Islet Cell Transplantation

Policy ID: S-144-028

Section: Surgery

Effective Date: July 01, 2022

Revised Date: October 18, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

Description

Autologous pancreas islet transplantation is performed during the pancreatectomy procedure. A suspension of isolated islet cells is created from the recipients resected pancreas specimen and then injected in the portal vein of the liver where the cells function as a free graft.

Allogeneic pancreas islet transplantation involves isolating islet cells from the pancreas of a cadaver donor, which are then purified and transplanted into the recipient via the portal vein or one of the tributaries of the liver where they take up residence and resume function.

Donislecel-jujn (Lantidra) is an allogeneic pancreatic islet cellular therapy for the treatment of adults with type 1 diabetes-related severe hypoglycemia who cannot attain target blood glucose levels despite intervention, also known as Brittle Type 1 Diabetes (T1D).

Criteria

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

Autologous pancreas islet transplantation not meeting the criteria indicated in this policy is considered not medically necessary.

Procedure Code

48160

Donislecel-jujn (Lantidra) may be considered medically necessary for the treatment of T1D when ALL of the following are met:

Adult individuals 18 years of age or older; and
A diagnosis of T1D for greater than or equal to 5 years; and
Individual is unable to approach target HbA1c; and
History of at least one (1) episode of severe hypoglycemia in the past three (3) years, defined as an event with symptoms compatible with hypoglycemia that required the assistance of another person, and which was associated with either a blood glucose level less than 50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration; and
Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of less than 54 mg/dL (3mmol/l); and
Documentation of intensive diabetes management and education that includes multiple daily injections of prandial and basal insulin or continuous subcutaneous insulin, frequent monitoring of blood glucose levels, use of continuous glucose monitor (CGM) or insulin pump; and
Donislecel-jujn (Lantidra) will be used in conjunction with concomitant immunosuppression; and
Individual does not have ANY of the following:
- Liver disease or renal failure; or
- History of renal transplant; or
- Active infection including hepatitis C, hepatitis B, HIV; or
- History of malignancies except squamous or basal skin cancer; or
- Co-existing cardiac disease such as myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure; or
- Stroke within the past six (6) months; or
- Recent (within 30 days) creatinine clearance less than 80 mL/min/1.73m ² by 24-hr urine collection; or
- Recent (within 30 days) macroalbuminuria greater than 300mg/ 24hr; or
- Serum creatinine consistently greater than 1.5 mg/dL; or
- Baseline Hb less than 12gm/dL in women, less than 13 gm/dL in men; or
- Recent (within 30 days) liver function test panel with any value greater than 1.5 times normal upper limits; or
- Recent (within 30 days) HbA1c greater than 12%; or
- Insulin requirement great than 0.7 IU/kg/day; or
- C-peptide response to glucagon stimulation, any C-peptide greater than 0.3ng/mL; or
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six (6) months.
Initial authorization will be for one (1) infusion.

Reauthorization Criteria

Reauthorization of donislecel-jujn (Lantidra) may be considered medically necessary when ALL of the following criteria are met:

Individual has not achieved independence from exogenous insulin after the first or second islet infusion; or
HbA1c has increased over 6.5% after the first or second islet infusion; and
A second or third islet infusion may be performed if individual does not achieve independence from exogenous insulin within one year of infusion (but no sooner than four (4) weeks after the previous infusion) or within one year after losing independence from exogenous insulin after a previous infusion; and
Individual has not exceeded max 3 infusions per lifetime; and
Reauthorization will be for one (1) infusion.

The use of donislecel-jujn (Lantidra) not meeting the criteria indicated in this policy is considered not medically necessary.

Allogeneic pancreas islet transplantation not meeting the criteria indicated in this policy is considered not medically necessary.

Procedure Codes

0584T

0585T

0586T

G0341

G0342

G0343

J3490

J3590

S2102

Outpatient HCPC (C Codes)

C9399

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code: 48160

K86.0

K86.1

Covered Diagnosis Codes for Procedure Code: J3490, J3590, and C9399

E10.10

E10.11

E10.21

E10.22

E10.29

E10.35

E10.36

E10.40

E10.41

E10.42

E10.44

E10.61

E10.62

E10.63

E10.64

E10.65

E10.69

E10.8

E10.9

Professional Statements and Societal Positions Guidelines

National Institute for Health and Care Excellence-2008

Guidance from the National Institute for Health and Care Excellence (2008) indicated the evidence on allogeneic pancreatic islet cell transplantation for type 1 diabetes has shown that serious procedure-related complications may occur, and the long-term immunosuppression required is associated with risk of adverse events. A related 2008 guidance addressed autologous islet cell transplantation for improved glycemic control after pancreatectomy and stated that studies have shown 'some short-term efficacy, although most require individuals' insulin therapy in the long term... complications result mainly from the major surgery involved in pancreatectomy (rather than from the islet cell transplantation).'

ND Committee Review

Internal Medical Policy Committee 11-14-2019 (Update No Change to Criteria)

Internal Medical Policy Committee 1-22-2020 Coding update

Internal Medical Policy Committee 3-17-2021 Revised policy language

Internal Medical Policy Committee 1-20-2022 Revised policy

Internal Medical Policy Committee 1-26-2023 Revision

Removed experimental/investigational statements.

Internal Medical Policy Committee 11-15-2023 Revision and Coding updates - Effective January 01, 2024

Added verbiage for Lantidra
Added procedure codes J3490, J3590, and C9399
Added diagnosis codes E10.10, E10.1, E10.21, E10.22, E10.29, E10.35, E10.36, E10.40, E10.41, E10.42, E10.44, E10.61, E10.62, E10.63, E10.64, E10.65, E10.69, and E10.9
Updated references.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-144-027

Section: Surgery

Effective Date: July 01, 2018

Revised Date: December 27, 2022

Revision Effective Date: March 06, 2023

Last Reviewed: January 26, 2023

Archived Date: December 31, 2023

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

Autologous pancreas islet transplantation not meeting the criteria indicated in this policy is considered not medically necessary

Procedure Codes

48160

Allogeneic pancreas islet transplantation for the treatment of type I diabetes mellitus is considered not medically necessary.

Procedure Codes

0584T

0585T

0586T

G0341

G0342

G0343

S2102

Covered Diagnosis Codes for Procedure Code: 48160

K86.0

K86.1

Professional Statements and Societal Positions Guidelines

National Institute for Health and Care Excellence-2008

Guidance from the National Institute for Health and Care Excellence (2008) indicated the evidence on allogeneic pancreatic islet cell transplantation for type 1 diabetes has shown that serious procedure-related complications may occur, and the long-term immunosuppression required is associated with risk of adverse events. A related 2008 guidance addressed autologous islet cell transplantation for improved glycemic control after pancreatectomy and stated that studies have shown "some short-term efficacy, although most require individuals insulin therapy in the long term... complications result mainly from the major surgery involved in pancreatectomy (rather than from the islet cell transplantation)."

ND Committee Review

Internal Medical Policy Committee 11-14-2019 (Update No Change to Criteria)

Internal Medical Policy Committee 1-22-2020 Coding update

Internal Medical Policy Committee 3-17-2021 Revised policy language

Internal Medical Policy Committee 1-20-2022 Revised policy

Internal Medical Policy Committee 1-26-2023 Revision

Removed experimental/investigational statements

Links

References (PDF)

Disclaimer

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