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Commentary: Transplantation's most troubling year in a decade signals it is time to revisit NOTA.

In the wake of organ donation and transplantation's most troubling year in recent memory, the time has come to revisit the National Organ Transplant Act (NOTA). Congress should hold hearings on the state of organ and tissue donation and transplantation system today - what's working, what's not and what needs to be changed.

Lets face it, NOTA is 20 years old and has never been revised. When the framework for the national transplant system was created, there was no way to anticipate how the field would change. There was tremendous optimism that ways could be found to get Americans to donate.

Remember required request? Didn't work.

Remember decoupling the request for donation from the pronouncement of death. Didn't work.

Remember the rapid increase in the number of transplant programs? Didn't increase the number of transplants but did generate negative publicity as programs and states fought over who gets the lifesaving organ.

The driving force behind most of the problems, of course, is the tremendous gap between the number of organs available for transplantation and the number of people on the waitlist for the scarce, lifesaving resource.

In many ways, 2006 provided a snapshot of what has gone wrong in transplantation over the last two decades:

*The year began as it ended, with the Los Angeles Times exposing a variety of irregularities in Southern California transplant programs. Problems unearthed included high turn-down rates for kidneys, high death rates following kidney transplantation, high death rates on the transplant waitlist, and inadequate staffing.

The granddaddy of them all was the unbelievably ill-advised decision by Kaiser Permanente to no longer pay for 1,500 Kaiser patients on waiting lists at two "outside" transplant centers - University of California San Francisco and University of California Davis. The largest HMO in the US had the audacity to tell its patients on the waiting list for a kidney that it would pay only for kidney transplants performed at its own hospital at Golden Gate Park in San Francisco. The Kaiser kidney program was ultimately shutdown and investigations by various agencies are continuing.

*The tissue banking community was rocked by two tissue recovery and processing scandals. The stolen body parts scandal involving New Jersey-based Biomedical Tissue Services (BTS), which was exposed in late 2005, continued to percolate as new evidence of gruesome backroom recovery practices involving funeral homes and the number of lawsuits filed grew throughout the year. Alistair Cooke, the genteel British broadcaster who hosted Masterpiece Theater became a symbol of the awfulness when it was revealed his bones and tissues had been "surgically plundered."

In August, the Food and Drug Administration (FDA) ordered Donor Referral Services (DRS), a human tissue recovery firm located in Raleigh, NC, to cease all manufacturing operations because of "serious deficiencies" in its manufacturing, donor-screening and record-keeping practices.

To date there have been no reports of recipients of tissue distributed by BTS or DRS contracting an infectious disease, but the FDA continues to investigate and the negative publicity continues to resonate.

*Public solicitation of organs, the buying and selling of organs (i.e. "valuable consideration"), media campaigns, transplant tourism, have all been in the news and are being debated. But the truth of the matter is when confronted with the odds of a loved one in need of a transplant dying on the waiting list people are willing to go to extreme measures without questioning the ethics or legality of their action.

*There are ongoing investigations into the problems cited above including the Government Accounting Office (GAO), FDA and possibly the Department of Health and Human Services Office of the Inspector General (OIG). Federal officials in charge of the nation's transplant programs and officers of the Organ Procurement and Transplantation Network (OPTN) and UNOS have already been interviewed by the GAO and a lengthy report is considered inevitable.

The FDA has hinted strongly that its investigation into tissue banking and processing irregularities will lead to increased oversight by the agency.

To its credit, the UNOS/OPTN Board of Director's Membership and Professional Standards Committee (MPSC) has moved quickly to address the lack of oversight problems that have come to light through the LA Times reporting. It should be noted that the Times has not just focused on California programs. It has also called attention to underperforming programs nationwide that have fallen below benchmarks established by the Centers for Medicare and Medicaid Services (CMS).

The OPTN/UNOS board of directors is expected to take some actions at its meeting in Tucson Dec. 13-14. There is no question CMS, HRSA, the GAO and perhaps even the OIG will be paying very close attention.

