HemoDoc, From Doctor to Patient

CMS and Home Hemodialysis: The Story of 40 Years of Neglect

By Peter Laird, MD

The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering.  The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.

End Stage Renal Disease Program

In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973. 

At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home. 

On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients  were on home dialysis including 59 PD patients at home.

The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program. 

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.

The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.

The politics of health cost containment: end-stage renal disease

R.A. Rettig (pages 132-133)

Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival of home patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers."When we look at patient survival on home dialysis," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .

But the political damage had been done. 

Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.

NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD  - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD  patient was at least $4000.

The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)

Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.

This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere  and at some time one who can make a difference inside our government will.

The Dialysis Dilemma: What Would Scrib Do?

By Peter Laird, MD

Despite the demonstrable progress in recent years delivering the message of optimal dialysis, from time to time, a very negative portrayal of dialysis emerges in the popular press that paints a shaded picture of the true miracle of hemodialysis that today sustains two to three million people around the world.

I was quite disappointed to read  a recent article that ended on just such a sour note of despair with dialysis despite celebrating the stories of both Bill Peckham and Nancy Spaeth who have graced the world with lives well lived despite ESRD. After all, both Bill and Nancy are still working and contributing greatly to their families, friends and community. It appears that the author of this article failed to capture the true miracle of saved lives with hemodialysis with their example she noted, but does not appear to truly understand.

The dialysis dilemma: urgent need vs. overtaxed system

A HALF CENTURY ago, nobody predicted so many people would have end-stage kidney disease. Or that treating it, per patient, would be one of government's most expensive entitlements.

Now, nephrologist Kelly says, the problem isn't picking which patients should get dialysis; it's that doctors, patients and families seem unable to pick which patients shouldn't.

A few months ago, at a NKC celebration, he called for reconstituting "The Committee" — albeit with a 180-degree change in its mission. It was a moment to pause.

Kelly fervently believes that health care is a right. But he also thinks dialysis has gone too far.

Unfortunately, the story of dialysis today is not that it has gone too far, but that it has not gone far enough. Hemodialysis machines operate in much the same fashion as they did when the doors to renal replacement therapy swung open with the ESRD program in 1973. Since that time, despite the technological revolution that we have seen throughout modern medicine with improved survival from technological advance, the basic components of hemodialysis remain remarkably the same. Although even here there are indeed improvements in buffers, hollow fiber tubing, software, and other aspects of delivering the provision of dialysis, one aspect that has not seen any improvement in hemodialysis is improved outcomes.

The for-profit dominated dialysis industry has focussed their efforts on improving the bottom line of corporate profits but as an industry they have not advanced the technology to improve outcomes in any sensible fashion. In this regard, dialysis has not gone too far at all. Nevertheless, Dr. Kelly is speaking of the ethical dilemmas of open access to this expensive care and not the need for further technological advances.

The dialysis dilemma: urgent need vs. overtaxed system

 Today, with the door to dialysis swung wide open, Kelly argues, doctors, families and patients need a committee because someone, somehow, has to say no.

He battles with himself out loud. "I think, 'Am I some kinda Hitlerian guy, that I want to stop all these treatments?' "

Then he recalls "Scrib," Scribner himself, fearlessly insisting that uncomfortable, tough issues be aired. "I frequently say, when I'm dealing with a case, 'What would Scrib do?' " Kelly says.

"I'm trying to do the right thing — what I think is the right thing."

The study of medical ethics can be summed up simply enough as doing the right thing in difficult circumstances. I am pleased that Dr. Kelly seeks the wisdom and knowledge that "Scrib" would advise America in these trying times. However, seeking to return to "God committees" more properly called death panels from his description is not the avenue that I believe Scrib would venture with the so called "dialysis dilemma" we face today.  Dr. Christopher Blagg wrote a touching and informative tribute to his lifelong friend and colleague shortly after Dr. Scibner's untimely death in 2003. One short paragraph in this tribute speaks loudly on where I believe Scrib would want us to go:

Belding Hibbbard Scribner - Better Known as Scrib

Scrib always said he had been lucky all his life, but he was successful because of his perseverance in problem solving and his delight in tinkering with devices. He was a great teacher and leader and a generous person. His first concern was always for patients, and his other major concerns included for-profit dialysis, the future of U.S. medicine, and the future of the world.

I believe Dr. Blagg characterized best "what would Scrib do?" by noting his devotion to patients first and foremost coupled with his ability for problem solving. The great tragedy of dialysis is not that we have too many patients in need of this life saving technology,  but instead that we have spent too little time problem solving and tinkering with  any new technology. Modern technology seems to have side-stepped the dialysis industry as it ground the constant drumbeat of profiteering above and beyond the love of the patients they serve truly giving a new definition to blood money.

