ESRD PPS comments, 12/17/09, 6:06 AM

To: Ms. Charlene Frizzera, Acting Administrator, Centers for Medicare and Medicaid Services

RE: CMS-1418-P: Medicare Programs; End-Stage Renal Disease Prospective Payment System; Proposed Rule

My name is Gary Peterson and I have been in the dialysis field since 1975 in variety of roles, including patient care, technical management, RN training, and product management. For the last eleven years, I have been the owner and editor of RenalWEB, a daily updated news and information web site. As this requires me to read and scan thousands of news and scientific articles about dialysis care every year, it provides me with a wide and independent perspective on ESRD care in the US.

As I have considered possible comments on the ESRD Prospective Payment System proposal for the last three months, I have become increasingly aware that what is primarily lacking in it is a mature sense of history. While it begins with a historical review that is technically correct, it does not acknowledge or reflect on serious mistakes from the past. Unfortunately, it builds on many of those past errors.

Back to the future

Imagine that after the federal ESRD legislation was signed into law in 1972, the people who created it had been given a glimpse of dialysis care in 2009. It is safe to say that they would have been shocked by a number of unforeseen developments and consequences.

First, they would definitely be shocked by the epidemic of diabetes and ESRD. They would find the number of patients and the overall ESRD costs to be staggering. Second, they would be amazed by the low, inflation-adjusted cost of a dialysis treatment compared to 1972. They would be very interested in the technological developments and market dynamics that made this possible. Third, after nearly forty years of medical advances, they would likely find the continuing high mortality rate among dialysis patients to be perplexing. They would be especially confused by recent studies that have shown that daily nocturnal patients can have survival rates similar to those with transplants from deceased donors.

Lastly, I believe they would be extremely disappointed by the widespread debilitation and disability among dialysis patients. Although a high percentage of dialysis patients were employed in 1972, working dialysis patients are now the exception and the vast majority of working-age dialysis patients today are disabled. I believe they would be disheartened and shocked that the moral and spiritual intentions of the legislation, that as a society we are willing to pay for medical treatments so that ESRD patients can live and contribute to society — that the potential and purpose of their lives are deemed valuable and even sacred — has been lost.

I believe they would find the failure of renal rehabilitation to be unfathomable. Most working-age patients were expected to become taxpayers. How would we explain that to them that instead of regularly celebrating their life successes in the press and media, most of the publicity is about how debilitating dialysis is? Or that the long-term dialysis patient who enjoys a normal life is “one in a million”? If they had known they were going to create hundreds of thousands of disabled people with this legislation, with all the additional overall societal costs and losses involved, it is unlikely the ESRD program would ever have been sponsored, let alone approved and funded.

Putting all these pieces together, these people from 1972 would be dumbfounded by the contradictions. How could dialysis treatment costs be so low, yet overall costs be so high and produce such poor survival and rehabilitation rates? What went so terribly wrong? How could this be fixed?

In addressing these questions, it becomes evident that some fundamental errors in the ESRD program occurred. These errors are mostly unnoticed today as they have combined, blurred, and evolved over time to become our well-entrenched medical practices and accepted government policies. Unfortunately, the proposed PPS builds on many of those fundamental errors.

Some simple solutions....

While it will take a great deal of writing to explain these errors and their unintended consequences, I believe that many solutions that can quickly return the ESRD program to its original intent and purpose are relatively simple — and can be accomplished at no or little extra costs to CMS. With relatively few changes, CMS can effectively leverage the financial power and needs of the large dialysis provider organizations as well as the innovative and creative energies of the smaller providers to increase rehabilitation — AND improve patient survival and lower average patient costs.


As most are interested in the solutions, these are listed here first in order of importance:

  1. Change the Medicare Secondary Payer (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. Home and nocturnal hemodialysis would flourish. At once, the corporations would have financial incentives to keep working-age patients as healthy as possible for as long as possible.

    (Patients will require protections, as proposed in the healthcare reform legislation currently working its way through Congress, 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.)

  2. Publicize and feature in Dialysis Facility Compare, MedPAC reports, and elsewhere the number of working age (18-67) dialysis patients who are working, students, and receiving vocational rehabilitation services. The results should be grouped by provider type (for profit or non-profit), hospital based or non-hospital based, physician, and/or corporation. With this publicity, even a small dialysis provider could drive improvements throughout the entire industry.

