Big Picture Questions for Dialysis Care in 2012

by Gary Peterson

This is the 40^th anniversary of the federal dialysis program legislation.  Has it been a success?  Is it on the right path?

Unlike every other field of chronic disease medical care, few improvements have been made in goals and issues that mean most for patients and taxpayers: survival, employment, and rehabilitation. The legislators who originally sponsored and supported this program in the 1970s would likely be shocked by how little progress had been made in allowing dialysis patients to lead “normal lives.” Perhaps it is time to ask some commonsense, big-picture questions about what this federal program is supposed to do.

When I was considering what questions are best to ask, someone pointed out to me that children with type 1 diabetes led very regimented lives forty years ago. Today, they can lead largely carefree lives. 

So as a starting point, I found it helpful to ask an even wider question about all chronic diseases.  What do patients with chronic diseases want?

The best and simplest answer I could find:  To live as normal lives as possible.

Keeping this answer in mind, here are some big-picture questions that Congress, patient organizations, and policymakers should consider:

• What is the best overall goal for renal replacement therapy? 
• What idea will bring the most improvements and innovations in renal replacement therapy?
• What goal can make renal replacement therapy economically sustainable? 
• What is psychologically best and most motivating for patients?

I would contend that the best answer(s) to these questions is the same: To live as normal lives as possible.

Unfortunately, the leading physicians and CMS are asking very different big-picture questions which get very different answers: 

• What medical actions will improve mortality statistics for dialysis patients?
• What medical actions will reduce hospitalization rates for dialysis patients?
• What will control the costs of providing renal replacement therapy?

The multi-billion-dollar, for-profit, dialysis providers are asking their own big-picture questions: 

• What services provide the highest profit margins in renal replacement therapy?
• What actions will increase profit margins?
• What will lower the costs of providing dialysis treatments?

And a final question for everyone: Which set of questions has driven the most changes in dialysis care over the last forty years?

It is time to finally recognize that financial incentives and profits are the most powerful forces in U.S. dialysis care.  Acknowledging that truth can allow us to fix past mistakes and begin creating a more balanced approach to renal replacement therapy that also utilizes these powerful, free market forces.

What is wrong

To start, the greatest financial incentive in dialysis care today discourages patient survival beyond 33 months on dialysis, what is called the Medicare Secondary Payer (MSP) period.  During the MSP period, corporations are allowed to bill private insurance companies at many times higher rates than Medicare’s reimbursement.  Created by Congress in 1981, MSP-period billing is the source of most of the profits in dialysis care today. Once a dialysis patient automatically becomes a Medicare patient after 33 months, there is little to no profit to be made caring for these patients.

In addition, little improvement in dialysis technology has been made for decades.   The dominant dialysis machine manufacturer, Fresenius Medical Care, has been selling essentially the same huge dialysis machine for the last 25 years.  No significant financial incentives have existed to drive major advancements in this technology.  There has been little progress in making dialysis machines portable, convenient, and easy to use.  No wonder the percentage of those using home hemodialysis machines is so low.

Corporations, leading physicians, and CMS have embraced a “herd medicine” approach as the way to achieve the most possible good.  Their methodology is mostly limited to examining their databases for biochemical markers or treatment data that seem to improve patient survival and/or hospitalization rates.  This approach is akin to driving forward by looking in the rear-view mirror.  It is also devoid of any emphasis on normalizing patients’ lives.

Leading nephrologists have been mired in statistical arguments for decades about how to improve patient survival.  As of late, they are offering solutions based on creating medical homes or accountable care organizations (ACOs) that will only further “medicalize” patients’ lives.  Using the same old technology, these solutions will make medical care the center of patients’ lives, only marginally increase patients’ satisfaction with their care, and will only further reduce their chances of living a normal life.

Shockingly, the largest for-profit dialysis corporations do not attempt to increase patient employment and rehabilitation.  They have jettisoned those functions from their corporations with no objections from CMS or Congress.  These corporations do not seek out patients’ input or feedback on how to better their care or normalize their lives.  The unemployment rate for working age patients is approximately 80%. The overall societal cost of debilitating hundreds of thousands of working-age patients has been ignored by CMS and Congress.  Again, no financial incentives have been created to normalize patients’ lives.

