Humana Solid Organ Transplants - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Solid Organ Transplants Page: 2 of 7 Internet- Only Manuals (IOMs) Pub. 100-02, Medicare Benefit Policy Manual, Chapter 11 Pub. 100-03, Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Sections 200 – 310.1) Coverage Determinations Chapter 11, End Stage Renal Disease Chapter 1, Part 4 Coverage Determinations NCD Adult Liver Transplantation NCD Heart Transplants 260.1 260.9 NCD Intestinal and Multi-Visceral Transplantation 260.5 NCD Islet Cell Transplantation in the Context of a Clinical Trial 260.3.1 NCD Pancreas Transplants 260.3 NCD Pediatric Liver Transplantation 260.2 Description Solid organ transplantation includes pre-transplant, transplant and post-discharge services, including the treatment of complications. Allogeneic islet cell transplants obtain islet cells from another individual for use in the affected person. Allogeneic islet cell transplants are performed in an individual with type 1 diabetes mellitus with the key goal being to eliminate the need for insulin administration. Autologous islet cell transplants are those obtained from and used in the individual’s own body, which are utilized to reduce the incidence of diabetes mellitus in an individual who have undergone a total or near total pancreatectomy due to chronic pancreatitis. Cardiopulmonary (heart and lung) transplants may be performed in an individual with end-stage lung disease that affects the heart (eg, severe pulmonary hypertension). Solid Organ Transplants Page: 3 of 7 Heart transplants may be performed in an individual with irreversible heart damage. Intestinal transplants may be performed in an individual with chronic, irreversible intestinal failure. The transplant allows the individual to become independent of total parenteral nutrition, restores vitamin and nutrient absorption of the small bowel and allows the individual to resume more normal eating habits. There are three categories of intestinal transplantation: intestine-alone transplant, intestine-liver transplant and one that includes stomach, duodenum and pancreas along with the small intestine and liver, which is also known as a multivisceral transplant. Kidney transplants may be performed to provide a healthy kidney for an individual with kidney failure. The transplant may be from a cadaver donor or from a living donor. Liver transplants may be performed in pediatric or adult individual with end-stage liver disease using a healthy liver graft from a donor. The transplant may be from a cadaver donor or a portion from a healthy living donor. Living-related donor segmental pancreas transplants may be performed in order to reduce waiting time for a matched cadaveric organ, to enhance immunologic compatibility and decrease cold ischemic injuries to the donated organ. Lung transplants involve the transplantation of a lung lobe or lobes, to replace the diseased lung(s) of individuals with end stage lung disease. The transplant may be from a cadaver donor or from a living donor. Multivisceral transplants may be performed in an individual who suffer from a loss of organ function due to injury or who have chronic gastrointestinal problems that have resulted in the failure of other organs. Multivisceral organ transplants include the small bowel and liver and can include the stomach, duodenum, jejunum, ileum, pancreas or colon. Pancreas after kidney (PAK) transplants may be performed in an individual with type 1 diabetes mellitus who have already had a successful kidney transplant to treat diabetic renal insufficiency. The goal of PAK transplantation is to prevent, slow or reverse additional secondary diabetic complications, including retinopathy, neuropathy and vasculopathy. Pancreas transplants may be performed in an individual who are nonuremic or preuremic with type 1 diabetes mellitus with the goal of improving quality of life by eliminating the need for exogenous insulin and its associated problems with imperfect glucose control and preventing or reversing secondary diabetic complications. Simultaneous pancreas/kidney (SPK) transplants may be performed to correct complications from type 1 diabetes mellitus. Complications of type 1 diabetes mellitus may include severe impairment of glucose metabolism, increased need for exogenous insulin, renal failure, dialysis, neuropathy, retinopathy and vascular disease. Organ preservation systems are utilized for maintaining organ viability after removal from the donor and during transport for transplantation. These systems include, but may not be limited to, the following: Ex Solid Organ Transplants Page: 4 of 7 Vivo Lung, Kidney Assist, Organ Care System (OCS Heart, OCS Liver, OCS Lung), OrganOx metra System, and RM3 Kidney Perfusion System. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for Adult Liver, Heart, Intestinal and Multi-visceral, Islet cell (context of a clinical trial), and Pancreas transplantation. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: Solid Organ Transplants The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage