Why U.S. Dialysis Care Has Been Stagnant
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Why Patients Have Not Been Heard
by Gary Peterson, 9/14/2015
(Last edited: (9/18,10:12 PM ET)
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Summary: After creating the foundation for successful chronic dialysis care in the 1960s, the U.S. fell behind other first-world countries in both dialysis care technology and patient outcomes. Renal replacement therapy in the U.S. has remained stagnant for several decades primarily due to federal policy missteps and patient-advocacy failures. The most significant misstep has been the failure to target and improve dialysis patient employment/rehabilitation rates for working-age patients. This target is necessary 1) to drive the technological advances and breakthroughs that make dialysis less burdensome; 2) to drive improvements in the medical and psychosocial wellbeing for this important subpopulation; 3) to create and sustain a strong culture of patient advocacy in the medical, business, and patient communities. Several other policy decisions regarding reimbursement and physician ownership have functioned, separately and together, to bring out the worst in U.S. nephrologists, both medically and morally. U.S. nephrologists’ financial interests in brick-and-mortar facilities and dialysis equipment continually eroded their roles as patient advocates over several decades. These financial conflicts of interest also greatly diminished their professional pursuits of optimal dialysis treatments, patients’ psychosocial wellbeing, home therapies, wearable and/or implantable artificial kidneys, as well as other major advances in renal replacement therapies. These policy missteps and patient-advocacy failures have created enormous institutional inertias that control U.S. dialysis care today. A new foundation for U.S. dialysis care, which includes a strong financial incentive to increase patient employment, is needed.
My personal experience
Even though I had worked in hospitals for over a year, I remember the overwhelming wonder and awe that I felt when I walked into a dialysis center for the first time in 1975. This field of medicine was at the forefront of great leaps in medical technology. In my first year working there, I recall being regaled by my supervisors and co-workers with stories about how primitive the technology was just a few years before in the 1960s and early 70s. Technological change was occurring very rapidly and everyone expected that our state-of-the-art technology of 1975 would be quickly surpassed and replaced. We believed that artificial kidney technology would very soon be smaller, portable, and even wearable, and that dialysis patients could easily lead near normal lives.
After three months of training, I went to work on the night shift as a patient care technician. Almost all of these nocturnal dialysis patients were employed during the day. I had the privilege of caring for a surgeon, an electrician, a food service manager, a TV repairman, a banker and many others. It seemed natural to me that most working-age dialysis patients continued to be employed despite their chronic illness.
All that changed very quickly. I had worked there for two years when they announced the night shift for patients would be discontinued. Within a year or two after that decision, I can’t remember more than one or two patients continuing to be employed after starting dialysis. The better technology that we had expected, never arrived.
Forty years later, it seems unimaginable that dialysis care has made so little medical and technological progress. Nearly all the machines are the same size and are based on technology developed in Europe in the 1970s. Almost all dialysis treatments take place within brick-and-mortar facilities. Improvements in mortality have lagged far behind other fields of medicine, especially for working-age patients. The latest USRDS data shows that less than 10% of working-age dialysis patients are employed. Long-time colleagues and I are saddened that, in terms of improving patients’ lives, this field of medicine seems to have gone backward in many ways since 1975. So what went wrong? Why has this field of medicine been ‘spinning its wheels’ for decades after getting off to such an impressive start?
A 'proven foundation' of chronic dialysis care
One of the first centers in the country to provide chronic dialysis care was established in Seattle in the 1960s. An elegant, proven foundation of chronic dialysis care emerged from the work of these pioneers in Seattle and a few other locations. They combined cutting-edge technology, breakthroughs in medicine, specialized nursing, dietary counseling, as well as vocational and psychosocial support. A Seattle machinist named Clyde Shields started on dialysis in 1960 and lived for eleven years. Unfortunately, due to costs and lack of federal coverage at the time, it has been estimated that in 1962 only one in fifty renal failure patients were receiving dialysis treatments. Fundraising efforts and donated services made it possible for these life-saving treatments to be extended to a greater percentage of patients over the next ten years.
