Pancreas Transplants

Re: Comments Regarding the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memorandum Related to Coverage for Pancreas Transplantation Alone

Ladies and Gentlemen:

We very much support CMS’ proposed decision to cover pancreas transplantation alone (PTA), in addition to transplantation of the pancreas simultaneously with and following kidney transplantation. The following brief preamble to our comments explains our role in organ procurement and transplantation and the context for these comments.

UNOS is a Virginia non-profit corporation that operates the National Organ Procurement and Transplantation Network (OPTN) under contract with the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), and pursuant to the National Organ Transplant Act of 1984, as amended (NOTA), and associated regulations. Among the duties assigned to the OPTN are responsibilities for developing and operating a national computer system for matching candidates in need of organ transplants with available donor organs and for establishing the medical criteria by which these donor organs are allocated among all candidates who are registered with the national matching system. UNOS also is tasked with providing input on proposed Federal regulations with potential impact upon the fields of organ procurement and transplantation as deemed relevant and appropriate by the OPTN/UNOS Board of Directors.

In accordance with these charges, OPTN/UNOS has developed organ-specific policies for the allocation of kidneys, livers, thoracic organs, pancreata (including islets), and intestinal organs. Also pursuant to these charges, OPTN/UNOS has established minimum procurement standards for organs that include requirements to assure organ procurement quality, safe packaging, and prevention of infectious disease transmission for diseases such as AIDS and hepatitis. The standards anticipate challenges that result from multiple organ recovery from single donors, and try to maximize the number of transplantable donor organs.

We very much appreciate the opportunity to comment on CMS’ proposed decision regarding PTA coverage. Comprehensive reimbursement strategies promote access to safe, appropriate medical therapies. They also may help facilitate pancreas recovery efforts overall, increasing use of a presently under-utilized resource, and providing relief for candidates in need of pancreas transplantation.

We have reviewed comments from the American Society of Transplant Surgeons (ASTS), dated August 26, 2005, submitted in response to CMS’ initial request for public comment regarding PTA coverage. We believe these comments thoroughly support PTA as an accepted, evidence-based medical therapy for treating type 1 diabetes, with the aim of inducing insulin-independence.

We note further that since 1988, OPTN/UNOS allocation policies have included criteria for the allocation of whole pancreas. Fairly recent changes to these policies differentiate in the allocation of pancreata for whole organ or pancreatic islet transplantation based upon donor age and body mass index (BMI). The intent is to facilitate pancreas recovery and placement. All pancreata are offered first at the local level of distribution for whole organ transplantation (with an exception permitted for combined solid organ-islet transplantation). They may be used for isolated pancreas transplantation (either alone or following a kidney transplant) or in combination with a donor kidney. The policy does not assign different priority based upon use as PTA or transplantation with kidney. Only a selected subset (i.e., donor age > 50 years or body mass index (BMI) > 30 kg/m2) is next offered for pancreatic islets. The system itself, developed with input and consensus from the medical community together with lay community participation, provides additional evidence of the benefit of pancreas transplantation, whether as a PTA or in combination with or following a kidney transplant.

Again, we appreciate the opportunity to comment on this important proposed coverage decision. If you have questions regarding our comments, or if we can provide information that would be useful to you as you reconsider the proposal, please do not hesitate to contact us.

Very truly yours,

/s/

Francis L. Delmonico, M.D.
President

/s/

Peter G. Stock, M.D., Ph.D.Chair, Pancreas Transplantation Committee

Less

The American Diabetes Association is pleased to comment on the Proposed Decision Memo for Pancreas Transplants (CAG-00295R).

Pancreas transplants can significantly improve the quality of life for people with type 1 diabetes by eliminating the need for insulin therapy, frequent blood glucose testing, and dietary restrictions. They can also eliminate acute, life-threatening hypoglycemic and hyperglycemic episodes in diabetes patients, as well as prevent long-term diabetes complications from worsening.

Pancreas transplants are primarily performed in one of two situations: simultaneously with kidney transplants (SPK); or after a kidney transplant has already been performed (PAK). Even though these are the most common practices, the Association feels that for certain patients “those with type 1 diabetes that cannot be controlled despite repeated and diligent efforts a pancreas transplant alone (PA) is a reasonable, effective, and often necessary course of treatment.

According to Pancreas and Islet Transplantation for Patients With Diabetes (Diabetes Care 23:112-116), while PA has a lower success rate than SPK or PAK, this may simply be a result of the greater difficulty in detecting pancreas rejection as compared to kidney rejection. Indeed, since anti-rejection therapy is risky in that it suppresses the patient's immune system, doctors often wait until organ rejection becomes evident before increasing immunosuppressant therapy to more aggressive levels. Because signs of kidney rejection typically appear in a patient's bloodwork sooner than do signs of pancreas rejection, kidney rejection tends to be more quickly treated with aggressive immunosuppressant therapy. As such, SPK and PAK patients experiencing organ rejection are more likely to receive aggressive anti-rejection treatment sooner than PA patients. Indeed, it is this earlier treatment that helps protect both the kidney and the pancreas and improves the success rate. With PA patients, on the other hand, there is an increased risk that organ (pancreas) rejection will go undetected until much later. Even given the somewhat lower success rate of PA, this is not reason enough to designate it too risky to perform in all cases. For some people with diabetes, the potential benefits of PA far outweigh the risks. In the Position Statement on Pancreas Transplantation for Patients With Type 1 Diabetes (Diabetes Care 23:117), the Association identified three criteria to determine PA candidacy:

1) a history of frequent, acute, and severe metabolic complications (hypoglycemia, hyperglycemia, ketoacidosis) requiring medical attention;
2) clinical and emotional problems with exogenous insulin therapy that are so severe as to be incapacitating; and
3) consistent failure of insulin-based management to prevent acute complications.

In the Proposed Decision Memo for Pancreas Transplants, CMS has incorporated the Association's recommended guidelines into their criteria for Medicare coverage of PA. CMS has limited PA coverage to type 1 patients with a consistent, documented history of insulin therapy failures and recurring life-threatening complications requiring hospitalization. They further require that PA be performed in approved kidney transplantation centers that are experienced in assisting with the medical and emotional needs of transplant patients. The Association believes that these are all reasonable limitations on PA that will still allow the patients who need it most to receive the care they need to improve their quality of life.

The Association applauds CMS's efforts to expand coverage of pancreas transplants to include coverage of PA for certain patients who meet the criteria listed above. In these cases, PA is a reasonable, effective, and necessary course of treatment.

Less