CurrentAlliance HealthPolicy Clinical Coverage Policy No: 11B-3

Islet Cell Transplantation

NC Medicaid clinical coverage policy governing coverage, limitations, provider billing and requirements for islet cell transplantation for Medicaid beneficiaries (includes EPSDT considerations for beneficiaries under 21).

Policy Summary

PayerAlliance Health

PolicyIslet Cell Transplantation

Policy CodePolicy Clinical Coverage Policy No: 11B-3

Change TypeNo material changes

Effective DateJanuary 1, 1994

Next Review Date

Key ActionProvider must verify each beneficiary's Medicaid eligibility every time the service is rendered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Autologous onlyType of islet transplantation covered

Allogeneic not coveredType of islet transplantation excluded (investigational)

No prior approval requiredPrior approval / prior authorization policy

1994Original effective date (policy history)

Medical Necessity and Coverage Determinations

General Medical Necessity

Medicaid shall cover the procedure, product, or service related to this policy when medically necessary, and:

ALL of the following

The procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the beneficiary's needs
The procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide
The procedure, product, or service is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary's caretaker, or the provider

Specific Covered Indications

Medicaid shall cover autologous islet transplants when ALL of the following are met:

ALL of the following

Islet autotransplantation is performed together with a total or near total pancreatectomy
Beneficiary has chronic pancreatitis
Procedure is medically necessary

Not Covered / Investigational

Medicaid shall not cover islet cell transplantation in the following situations:

ANY of the following

Allogeneic islet transplantation (considered investigational for treatment of type I diabetes)
Islet cell transplantation for any other indications not specified as covered (considered investigational)
When the beneficiary does not meet eligibility requirements in Section 2.0 or the criteria in Section 3.0
When the procedure is duplicative of another provider's procedure, product, or service
When the procedure, product, or service is experimental, investigational, or part of a clinical trial
Behavioral / compliance exclusions
- Beneficiary's psychosocial history limits ability to comply with pre- and posttransplant medical care
- Current beneficiary or caretaker non-compliance that makes compliance with a disciplined medical regimen improbable

EPSDT (Beneficiaries under 21)

EPSDT may override policy limitations for beneficiaries under 21 when medically necessary to correct or ameliorate a condition, but prior approval requirement (if any) remains applicable:

ALL of the following

EPSDT covers services that are medically necessary to correct or ameliorate defects, illnesses, or conditions for beneficiaries under 21
EPSDT does not require coverage of services that are unsafe, ineffective, or experimental/investigational
If a service requires prior approval, EPSDT does not eliminate the requirement for prior approval

Coding Guidance and Claim Types

Coding guidancemixed

CPT/HCPCS/ICD-10	Policy states providers must report the most specific CPT, HCPCS and ICD-10-CM codes in effect at time of service. Specific procedure codes for islet transplantation are not listed in this policy; use most specific existing codes or appropriate unlisted procedure code with special report.
Unlisted Procedure or Service (CPT/HCPCS)	If no specific CPT/HCPCS exists, report using appropriate unlisted procedure/service code per current coding manuals and include required special report.

Claim typesmixed

837P / CMS-1500	Professional claim type
837I / UB-04	Institutional claim type (Institutional claims must follow National Uniform Billing Guidelines)

Actionable Provider Requirements

Documentation Required

Verify beneficiary Medicaid eligibility at each service

Provider shall verify each Medicaid beneficiary's eligibility each time the service is rendered.

Documentation Required

Retain surgeon certification of FDA requirements

A statement signed by the surgeon certifying that all FDA requirements for implants, products, and devices used in islet cell transplantation have been met must be retained in the beneficiary's medical record and made available for review upon request.

Documentation Required

Use current coding editions and most specific codes

Report ICD-10-CM, PCS, CPT and HCPCS codes to the highest level of specificity in effect at the time of service and follow National Coding Guidelines; if no specific CPT or HCPCS code exists, report using the appropriate unlisted procedure/service code and include the required special report per the current codebook instructions.

Prior Authorization

Prior approval not required

Medicaid does not require prior approval for islet cell transplantation. Note: EPSDT for beneficiaries under 21 does not eliminate prior approval requirements when a service otherwise requires prior approval.

Documentation Required

Provider eligibility to bill

Providers billing for this procedure must meet Medicaid participation qualifications, have a current signed DHHS Provider Administrative Participation Agreement, and bill only for procedures within their licensed scope of practice. Institutional claims must follow National Uniform Billing Guidelines and place of service is Acute Inpatient Hospital.

Meet Medicaid qualifications for participation and maintain a current signed DHHS Provider Administrative Participation Agreement.
Bill only for procedures, products, and services within the provider's licensed scope of clinical practice.
Institutional claims must follow National Uniform Billing Guidelines; place of service: Acute Inpatient Hospital.

Clinical and Regulatory Context

Autologous islet cell transplantation is performed at the time of a total or near‑total pancreatectomy for beneficiaries with chronic pancreatitis to reduce the likelihood of post‑operative insulin‑dependent diabetes. During the pancreatectomy, islet cells are isolated from the resected pancreas and infused into the beneficiary's liver via the portal vein where they function as a free graft to continue insulin production. Modern islet isolation techniques report success rates of approximately 55% in preserving endogenous insulin function.

Allogeneic islet transplantation — where islet cells from donor pancreas tissue are transplanted into a different individual, typically to treat type 1 diabetes — is considered investigational by this policy. The U.S. Food and Drug Administration regulates islet cells; allogeneic islet cells are classified as somatic cell therapy and require premarket approval. Because islet cells also fall under the drug definition, clinical studies must meet Investigational New Drug (IND) requirements to evaluate safety and effectiveness before routine clinical use.

Defined Terms

Definitions

Autologous islet transplantationIslet cells isolated from the beneficiary's resected pancreas and infused into the beneficiary's liver (portal vein) at time of pancreatectomy to preserve insulin production.

Allogeneic islet transplantationIslet cells obtained from donor pancreas tissue and transplanted into a different individual; considered investigational by this policy for type 1 diabetes.

Regulatory status of allogeneic islet cellsAllogeneic islet cells are regulated by the U.S. Food and Drug Administration as somatic cell therapy and require premarket approval and compliance with IND regulations.

Policy Metadata and Scope

This document is NC Medicaid Clinical Coverage Policy No: 11B-3 governing islet cell transplantation. Policy effective date: January 1, 1994; Amended Date/Last review: August 15, 2023. Next review date: not specified. The policy applies to NC Medicaid beneficiaries and includes EPSDT considerations for beneficiaries under age 21. Prior approval is not required for islet cell transplantation under this policy.

Policy Summary

PayerAlliance Health

PolicyIslet Cell Transplantation

Policy CodePolicy Clinical Coverage Policy No: 11B-3

Change TypeNo material changes

Effective DateJanuary 1, 1994

Next Review Date

Key ActionProvider must verify each beneficiary's Medicaid eligibility every time the service is rendered.

SourceLink

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