Medicare legislation was passed in 1965, providing federal health insurance for those over age 65. By the early 1970s, it had been well established that dialysis therapy worked. Nearly everyone envisioned that these patients would live near normal, productive lives. Nephrologists and patient groups began lobbying to extend federal coverage to dialysis patients. Many contend that Congress and public opinion was ultimately swayed by the testimony of a financially distressed salesman, Shep Glazer, who testified in Washington, D.C. while being dialyzed. (See this video about the impact of his testimony.) Ultimately, legislation was signed into law by Richard Nixon in 1972 and end-stage renal disease remains the only medical condition that is covered under Medicare for patients of all ages.
Unfortunately, the U.S. did not continue to build on this proven foundation of renal re/habilitation, largely due to rapid changes in patient demographics. Before federal legislation was passed in 1972, there were few patients beyond age 50 on dialysis. In order to be selected for dialysis treatments, patients also had to be leading active, productive lives. Starting in 1973, patients over age 50, those with diabetes, and the elderly were routinely accepted on dialysis. Within a few years, the dialysis population rapidly increased and the average age of a dialysis patient jumped by twenty years. With this rapid influx of older patients, the original focus and direction of U.S. dialysis care was gradually lost.
Although patient employment was specifically mentioned in the legislation and was expected to be natural target and outcome of dialysis care, employment rates for working-age patients were not monitored or targeted by government regulators. Employment was also quickly abandoned as a medical treatment goal by the nephrology community (employment rates for working-age patients were not reported in the USRDS until 2014). Instead, nephrologists found themselves focusing on the medical needs of the ‘average’ dialysis patient, creating the standards of ‘not dead’ and ‘not in the hospital’ that continue to define dialysis care in the U.S. Renal rehabilitation became virtually nonexistent.
Financial incentives and physician ownership
In the early 1970s in the U.S., almost all healthcare institutions were non-profits. When the federal legislation was passed that funded dialysis care under the Medicare system, non-profit organizations were formed in many urban areas to provide dialysis-related services. Many large community and university hospitals also built dialysis centers. A few nephrologists and businessmen went in a different direction, creating for-profit corporations to specifically provide dialysis treatments. All approaches flourished in the 1970s and 1980s.
At first, the government simply reimbursed dialysis centers for their treatment costs. Without cost containment policies, however, excessively high bills for dialysis treatments quickly became the norm. The government responded in 1983 with a composite rate ‘bundle’ system, effectively setting a fixed reimbursement rate based on three-times-a-week hemodialysis treatments. Despite inflation, this rate would remain virtually unchanged for over 20 years. While this thrilled many government officials, it meant that the dialysis clinic owners that were doing the least for their patients were the most financially successful.
Despite this stagnant reimbursement rate, hundreds upon hundreds of nephrologist in large and medium population areas would become multimillionaires in the 1980s, 90s, and 00s from dialysis care. The system of care gave U.S. nephrologists several ways to earn a living and to acquire wealth:
The Stark Law, which today consists of several pieces of legislation, was originally passed in 1989 as a cost-containment policy for Medicare. It prohibited physicians from having ownership stakes in the clinics or laboratories to which they refer Medicare patients and was intended to prevent the overutilization of medical services. Nephrologists were given an exemption, as no significant conflicts of interest were thought to exist because hemodialysis treatments were limited to three-times-a-week and treatment reimbursement was a fixed amount. Many nephrologists also believed they would be better patient advocates if they could control the allocation of the financial resources of their dialysis facilities.
- Earn the monthly payment from Medicare for overseeing an individual dialysis patient’s care
- Be a medical director in a hospital or non-profit corporation
- Be a medical director in a for-profit corporation, often with profit incentives
- Be an owner (full or part) of a dialysis facility and earn fees for administrative and/ or medical director duties, as well as sharing in the profits. Depending on the nephrologist’s choice, the facility was run on a spectrum from maximizing profit to optimal patient care.
- Have an ownership stake in a dialysis facility as a long-term investment which could be sold to the large for-profit corporations.
Instead, more and more U.S. nephrologists found they could extract great wealth from the free-market dialysis care system by building their own dialysis centers and then ‘selling’ both the facilities and their patients to large for-profit dialysis corporations when market conditions were optimal. These large corporations would then implement their ‘efficient’ staffing, clinical and operational policies, as well as utilize their economies of scale, to lower clinic operating costs even more. Once their clinics were sold to a for-profit corporation, nephrologists had little control over patient-related spending and their patient advocacy roles became minimal. With stagnant Medicare reimbursement rates, hospitals and non-profits also sold their dialysis businesses. In the end, the for-profit corporation model came to dominate U.S. dialysis care.
