CurrentCentenePolicy CP.MP.102

Pancreas Transplantation

Medical necessity criteria, contraindications, coding, and coverage stance for pancreas transplantation procedures (SPK, PAK, PTA), autologous islet cell transplantation, and retransplantation for Centene health plans.

Policy Summary

PayerCentene

PolicyPancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that candidate meets procedure-specific criteria (e.g., PTA: severe hypoglycemia unawareness or recurrent severe metabolic complications and management by an endocrinologist for ≥12 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

SPK/PAK/PTAtypes covered

<20GFR threshold

Medically necessaryautologous islet

codes listedCPT coding

~25kregistry cases cited

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Pancreas Transplant Coverage Criteria

Covered when ALL of the following are met for the specified transplant type

General diagnostic indications: Diagnosis of diabetes mellitus requiring insulin (members with insulin requirement >1 unit/kg should be closely evaluated as they may be less likely to benefit); OR diagnosis of exocrine pancreatic insufficiency; OR requirement for procurement/transplantation of a pancreas as part of a multiple-organ transplant for technical reasons.

Contraindications absent: Member does not have any listed contraindications (examples include: malignancy with high risk of recurrence or death; GFR >= 40 mL/min/1.73 m2 unless being considered for multiorgan transplant; recent stroke or acute coronary syndrome within 30 days or myocardial infarction within 6 months; septic shock; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multiorgan transplant; active infection with highly virulent/resistant microbes poorly controlled pre-transplant; active tuberculosis; HIV with detectable viral load unless on effective ART with CD4 > 200 and absence of active AIDS-defining infection; progressive cognitive impairment; inability to adhere to regimen even with caregiver support; active substance use or dependence; chronic non-healing wounds; significant comorbidities expected to limit survival).

PTA-specific: Pancreas Transplant Alone (PTA): documentation of severe hypoglycemia unawareness OR recurrent, severe, potentially life‑threatening metabolic complications (e.g., recurring severe hypoglycemic attacks, recurring severe ketoacidosis, marked hyperglycemia) AND clinical (and/or emotional) problems with exogenous insulin therapy so severe as to be incapacitating or consistent failure of insulin‑based management to prevent acute complications; medically managed by an endocrinologist for at least 12 months.

SPK-specific: Simultaneous Pancreas‑Kidney transplant (SPK): meets PTA criteria AND presence of uremia AND end‑stage renal disease defined by requirement for dialysis or expected to require dialysis within 12 months.

PAK-specific: Pancreas After Kidney transplant (PAK): meets PTA criteria AND GFR < 20 mL/min (or CrCl 20 mL/min) (value need not be the most recent) AND stable kidney transplant function as defined by stable creatinine clearance ≥ 30 mL/min and absence of significant proteinuria, and prior successful kidney transplant without significant chronic rejection.

Autologous islet cell transplantation

Covered when ALL of the following are met

Autologous islet transplant indication: Autologous islet cell transplantation is considered medically necessary as an adjunct to total or near‑total pancreatectomy for severe, refractory chronic pancreatitis.

Pancreas retransplantation

Covered when ALL of the following are met

Retransplantation: Pancreas retransplantation is medically necessary after one failed primary pancreas transplant (retransplantation after two or more failed primary pancreas transplants is not supported).

Not supported indications

Not covered

Not supported: Allogeneic islet cell transplantation or xenotransplantation; retransplantation after two or more failed primary pancreas transplants; SPK transplantation for patients with amputation due to peripheral obstructive vascular disease; and use of pancreas transplant procedures for indications other than those specified above are not supported by current evidence.

Allogeneic islet cell transplantation and xenotransplantation are not supported by this policy. The document explicitly lists “Allogeneic islet cell transplantation or xenotransplantation” among indications for which current evidence does not support use of pancreas transplant procedures. Additionally, specific islet-cell CPT codes are identified as not supporting coverage: 0584T, 0585T, and 0586T. The HCPCS code S2065 (simultaneous pancreas-kidney transplantation) is also listed in the section of codes that do not support the coverage criteria in this context.

When applying this clinical policy to Medicaid members/enrollees, state Medicaid coverage provisions take precedence if they conflict with the policy. Providers should refer to the applicable state Medicaid manual for any coverage provisions that govern pancreas transplant services.

Use of pancreas transplant procedures for indications other than those specified in this policy is considered not supported by current evidence. The policy explicitly calls out that procedures performed for non‑specified indications — including allogeneic islet cell transplantation or xenotransplantation — are not supported. Providers should not rely on pancreas transplant procedure codes for indications outside the listed, medically necessary indications.

Coding and Billing

Covered CPT CodesCPTCovered

48160	Pancreatectomy, total or subtotal, with autologous transplantation of 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 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 prior
48552	Backbench reconstruction of cadaver donor pancreas allograft to transplantation, venous anastomosis, each
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
50323	Backbench standard preparation of cadaver donor renal allograft 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 prior
50325	Backbench standard preparation of living donor renal allograft (open or laparoscopic) to transplantation, including dissection and removal of perinephric fat

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CPT/HCPCS Codes that do not support coverage criteriamixedNot 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
S2065	Simultaneous pancreas kidney transplantation (HCPCS)

Glomerular filtration rate (GFR)

GFR threshold for PAK candidacyGFR < 20 mL/min (value does not have to be the most recent) — specified as criterion for Pancreas After Kidney [PAK] candidacy

Alternative renal measureCreatinine clearance (CrCl) ≈ 20 mL/min may be used as equivalent to GFR < 20 mL/min for PAK consideration

Use in ESRD definition for SPKEnd-stage renal disease for SPK is defined by requirement for dialysis or expectation to require dialysis within 12 months (GFR threshold noted specifically for PAK)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for listed pancreas transplant and donor/recipient procedure codes. Providers must obtain authorization before scheduling or performing these services to ensure coverage consideration.

Affected CPT codes: 48160, 48550, 48551, 48552, 48554, 48556, 50300, 50320, 50323, 50325
Not supported CPT/HCPCS: 0584T, 0585T, 0586T; HCPCS S2065 noted

Prior Authorization

Prior Authorization Applicability and External Coverage Rules

Prior authorization requirements apply across commercial, Medicare and Medicaid lines of business; however, providers should review and apply any applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Coverage Articles, and state Medicaid provisions for consistency. For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy.

Review Medicare NCDs/LCDs and Coverage Articles for consistency prior to authorization decisions
State Medicaid rules override this policy where conflicts exist

Denial Risk

Contraindications May Trigger Denial

Requests may be denied when the member has any listed contraindication. Examples include active high-risk malignancy, recent myocardial infarction or stroke within specified timeframes, septic shock, active uncontrolled infection, active tuberculosis, detectable HIV viral load without meeting specified criteria, progressive cognitive impairment, inability to adhere to post-transplant regimen, active substance use/dependence (including tobacco/vaping/unsanctioned marijuana or IV drug use without evidence of risk-reduction), chronic non-healing wounds, or significant comorbidities expected to limit survival.

Malignancy with high risk of recurrence or death related to cancer
Myocardial infarction within 6 months or stroke/acute coronary syndrome within 30 days
Septic shock; active, poorly controlled highly virulent/resistant infections; active tuberculosis
HIV with detectable viral load unless criteria met (CD4 >200, on effective ART, absence of active AIDS-defining infection)
Progressive cognitive impairment; inability to adhere to regimen; active substance use/dependence without risk-reduction evidence
Chronic non-healing wounds; significant comorbidities limiting post-transplant survival

Documentation Required

Clinical Criteria Documentation Required

Clinical documentation submitted with authorization requests must demonstrate that the member meets the procedure-specific medical necessity criteria (e.g., for Pancreas Transplant Alone: severe hypoglycemia unawareness, recurrent life‑threatening metabolic complications, failure of insulin-based management as specified; for SPK/PAK: documentation of ESRD/uremia or kidney transplant status and that PTA criteria are met). Documentation should include relevant history, specialist (endocrinologist) management for required durations, lab and renal function data, hospitalization/ER records for events, and evidence of attempts at medical management where applicable.

For PTA: evidence of severe hypoglycemia unawareness and documentation of recurrent severe metabolic complications or incapacitating failure of insulin therapy
For SPK: evidence of end-stage renal disease (dialysis or expected need within 12 months) and PTA criteria met; for PAK: stable kidney transplant function and PTA criteria met
Evidence of management by an endocrinologist for at least 12 months when required
Include hospital/ER records, specialist notes, lab values (e.g., GFR/CrCl), and adherence/support assessments

Documentation Required

Follow Plan Terms, Exclusions, and Documentation Requirements

Coverage decisions are subject to the member's benefit terms, exclusions and limitations. Providers must follow plan terms and submit documentation supporting medical necessity. This policy guides medical necessity determinations but does not guarantee payment; state and federal requirements and Health Plan administrative policies also apply.

Coverage subject to evidence of coverage/certificate/policy terms and plan exclusions/limitations
Decisions may be influenced by state/federal requirements and Health Plan administrative policies
Providers should submit complete supporting documentation to facilitate authorization and claims processing

Step Therapy

No Step-Therapy Mandated

No step-therapy sequence is mandated by this policy. Prior medical therapies requirements that previously existed (such as specific step sequences) have been removed; authorization should be based on the clinical criteria and documentation rather than a required step-therapy algorithm.

