CPT 48160, G0431, S2102, G0343 -Islet Transplantation

Code Description CPT

48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells

HCPCS

G0341 Percutaneous islet cell transplant, includes portal vein catheterization and infusion
G0342 Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
G0343 Laparotomy for islet cell transplant, includes portal vein catheterization and infusion
S2102 Islet cell tissue transplant from pancreas; allogeneic


Islet Transplantation

Introduction

The pancreas is an organ that stretches lengthwise across the abdominal area below the stomach. Within the pancreas are cell clusters commonly called “the islets.” Included in the islets are beta cells which make, store, and release insulin. Treating chronic inflammation of the pancreas may mean removing the pancreas. Removing the pancreas also removes the islets and the beta cells, which then leads to type 1 diabetes. To prevent the development of type 1 diabetes in people who have their pancreas removed, their own islet cells can be harvested and injected into a specific vein in the liver. Published medical studies show that islet cell transplantation appears to significantly decrease the development diabetes after the pancreas is removed. In this situation, islet cell transplantation may be considered medically necessary. Islet cell transplantation using donor cells is being studied as a technique to treat existing type 1 diabetes. There is not enough medical evidence to show how well this works to treat type 1 diabetes. Larger and longer studies are needed. For these reasons, islet cell transplantation to treat existing type 1 diabetes is investigational (unproven).

Note:  The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 

Policy Coverage Criteria

Procedure Medical Necessity  Autologous pancreas islet transplantation

Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near total pancreatectomy in patients with chronic pancreatitis.

Procedure Investigational
Allogeneic islet transplantation
Islet transplantation, all other

Documentation Requirements

Allogeneic islet transplantation is considered investigational for the treatment of type 1 diabetes.  Islet transplantation is considered investigational in all other situations.

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following: * Office visit notes that contain the relevant history and physical:
o Patient had pancreas removed because of chronic pancreatitis 


Guidelines Nationally Covered Indications

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.

Pancreas transplants alone (PA) are reasonable and necessary for Medicare beneficiaries in the following limited circumstances:

• PA will be limited to those facilities that are Medicare-approved for kidney transplantation. Approved centers can be found at Approved Transplant Programs

• Patients must have a diagnosis of type I diabetes:

* Patient with diabetes must be beta cell autoantibody positive; or

* 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;

• Patients must have been optimally and intensively managed by an endocrinologist for at least 12 months with the most medically-recogni
zed advanced insulin formulations and delivery systems;

•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;

• 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,

• Patients must otherwise be a suitable candidate for transplantation.

If a kidney and pancreas transplants are performed simultaneously, the claim should contain a diabetes diagnosis code and a renal failure code or one of the hypertensive renal failure diagnosis codes. The claim should also contain two transplant procedure codes. If the claim is for a pancreas transplant only, the claim should contain a diabetes diagnosis code and a status code to indicate a previous kidney transplant. If the status code is not on the claim for the pancreas transplant, UnitedHealthcare will  search the beneficiary's claim history for a status  code indicating  a prior kidney transplant.

CPT Code Description

48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or  pancreatic islet cells (Not  covered by Medicare)

48554 Transplantation of pancreatic allograft (CMS sourced)

ICD- 10 Procedure Code Description

0FYG0Z0 Transplantation of pancreas, alloge neic, open approach  (CMS sourced)

0FYG0Z1 Transplantation of pancreas, syngeneic, open approach  (CMS sourced)




Blue Cross and Blue Shield Association Islet Cell Transplantation Billing /Coding/Physician Documentation Information


Applicable service codes:

48160, 48999, G0341, G0342, G0343, S2102

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless  all specific information needed to make a medical necessity determination is included. 


Coding 



Evidence Review 

Description

Performed in conjunction with pancreatectomy, autologous islet transplantation is proposed to reduce the likelihood of insulin-dependent diabetes. Allogeneic islet cell transplantation is being investigated as a treatment or cure for patients with type 1 diabetes.

Background  Chronic Pancreatitis

Primary risk factors for chronic pancreatitis may be categorized as the following: toxicmetabolic, idiopathic, genetic, autoimmune, recurrent and severe acute pancreatitis, or obstructive (TIGAR-O classification system). Patients with chronic pancreatitis may experience intractable pain that can only be relieved with a total or near total pancreatectomy. However, the pain relief must be balanced against the certainty that the patient will be rendered an insulin-dependent diabetic.

Type 1 Diabetes

Glucose control is a challenge for individuals with type 1 diabetes. Failure to prevent disease progression can lead to long-term complications such as retinopathy, neuropathy, nephropathy, and cardiovascular disease.


Islet Transplantation

In autologous islet transplantation during the pancreatectomy procedure, islet cells are isolated from the resected pancreas using enzymes, and a suspension of the cells is injected into the portal vein of the patient’s liver. Once implanted, the beta cells in these islets begin to make and release insulin. 

Allogeneic islet transplantation potentially offers an alternative to whole-organ pancreas transplantation. In the case of allogeneic islet cell transplantation, cells are harvested from a deceased donor’s pancreas, processed, and injected into the recipient’s portal vein. Up to 3 donor pancreas transplants may be required to achieve insulin independence. However, a limitation of islet transplantation is that 2 or more donor organs are usually required for successful transplantation, although experimentation with single-donor transplantation is occurring. A pancreas that is rejected for whole-organ transplant is typically used for islet transplantation. Therefore, islet transplantation has generally been reserved for patients with frequent and severe metabolic complications who have consistently failed to achieve control with insulin-based management. Allogeneic transplantation may be performed in the radiology department. 

In 2000, a modified immunosuppression regimen increased the success of allogeneic islet transplantation. This regimen is known as the “Edmonton protocol.”