Patient advocacy failure
With their ownership stakes in brick-and-mortar facilities and facing a stagnant Medicare reimbursement rate, nephrologists embraced cost-containment in unexpected ways. A ‘one-size-fits-all’ mentality became the norm for dialysis care. Virtually no one foresaw that most nephrologists would utilize the cheapest, fast, and often iatrogenic dialysis treatment for nearly all their patients. Kt/V (or urea kinetic modeling) was widely embraced as the gold standard of care, providing patients with minimal hemodialysis treatments based on two outcomes: ‘not dead’ and ‘not in the hospital.’ Two hemodialysis treatment shifts were made to fit into one 8-hour staff shift. Only a small percentage of clinics provided treatment times that began after 5 pm.
Despite its proven negative effects on mortality and hospitalization rates, psychological depression remains rampant and unaddressed among dialysis patients. The lack of advocacy for patient psychosocial wellbeing has been especially damaging for working-age patients. While U.S. nephrologists will acknowledge the psychosocial benefits of employment, they have never acknowledged the psychosocial and economic harm that unemployment causes working-age patients and their families. They have not even acknowledged that employment is the most important psychosocial societal norm for working-age individuals in the U.S. For far too many working-age patients, unemployment leads to a downward spiral of depression and helplessness.
Ownership stakes in brick-and-mortar dialysis facilities by nephrologists also effectively killed the development of breakthrough technologies for dialysis. Advances in dialysis care had to fit within the brick-and-mortar facility model, both physically and financially. While smaller, portable, wearable, and easy-to-operate dialysis devices would have greatly benefitted working-age patients, these technology breakthroughs would have been financially devastating for nephrologist owners and the dialysis corporations. Stagnant technology sustained the wealth generation pathway for nephrologists for decades. Promising technology, such as the small, portable REDY machine that utilized sorbent technology developed by NASA, disappeared from the U.S. market. Hemodiafiltration, an advanced renal replacement therapy that appears to offer many advantages over standard dialysis treatments, is widely utilized in Europe and Japan. It is virtually unknown in the U.S. Few would foresee that many nephrologists would not refer patients for home training or for transplantation in order to keep chairs filled in their dialysis facilities.
Targeting only mortality and hospitalizations as medical targets meant that nephrologists did not have to engage patients about what was important to them. By the 1990s, many nephrologists rarely saw their dialysis patients. ‘Quality’ dialysis care became about biochemical markers and ‘fixing the numbers.’ Virtually no patient feedback or suggestions were incorporated into dialysis facility operations or care. Patient psychosocial needs were ignored. Social workers were given enormous caseloads and were reassigned to duties related to medical insurance and patient transportation. It became normal to encourage working-age patients to become medically disabled.
The U.S. dialysis care system long ago stopped responding to patients' needs. Studies have shown that the priorities for dialysis care set by both the government and nephrologists are not the priorities that are important for patients. Unlike other fields of medicine, patient focus groups have rarely been utilized to better patient care. According to the few U.S. patient focus groups (1) (2) that have been done, the patients’ biggest complaints are that they are not respected as human beings and that their individual needs and concerns are ignored by their caregivers. As an example, the largest U.S., for-profit, dialysis provider proudly touts its team community. Unfortunately, their team concept does not include the patients. Patient concerns about employment and rehabilitation remain essentially unknown. Repeated polls have shown that an overwhelming number of U.S. dialysis care professionals would NOT accept, either for themselves or their own family members, the standard dialysis care that over 85% of their patients receive.
U.S. nephrologists have become an insular professional group. They will not publically criticize each other’s business partnerships, financial gains, medical practices, or morality. Today most dialysis care nephrologists are affiliated with the one of the two large, for-profit, dialysis corporations that dominate U.S. dialysis care. As employees of these corporations, the nephrologists’ financial interests are firmly aligned with the corporations’ business interests. As a group, nephrologists never take patient advocacy stances that are in conflict with the largest for-profit corporations. As employees they have willingly followed medication regimens that maximize corporate profits, resulting in whistleblower suits that have recently been settled for hundreds of millions of dollars. They have tolerated widespread corporate cheating in reporting quality-of-care data. This field of medicine no longer attracts the best and brightest. Young nephrologists know that criticizing this system of care – with all its obvious flaws -- means committing professional suicide.
