CMS modified NCD 107 governing pancreas transplant coverage policy, effective March 7, 2026. Here's what billing teams need to know.

The Centers for Medicare & Medicaid Services updated NCD 107 — the National Coverage Determination for pancreas transplantation — with a change type of Modified as of 2026-03-07. This policy controls Medicare reimbursement for whole organ pancreas transplants, pancreas-after-kidney transplants, and pancreas transplants alone (PA). The policy does not list specific CPT or HCPCS codes, so your billing team will need to reference your transplant center's charge capture standards alongside these coverage criteria.


Quick-Reference Table

Field Detail
Payer CMS (Centers for Medicare & Medicaid Services)
Policy Pancreas Transplants — NCD 107
Policy Code NCD 107
Change Type Modified
Effective Date 2026-03-07
Impact Level High
Specialties Affected Transplant surgery, endocrinology, nephrology, inpatient hospital billing
Key Action Audit your pancreas transplant documentation against the six-criteria checklist for pancreas-alone (PA) cases before billing

CMS Pancreas Transplant Coverage Criteria and Medical Necessity Requirements 2026

The CMS pancreas transplant coverage policy under NCD 107 covers two distinct scenarios. Understanding which one applies to your patient determines how you build the medical necessity argument — and whether the claim survives review.

Scenario 1: Simultaneous or Post-Kidney Pancreas Transplant

Medicare covers whole organ pancreas transplantation when it happens simultaneously with a kidney transplant or after a kidney transplant. This coverage has been in place since July 1, 1999. If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy billing starts from the date of discharge for the pancreas transplant inpatient stay — not the kidney transplant stay. That distinction matters for your immunosuppression claims.

Scenario 2: Pancreas Transplant Alone (PA)

Coverage for PA cases is narrower. CMS has covered PA since April 26, 2006, but only under strict conditions. Six criteria must all be met. Missing even one is grounds for claim denial.

Here are the six requirements:

#Covered Indication
1

Facility approval. The procedure must happen at a Medicare-approved kidney transplantation center. Your transplant center's Medicare approval status is the first gate. Verify this in the CMS ESRD data at cms.gov before submitting.

2

Type I diabetes diagnosis. The patient must have a documented Type I diabetes diagnosis. CMS accepts two pathways to establish this:

    Beta cell autoantibody positive test result, or
3Insulinopenia confirmed by a fasting C-peptide level at or below 110% of the lower limit of the lab's normal range. CMS only accepts this C-peptide result if a concurrent fasting glucose of 225 mg/dL or less was obtained at the same time. A C-peptide without that same-draw glucose doesn't count.
  • Labile diabetes with life-threatening complications. The patient must have a documented history of medically uncontrollable labile (brittle) insulin-dependent diabetes. The complications must be severe, recurrent, and acutely life-threatening — and they must have required hospitalization. CMS names three qualifying complications: frequent hypoglycemia unawareness, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks. "Recurrent" and "severe" both need to be documented with specificity. Vague chart notes won't hold up.

  • 12 months of intensive endocrinology management. The patient must have been under the active care of an endocrinologist for at least 12 months. That care must use the most medically recognized advanced insulin formulations and delivery systems available. If your patient's record shows a primary care physician managing their diabetes without specialist oversight, this criterion fails.

  • Emotional and mental capacity. The patient must have the capacity to understand the serious risks of surgery and the lifelong commitment to immunosuppression. This needs documented evidence — not just a checkbox. A formal psychiatric or psychological evaluation is the standard way to establish this.

  • General transplant candidacy. The patient must otherwise be a suitable transplant candidate under standard surgical and medical criteria.

  • All six must be documented in the medical record before billing. Prior authorization requirements are not explicitly called out in the NCD text, but given the complexity and cost of pancreas transplant billing, confirm with your MAC whether prior auth is required before scheduling.

