Key facts for NCD 260.3.1
- Benefit category
- Inpatient Hospital Services, Physicians' Services
- Effective date
- 10/01/2004
- Implemented 10/04/2004
- Transmittal
- Transmittal 18
- Versions published
- 1
- Manual chapter
- 260
- NCD Manual (Pub. 100-03)
TL;DR
NCD 260.3.1 sets Medicare's national policy for islet cell transplantation in the context of a clinical trial under the benefit category "Inpatient Hospital Services, Physicians' Services", effective 10/01/2004 and implemented 10/04/2004. Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s). The term 'routine costs' means… It has been revised once since publication and binds every Medicare Administrative Contractor nationally.
Item or service described
A. General
As a result of section 733 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108-173), The Secretary of the Department of Health and Human Services, acting through the National Institute of Diabetes and Digestive and Kidney Disorders, shall conduct a clinical investigation of pancreatic islet cell transplantation that includes Medicare beneficiaries.
The transplant is performed on patients with Type I diabetes. A typical islet cell transplant requires over 500,000 islet cells, but varies depending on the recipient’s weight. One of the desired patient outcomes is insulin independence. Elimination of clinically significant hypoglycemia episodes and improved glucose control are other important patient outcomes.
One or more pancreata are obtained from donor(s). The islets must be removed within hours after the recovery of the donor pancreas to ensure viability. The islet cells are transplanted by injection into the portal vein of the recipient either using direct visualization, guided ultrasound or percutaneously. The islet cell transplant may be performed alone, in combination with a kidney transplant, or after a kidney transplant. Islet recipients require immunosuppressant therapy to prevent rejection of the transplanted islet cells. Routine follow-up care is necessary for each trial participant.
Indications and limitations of coverage
B. Nationally Covered Indications
Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s). The term 'routine costs' means reasonable and necessary routine patient care costs, including immunosuppressive drugs and other follow-up care, as defined in section 310.1 of the NCD Manual.
Specifically, Medicare will cover transplantation of pancreatic islet cells, the insulin producing cells of the pancreas. Coverage will include the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.
C. Nationally Noncovered Indications
Partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial continues to be noncovered.
D. Other
Not applicable.
(This NCD last reviewed July 2004.)
Text reproduced from the CMS Medicare Coverage Database record for NCD 260.3.1 version 1. View the original on cms.gov.
Revision history
02/2017 - This change request (CR) is the 11th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, CR9751, and CR9861, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1798 ) (CR9982)
02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1792 ) (CR9861)
01/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy.Implementation date: 04/01/2013 Effective date: 10/1/2015. ( TN 1165 ) (CR 8109)
07/2004 - Covered costs of transplantation of pancreatic islet cell, but only in context of an NIH-sponsored clinical trial. Effective date 10/01/2004. Implementation date 10/04/2004. ( TN 18 ) (CR 3385)
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 260.3.1
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 260.3.1
What does NCD 260.3.1 cover?
Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s). The term 'routine costs' means reasonable and necessary routine patient care costs, including immunosuppressive drugs and other follow-up care, as defined in section 310.1 of the NCD Manual. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 260.3.1 take effect?
The current version (1) is effective 10/01/2004, implemented 10/04/2004, published in transmittal 18. This is the only published version.
Does a Local Coverage Determination override NCD 260.3.1?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.