Dialysis and the Problem of Unintended Consequences

A recent New York Times article by Gina Kolata highlighted the debate surrounding dialysis as an end-of-life treatment.  In reading the article and surfing the internet for counter-arguments, I found two points of interest.

Background

According to the Medicare ESRD Network Organizations Manual, Section 299I of the Social Security Amendments of 1972, Pub. Law 92-603, which “created the National End Stage Renal Disease (ESRD) Program … [and] extended Medicare coverage to individuals with ESRD who require either dialysis or transplantation to maintain life.”  In addition, depending on your perspective, Sec. 299I requires/limits the entitlements for/to individuals under the age of 65 who have insurance coverage (remember this age and insurance coverage part — it will be important later in the discussion).

By the time the legislation was adopted in 1972, only 10,000 individuals were being dialyzed in the country and only 20,000 to 25,000 were considered candidates for the procedure.  Section 299I was estimated to cost $250 million over the first four years.  Now, according to the N.Y. Times, about 400,000 people will undergo dialysis at an estimated cost of $40 billion to $50 billion in this year alone.

Has the entitlement had the unintended consequence of benefiting those over 65?

Kolata argues that this law was intended “to keep young and middle-aged people alive and productive” and has had the unintended consequence of financing dialysis treatment for (primarily elderly) individuals who are too sick to benefit from the treatment.  She explains:

When Congress established the entitlement to pay for kidney patients in October 1972… [Congress expected] that most of those patients would be healthy — except for their failed kidneys — and under age 54.

Now… More than a third of the patients are 65 or older, and they account for about 42 percent of the costs. People over 75 make up the fastest-growing group of dialysis patients. And most elderly dialysis patients have other serious diseases like diabetes, heart failure, stroke and even advanced dementia. One-third of them have four or more chronic conditions.

Others, however, would argue that Sec. 299I has not benefited the elderly because they were already entitled to Medicare coverage prior to its enactment.  In the “Dialysis from the sharp end of the needle” blog, Bill Peckham writes in response to Kolata’s argument:

No no no. Dialyzors who are “old and have other medical problems” have access to Medicare due to age or disability, “patients who take advantage of the law” are few: only about 25,000 people [out of about 417,000] have access to Medicare as a consequence of Section 299I of the Social Security Amendments of 1972.

Well…  According to Kaiser, the source of Peckham’s figures, only 5.8% of Medicare enrollees with ESRD directly benefit from Section 299I.  But what about indirect benefits? A comprehensive history of Section 299I can be found in Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972, a chapter in Biomedical Politics.  Richard A. Rettig writes:

It was presumed that the benefit existed for the elderly, however, because a Medicare benefit could not be established for those under 65 and not be available for the elderly. In fact, very few elderly persons were being dialized at the time and none were receiving transplants.  Although the Bureau of Health Insurance had answered several inquiries in the previous year, the nature and extent of coverage for the elderly had not been clarified.

The entitlement for those under the age of 65 extends from the third month after “a course of renal dialysis is initiated” until a year after the person has a renal transplant or ends the course of dialysis.  This section could have been read to provide an entitlement to dialysis and renal transplant solely to those under the age of 65, or it could be interpreted to create a near universal entitlement to such treatments.

It seems that President Nixon’s administration read Section 299I according the latter interpretation, because in his statement on the Signing of the Social Security Amendment of 1972 Nixon said, “it extends Medicare coverage for kidney transplants and renal dialysis.”

Aggressive Treatment and End of Life Care

“Clearly, when the program was initiated in the 1970s, the hope and expectation was that this program would return otherwise healthy people back into society so they could work and be productive,” said Dr. Manjula Kurella Tamura, a kidney specialist at Stanford. But, she added, “dialysis at the end of life is a different sort of treatment.”

A second important aspect of the article is its focus on end-of-life care.  Even Peckham concedes that, “caring for the elderly is expensive and aggressive treatment may not always be in the interest of the ill. That is a serious discussion our electorate should have but has not been able to have.”

The article highlights new clinical practice guidelines produced by the Renal Physicians Association designed to promote, through shared decision-making and informed consent, “medical management without dialysis.”  Particularly concerning is that the provision of dialysis gives patients false hope of survival.  According to the NY Times:

Recent studies have found that dialysis does not prolong life for many elderly people with other serious chronic illnesses. One study found that the procedure’s main effect is to increase the chances that such patients will die in the hospital rather than at home.

Yet, a 78-year-old woman is quoted as saying, “I go to dialysis because I want to live.  I want dialysis.”  Although he doctors explained that dialysis would not necessarily prolong her life, she chose aggressive treatment because, “Some life is better than no life.”  This anecdotal story raises a HUGE informed consent problem because it appears that the patient may not have understood the risks and benefits of undergoing dialysis.

