each year from the large for-profit provider corporations both as employees and in various forms of grants. In terms of negative effects on patients’ lives, this professional conflict of interest has become a major policy mistake.

It can be easily argued that large for-profit corporations have a powerful influence — far greater than most nephrologists — on dialysis patient care. This was especially apparent with the prescribing of anemia drugs before the FDA “black box” warnings in 2007. These drugs had become a major source of profit for the largest corporations. USRDS data has shown that ESA use at DaVita clinics significantly exceeded industry norms. Corporate officers there fended off accusations of excessive use of ESAs by insisting that their physicians had signed the orders and acted in the patients’ best interests. In a striking contrast, USRDS data for that same period showed that DCI nephrologists gave the lowest doses of ESAs, which is striking because DCI is also the only non-profit corporation among the large and medium-sized dialysis provider corporations. DCI also consistently has the best hospitalization and survival rates according to USRDS data.

The monopoly that Amgen has enjoyed in CKD5 care for over twenty years has provided it with tens of billions of dollars in pure profit. For many of those years, many felt that Amgen and some nephrologists ignored the potential dangers of overuse of this medication in the pursuit of profits. Far too many nephrologists also accepted speaking fees and “unrestricted” grant money from Amgen, and far too few were willing to speak out against these practices. Ultimately, this corporate and physician behavior made the ESA “bundle” necessary.

It is now undeniable that dialysis care in the U.S. is a big business. The reality is that the large, for-profit corporations must answer first to shareholders. Thousands of nephrologists now derive a significant portion of their income from these corporations, are their contracted employees, and must also serve these shareholders. Many nephrologists also have a financial interest in utilizing the existing dialysis stations in their facilities, yet most of these nephrologists would not accept the care for themselves that they provide the vast majority of their patients. Even more potential professional conflicts of interest arise when a large dialysis provider also manufactures several of the medications used by its patients .

With large corporations now dominating dialysis care as well as having significant influences over nephrologists, Congress and CMS can no longer rely on most nephrologists to act solely in patients’ best interests. Until new financial incentives are created, policymakers should expect many nephrologists to continue to target suboptimal, and even minimal levels, of overall health and well-being for these vulnerable patients.

Not-So-Evident Problems and Mistakes: Psychosocial

The unpleasant realities of being a dialysis patient in the US

When patients reach CKD5, many find their normal life “falls apart” as they must deal with the many burdens of their illness on a continuous basis. Few human life experiences bring such dramatic health, psychological, and lifestyle changes. Replacing the human kidney requires patients to accept and endure the greatest treatment burden of any chronic disease. Psychosocial services, once considered essential components of successful long-term dialysis care, have been nearly eliminated today. Instead of making patients’ lives easier in living with CKD5, most dialysis centers do not provide the resources that patients need and require to continue living a normal life.

An awful standard of care has evolved over the last thirty years. Today, patients are routinely expected to give up their normal lives when they start dialysis treatments. Social workers routinely encourage their patients to seek disability status when they begin dialysis treatments. Patient employment and renal rehabilitation are no longer valued. While not a direct correlation, Medicare does pay for cardiac and pulmonary rehabilitation, but there are no similar programs for renal rehabilitation. Renal social workers now have unbelievable caseloads of 150 patients or more and spend most of their time on transportation and insurance matters.

For the most part, the patients are expected to shape their lives around the dialysis clinic hours and medical appointments. Most dialysis units do not have shifts starting after 5 pm. Once connected to a dialysis machine in a busy, noisy, and sometimes hostile hemodialysis center, most patients struggle to get their basic needs met. Most patients want to avoid more time in this environment. They often leave the facility feeling washed out and exhausted, making work impossible and normal roles in family life difficult. The amount of dialysis therapy they receive is often minimal, leaving most patients feeling as if they are being constantly poisoned or drugged. The medical and financial models that have evolved today are designed to work best when people with renal failure become professional revenue streams – instead of people trying to lead normal lives.

Most dialysis corporations and their employees create a powerful ‘nocebo’ effect on their patients. Unlike the placebo effect, which produces positive outcomes based on beliefs, the nocebo effect produces negative outcomes. Few dialysis facility employees have had experiences with long-term patients who are successful and empowered. These employees see a system that infantilizes patients and only provides short-time hemodialysis treatments during workday hours as completely normal. By failing to develop any expertise in patient employment or rehabilitation in the CKD5 industry, nearly every contact with a healthcare professional imparts a nocebo effect on patients.

Nearly everyone involved in providing ESRD care is invested – professionally, psychologically, and financially – in the “sick” ESRD patient care model. Two generations of medical professionals have trained and educated who see hemodialysis patients as sick and debilitated. Most professional dialysis care givers have never been involved in the care of thriving, well-dialyzed, hemodialysis patients. All their skills and experiences are based on taking care of minimally-dialyzed patients. Many of the usual medicine and nursing interventions are for symptoms or conditions that only exist when patients are under-dialyzed.

Another example shows how pervasive this effect is. Two new models of CKD5 care appeared in print within the last two years, one in Nephrology News and Issues and the other in Nephrology Nursing Journal. Both were written by groups of leading experts in comprehensive CKD5 care. Neither article mentioned the words ‘employment’ or ‘rehabilitation’ a single time.

It is widely underappreciated that dialysis provider corporations have nearly unlimited power and influence to control and intimidate patients, intentionally or not. Patients must rearrange their lives around dialysis clinic hours and clinic appointments. Few patients have the energy to participate in the change process. Those that demand additional care to support heir employment status or a normal quality of life can be labeled as problem patients. They can be threatened, using documented "behavior" problems, with dismissal or banning from the dialysis facility nearest to their homes

Those patients that still want to participate in the change process are often buried in excessive information with little help to sort through fifty years of nephrology history, medical studies, and federal legislation. When these frustrated patients are allowed to speak openly in formats such as patient-only support groups, these meeting often quickly become emotional complaint sessions, as patients vent long-suppressed anger and frustrations with the quality of their care.

Patient organizations rarely, if ever, speak out against the practices at the large dialysis provider organizations. Most depend on these companies for their financial existence. Most of the prominent so-called patient-led organizations are controlled by non-patients, many with connections to Kent Thiry, the CEO of DaVita.

