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    v1.0.28
    OpenPayerPolicy UpdatesTransplantCentene Pancreas Transplant Coverage Update | Open…
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    ModifiedCentenePolicy CP.MP.102

    Pancreas Transplantation

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    Defines medical necessity criteria, contraindications, and coding guidance for pancreas transplantation (PTA, SPK, PAK), autologous islet autotransplantation, and retransplantation for Centene-affiliated health plans; affects providers requesting coverage for these procedures.

    Policy Summary
    PayerCentene
    PolicyPancreas Transplantation
    Policy CodePolicy CP.MP.102
    Change TypeAnnual review — material updates
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit documentation demonstrating medical necessity (diagnosis, endocrinology management for ≥12 months for PTA, and relevant renal status for SPK/PAK).
    SourceLink

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    POLICY UPDATE CHANGES

    Changed myocardial infarction timing from within 30 days to within 6 months and reworded information about stroke or acute coronary syndrome.

    Added 'Recurring severe hypoglycemic attacks' to candidate criteria (I.C.1.a.ii).

    Added CPT code 50328 to the coding list.

    3transplant types covered
    1 yearendocrinology management pre-PTA
    ≤20 mL/minSPK GFR threshold
    50328new CPT code added
    Updatedreferences updated

    Coverage Criteria for Pancreas Transplantation

    Initial transplant medical necessity

    Pancreas transplantation (PTA, SPK, PAK) is medically necessary when ALL of the following groups of criteria are met as specified per transplant type:

    Overall eligibility

    • Indications: Diagnosis: diabetes mellitus requiring insulin; exocrine pancreatic insufficiency; need for pancreas as part of multiorgan transplant for technical reasons.
    • Contraindications absent: Member does NOT have any listed contraindications including: malignancy with high risk of recurrence or death related to cancer; GFR < 40 mL/min/1.73m2 unless being considered for multiorgan transplant; recent stroke or acute coronary syndrome or myocardial infarction within specified timing; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multiorgan; septic shock; active uncontrolled infection (including active tuberculosis); HIV with detectable viral load unless CD4 >200, no active AIDS-defining infection/malignancy, and on effective ART; progressive cognitive impairment; inability to adhere to regimen; active substance use/dependence; chronic non-healing wounds; significant comorbidities limiting survival; other severe uncontrolled medical conditions.
    PTA-specific: PTA requires ALL of the following: (a) recurrent, severe, and potentially life‑threatening metabolic complications documented by chart notes, ER visits, or hospitalizations (any of: severe hypoglycemia unawareness; recurring severe hypoglycemic attacks; marked hyperglycemia; recurring severe ketoacidosis); (b) clinical or clinical plus 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.
    SPK-specific: SPK requires ALL of the following: (a) meets PTA criteria; (b) end‑stage renal disease (ESRD), defined by presence of uremia AND requires dialysis or is expected to require dialysis within 12 months; (c) GFR < 20 mL/min or creatinine clearance (CrCl) < 20 mL/min (value need not be the most recent).
    PAK-specific: PAK requires ALL of the following: (a) meets PTA criteria; (b) underwent a prior successful kidney transplant without significant chronic rejection; (c) stable kidney transplant function defined by creatinine clearance ≥ 30 mL/min AND absence of significant proteinuria.

    Islet autotransplantation

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

    Retransplantation

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

    Not supported / unproven indications

    Not supported indications: Not supported: retransplantation 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; and other indications not specified as covered.

    Revised candidate timing and indications

    Policy updates affecting candidate criteria and timing restrictions

    Timing restriction for recent myocardial infarction: Recent myocardial infarction within 6 months is noted as a consideration/contraindication for candidacy evaluation (revised from within 30 days).6 months

    Reworded in annual review.

    Indications added: Recurring severe hypoglycemic attacks added as an explicit indication under PTA candidate criteria (I.C.1.a.ii).

    Newly added in annual review.

