CurrentKaiser PermanentePolicy N/A

Kaiser Permanente Clinical Review Criteria - Islet Cell Transplantation

Defines Kaiser Permanente Clinical Review Criteria for islet cell transplantation, including coverage determinations for Medicare and non‑Medicare members, supporting background, and applicable procedure codes. Specifies that islet cell transplantation is considered not medically necessary for non‑Medicare members based on available evidence and lists CPT/HCPCS codes.

Policy Summary

PayerKaiser Permanente

PolicyKaiser Permanente Clinical Review Criteria - Islet Cell Transplantation

Policy CodePolicy N/A

Change TypeRevised — CPT codes added; revision history updated

Effective Date

Next Review Date

Key ActionWhen requesting review for islet cell transplantation, submit the last 6 months of clinical notes from the requesting provider and/or specialist.

POLICY UPDATE CHANGES

06/23/2020: Added CPT codes 0584T, 0585T and 0586T.

Revision history entries list multiple review dates through 12/03/2024.

1Medicare policy referenced (NCD)

1Non-Medicare stance: not medically necessary

3CPT/Category III codes listed

4HCPCS/G-codes listed

Defines Kaiser Permanente Clinical Review Criteria for islet cell transplantation, with a mixed coverage stance: for Medicare members coverage is determined per applicable Medicare policy statements (e.g., NCD 260.3.1) and is considered medically necessary when Medicare criteria are met, while for non‑Medicare members islet cell transplantation is considered not medically necessary. The policy lists applicable procedure codes: CPT Category III codes 0584T, 0585T, 0586T (not medically necessary for non‑Medicare) and HCPCS/G‑codes G0341, G0342, G0343 (used for Medicare determinations).

Key facts — dates, evidence, and code counts

last_review2024-12-03

notable_evidenceShapiro et al., NEJM 2000; islet cell transplantation in seven patients (case series)

evidence_count3 small case series (sample sizes < 10)

Medicare_policy_referencedNCD: Islet Cell Transplantation in the Context of a Clinical Trial (260.3.1)

Non-Medicare_stanceConsidered not medically necessary

CPT_Category_III_codes_count3 (0584T, 0585T, 0586T)

HCPCS_G-codes_count4 (G0341, G0342, G0343, S2102)

Medical‑Necessity Criteria

Medicare Coverage Determination

Medicare members

Considered medically necessary when criteria in the applicable Medicare policy statements (e.g. NCD: Islet Cell Transplantation in the Context of a Clinical Trial (260.3.1)) are met

Follow CMS/NCD requirements for Medicare members

Non-Medicare Coverage Determination

Islet cell transplantation is considered not medically necessary for non‑Medicare members

Insufficient evidence in the published medical literature to show the service/therapy is as safe and effective

Documentation Required for Review

If requesting review for this service, please send the following documentation:

Last 6 months of clinical notes from requesting provider and/or specialist

Coding

Considered medically necessary when Medicare criteria met / HCPCS G-codes (Medicare)HCPCSCovered

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

Provider Actions

Documentation Required

Submit clinical notes for review

When requesting review for islet cell transplantation, submit the last 6 months of clinical notes from the requesting provider and/or specialist.

Last 6 months of clinical notes from requesting provider and/or specialist

Prior Authorization

Medicare member coverage follows NCD

For Medicare members, coverage is determined per applicable Medicare policy statements (e.g., NCD: Islet Cell Transplantation in the Context of a Clinical Trial (260.3.1)). Providers must meet those Medicare criteria for coverage.

G0341
G0342
G0343

Background & Evidence

Published evidence is limited to small case series and early reports; searches found no randomized controlled trials or meta-analyses and only three empirical clinical articles with sample sizes < 10. The Medical Technology Assessment Committee concluded that the effectiveness of islet cell transplantation for type 1 diabetes cannot be determined based on current published evidence and that the procedure does not meet Kaiser Permanente Medical Technology Assessment Criteria.

Metric	Value
Number of empirical clinical articles found	3 small case series (sample sizes < 10)
Notable study	Shapiro et al., NEJM 2000; islet cell transplantation in seven patients with mixed follow-up results

Name	Number	Type	Effective Date
Islet Cell Transplantation in the Context of a Clinical Trial	260.3.1	NCD

Revision History

2000-11-17review

Initial review documented in revision history (11/17/2000).

2011-05-03review

Policy review noted (05/03/2011).

2011-08-02review

Policy review noted (08/02/2011).

2012-06-05review

Policy review noted (06/05/2012).

2013-04-02review

Policy review noted (04/02/2013).

2014-02-04review

Policy review noted (02/04/2014).

2014-12-02review

Policy review noted (12/02/2014).

2015-10-06review

Policy review noted (10/06/2015).

2016-08-02review

Policy review noted (08/02/2016).

2017-06-06review

Policy review noted (06/06/2017).

2020-06-23code_update

Added CPT Category III codes 0584T, 0585T, and 0586T.

2023-03-07review

Policy review noted (03/07/2023).

2024-12-03reviewLatest

Revision history entries list multiple review dates through 12/03/2024 (last review date).