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Medical necessity criteria, contraindications, and coding guidance for pancreas transplantation procedures (PTA, SPK, PAK) and autologous islet cell transplant as an adjunct to pancreatectomy; applies to Ambetter Nevada members/enrollees and providers requesting coverage.
Policy Summary
PayerAmbetter Nevada
PolicyPancreas Transplantation
Policy CodePolicy CP.MP.102
Change TypeCriteria revision, coding update, and structural edits
Effective Date
Next Review Date
Key ActionObtain prior authorization and document type I diabetes, recurrent severe hypoglycemia, and relevant cardiovascular history per revised timing when requesting pancreas transplant coverage.
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POLICY UPDATE CHANGES
Changed myocardial infarction timing from within 30 days to within 6 months and reworded stroke/acute coronary syndrome information.
Added I.C.1.a.ii 'Recurring severe hypoglycemic attacks'.
Added CPT code 50328.
Specified criteria I.A.1 to 'type I' diabetes and removed extraneous parenthetical language.
Moved contraindications under I.B. to section I.C.
PTA, SPK, PAK, autologous islettypes of pancreas transplant covered
GFR <20SPK renal function threshold
CrCl ≥30PAK kidney function
CPT codes listedprocedure coding provided
50328new procedure code
Recurring hypoglycemianew explicit indication
Coverage and Medical Necessity Criteria
Initial Transplant Coverage Criteria
Pancreas transplantation is covered when ALL of the following grouped criteria are met per transplant type
I.A - Indication: Member/enrollee has one of: (1) Diagnosis of diabetes mellitus type I requiring insulin; (2) Diagnosis of exocrine pancreatic insufficiency; (3) Requirement for procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons.
I.B.1 - PTA specific: For Pancreas Transplant Alone (PTA), all of the following: a) Recurrent, severe, and potentially life‑threatening metabolic complications that required medical attention, documented by chart notes, emergency department visits, or hospitalizations, including any of: i. Severe hypoglycemia unawareness; ii. Recurring severe hypoglycemic attacks; iii. Marked hyperglycemia; iv. Recurring severe ketoacidosis; b) Clinical and/or emotional problems with exogenous insulin therapy that are incapacitating or failure of insulin‑based management to prevent acute complications; c) Has been medically managed by an endocrinologist for at least 12 months.
I.B.2 - SPK specific: For Simultaneous Pancreas‑Kidney (SPK), all of the following: a) Meets the PTA criteria above; b) End‑stage renal disease (ESRD), defined by both presence of uremia and requires dialysis or is expected to require dialysis within the next 12 months; c) Glomerular filtration rate (GFR) < 20 mL/min or creatinine clearance (CrCl) < 20 mL/min, or dialysis dependent.
I.B.3 - PAK specific: For Pancreas After Kidney (PAK), all of the following: a) Meets the PTA criteria above; b) Underwent a successful kidney transplant without significant chronic rejection of the kidney transplant; c) Stable kidney transplant function defined by both: i. Stable creatinine clearance ≥ 30 mL/min; ii. Absence of significant proteinuria specified as greater than 500 mg/day.
Contraindications (exclusion): Coverage only if member/enrollee does NOT have any of the following contraindications: malignancy with high risk of recurrence or death related to cancer; GFR < 40 mL/min/1.73 m2 unless being considered for multiorgan transplant; stroke or acute coronary syndrome within 30 days; myocardial infarction within six months (excluding demand ischemia); acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multiorgan transplant; septic shock; active infection with highly virulent/resistant microbes poorly controlled pre‑transplant; active tuberculosis; HIV with detectable viral load unless CD4 > 200 cells/mm3, absence of active AIDS‑defining opportunistic infection or malignancy, and currently on effective ART; progressive cognitive impairment; inability to adhere to necessary regimen even with caregiver support; active substance use or dependence (including current tobacco, vaping, marijuana use unless prescribed, or IV drug use) without convincing evidence of risk reduction or acceptable urgent‑timeline commitments; chronic non‑healing wounds; significant comorbidities limiting survival (advanced cardiopulmonary, cardiovascular, cerebrovascular, or peripheral vascular disease); or other severe uncontrolled medical conditions expected to limit survival after transplant.
Additional Coverage
Other covered indications: Autologous islet cell transplant is medically necessary as an adjunct to a total or near‑total pancreatectomy for severe, refractory pancreatitis. Pancreas retransplantation is medically necessary after one failed primary pancreas transplant.
Not Medically Supported Indications
Not supported indications: Coverage is not supported for: re‑transplantations after two or more failed primary pancreas transplants; allogeneic islet cell transplantation or xenotransplantation; SPK transplantation for patients with amputation due to peripheral obstructive vascular disease; and for the treatment of other conditions not specified as covered.