    The policy explicitly identifies several pancreas transplant-related procedures and scenarios that are not supported for coverage. These include retransplantation after two or more failed primary pancreas transplants and allogeneic islet cell transplantation or xenotransplantation. Requests for retransplantation beyond one prior failed primary transplant should be considered not covered unless otherwise specified in the member's benefits or applicable law. (See exceptions for autologous islet autotransplantation in other sections.)

    Coverage decisions under this policy are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable legal and regulatory requirements. This clinical policy is guidance to inform medical necessity determinations and does not guarantee payment; providers must follow Health Plan administrative policies and submit documentation consistent with the member's benefits and any applicable state or federal requirements.

    Simultaneous pancreas–kidney (SPK) transplantation is specifically listed as not supported for patients with amputation due to peripheral obstructive vascular disease. The policy also states that procedures or indications not explicitly listed as covered (for example, indications outside the specified diabetes/exocrine insufficiency/multiorgan technical needs) are considered unsupported by current evidence and therefore not covered.

    This policy characterizes its medical necessity criteria as a guide for coverage determinations; explicit lists of not medically necessary conditions in the excerpt are limited. Where a condition is not listed as covered, the policy indicates it is unsupported. Providers should rely on the medical necessity criteria and supporting documentation when requesting coverage, and recognize that additional NMN conditions may exist in the full policy outside this excerpt.

    Procedure and Billing Codes

    Prior Authorization

    Provider Actions and Billing Notes

    Prior authorization is required for pancreas transplantation procedures. Coverage is conditional on the member's benefits, applicable state and federal regulations, and meeting the clinical criteria in this policy. Providers must submit documentation demonstrating medical necessity and adherence to contraindication thresholds (e.g., GFR/CrCl criteria) and applicable transplant-specific requirements. Failure to document indications, contraindications, or jurisdictional precedence may result in claim denial or retrospective denial of payment.

    • Prior authorization required for pancreas transplant procedures and related donor/recipient services.
    • Coverage is subject to member benefit coverage and state/federal regulations; verify benefits prior to scheduling.
    • Document clinical indications, GFR/CrCl values, transplant type (PTA, SPK, PAK), prior transplant history, and specialist management (e.g., endocrinology involvement) in the medical record.
    • Denial risk if indications or contraindications are not met, if documentation is incomplete, or if jurisdictional precedence limits coverage.
    Covered CPT CodesCPTCovered
    48160Pancreatectomy, total or subtotal, with autologous transplantation of pancreatic islet cells
    48550Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation
    48551Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation
    48552Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastomosis, each
    48554Transplantation of pancreatic allograft
    48556Removal of transplanted pancreatic allograft
    50300Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral
    50320Donor nephrectomy (including cold preservation); open, from living donor
    50323Backbench standard preparation of cadaver donor renal allograft prior to transplantation
    50325Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation
    1–10 of 11
    1/2
    CPT / HCPCS Codes Not Supporting CoveragemixedNot Covered
    0584TIslet cell transplant, percutaneous
    0585TIslet cell transplant, laparoscopic
    0586TIslet cell transplant, open
    S2065Simultaneous pancreas kidney transplantation (HCPCS)
    Added Covered CPT Codes (Revision)CPTCovered
    50328Donor nephrectomy, laparoscopic (added in 01/25 revision)
    GFR / CrCl thresholds
    GFR / CrCl thresholds

    Provider Requirements and Authorization

    Prior Authorization

    Prior authorization and submission of medical necessity documentation

    Pancreas transplantation requires prior authorization per Health Plan processes and the request must include documentation consistent with medical necessity criteria (diagnosis, indications, absence of contraindications, and type‑specific requirements).

    • Submit clinical documentation demonstrating that the member meets the policy's medical necessity criteria for the transplant type requested.
    • Follow Health Plan prior authorization procedures and timelines for review.
    Note

    Include annual review updates in authorization requests

    When requesting authorization, include any policy‑specified updates or revisions relevant to candidacy (for example, the policy notes additions and revisions from the annual review).

