CurrentAetnaPolicy 0601

Pancreas Transplantation Alone (PTA) and Islet Cell Transplantation

Defines Aetna's medical necessity, contraindications, experimental/investigational exclusions, and coding guidance for pancreas transplantation alone (PTA), pancreas autotransplantation, and islet cell transplantation including FDA-approved donislecel-jujn (Lantidra) for commercial medical plans.

Policy Summary

PayerAetna

PolicyPancreas Transplantation Alone (PTA) and Islet Cell Transplantation

Policy CodePolicy 0601

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrecertification of donislecel-jujn (Lantidra) is required; document medical necessity including chart notes/ER visits/hospitalizations and failure of intensive diabetes management (e.g., HbA1c > 8.0) when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update

3Major covered procedures (PTA, islet allotransplantation, islet autotransplantation)

max 3Maximum Lantidra infusions

>=18Minimum age for Lantidra

90%Participants with ≥1 serious adverse reaction (Lantidra studies)

13%

Procedure-related bleeding incidence (studies)

21/30Participants achieving ≥1 year insulin independence (studies)

Coverage Summary

This policy addresses Aetna's coverage for pancreas transplantation alone (PTA), pancreatic islet allotransplantation with FDA‑approved donislecel‑jujn (Lantidra), and islet autotransplantation (TPIAT). PTA is a covered option for a small, highly selected group of insulin‑dependent patients with labile (brittle) diabetes and recurrent severe metabolic complications when institutional or specified general and disease‑specific criteria are met. Islet allotransplantation with Lantidra is covered for adults (age >= 18) with type 1 diabetes who have repeated severe hypoglycemia despite intensive management and who will receive concomitant immunosuppression (with a maximum of 3 infusions). Islet autotransplantation is covered for patients undergoing near‑total or total pancreatectomy for severe, refractory chronic pancreatitis.

Key thresholds and summary facts

Hemoglobin A1c> 8.0

Age for Lantidra>= 18 years

Maximum Lantidra infusionsMaximum of 3 infusions

Creatinine clearance> 40 ml/min

CD4 count (HIV)> 200 cells/mm3 for more than 6 months

Ejection fraction thresholds>=40% (adequate); <35% = absolute contraindication; 35%-40% = relative contraindication

Medical Necessity Criteria

Pancreas Transplantation Alone (PTA) - General and Disease-specific Medical Necessity

PTA without kidney transplant is medically necessary when all of the following general and disease specific criteria are met (or institution selection criteria are met):

General Criteria

Controlled HIV/AIDS infection defined by all of: CD4 count greater than 200 cells/mm3 for more than 6 months; HIV-1 RNA (viral load) undetectable; no other complications from AIDS (e.g., opportunistic infection or neoplasm); on stable anti-viral therapy more than 3 monthsCD4 > 200 cells/mm3 for >6 months
General medical and organ function requirements: Absence of ongoing or recurrent active infections that are not effectively treated; documentation of compliance with medical management; adequate cardiac status (e.g., no angiographic evidence of significant coronary artery disease, ejection fraction >= 40%, no myocardial infarction in last 6 months, negative stress test); satisfactory kidney function (creatinine clearance > 40 ml/min); no malignancy (except non-melanomatous skin cancers or low-grade prostate cancer) or malignancy completely resected OR malignancy adequately treated such that risk of recurrence is small (upon medical review)

Experimental, Investigational, and Not Medically Necessary

Experimental and Investigational (Not Medically Necessary)

Aetna considers any of the following experimental and investigational:

Experimental / Investigational Procedures: Ex-situ machine pancreas perfusion (in hypothermic or normothermic settings) for pancreas transplantation; pancreatic islet xenotransplantation; PTA for increased longevity; PTA primarily indicated for lifestyle issues (e.g., desire to no longer take insulin)

Safety and effectiveness not established in peer-reviewed literature

HCPCS codes not covered for indications listed in the CPBHCPCSNot 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

CPT codes not covered for indications listed in the CPBCPTNot Covered

Ex-situ machine pancreas perfusion

No specific code - procedure considered experimental/investigational

CPT codes designated experimental/investigationalCPTExperimental

Ex-situ machine pancreas perfusion

Procedure considered experimental and investigational (no specific code)