Patient voices are now several developmental stages behind professional organizations and corporations in terms of being effectively heard in Washington. Corporations have been using the enormous profits they make in dialysis care to “educate” lawmakers and physicians about dialysis financial matters and the best clinical practices for patients. Over the last decade, they have spent millions of dollars for lobbying Congress so as to control policy formation. While this has resulted in billions of profits, as well as eight-digit yearly incomes for a few top executives, it has brought neither optimal health, nor rehabilitation, nor empowerment for the vast majority of dialysis patients.

Lack of data from patients’ perspectives

In every business, gathering voice-of-the-customer data has become integral to developing new products and services to best serve the customer. Why has this not happened in dialysis care?

While there are decades of biochemical markers and treatment parameters in databases, there have been no mechanisms in place to collect and report feedback from patients as to what they find most important about their own care. Neither CMS nor the dialysis providers have records of patients’ experiences to aid them in understanding or quantifying the many factors that help patients survive and thrive on dialysis.

Forty years after the start of routine, long-term dialysis care we still do not have a vocabulary, definitions, or language to quantify the patients’ experiences. The terms illness burden, treatment burden, disease burden, and even patient-centered care remain undefined from the collective patient perspective. If evidence-based medicine is going to perform retrospective studies on the effects of psychosocial factors on patient survival and care, they will find little data with which to work. There have been no studies focused on determining the amount of dialysis therapy that is needed to feel well enough to stay employed. Without this information on patients’ psychosocial needs and illness burdens, the current model of dialysis care has little chance of improving.

Patient voices are not being heard through the corporations. Despite the caring and benevolent tones set in their annual corporate reports, the large dialysis provider corporations do not seek out honest patient opinions and feedback. Instead, these corporations continue to insist to shareholders that Kt/V and URR are effective measures of dialysis adequacy and quality care.

Nor are mature patient voices and opinions being developed by CMS. At the CMS Town Hall Meeting in October 2009, no in-center patients who spoke, even though they constitute over 90% of the patients. In Sept. 2010, CMS held an Open Door Forum conference call to educate patients on the proposed Quality Improvement Program (QIP) and the comment period. Unfortunately, even though it was sixty-day comment period, CMS held this meeting on Sept. 21, three days before the comment period ended on Sept. 24th. Only 250 persons listened to the call. Per usual, patients were told of a large amount of information they had to digest before commenting. CMS staff members also reiterated the fact that the QIP program would only be based on existing data they currently had.

Missing and undefined concepts: illness burden and treatment burden

In the last year, I was able to ask two of the most respected leaders of the dialysis field, the CEO of the largest dialysis provider and the top nephrologist/scientist, which dialysis therapy they would choose for themselves if they faced renal failure. Both answered essentially the same. Analyzing their selection offers insights not only into what is likely the best possible care, but also what has gone wrong conceptually for the vast majority of patients.

Both these gentlemen would continue to work. To do so, both would choose every-other-day, nocturnal, 8-hour, in-center, hemodialysis treatments. This is more than double the amount of dialysis than most patients receive. It is also a therapy that is not offered anywhere in the U.S. at this time (every other night, in-center, no 2-day weekend). It is also interesting to note that this modality would likely not be profitable under Medicare reimbursement and is only possible due to MSP-period reimbursement.

What is especially conceptually interesting and revealing is that they both would choose to minimize their illness burden and treatment burden of their kidney disease. By getting more than double the amount of standard therapy, they would likely minimize their illness burden, greatly reducing or eliminating many of the complications that most patients experience. The every-other-day treatments, with no 2-day weekend, also would greatly reduce their cardiovascular disease risk.

They would reduce their treatment burden by choosing nocturnal treatments, as it would combine dialysis treatments with restorative sleep. This dialysis modality would minimally interfere with normal lives, and most importantly, leave their days free for work. By choosing in-center treatments, they would also minimize the treatment burden on themselves, their families, and their homes.

If they themselves had to go on dialysis, despite the lack of definitive studies, most nephrology professionals would use their professional knowledge to minimize both their illness burden and treatment burden. They would make it a priority to continue their normal life activities. Sadly, few top nephrologists are willing to go on the record as to what treatment modality they would choose for themselves or a family member. Many will state - off the record – that they would find standard, in-center hemodialysis treatments, which over 90% of their patients receive, simply unbearable. Even though patients are educated to some degree about their choice of treatment modalities, they are not informed of the illness and treatment burdens of standard, daytime, in-center treatments. Again, unfortunately for patients, this is a moral failure that even a child can recognize.

Another concept not yet recognized is that decreasing the patient's illness burden with more dialysis therapy can also increase the patient's treatment burden. From a psychosocial point of view, requiring patients to sit in chairs for longer periods of time likely makes dialysis treatments increasingly toxic. Treatment burden is a complex individual issue, involving dozens of factors including life disruptions, inconvenience, and impact on family life. Unfortunately, this issue is not widely recognized by mainstream nephrology at this time and even patient advocates disagree on its definitions. However, common sense suggests that many studies on longer and more frequent dialysis treatments are significantly flawed because they did not consider the psychosocial burdens of each treatment approach.

Without studies that include the impact of psychosocial issues and treatment burden, the best sources of information today are those relatively few patients have experienced both in-center dialysis care and self-managed dialysis care. They know how they feel and how life is experienced both with too little dialysis — often based on a standard Kt/V of 1.2 — and with double this amount of dialysis treatment time. CMS and the corporations must work with these patients to identify and quantify the concepts of illness and treatment burden, especially with the problems that arise from too little dialysis and from the intrusiveness of medical care.

A model of care has evolved that downplays and ignores the psychosocial needs of dialysis patients

Since the introduction of Kt/V and the composite rate, the patients' illness burden — and the mortality rate — has not significantly decreased. Meanwhile, the treatment burdens that most patients must bear have significantly increased. Unfortunately, the cumulative effects of these additional treatment burdens on patient survival remain essentially unacknowledged and unstudied by nephrologists. Typically, when nephrologists seek to improve patient care or the mortality rate, almost all continue to focus on biochemical markers and medical causes.

Instead of continuing to allow the medical problems defined by the nephrologists to dominate all other concerns in dialysis care, a new model of care is required that elevates the importance of the patients’ psychosocial needs, as well as their insights as to what constitutes good and/or bad care. Caregivers must also realize that if patients’ psychosocial needs are not being addressed or met first, they are far less likely to thrive on dialysis, let alone comply with medical treatment and pursue excellence in their medical care.