Further notes on employment
The lack of focus on employment/rehab is the result of several factors: CMS (Centers for Medicare & Medicaid Services) never identified it as a useful measure, nephrologists failed to be patient advocates and to consider patients’ psychosocial needs (often due to their own financial interests), patient groups never grasped the importance of the issue, and Congress failed to get the correct input from dialysis professionals and patients so that they could target these important outcomes and provide the necessary incentives.
Those who say an emphasis on employment will ignore most dialysis patients’ needs are missing far more important points. NO emphasis on employment leads to widespread disability, virtually no patient engagement, technology stagnation, and quality improvement programs that are limited to areas that must benefit all patients such as infection control, safety, and comfort. With employment as a medical target, the knowledge base about dialysis patient wellbeing would grow immensely.
No emphasis on employment means the goal for renal replacement therapy from the early 1970s --- allowing patients to live as normal lives as possible -- will remain unfulfilled. Taxpayers expect employment to be an outcome of successful dialysis care. There is no better public example of excellence in dialysis care than employed patients. If ESRD patients remain employed, providers tend to be performing all aspects of their care well. More than any other treatment goal, targeting high employment rates will drive faster technological advances that make dialysis devices smaller and portable, which benefits all patients.
Once dialysis patients become disabled, they rarely return to employment. Once disabled, their view of the trajectory of their life on dialysis, both medically and financially, seems to permanently change. Patients also fear losing their disability benefits if they fail in their efforts to return to the workplace. Due to this, the best initial approach may be ‘renal habilitation’, a focus on keeping new dialysis patients employed by engaging them in Stages 3 and 4 of CKD care.
Considering the public examples of successful of dialysis care exemplified by Clyde Shields and Shep Glazer over forty years ago, the ultimate irony for both patients and taxpayers is that the two largest for-profit dialysis corporations that dominate U.S. dialysis care today have virtually ignored employment and rehabilitation for decades. Nephrologists have undertaken some medical initiatives, such as the Peer initiative, to undo the harm done by their cost-cutting efforts that resulted in fast, cheap dialysis treatments. They now see fluid volume control as far more important than Kt/V. However, they are still failing to address the enormous psychosocial harm being done to the fastest growing group of new dialysis patients, the working-age subpopulation. Too often these patients are effectively being told, “Dialysis is your job.”
Enormous institutional inertias
Instead of building a continually improving system of medical care upon the ‘proven foundation’ from the 1960s, the U.S. dialysis care establishment instead created a stagnant morass of conflicts of interest. Dialysis patients long ago become cash cows for dialysis corporations, influential nephrologists, and drug companies. These entities use their professional, financial, and legal might to control and formulate CMS policies. They have little interest in changing policies that would dilute their power or devalue their investments in dialysis facilities, machines, or current therapies. The federal quality improvement programs, which have generated bureaucracies both within the government and the dialysis corporations, have been operating for more than a decade and do not include employment or rehabilitation.
Effective, independent, patient advocacy voices are virtually nonexistent. Nearly all the advocacy efforts of dialysis-related organizations have collapsed under the umbrella of Kidney Care Partners, a lobbying organization controlled by the largest dialysis corporations. This group strictly limits patient voices and participation. In terms of funding, nearly all patient groups, professional nephrology organizations, and non-profit corporations must all rely on corporate donations/programs to exist. These groups also compete against each other for turf, corporate funds, and private donations. As a result, national advocacy efforts lack coordination and agreed-upon priorities. There are virtually no patient advocacy programs that are integrated into the dialysis care system to help patients lead as normal lives as possible. Too often, patient advocacy means some cheerleading and being given a packet of educational material. Nephrologists, who are supposed to function as the patient advocates, are now effectively controlled through their corporate employment contracts and the corporate funding of professional nephrology programs. These conflicts of interest have also greatly lessened U.S. nephrology’s interest in future renal replacement therapies such as xenotransplantation, implantable artificial kidneys, and regenerative medicine.
