December 2009


If you want to become an organ donor upon your death but don’t know how to register, you can go to the DonateLife website and follow the instructions for the state in which you reside. Or if you have to justify your purchase of an iPhone, you can go to the Apple iTunes Store and download an app that helps you do it. The app is called DonateLives and is made by Serenity Integration, LLC.

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The Senate version of the health care bill, H.R.3590 passed yesterday. Unfortunately, it does not contain the provision to extend Medicare coverage for immunosuppressive drugs after a kidney transplant that transplant advocates, including me, supported. But it also does not contain the provision to reduce payments to dialysis centers which was lobbied against by the Kidney Care Partners. The House version of the bill H.R.3962 contains both provisions. My guess is both provisions are now dead and will not appear in the reconciled bill.

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While reading the Senate bill, I noticed that the opening paragraph says this:

“To amend the Internal Revenue Code of 1986 to modify the first-time homebuyers credit in the case of members of the Armed Forces and certain other Federal employees, and for other purposes.”

What’s up with that?

Well, if you remember your high school civics classes, only the House can start a revenue bill. To get around that proscription, the Senate just takes an existing House revenue bill, strikes all of the content except the enacting clause, and replaces it with their desired content.

Here’s another interesting tidbit I learned. While the Senate bill was being debated, the Democrats worried that the GOP would block the bill using a filibuster, in which opponents of a bill prevent it from coming to a vote by not yielding the floor. To prevent that, they used a cloture vote which stops all debate. This vote requires a three-fifths majority (60 out of 100) to pass, which the Democrats hold. To see how divisive politics has become in the U.S., look at the graph below showing how more frequent cloture votes have become in the past year.

ClotureVoting

Frequency of Senate cloture votes by biennial terms. Image from Wikipedia

The above chart could be made more informative by indicating the ratio of Democrats to Republicans in the Senate each year and which party held the House of Representatives. My guess is that cloture votes are much more likely when the ratio is close to 60-40 and the majority party in the Senate also holds the House. That’s because when the minority party is weak, the threat of a filibuster is one of the few tools it has available to modify legislation. And when the ratio is close to 60-40, there is some uncertainty whether there will be enough votes to stop the filibuster.

In my last blog post, I hinted at a possible conflict of interest between transplant centers and the dialysis industry. That is, transplant centers want to encourage all of their patients with end stage renal disease (ESRD) for whom renal replacement therapy is medically advisable to consider the option. On the other hand, dialysis centers, equipment manufacturers, and pharmaceutical companies believe that they are providing the best treatment option for their patients.

Another Dec 2009 blog post hints at this conflict of interest by noting the low-level of compliance by dialysis treatment centers to the Medicare requirement that they inform patients of the renal replacement therapy option and help patients get on the UNOS waiting list. Dialysis centers want their patients (customers) to be comfortable. It is unlikely the staff wants to make patients anxious by consistently reminding them of the need to find a donor, get a transplant, and get off of dialysis. Further, patients have much more contact with the personnel at the dialysis center, where they go several times a week for several hours per visit, than they do with the physicians at their local hospital (which may not be a transplant center) or with transplant nephrologists or surgeons at a transplant center. Thus, to avoid cognitive dissonance, patients may discount advice they receive from physicians to find a donor since it is an emotionally difficult task and conflicts with the patient’s image of good care they are getting from the dialysis center.

In an earlier blog post, I noted that current Medicare policy misallocates resources by subsidizing expensive dialysis for the life of the patient but limits subsidies for immunosuppressant medication to only three years after a kidney transplant. I support the addition of lifetime coverage for antirejection drugs proposed in the House and Senate versions of the health care reform bill. I thought this was uncontroversial. However, the issue is more complex than I first believed.

A story in the Dec 14, 2009 New York Times points out that adding this coverage may have the unintended consequence of causing dialysis centers in rural areas to close. This is because the bill will reduce Medicare reimbursement rates for dialysis treatment. Dialysis centers with a higher proportion of Medicare patients will be hurt the most, as will smaller dialysis centers, which tend to have higher fixed costs, The centers most likely to be affected are in rural areas which serve sparsely populated regions and serve an older population that is less likely to have private insurance. Many of them may be forced to close. The Kidney Care Partners, a coalition that includes kidney patients, dialysis centers, pharmaceutical firms, equipment manufacturers, and the National Kidney Foundation, is lobbying Congress to not allow this to happen, even if this means dropping the increased coverage for antirejection drugs.