Finally, due to the perceived complexity of dialysis care, Congress, CMS, and patient organizations continue to rely on a few industry experts for leadership. It is time for patients, Congress and federal policymakers to take back control and direction of the U.S. dialysis program with some commonsense questions.  The last congressional hearings on dialysis care were held over ten years ago.

Creating a financial incentive that changes everything

Instead of continuing to rely on only a few physicians and engineers in the dialysis corporations to provide new solutions, Congress should unleash the genius and drive of entrepreneurs, universities, investors, technology incubators, and patients to work on normalizing and extending patients’ lives.  With the Supreme Court’s decision on the Accountable Care Act, Congress can now utilize and align these powerful forces by modifying the conditions of a single, existing, financial incentive – the MSP period.

First, a “marker” of improvement is needed. While the concept of “normal lives” is difficult to measure, the best marker available that can be easily quantified is the employment rate for working-age patients.  Providing a significant financial incentive to keep working-age patients employed as long as possible would drive rapid improvements in both technology and overall care that would benefit all patients, regardless of age or employment status.  If a patient is leading a normal productive life, the medical statistics and biochemical markers will most likely be normal as well. 

The last step is to tie this employment marker to the most significant financial incentive that already exists in the dialysis industry, the MSP period. Currently, the largest dialysis corporations are already leading significant efforts to have Congress extend the MSP period from 30 to 42 months – without any conditions attached.  This 12-month increase would greatly increase their profits without having to improve technology, patient employment, or rehabilitation.  

Instead, by simply extending the MSP period for as long as dialysis patients are employed, Congress would align patients’ best interests, taxpayers’ intentions, and the largest for-profit dialysis corporations.  With this significant financial incentive, patient survival rates would finally significantly improve.  Dialysis technology, which has been stagnant for decades, would rapidly incorporate breakthroughs in other scientific fields.  The entire field of renal replacement therapy, which has lagged far behind other chronic diseases, would finally strive years to normalize patients’ lives. Most important of all, this action would create a new path of progress and begin to return this entire industry to a balanced, patient-centered, model of care.

Necessary details,  caveats, and small print (of course)

This employment-based incentive is not intended to replace existing quality assurance or quality improvement incentive programs.  It is not intended to be the sole measure of quality dialysis care. To assist small businesses that provide health insurance to their employees, some tax incentives, special provisions, or exemptions would also likely be needed to encourage them to retain and hire dialysis patients.  MSP-period fees may need to be limited. Current CMS regulatory safeguards would need to be enforced to prevent the “cherry-picking” of employed patients and the possible mistreatment of non-working patients.

Comments

[David]

I am completely and utterly perplexed at the absolute lack of response to the FDA approval of a signifficant advancement in dialysis treatment has gone unrecognized and not utilized. I am speaking of the OL-Pur Mid-dilution Hemodiafiltration Module developed by a small Start-Up going by the name of NEPHROS. Fresenius even touts on their own website the far superior efficacy of their own Online HDF Dialysis Machine (the 5008 - for which they have not been able to get FDA approval)on their Euro website. The NEPHROS model goes a step further by introducing their patented Mid-diultion process that has proven to increase health and survival signifficantly. Also, not only does NEPHROS offer their cutting-edge technology in their own dialysis machine, they also produce an add-on OL MD HDF that converts any hemodialysis machine into one offering the substantial benefits of OL MD HDF. Why on earth is this not being made available now that it is FDA approved? Why hasn't Congress/CMS or even the Surgeon General mandated its use? Why must dialysis patients travel to Canada or Europe in order to get cutting edge treatment?

[Norman]

Where do you get this? Where are the trials? or are you talking about HDF in general?
Re:"The NEPHROS model goes a step further by introducing their patented Mid-diultion process that has proven to increase health and survival signifficantly."

In addition, NEPHROS filters are not universal, for example they don't work on NxStage machines: Re: "add-on OL MD HDF that converts any hemodialysis machine into one offering the substantial benefits of OL MD HDF"