While the connection between depression and survival has been medically established in chronic dialysis care, it is mostly ignored in today’s care models. Nephrologists simply do not consider or try to address the often whelming psychological and lifestyle burdens that patients routinely face. In reality, with little psychosocial expertise remaining in the industry, there are few professional tools to quantify it or address these problems. Additionally, nephrologists receive no renal rehabilitation instruction during their training.

Perhaps it is time to consider that rehabilitation and psychosocial needs are as important as medical needs for long-time survival with this chronic disease. Despite the current professional posture, most nephrologists will acknowledge – off the record - that the mind/body connection is very important for their patients. I have found prominent nephrologists willing to agree with these statements:

• A patient’s ‘will to live’ or ‘reason to live’ greatly impacts their continued survival.

• If the patient’s spirit or soul dies, the body will soon follow.

In long-term dialysis care, it appears essential for patients to maintain connections to a purpose and the meaningful experiences in their lives. While currently not acknowledged, maintaining these connections appears to be a necessary component for successful, long-term dialysis care. Long-term medical care cannot be a goal in itself.

Recognizing this reality justifies establishing patient employment and renal rehabilitation as essential goals in this area of medicine.
It is time to rebuild the decimated psychosocial services of today's dialysis care system. Going forward, in addition to reducing the caseloads of social workers, there should be far more peer-to-peer support services. More educated patient mentors and ombudsmen will be required, not only to help reduce the psychological burdens and provide support, but also to build and maintain these essential connections in patients’ lives.

No definition of ‘patient-centered care’

It is time to recognize that the model of care that has evolved over the last forty years is no longer patient-centered. Scientific terms and language to describe the patient experiences has not been developed and refined. In today's system, people with renal failure are valued more as professional patients (i.e. revenue streams) by most providers than as employed, tax-paying citizens. In recent decades, dialysis professionals and corporations have focused almost solely on improving biochemical markers, rather than life outcomes such as employment, rehabilitation, and health-related quality of life.

The best definition of patient-centered care may come from the previously mentioned CEO and nephrologist/ scientist. Analyzing their choice of dialysis modalities, it appears that excellence in dialysis care from the patient's perspective should be an unobtrusive as possible and leave each patient feeling well enough to live as much of their normal lives as possible for as long as possible. This means finding the balance that minimizes both the illness burden and the treatment burden for each patient. This could be a new, simple, and individualized definition of excellent dialysis care that far exceeds the capabilities of Kt/V.

Patient empowerment

Some patients thrive on long-term dialysis. Mostly on their own, these patients have become self-educated, discovered what works best for them, and now manage their own care. Instead of accepting standard, in-center hemodialysis treatments, most have found ways of getting much more dialysis therapy without further disrupting their normal lives. Most of these remarkable people have been able to minimize both their illness and treatment burdens. Many have not been hospitalized in years. They are active and many remain employed and are tax-paying citizens — as was envisioned some forty years ago when the federal dialysis program began.

What these patients share is that have become empowered. They know that their understanding of their condition and problems are superior to anyone else’s. They have become experts of their own personal care. While they still need physicians to oversee their overall medical care, they take control of as much of their dialysis care as they can. They do not accept in-center care that infantilizes them nor frustrates them in their quest for better care and a better life. Some of them have been labeled “disruptive” because they demand more staff time, individual education, and a higher level of care.

Thirty-five years after dialysis treatments became widely available, we should have a medical and professional culture that provides superior medical care, as well as educates, supports, and empowers patients. Instead we provide medical care that increases both their illness and treatment burden, as well as reduces them to being professional patients who are debilitated, disabled, and depressed. We have created a system that has no memory of what makes patients successful and empowered.


Not-So-Evident Problems and Mistakes: Medical

Medical technology is not enough

Since Descartes, most medical expertise has focused on separating the mind from the body and then dividing humans into further parts. At the ESRD conference in April 2009 in Boston, it was shown that only 14% of current morbidity and mortality can be accounted for by assessing the CMS-mandated clinical performance markers that most dialysis facilities report (albumin, Ca, P, Kt/V, PTH, cholesterol, etc.). There is obviously so much more to consider.

Physicians are considered the experts in CKD5 patient care, yet they receive little training in meeting psychosocial needs in CKD5 care, nor do they receive any training in renal rehabilitation. Put bluntly, because they have little expertise in psychosocial aspects of CKD5, they routinely consider it outside the scope of their practices. This was never more evident than at the 2009 Boston ESRD conference. While these well-intentioned physicians at the Boston conference did effectively discredit the use of Kt/V and URR as sole measures of dialysis adequacy, they continued nephrology's mistake of discounting the effects of psychosocial concerns and treatment burdens on mortality. Not a single presentation at this four-day conference centered on the psychosocial needs of the patients, despite the widespread use of the surveys like the KDQOL- SF and KDQOL-36. Only one presentation mentioned depression beyond a single sentence or two.

Despite many recommendations from the 2009 Boston conference for improving patient medical outcomes, patient groups have not embraced the conference’s actions with any sense of urgency or enthusiasm. Yet, patients seem to instinctively know that medical care by itself is not enough. This strange disconnect has been almost unnoticed.

Nephrologists and scientists must stop their "fix the numbers" approach and thinking that a single medical measure (Kt/V, URR, hemodialysis product) can represent good dialysis care. It must be a multi-dimensional approach. Nephrologists must accept that the pursuit of excellence in dialysis care is almost futile without aligning the provision of medical care with each patient’s individual life interests.

Many empowered patients have spoken of the importance of having a strong personal relationship with their physician. Optimal dialysis care should be largely driven by relationships that provide full disclosure of scientific facts and the professionals’ personal opinions to patients. Successfully treating this chronic illness requires the physician to be more than a scientific expert. Not unlike the role of a traditional medicine man or woman, the relationship itself becomes an important component of the overall treatment and is perceived as highly therapeutic and positive.

CKD5 care must have a model of its own

If dialysis care professionals are going to make major improvements in patient survival and quality of life, a dramatically new model of care is needed. It must greatly differ from care models used for CKD stages 1-4, when patients' lives are not significantly disrupted by their disease. When patients reach stage 5 and require dialysis treatments to survive, the model of care must expand to include psychosocial concerns and treatment burdens, as well as the financial goals of all parties involved.

