CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Islet Cell Transplant

Defines coverage and medical necessity criteria for autologous and allogeneic pancreatic islet cell transplantation for BlueCHiP for Medicare and Commercial products, including coding and billing instructions for Medicare clinical trials.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Islet Cell Transplant

Policy CodePolicy N/A

Change TypeClarified coding and effective dates

Effective DateJun 1, 2006

Next Review Date

Key ActionDocument member diagnosis of chronic pancreatitis (ICD-10 K86.1) and that the islet transplantation is performed as an adjunct to a total or near-total pancreatectomy.

SourceLink

POLICY UPDATE CHANGES

Policy updated to list effective dates for CPT/T-codes (0584T/0585T/0586T effective 1/1/2020) and to indicate these codes are invalid for BlueCHiP for Medicare (use G-codes for CMS-approved studies).

CoveredAutologous covered for chronic pancreatitis with pancreatectomy

RestrictedAllogeneic covered only in Medicare clinical trial

ExcludedAllogeneic not medically necessary for Commercial

Coverage Summary

Scope: This policy defines coverage and medical necessity criteria for autologous and allogeneic pancreatic islet cell transplantation for BlueCHiP for Medicare and Commercial products, and includes coding and billing instructions for Medicare clinical trials.

Overview and high-level stance: Autologous islet transplantation performed as an adjunct to a total or near-total pancreatectomy for members with chronic pancreatitis is considered medically necessary/covered. Allogeneic islet transplantation for type 1 diabetes is investigational/restricted: it is considered not medically necessary for Commercial products and is covered for BlueCHiP for Medicare only when provided as part of an approved CMS/NIH clinical trial with appropriate clinical trial billing modifiers and codes.

Medical Necessity Criteria

Autologous Islet Transplantation - Medically Necessary

Autologous pancreas islet transplantation is considered medically necessary as an adjunct to a total or near total pancreatectomy in members with chronic pancreatitis when ALL of the following are met:

ALL of the following

Performed as an adjunct to a total or near-total pancreatectomy
Member has chronic pancreatitis (ICD-10 K86.1 Other chronic pancreatitis)

Autologous Islet Transplantation - Not Covered/Not Medically Necessary

Autologous islet transplantation is considered not covered or not medically necessary for BlueCHiP for Medicare and Commercial products in all other situations

ANY of the following

Autologous islet transplantation performed outside the context of total or near-total pancreatectomy for chronic pancreatitis

Allogeneic Islet Transplantation - BlueCHiP for Medicare

Allogeneic pancreatic islet cell transplantation is covered for BlueCHiP for Medicare members only as part of an approved CMS/National Institutes of Health clinical trial when ALL of the following apply:

ALL of the following

Member is enrolled in an approved clinical trial (CMS approved clinical study / NIH-sponsored clinical trial)
Services billed with appropriate clinical trial modifier (e.g., Q0 for investigational clinical service in approved research study or Q1 for routine clinical service in an approved clinical research study)

Allogeneic Islet Transplantation - Commercial Products

Allogeneic islet transplantation is considered not medically necessary for the treatment of type 1 diabetes

ANY of the following

Allogeneic islet transplantation for treatment of type 1 diabetes (Commercial products)

Coding

Covered CPT/Procedure for Autologous Transplant (both lines)CPTCovered

48160

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

Covered Diagnosis for Autologous TransplantICD-10Covered

K86.1

Other chronic pancreatitis

BlueCHiP for Medicare Covered Study HCPCS/G-codes (must use modifier Q0/Q1 for study billing)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

BlueCHiP for Medicare - Invalid/Replaceable Codes (use G-codes above)CPT/HCPCSNot Covered

0584T	Islet cell transplant, percutaneous (effective 1/1/2020) - invalid for BlueCHiP for Medicare; file with appropriate G code
0585T	Islet cell transplant, laparoscopic (effective 1/1/2020) - invalid for BlueCHiP for Medicare; file with appropriate G code
0586T	Islet cell transplant, open (effective 1/1/2020) - invalid for BlueCHiP for Medicare; file with appropriate G code
S2012	Islet cell tissue transplant from pancreas, allogeneic - invalid for BlueCHiP for Medicare; file with appropriate G code

Commercial Products - Not Medically Necessary Procedure CodesmixedNot Covered

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
0584T	Islet cell transplant, percutaneous (effective 1/1/2020)
0585T	Islet cell transplant, laparoscopic (effective 1/1/2020)
0586T	Islet cell transplant, open (effective 1/1/2020)
S2102	Islet cell tissue transplant from pancreas, allogeneic

Provider Actions & Billing Rules

Documentation Required

Document chronic pancreatitis and pancreatectomy

Document that the member has chronic pancreatitis (ICD-10 K86.1) and that the islet transplantation was performed as an adjunct to a total or near‑total pancreatectomy (CPT 48160) to support coverage for autologous islet transplantation.