  3. Redefine the federal ESRD program primarily as a renal rehabilitation program. Require providers and nephrologists to set appropriate medical and treatment goals to achieve each patient’s rehabilitation goals.

  4. Establish a patient-led ESRD Network organization or establish patient-led working groups in existing ESRD Network organizations to develop policies that increase renal rehabilitation.

  5. Create a case-mix adjuster for employment or consider employment an adequate justification for extra treatments.

  6. Encourage more ESRD patients to work by providing financial and/or tax incentives for patients, providers, and employers.

  7. Establish minimum medical and treatment standards based on biochemical markers AND patient-reported mental and physical function scores for those not choosing rehabilitation goals.

.... for some fundamental errors

As to the fundamental errors of the ESRD program, the three largest in order of occurrence are:

  1. The ESRD program was created under Medicare, but it was never defined as a renal rehabilitation program. Under Medicare auspices, it adopted a one-size-fits-all approach that was appropriate for a typical, non-working, retired, Medicare beneficiary. No renal rehabilitation expertise, reporting, or effective patient feedback system was developed. The current proposed PPS does not address this.

  2. When Medicare introduced the composite rate payment system in 1983, it chose — either purposefully or inadvertently — to utilize for-profit corporate forces in its cost control strategies. Unfortunately, instead of using balancing financial incentives that lowered costs AND improved outcomes, it only provided incentives for lowering dialysis treatment costs and, if effect, shortening hemodialysis treatment times. Without counter-balancing incentives to improve patient survival and rehabilitation, the composite rate system has produced a slow, continuous, almost unnoticed decline in the quality of patient lives (inversely related to cost-of-living inflation?). The current proposed PPS builds on both the success and failures of the composite rate system. While it has been very successful in controlling dialysis treatment costs, it has had an unintended disastrous effect on patient survival and rehabilitation.

  3. Today’s payment system for the ESRD program is a patchwork of fixes and adjustments from many different sources and perspectives. Today, the MSP period unintentionally functions to work against long-term patient survival and rehabilitation. Additionally, the separation between Medicare Part A and Part B, which does not exist in commercial insurance, makes it impossible for savings in Part A to offset the higher costs in Part B that are often necessary to achieve improved outcomes and overall savings in the ESRD program. Unfortunately, this proposal for a PPS continues and exacerbates these perverse financial incentives. No top-to-bottom review has ever been done of the federal ESRD payment system and its short and long-term effects on patients. After receiving so much feedback with this proposed PPS, there is likely no better time for a complete review of ESRD payment policies.

The vast majority of the proposed PPS focuses on attempting to lower Part B overall costs. It will likely curtail some wasteful practices, especially excessive use of ESAs. It also includes some very initial considerations for improving outcomes for dialysis patients. However, because this proposal is limited in its scope by the conditions of the MIPPA, it does not include considerations for Medicare Part A or the MSP period, and by itself cannot address the all the urgent survival and financial incentive problems patients are currently facing. It can, however, undertake some of the solutions to prevent further setbacks to renal rehabilitation in the US.

Financial incentives

It is not a chance occurrence that of all the large dialysis provider organizations today, the one with the lowest mortality and hospitalization rates is the only one that is a non-profit corporation, Dialysis Clinics, Inc. (See recent USRDS yearly reports.) In the long term, despite professional ethics, CMS and the dialysis providers have efficiently produced the exact results one would expect from existing financial incentives. For these reasons, I strongly recommend to the HHS Secretary and the CMS Administrator that they begin an urgent top-to-bottom review of ESRD payment policies and the fundamental economic incentives they create in patient care.

In the ESRD industry today, the most powerful financial incentive is to increase profits by lowering treatment costs. It would probably distress most patients to discover that the Medicare payment system has inadvertently created financial disincentives for them to survive longer than thirty months on dialysis. This is when, under current MSP policy, they become eligible for Medicare and the lower Medicare payment rates for dialysis treatments begin. Under this policy, most working-age patients actually become a financial liability for the for-profit corporations if they live and thrive beyond thirty months.