A whole patient approach is required for CKD5. If new entities such as accountable care organizations (ACOs) or medical homes simply consider CKD5 care an extension of the medical care provided in CKD stages 1 through 4, there will be no improvements in renal rehabilitation, patient employment, or depression. Unlike acute illnesses, medical care alone will never be enough from the patients' perspectives in long-term dialysis care.

EBM alone is too limiting in a complex chronic disease

For the last twenty years, corporate and government policies have been increasingly based on evidence-based medicine (EBM). Unfortunately for patients, EBM has focused almost solely on improving biochemical markers, rather than life outcomes such as employment, rehabilitation, and health-related quality of life. While it is true that EBM has excelled at assessing the efficacy of a new medication or a treatment modification in CKD5, the current body of EBM has gathered little psychosocial data for CKD5 patients.

In reality,
no studies are likely to be designed and completed that consider all the factors that influence the patients’ treatment burdens. At this time, nephrology simply lacks the language skills to define illness burden and treatment burden as well as any established system to quantify their impact on patients’ lives. Even with a concerted effort for a decade, It is highly unlikely that EBM alone will be effective — ever in addressing all the interweaving psychological and medical complexities of a whole-patient model that is necessary for CKD5.

As CKD5 patient activists and advocates know well, this situation is extremely frustrating. Proponents and adherents of EBM usually demand that sufficiently-powered, double-blind, randomized clinical trials be completed before policies are changed. By pursuing this EBM “purity,“ these EBM proponents and adherents have effectively ignored the numerous quality of life improvements enjoyed by self-empowered patients. These patients have used the preponderance of available information — as well as common sense — to prolong their lives and improve their care. In the meantime, most patients are told they must sacrifice their health and lives waiting for these studies to be designed, implemented, and completed, as only then can existing corporate and government policies be “safely” changed. Meanwhile, virtually no dialysis care professionals would choose the care that most of their patients receive. Staying true to EBM purity, we are stuck with a self-defeating model of care.

Most EBM studies in CKD5 are driven by the interests and the money of pharmaceutical, provider, or device companies. Since EBM can only address issues for which it has data, EBM will not be able to effectively address quality-of-life issues in CKD5 care anytime soon. While nephrologists have found much money and help available for pharmaceutical studies, they will likely find little support available of similar quality for studies focused entirely on psychosocial needs and treatment burden.

Under this current model of care based on EBM, nephrologists are limited to a narrow perspective in treating dialysis patients. It is obvious that a new model of care is required that also includes traditional medical wisdom, common sense, and simply listening to successful patients.

In conclusion

A review of the evident and not-so-evident problems and mistakes in dialysis care paint a depressing and unpromising picture for today's dialysis patients. Patient survival statistics and rehabilitation rates are dismal. Financial incentives have evolved to the point where they are no longer coherent and even harmful. Corporate financial goals are often aligned against patients' long-term survival and many nephrologists have aligned their interests with corporations. Important and necessary psychosocial services have been decimated. Nephrology is stuck in a limiting and often self-defeating model of medical care.

This is not a patient-centered system of care. In the end, perhaps it is also time to consider that by downplaying and ignoring psychosocial concerns and treatment burdens, nephrologists have allowed the wrong dialysis facilities, the wrong architecture, the wrong technologies, and the wrong professional skills, and the wrong leaders to dominate dialysis care today.

There are many changes coming in dialysis care due to the new “bundle.”  There is a growing focus on new entities such as accountable care organizations and medical homes for dialysis patients. Unfortunately, at this time, all of these changes and entities build on the past mistakes and existing problems in dialysis care. Despite the enormous investment of time and effort, these "medical" solutions continue to stray even further from the essential foundations of long-term, patient-centered care.

If CMS, industry leaders, and some nephrologists continue to resist change based on arguments concerning the lack of EBM, then today's too few successful and empowered patients should hold publicly confront them for all the failures of the federal dialysis program — the unnecessary early deaths, as well as the widespread debilitation, disability, and depression, and complete lack of renal rehabilitation — as well as for their professional hypocrisy.


 

A New Model

Solutions and corrections to the evident and not-so-evident problems in dialysis care are not likely to be found in more randomized controlled trials, quality improvement programs, state inspections, or in CROWNWeb data. Simply providing gradually improving evidence-based medicine, by itself, is not enough. A new model of care is needed that values patient experiences, input, and suggestions for long-term care and identifies their most important needs. Resources to meet these needs must be built up as quickly as possible. It must also address the dysfunctional financial incentives that have evolved and solutions that can quickly align them with the patients' most basic interest — long-term survival.

Towards these ends, this paper introduces an all-inclusive, self-balancing model for dialysis care that is much wider in scope than is commonly considered today. It views the psychosocial and economic components of dialysis care as important as the medical care. This new model acknowledges the spike — even the explosion — of psychosocial needs that patients experience when they enter CKD5. By design, it recognizes that EBM alone cannot deliver the best possible care in this complex chronic disease. While it does include EBM as a significant part, this new model is also — by design — far more patient-centered than current models. It also includes all the human, economic, and organizational factors that can influence patient life outcomes — and society.

A New Foundation: Four Quadrants

No well-known healthcare model could be found that would address all the problems and mistakes in dialysis care. However, a model from outside healthcare was found that can perform these functions. It is beginning to be utilized for other healthcare disciplines that are turning to a more patient-centered focus. The essential beauty of this basic four-quadrant model design, developed by Ken Wilber, is that it is "all-inclusive" and quickly shows major omissions in any comprehensive approach to complex problems.

In essence, the four quadrants are: individual patient knowledge/experiences, individual medical care provided, collective patient knowledge/experiences, and all organizations involved in dialysis care.

Quadrant I: Individual Internal
This quadrant represents each individual patient’s personal knowledge and experience with CKD5. Among the components: personal attitudes, thoughts, actions, beliefs, experiences, needs, culture, and knowledge all contribute to individual definitions of treatment and illness burdens.

Quadrant 2: Individual External
This quadrant represents each patient's individual medical care they are provided. Among the components: dialysis modality, dose, and frequency duration. Clinicians' expertise and philosophy of care, as well as financial motivations. Frequency, depth and quality of patient’s relationship with MDs and caregivers. Patient education and empowerment programs in clinic.

