ModifiedAmbetter GeorgiaPolicy CP.MP.102

Pancreas Transplantation

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Medical necessity and coding criteria governing coverage for pancreas transplantation (PTA, SPK, PAK), autologous islet autotransplantation, retransplantation, and exclusions for Ambetter Georgia members.

Policy Summary

PayerAmbetter Georgia

PolicyPancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeCriteria revisions and additions (contraindications consolidatednumeric thresholds removednew documentation requirements)

Effective DateJul 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation showing at least 12 months of endocrinology management for pancreas transplant alone and required clinical/renal records to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that medical therapy does not exist or has failed from criterion I.A.

Removed C‑peptide values and BMI requirements from Criteria I.B.1 and I.B.2; noted high insulin requirements (>1 unit/kg) may reduce likelihood of benefit.

Added indication for exocrine pancreatic insufficiency in I.B.2 and indication for pancreas procurement/transplant as part of multiple organ transplant in I.B.3.

Moved many contraindications into a consolidated contraindications section (I.C.) and updated specific contraindications (e.g., changed 'chronic' to 'active' infection).

Added requirement for medical management by an endocrinologist for at least 12 months for pancreas transplant alone (I.D.1.c).

Added I.C.1.a.ii 'Recurring severe hypoglycemic attacks' as a listed clinical element.

Changed myocardial infarction window in I.B.3 from 30 days to within 6 months and reworded stroke/acute coronary syndrome language.

Added CPT code 50328 to coding.

Added note to reference CP.MP.250 Lantidra (donislecel) for criteria related to allogeneic pancreatic islet cellular therapy.

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ModifiedAmbetter GeorgiaPolicy CP.MP.102

Pancreas Transplantation

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Policy Summary

PayerAmbetter Georgia

PolicyPancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeCriteria revisions and additions (contraindications consolidatednumeric thresholds removednew documentation requirements)

Effective DateJul 1, 2026

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Removed requirement that medical therapy does not exist or has failed from criterion I.A.

Removed C‑peptide values and BMI requirements from Criteria I.B.1 and I.B.2; noted high insulin requirements (>1 unit/kg) may reduce likelihood of benefit.

Added indication for exocrine pancreatic insufficiency in I.B.2 and indication for pancreas procurement/transplant as part of multiple organ transplant in I.B.3.

Moved many contraindications into a consolidated contraindications section (I.C.) and updated specific contraindications (e.g., changed 'chronic' to 'active' infection).

Added requirement for medical management by an endocrinologist for at least 12 months for pancreas transplant alone (I.D.1.c).

Added I.C.1.a.ii 'Recurring severe hypoglycemic attacks' as a listed clinical element.

Changed myocardial infarction window in I.B.3 from 30 days to within 6 months and reworded stroke/acute coronary syndrome language.

Added CPT code 50328 to coding.

Added note to reference CP.MP.250 Lantidra (donislecel) for criteria related to allogeneic pancreatic islet cellular therapy.

PTA, SPK, PAK, isletTransplant types addressed

GFR <20SPK renal threshold

GFR <40Contraindication threshold

1 failedRetransplantation allowed after

50328Procedure code added

12 moEndocrinology care required

Coverage and Medical Necessity Criteria

inv-01: Initial transplant coverage criteria

Covered when ALL of the following are met:

Root

Qualifying diagnosis: Member has one of: (1) diabetes mellitus type I requiring insulin; (2) exocrine pancreatic insufficiency; (3) requirement for procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons.
Procedure-specific
- PTA criteria: Pancreas Transplant Alone (PTA) — all of: (a) Recurrent, severe, and potentially life‑threatening metabolic complications documented by chart notes, ED visits, or hospitalizations, including severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, or recurring severe ketoacidosis; (b) Clinical and/or emotional problems with exogenous insulin therapy that are incapacitating or consistent failure of insulin‑based management to prevent acute complications; (c) Has been medically managed by an endocrinologist for at least 12 months.
- SPK criteria: Simultaneous Pancreas‑Kidney (SPK) — all of: (a) Meets PTA criteria; (b) End‑stage renal disease (uremia) and requires dialysis or expected to require dialysis within 12 months; (c) GFR < 20 mL/min or CrCl < 20 mL/min, or is dialysis dependent.
- PAK criteria: Pancreas After Kidney (PAK) — all of: (a) Meets PTA criteria; (b) Underwent a successful kidney transplant without significant chronic rejection; (c) Stable kidney transplant function defined by creatinine clearance ≥ 30 mL/min and proteinuria ≤ 500 mg/day.
Contraindications: Member does not have ANY of the listed contraindications (see exclusions/contraindications list).

inv-02: Autologous islet and retransplantation

Autologous islet autotransplant: Autologous islet cell transplant is medically necessary as an adjunct procedure to total or near‑total pancreatectomy for severe, refractory pancreatitis.

Retransplantation: Pancreas retransplantation is medically necessary after one failed primary pancreas transplant.

inv-03: Not supported indications

Unapproved indications: Pancreas transplant procedures are not supported for: re‑transplantations after two or more failed primary pancreas transplants; allogeneic islet cell transplantation or xenotransplantation; SPK for patients with amputation due to peripheral obstructive vascular disease; or for other conditions not specified in this policy.

inv-04: Coverage criteria (high-level)

Policy defines coverage when specified candidate criteria (I.A, I.B, I.D) are met and no contraindications (I.C) are present; revisions updated these sections.

I.A general candidate qualifications: I.A describes qualifying diagnoses; prior requirement that medical therapy does not exist or has failed was removed per revision history.

See policy I.A for exact qualifying diagnoses.

I.B indications: I.B expanded to I.B.a–c and includes indications such as exocrine pancreatic insufficiency and need for pancreas procurement/transplant as part of multiorgan transplant; numeric C‑peptide and BMI thresholds were removed.

See policy I.B for procedural subcriteria (PTA, SPK, PAK).

I.C contraindications: Contraindications were consolidated under I.C and updated (e.g., 'active' infection language, added recurring severe hypoglycemic attacks, chronic non‑healing wounds, and significant comorbidities).

See policy I.C for the full contraindications list.

The policy explicitly excludes allogeneic islet cell transplantation and xenotransplantation from coverage. It also states that pancreas retransplantation is medically necessary after one failed primary pancreas transplant, but re-transplantation after two or more failed primary pancreas transplants is not supported. Additional non‑supported indications include SPK transplantation for patients with amputation due to peripheral obstructive vascular disease and other conditions not specified as covered in the policy.

The policy removed prior numeric cutoffs for candidate selection — specifically C‑peptide and BMI thresholds were removed from the criteria. The revisions also consolidated and clarified contraindications, replacing language such as 'chronic infection' with 'active infection' and expanding candidate indications to include exocrine pancreatic insufficiency and pancreas procurement/transplant as part of a multiorgan procedure for technical reasons.

Procedures reported with CPT codes 0584T, 0585T, and 0586T (islet cell transplant codes) are listed in the policy as not supporting coverage. These codes describe islet cell transplantation with portal vein catheterization and infusion performed percutaneously, laparoscopically, or via open approach.

Requests that do not meet the specified candidate criteria or that are affected by any of the consolidated contraindications are considered not medically necessary. Examples of contraindications that would preclude coverage include active infections (including active tuberculosis and uncontrolled virulent/resistant infections), significant comorbidities such as advanced cardiopulmonary or cardiovascular disease, progressive cognitive impairment, inability to adhere to post‑transplant regimens, active substance use or dependence without convincing risk‑reduction evidence (with limited exceptions for prescribed marijuana), and chronic, non‑healing wounds.

Candidate Selection and Indications

inv-30: Candidate criteria

Eligible diagnoses: Type 1 diabetes requiring insulin; exocrine pancreatic insufficiency; requirement for pancreas as part of multiorgan transplant for technical reasons.

PTA candidate: Meets all PTA elements: recurrent, severe metabolic complications (documented by chart notes/ED/hospitalizations), incapacitating clinical/emotional problems with insulin therapy or failure of insulin to prevent acute complications, and medical management by an endocrinologist for at least 12 months.

