(Medicare National Coverage Determinations Manual)

Liver transplantation is covered for Medicare beneficiaries when performed in a pediatric hospital that performs pediatric liver transplants if the hospital submits an application which CMS approves documenting that:   The hospitals pediatric liver transplant program is operated jointly by the hospital and another facility that has been found by CMS to meet the institutional coverage criteria in the Federal Register notice of April 12, 1991;    The unified program shares the same transplant surgeons and quality assurance program (including oversight committee, patient protocol, and patient selection criteria); and    The hospital is able to provide the specialized facilities, services, and personnel that are required by pediatric liver transplant patients.   260.3 - Pancreas Transplants (Effective April 26, 2006)  (Rev. 56, Issued: 05- 19-06, Effective: 04 -26-06, Implementation: 07- 03-06 Carriers/10- 02-06 FIs)  A.  General   Pancreas transplantation is performed to induce an insulin- independent, euglycemic state in diabetic patients.  The procedure is generally limited to those patients with severe secondary complications of diabetes, including kidney failure.  However, pancreas transplantation is sometimes performed on patients with labile diabetes and hypoglycemic unawareness.   B.  Nationally Covered Indications   Effective for services performed on or after July 1, 1999, whole organ pancreas transplantation is nationally covered by Medicare when performed simultaneous with or after a kidney transplant.  If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy begins with the date of discharge from the inpatient stay for the pancreas transplant.  Effective for services performed on or after April 26, 2006, pancreas transplants alone (PA) are reasonable and necessary for Medicare beneficiaries in the following limited circumstances:    1. PA will be limited to those facilities that are Medicare -approved for kidney transplantation. (Approved centers can be found at http://www.cms.hhs.gov/ESRDGeneralInformation/02_Data.asp#TopOfPage .)   2. Patients must have a diagnosis of type I diabetes:    Patient with diabetes must be beta cell autoantibody positive; or     o Patient must demonstrate insulinopenia defined as a fasting C -peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method.  Fasting C -peptide levels will only be considered valid with a concurrently obtained fasting glucose  <225 mg/dL.   3. Patients must have a history of medically -uncontrollable  labile (brittle) insulin -dependent diabetes mellitus with documented recurrent, severe, acutely life -threatening metabolic complications that require hospitalization.  Aforementioned complications include frequent hypoglycemia unawareness or recurring severe ketoacidosis, or recurring severe hypoglycemic attacks;    4. Patients must have been optimally and intensively managed by an endocrinologist for at least 12 months with the most medically -recognized advanced insulin formulations and delivery systems;    5. Patients must have the emotional and mental capacity to understand the significant risks associated with surgery and to effectively manage the lifelong need for immunosuppression; and,   6. Patients must otherwise be a suitable candidate for transplantation.   C.  Nationally Non -Covered Indications   The following procedure is not considered reasonable and necessary within the meaning of section 1862(a)(1)(A) of the Social Security Act:   1. Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial (see section 260.3.1 of the National Coverage Determinations Manual).   D.  Other   Not applicable.   (This NCD last reviewed April 2006.)   260.3.1 - Islet Cell Transplantation in the Context of A Clinical Trial (Effective October 1, 2004)  (Rev. 18, Issued 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04)  A.  General   As a result of section 733 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108- 173), The Secretary of the Department of Health and Human Services, acting through the National Institute of Diabetes and Digestive and Kidney Disorders, shall conduct a clinical investigation of pancreat ic islet cell transplantation that includes Medicare beneficiaries.   The transplant is performed on patients with Type I diabetes.  A typical islet cell transplant requires over 500,000 islet cells, but varies depending on the recipients weight.  One of the desired patient outcomes is insulin independence.  Elimination of clinically significant hypoglycemia episodes and improved glucose control are other important patient outcomes   One or more pancreata are obtained from donor(s).  The islets must be removed within hours after the recovery of the donor pancreas to ensure viability.  The islet cells are transplanted by injection into the portal vein of the recipient either using direc t visualization, guided ultrasound or percutaneously.  The islet cell transplant may be performed alone, in combination with a kidney transplant, or after a kidney transplant.  Islet recipients require immunosuppressant therapy to prevent rejection of the transplanted islet cells.  Routine follow -up care is necessary for each trial participant.   B.  Nationally Covered Indications   Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH) -sponsored clinical trial(s).  The term `routine costs' means r easonable and necessary routine patient care costs, including immunosuppressive drugs and other follow -up care, as defined in section 310.1 of the NCD Manual.   Specifically, Medicare will cover transplantation of pancreatic islet cells, the insulin producing cells of the pancreas.  Coverage will include the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.  C.  Nationally Noncovered Indications   Partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial continues to be noncovered.   D.  Other   Not applicable.   (This NCD last reviewed July 2004.)   260.4 - Reserved  (Rev. 1, 10- 03-03)  260.5 - Intestinal and Multi- Visceral Transplantation (Effective May 11, 2006)  (Rev. 58, Issued:  05- 26-06; Effective:  05 -11-06; Implementation:  06- 26-06)  A.  General   Medicare covers intestinal and multi- visceral transplantation for the purpose of restoring intestinal function in patients with irreversible intestinal failure.  