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 |
| Anti-thymocyte globulin use in non-renal transplantation | Not Covered Under NCD 148 | N/A | NCD 148 covers renal transplantation only; other transplant settings are not addressed by this policy |
| Anti-thymocyte globulin as replacement for conventional immunosuppression | Not Covered | N/A | Policy requires adjunctive use only — not as a substitute for steroids or anti-metabolic drugs |
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. |
| 4 | Check your MAC's local coverage determinations for supplemental requirements. NCD 148 sets the floor for Medicare coverage, but your MAC can impose additional billing guidelines, documentation standards, or prior authorization requirements on top of it. Contact your MAC or check their website for any LCD that intersects with this drug class. If you're billing in a multi-state region, check each MAC separately. |
| 5 | Flag any off-label transplant use for compliance review immediately. If your facility uses equine anti-thymocyte globulin in non-renal transplant cases and has been billing Medicare, stop and get your compliance officer involved before March 7, 2026. NCD 148 covers renal transplantation only — other transplant settings are not addressed by this policy and should not be assumed covered. Continuing to bill for uses outside this policy's scope after the effective date is a real claim denial risk — and potentially more. |
| 6 | Build a monitoring process for future FDA approvals in this drug class. NCD 148 signals that CMS will consider coverage for newly approved lymphocyte globulin preparations as FDA approval happens. Set a calendar reminder for your pharmacy and billing teams to review NCD 148 and any MAC guidance whenever a new product in this class gets FDA clearance. Reimbursement doesn't follow automatically — you'll need to confirm each new product's coverage status before billing. |
| 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 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:
- NCD 148 identifies no specific HCPCS code for lymphocyte immune globulin, anti-thymocyte globulin (equine). Work with your MAC and pharmacy billing team to determine the correct code for this product. J-codes for biologics do change, and using an outdated or incorrect code is one of the most common causes of preventable claim denial in infusion billing.
- NCD 148 specifies no ICD-10 codes. Your coding team should assign the appropriate diagnosis code based on their coding resources and MAC guidance — not from this policy document. The right level of specificity still matters for medical necessity support, so confirm your coding approach with a qualified coder or your MAC.
- If your MAC has issued an LCD that intersects with this drug class, that LCD may contain a code list. That code list would govern alongside NCD 148, not instead of it.
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.
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.