SPK candidate: Meets PTA criteria AND has ESRD (uremia) AND requires dialysis or is expected to require dialysis within 12 months AND GFR < 20 mL/min or CrCl < 20 mL/min, or is dialysis dependent.

PAK candidate: Meets PTA criteria AND underwent successful kidney transplant without significant chronic rejection AND stable kidney function (CrCl ≥ 30 mL/min and proteinuria ≤ 500 mg/day).

Contraindications to Transplant

The policy lists consolidated contraindications that include malignancy with high risk of recurrence or death and a renal function threshold of GFR < 40 mL/min/1.73 m2 as a contraindication unless the candidate is being considered for a multiorgan transplant. Several contraindications were relocated into section I.C. during revisions to clarify applicability and wording.

Procedure and Billing Codes

CPT Codes that support coverage criteriaCPTCovered

48160	Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
48550	Pancreatic islet cells Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation
48551	Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding soft tissues, splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels
48554	Transplantation of pancreatic allograft
48556	Removal of transplanted pancreatic allograft
50300	Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral
50320	Donor nephrectomy (including cold preservation); open, from living donor
50328	Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each
50340	Recipient nephrectomy (separate procedure)
50360	Renal allotransplantation, implantation of graft; without recipient nephrectomy

1–10 of 11

1/2

CPT Codes that do not support coverage criteriaCPTNot Covered

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, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; laparoscopic
0586T	Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; open

HCPCSHCPCS

S2065

Simultaneous pancreas kidney transplantation

Covered CPT Codes (mentioned)CPTCovered

50328

Pancreatectomy or pancreas transplant procedure code (as added to coding list in policy)

Kidney function thresholds — SPK / Contraindication

SPK eligibility renal thresholdGFR < 20 mL/min or creatinine clearance (CrCl) < 20 mL/min, or dialysis dependent

Contraindication renal thresholdGFR < 40 mL/min/1.73 m2 is a contraindication unless being considered for multiorgan transplant

GFR recency noteGFR used in evaluation does not have to be the most recent value

Myocardial infarction exclusion window

Myocardial infarction exclusion windowMyocardial infarction within 6 months (excludes demand ischemia)

Related cerebrovascular window

Authorization, Documentation, and Denial Risk

Prior Authorization

Prior authorization required; use listed CPT/HCPCS

Prior authorization is required for pancreas transplantation requests and will be evaluated against the policy's medical necessity criteria. Use the CPT and HCPCS codes listed in the policy when requesting authorization; the policy identifies codes that support coverage and codes that do not support coverage.

Prior authorization required and evaluated against medical necessity criteria using policy-defined candidate and procedure-specific criteria.
Submit procedure codes exactly as listed; policy separates codes that support coverage (e.g., 48160, 48554, 50300, 50320, 50360, 50365) from codes that do not support coverage (0584T, 0585T, 0586T) and includes HCPCS S2065.

Prior Authorization

Include CPT 50328 on prior authorization requests

Prior authorization is required for pancreas transplantation procedures; CPT code 50328 is explicitly included in the policy's coding list and should be included on authorization requests where applicable.

Include CPT 50328 among the procedure codes when applicable — it was added to the policy coding list.

Definitions and Terminology

PTA — Pancreas Transplant Alone

DefinitionPancreas Transplant Alone (PTA): transplantation of a pancreas for a patient meeting PTA-specific criteria (recurrent severe metabolic complications or incapacitating problems with insulin) without concurrent kidney transplant

Primary indicationsRecurrent, severe, potentially life‑threatening metabolic complications (e.g., severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, recurring severe ketoacidosis)

Pretransplant requirementMust have been medically managed by an endocrinologist for at least 12 months

SPK — Simultaneous Pancreas-Kidney Transplant

DefinitionSimultaneous Pancreas-Kidney (SPK): pancreas transplant performed at the same time as kidney transplant for candidates who meet PTA criteria and have end-stage renal disease

Renal context for eligibility

Pre-Transplant Evaluation and Program Requirements

Note

Evaluation: endocrinology care ≥12 months; renal and transplant evidence required

PTA candidates must have documentation showing management by an endocrinologist for at least 12 months; SPK/PAK requests must include renal function documentation and, when applicable, evidence of prior successful kidney transplant.

