Pancreas Transplantation (Including Simultaneous Pancreas-Kidney, Pancreas Alone, and Pancreas after Kidney)
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This policy governs coverage and medical necessity criteria for pancreas transplantation (including simultaneous pancreas-kidney, pancreas alone, and pancreas after kidney) and retransplantation for members of Blue Cross Blue Shield - Iowa.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Pancreas Transplant Alone (PTA)
Covered when ALL of the following are met for each transplant type as specified:
Pancreas Transplant Alone (PTA) - general
- Severity criteria for PTA: Documented severe hypoglycemia unawareness (chart notes or ED visits) OR documented potentially life-threatening labile diabetes (chart notes or hospitalization for DKA)
See Policy Guidelines for details
Pancreas-after-Kidney (PAK)
PAK permits benefit from a prior kidney graft and subsequent pancreas transplant to improve quality of life
Simultaneous Pancreas-Kidney (SPK)
SPK is intended for individuals with insulin-dependent diabetes and renal insufficiency
Initial transplant coverage criteria
Covered when ALL of the following are met for the specified transplant type
Supported by policy populations and PICO descriptions
Intervention described in policy sections for PAK, SPK, and PTA
Insulin therapy is the usual comparator and documentation of rationale is required
Retransplantation
Early technical graft loss may permit retransplant without substantial additional risk; chronic rejection and sensitization may increase risk and affect timing
Retransplantation criteria and precautions
Retransplantation considerations — proceed when ALL of the following apply
Chunk 18
Chunk 18 and center-specific practice (chunk 55)
General candidate coverage criteria (SPK, PTA, retransplant)
Covered when ALL of the following are met
Supported by clinical context and populations sections
Documentation of comparator therapy and prior management is required
Center judgement and evaluation per policy; consider nephrotoxic immunosuppression risks
Initial retransplant coverage criteria
Covered when ALL of the following are met
OPTN listing criteria apply
Centers may delay retransplant to allow immune reconstitution and plan augmented immunosuppression
Pancreas transplantation (PTA, PAK, SPK) and retransplantation are considered investigational when the policy's specified medical necessity criteria are not met. Requests that do not satisfy the stated coverage criteria may be denied because the available evidence is insufficient to demonstrate a net health benefit.
The evidence base comparing pancreas transplantation with medical management is limited. There are no randomized controlled trials that directly compare pancreas transplantation (including SPK) to insulin therapy or dialysis; published data are primarily retrospective single‑center series and registry reports.
Candidates for pancreas transplant alone should be counseled about the potential for nephrotoxic immunosuppression to worsen renal function. Patients in whom immunosuppressive therapy is likely to cause progressive renal injury such that the risks outweigh potential benefits should be considered poor candidates for PTA and require careful center‑level assessment and counseling.
Exclusions and contraindications include active systemic or opportunistic infections and active malignancy. Per guideline recommendations, candidates should not have unresolved opportunistic infections, untreated active malignancy, chronic wasting or severe malnutrition, or a history of certain excluded opportunistic infections (for example, progressive multifocal leukoencephalopathy, chronic interstitial cryptosporidiosis, primary CNS lymphoma, or visceral Kaposi's sarcoma) until these conditions are resolved and the candidate is otherwise appropriate for immunosuppression.
This policy section does not list any additional explicit coverage exclusions beyond the contraindications and investigational stance described elsewhere in the document.
Any pancreas transplant (PTA, PAK, SPK) or retransplantation that does not meet the policy's medical necessity criteria is considered investigational / not medically necessary and may be denied.
Pancreas transplant alone (PTA) has limited generalizability for most nonuremic type 1 diabetic patients. PTA may be appropriate only in very select, exceptional cases with life‑threatening or severely disabling diabetic complications (for example, hypoglycemia unawareness or labile diabetes); decisions for nonuremic patients should be individualized by weighing the risks of surgery and lifelong immunosuppression against potential benefits.
Pancreas retransplantation is generally not considered a life‑saving procedure. Retransplant should be considered only after careful assessment of risks and benefits; because retransplantation carries additional surgical and immunologic risks (including sensitization and potential difficulty finding a compatible donor), the decision should be individualized and documented by the transplant center.
