Pancreas Transplants — NCD 107 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 107 governing pancreas transplant coverage, with the policy carrying an effective date of March 7, 2026. If your facility bills for pancreas transplants — standalone or combined with kidney transplants — here's what your billing team needs to know now.

CMS pancreas transplant coverage policy under NCD 107 Medicare has strict patient eligibility criteria that directly determine reimbursement. This policy applies to inpatient hospital services, and the criteria for pancreas transplant alone (PA) are significantly more demanding than those for simultaneous pancreas-kidney (SPK) or pancreas-after-kidney (PAK) procedures. The policy does not list specific CPT or HCPCS codes, so code assignment depends on your facility's internal charge capture and your Medicare Administrative Contractor's billing guidance.

---

Quick-Reference Table

Field	Detail Copy
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Pancreas Transplants
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 patient eligibility documentation against NCD 107 criteria before submitting pancreas transplant claims

---

CMS Pancreas Transplant Coverage Criteria and Medical Necessity Requirements 2026

The coverage policy under NCD 107 splits into two distinct tracks. Your billing team needs to know which track applies to each patient — because the medical necessity criteria are different, and the documentation requirements are not interchangeable.

Track 1: Simultaneous Pancreas-Kidney (SPK) or Pancreas-After-Kidney (PAK)

CMS covers whole organ pancreas transplantation when performed simultaneous with or after a kidney transplant. This coverage has been in place since July 1, 1999. For PAK procedures, immunosuppressive therapy coverage begins with the date of discharge from the inpatient stay for the pancreas transplant — not the kidney transplant. Get that date right in your billing records or you'll create a reimbursement problem downstream.

Track 2: Pancreas Transplant Alone (PA)

This is where most claim denial risk lives. PA coverage is far more restricted. It became effective April 26, 2006, and it applies only under a specific, narrow set of conditions. Every one of the following criteria must be met — this is not a pick-three situation.

First, the facility must be Medicare-approved for kidney transplantation. CMS will not cover a PA procedure at a facility that isn't on the approved kidney transplant center list, even if the facility is otherwise qualified to perform the surgery. Confirm your facility's status before billing.

Second, the patient must have a confirmed diagnosis of type 1 diabetes. CMS defines this in one of two ways:

#	Covered Indication Copy
1	The patient is beta cell autoantibody positive, OR
2	The patient demonstrates insulinopenia, defined as a fasting C-peptide level at or below 110% of the lower limit of the lab's normal range — and that C-peptide level is only valid when paired with a concurrently obtained fasting glucose of 225 mg/dL or less.

That C-peptide rule has a lot of moving parts. The glucose must be drawn at the same time as the C-peptide. If your documentation doesn't show both values from the same draw, the criterion fails. That's a denial waiting to happen.

Third, the patient must have a documented history of medically uncontrollable labile (brittle) insulin-dependent diabetes with recurrent, severe, acutely life-threatening metabolic complications requiring hospitalization. CMS specifies three qualifying complications: frequent hypoglycemia unawareness, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks. General "poor diabetes control" is not enough. The documentation needs to show specific, documented episodes that required inpatient care.

Fourth, the patient must have been managed by an endocrinologist for at least 12 months using the most advanced medically recognized insulin formulations and delivery systems. This isn't a soft requirement. Twelve months of documented, intensive endocrinologist management is a hard floor.

Fifth, the patient must have the emotional and mental capacity to understand the surgical risks and manage lifelong immunosuppression. Document this assessment explicitly. A transplant evaluation note that doesn't address this point creates a gap in your medical necessity record.

Sixth, the patient must otherwise be a suitable transplant candidate. This is the most subjective criterion, but it still needs clinical documentation.

Prior authorization requirements for pancreas transplants are not addressed in NCD 107 itself. However, your Medicare Administrative Contractor may have additional requirements. Check with your MAC before scheduling PA procedures, particularly for inpatient admissions at facilities that don't regularly bill this procedure.

---

CMS Pancreas Transplant Exclusions and Non-Covered Indications

One exclusion is stated clearly in NCD 107, and it carries financial exposure if your team doesn't catch it at the point of service.

Transplantation of partial pancreatic tissue or islet cells is not covered under standard Medicare. CMS does not consider this procedure reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

The only exception: islet cell transplantation performed within the context of a qualifying clinical trial. If that's what your facility is doing, coverage falls under NCD 260.3.1, not NCD 107. Make sure your billing team knows the distinction. Billing an islet cell procedure under the wrong NCD framework will produce a claim denial and potentially create compliance exposure.

This matters especially for transplant centers exploring newer approaches to diabetes management. If your program is moving toward islet cell work outside of a formal clinical trial, there is no Medicare coverage path right now.

---

Coverage Indications at a Glance

---

CMS Pancreas Transplant Billing Guidelines and Action Items 2026

The real issue with pancreas transplant billing is documentation. The criteria are specific enough that a single missing element — one lab value, one missing endocrinologist note — can sink a claim. Here's what to do now.

Copy Action Items

---

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

A Note on Codes

NCD 107 does not list specific CPT, HCPCS, or ICD-10 codes. This is worth flagging directly: pancreas transplant billing requires code assignment based on your facility's charge capture protocols, your MAC's local billing guidelines, and the specific procedure performed (SPK, PAK, or PA).

Do not use this policy document as a code source. Reference your MAC's instructions and the CMS Claims Processing Transmittal TN 957 — linked in the official policy — for procedural billing guidance.

For ICD-10-CM diagnosis codes, the documentation of type 1 diabetes, hypoglycemia unawareness, ketoacidosis, and kidney failure will drive code selection. Work with your clinical documentation improvement (CDI) team to make sure the primary and secondary diagnoses on the claim accurately reflect the NCD 107 eligibility criteria. A patient who qualifies for a PA procedure has a specific clinical profile — and that profile needs to show up in the diagnosis coding, not just the medical record.

If your coding team regularly handles transplant billing, they likely already have a code set in use. The action item here is to reconcile that existing code set against the NCD 107 criteria to confirm alignment. If you're not sure your coding is consistent with the policy, that's a conversation for your compliance officer before March 7, 2026.

---