Quadrant 3: Collective Internal
This quadrant represents the collective patient knowledge and experiences. Among the components: collective illness and treatment burdens. Collective employment issues, psychosocial needs, and health-related quality of life. Identifies disparities in care. Competency of patient-to-patient mentoring and advocacy.

Quadrant 4: Collective External
This quadrant represents all the high-level organizations playing a role in U.S. dialysis care today. Among the components: evidence-based medicine, government and corporate policymaking, Financial incentives and goals, profit or non-profit providers, payers, different societal and cultural influences.

This model recognizes that chronic disease patients' life goals and psychosocial needs must be considered as important as medical goals in order for them to be fully engaged and participating in their healthcare. In its optimal form, it considers patients with life-altering chronic conditions to be equal partners with physicians and policymakers. In order for the model to work for every patient, the four quadrants must be seen as equally important.


Using Wilber's 4-quadrant design, this model of care — specifically for CKD5 care in the U.S. — provides:

  • a "whole patient" approach, as well as a "whole system" approach
  • an undeniable patient focus that emphasizes patients' goals
  • a symbol specifically for CKD5 care, the four-quadrant circle
  • a framework for communication among all participants at all levels
  • a visual tool for illustrating disease burdens as well as dysfunctional approaches to CKD5 care
  • a self-righting system with built-in collaborations and tensions that provide growth, correction, and constant improvement
  • a model that allows each patient to become a full partner, even a leader, in the decision-making processes concerning their care
  • a structure for incorporating patient feedback and input, rather than waiting for decades more of evidence-based medicine research to be done
  • a way to incorporate existing models of care (EBM, psychosocial, rehabilitation) where they apply
  • features of a scalable model that can be applied to a single patient, a single dialysis facility, hundreds of facilities, or all dialysis patients
  • a model that can be tailored specifically for the unique realities of the U.S. market and the U.S. government

By utilizing a framework that includes more than just medical care, this four-quadrant model can provide many more explanations and possible solutions for the frustrating, long-term failures we have seen in CKD5 care. This model not only has the capability of vastly improving CKD5 care for patients, by providing a greatly increased focus on CKD5 patient employment and rehabilitation within a short amount of time, but also for reinvigorating and refocusing the practices of nephrology professionals.

New Model vs. Today's System

At a glance, it is evident that today's system ignores the left half side of the four quadrants, where the patients’ individual and collective psychosocial needs reside. These diagrams visually demonstrate why the current US system of care has been so unsuccessful: The larger the area covered, the more that quadrant’s concerns are being addressed and in control.

 
New model for optimal patient well-being in dialysis care   Existing system of dialysis care in the U.S.
     

There is little argument that dialysis care in the U.S. is dominated by the priorities of the largest for-profit corporations. It is a shock to most people to discover that the patients have so little influence on their care and policy formation concerning their care. It is a system that provides little voice and has no memory of patient experiences with dialysis care.

 

The need to expand quadrant III

The patients’ language must be developed to increase their influence. In addition to the current quality of life surveys being used, patients must define and control the concepts of treatment burden, illness burden, and patient-centered dialysis care. In order to be free of corporate influence, CMS should create an ESRD Network 19 that is patient-controlled.

To begin to change this, we are opening the "Fix Dialysis" web site to allow patients and dialysis care professionals to post what they believe is important in helping patients survive and thrive while on dialysis. Instead of waiting for CMS to develop meaningful rating systems, independent resources should be developed that rate providers in terms of illness and treatment burden shifted to patients, as well as draw attention to best and worst practices.


Relationships between the quadrants


Substantial collaborations, as well as a healthy tension, must exist between the bordering quadrants for the model to operate successfully for all patients. Balanced feedback and communication between the quadrants ensures constant improvement.

 
Optimal CKD5 model of collaborations, communications, and necessary tensions   Today's model of communication in CKD5 care in the US
     
Currently, individual patients have little chance of a "fair fight" with other quadrants. Until patient organizations develop strong, proactive voices for optimal dialysis care, individual patients will have a much harder time justifying better care for themselves.

Crosshairs Design

A key feature of the four-quadrant model is the crosshairs that separates the quadrants. The severity of its distortion also represents the severity of dysfunction in the dialysis care system. The model is especially powerful for exploring how to return the crosshairs to a more balanced position.

Shifting the illness and treatment burdens to patients

The movement of vertical line of the crosshairs to the left or right is useful in thinking of the shifting of illness and treatment burdens to the patient. The further to the left that the vertical line appears in the circle, the more illness and treatment burdens have been shifted to the patient.



By considering the concept of ‘shifting’ burdens, one can obtain a disturbing insight into how corporate profits have been made since the introduction of the composite rate. By shifting as much illness burden and treatment burden to the patients as possible, providers can increasingly lower their treatment costs and increase their profits. Adhering to a minimal standard of care, such as Kt/V=1.2 or URR=65, is one of the many ways to force patients to bear a high illness burden while keeping operating costs at a minimum.

Hundreds of small decisions that involve streamlining clinic operations and making them more "efficient" can all add to the patients’ treatment burdens. These range from cutting back on psychosocial services, to reducing the number of needle types available, to eliminating blankets. Unless patient groups or the nephrologist is willing to push back, the individual patients will likely see no improvements in illness burden — and only increasing treatment burdens.

Why the crosshairs moved

When chronic dialysis treatments began being funded by Medicare in 1972, the model of care was far more balanced than it is today. There were far more emphasis on the patients’ psychosocial needs that time. In 1983, when Congress enacted the composite rate system to control costs, they unfortunately failed to also establish life-outcome goals that would balance the inevitable cost-cutting. Nearly all nephrologists then began increasingly focusing almost solely on medical issues and biochemical markers. The long, slow decline of psychosocial services began.

After the introduction of the composite rate, both legislators and CMS accepted for-profit corporations and massive corporate consolidations as the best way to lower costs and deliver the majority of dialysis care in the US. This has resulted in two large, for-profit corporations that have increased their influence to the point that they now dominate dialysis care at nearly every level. By advocating for biochemical markers (Kt/V) rather than patient-centered priorities, these corporations have been able to lower costs and minimize the patients' influence on the model of care, as well as shift illness and treatment burdens to the patients. By controlling patient groups’ funding, it has been easy for the corporations to also control the patients' political influence and public voice.