Updated eligibility and exclusion criteria (summary)
Policy criteria were updated in multiple sections; representative changes include:
Eligibility timing and indications: Specified I.A.1 to 'type I' diabetes; added recurring severe hypoglycemic attacks to I.B.1.a; changed myocardial infarction timing to within greater than 6 months (revised from 30 days); reworded stroke/acute coronary syndrome language; added CPT code 50328; clarified dialysis dependence in SPK criteria and added specification for proteinuria (>500 mg/day) in PAK.myocardial infarction > 6 months
See policy sections I.A, I.B, I.C for full details.
The policy states that certain procedures and indications are excluded from coverage. Specifically, allogeneic islet cell transplantation or xenotransplantation and re-transplantations after two or more failed primary pancreas transplants are not supported by current evidence and therefore are excluded from coverage. These exclusions are listed alongside other unsupported indications and should be referenced when evaluating requests that fall outside the defined medically necessary indications.
Contraindications that were previously placed under section I.B. have been relocated to section I.C. The extract provided does not include the full, enumerated contraindications text in the relocated section; reviewers should consult the complete policy for the specific contraindication language now found in I.C.
The policy identifies procedures and clinical indications that are not supported by the current evidence base and therefore are not covered. The document explicitly lists those in sections IV.A–IV.D — for example, re-transplantations after two or more failed primary pancreas transplants and allogeneic islet cell transplantation or xenotransplantation — and states these should be denied as not medically necessary.
No additional explicit not medically necessary conditions are present in the extract beyond the IV.A–IV.D items already summarized; the policy notes that explicit NMN conditions beyond those listed were not included in this portion of the document.
Transplant Candidate Selection
Transplant candidate criteria
Candidate selection criteria mirror coverage criteria for PTA, SPK, and PAK.
Candidate requirements: Type I diabetes requiring insulin or exocrine pancreatic insufficiency or need for pancreas in multiorgan transplant; for PTA: documented recurrent severe metabolic complications (severe hypoglycemia unawareness; recurring severe hypoglycemic attacks; marked hyperglycemia; recurring severe ketoacidosis) and endocrinologist management ≥ 12 months; for SPK: ESRD with uremia and need for or expected need for dialysis within 12 months and GFR <20 mL/min or CrCl <20 mL/min or dialysis dependence; for PAK: prior successful kidney transplant without significant chronic rejection and stable kidney function (CrCl ≥30 mL/min and absence of significant proteinuria >500 mg/day).
Candidate criteria updates
Documented candidate selection refinements included in revisions:
Type I diabetes requirement: I.A.1 was specified to 'type I' diabetes as part of candidate criteria.
Contraindications
Absolute or relative contraindications to pancreas transplantation are specified and include, among others: malignancy with high risk of recurrence or death related to cancer; glomerular filtration rate < 40 mL/min/1.73 m2 unless the candidate is being considered for multiorgan transplant; recent stroke or acute coronary syndrome within 30 days; myocardial infarction within six months; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multiorgan transplant is planned; septic shock; active uncontrolled infections including tuberculosis; uncontrolled HIV (detectable viral load) unless specified conditions are met (CD4 >200, on effective ART, absence of active AIDS-defining opportunistic infection); progressive cognitive impairment; inability to adhere to required regimens even with caregiver support; active substance use or dependence including current tobacco/vaping/marijuana use unless prescribed; chronic, non-healing wounds; significant comorbidities limiting survival; and other severe uncontrolled medical conditions expected to limit post-transplant survival.
The policy documentation indicates that contraindications were moved from section I.B. to I.C. in the revision. The extract provided does not include the full relocated contraindications list in that new location; clinicians and reviewers should refer to the full policy to confirm the current placement and exact wording of each absolute or relative contraindication.
Pre-transplant Evaluation and Documentation
Prior Authorization
Prior Authorization Required
Prior authorization is required for all pancreas transplant procedures. Submit prior authorization requests to Ambetter Nevada with supporting clinical documentation before scheduling surgery.
Affected CPT/HCPCS may include pancreas transplant procedure and associated transplant billing codes — verify with payer-specific billing guidance.
Failure to obtain prior authorization may result in claim denial or retrospective review and potential noncoverage.
Documentation Required
Documentation and Denial Triggers
Provide complete clinical documentation to support medical necessity. Incomplete documentation or absence of required records is a common denial trigger.
Clinical documentation required: relevant chart notes, emergency department visits, and hospitalizations documenting metabolic complications (e.g., severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, recurring severe ketoacidosis).
Provider Actions, Prior Authorization, and Documentation
Prior Authorization
Request prior authorization using listed CPT/HCPCS codes
Obtain prior authorization for pancreas transplant procedures and reference the policy’s listed CPT/HCPCS codes when requesting authorization; use the codes provided to identify the procedure(s) in the authorization request.