When a government agency intends to utilize profit-driven corporations to achieve its healthcare goals, it should recognize that there are no stronger drivers of corporate, professional, and personal behaviors than the financial incentives it creates. While it is true that these financial incentives have not driven heartless decisions concerning individual patient care, these incentives do influence a thousand little decisions over many years at all levels of a for-profit corporation. These cumulatively lead to attitudes, beliefs, and a culture that can increasingly ignore the most important concerns of the patients.

In the end, Medicare did what it does best – control medical costs for elderly and non-working patients. In the end, corporations have done what they are designed to do – maximize profits from financial opportunities created by Medicare policies. Clearly, when attempting to achieve healthcare outcomes through for-profit corporation, we need balanced financial incentives that reward the desired patient-centered, age-appropriate, and holistic health outcomes we intend — AND lower costs.

Financial incentives can greatly influence who is promoted into management positions at all levels in a dialysis provider corporation. As an example, if there are financial incentives to increase the use of a medication, a physician who is medically aggressive is likely to be promoted into the chief medical officer position. If there are instead financial incentives for patients to continue working, a physician who is specializes in renal rehabilitation is more likely to become chief medical officer. When forming its policies, Medicare should always keep in mind in its ability to leverage large changes in dialysis provider organizations and nephrology — with just a few well-placed words.

Altering the MSP period should allow CMS to remain “budget neutral” in Part B costs while greatly encouraging renal rehabilitation for the patients that desire it, as long as discrimination is harshly punished when identified. As only 21% of prevalent patients age 18-54 were working in 2007 (USRDS ADR 2009, p. 730), and only 15% of all patients have been estimated to be working one year after starting dialysis, changing this policy would have a small effect initially on private insurance companies. If renal rehabilitation suddenly became widely successful, the political process could be used to negotiate payment policy changes.

Short duration, three-times-a week hemodialysis treatment

The biggest medical mistake that this proposal continues is the overuse of short, three-times-a-week hemodialysis treatments provided in-center during the workday. The widespread use of this treatment modality for nearly all patients, young and old, has been the biggest error made by the dialysis care community. After decades of pursuing shorter and minimum treatment times, it is becoming clear that longer and more frequent dialysis treatments provide the best physical and mental functioning and psychosocial well-being.

This mistake was the result of a “perfect storm” of conditions: assessing “adequate” dialysis by Kt/V, the composite rate, high-flux dialyzers, volumetric-control machines, the desire to treat more patients on more shifts in a treatment day, corporate consolidations, and the patients desire to spend as little time as possible on dialysis. Each provided its own reasons and logic to shorten dialysis treatment times as much as possible. As bad as it is for patients, this treatment modality is now firmly entrenched in our government policies, corporate operations, clinic architecture, dialysis equipment, medical education, and jobs.

With a perfect storm of conditions all leading to shorter dialysis treatments, patients failed to receive enough dialysis therapy to lead full, meaningful lives. Most live their lives feeling as if they are being continually poisoned or drugged.

Combining longer and more frequent dialysis treatments with restorative sleep is the key to rehabilitation for many. It appears that longer treatments during normal work hours lead to depression, further disability, and higher mortality for working-age patients. No able-bodied patient wants to endure longer treatment times in-center and in chairs with television watching as a primary life activity.

If suddenly faced with ESRD, virtually no dialysis care professional would choose to receive, for themselves or a family member, the treatments that over 92% of their patients receive. Almost no patients in the U.S. receive the care that most nephrologists would select for themselves. With today's financial incentives, treatment choices that make sense at the personal level for professionals can rarely be implemented at the organizational level for patients.

Nephrology

Another problem is that the medical practice of nephrology has failed to widen, evolve, and develop in the correct directions to meet patients’ needs. Most nephrologists have become specialists in managing biochemical markers, instead of focusing on assisting them in leading meaningful lives. While nephrologists are rediscovering the benefits of simply talking to patients, as with new patients in the PEAK program, few understand or appreciate how much of the traditional “medicine man” role is needed in a demanding chronic illness.

Nephrology should have a well developed branch called renal rehabilitation medicine. Instead, renal fellows receive little to no training in renal rehabilitation and few nephrologists have developed any solid experience, let alone expertise in the field. Disability and depression have grown common and accepted. Even the latest “medical home” models developed by leading nephrologists do not include rehabilitation. Most patients are simply left on their own, trying to figure out how to feel better and, if possible, live a meaningful life.