Beyond that, however, Congress needs to pay serious attention to these problems. I believe the transplant community should take the lead in calling for congressional hearings to explore the current state of the organ and tissue transplantation and donation system in the US. Here are some of the issues that should be discussed:

*Oversight - One of the major problems is not necessarily the lack of oversight, but the lack of a single authority with oversight responsibilities. CMS and HRSA are the federal agencies with that charge but they often seem out of sync. Add the "voluntary oversight" by the OPTN and UNOS, and even the Joint Commission on the Accreditation of Healthcare Agencies (JCAHO), and it muddies the water even further.

An audioconference on the Joint Commission Organ Transplant Center Certification Program presented by Transplant News on Nov. 16 revealed that transplant centers are concerned that the Joint Commission rules, which are voluntary and CMS regulations which will be mandatory, may be redundant. The Joint Commission rules are scheduled to be implemented on March 31, 2007. However, the CMS transplant center regulations are expected to be published at least a month earlier.

*Valuable consideration --This is a hot button topic that needs to be discussed. NOTA strictly forbids valuable consideration in any form but it has become apparent it isn't just about prohibiting the buying and selling of organs.

On Nov. 20 surgical teams at Johns Hopkins completed the first five-way donor kidney swap among 10 individuals. All five organ recipients - three men and two women -- are reportedly doing fine, as were the five donors. However, under a strict interpretation of NOTA, live kidney paired donation may be illegal. Robert Montomgery, MD, the Hopkins surgeon who led the complex operation, told the Baltimore Sun this "triumph of the human spirit over adversity" was carried out under a legal cloud that Congress might have created unintentionally 22 years ago.

"The legality of what we have done here is unclear, yet no one who has a mind or a heart could say that it was wrong," Montgomery said. While no money changes hands in live kidney-paired donation, however, "you are donating a kidney to someone you don't know, with the presumption that your loved one will receive an organ in return," he explained.

Senator Carl Levin (D-MI) has introduced legislation (S.2306) the Living Kidney Organ Donation Clarification Act - which aims to clarify "ambiguous language" in Section 301 of NOTA to assure kidney paired donation is not to be considered the purchase of an organ. That legislation was not passed and is expected to be reintroduced when the newly constituted Congress convenes in 2007.

I believe the hearings should also feature testimony on valuable consideration, i.e. buying and selling organs. There is no consensus in the US on the issue and more and more groups believe, as I do, that at the very least a trial should be held to determine what the impact on donation - negative or positive - might be.

*The revised Uniform Anatomical Gift Act - In July the National Conference on Uniform State Laws (NCCUSL) adopted the first revised UAGA in 20 years. The NCCUSL says it anticipates the revised UAGA will be introduced in 31 states in 2007. However, getting it adopted is going to mean hard work. The last revision in 1987 was only adopted by 26 states. Testimony on the new UAGA could give it a much better chance of passage in all 50 states over the next 2-3 years.

*Public solicitation of organs - NOTA clearly says directed donations are legal which prohibits any legal crackdown on billboards, solicitation for organs on the Internet, etc. That may be ok but testimony on the pros and cons would be valuable in deciding what is appropriate and what isn't.

*Medical tourism - As long as there is a major donor shortage and countries like the Philippines, China, etc. are actively advertising for people to get high quality, safe transplants, this is going to be a worldwide issue. Despite the best intentions of the World Health Organization and the Transplantation Society, it seems unlikely to abate in the near future.

*Tissue banking and processing regulation changes - Senator Charles Schumer (D-NY) has drafted legislation and hearings are likely to be held. Tissue banking is already pretty heavily regulated by the FDA but the BTS and DRS scandals have ignited a firestorm of bad publicity and raised safety issues that should be discussed.

Any way you look at it, 2007 looks to be a very interesting year for the transplant community. Hopefully the problems exposed this year will lead to a major fine tuning of the federal and voluntary oversight of the nation's organ and tissue donation and transplantation system.
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Title Annotation:National Organ Transplant Act of 1984
Comment:Commentary: Transplantation's most troubling year in a decade signals it is time to revisit NOTA.(National Organ Transplant Act of 1984)
Author:Warren, Jim
Publication:Transplant News
Geographic Code:1USA
Date:Dec 1, 2006
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Next Article:CMS to cease funding two California heart transplant programs for failure to meet minimum standards.

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