Ultimately, this has been a failure of patient advocacy. Neither the ESRD Networks nor the Medicare Payment Advisory Commission has ever considered the patients’ illness burdens or treatments burden in their actions. Most nephrologists have focused instead on medical issues and many have aligned their financial interests with corporations. Corporations answer first to shareholders. Patients became valued primarily as a “per head” commodity to many of those that own dialysis facilities. Compared to forty years ago, compassion and empathy have greatly diminished within this field of medicine.

Considerations for moving the crosshairs

Obviously, the size of the patient quadrants (I and III) must be increased. The large for-profit corporations (IV) are unlikely to give up their influence and power without a major fight. Non-profit and privately held corporations can act for the good of the patients, but only within certain financial limitations. The officers of publicly held corporations with widely traded stock cannot move the crosshairs for the good of the patients alone. As powerful as they are, they can only act if their actions are also good for the stockholders.

CMS should not expect the nephrologists who work for the for-profit corporations to have sufficient power to do the right thing for the patients. Not only has it now become acceptable for the majority of nephrologists to accept financial compensation from the major for-profit dialysis corporations, but too much brutish legal power is held by the corporations over nephrologists that challenge them. Only by changing the financial incentives for these corporations can policymakers effectively force them to act in the patients’ best interests.

Until independent patient voices are nurtured, developed, supported, and strengthened, the crosshairs are unlikely to be significantly moved by existing patient groups anytime soon.
In terms of patient actions, perhaps the best hope today lies in having those few successful and empowered patients stage a very politically-smart public event that would have the public demanding changes to today's system of dialysis care.

In reality, evidence-based medicine will never be able to arrive the best possible care for each individual. However, financial incentives that encourage dialysis providers to keep patients their healthiest, both physically and mentally, can perform the same function. The U.S. long ago allowed market forces into its healthcare system for its "positive" effects. It is logical, therefore, that policymakers should use the corporations’ inherent quest for profits to deliver improved services for patients. By aligning the policymakers’ needs to increase the size of the patient quadrants (I and III) with the need of the large corporations to increase profits, we can restore balance to the dialysis care model. Such a solution can also ensure the survival of small and medium-size dialysis providers and the needed diversity they provide.

Graphical Model for Patient-Centered Care

By definition, the 4-quadrant model contains everything that can possibly influence patients. Therefore, subsets of information from this model can be used to create a graphical representation of patient-centered care.

A derivation: driving forces

The driving forces in dialysis care, for both individuals and organizations, are spread across the four quadrants. In examining the motivations of all the involved parties, three essential driving forces can be identified:

• Patient needs (medical and psychosocial)
• Pursuit of medical excellence
• Financial goals
   
Basic 4 Quadrant Design
Driving Forces in Dialysis Care


Return to an earlier definition of patient-centered care

In the earliest days of dialysis, the number of patients that needed treatment far exceeded the number of machines and financial resources that were available. In order to make the difficult decisions as to which patients would live or die, selection committees prepared and reviewed summaries that encapsulated what each patient expected and hoped to do with their life if they were chosen to receive dialysis treatments. The committees were forced to rate the purpose and even the importance of each life. Once a patient was selected to receive treatments, the team of caregivers was dedicated to supporting each patient’s core duties and roles in their family and society.

Fortunately, we no longer have selection committees, but an important function they performed in defining the purpose of each patient's care is missing today. Looking back now, the reason why long-term dialysis care was so promising at that time was that all the medical, nursing, dietary, and social services professionals were centered on each patients’ goals. By graphically placing the patient's core goals as the center of the driving forces in dialysis care, it is possible to return to the definition of patient-centered care that was so routinely arrived at more than forty years ago.


Two Recommendations

While there are vast differences between this new model of care and the existing system of care, just two minor changes will provide major progress in moving the crosshairs back to a balanced position.

  • #1 - The federal end-stage renal disease program should be redefined as a renal re/habilitation program
  • #2 - Extend the MSP period for patients that are employed, in school, and under age 25


These recommendations should NOT increase costs for the U.S. and state governments. Their economic soundness depends on having whole patient and whole system viewpoints and relies on these fundamental assumptions:

  • The more patients that are employed, the more taxes will be paid to the federal and state governments.
  • By extending the MSP period, private insurance payments — not Medicare - will provide a temporary burst of spending to produce an increase of 30,000 - 50,000 employed dialysis patients within the next few years.
  • The more patients that are employed and/or rehabilitated, the less social services and economic resources they consume.
  • Employed patients are healthier than today's average disabled patient and are less likely to be hospitalized.
  • Redefining the ESRD program as a renal rehabilitation program will result in fewer new patients starting dialysis who consume enormous Medicare benefits in the last few months of life.
  • As a group, for their own psychosocial well-being, patients should provide more services to fellow patients, their communities, and society.

#1 - The federal end-stage renal disease program should be redefined as a renal re/habilitation program

It was a major mistake nearly forty years ago NOT to define the federal dialysis program as a renal rehabilitation program.

To do so now would finally acknowledge that successful long-term dialysis care requires a major psychosocial component and that patients must retain the connections to their meaningful life experiences and/or a purpose in life. Experience has shown that medical care alone is not enough.

This does not mean throwing existing patients who are not working off of dialysis. It does mean that the contract between CKD5 patients and society needs to be redefined and rewritten society in terms of the appropriateness and purpose of long-term dialysis care. These discussions should occur over the next few years.

The name change alone will cause major shifts in perception, expectation, and belief about the appropriateness of long-term dialysis care. The shift in definition would change physicians’ recommendations for many new patients who are considering long-term dialysis care. The name change would shift the “ESRD” program’s direction from nursing home care or hospice-like care to one of rehabilitation, which was its original intent. For far too many patients with severe dementia and multiple comorbidities, dialysis becomes torture rather than treatment. The provision of long-term treatments should be based on the expectation of meaningful participation in family and/or societal roles.

Today, a physician must provide a monthly medical justification if a patient wishes to receive more than three hemodialysis treatments per week. Instead, a completely different mindset is needed. It should be expected that a patient will need more than today's standard, 3x/week treatments in order to stay employed and enjoy successful long-term rehabilitation. Patients should be routinely educated that nearly all dialysis care professionals believe that rehabilitation will require longer and more frequent dialysis treatments.