Perhaps more nephrologists should talk to hemodialysis patients who have experienced both these scenarios:

  • Dialyzing for three hours three-times-a-week during the business day in a crowded, busy, noisy, sometimes hostile, hemodialysis center environment. Leaving the facility feeling washed out and exhausted, making work impossible and normal roles in family life difficult.

  • Dialyzing every-other-day for 6+ hours at night while sleeping in a quiet, supportive environment. Starting the day feeling rested and restored, making employment possible and enjoying a near normal family life.

By focusing on biochemical markers for non-working, in-center HD patients, nephrologists are failing to consider the most important psychosocial components that determine so much of a patient's quality of life. We need to remember that the original intent and purpose of federal ESRD legislation was to create a renal rehabilitation program. Most nephrologists have forgotten this. The reason why almost no dialysis care professionals would choose to dialyze in their own facilities is that they know they could have a much higher quality of life with modalities other than short, 3-times-per-week hemodialysis.

Patient rehabilitation classifications

The PPS proposal continues the one-size-fits-all approach to dialysis therapy focused on in-center hemodialysis. CMS should have long ago developed classifications for renal rehabilitation based on age and life goals. 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 accepted that a patient will need more than that 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. Compliance with dialysis dose requirements should become a non-issue when these patients are targeting and begin enjoying higher levels of rehabilitation. 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.

Some patients will choose not to pursue any sort of rehabilitation. Renal rehabilitation is demanding, 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.

Quality Measures

The proposed PPS continues current CMS policies of measuring quality of care by using URR and hemoglobin levels. Again, this carries over long-term mistakes from the past and ignores the patients’ experiences. Few people realize it, but by using Kt/V and URR, Medicare is targeting the mortality rates from a model that was developed over thirty years ago that has also proven no more predictive of morbidity and mortality than patient self-reported physical and mental functioning scores. When one considers that, it is not surprising that there has been so little improvement in survival.

As for hemoglobin, over $35 billion has been spent on ESAs in the last twenty years to boost hemoglobin levels, much of it justified by expected improvements in survival and quality of life. However, survival rates have not significantly improved and a lower percentage of patients now work than when the ESRD program was established and before the introduction of ESAs. Without patient-centered, rehabilitation-focused, financial incentives in place, industry forces have justified the use of costly (and profitable) medications to improve biochemical markers that have, unfortunately, resulted in few improvements in patients’ lives.

Now is the time to finally break the awful practice of measuring quality care solely by biochemical markers. It is time to establish case mix adjusted physical and mental functioning scores from patient self-report data and expect dialysis providers to improve the scores that indicate higher risk of hospitalization or death. When patients self-report depression, they have a 48% higher risk of death.

What if…

Had the ESRD program continued as a renal rehabilitation program, we would likely have discovered that patients need much more time on dialysis than today’s accepted Kt/V or URR levels provide in order to stay employed over long periods. We would have also discovered that long treatment hours in dialysis center chairs during working hours leads to depression. We likely would have discovered that combining sleep or restorative life activities with long dialysis treatments greatly reduces depression. We would have seen many companies providing simple, easy-to-use and maintain home hemodialysis machines. We would have seen more dialysis providers specializing in renal rehabilitation and fewer of them overmedicating patients and providing minimal dialysis treatments. With well-developed employment and rehabilitation data reporting, the reports by CMS staffers to MedPAC — and their ensuing discussions — would be very different.

We would NOT have seen the building of thousands of dialysis facilities designed for short dialysis treatments with staffing shortages of all disciplines, the lowering of professional to technical staff, and so many treatment facilities with stressful — and often hostile and frightening — environments.

If there are no rehabilitation incentives

If Medicare is not going to provide renal rehabilitation incentives, we should then offer all possible incentives for kidney donations that would provide transplants for working age patients. With many immunosuppressants now coming off patent protection, it will be far better — morally and economically — for the patients, CMS, and our tax-paying society.

History lessons

We in ESRD care in the US would greatly benefit from the work of a medical historian and medical economist to sort through the developments, successes, and failures of the program. If we do not understand the past, it is the patients who are condemned to pay — with their lives — for our repeated mistakes.


End.