    This is a high-stakes coverage policy. If you're uncertain how your patient population maps to these criteria, loop in your compliance officer before submitting claims.


    CMS Pancreas Transplant Exclusions and Non-Covered Indications

    CMS is direct about what NCD 107 does not cover. Partial pancreatic tissue transplants and islet cell transplants are not considered reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

    There is one exception. Islet cell transplantation performed within an approved clinical trial may qualify under NCD 260.3.1 — the Clinical Trials policy. If your facility participates in islet cell transplant research, that's a separate billing path with its own requirements. Billing a standalone islet cell transplant outside a clinical trial will result in claim denial under NCD 107.

    This distinction is important. Surgeons occasionally perform partial resections or islet cell procedures as part of complex pancreatic cases. If the operative notes support islet cell work outside a clinical trial, expect the claim to be denied under this coverage policy.


    Coverage Indications at a Glance

    Indication Coverage Status Notes
    Whole organ pancreas transplant simultaneous with kidney transplant Covered Covered since July 1, 1999; inpatient hospital benefit
    Whole organ pancreas transplant after kidney transplant Covered Immunosuppression billing starts from PA discharge date, not kidney transplant discharge
    Pancreas transplant alone (PA) — Type I diabetes, all six criteria met Covered Covered since April 26, 2006; all six medical necessity criteria must be documented
    + 4 more indications

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    This policy is now in effect (since 2026-03-12). Verify your claims match the updated criteria above.

    CMS Pancreas Transplant Billing Guidelines and Action Items 2026

    The effective date of March 7, 2026 means your billing and clinical documentation teams need to act now. Here are the steps that matter.

    #Action Item
    1

    Audit your PA case documentation against all six criteria. Pull your pancreas transplant alone claims from the past 12 months. Run them against the six PA criteria above. If any case is missing documentation on the C-peptide draw, the concurrent fasting glucose, or the 12-month endocrinology history, flag it for review before the next submission cycle.

    2

    Verify facility approval status. Confirm your facility's Medicare approval for kidney transplantation. The CMS ESRD data is the source of record. If your facility performs pancreas transplants but isn't listed as a Medicare-approved kidney transplant center, PA claims will not be covered. Address this gap with your compliance officer immediately.

    3

    Establish a documentation protocol for C-peptide labs. The concurrent fasting glucose requirement is a common failure point. A C-peptide result drawn without a same-visit fasting glucose at or below 225 mg/dL is invalid under this coverage policy. Work with your lab and clinical teams to ensure the order sets capture both values on the same draw.

    + 4 more action items

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    If your transplant program bills a significant volume of PA cases, bring your compliance officer and billing consultant into a documentation review before March 7, 2026. The criteria are specific, the financial exposure is high, and the claims are visible.


    Sample Version Diff Line-by-line changes
    Previous VersionCurrent Version
    Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
    Prior authorization is not requiredPrior authorization is required for initial treatment
    Documentation must include clinical historyDocumentation must include clinical history
    + 1 more action items

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    CPT, HCPCS, and ICD-10 Codes for Pancreas Transplants Under NCD 107

    The policy data for NCD 107 does not list specific CPT, HCPCS, or ICD-10 codes. This is common for older NCDs that predate current code-level specificity in CMS policy documents.

    For pancreas transplant billing, your transplant billing team and MAC should be your primary sources for the correct procedure codes. Standard transplant coding references — including CMS Claims Processing Transmittal TN 957, which is the cross-reference document for NCD 107 — govern how these claims are structured and submitted.

    Reference TN 957 (Medicare Claims Processing) directly for claims processing instructions: cms.gov Transmittal R957CP.

    Work with your coding team to confirm the correct procedure and diagnosis codes reflect the specific transplant type (simultaneous pancreas-kidney, pancreas-after-kidney, or pancreas alone) and that the supporting ICD-10-CM diagnosis codes clearly establish the Type I diabetes diagnosis with documented complications.


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