48160
K86.1

Billing Rule

Clinical trial billing modifier for Medicare

For BlueCHiP for Medicare members treated as part of a CMS‑approved clinical study, claims must be billed with the appropriate clinical trial modifier: Q0 for investigational clinical service in an approved research study or Q1 for routine clinical service in an approved clinical research study. BlueCHiP for Medicare claims filed without the Q0 modifier will deny as not covered.

Q0
Q1
Note: Use G0341/G0342/G0343 for Medicare clinical study billing

Billing Rule

Use G-codes for Medicare clinical study billing

For BlueCHiP for Medicare clinical study billing, use the listed G‑codes (G0341, G0342, G0343). The T‑codes (0584T, 0585T, 0586T) and listed S codes (S2012, S2102/S2102 variant) are invalid for BlueCHiP for Medicare and should be filed with the appropriate G code instead.

G0341
G0342
G0343
0584T
0585T
0586T
S2012
S2102

Background, Evidence and Definitions

Autologous versus allogeneic context: Autologous islet transplantation uses islet cells isolated from the patient’s resected pancreas during pancreatectomy and is performed to reduce the likelihood of insulin-dependent diabetes after total or near-total pancreatectomy for chronic pancreatitis. Allogeneic islet transplantation uses islet cells harvested from deceased donor pancreata and may require multiple donors; it is being investigated as a treatment for type 1 diabetes and has variable long-term outcomes. Regulation: The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion under 21 CFR parts 1270 and 1271, and islet cells are included in these regulations.

Topic	Summary
{"text":"Autologous islet transplantation evidence","status":""},{"text":"Case series and systematic reviews indicate autologous islet transplantation performed with total or near-total pancreatectomy decreases incidence of diabetes after pancreatectomy, is not associated with serious complications in this context, and evidence is sufficient for a net health benefit.","status":""}
{"text":"Allogeneic islet transplantation evidence","status":""},{"text":"Randomized trial and case series show some benefit (eg, reduced severe hypoglycemia) but limited follow-up, inconsistent long-term benefit, and overall evidence is insufficient to determine effects on health outcomes for type 1 diabetes.","status":""}
{"text":"Medicare coverage","status":""},{"text":"Medicare covers pancreatic islet transplantation for patients with type 1 diabetes only when participating in an NIH/CMS-approved clinical trial; procedures outside approved trials are not covered.","status":""}

Autologous islet transplantation: Islet cells isolated from the patient's resected pancreas during pancreatectomy and infused into the portal vein of the same patient; performed as an adjunct to total or near-total pancreatectomy to reduce post‑pancreatectomy diabetes.

Allogeneic islet transplantation: Islet cells harvested from a deceased donor pancreas, processed, and infused into a different recipient's portal vein; may require multiple donor pancreata and is investigational for type 1 diabetes.

BlueCHiP for Medicare: The BCBSRI Medicare product line that must follow CMS national and local coverage determinations and may have coverage that differs from Commercial products; Medicare covers allogeneic islet transplantation only in NIH‑sponsored/CMS‑approved clinical trials when policy requirements (including trial modifiers and allowed G‑codes) are met.

Name	Number	Type	Effective Date
{"text":"ISLET CELL Transplantation in the Context of a Clinical Trial","status":""},{"text":"260.3.1","status":""},{"text":"NCD","status":""},{"text":"","status":""}

Revision History

2020-01-01code_update

CPT/T-codes 0584T (percutaneous), 0585T (laparoscopic), and 0586T (open) became effective 1/1/2020; these T-codes are listed as invalid for BlueCHiP for Medicare and should be filed with the appropriate G-code (G0341, G0342, or G0343).

2020-01-07policy_reviewLatest

Policy last updated/reviewed on 01/07/2020.

2006-06-01policy_effective

Policy effective date: 06/01/2006.

2020-03publication_note

Provider Update publications cited through 2020; no clinical policy statement changes indicated in header (non-material).