Other CPT/HCPCS codes not covered (from brief)mixedNot Covered

No codes listed

Coding

CPT codes covered if selection criteria are metCPTCovered

0584T	Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; percutaneous
0585T	Islet cell transplant, laparoscopic
0586T	Islet cell transplant, open
48160	Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
48550	Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation
48551	Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation
48552	Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastamosis, each
48554	Transplantation of pancreatic allograft
48556	Removal of transplanted pancreatic allograft

Other related CPT codes (neutral/informational)CPT

36481	Percutaneous portal vein catheterization by any method [Hepatic portal vein infusion]
80069	Renal function panel
82947	Glucose; quantitative, blood (except reagent strip)
82948	Glucose; blood, reagent strip
82950	Glucose; post glucose dose (includes glucose)
82962	Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use

HCPCS codes coveredHCPCSCovered

S2102	Islet cell tissue transplant from pancreas; allogeneic
donislecel-jujn (Lantidra)	No specific HCPCS code listed (precertification required)

HCPCS codes not covered for indications listed in the CPBHCPCSNot 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

ICD-10 codes covered if selection criteria are metICD-10Covered

E08.649	Diabetes mellitus due to underlying condition with hypoglycemia without coma
E10.10-E10.9	Type 1 diabetes mellitus (range listed)
E11.00-E11.9	Type 2 diabetes mellitus (range listed)
E15	Nondiabetic hypoglycemic coma
E16.0-E16.2	Hypoglycemia (range listed)
E79.0	Hyperuricemia without signs of inflammatory arthritis and tophaceous disease
E87.20,E87.21,E87.22,E87.29	Acidosis (codes listed)
E89.1	Postprocedural hypoinsulinemia
K86.0-K86.1	Chronic pancreatitis (range listed)
R78.71	Abnormal lead level in blood

1–10 of 17

1/2

ICD-10 codes as absolute contraindication for this CPBICD-10Not Covered

I10	Essential (primary) hypertension
I15.0-I15.9	Secondary hypertension (range)
I16.0-I16.9	Hypertensive crisis (range)
I21.01-I21.A9	Acute myocardial infarction (range)
I22.0-I22.9	Subsequent STEMI and NSTEMI myocardial infarction (range)
I25.10-I25.119	Atherosclerotic heart disease of native coronary artery (range)

ICD-10 codes as relative contraindication for this CPBICD-10

F10.10-F19.99	Mental and behavioral disorders due to psychoactive substance use (range)
I73.00-I73.9	Other peripheral vascular diseases (range)

Provider Actions and Billing Guidance

Prior Authorization

Precertification required for Lantidra

Precertification of donislecel-jujn (Lantidra) suspension is required of all Aetna participating providers and members in applicable plan designs. Contact National Medical Excellence (NME) for precertification at 877-212-8811. The affected drug code: donislecel-jujn (Lantidra).

Contact NME: 877-212-8811
Precertify donislecel-jujn (Lantidra)

Documentation Required

Document medical necessity and prior treatments

Document medical necessity and prior treatments for severe metabolic complications. Required documentation should include chart notes and records of emergency room visits and/or hospitalizations for hyperglycemia, hypoglycemia, hypoglycemic unawareness, or ketoacidosis; evidence of attempts at intensive diabetes management and education; and evidence of failure of exogenous insulin-based management (e.g., HbA1c > 8.0 where applicable).

Background, Evidence, and Definitions

The clinical rationale is that, although exogenous insulin is effective for most patients, a rare subset (<1%) with insulin‑dependent diabetes experience unpredictable, life‑threatening metabolic events (severe hyperglycemia, hypoglycemia, ketoacidosis, and hypoglycemic unawareness) for whom pancreas replacement strategies may be appropriate. PTA outcomes have improved over time with technical refinements, newer immunosuppressive regimens, and better candidate selection, but PTA remains contraindicated in patients with significant cardiovascular disease and lacks evidence for prolonging survival or preventing long‑term diabetic complications. Prior to Lantidra's approval, islet allotransplantation was considered investigational or experimental by many reviews and health‑technology assessments because evidence was limited by small numbers, short follow‑up, heterogeneous methods, and lack of standardized reporting; while early studies showed short‑term insulin independence in selected patients, long‑term durability and comparative effectiveness were uncertain. The FDA approval of Lantidra in June 2023 was based on small single‑arm studies showing some patients achieving prolonged insulin independence but also high rates of serious adverse events related to the infusion procedure and required immunosuppression.