Patient rehabilitation classifications

CMS should have long ago developed classifications for renal rehabilitation based on age and life goals. As a starting point, I would propose these five classifications:

• Patient seeks rehabilitation, under age 60 – At least every-other-day hemodialysis or PD. Yearly medical justification for optimal treatment required to prove employment, family care, schooling, or community involvement. Continuous MSP (with harsh penalties for employers who discriminate against dialysis patients or the worker through whom they have health insurance). Priority for nocturnal treatment. Specialized “expert patient” training for optimal therapy. Extra payments for home training.

• Patient seeks rehabilitation, over age 60 – At least every-other-day hemodialysis or PD. Bi-yearly medical justification for optimal treatment required to prove employment, family care, or community involvement. MSP period, if applicable, 48 months (with harsh penalties for employers who discriminate against dialysis patients or the worker through whom they have health insurance). “Expert patient” training on request. Extra payments for home training.

• Patient refuses rehabilitation, under age 60 – Three-times-a-week, in-center or home hemodialysis, or PD. MSP period is 30 months. Monthly justification for “non-rehabilitation” treatment choice required.

• Patient refuses rehabilitation, over age 60 – Three-times-a-week, in-center hemodialysis, daytime treatment or PD. MSP period, if applicable, is 30 months. Yearly justification for “non-rehabilitation” treatment choice required.

• Patients under age 25 – At least every-other-day in-center or home hemodialysis or PD. Continuous MSP (with harsh penalties for employers who discriminate against dialysis patients or the worker through whom they have health insurance). Priority for nocturnal treatments. Specialized “expert patient” training for optimal therapy. Extra payments for home training.

Significantly more dialysis therapy than standard in-center treatments (thrice weekly Kt/V=1.2 or URR=>65%) is the most essential component for renal rehabilitation. A choice of employment or renal rehabilitation should be an automatic medical justification for every-other-day hemodialysis. Under the new "bundle", this would provide a significant increase in revenues for providers, as they would not have to increase the patient's medications or lab work that is now included in every treatment under the bundle (Bill Peckham's idea).

Some patients will choose not to pursue any sort of rehabilitation. Renal rehabilitation requires a high degree of compliance with prescribed medical care and is not for everyone. Some patients will always choose the minimal treatment possible. In those cases, dialysis providers and caregivers must be non-judgmental, evaluate each patient’s reasons, and provide education to separate myth from fact about work expectations, benefits loss, and work incentive programs. Providers should treat physical and emotional symptoms that limit motivation while providing a level of care that allows these patients to live as well as possible and for CMS to avoid excessive care costs.

Programs for renal rehabilitation

The economic and environmental realities of the 2010s will likely require that federal entitlement programs be modified and, if possible, integrated into greater societal goals. Instead of accepting the creation of more disabled patients, policymakers are likely to encourage patients to remain connected, if not to their normal roles in society, then to projects and purposes that contribute to their community and a greater good. If fact, providers should be expected to facilitate those connections as a necessary component of successful dialysis care.

There are three areas where a natural fit appears to exist for dialysis patients to provide more services to fellow patients, their communities, and society:

  • Kidney disease and diabetes education
  • Patient care and support of fellow patients
  • Environmental service: including water and power conservation, as well as urban farming and re-forestation

Perhaps one of the more elegant ways to remedy much of what is wrong in dialysis care today is to require that large dialysis provider organizations employ dialysis patients. It would quickly educate co-workers as to what actions and environments reduce treatment and illness burdens. It would also provide the feedback, collaborations, and tensions that are necessary in a balanced, organic, healthcare system that is always self-improving.

It is also time for the dialysis community to strongly consider accepting environmental responsibilities for the medical care it provides. Among the supporting reasons and benefits:

  • Joint project for corporations, patient groups, and individual patients.
  • Could be a legislative bridge between groups with opposing political views, i.e. large corporations and progressive social activists
  • Negates the carbon footprint of dialysis care
  • Dialysis units typically send thousands of gallons of uncontaminated water down the drain every day
  • Offers a give-back by patients to society for providing life-sustaining care
  • Would make the dialysis industry the first healthcare sector to take environment responsibility for the care it provides
  • Create meaningful experiences for patients, i.e. growing and nurturing living things that sustain other life
  • Provides a purposeful social participation, essential for successful dialysis care, for retirees
  • Can meet a need in local communities for fresh produce, especially in inner city "food deserts"

#2 - Extend the MSP period for patient that are employed, in school, and under age 25

There is no better example or public showcase of excellence in dialysis care than a healthy, employed patient. The fastest and best way to increase this outcome is to provide substantial and very specific financial incentives to the dialysis providers to provide more dialysis and produce more working patients.

Market forces and financial incentives, being the strongest drivers of corporate and employee behaviors, must exist to improve long-term survival, employment, and rehabilitation. Substantial financial incentives can produce significant results much faster than waiting for years to develop and execute randomized controlled trials that will finally show definitively what professionals and empowered patients have known for years.

Medicare Secondary Payer (MSP) payments are now the most important component of dialysis care economics. Dialysis providers are allowed to charge private insurance companies much higher rates (than Medicare) for the first 30 months that a patient is on dialysis. Without at least a few "private payer" patients, most dialysis centers would have to close. MSP payments can also be, by far, the biggest "carrot" to change industry behaviors.

The simplest and most dramatic improvement to the financial incentives can be made by changing the MSP period for employed, child-rearing, in-school, or under-age-25 dialysis patients from 30 months to a continuous period. This simple change would revolutionize dialysis care by turning dialysis provider corporations into renal rehabilitation companies overnight.

At once, the corporations would have financial incentives to keep working-age patients as healthy as possible for as long as possible. These corporations would undertake major programs to reduce the illness and treatment burdens of working patients. Home therapy and nocturnal hemodialysis would flourish. They would invest in the development of technology to make dialysis treatments as unobtrusive as possible. Meaningful and effective psychosocial and rehabilitation services would be rebuilt as quickly as possible using existing and proven models.

By producing tens of thousands of healthy, working patients, there would finally be overwhelming observational data that would justify longer and more frequent hemodialysis treatments. Corporate reports would feature patient employment data for the first time. Evidence-based medicine could no longer justify ignoring the obvious benefits.

(Patients will require protections from life-time caps on benefits, termination of insurance coverage, and unfair employment termination due to excessive healthcare coverage needs. Safeguards should also be in place to prevent providers from extending the MSP when patients are no longer significantly employed. Nor should private payers be allowed to pay Medicare rates during the MSP period.)