No explicit step-therapy or required trial sequence is specified in the policy
Authorization decisions should focus on meeting the listed medical necessity criteria

Pre-Transplant Evaluation Requirements

Documentation Required

PTA evaluation: document severe hypoglycemia unawareness and endocrinology management

For PTA evaluation, include documentation of severe hypoglycemia unawareness or recurrent, severe metabolic complications and evidence of management by an endocrinologist for at least 12 months.

Provide chart notes, ER/hospital records documenting recurrent severe hypoglycemic attacks, recurrent ketoacidosis, or marked hyperglycemia
Document endocrinology follow‑up and treatment for ≥12 months

Note

Consult OPTN, NCD/LCD and guideline requirements before submission

Providers should consult the referenced clinical guidelines and applicable NCDs/LCDs (including OPTN and CMS determinations) for any required evaluation steps prior to approval.

Review OPTN policies and CMS NCDs/LCDs as part of the preauthorization evaluation
Ensure submitted evaluation steps align with referenced guidelines in the policy

Definitions

SPK / PAK / PTA — Definitions

SPK (Simultaneous Pancreas-Kidney)Pancreas transplant performed at the same time as a kidney transplant — established for diabetic patients with advanced chronic kidney disease or end-stage renal disease; frequently the most common pancreas transplant type (≈90% of US cases)

PAK (Pancreas After Kidney)Pancreas transplant performed after a prior successful kidney transplant — candidacy requires meeting PTA criteria plus renal thresholds (GFR <20 mL/min or CrCl ≈20 mL/min) and stable kidney transplant function

PTA (Pancreas Transplant Alone)Pancreas transplant performed without concurrent kidney transplant — indicated for patients with severe, refractory type 1 diabetes meeting PTA-specific criteria (e.g., severe hypoglycemia unawareness or recurrent, severe metabolic complications) and managed by an endocrinologist

Autologous islet cell transplantation

DefinitionAutologous pancreatic islet cell transplantation: transfer of a patient’s own islet cells into the hepatic portal vein following total or near-total pancreatectomy, performed as an adjunct to pancreatectomy for severe, refractory chronic pancreatitis

Clinical contextIntended to preserve endocrine function and reduce post-pancreatectomy diabetes in patients undergoing pancreatectomy for debilitating chronic pancreatitis

Coverage stanceConsidered medically necessary as an adjunct to total or near-total pancreatectomy for severe, refractory pancreatitis per policy

Pancreas transplantation

General definitionSurgical transplantation of a pancreas (including as part of simultaneous pancreas-kidney procedures) to restore endogenous insulin secretion and reduce progression of diabetic complications

IndicationsPrimarily performed for type 1 diabetes; SPK for patients with advanced chronic kidney disease or end-stage renal disease; PTA and PAK used for selected patients meeting specific clinical criteria

Supporting literature/guidelinesReferenced sources include the International Pancreas Transplant Registry trend analysis (Gruessner 2011), OPTN policies, ADA Standards of Care 2024, and transplant textbooks/reviews

Post-Transplant Care and Coverage

Immunosuppression and post-transplant monitoring

Essential rolePost-transplant immunosuppression regimens are required for pancreas recipients due to pancreas immunogenicity and are implied as essential to preserve graft function

Monitoring impliedPost-transplant follow-up and monitoring are necessary, though specific immunosuppressive regimens and monitoring protocols are not detailed in this policy section

Higher immunosuppression needsPancreas recipients may require higher levels of immunosuppression compared with other solid organ transplants

Pancreas transplant follow-up and related services

Alignment with OPTN policiesPost-transplant follow-up and related services should align with Organ Procurement and Transplantation Network (OPTN) policies referenced in the policy

Medicare/Medicaid considerationsProviders must review applicable Medicare NCDs/LCDs and state Medicaid provisions to ensure consistency with coverage determinations for post-transplant care

Documentation and plan termsCoverage of follow-up services is subject to plan terms, conditions, exclusions, and limitations; state Medicaid provisions take precedence when conflicts exist

OpenPayer

Pancreas Transplantation

Coverage Criteria for Pancreas Transplantation

Coding and Billing

Provider Actions, Authorization, and Documentation

Candidate Selection Criteria

Contraindications

Pre-Transplant Evaluation Requirements

Transplant Center and Operational Requirements

Background and Rationale

Definitions

Post-Transplant Care and Coverage