    • Ensure authorization submissions reflect current criteria (e.g., removed/updated criteria and added indications noted in the revision history).

    Candidate Selection for Transplant

    Candidate selection

    Candidate selection requires meeting indication(s) and absence of listed contraindications; type‑specific criteria apply.

    General candidate criteria: Has an indication (diabetes requiring insulin; exocrine pancreatic insufficiency; or technical need for pancreas in multiorgan transplant) AND does not have any contraindications listed in policy (e.g., malignancy with high recurrence risk; GFR <40 mL/min/1.73m2 unless multiorgan; recent stroke/ACS or MI within specified timing; acute liver failure/cirrhosis unless multiorgan; septic shock; uncontrolled active infection including TB; HIV with detectable viral load unless CD4>200, on effective ART, and no active AIDS‑defining infection; progressive cognitive impairment; inability to adhere to regimen; active substance use/dependence; chronic non‑healing wounds; significant comorbidities limiting survival; other severe uncontrolled conditions).

    Updated candidate considerations

    Updates to candidate selection criteria documented in the annual review.

    Severe hypoglycemia: Recurring severe hypoglycemic attacks were added as a candidate indication (I.C.1.a.ii).

    Annual review added this item.

    Contraindications to Transplant

    Contraindications to pancreas transplantation include a range of clinical conditions that, if present, generally preclude candidacy until resolved or may represent absolute exclusions. Key contraindications highlighted include malignancy with high risk of recurrence or death related to cancer and impaired renal function thresholds relevant to transplant type. For full details and the complete enumerated list of contraindications, refer to the contraindications section of the policy.

    Additional contraindications enumerated in the policy include: GFR < 40 mL/min/1.73 m2 (unless the member is being considered for a multiorgan transplant), active or uncontrolled infections (including tuberculosis and certain highly virulent/resistant organisms), and active substance use or dependence that would impair adherence to post‑transplant care.

    Cardiac events and cerebrovascular disease are addressed as important candidacy considerations: the policy notes recent myocardial infarction within 6 months (revised from 30 days) and stroke or acute coronary syndrome as factors that may preclude or delay transplant until clinically appropriate.

    Other listed contraindications include acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction (unless being considered for multiorgan transplant), septic shock, and other severe uncontrolled medical conditions expected to limit survival after transplant.

    Human immunodeficiency virus (HIV) infection is a contraindication unless the member is on effective antiretroviral therapy with undetectable viral load and a CD4 count > 200 cells/mm3 and has no active AIDS‑defining opportunistic infection or malignancy.

    Progressive cognitive impairment or inability to adhere to the regimen necessary to preserve the transplant (even with caregiver support) are contraindications due to the intensive post‑transplant management required.

    Pretransplant Evaluation

    Step Therapy

    Evaluation: endocrinology management and SPK requirements

    PTA candidates must have been medically managed by an endocrinologist for at least 12 months; SPK candidates must meet PTA criteria plus documentation of ESRD (uremia and need for dialysis or expected need within 12 months) and applicable GFR/CrCl thresholds.

    • Document ≥12 months of endocrinologist management for PTA.
    • For SPK, include evidence of uremia and dialysis requirement or expected dialysis within 12 months and GFR/CrCl values as specified in the policy.
    Note

    Evaluation guidance and reference sources for pretransplant workup

    Pretransplant evaluation should follow cited standards and consensus guidance (for example, UpToDate, American Diabetes Association, and OPTN) and detailed pretransplant workup referenced in the policy and literature.

    • Use referenced guidance (UpToDate, ADA, OPTN) to inform pretransplant assessment and documentation.
    • Include workup elements consistent with the cited sources when submitting authorization requests.

    Transplant Center Requirements

    Documentation Required

    Transplant center processes should support policy requirements

    Transplant center processes and capabilities are implied as part of candidate evaluation and care coordination; providers should ensure center processes align with the policy's clinical requirements though specific accreditation/volume criteria are not enumerated in this excerpt.