It is imperative that some significant financial incentives for delivering employed patients be created as soon as possible. Even if the MSP period for employed patients is only doubled, to 60 months, it would still have a huge impact. Instead of virtually all patients being disabled at 30 months, there would be tens of thousands of patients still working after five years on dialysis.

There are some self-insured groups such as the United Auto Workers (UAW) that have objected to extending the MSP. Negotiations should begin at once to ensure that their own members receive the optimal care that dialysis professionals would choose for themselves. Some creative restructuring of the MSP system may be required to make this solution more politically acceptable.

Extending the MSP period would reduce Medicare expenses. It would also provide a needed infusion of funds to rebuild the professional expertise that has been decimated by decades of counterproductive financial incentives. The dialysis industry no longer has a large pool of professionals that can support a sudden focus and large effort on patient-centered care. Current staff will have to be retrained to specialize in long-living patients, home therapies, self-care, and reducing treatment burdens, as well as increasing peer-to-peer mentoring, patient employment, and renal rehabilitation.

After several years of extended MSP-period payments, patient survival will likely be significantly increased, the professional expertise will be built back up, the appropriate technology being developed, and efficiencies re-established. At that time, a system closer to a all-payer rate could then be implemented, this time with patient life-outcomes (rehabilitation, employment) as part of the overall reimbursement system.


A Side-by-Side Comparison

     
New Model of Care; Balanced Four Quadrants
 
Existing System of Care
     
  • Targets life outcomes: health related quality-of-life, employment, rehabilitation, and survival
 
  • Targets a biochemical marker (urea) from a single treatment per month
  • Patient centered
 
  • Organization centered
  • Focuses on whole patient
 
  • Focuses on treating the patient's body; psychosocial needs largely ignored
  • Patients normally seen as well; Uses a well-patient model
 
  • Uses a sick-patient model
  • Primarily defined as a renal rehabilitation program
 
  • Defined as an end-stage renal disease program
  • Values patient feedback and input
 
  • While there are decades of biochemical markers in databases, there have been no mechanisms in place to collect and report feedback from patients as to what they find most important in helping them survive and thrive on dialysis.
  • Recognizes spike/explosion of psychosocial needs when patients reach CKD5 and addresses them
 
  • Does not address additional psychosocial needs when patients reach CKD5
  • Policymaking combines inputs from EBM, observational data, collective patient feedback, and individual needs
 
  • Relies almost soley on evidence-based medicine for one-approach-fits-all policymaking
  • Pursues research and development (R&D) with patient-centered priorities
 
  • Pursues R&D with industry-centered priorities
  • Establishes a minimum definition of dialysis adequacy and allows patients to determine their own definitions of dialysis adequacy
 
  • Usually forces patients to accept minimal definitions of dialysis adequacy
  • Focused on patient empowerment. Encourages all patients to increase their knowledge and expertise
 
  • Produces few "expert" patients
  • Provide financial incentives for producing employed and long-living patients
 
  • Provides no financial incentives for employment and instead provides disincentives for increasing survival beyond thirty months.
  • Reports patient employment
 
  • No corporate or governmental reporting of patient employment
  • Renal social workers are utilized to help patients keep their jobs, learn local resources, and treat depression
 
  • Renal social workers are spread too thin and primarily utilized to ensure private insurance coverage
  • Promotes development of new, easier to use self-care equipment
 
  • Promotes continued use of existing dialysis facilities and dialysis equipment
  • Controls Medicare Part A and B costs
 
  • With composite rate and bundling, effectively controls only Medicare Part B costs
  • Increases patient employment and societal participation
 
  • Increases number of disabled and debilitated persons
  • Focused on bigger economic picture and lowering overall costs to society.
 
  • Focused on controlling treatment costs while increasing overall societal costs
  • Addresses environmental issues
 
  • Ignores environmental issues
  • Chronic disease life management model
 
  • Closer to acute illness medical model
  • Encourages patient culture of advocacy, self-management, rehabilitation, employment, and being tax-paying citizens
 
  • Encourages patient culture of disability and entitlement
  • Patient advocates, ombudsmen, and necessary tensions built into system
 
  • Effective patient advocates rarely encountered. Patient-led groups must rely on corporate funding, virtually guaranteeing non-confrontational public stances. System has little chance of improvement.
  • Rebuilds psychosocial services; creates numerous avenues for peer-to-peer counseling and mentoring
 
  • Decimates psychosocial services
  • Addresses psychosocial issues and depression on an individual basis
 
  • Psychosocial issues and depression avoided and/or ignored; too complex for evidence-based medicine
  • Preferred and/or selected by professionals in dialysis care
 
  • Avoided by professionals in dialysis care
  • Patients feel well and choose amount of therapy / dialysis dose
 
  • Patient constantly feel poisoned or drugged; forced to accept minimal therapy / dialysis dose
  • Can improve outcomes with sense of urgency
 
  • Can only improve outcomes after lengthy evidence-based medicine trials are done
  • Clinic hours and treatment times meet patient needs
 
  • Clinic hours and treatment times meet corporate needs
  • Corporations answer first to patients
 
  • Corporations answer first to shareholders and fund managers
  • Patients are true customers
 
  • CMS/State surveyors are true customers


Final Words

Ultimately, this is a challenge to the top nephrologists and the business leaders of the dialysis industry. Today, their legacy is wealthy nephrologists, very profitable multi-billion-dollar businesses, a CEO who has likely made more than $100 million on dialysis care, a branch of medicine that has shown virtually no improvement in patient survival in more than twenty years, and hundreds of thousands of debilitated patients. It is hoped they will seriously consider the issues this paper raises and the model of care it offers. If they do not agree, they should provide a new model of care that:

  • will actively address many of the long-term problems in dialysis care, and
  • would be the model of care that they would choose for themselves and their family members.

If nothing else, I would recommend this book by Harvard business administration professor Richard Tedlow that was released earlier this year: Denial: Why Business Leaders Fail to Look Facts in the Face---and What to Do About It. It is an interesting study in the attractiveness of denial, of self-delusion in large companies, and of the tactics that are commonly used in denial.

Ethically, morally, and spiritually, we can do so much better.

Gary Peterson, October 2010
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