Key to the decision to forego, commence, or withdraw dialysis is a properly informed consent. The above guidelines state that certain patients, including those age 75 years and older, those with high comorbidity scores, those with marked functional impairment, or those with severe chronic malnutrition, “should be informed that dialysis may not confer a survival advantage or improve functional status over medical management without dialysis and that dialysis entails significant burdens that may detract from their quality of life.”

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The ESRD program has provided life-saving dialysis to many people.  However, as with many other tests and treatments performed in the last year of life, it is important to ensure that patients (or their legal decision-makers) are properly informed about the risks and benefits of all options, including palliative care, at the end of life.

Donate a Kidney and Get Out of Jail

I can’t read another paean to Mississippi Gov. Haley Barbour for granting a release from imprisonment to Gladys Scott on condition that she “donate” a kidney to her sister.

The Scott sisters were sentenced to life 16 years ago for an armed robbery that yielded them $11. The women will be eligible for parole in 2014.

Civil rights advocates have sought the two women’s release for some years, arguing that their sentences were excessive.

Barbour’s decision has been hailed by the NAACP President and CEO as “a shining example of the way a governor should use the power of clemency.” A primary reason cited by Barbour for his decision is that sister Jamie’s dialysis is costing the state a lot of money. According to Gladys Scott’s attorney, the idea that she donate a kidney to her sister was her own, which is why he included it in the petition for release.

While available reports do not provide sufficient facts for robust legal-moral analysis, this story raises issues that should give us pause.

First and foremost, I am concerned on Gladys Scott’s behalf that a kidney donation is in neither her short- or long-term best interests - I can only wonder whether her own health makes her an ideal donor after serving a 16-year prison sentence.

We don’t know what led to Jamie’s end-stage renal disease, but it is crucial that Gladys know what her own risk for the disease is before she gives up a healthy kidney. Will her physicians feel comfortable recommending against the surgery if her long-term prognosis is poor - would such a decision result in the revocation of the prison release, or is the release contingent upon a medical “OK” for the procedure?

Compromise

To what extent will the transplant physicians be required to compromise their own ethical duties to the health of these women to accommodate their desire for freedom?

Hopefully, Barbour’s release decision depends upon Gladys’ willingness to be considered as an organ donor, as opposed to her having to actually go through with it.

While I believe it possible that Gladys wishes to donate her kidney to save her sister’s life, the conditions under which she has made this decision are hardly ideal to voluntariness, which our law normally dictates is a necessary condition precedent to organ donation.

These women have been incarcerated their entire adult lives, and have likely made very few decisions on their own behalf, much less life-and-death ones.

Other doubts haunt this scenario. If indeed the Scott sisters merited a suspension of their sentences because they are excessive, then the governor should have made his decision for that reason, thereby enabling the women to resolve how to proceed in addressing Jamie’s kidney failure in the context of their private lives, without state compulsion and outside the glare of the media.

I hope they have significant and stable support upon their release - in addition to undergoing a significant medical procedure, they may not be well-prepared for successful reentry even in the best of circumstances.

Barbour cites the opportunity to save the state health costs by releasing the sisters to pursue the transplant. If the transplant is both a cost-effective and humane alternative to dialysis (which I believe it is) why wasn’t it allowed during the sisters’ incarceration?

While the state may be expecting to save money for the sisters’ health care, it is presumably Medicare that will be covering the cost of the transplant and the extremely expensive post-surgical anti-rejection drugs that Jamie will require (although Jamie’s eligibility for Medicare will likely be fraught with hurdles).

Thus, a large part of the state’s motivation here seems to be the chance to shift Scott from the state’s Medicaid roll to the federal government’s Medicare program.

A fragmented system

While this might work out in the end for the Scott sisters, it represents yet another perversity of our fragmented health care system.

The Scott sisters must be wonderfully excited about their imminent release, and the possibility of saving Jamie’s life, and I am pleased for them.

I am less excited, however, about Barbour’s decision becoming a precedent for other governors.

This article originally appeared in The Record, New Jersey’s most awarded newspaper.

Kidney Sales, a Free-Market Approach

Recent events in New Jersey have served to highlight deficiencies in the Kidney Market.

The impoverished of the world, at present, freely considering their options in a market economy, have taken to selling their kidneys, valued at roughly $160,000 on the less than open market, to kidney brokers for the approximate sum of, give or take, $10,000.

At present one may sell a body part legally only in Iran. Thus, as anyone steeped in the strict virtues of Chicago School economics would tell you, the Market in Kidneys suffers at present from “distortions.” The problem, of course, is two fold: the almost universal illegality has added risk to the cost; and limited access to the market has allowed the brokers, through government interference and lack of open competition, to exclude others from their fair share of the profit.

The Kidney Exchange

Patterned after the stock exchange (or perhaps the commodity exchange is a more apt analog), I propose we create, as part of a market driven health reform initiative, a Kidney Exchange. Value maximization will ensure the free flow of kidneys into the most appropriate markets and the most appropriate recipients.

