Kidney Transplants, Pancreas Transplants, and Simultaneous Kidney/Pancreas Transplants
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Criteria and coverage stance for kidney transplants, pancreas transplants, simultaneous kidney/pancreas transplants, and retransplants for Capital BlueCross products covered by this policy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Kidney and Pancreas Transplantation
Investigational indications
Investigational indications — Transplantation is considered investigational (not covered) when the specific scenario does not meet the medically necessary criteria listed for kidney or pancreas transplantation. There is insufficient evidence to support a general conclusion concerning health outcomes or benefits for these other situations.
ALL of the following
- Kidney transplant is considered investigational for all situations other than those meeting the medically necessary criteria for kidney transplantation as described in this policy.
- Pancreas transplant is considered investigational for all situations other than those meeting the medically necessary criteria for pancreas transplantation as described in this policy.
- Combined or simultaneous transplant scenarios not meeting the specified criteria for simultaneous kidney/pancreas transplantation are investigational.
- Retransplantation outside of candidates who meet retransplantation criteria (e.g., where procedure is expected to be futile due to comorbid disease or post-transplant care is expected to be inadequate) is investigational.
- Any other organ-specific or clinical scenarios not explicitly listed as medically necessary in this policy are considered investigational due to insufficient evidence of net health benefit.
Candidate Evaluation and Listing Criteria
Waitlist/listing criteria
Listing and waitlist considerations:
Earliest wait time date includes date when GFR or creatinine clearance ≤ 20 mL/min or when dialysis was initiated (chunk 3).
Providers should document these parameters to support candidacy and waitlist calculations (chunk 12, 3).
Organ-specific candidate criteria
Organ-specific candidate criteria reflected in evidence summaries:
Registry data and case series support benefit (chunks 18, 19).
Supported by registry and retrospective studies with reported 3‑year survival ~94–95% (chunks 20, 21).
Specific severity criteria described in policy (chunk 7).
Contraindications and Futility Considerations
Transplant centers should evaluate candidates comprehensively; the listed conditions are commonly accepted contraindications but are not exhaustive. Each candidate should be assessed for modifiable risks (for example, treatment of infection or stabilization of psychosocial factors) prior to final coverage determinations.
When submitting prior authorization requests, providers should include documentation addressing the presence or absence of listed contraindications, relevant oncologic history, infection status, comorbid conditions that may affect post-transplant outcomes, and psychosocial assessment results. Coding must align with the Coding and Coverage Determination section of this policy to ensure appropriate adjudication.
No explicit absolute or relative contraindications beyond those listed are specified in the policy text; however, transplantation may be denied when expected to be futile due to comorbid disease or when post-transplant care is expected to be inadequate. The transplant center's clinical judgment and payer review together determine final coverage decisions.
Provider Actions, Prior Authorization, and Documentation
Preauthorization required for covered transplants
Kidney transplants (living or deceased donor) and pancreas transplants (including simultaneous kidney/pancreas and pancreas alone in specified indications) are considered medically necessary for selected candidates and therefore require preauthorization consistent with plan benefit variations.
Follow listed procedure & diagnosis codes for coverage review
Procedure and diagnosis codes listed in the policy are associated with services 'Covered when medically necessary'; prior authorization and coverage determinations should follow member benefit terms and medical necessity review.
- Procedure codes listed under 'Covered when medically necessary' (see policy coding table).
- Diagnosis codes listed under 'Covered when medically necessary' (see policy coding table).
Prior authorization details not specified in these sections
The provided document sections reference OPTN policies and the CMS NCD but do not specify a detailed prior authorization code list or other granular prior authorization steps in these chunks.
No step‑therapy required before listing
No step‑therapy sequencing is specified in the policy text; evaluation for transplant may begin prior to dialysis initiation based on anticipated wait time.
- Listing consideration may begin before GFR ≤20 mL/min or dialysis initiation when appropriate.
Unlabeled inventory entry — verify local requirements
Provider attention: an inventory entry in the brief has no label or text; confirm there are no additional plan‑specific prior authorization or coding instructions beyond those in the policy.
No step‑therapy requirements in referenced content
Reiteration: these chunks do not describe any required step‑therapy prior to transplant evaluation or listing.
Document GFR and dialysis initiation for waitlist timing
Document renal function (e.g., GFR or measured/estimated creatinine clearance) and the date dialysis was initiated, as these factors are used for waitlist timing and priority assessment.
- Record GFR or creatinine clearance values (earliest date ≤20 mL/min used for wait time calculations).
- Document date regular dialysis was initiated for ESRD.