Include any relevant HCPCS codes (e.g., S2065) or informational islet codes as applicable for the procedure context.
Prior Authorization
Prior authorization required when billing CPT 50328
Prior authorization is required when billing CPT 50328; ensure the authorization request references CPT 50328 and that all medical necessity criteria are documented in the request.
CPT 50328 (backbench reconstruction; arterial anastomosis) was added to the policy’s covered procedure list and requires prior authorization.
Attach supporting clinical documentation that demonstrates criteria are met when submitting for CPT 50328.
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, and Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to splenic artery.
Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary.
Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary.
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CPT/HCPCS Codes that do not support coverage criteria / informationalmixedNot Covered
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; percutaneous.
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; laparoscopic.
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; open.
SPK renal function thresholdGFR < 20 mL/min or creatinine clearance (CrCl) < 20 mL/min (or dialysis dependent) — required for Simultaneous Pancreas-Kidney (SPK).
PAK kidney function requirementStable creatinine clearance ≥ 30 mL/min — required to qualify for Pancreas After Kidney (PAK).
PAK proteinuria criterionAbsence of significant proteinuria specified as greater than 500 mg/day for stable kidney transplant function in PAK.
Immunosuppressive drug threshold
Documented threshold addedPolicy specifies an immunosuppressive drug threshold described in the document as 'specified as greater than 500mg/day' (I.B.3.c.ii).
Definitions and Background
Pancreas transplantation (including PTA, SPK, and PAK) can restore endogenous insulin secretion, slow progression of diabetic complications, and improve quality of life, particularly in patients with type I diabetes. Autologous islet cell transplantation is considered medically necessary as an adjunct to total or near-total pancreatectomy for severe, refractory pancreatitis. Policy revisions clarified candidate eligibility (specifying type I diabetes), added recurring severe hypoglycemic attacks as an explicit indication, and updated timing-based cardiovascular exclusions (changing myocardial infarction timing to within 6 months). The coding list was also expanded with the addition of CPT 50328.
SPK (Simultaneous Pancreas-Kidney)
DefinitionSimultaneous Pancreas-Kidney transplant (SPK): pancreas and kidney transplanted together for diabetic patients with end-stage renal disease (ESRD).
Typical indicationPrimarily indicated for type 1 diabetic patients with advanced chronic kidney disease or ESRD; SPK accounts for most pancreas transplants.
Coverage criteria linkSPK coverage requires meeting PTA criteria plus ESRD definition (uremia and dialysis requirement or expected dialysis within 12 months) and GFR/CrCl thresholds.
Center Requirements and Post-Transplant Coverage
Note
Center must follow established surgical and immunosuppression practice and use correct CPT coding
Transplant centers should adhere to established practice standards, including specialized surgical and immunosuppression expertise; reference the policy’s procedural CPT coding and backbench preparation codes in operative and billing documentation.
Ensure center demonstrates appropriate surgical and immunosuppression capabilities.
Use the policy’s listed CPT/backbench codes (e.g., 48551–48554; 50323–50328) in operative notes and billing documentation.
Note
Follow OPTN/CMS standards; specific center thresholds not specified in extract
The policy references OPTN and CMS NCD guidance and implies adherence to transplant center requirements, but specific center accreditation or volume thresholds are not specified in this extract; centers should follow applicable OPTN/CMS standards.
When applicable, document compliance with OPTN/CMS requirements and center-specific accreditation.
Attach supporting evidence of adherence to external regulatory/OPTN/CMS policies if relevant to the authorization.
Policy Summary
PayerAmbetter Nevada
PolicyPancreas Transplantation
Policy CodePolicy CP.MP.102
Change TypeCriteria revision, coding update, and structural edits
Effective Date
Next Review Date
Key ActionObtain prior authorization and document type I diabetes, recurrent severe hypoglycemia, and relevant cardiovascular history per revised timing when requesting pancreas transplant coverage.
Indications added: Recurring severe hypoglycemic attacks added to the PTA criteria (I.B.1.a.ii).
Documentation of endocrinology management: evidence member has been managed by an endocrinologist for at least 12 months prior to request.
Transplant-specific documentation: indication for type of transplant (PTA, SPK, PAK) with corresponding criteria (e.g., ESRD with dialysis or expected dialysis within 12 months and GFR/CrCl thresholds for SPK; stable kidney function and absence of significant rejection for PAK).
Contraindications: documentation that none of the contraindications are present (e.g., uncontrolled infection, active TB, recent stroke/MI, active malignancy with high recurrence risk, significant comorbidities, active substance use or tobacco/vaping without evidence of risk reduction).
Required supporting items: lab results (GFR/CrCl, viral load/CD4 if HIV), dialysis records, transplant center evaluation notes, psychosocial evaluation including adherence assessment, substance use testing results when applicable, and multidisciplinary transplant committee recommendations.