This is stupid. There is no reason to link these two actions. Increasing funding for post-operative medications will encourage more kidney patients to seek a transplant and make it more likely that patients that do get a transplant will adhere to their drug regimen. This will enhance patient quality of life, potentially increase longevity, and possibly even reduce overall Medicare costs. Reducing Medicare reimbursement rates for dialysis will reduce costs, but it does nothing to encourage patients to switch their treatment from dialysis to renal replacement.

[Update 1: I added a final paragraph explaining that the two funding decisions should be independent.]

[Update2: The Senate version of the health care bill, H.R.3590, passed on Dec 24. It does not contain the provision to extend Medicare coverage for immunosuppressive drugs or to reduce payments to dialysis centers.]

A recent (Dec 2009) blog post discussed the issue of kidney patients with end stage renal disease (ESRD) who get on the UNOS transplant waiting list, but are unable to get a donor organ. Today’s entry will explore the problem of kidney patients who for some reason don’t ever get on the waiting list.

Not all patients with ESRD are good candidates for transplants. For instance, they may have one or more comorbidity factors (specifically, they are not healthy enough to undergo surgery, had cancer within the past five years, have heart disease, or have type 2 diabetes). These patients won’t get on the waiting list. However, some patients don’t get on the list for the wrong reasons. For instance, because of miscommunication, some patients are never informed that renal replacement therapy is an option for them. Among patients who are told, some decide they don’t want the transplant surgery.

All patients with ESRD should be told that a transplant is the preferred option when it is medically advisable. However, it is not clear how many patients are told this or understand it.  In a report published in Dec 2009 Pittsburgh Tribune-Review, investigators looked at Medicare records and found that at many dialysis clinics none of the patients have been informed of the transplant option and the centers had no patients on the transplant waiting list. However, the story concedes this may be due to a timing issue. The Medicare forms are filled out when the patient first visits the clinic and the patient may not be informed at that time. The records are not updated if the patient’s status changes at a later date.

Some patients don’t get on the list because of biases (possibly unconscious) by doctors when advising patients. For instance, a study published in the Oct 1999 Health Services Research shows that patients with only Medicare insurance coverage (who are more likely to be minority, female, and poor) were less likely to be placed on the U.S. transplant waiting list than patients with private insurance. Since the research only looked at statistical data rather than conducted patient interviews, it isn’t clear if the result is because 1) patients without insurance are actually less likely to be good candidates, 2) doctors are less likely to inform patients without insurance of treatment options, or 3) the patients were advised, but did not follow through. In any case though, nephrologists should be made aware of the potential bias and take steps to ensure their advice and actions do not discriminate against patients based on insurance status, race, gender, or income.

Another study in Jan 2009 J. Amer. Soc. Nephr. (subscription required) found that women over 45 are less likely to be placed on the kidney transplant list than men. This bias persists even though women are as likely to survive as men.

A study in Oct 2009 Amer. J. Transpl. (subscription required) found that African-Americans were 27% less likely than Caucasians to be recommended for kidney-pancreas transplants. Hispanics were 25% less likely to be recommended. The authors speculate that some of the bias may be due to physicians incorrectly assuming that African-Americans have type 2 diabetes and are thus ineligible for a two-organ transplant. Changes in Medicare legislation in 1999 to cover two-organ transplants increased transplant rates for all races, but did not close the gap.

Even if a patient gets on the waiting list, they may not get an organ. A study in Feb 2008 J. Amer. Soc.  Nephr. (subscription required) found that the more obese a patient was (as measured by body mass index or BMI), the more likely the patient was to be skipped for another patient on the list. It is possible that these patients had other comorbidity factors that disqualified them for a transplant, but it may also be due to a bias toward selecting non-obese patients.

What about patients who are informed of the transplant option but decide they don’t want to be placed on the list? One possible reason is that they believe that a kidney transplant should be a last resort, after undergoing dialysis. Until I decided to become a kidney donor, I thought the preferred treatment for kidney patients with ESRD was to first try dialysis and if that failed, then get a transplant. However, that is not true. Studies have shown that if the patient is a suitable transplant candidate, then an early transplant, called a preemptive transplant, results in superior outcomes and is the preferred treatment. Dialysis is used only because of the shortage of organs. Unfortunately, a recent survey reported in Nov 2009 Amer. J.  Nursing shows that up to half of kidney patients believe that dialysis must precede a transplant and 60% viewed transplantation as a last resort.