There are no additional explicit statements in this section identifying specific conditions as 'not medically necessary' beyond the policy's general rule that procedures not meeting medical necessity criteria are investigational or not medically necessary.
Candidate Selection and Eligibility
PTA candidate criteria
Candidate selection for PTA requires one of the following severity criteria:
Most PTA recipients are type 1 diabetics; type 2 comprised 22.4% of pancreas transplants in 2022.
PAK and SPK candidate criteria
Other transplant candidate stances:
PAK candidates as described in policy
SPK candidates as described in policy
Candidate selection
Candidate populations described in the evidence review
Population of interest per evidence review
Population of interest for SPK
Candidate groups
Candidate populations addressed in this section
Candidate eligibility
OPTN- and guideline-based candidate requirements and HIV-specific considerations
From OPTN registration requirements
Per American Society of Transplantation guideline
Contraindications to pancreas transplantation include known current malignancy (including metastatic cancer) or recent malignancy with high risk of recurrence, untreated systemic infection or active opportunistic infection, and other systemic conditions that would make lifelong immunosuppression unsafe. Psychosocial conditions or substance dependency that would impair adherence to therapy, significant comorbid irreversible end‑stage disease unrelated to kidney disease, and a history of specific excluded opportunistic infections are additional contraindications; centers should also evaluate sensitization and the potential inability to obtain a negative donor crossmatch prior to retransplantation.
Authorization, Documentation, and Billing Requirements
Prior approval required
Prior approval is required.
Prior authorization: document OPTN/UNOS prioritization and listing intent
Document indication and transplant prioritization per OPTN/UNOS severity and mortality criteria in the prior authorization request; indicate whether the candidate is being listed and the transplant type (PAK, SPK, or pancreas-alone).
- Reference OPTN/UNOS prioritization and mortality-based severity criteria in the request
- Specify whether listing is for pancreas-alone, pancreas-after-kidney, or simultaneous pancreas-kidney
Specify transplant type and clinical indication in prior auth
Prior authorization requests must document the transplant type (SPK, PTA, or retransplant) and the clinical indication (insulin‑dependent diabetes with uremia or severe diabetic complications) and note prior treatments attempted.
- State transplant type: SPK, PTA, PAK, or retransplant
- State indication: insulin-dependent diabetes with uremia (for SPK) or severe diabetic complications (for PTA)
- Document prior treatments (e.g., optimal medical management, insulin therapy)
Verify waiting list registration requirements
Confirm in the prior authorization that the candidate meets pancreas or kidney‑pancreas waiting list registration requirements (diagnosis of diabetes or pancreatic exocrine insufficiency; for kidney‑pancreas also renal insufficiency).
- Indicate diabetes diagnosis or pancreatic exocrine insufficiency
- For combined kidney-pancreas, document renal insufficiency
Report procedure codes and inpatient place/type of service
Report pancreas transplant services with the appropriate CPT/HCPCS codes and indicate inpatient surgical place/type of service; ensure prior authorization per payer process when required.
Verify member benefits and contract language before authorization
Verify individual member benefits and applicable contract language prior to submitting an authorization request; benefit determinations depend on the member's contract.
- Confirm benefit existence and any exclusions or limitations before requesting prior approval
Document rationale versus insulin therapy
Document why transplant is preferred to ongoing insulin therapy in the record and prior authorization, citing specific clinical rationale for choosing transplant over insulin management.
- Explain why insulin therapy is insufficient or inferior for this candidate
- Provide clinical evidence supporting transplant as preferred therapy
Document failure or insufficiency of insulin therapy
Provide documentation that medical management with insulin therapy has failed or is insufficient when considering PTA or SPK; include chart notes, ED visits, or hospitalizations demonstrating inadequate control.
- Include evidence of persistent severe hypoglycemia unawareness or hospitalizations for DKA despite optimal insulin therapy
- Document attempts at and response to optimal medical management
Provide evidence of conservative management (insulin therapy)
Prior authorization may require documentation of ongoing conservative management (insulin therapy) and attempts to manage diabetic complications prior to transplant consideration, especially after graft failure.