label	value
FDA approval
June 2023 approval of Lantidra (donislecel-jujn) for adults with type 1 diabetes with repeated severe hypoglycemia despite intensive management
Dosage recommended minimum
5,000 EIN/kg initial; 4,500 EIN/kg for subsequent infusions; max tissue volume 10 cc per infusion; max 1 x 10^6 EIN per bag
Lantidra clinical trial participants
30 adult participants; 11 received one infusion, 12 received two, 7 received three
Insulin independence (trial outcome)
21 of 30 participants did not need insulin for a year or more (11: 1–5 years; 10: >5 years)
Serious adverse reactions (trial)
90% had ≥1 serious adverse reaction; major causes: infusion procedure and immunosuppression
Procedure-related bleeding (trial)
13% liver laceration/hematoma/hemorrhage
Infection with immunosuppression (trial)
87%
Malignancy with immunosuppression (trial)
37%

Allotransplantation: Transplantation of islet cells from a genetically non‑identical donor of the same species (also termed allogeneic or allotransplantation).

Autotransplantation: Transplantation of the member's own islet cells (autologous/autotransplantation), typically performed when undergoing near‑total or total pancreatectomy for severe, refractory chronic pancreatitis.

EIN (Equivalent Islet Number): Abbreviation used to denote islet quantity; for Lantidra dosing the recommended minimum is 5,000 EIN/kg for an initial infusion and 4,500 EIN/kg for subsequent infusions, with a maximum infusion tissue volume of 10 cc and up to 1 x 10^6 EIN per bag.

Medicare Determinations

name	number	type	effective date
Medicare Part B Criteria (reference)

NCD

Decision memo for pancreas transplants
CAG-00295R
NCD
2006-04-26

Revision History

2006-04-26Medicare decision memo

Centers for Medicare & Medicaid Services decision memo for pancreas transplants (CAG-00295R) published.

2023-06-29FDA approvalLatest

FDA approved Lantidra (donislecel-jujn) as the first allogeneic pancreatic islet cellular therapy for adults with type 1 diabetes with repeated severe hypoglycemia despite intensive management.

Policy Summary

PayerAetna

PolicyPancreas Transplantation Alone (PTA) and Islet Cell Transplantation

Policy CodePolicy 0601

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

EF >= 40%; CrCl > 40 ml/min

Disease Specific Criteria

Recurrent severe metabolic complications: Member has recurrent, acute and severe metabolic and potentially life-threatening complications requiring medical attention (documented by chart notes, frequent ER visits and/or hospitalizations), which may include hyperglycemia; hypoglycemia; hypoglycemic unawareness associated with high risk of injury; or ketoacidosis
Failure of exogenous insulin-based management: Consistent failure of exogenous insulin-based management despite aggressive conventional therapy including adjusting frequencies and amounts of insulin injected; measuring multiple blood glucose levels daily; modifying diet and exercise; monitoring HgbA1c levels; defined by inability to achieve sufficient glycemic control (HbA1c > 8.0) or recurrent hypoglycemic unawarenessHbA1c > 8.0

Composite PTA Criteria: All General Criteria and Disease Specific Criteria must be met

Pancreas Retransplantation

Medical necessity conditions for retransplantation

After failed primary: Pancreas retransplantation after a failed primary pancreas transplant when member meets the selection criteria stated above
After multiple prior failures: Pancreas retransplantation after 2 or more prior failed pancreas transplants may be considered medically necessary upon individual case review

PTA Contraindications

Absolute and relative contraindications

Absolute Contraindications (PTA not medically necessary): Prohibitive cardiovascular risk where risks exceed benefits (examples include angiographic evidence of significant non-correctable coronary artery disease); ejection fraction less than 35%; myocardial infarction within last 6 months; refractory uncontrolled hypertensionEF < 35%

Examples listed are not exhaustive

Relative Contraindications (may be considered if documented benefit outweighs risks): Ejection fraction 35% to 40%; severe peripheral vascular disease; unstable alcohol or substance use disorder (exception allowed with documentation within 4 weeks demonstrating 3 months of stability from treating addiction medical professional or psychiatrist)EF 35% - 40%

