Intestinal and Multi-visceral Transplantation

It is very important that CMS maintains rigorous standards for the credentialing of intestinal transplant programs and I appreciate that setting the criteria for approval as a center of excellence is a difficult task. I think that going forward it will be important to set appropriate volume and survival criteria. I am not certain what the ideal number of cases per year should be, but I am certain of one thing. Intestinal transplantation is a surgical endeavor and the two most important elements required to have a successful intestinal transplant program are 1. the presence of a surgeon with the experience and interest in intestinal transplantation, and 2. an experienced world class transplant program. Using those criteria it is obvious that there are three transplant centers that should be centers of excellence that are not currently on the list. The three programs are University of Wisconsin, University of Minnesota, and University of Washington. Drs. D'Alessandro, Gruessner, and Reyes are giants in the field of intestinal transplantation and have each made countless contributions to the care of patients receiving intestinal transplants. I think it would be very reasonable to approve each of these three programs based on Center excellence and surgical experience in lieu of the current Medicaire requirements.

Approval of these three programs would be of benefit to the patients in their respective regions that are now required to travel great distances to receive care that is available in their local area. I for one am very supportive of Wisconsin's petition for designation as a center of excellence for intestinal transplantation. I my mind they reached that status a long time ago.

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The Medical University of South Carolina (MUSC) respectfully submits the following comments in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed decision memo for Reconsideration of its National Coverage Decision for Intestinal and Multi-visceral Transplantation (CAG-00036R).

MUSC has a long-standing commitment to the practice of organ transplantation and to providing quality medical treatment to those in need of assistance. As such, we are concerned that the current NCD does not take into consideration very genuine access concerns created by the CMS policy position. Many transplant centers simply do not serve patient populations that require 10 intestinal and multi- visceral transplants within a one-year period of time. However, these same transplant centers provide high-quality care that results in overwhelmingly successful transplant outcomes in other transplant areas. Thus, the current CMS policy, perhaps unintentionally, discourages such high quality transplant centers from moving forward with intestinal and multi-visceral transplant programs because reimbursement for such procedures will ultimately be determined by the number of and characteristics of patients that seek the center’s care during a 12 month period of time. The result is that patients are forced to travel sometimes several states away to receive a transplant that could have been conducted in a facility much closer to home. Most high quality transplant centers have long and established histories of conservative medical practice. No transplant center is likely to move forward with intestinal and multi- visceral transplants without the established medical team and transplant expertise in place to accomplish satisfactory outcomes. CMS’s policy appears to disregard the breadth of experience and the wealth of expertise that can develop through high-quality, low-volume intestinal and multi-visceral transplant programs - all at the expense of the beneficiaries CMS is trying to protect.

Moreover, we are concerned that the current CMS coverage policy disadvantages minority and low- income populations. South Carolina, for example, has a large African-American population as well as s disproportionately high number of low-income individuals which MUSC serves. These groups do not have the ability to travel long distances for access for organ transplantation – so over time, the existence of additional transplant centers in the United States performing these procedures is likely to enhance access for minority and low-income populations. In addition, MUSC is concerned that CMS appears to have misread the literature that it references in its proposed decision memo. CMS uses a wide range studies as evidence of a standard based on the annual volume of transplants, when much of the research cited actually discusses outcomes related to the cumulative number of transplants conducted by transplant facilities. In other circumstances, CMS discusses studies that appear to have no bearing on whether a volume-based standard is appropriate for determining reimbursement for intestinal and multi-visceral transplants at particular transplant centers. MUSC respectfully encourages CMS to review the studies cited in the proposed memo, as well as the additional information provided by the University of Wisconsin, to better ascertain the graft survival rates of intestinal and multi-visceral procedures at transplant centers on both an annual and cumulative level.

Finally, the ten transplants-per-year standard is inconsistent with CMS’ proposed rule outlining new conditions of participation for the approval and re-approval of Medicare transplant centers. The proposed rule eliminates the ten transplants-per-year criteria as well as patient survival criteria for transplant centers generally. At this juncture then, it simply does not make sense to hold intestinal and multi-visceral transplants to a volume-per-year standard.

MUSC strongly believes that the quality of a transplant center should be evaluated by the transplant center’s ability to provide safe and successful organ transplants, not by the annual volume of one specific transplant procedure. As such, we support a standard that would permit centers that have performed 10 cumulative intestinal transplants with one year patient survival of 65 percent (using the Kaplan-Meier technique) to become eligible for Medicare coverage for intestinal and multi-visceral transplantation. The policy proposed by the University of Wisconsin is a reasonable approach that encourages quality transplant facilities to take on these difficult surgical procedures while ensuring that Medicare only reimburses facilities that have proven they can successfully treat this particular patient population. We hope you find the above comments useful as you reconsider this policy, and please let me know if MUSC can be of any further assistance as you continue your deliberations.

Respectfully submitted,

Prabhakar Baliga, MD
Professor of Surgery,
Chief, Division of Transplant Surgery,
Medical University of South Carolina

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The current CMS coverage for intestinal and multi-visceral transplantation (IMVT)is unsubstantiated, unfair, lacks a scientific basis, breeds favoritism and is open to litigation. Several analyses by the Intestinal Transplant Registry have shown that only a small graft and pt survival advantage can be demonstrated for centers that have performed > 10 IMVTs total (and not per year, as erroneaously stated in previous CMS correspondence). As most intestinal txs are performed simultaneously with a liver tx, all centers with (1) a proven record of > 10 IMVTs (and with IMVT-specific infrastructure, such as surg/med directors etc) and (2) an active CMS-accredited liver tx program should be eligibable to obtain CMS-coverage. It is also unfair to the patients' families to make them travel long distances if a local/regional tx center could offer IMVTs. In summary, the current CMS policy requires overhaul and contradicts the spirit of equal access to IMVT for all citizens.

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