Point32 Solid Organ Transplant: Pancreas-Kidney Transplant, Pancreas Transplant, Pancreas Islet Cell Transplant(Eff. beginning 1.1.24) Form

Combined transplantation of the kidney and pancreas

Combined transplantation of the kidney and pancreas may be indicated for those Members for whom pancreas transplant is indicated who also have concomitant diabetic ESRD. Kidney and pancreas transplant candidates might be currently on dialysis or might require dialysis in the near future. Pancreas transplant alone has specific indications for Type I diabetes that is so severe that routine exogenous insulin therapy is inefficient. Pancreas islet cell transplant may be useful as an autograft in the setting of total pancreatectomy for chronic pancreatitis. Type II diabetes is not an indication for pancreas transplantation.

To initiate the prior authorization process, it is necessary to complete and submit the Pancreas Transplant Request for Coverage Form and the Kidney Transplant Request for Coverage Form, if applicable.

Clinical Guideline Coverage Criteria

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan Members. MassHealth Medical Necessity Determinations and CMSPoint32Health companies2111779Solid Organ Transplant: Pancreas-Kidney Transplant, Pancreas Transplant, Pancreas Islet Cell Transplant1National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals are the basis for coverage determinations where available.

For Tuft’s Health One Care plan Members the following criteria is used:

• Pancreas Transplants NCD 206.3
• MassHealth Medical Necessity Determinations for Organ Transplant Procedures

Pancreas Transplantation Alone:

1. Absence of clinical history of emotional, psychological, or behavioral events precluding diligent compliance with insulin-based regimen to control blood sugar that has resulted in hospitalization within the two years prior to authorization; and
2. Consistent failure of insulin-based management to prevent acute complications, despite documented diligent Member compliance with transplant program recommendations; and
3. History of frequent, acute, and severe metabolic complications (hypoglycemia, marked hyperglycemia, ketoacidosis) requiring recurrent hospitalization

Simultaneous Pancreas-Kidney Transplant (SPK):

The Plan may authorize a simultaneous pancreas-kidney transplant (SPK) for Members with end stage renal disease from Type I diabetic nephropathy for Members aged 18 to 55 who meet all of the criteria for a kidney transplant.

Pancreas Transplantation after a previous kidney transplant:

The Plan may authorize pancreas transplantation after a previous kidney transplant for Members with Type I diabetes mellitus who meet all of the criteria for a simultaneous pancreas-kidney transplant (SPK).

Autologous Islet Cell Transplantation:

The Plan may authorize an autologous islet cell transplantation as an adjunct to a total or near total pancreatectomy in Members with chronic painful pancreatitis only if the Member is having the procedure performed at a center with an experimental pancreatic islet cell transplant program and appropriate islet cell extraction /purification techniques available on site.

Limitations

The Plan will not authorize coverage of a pancreas-kidney, pancreas, or pancreas islet cell transplant for Members with ONE of the following:

1. Active or uncontrolled alcohol use disorder or substance use disorder
2. Advanced ileo-femoral vascular disease
3. Any past history of active tuberculosis, systemic or localized solid organ fungal infection excluding candida dermatitis, solid organ viral infection (e.g., hepatitis, encephalitis, mumps) and malignant neoplasm other than basal cell carcinoma within the past five years
4. Any unresolved psychosocial concerns or history of noncompliance with medical management
5. History of malignancy within past 5 years of transplantation

Human immunodeficiency virus (HIV) disease unless ALL of the following are met:

1. CD4 count greater than 200 cells/mm3 during 3 months prior to transplantation
2. Undetectable HIV-1 ribonucleic acid (RNA)
3. Stable anti-retroviral therapy for > 3 months
4. Absence of serious complications associated with or secondary to HIV disease (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections; Kaposi’s sarcoma; or other neoplasm)

Obesity:

Patients’ weight over 130% of ideal (BMI 25-28 kg/m2 to encompass NIH and CDI guidelines) or BMI ≥ 35 kg/m2

Serous conditions that create an inability to tolerate transplant surgery or post-transplant care

The Plan will not authorize coverage of an Islet cell transplant alone for diabetes mellitus because it is considered to be experimental and investigational

Note: Smoking has been strongly correlated to adverse health and surgical outcomes. There is evidence to show that smoking, both by donors and by recipients, has a major impact on outcomes after organ transplantation. Smoking cessation is strongly recommended for both donors and recipients prior to transplantation.

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