Requesting physician must document consideration and that benefits outweigh risks

Islet Cell Transplantation - Allotransplantation (Lantidra) Initial Approval Criteria

Allotransplantation with FDA-approved Lantidra is medically necessary when all of the following are met:

Lantidra Initial Approval Criteria

Age: Member is 18 years of age or older>= 18 years
Disease and severity: Member has type 1 diabetes and is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education
Immunosuppression: Lantidra will be used in conjunction with concomitant immunosuppression therapy (e.g., mycophenolate mofetil, sirolimus, tacrolimus)
Concomitant immunosuppression is required to maintain graft viability
No renal transplant: Member has not received a renal transplant
Maximum infusions: Administration has not exceeded a maximum of 3 infusions (transplants)Maximum of 3 infusions
There are no data regarding safety/effectiveness for >3 infusions

Islet Cell Transplantation - Continuation/Repeat Infusion Criteria

Conditions under which additional Lantidra infusions may be repeated:

Repeat Infusion Criteria: Member meets all initial approval criteria and member has not achieved independence from exogenous insulin within one year of infusion or within one year after losing independence from exogenous insulin after a previous infusionFailure to achieve insulin independence within 1 year

No data for >3 infusions

Islet Cell Transplantation - Autotransplantation

Autotransplantation is medically necessary for:

Islet Autotransplantation: Members undergoing near-total or total pancreatic resection for severe, refractory chronic pancreatitis

Autotransplantation (autologous) performed concurrently with pancreatectomy to preserve islet function

Chart notes documenting severe metabolic complications
Records of ER visits and/or hospitalizations
Documentation of intensive diabetes management and education attempts
HbA1c results (evidence of HbA1c > 8.0 where applicable)

Documentation Required

Document consideration of relative contraindications

For members with relative contraindications (e.g., EF 35%–40%, severe peripheral vascular disease, unstable substance use), the requesting physician must document that these were considered and that benefits outweigh risks. For substance use, an exception requires supporting documentation within 4 weeks demonstrating 3 months of stability from the treating addiction medical professional or psychiatrist.

Physician documentation that relative contraindications were considered and benefits outweigh risks
If substance use disorder: documentation (within 4 weeks) demonstrating 3 months of stability

Billing Rule

CPT/HCPCS coding guidance

Report the listed CPT and HCPCS codes when selection criteria are met. Note that there is no specific HCPCS drug code listed for Lantidra (donislecel-jujn); S2102 is listed for allogeneic islet cell transplant and certain G-codes are not covered for CPB indications.

Affected codes: 0584T, 0585T, 0586T, 48160, 48550, 48551, 48552, 48554, 48556, S2102, G0341, G0342, G0343
No specific HCPCS drug code listed for donislecel-jujn (Lantidra)

Documentation Required

Use of concomitant immunosuppression with Lantidra

Lantidra must be used in conjunction with concomitant immunosuppression; providers must consider the risks of immunosuppression and follow labeled warnings and contraindications related to immunosuppressive therapy (including increased risk of severe infections, malignancy, and other immunosuppression-related risks).

Consider immunosuppression risks when planning Lantidra therapy
Follow labeled warnings/contraindications related to immunosuppression

Documentation Required

Contraindications and patient selection for Lantidra

Do not administer Lantidra to patients for whom immunosuppression is contraindicated. Exclude patients whose diabetes is well-controlled with insulin or who can prevent repeated severe hypoglycemia with intensive management. Also consider exclusion for patients with liver disease, renal failure, or prior renal transplant per labeled limitations.

Contraindicated if immunosuppression cannot be used
Exclude if diabetes is well-controlled or severe hypoglycemia can be prevented with intensive management
Consider exclusion for patients with liver disease, renal failure, or prior renal transplant

Documentation Required

Avoid repeat intraportal islet infusions after portal thrombosis

Repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis unless the thrombosis was limited to second- or third-order portal vein branches. Document prior portal thrombosis and whether it was limited to second- or third-order branches if repeat infusion is being considered.

Avoid repeat intraportal infusions after prior portal thrombosis
Exception: thrombosis limited to second- or third-order portal vein branches