Intestinal failure is defined as the loss of absorptive capacity of the small bowel secondary to severe primary gastrointestinal disease or surgically induced short bowel syndrome.  It may be associated with both mortality and profound morbidity.  Multi- visceral transplantation includes organs in the digestive system (stomach, duodenum, pancreas, l iver and intestine).  The evidence supports the fact that aged patients generally do not survive as well as younger patients receiving intestinal transplantation.  Nonetheless, some older patients who are free from other contraindications have received the procedure and are progressing well, as evidenced by the United Network for Organ Sharing (UNOS) data.  Thus, it is not appropriate to include specific exclusions from coverage, such as an age limitation, in the national coverage policy.   B.  Nationally Covered Indications   Effective for services performed on or after April 1, 2001, this procedure is covered only when performed for patients who have failed total parenteral nutrition (TPN) and only when performed in centers that meet approval criteria.   1.  Failed TPN   The TPN delivers nutrients intravenously, avoiding the need for absorption through the small bowel.  TPN failure includes the following:    Impending or overt liver failure due to TPN induced liver injury.  The clinical manifestations include elevated serum bilirubin and/or liver enzymes, splenomegaly, thrombocytopenia, gastroesophageal varices, coagulopathy, stomal bleeding or hepatic fibrosis/cirrhosis.    Thrombosis of the major central venous channels; jugular, subclavian, and femoral veins.  Thrombosis of two or more of these vessels is considered a life threatening complication and failure of TPN therapy.  The sequelae of central venous thrombosis are lack of access for TPN infusion, fatal sepsis due to infected thrombi, pulmonary embolism, Superior Vena Cava syndrome, or chronic venous insufficiency.    Frequent line infection and sepsis.  The development of two or more episodes of systemic sepsis secondary to line infection per year that requires hospitalization indicates failure of TPN therapy.  A single episode of line related fungemia, septic shock and/or Acute Respiratory Distress Syndrome are considered indicators of TPN failure.    Frequent episodes of severe dehydration despite intravenous fluid supplement in addition to TPN.  Under certain medical conditions such as secretory diarrhea and non-constructable gastrointestinal tract, the loss of the gastrointestinal and pancreatobiliary secretions exceeds the maximum intravenous infusion rates that can be tolerated by the cardiopul monary system.  Frequent episodes of dehydration are deleterious to all body organs particularly kidneys and the central nervous system with the development of multiple kidney stones, renal failure, and permanent brain damage.   2.  Approved Transplant Facilities   Intestinal transplantation is covered by Medicare if performed in an approved facility.  The criteria for approval of centers will be based on a volume of 10 intestinal transplants per year with a 1 -year actuarial survival of 65 percent using the Kaplan -Meier technique.   C.  Nationally Non -covered Indications   All other indications remain non- covered.   D.  Other   NA.  (This NCD last reviewed May 2006.)   260.6 - Dental Examination Prior to Kidney Transplantation  (Rev. 1, 10- 03-03) CIM 50 -26  Despite the dental services exclusion in 1862(a)(12)  of the Act (see the Medicare Benefit Policy Manual, Chapter 16, General Exclusions From Coverage, 140;), an oral or dental examination performed on an inpatient basis as part of a comprehensive workup prior to renal transplant surgery is a covered service.  This is because the purpose of the examination is not for the care of the teeth or structures directly supporting the teeth.  Rather, the examination is for the identification, prior to a complex surgical procedure, of existing medical problems where  the increased possibility of infection would not only reduce the chances for successful surgery but would also expose the patient to additional risks in undergoing such surgery.  Such a dental or oral examination would be covered under Part A of the program if performed by a dentist on the hospitals staff, or under Part B if performed by a physician.  (When performing a dental or oral examination, a dentist is not recognized as a physician under 1861(r)  of the Act.)  (See the Medicare General Information, Eligibility, and Entitlement Manual, Chapter 5, Definitions, 70.2, and the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 150.)   260.7 - Lymphocyte Immune Globulin, Anti -Thymocyte Globulin (Equine)  (Rev. 1, 10- 03-03) CIM 45 -22  The lymphocyte immune globulin preparations are biologic drugs not previously approved or licensed for use in the management of renal allograft rejection.  A number of other lymphocyte immune globulin products of equine, lapine, and murine origin are curre ntly under investigation for their potential usefulness in controlling allograft rejections in human transplantation.  These biologic drugs are viewed as adjunctive to traditional immunosuppressive products such as steroids and anti -metabolic drugs.  At pr esent, lymphocyte immune globulin preparations are not recommended to replace conventional immunosuppressive drugs, but to supplement them and to be used as alternatives to elevated or accelerated dosing with conventional immunosuppressive agents.   The FDA has approved one lymphocyte immune globulin preparation for marketing, lymphocyte immune globulin, anti -thymocyte globulin (equine).  This drug is indicated for the management of allograft rejection episodes in renal transplantation.  It is covered under Medicare when used for this purpose.  Other forms of lymphocyte globulin preparation which the FDA approves for this indication in the future may be covered under Medicare.   260.8 - Reserved  (Rev. 1, 10- 03-03) Reserved   260.9 - Heart Transplants  (Rev. 95; Issued:  09- 10-08; Effective Date:  05 -01-08; Implementation Date: 12 -01-08)  A.  General   Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. (See CMS Ruling 87- 1.)  B.  Exceptions