Step Therapy
Step therapy not applicable
No step therapy or sequencing is specified for pancreas transplantation in this policy; providers should not expect a mandated trial of alternative therapies as a prior step in authorization.
Note
Documentation Required
Submit clinical event records documenting recurrent severe metabolic complications
Include chart notes, emergency department visit records, or hospitalization documentation that specifically describe recurrent severe metabolic complications (examples in policy: severe hypoglycemia unawareness; recurring severe hypoglycemic attacks; marked hyperglycemia; recurring severe ketoacidosis) to support PTA indications.
Provide event dates, clinical course, and interventions (e.g., ED treatment, admissions).
Clearly link documented events to the medical necessity rationale for PTA.
Documentation Required
Provide comprehensive clinical justification and diagnostic data
Document clinical justification for pancreas transplant eligibility including specification of diabetes type I when required, occurrences of recurring severe hypoglycemic attacks if applicable, renal function measurements for SPK/PAK eligibility, and pertinent cardiovascular history per the revised timing criteria.
Specify diagnosis of type I diabetes where applicable.
Include GFR or creatinine clearance values and dialysis status for SPK candidacy (GFR <20 mL/min or CrCl <20 mL/min or dialysis dependent).
For PAK, document stable creatinine clearance ≥30 mL/min and absence of significant proteinuria (>500 mg/day).
Include cardiovascular event timing (see updated MI/stroke timing) in clinical history.
Denial Risk
Denial risk if medical necessity criteria are not met
Requests that fail to meet the policy’s medical necessity criteria for PTA, SPK, or PAK — including absence of documented severe metabolic complications, lack of endocrinology management for ≥12 months (for PTA), or not meeting renal function/dialysis criteria for SPK/PAK — may be denied.
Ensure documentation of recurrent severe metabolic complications and endocrinologist management ≥12 months for PTA.
For SPK, document ESRD status and GFR/CrCl <20 mL/min or dialysis dependence.
For PAK, document stable CrCl ≥30 mL/min and absence of significant proteinuria (>500 mg/day).
Denial Risk
Timing-based denial risk for recent MI or stroke/ACS
Verify and document timing of recent cardiovascular events per the policy’s revised language; failure to meet the updated timing criteria (for example, myocardial infarction within the past 6 months) may result in denial.
Record dates of myocardial infarction and stroke/acute coronary syndrome and confirm they meet the policy’s allowable timeframes before transplant consideration.
Context of threshold
This threshold was added in the revisions noted in the policy update language and applies to the specified criterion where referenced.
Post-transplant implicationImmunosuppression is required post-transplant; this numeric threshold clarifies an upper/larger-dose specification for the referenced agent in policy text.
PTA (Pancreas Transplant Alone)
DefinitionPancreas Transplant Alone (PTA): pancreas transplant performed for recurrent, severe metabolic complications of diabetes without concurrent kidney transplant.
IndicationsPTA indicated for recurrent severe metabolic complications (severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, recurring severe ketoacidosis) and failure of insulin management.
Management requirementCandidate must have been managed by an endocrinologist for at least 12 months prior to PTA.
Autologous islet cell transplant
DefinitionAutologous islet cell transplant: transplantation of the patient’s own islet cells into the liver via the portal vein after total or near-total pancreatectomy to reduce post-surgical diabetes risk.
IndicationMedically necessary as an adjunct to total or near-total pancreatectomy for severe, refractory chronic pancreatitis.
Procedure contextPerformed following pancreatectomy to preserve endogenous insulin secretion and improve quality-of-life outcomes related to chronic pancreatitis.
Type I diabetes
TermType I diabetes (specified in policy as the required diabetes type for candidate eligibility).
Role in eligibilityPolicy I.A.1 specifies diagnosis of diabetes mellitus type I requiring insulin as an entry criterion for pancreas transplantation.
Clinical contextPancreas transplantation is primarily performed in patients with type 1 diabetes to restore endogenous insulin secretion.
Immunosuppressive therapy and graft monitoring
Standard of care statementPost-transplant immunosuppression and graft monitoring are expected as standard of care for pancreas recipients, though the policy does not detail specific regimens or durations.
Immunosuppression necessityPancreas recipients typically require extensive immunosuppression; pancreas grafts may need higher immunosuppression due to immunogenicity or autoimmune status.
Policy specificityThe document references immunosuppression requirements but does not specify drug regimens or monitoring schedules within this policy.
References governing post-transplant coverage
Regulatory referencesReferences include CMS National Coverage Determination for pancreas transplants and OPTN policies which inform post-transplant coverage considerations.
Scope of guidanceThese referenced policies govern broader post-transplant requirements and center standards, but the current document does not list specific coverage durations or services.
Where to consultProviders should consult CMS NCD and OPTN policies for detailed post-transplant coverage and center-specific requirements.