Another potential reason that a kidney patient with ESRD would decline a transplant is fear of surgery. A focus group of medical professionals conducted in South Carolina revealed fear of surgery to be one of six perceived barriers to living donor kidney transplantation among African-Americans. The results are reported in June 2006 J. Natl. Medical Assoc. The emotional stress continues after receiving an organ transplant and fear of this may also discourage accepting a transplant.

Finally, concerns about the cost of surgery and the ongoing costs of immunosuppressive medication may discourage some patients. As mentioned in an Sep 2009 blog post, Medicare covers the cost of dialysis but not antirejection drugs. So even though dialysis is expensive and leads to lower quality of life, some patients may choose it rather than a transplant because it is more affordable for them.

[Update: I added a paragraph about an article in the Pittsburgh Tribune Review.]

The AP reported on Dec 14 that three kidney transplant chains involving a total of 26 patients has just been completed at Georgetown University Hospital and Washington Hospital Center, both in Washington DC. Each chain started with an altruistic donor, one of whom is a volunteer for the National Kidney Foundation who wanted to “walk the talk.” The article indicates that the number of surgeries could have been greater, but one donor-recipient pairs was dropped because of health issues and one of the chains was broken when a recipient was unable to tolerate the anesthesia and his surgery was halted. The donor kidney was given to another patient who was not paired with an unmatched donor, stopping the chain. The AP provided a slideshow of images on Dec 15 and a chart outlining the chain of donors and recipients.

13way

Flowchart showing three intertwined exchanges. Image from Georgetown University Hospital

Unfortunately, the article doesn’t make clear why all the surgeries were done in a short time span. Each chain could have been done separately. Further, one of the advantages of chains started by altruistic donors is they eliminate the need for simultaneous surgeries, as explained below. For an example of a long slowly growing chain see a Nov 2009 blog post that highlights a single chain involving 21 patients that has been going on for over two years now.

In a 2-pair exchange (see figure below), two unmatched pairs, labeled 0 and 1, agree to swap donors. The exchanges are almost always done simultaneously. If they do not, there is a risk of the following scenario. Let’s say the donor in pair 0 and recipient in pair 1 complete the transplant. Then later, before the transplant between the donor in pair 1 and recipient in pair 0 can take place, the donor is no longer available (either because of health reasons or the donor declines the surgery). Now the recipient in pair 0 is in a much worse position. He/she does not get a kidney and will no longer have an unmatched donor available to re-enter the exchange.

2PairExchange

Two-pair kidney swap. Image by George Taniwaki

The need for simultaneous surgeries is eliminated with chains started by altruistic donors. As can be seen below, if any donor becomes unavailable, the next unmatched pair in the chain is only slightly worse off than before. The recipient no longer has a matched kidney available, but can re-enter the exchange to find a new one.

Chain

Kidney chain. Image by George Taniwaki

A very surprising fact about the chain started by the altruistic donor at the NKF is that he was not the first person in his chain to donate chronologically. I have never seen this before in any other donor chains I have read about. At least two of the recipients in his chain received transplants after their donors gave their kidneys to someone else. This can be seen clearly in a diagram provided by the hospital.

[Update1: I added a link to the chart and added comment that the chains could have been longer.]

[Update2: Added comment that new diagram provided by Georgetown Hospital reveals an unusual aspect of this chain is that the donations were not sequential.]

Windows Live Spaces doesn’t allow blog entries to have multiple category tags. So below are links to recent entries I posted under the Health and Wellness category that are also relevant to data-based decision making.

Mar 17, 2010 – Kidney exchanges will save patients’ lives (part 1) – better software

Dec 25, 2009 – Senate health care bill does not contain extension

Dec 18, 2009 – Too many patients with ESRD don’t get kidneys (part 2) – unequal access

Dec 5, 2009 – Too many patients with ESRD don’t get kidneys (part 1) – finding a live donor

Nov 30, 2009 – Is donating a kidney safe?

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