Private health insurance for dialysis patients has become the biggest source of profits in the dialysis industry. The most powerful ‘dialysis patient advocacy’ organization in Washington, DC is the American Kidney Fund (AKF) . It essentially functions as an investment arm – or rigged slot machine -- for the dialysis corporations. Due the Medicare Secondary Payer (MSP) policy enacted by Congress, if a patient has private insurance, Medicare reimbursement for dialysis treatments do not go into effect until 33 months after starting dialysis. Dialysis corporations are allowed to charge private insurers many times the Medicare reimbursement rate. By law, dialysis corporations are not allowed to directly pay a patient’s health insurance premiums, so instead the corporations contribute tens of millions of dollars to the AKF, which in turn provides funds to patients to pay their private insurance premiums. Over several decades, this MSP policy has eliminated any financial incentive for dialysis corporations to extend patient survival beyond 33 months. In addition, few employers with health insurance benefits want to hire dialysis patients as it greatly increases the costs of health premiums for both the company and its employees.
(It needs to be noted that with the passage of the Affordable Care Act (Obamacare) and its provision that health insurance cannot be denied due to pre-existing conditions, dialysis corporations are reportedly moving some patients from one insurance plan/exchange to another in order to extend the higher MSP reimbursement rates beyond 33 months.)
Perverse financial incentives have also made dialysis patient hospitalizations a source of significant profits for the dialysis corporations. The large, for-profit, dialysis companies control most of the acute dialysis care contracts in hospitals. While Medicare reimbursement for dialysis treatments performed in outpatient facilities has remained stagnant, dialysis corporations can charge exorbitant fees for acute care treatments performed in hospitals. Unfortunately for patients, this led to slow improvements in hospitalization rates for dialysis patients for decades. Medicare has tried to contain these costs and better coordinate patients’ care through the establishment of ESRD Seamless Care Organizations (ESCOs). However, the large, for-profit corporations have proven to be less than enthusiastic participants in this project.
Finally, there is little political will to change this system, even though the U.S. dialysis care is a largely taxpayer-funded system that consumes approximately 7 percent of the Medicare total budget. In a taxpayer-funded system, physicians are supposed provide a balance against business profiteering by pursuing the patients' best interests and demanding changes that improve their lives. Instead, this balance has been lost and virtually all legislative influence, power, and control have been usurped by the for-profit, dialysis corporations (also see the Kidney Care Council (KCC) web site). When dialysis-related legislation is passed in today’s do-nothing Congress, it is never debated. Instead, provisions authored by and favoring dialysis corporations and drug companies are slipped into unrelated spending bills at the last minute. Only the largest corporations, through significant campaign contributions, are able to make Congress act in this manner. All these enormous institutional inertias and perverse financial incentives keep U.S. dialysis technology stagnant, patients unheard, and their lives little improved. Yet, Congress has not held hearings on the problems in dialysis care since year 2000.
What can be done
It seems logical and fiscally appropriate that a strong financial incentive to increase dialysis patient employment, without increasing government spending, could remedy many of the faults in the U.S. dialysis care system. It would drive more patients to home and nocturnal therapies. Extending the MSP 33-month period for employed patients, but not allowing exorbitant fees to be charged, could do this. Tax breaks for employers hiring dialysis patients could function as another effective incentive. A federal health insurance exchange for working-age dialysis patients could also drive improvements in many areas.
Grasping and understanding the many variables and their effects in U.S. dialysis care --- which include medical, patient, regulatory, congressional, economic, and corporate factors – has proven to be difficult, if not impossible, for even long-term professionals. However, it is evident to all that a new foundation for dialysis care is needed. Excellence in dialysis care appears to require the balancing of a complex, changing, and interacting mix of functions that should:
The U.S. has not performed any of these functions well, let alone successfully coordinate their positive aspects. Honest voices are needed, especially at the highest levels, starting with the first bullet point.
- allow patients to live as normal lives as possible
- deliver appropriate, non-iatrogenic, ever-improving, and integrated medical care
- continually aim to improve the psychosocial wellbeing of patient subpopulations
- set effective government policies that protect patients, improve care, and contain overall costs (including disability)
- create financial incentives for business and nephrologists that continually drive improvements in patients’ lives, dialysis technologies, and new renal replacement therapies
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