- Document ongoing insulin therapy after graft failure when applicable
- Provide timeline and details of conservative management efforts
Document severe, disabling, or life‑threatening diabetic complications for PTA
For PTA candidates include documentation of severely disabling or potentially life‑threatening complications from insulin‑dependent diabetes (e.g., chart notes/ED visits for severe hypoglycemia unawareness or hospitalization for diabetic ketoacidosis).
- Chart notes or ED visit records demonstrating severe hypoglycemia unawareness
- Hospitalization records for DKA or other life‑threatening labile diabetes events
Include clinical and regulatory documentation (end‑stage organ failure, prior transplant, CFR compliance)
Include documentation of life‑threatening or disabling end‑stage organ failure, prior transplant history, and compliance with human tissue regulatory requirements (CFR Title 21 parts 1270 and 1271) in the record for solid organ transplantation.
- Document prior transplant history and cause of graft failure if applicable
- Document compliance with CFR Title 21, parts 1270 and 1271 for human tissues
Include supporting clinical records and study-relevant details
Supporting clinical documentation should include study-relevant details as appropriate and operationally must document prior medical management, severity of diabetic complications, and the rationale for choosing transplant.
- Document study design/duration/outcomes when citing literature
- Record clinical notes showing prior management and rationale for transplant
Document diagnosis and HIV-specific criteria for candidates
For listing and authorization, document diabetes diagnosis or pancreatic exocrine insufficiency; for HIV-positive candidates also include CD4 count, undetectable viral load, ART adherence, absence of active opportunistic infection or malignancy, and appropriate HIV follow-up.
- Document diabetes diagnosis or pancreatic exocrine insufficiency for listing
- For HIV-positive candidates, provide CD4 count (>200 cells/mL for ≥3 months), undetectable viral load on ART, and adherence documentation
Use appropriate CPT/HCPCS and diagnosis codes in documentation and claims
Use appropriate CPT, HCPCS, revenue, and ICD diagnosis codes to report provider services for pancreas transplantation and include necessary coding details in the authorization and claim.
Requests not meeting criteria considered investigational / may be denied
Requests that do not meet the policy's medical necessity criteria are considered investigational and may be denied; ensure all coverage criteria are documented in the request.
- If documentation does not meet listed criteria for PTA, PAK, SPK, or retransplantation, the request may be denied as investigational
Sensitization and crossmatch difficulty increase retransplant complexity
Document sensitization history and donor matching challenges; a history of sensitization or inability to obtain a negative crossmatch may increase retransplant complexity and affect approval.
- Include sensitization data and prior transplant immunologic history
- Note potential difficulty in finding a negative crossmatch
Selection-related denial risk for PTA when renal risk is high
Poor candidate selection for PTA (such as patients at high risk for progressive renal decline where nephrotoxic immunosuppression may worsen renal function) can lead to denial or non‑coverage; document risk counseling and center assessment.
- Document assessment of renal risk and counseling about nephrotoxic immunosuppression
- Provide justification why benefits outweigh risks for PTA candidates
Retransplantation may be denied for high sensitization or contraindications
Retransplantation may be denied if the patient is highly sensitized or has surgical/medical contraindications that preclude acceptable donor matching or safe surgery; include assessment of these factors in the request.
- Document surgical/technical contraindications and degree of sensitization
- Provide rationale if retransplant is being pursued despite these risks
Coding errors or incorrect place/type of service may lead to denial
Claims or prior authorization requests may be denied or improperly processed if services are not reported with appropriate CPT/HCPCS/ICD codes or correct place/type of service; verify coding prior to submission.
- Ensure CPT/HCPCS and ICD codes match the service provided
- Confirm place/type of service is listed as inpatient surgery when appropriate
Miscellaneous provider actions: center evaluation, timing, OPTN references
Document any additional provider-action items relevant to authorization such as center evaluation, timing considerations for retransplant, and reference to OPTN/UNOS policies when applicable.
- Document center-specific evaluation and timing decisions for retransplant
- Reference OPTN/UNOS policies as supporting justification
Procedure and Diagnosis Codes
| No codes listed |
| No codes listed |
Pre-Transplant Evaluation and Documentation
Document severity indicators and standard transplant evaluation
Provide documentation of severity indicators (chart notes, ED visits, hospitalizations) for PTA candidates and complete standard transplant evaluation per transplant center practice as part of the authorization record.