PTA: attach endocrinology clinic notes covering ≥12 months.
SPK: include GFR/CrCl values or dialysis status (GFR <20 mL/min or CrCl <20 mL/min, or dialysis dependent).
PAK: include evidence of prior successful kidney transplant and stable kidney function (CrCl ≥30 mL/min and proteinuria ≤500 mg/day).

Note

GFR need not be the most recent; PTA requires 12 months endocrinology care

The GFR value used in evaluation does not need to be the most recent recorded value; for PTA, the policy requires documentation of at least 12 months of endocrinology management.

When submitting GFR/CrCl for renal eligibility, any valid recent value may be used (need not be the most recent).
Ensure the 12‑month endocrinology management documentation is included for PTA requests.

Post-Transplant Management and Follow-up

Immunosuppression management and monitoring

Implied requirementPost-transplant immunosuppression and follow-up are required for pancreas recipients, who generally need extensive immunosuppression regimens

Detail levelSpecific immunosuppression drugs, dosing, and monitoring protocols are not specified in this policy window

RationalePancreas recipients may require higher levels of immunosuppression due to pancreas immunogenicity or recipient autoimmune status

Follow-up and criteria alignment for multi-organ transplants

PTA criteria applicabilitySPK and PAK also require that the candidate meet PTA criteria when applicable

Evaluation noteDocumentation requirements for SPK/PAK include renal function and evidence that PTA criteria are satisfied

Background and Scope

Background: Pancreas transplantation (including Simultaneous Pancreas‑Kidney [SPK], Pancreas After Kidney [PAK], and Pancreas Transplant Alone [PTA]) can restore endogenous insulin secretion and improve quality of life for people with type 1 diabetes. SPK is commonly performed for patients with end‑stage renal disease and represents the majority of pancreas transplants. The policy also recognizes autologous islet autotransplantation as medically necessary when performed as an adjunct to total or near‑total pancreatectomy for severe, refractory pancreatitis.

Policy Summary

PayerAmbetter Georgia

PolicyPancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeCriteria revisions and additions (contraindications consolidatednumeric thresholds removednew documentation requirements)

Effective DateJul 1, 2026

Next Review Date

SourceLink

On This Page

I.D pretransplant/evaluation: I.D includes evaluation requirements; added requirement that PTA candidates be medically managed by an endocrinologist for ≥12 months and clarifies that SPK/PAK also require PTA criteria to be met; GFR used in evaluation need not be the most recent value.

See policy I.D for documentation specifics.

inv-31: Candidate criteria (summary)

Summary of candidate selection elements and procedural indications for pancreas transplant types (PTA, SPK, PAK).

PTA specific: For Pancreas Transplant Alone (PTA), member must have been medically managed by an endocrinologist for at least 12 months; SPK and PAK require that PTA criteria are also met.>=12 months endocrinology care

Indications expanded: I.B was expanded to include exocrine pancreatic insufficiency and pancreas procurement/transplant as part of multiple organ transplant for technical reasons; policy removed prior numeric C‑peptide and BMI thresholds.

Stroke or acute coronary syndrome within 30 days listed as a separate contraindication

Policy change noteMI window was changed from 30 days to within 6 months in criteria updates

Endocrinologist management duration

Minimum endocrinology follow-up for PTAMember must have been medically managed by an endocrinologist for at least 12 months for Pancreas Transplant Alone (PTA)

Documentation impactFailure to document >=12 months endocrinology management may risk denial for PTA requests

ApplicabilityThis requirement applies specifically to PTA candidates (pancreas transplant alone)

Ensure authorization requests reference the policy-supported CPT codes for pancreas and renal transplant procedures.

Note

Certify procedure meets diagnosis, procedure criteria, and no contraindications

Document that the requested procedure meets the policy's qualifying diagnosis and procedure‑specific criteria and that no contraindications (I.C.) are present; failure to demonstrate these elements may lead to denial.

