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:
|
| 3 | Insulinopenia 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 |
| Pancreas transplant alone (PA) — criteria not fully met | Not Covered | Missing any single criterion results in non-coverage |
| Islet cell transplantation (outside clinical trial) | Not Covered | Excluded under section 1862(a)(1)(A) of the Social Security Act |
| Islet cell transplantation (within approved clinical trial) | Conditionally Covered | Must meet NCD 260.3.1 clinical trial requirements |
| Partial pancreatic tissue transplantation (outside clinical trial) | Not Covered | Excluded under section 1862(a)(1)(A) of the Social Security Act |
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 | Clarify immunosuppression billing for post-kidney PA cases. If a patient received a kidney transplant and later receives a pancreas transplant, immunosuppression billing starts at the PA discharge date. Make sure your charge capture doesn't inadvertently backdate immunosuppression to the kidney transplant. That's a billing error with audit exposure. |
| 5 | Document the endocrinology management timeline explicitly. The 12-month intensive management requirement needs dates, provider names, and the specific insulin formulations and delivery systems used. A summary note that says "patient managed by endocrinologist" is not enough. The record needs to show the duration, the specialist involvement, and the use of advanced therapy. |
| 6 | Separate islet cell clinical trial billing from standard transplant billing. If your facility participates in islet cell transplant trials, keep those claims entirely separate from NCD 107 submissions. They route under NCD 260.3.1 with their own billing guidelines. Mixing the two creates confusion and claim denial risk. |
| 7 | Confirm prior authorization requirements with your MAC. NCD 107 doesn't mandate prior auth explicitly, but pancreas transplants are high-dollar inpatient claims. Your Medicare Administrative Contractor may have local requirements that layer on top of the NCD. Call your MAC contact or check their local coverage determination (LCD) database before the effective date of March 7, 2026. |
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.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
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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