In the interest of fairness and transparency, full reports on each putative “donor” will be submitted to the exchange by medical clinicians who (as is the current practice among medical device researchers) will be paid in stock options in the subjects of their examinations. This stake in the endeavor will ensure commitment to the process. These reports will function as the basis for prospectus and, in the case of those not yet ready for immediate harvest, ongoing quarterly reports.

We would not, of course, limit the purchase of kidneys to those who “need” the actual kidneys, as that too would tend to skew the market. “Need” must be determined through the time-tested criteria of the market: availability of, and a willingness to use, investment capital.

Because, however, even with the most thorough information that money can buy, things can on occasion go awry, we will need a market instrument to ensure protection in the event of failure. Kidney Default Swaps (KDS), an insurance of sorts keyed to whether or not the putative “donor” ultimately tenders a viable kidney. Further, KDS could be patterned after the Credit Default Swap–in that we can allow investors with no connection or insurable interest in the transaction to wager freely on the ultimate outcome–thus creating another lucrative market.

Of course, to combat inefficiencies, a wholesale market will ultimately develop, procurement and development syndicates will be set up, and branded groups of similar subjects will be packaged together for large investors like collateralized mortgage securities.

This investor/market driven approach will further ensure the development of a “Pipeline” to enhance quality and dismiss with the vagaries of procurement.

And lest we forget the benefit to the “donor,” the market too will provide for it. Obviously, anyone who has invested a handsome sum in 4 year old boys from Pakistan (”Pak-Neph B4, b. type O+, trading at…”) will have great interest in safeguarding his investment–nourishing well those kidneys until they are ready for harvest upon demand.

Considering the environmental risks involved for the “free range” donor in many prime but impoverished areas, “harvest banks” to house homegrown investments will, of course, be built. Within the sterile confines of such banks, subjects will grow, watered and fed and exercised to ensure sufficient blood flow and proper kidney function. Subjects kept thus would of course demand a premium on the open market.

Furthermore, upon harvest and release into world, such harvest bank subjects can also readily be expected to breed. Uneducated and untrained in any vocation (market contraindicated) one can reasonably expect them to turn over for modest profit the products of their breeding to the market for eventual harvesting–thus ensuring a steady supply of prime kidneys for generations to come. Naturally, the best genetic lines of kidneys will be identified–arrangements can be made (”Pak-Neph B14/Braz-NephG16, b. type AB+, trading at…), profits in accord.

The addition to one’s portfolio of such financial instruments as “Kidney Futures” or “Kidney Options,” will, I believe, prove a handsome reward to savvy holders. And a thriving business in Kidneys could well be just the market innovation that this economy needs to pull it out of its current doldrums. A Kidney Exchange will provide a swift feast of employment and real wealth.  And of course, we need not be limited to kidneys, there are many other organs that the poor do not, and cannot, use to best advantage.

Conclusion

280 years have passed since Jonathan Swift offered his “Modest Proposal” for solving the pangs of poverty in Catholic Ireland through the sale and eating of Irish babies.[1] Consider this an update of sorts.

There is, however, one distinction between the Swift model that is worth noting: considering the high market value of Irish babies, Swift proposes a preference in procurement for ravenous English Landlords:

I grant this food will be somewhat dear, and therefore very proper for landlords, who as they have already devoured most of the parents, seem to have best title to the children.

A Kidney Exchange, less sentimental but more modern, would, of course, put the preference where the invisible hand of the market deems it best (though under Swift’s criteria the  IMF, and World Bank would seem to be the  sentimental favorites). In this way it would allow, as we do now with private health insurance, that most efficient of instruments, the market, to decide who lives or dies.

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[1] Swift notes that before the age of 12, Irish children were  not particularly saleable or employable, and that “They can very seldom pick up a livelihood by stealing till they arrive at six years old.” His solution stems from the following:  “I have been assured by a very knowing American of my aquaintance in London that a young healthy child well nursed is at a year old a most delicious, nourishing, and wholesome food, whether stewed, roasted, baked, or boiled; and I make no doubt that it will equally serve in a fricassee or a ragout.” His modest proposal: “I do therefore humbly offer it to public consideration that of the hundred and twenty thousand children, already computed, twenty thousand may be reserved for breed…. That the remaining hundred thousand may at a year old be offered in sale to persons of quality and fortune through the kingdom, always advising the mother to let them suck plentifully in the last month, so as to render them plump and fat for a good table.”

The full title of the piece is “A Modest Proposal For Preventing The Children of Poor People In Ireland From Being A Burden To Their Parents Or Country, And For Making Them Beneficial To The Public.” Though most noted for his relatively benign Gulliver’s Travels, Swift’s Modest Proposal helped make him a hero among the Irish.