Coding listed is not definitive for coverage
Coding lists in the policy may not be exhaustive and the presence of a code in the document does not by itself guarantee coverage; coverage is determined by member benefit terms and medical necessity review.
- Use policy rules and member benefits to determine coverage, not code listing alone.
Policy history documents coding review; no extra PA history here
Policy history notes coding was reviewed during prior updates but these chunks do not provide additional provider documentation or prior authorization history details.
No additional explicit denial triggers stated here
These referenced chunks do not state explicit denial triggers beyond the contraindications and futility language elsewhere in the policy.
Contraindications remain potential denial triggers
Potential contraindications previously listed in the policy (see contraindications callout) may lead to denial; providers should assess and document these conditions during evaluation.
Procedure and Diagnosis Coding
| E10.10 | Type 1 diabetes mellitus with ketoacidosis without coma |
| E10.11 | Type 1 diabetes mellitus with ketoacidosis with coma |
| E10.21 | Type 1 diabetes mellitus with diabetic nephropathy |
| E10.22 | Type 1 diabetes mellitus with diabetic chronic kidney disease |
| E10.29 | Type 1 diabetes mellitus with other diabetic kidney complication |
| E10.641 | Type 1 diabetes mellitus with hypoglycemia with coma |
| E10.649 | Type 1 diabetes mellitus with hypoglycemia without coma |
| E10.65 | Type 1 diabetes mellitus with hyperglycemia |
| E10.69 | Type 1 diabetes mellitus with other specified complication |
| E10.8 | Type 1 diabetes mellitus with unspecified complications |
| affected codes | The policy history notes coding was reviewed with no changes; specific codes are not listed in this section. |
Definitions and Abbreviations
Pre-Transplant Evaluation Requirements
Perform comprehensive prelisting evaluation (GFR, dialysis, comorbidities)
Evaluation should include assessment of kidney function (GFR), dialysis status, comorbid disease assessment to determine futility risk, and psychosocial/substance‑use evaluation prior to listing.
- Assess GFR and document creatinine clearance when available.
- Assess dialysis status and date of initiation.
- Evaluate comorbid conditions that could make transplant futile or unsafe.
- Perform psychosocial and substance‑use assessment for adherence risk.
Follow OPTN/CMS guidance for evaluation; policy cites registries
The policy references national guidance and registry sources (OPTN/UNOS, CMS) as informing evaluation but does not enumerate a separate, exhaustive preapproval workup in these chunks.
Use cited evidence and OPTN/CMS resources for selection guidance
Cited literature and registry resources support outcomes and retransplantation considerations; providers should rely on OPTN and CMS resources as needed for detailed evaluation and selection criteria.
Transplant Center Requirements and Certification
Center judgment required for candidate suitability
Transplant center judgment determines candidate suitability and potential contraindications; the policy references Blue Distinction and certification resources but does not mandate specific center‑level volume or accreditation requirements in these chunks.
- Transplant center evaluation of individual risks and contraindications is required.
- References to Blue Distinction and CMS certification imply reliance on certified centers but do not add explicit certification requirements in these sections.
Ensure evaluation by an appropriate transplant center
Transplant center judgment and certification considerations are emphasized; providers should ensure candidate evaluation is performed by an appropriate transplant program consistent with national guidance.
Adhere to OPTN/CMS program and certification standards
Center‑level expectations rely on OPTN/UNOS policies and CMS transplant certification resources cited in the policy; providers should follow those programmatic and certification standards when documenting candidacy.
Policy relies on certified transplant centers (per CMS/OPTN citations)
References include CMS transplant certification resources and OPTN policies, implying reliance on certified transplant centers for evaluation and care, although explicit accreditation requirements are not listed in these chunks.
Post-Transplant Care, Immunosuppression, and Monitoring
Background and Rationale
Solid organ transplantation (kidney and pancreas) is presented as a treatment option for end‑stage organ failure that can improve survival and quality of life. The policy notes that transplant recipients require lifelong immunosuppression and that OPTN/UNOS registry data inform outcomes and candidate selection.
Policy Revision History
Updated policy guidelines, product variations, background, rationale, ICD-10 table, and references; no changes to procedure codes.
No change to policy statements; references reviewed and updated; coding reviewed with no coding changes.
Clinical benefit added to the policy.
No change to policy statement; background updated; references reviewed and updated; coding reviewed, no changes.
No change to policy statement; FEP, background, and references updated; no coding changes.
No change to policy statement; coding reviewed; background, rationale, and references updated.
Policy statement unchanged; FEP and product variation statements updated; references reviewed and updated; coding reviewed with no changes.
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