CMS Modified NCD 148 for Lymphocyte Immune Globulin, Anti-Thymocyte Globulin (Equine), Effective March 7, 2026 — What Billing Teams Need to Know

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 148, the National Coverage Determination governing lymphocyte immune globulin, anti-thymocyte globulin (equine) coverage under Medicare, effective March 7, 2026. Here's what changes for billing teams.

This update touches a narrow but high-stakes category of biologic drugs used in renal transplant care. The CMS anti-thymocyte globulin coverage policy confirms FDA-approved equine-origin lymphocyte immune globulin as a covered Medicare benefit when used to manage renal allograft rejection episodes. The policy does not list specific CPT or HCPCS codes, which creates a documentation burden your billing team needs to address now — before a claim denial lands in your queue.


Quick-Reference Table

Field Detail
Payer CMS (Centers for Medicare & Medicaid Services)
Policy Lymphocyte Immune Globulin, Anti-Thymocyte Globulin (Equine)
Policy Code NCD 148
Change Type Modified
Effective Date 2026-03-07
Impact Level Medium — narrow indication, but high per-claim dollar value
Specialties Affected Nephrology, Transplant Surgery, Hospital Pharmacy, Infusion Billing
Key Action Confirm your claims for anti-thymocyte globulin (equine) tie explicitly to renal allograft rejection management in the medical record before submitting to Medicare

CMS Anti-Thymocyte Globulin Coverage Criteria and Medical Necessity Requirements 2026

NCD 148 sits in the Drugs and Biologicals benefit category. That placement matters because it means coverage hinges on FDA approval status and specific indication — not just physician order.

The Centers for Medicare & Medicaid Services covers lymphocyte immune globulin, anti-thymocyte globulin (equine) under Medicare for one approved indication: management of allograft rejection episodes in renal transplantation. That's it. The coverage policy is narrow by design. This drug class exists as an adjunct to conventional immunosuppressive therapy — steroids, anti-metabolic drugs — not as a replacement for it.

Medical necessity documentation needs to reflect that adjunctive role. If your records show anti-thymocyte globulin used as a first-line agent or without concurrent conventional immunosuppression, expect scrutiny. The policy is explicit that these preparations supplement, not replace, traditional immunosuppressive regimens.

The policy also addresses future FDA approvals. Any other lymphocyte globulin preparation the FDA approves for renal allograft rejection may be covered under Medicare. That "may be" language is intentional — future products still need to meet medical necessity criteria before Medicare reimbursement follows automatically. Watch for LCD updates from your Medicare Administrative Contractor as new products reach approval.

Prior authorization requirements are not specified within NCD 148 itself. However, your MAC may have issued additional guidance or local coverage determinations that impose prior auth requirements on this drug class. Check with your MAC directly before assuming no prior authorization is needed, especially for high-cost biologic administrations.


CMS Anti-Thymocyte Globulin Exclusions and Non-Covered Indications

NCD 148 is unusually direct about what isn't covered. Any lymphocyte immune globulin preparation that lacks FDA approval for renal allograft rejection is not a covered Medicare benefit under this policy. That includes a significant number of products currently under investigation.

Equine, lapine, and murine origin preparations are all named as under investigation. None of those investigational products qualify for Medicare coverage under NCD 148 — regardless of clinical rationale, physician intent, or hospital formulary decisions. "Under investigation" means not covered. Full stop.

NCD 148 specifies coverage only for renal transplantation. Use in other transplant settings is not addressed by this policy and should not be assumed covered under NCD 148. That's a real exposure point for transplant centers with mixed programs.

The non-covered use of these drugs as standalone immunosuppression — replacing rather than supplementing conventional agents — is another documentation trap. Make sure your clinical notes and pharmacy records show the adjunctive use pattern the policy requires.


Coverage Indications at a Glance

Indication Status Relevant Codes Notes
Renal allograft rejection management — FDA-approved equine preparation Covered No specific codes listed in NCD 148 Must be adjunctive to conventional immunosuppression; FDA approval required
Future FDA-approved lymphocyte globulin preparations for renal rejection Potentially Covered Not yet assigned Requires FDA approval for this specific indication before Medicare coverage applies
Investigational equine, lapine, or murine origin preparations Not Covered N/A Under investigation status = no Medicare coverage under NCD 148
+ 2 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 Anti-Thymocyte Globulin Billing Guidelines and Action Items 2026

The absence of specific CPT or HCPCS codes in NCD 148 is the central billing challenge here. That's not an oversight — it reflects how CMS structured this older NCD. Your billing team carries the burden of correct code assignment and documentation linkage. Here's how to handle it.

#Action Item
1

Confirm your HCPCS code assignment before the March 7, 2026 effective date. NCD 148 does not identify a specific HCPCS code for anti-thymocyte globulin (equine). Your billing team needs to determine the correct code through your MAC and your pharmacy billing team — not from this policy document. Contact your MAC directly for billing guidance on this drug, and confirm your pharmacy billing team is using a code that your MAC recognizes as appropriate for this product. Do not assume an existing code is correct because it's been used before — verify it against current HCPCS updates and your MAC's billing guidance.

2

Audit your diagnosis code linkage on existing claims. Every Medicare claim for this drug must link to a diagnosis that supports renal allograft rejection. Pull your last 90 days of claims for anti-thymocyte globulin (equine) and check that the primary diagnosis code reflects a renal transplant rejection episode — not just transplant status or a general immunosuppressed state.

3

Update your clinical documentation templates to capture adjunctive use explicitly. The policy requires that anti-thymocyte globulin (equine) be used alongside conventional immunosuppressive therapy. Your physician notes, pharmacy records, and nursing documentation should all confirm concurrent steroid or anti-metabolic drug administration. One document showing this is not enough — the whole record needs to tell a consistent story.

+ 3 more action items

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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 Anti-Thymocyte Globulin (Equine) Under NCD 148

NCD 148 does not list specific CPT, HCPCS, or ICD-10 codes. This is a documented characteristic of this NCD, not a gap in the policy update itself. The absence of a code table in the source document is intentional.

What This Means for Anti-Thymocyte Globulin Billing

You still need to assign codes. The policy establishes the coverage criteria — your billing team and your MAC determine the correct code assignment. Here's how to approach this:

If you're uncertain how your current charge capture maps to NCD 148's coverage criteria, talk to your compliance officer or a billing consultant who specializes in transplant or infusion services before the effective date.


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