What would Scrib do? I believe he would tinker and problem solve with newer and improved technology and freely give that technology to medicine for no profit of his own as he did with the Scribner Shunt. Instead of profiting millions of dollars personally by his new invention, Dr. Scribner freely gave this life saving device to the entire medical community which is an ethic sadly missing today.

I don't believe that Nancy Spaeth and Bill Peckham wish to be known for an article essentially calling for death panels in the current world of re-engineering dialysis. Instead, they are filled with courage and devotion to this modern medical miracle made possible by a humble man. Where is our present day teacher and leader who shall advance the provision of dialysis in the same spirit of saving lives as both Bill and Nancy testify daily? Both knew and loved Dr. Scribner who served not only as a mentor, encourager and teacher, but as their lifelong friend. Dr. Scribner did not heed the modern admonition of doctors not getting attached to their patients, he instead embraced them with all of his heart and mind and soul.

How many nephrologists today have patients that will outlive them? Even Dr. Scribner's very first patient, Clyde Shields,  lived for over eleven years before cardiovascular disease claimed his rejuvinated life. The amazing panel of Dr. Scribner's patients have lived lives testifying of this truly remarkable invention. (here, and here)

I believe he would approach all patients with severe renal impairment with a courageous strength to save lives above all other concerns. Has dialysis gone too far? No, not at all. It has instead failed to advance far enough that the provision of dialysis is still far too excessively expensive and strangled by an industry that cares first and foremost about reaping ever enlarging corporate profits. What would Scrib do? I believe Dr. Blagg told us quite clearly in his loving tribute that he would focus on the patient tinkering with new technology and giving it all freely away to save lives. Yes, that is what Scribner would not only do, but that is what he did. 

Home Hemodialysis Competency is Lacking in American Nephrology Training Programs

By Peter Laird, MD

Home hemodialysis was at the forefront of bringing into account hemodialysis modality as an accepted medical procedure in the early 1960's. The financial constraints of chronic hemodialysis especially in-center were beyond the resources of most institutions shortly after Belding Scribner, MD revolutionized the treatment of chronic renal failure with the "Scribner" Shunt. By the time that the 1973 ESRD program provided financial relief for all eligible US patients with renal failure, nearly half of the patients treated at that time dialyzed in the comfort of the their own home. Sadly, far too many new nephrology graduates have forgotten these lessons from the history of dialysis.

In a recent CJASN publication written by Jeffrey Berns, MD, the editor of the Medscape nephrology news section, notes that 65% of recent nephrology graduates lacked competent training in managing home hemodialysis patients. Only 15% of these fellows surveyed felt competent to manage home hemodialysis pateints:

A Survey-Based Evaluation of Self-Perceived Competency after Nephrology Fellowship Training

Areas in which more than 25% of fellows during their second or later year of training answered “No” included cystic kidney diseases (50.1%), plasmapheresis (60.1%), renal US (51.8%), PD (36.5%), home HD (65.0%), arte- riovenous access management (34.4%), nephrolithiasis (34.7%), geriatrics (25.2%), and palliative care (37.4.%) (M. Rosner, personal communication). Thus, several of the areas cited by respondents to the survey reported here as not providing adequate training were similarly cited by fellows still in training, emphasizing the need to address these areas of training.

I had an  interesting encounter with an expert in transplant nephrology when I had an iron infusion at Kaiser Sunset in Los Angeles last year. While rounding  during the hemodialysis session, I asked him if he was familiar with Pauly's study on nocturnal hemodialysis outcomes vs. transplant finding comparable outcomes in mortality. (here) This nephrologist who had just completed a prestigious transplant nephrology training program at Cedar-Sinai and was able to advocate credibly for transplantation but he was not able to discern how daily nocturnal dialysis faired against his preferred renal replacement modality. If a transplant nephrologist from such a well respected institution cannot truly give informed consent on transplant vs nocturnal hemodialsyis even as a bridge to transplant, how then shall we expect the average training program to rise to a level of proficiency in home hemodialysis modalities?

The true repository of home hemodialysis knowledge is not found in the majority of nephrology programs in this nation but it instead resides within the collective patient advocacy sites and foreign nephrology programs much more so than the average nephrology program in the United States.  Dr. John Agar has long advocated for home hemodialysis utilization as a first choice for the majority of patients new to dialysis. Many patients in Australian nephrology practices dialyze in the comfort of their homes and have much better outcomes than those in conventional in-center treatment centers.