    • Ensure the transplant center documents adherence to the policy's clinical criteria (e.g., endocrinology follow‑up, management of comorbidities) in the authorization packet.
    Note

    Refer to OPTN and center requirements for transplant operations

    Refer to OPTN policies and applicable transplant center requirements (e.g., accreditation standards) when coordinating evaluation and transplantation; the policy cites OPTN guidance as a reference for center practices.

    • Include documentation demonstrating the center follows OPTN policies or other recognized transplant standards where relevant to the request.

    Post-Transplant Services and Management

    Immunosuppression management
    Immunosuppression overviewPancreas transplant recipients require extensive immunosuppression regimens; pancreas may be more immunogenic and often necessitates higher levels than other solid organs.
    Specific regimensSpecific drug regimens and dosing are not detailed in this excerpt of the policy.
    Implication for centers/providersTransplant centers should plan for intensive post-transplant immunosuppressive management and monitoring.
    Post-transplant services referenced generically
    Alignment with OPTNPost-transplant coverage and follow-up should align with OPTN policies referenced in the policy's citation list.
    Benefit limitationsCoverage for post-transplant services is subject to the member's coverage documents, terms, exclusions, and limitations.

    Background and Scope

    Pancreas transplantation—including pancreas transplant alone (PTA), simultaneous pancreas‑kidney transplant (SPK), and pancreas after kidney transplant (PAK)—can restore endogenous insulin secretion and improve glycemic control and diabetes‑related outcomes in selected patients with insulin‑dependent diabetes. SPK comprises the majority of pancreas transplants in the U.S. and is performed in patients with concurrent end‑stage renal disease; autologous islet autotransplantation is used as an adjunct to total or near‑total pancreatectomy for severe, refractory chronic pancreatitis.

    Definitions and Transplant Types

    Transplant types
    PTA (Pancreas Transplant Alone)Pancreas transplantation performed as pancreas-only to restore endocrine function in insulin-dependent patients.
    SPK (Simultaneous Pancreas–Kidney)Simultaneous pancreas and kidney transplant for patients with advanced chronic kidney disease or end-stage kidney disease; SPK comprises the majority of pancreas transplants.
    PAK (Pancreas After Kidney)Pancreas transplant performed after prior successful kidney transplant, requiring stable renal function (CrCl ≥30 mL/min) and no significant proteinuria.
    Pancreas transplantation definition
    DefinitionSurgical transplantation of a donor pancreas to restore endocrine (insulin) function in patients with insulin-dependent diabetes; may be performed as pancreas-alone or in combination with kidney transplantation (SPK).
    Purpose
    Policy Summary
    PayerCentene
    PolicyPancreas Transplantation
    Policy CodePolicy CP.MP.102
    Change TypeAnnual review — material updates
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit documentation demonstrating medical necessity (diagnosis, endocrinology management for ≥12 months for PTA, and relevant renal status for SPK/PAK).
    SourceLink
    On This Page
    Coverage Criteria for Pancreas TransplantationProcedure and Billing CodesProvider Requirements and AuthorizationCandidate Selection for TransplantContraindications to TransplantPretransplant EvaluationTransplant Center RequirementsPost-Transplant Services and ManagementBackground and ScopeDefinitions and Transplant Types
    GFR < 20 mL/min OR CrCl < 20 mL/min required for PTA eligibility; for PAK stable kidney function requires CrCl ≥ 30 mL/min and absence of significant proteinuria.
    (placeholder)Refer to full policy text for any additional jurisdictional or documentation specifics not captured here.
    Billing Rule

    Match requested services to covered procedure codes

    Providers must reference the policy's coding and coverage lists when preparing authorization requests and ensure requested services match covered procedure codes.