- Include ED/hospital records and clinic notes demonstrating severity
- Document completion of standard transplant evaluation steps per center
Record severity indicators and evaluation findings for listing
Include documentation of severity indicators (ED visits, hospitalizations, chart notes) for PTA and ensure transplant evaluation processes are recorded in the candidate's file for prior authorization and listing.
- Attach relevant acute care visit documentation
- Document multidisciplinary transplant evaluation outcomes
Confirm standard evaluation processes and include severity evidence
Ensure documentation shows standard transplant evaluation processes were completed and severity indicators are included for PTA candidates when requesting authorization or listing.
- Provide evidence of psychosocial, surgical, and medical evaluations
- Include any risk mitigation plans developed by the transplant center
Capture severity indicators and center risk assessment in evaluation records
Transplant evaluation documentation should capture severity indicators (ED visits, hospitalizations, chart notes) and center-specific assessment of surgical risk and immunosuppression counseling as part of the authorization package.
- Document informed consent discussions about immunosuppression risks
- Include assessment of surgical candidacy in records
Include objective severity data and evaluation completion
Document severity indicators and complete transplant evaluation per center practice; include relevant objective data that support medical necessity for listing and transplant.
- Attach laboratory, imaging, and functional testing relevant to transplant candidacy as available
- Record multidisciplinary team decisions regarding candidacy
Reference OPTN/UNOS, CMS, and guideline literature in evaluation documentation
When submitting authorization or listing documentation, reference OPTN/UNOS policies, CMS transplant certification requirements, and guideline literature as applicable to support evaluation and listing decisions.
- Cite OPTN/UNOS policy references to support listing/prioritization
- Reference CMS transplant certification requirements when relevant
Transplant Center Responsibilities and Qualifications
Center judgment governs contraindications and suitability
Transplant center judgment governs contraindications and candidate suitability; no specific accreditation or minimum volume requirements are specified in this policy section — document the center's assessment and protocols.
- Record the transplant center's contraindication assessment and rationale
- Document center protocols used to evaluate candidate suitability
Document center assessment of contraindications and suitability
Document the transplant center's evaluation of contraindications and suitability for transplant; this policy does not stipulate specific accreditation or volume minimums but centers should record their assessment.
- Include center-specific contraindication assessments in the authorization record
- Note any center-level requirements relied upon for selection
Document center judgment; no accreditation/volume required by policy
Transplant centers should document their judgment regarding candidate suitability and any contraindications; the policy does not mandate accreditation or case-volume thresholds in this section.
- Provide center determination documentation when requested
- Include any center quality or credentialing statements if available
Record center contraindication assessments and supporting evaluations
Centers must document potential contraindications and suitability assessments for each candidate; the policy leaves center-specific judgment to transplant programs without prescribing accreditation or volume requirements.
- Record multidisciplinary determinations on contraindications
- Attach relevant supporting evaluations and consultations
Document center clinical judgment; no policy-specified accreditation/volume
Transplant centers should document their clinical judgment about contraindications and candidate suitability in the medical record; this policy does not establish required accreditation or minimum procedural volumes.
- Ensure documentation of center protocols and decisions is available for review
- Provide evidence of center follow-up and monitoring plans
Document center protocols for timing and immunosuppression planning
Document center-specific determinations about contraindications and transplant suitability; include any protocols used to guide timing of retransplantation and immunosuppression strategies.
- Provide center plans regarding timing of retransplant and immunosuppression
- Document any measures taken to mitigate sensitization or infection risk
Include CMS and OPTN policy references where relevant to center certification
References to CMS transplant certification and OPTN policies in this policy imply the relevance of transplant center certification and federal transplant program requirements; include such references in documentation when applicable.
- Cite CMS transplant certification resources when relevant to authorization
- Reference OPTN policy documents as supporting evidence
Follow-up, Surveillance, and Retransplant Considerations
Background, Definitions, and Context
Pancreas transplantation is the surgical placement of a healthy pancreas to restore glucose control in individuals with insulin‑dependent diabetes. It is performed to correct severe diabetic complications and, in selected patients, to prevent or reverse secondary end‑organ effects of diabetes by restoring endogenous insulin production.
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