Confirm requested procedure is PTA, SPK, or PAK and meets the detailed criteria for that procedure.
Verify and document absence of any contraindications listed under I.C. in the policy.

Note

Specify transplant type and exact criteria met on request

Ensure authorization request clearly states the transplant type (PTA, SPK, PAK) and the specific criteria elements that are met (e.g., recurrent severe metabolic complications, ESRD/dialysis status, stable kidney function) to expedite review.

For SPK, document presence of uremia and dialysis dependence or expectation of dialysis within 12 months and GFR/CrCl values as required.
For PAK, document prior successful kidney transplant and stable renal function (CrCl ≥ 30 mL/min and proteinuria ≤ 500 mg/day).

Documentation Required

Submit chart notes/ED/hospital records of severe metabolic complications

Provide chart notes, emergency department records, or hospitalizations that document recurrent, severe, and potentially life‑threatening metabolic complications to justify PTA medical necessity.

Include documentation of any of: severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, or recurring severe ketoacidosis.
Attach relevant ED visit or hospitalization reports and clinician notes describing the events and interventions.

Documentation Required

Provide renal function and kidney transplant documentation

For SPK and PAK candidates, include objective renal function documentation and, when applicable, documentation of kidney transplant function.

Provide GFR or creatinine clearance values and state dialysis status (dialysis dependent or expected within 12 months) for SPK eligibility.
For PAK, provide creatinine clearance (≥ 30 mL/min) and quantification of proteinuria (≤ 500 mg/day) to demonstrate stable kidney transplant function.

Documentation Required

Document ≥12 months endocrinology management for PTA

Include documentation that the member has been medically managed by an endocrinologist for at least 12 months for pancreas transplant alone (PTA), as required by the policy.

Provide endocrinology clinic notes spanning ≥ 12 months documenting medical management and attempts at insulin-based therapy.
If applicable, note that the GFR used in evaluation does not have to be the most recent value per policy guidance.

Denial Risk

Non‑compliance with medical necessity criteria may result in denial

Requests that do not meet the policy's medical necessity criteria — including diagnosis, procedure‑specific requirements, or presence of any listed contraindications — may be denied.

Failure to show that the member meets PTA/SPK/PAK criteria or presence of any contraindication under I.C. are explicit denial triggers.
Codes listed as not supporting coverage (0584T–0586T) will not support authorization for pancreas transplant procedures.

Denial Risk

Lack of ≥12 months endocrinology management for PTA risks denial

Failure to document at least 12 months of medical management by an endocrinologist for pancreas transplant alone (PTA) may result in denial of the request.

For PTA, authorization requires explicit documentation of ≥ 12 months endocrinology care as stated in criteria I.B.1.c.
Ensure endocrinology records are submitted; absence of this documentation is an identified denial risk.

Requires ESRD with uremia and need for dialysis or expected dialysis within 12 months

Renal function thresholdGFR < 20 mL/min or CrCl < 20 mL/min, or dialysis dependent

PAK — Pancreas After Kidney Transplant

DefinitionPancreas After Kidney (PAK): pancreas transplant for a patient who previously underwent a successful kidney transplant and meets PTA criteria

Kidney transplant stability criteriaRequires stable kidney transplant function defined by creatinine clearance ≥ 30 mL/min and proteinuria ≤ 500 mg/day

Rejection exclusionNot eligible if there is significant chronic rejection of the kidney transplant

Recurring severe hypoglycemic attacks

Clinical element listedRecurring severe hypoglycemic attacks are specified as a documented recurrent, severe metabolic complication supporting PTA consideration (I.B.1.a.ii)

Documentation examplesRequires chart notes, ED visits, or hospitalizations documenting the events

Relationship to PTA criteriaCounts as one of the qualifying metabolic complications under PTA indications

Note

Center must meet standard transplant program expectations (no specific accreditations listed)

The policy references standard transplant program expectations but does not list specific accreditation or minimum volume requirements; ensure your program meets usual OPTN/CMS/standard transplant program expectations.

If accreditation or program‑specific documentation is requested, provide standard center credentials and evidence of transplant program capability per OPTN/CMS norms.

GFR recencyGFR used in evaluation does not have to be the most recent value