    • Do not rely on coding not listed as supporting coverage; cross‑check EDI/claims coding against the policy.
    Documentation Required

    Required clinical documentation to support medical necessity

    Required clinical documentation must demonstrate the diagnosis and severity consistent with the transplant type: diagnosis of diabetes requiring insulin or exocrine pancreatic insufficiency, chart notes/ED visits/hospitalizations documenting recurrent severe metabolic complications for PTA, evidence of endocrinology management for ≥12 months for PTA, and renal status documentation for SPK/PAK as specified.

    • For PTA: chart notes, ER/hospital records documenting severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, or recurring severe ketoacidosis; documentation of ≥12 months endocrinology management.
    • For SPK/PAK: documentation of ESRD, uremia, dialysis status or expected need for dialysis within 12 months, and GFR/CrCl values per policy thresholds.
    Documentation Required

    Documentation submission and jurisdictional precedence

    Follow Health Plan administrative policies and the member's coverage documents when submitting documentation; for Medicaid or Medicare members, applicable state Medicaid provisions or Medicare NCDs/LCDs take precedence and should be referenced.

    • Check state Medicaid manuals for Medicaid members when state provisions conflict with this policy.
    • Review applicable Medicare NCDs/LCDs and Coverage Articles for Medicare members prior to applying policy criteria.
    Denial Risk

    Denial risk if indications or contraindications not documented

    Requests may be denied if documentation does not show the member meets indication criteria or if listed contraindications are present (e.g., malignancy with high recurrence risk, uncontrolled infection, GFR below specified thresholds unless multiorgan transplant).

    • Denials commonly occur when there is no documentation of diabetes requiring insulin, exocrine pancreatic insufficiency, technical need for multiorgan transplant, or when contraindications (e.g., active uncontrolled infection, malignancy with high recurrence risk) are documented.
    • Verify GFR/CrCl and other contraindication criteria before submission.
    Note

    Coverage subject to member benefits and regulations

    Coverage is conditional on the member's plan terms, exclusions, limitations, and applicable legal/regulatory requirements; failure to meet plan or state/Medicare requirements may result in denial or noncoverage.

    • Confirm member benefit coverage and any plan‑level exclusions prior to proceeding with authorization or scheduling.
    Cardiac event timing: Timing for recent myocardial infarction in candidacy considerations changed to within 6 months (I.B.3.).6 months

    Revised wording in annual review.

    Chronic, non‑healing wounds and significant comorbidities expected to limit post‑transplant survival are listed as contraindications because they increase perioperative risk and limit long‑term benefit.

    Active tuberculosis and other active infections that are uncontrolled prior to transplant are contraindications until adequately treated and controlled.

    Current active substance use or dependence (including current tobacco, vaping, or illicit IV drug use) without evidence of risk‑reduction or commitment to behavior change is a contraindication; exceptions may be considered in urgent situations with documented mitigation efforts.

    Significant comorbid conditions or other severe uncontrolled medical problems that are expected to limit survival after transplant are contraindications to proceeding with pancreas transplantation.

    This policy was revised to clarify timing for recent major cardiac events and to add specific candidate indications. Clinicians and reviewers should apply the updated timing (MI within 6 months) and the full contraindication list in the context of the member's overall benefits and applicable legal/regulatory requirements.

    Where renal function thresholds are used in candidacy decisions, the policy distinguishes by transplant type. For example, SPK candidacy references GFR < 20 mL/min or CrCl < 20 mL/min, while a general contraindication threshold of GFR < 40 mL/min/1.73 m2 applies unless the patient is being considered for multiorgan transplant. Refer to the detailed criteria for precise application.

    This list is a summary of the principal contraindications; the full policy contains the complete enumerated list and contextual guidance for absolute versus relative exclusions and clinical exceptions.

    Medicare/Medicaid precedenceFor Medicare or Medicaid members, applicable NCDs/LCDs or state Medicaid provisions take precedence and should be referenced.
    To restore glucose-regulated endogenous insulin secretion, decrease progression of diabetic complications, and improve quality of life.
    ContextsIncludes pancreas transplant alone (PTA), simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK) procedures.