The fact that most American nephrologists are ignorant of the history of dialysis nor do they have a concerted interest in this modality does not bode well for the future of improving American dialysis outcomes.  The grave of Belding Scribner who freely gave of his invention to save lives haunts the halls of all of these nephrology programs that find it incredulous that the majority of patients dialyzed at home in the 1960's with primitive equipment by today's standards.

The truth remains that there is a major generational gap between the pioneers of dialysis and the current graduates who view dialysis as a futile and unworthy treatment option for the majority of patients when in fact if employed in a quotidian fashion with increased frequency and duration can and does offer a return of useful life.

Perhaps some day, Scribner's dream of an informed and enthusiastic acceptance of this "noble experiment" will come to pass in America despite the fact that one of the greatest medical technologies remains in the hands of a profession truly unworthy of how well they could but don't use this modern medical miracle. Perhaps someday, restoration of whole individuals will be commonplace instead of the unusal oddity when it comes to dialysis.  That day is one nephrology progam at a time away from acceptance even in the best institutions. Perhaps someday. We can only hope.

 

Are American Nephrologists Dialysis Money Sucking Leaches?

By Peter Laird, MD

In a recent post on HemoDoc, (here) I evaluated calls by some in nephrology to increase payment for their services. There is no doubt that many American physicians truly earn their pay and I have no doubt that my colleagues in nephrology do likewise work hard. However, at least one person took exception to my essay and categorically stated that nephrologists are not "dialysis money sucking leaches." However, the unfortunate historical record of American dialysis care does not corroborate that statement. (here)

While we can look to multifactorial improvement in cardiovascular outcomes not simply from revascularization alone as correctly pointed out in the above comment, but instead by a combination of advances in the pharmacologic interventions of myocardial infarction and improvements in revascularization techniques as well which I duly noted in my post; sadly I cannot state the same about dialysis outcomes in the US.

The point of comparison is the measurable advances we see in the treatment of cardiovascular disease in the general population vs. the stagnation of dialysis outcomes in the United States in particular.  When I see the median longevity on dialysis of 36-38 months, (here) which has not improved substantially for decades despite a concerted effort by many to promote optimal dialysis techniques, I must question the American nephrologist individually and collectively who are the only doctors legally able to prescribe dialysis treatments.

Indeed, what technological advances can we point to in the standard in-center treatment of the majority of American dialysis patients that has relieved pain and suffering of our patients in as dramatic a fashion as in many other areas of medicine?

As a dialysis patient myself, I do not take lightly the denial of individualized care I have seen in many units personally. I have been subject to cattle call dialysis sessions where I was yelled at for coming 25 minutes early instead of 30 minutes and suffered inadequate clearances simply because that unit refused my standard treatment at my home center. (here) To deny the existence of money sucking leaches in the field of nephrology is to remain in denial of the truth of the for-profit dialysis industry of the last 40 years.

Clinics Pad Kidney Dialysis Costs

By Jack Anderson

"Washington - Of all the corporate Scrooges in the world, none is lower than one that would squeeze profits form the sick and debilitated."

Today, the American nephrologist cannot stand up and proclaim significant improvements in the treatment of ESRD in the same manner that you can for a broad segment of other high tech specialties. 2012 was supposed to be a year when we saw new dialysis technologies approved by the FDA but 2012 has come and gone and we are not doing any better today than we did in 2011.

I could easily have cited improvements in the treatment of childhood leukemia or peptic ulcer disease or a myriad of other conditions but only used improvements in cardiovascular outcomes as one ready example. Focusing on my one example renders no justice at all to the deficiencies of dialysis care in America that lie entombed in stagnation and an intransigent resolution to not change the system whatsoever. In the meantime, patients on hemodialysis in America have a worse prognosis than AIDS patients and many cancer patients. Shall we gain any benefit by criticizing those who stand up and ask simply why cannot we do better today than we did yesterday?

This remains a uniquely American debate since the rest of the developed world has long since embraced the basic tenants of optimal dialysis. America remains paralyzed by an industry that is one of the most profitable in the US, (here) that is unless you are one of the unfortunate patients beginning dialysis today that only has 36-38 months of median life expectancy remaining. I believe that the American nephrologists have much that they need to account. We could do better and we should do better but shall we do better is the unanswered question.  There remain many champions of dialysis improvement in America, but sadly in my own venture as a dialysis patient, they appear to be few in number collectively. What then do we call the many American nephrologists who do not advocate for documented improvements in basic dialysis outcomes in America?