J1561 HCPCS code: Injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg
J1561 is the HCPCS Level II code for injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg. In 2024 Medicare paid an average of $38.11 per service for J1561 across 3,493,569 services. Its Medicare coverage code is D (Special coverage instructions apply): Medicare covers it when its national or local coverage criteria are met. The NCCI unit limit is 360 per day on DME suppliers. Medicare volume rose 26% from 2022 to 2024 (2,782,041 to 3,493,569 services). In 2024, about 2,077 clinicians billed Medicare for J1561 for 4,107 beneficiaries; Texas, New York, California accounted for 52% of services.
Code details
| Field | Value |
|---|---|
| Section | J codes — Drugs administered other than oral method |
| Coverage code | D — Special coverage instructions apply |
| Pricing indicator | 51 — Drug or biological (priced per ASP/average sales price rules) |
| BETOS category | O1E — Other drugs |
| Added | 2008-01-01 |
| Last action effective | 2013-01-01 |
Who bills J1561 (2024)
| Measure | Value |
|---|---|
| Clinicians billing (by place of service) | 2,077 |
| Medicare beneficiaries | 4,107 |
| States with claims | 36 |
| Share of services in top 3 states (Texas, New York, California) | 52% |
Counts only. Supplier and clinician names, contact lists and state-by-state detail are in Caduvo.
Medicare utilization for J1561, 2022–2024
| Year | Services | Beneficiaries | Avg. allowed | Avg. paid |
|---|---|---|---|---|
| 2022 | 2,782,041 | 3,658 | $43.40 | $34.61 |
| 2023 | 2,801,379 | 3,521 | $47.39 | $37.73 |
| 2024 | 3,493,569 | 4,107 | $47.87 | $38.11 |
States with the most J1561 services (2024)
| State | Services | Avg. paid |
|---|---|---|
| Texas | 1,069,658 | $38.25 |
| New York | 378,147 | $37.62 |
| California | 354,684 | $38.38 |
| Florida | 130,862 | $37.47 |
| South Carolina | 119,946 | $38.06 |
NCCI unit limits (MUE)
| Claim type | Max units per day | Rationale |
|---|---|---|
| DME suppliers | 360 | Clinical: Data |
| outpatient hospital claims | 360 | Clinical: Data |
| practitioner claims | 360 | Clinical: Data |
Medicare policy articles for this code
- A56718: Billing and Coding: Intravenous Immunoglobulin (IVIG) (Palmetto GBA (MAC - Part A, MAC - Part B))
- A56779: Billing and Coding: Intravenous Immune Globulin (CGS Administrators, LLC (MAC - Part A, MAC - Part B))
- A56786: Billing and Coding: Immune Globulin (Novitas Solutions, Inc. (MAC - Part A, MAC - Part B))
- A57160: Billing and Coding: Immune Thrombocytopenia (ITP) Therapy (CGS Administrators, LLC (MAC - Part A, MAC - Part B))
- A57187: Billing and Coding: Immune Globulin Intravenous (IVIg) (Noridian Healthcare Solutions, LLC (MAC - Part A, MAC - Part B))
- A57554: Billing and Coding: Immune Globulins (WPS Insurance Corporation (MAC - Part A, MAC - Part B))
- A57778: Billing and Coding: Immune Globulin (First Coast Service Options, Inc. (MAC - Part A, MAC - Part B))
- A59105: Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG) (National Government Services, Inc. (MAC - Part A, MAC - Part B))
Covered diagnoses (1,446 ICD-10-CM codes)
The diagnoses most often listed as covered in the policy articles above:
| ICD-10-CM | Diagnosis | Articles listing it |
|---|---|---|
| D69.3 | Immune thrombocytopenic purpura | 8 |
| C90.00 | Multiple myeloma not having achieved remission | 7 |
| C91.10 | Chronic lymphocytic leukemia of B-cell type not having achieved remission | 7 |
| C91.12 | Chronic lymphocytic leukemia of B-cell type in relapse | 7 |
| D59.0 | Drug-induced autoimmune hemolytic anemia | 7 |
| D59.11 | Warm autoimmune hemolytic anemia | 7 |
| D59.12 | Cold autoimmune hemolytic anemia | 7 |
| D59.13 | Mixed type autoimmune hemolytic anemia | 7 |
| D80.0 | Hereditary hypogammaglobulinemia | 7 |
| D80.2 | Selective deficiency of immunoglobulin A [IgA] | 7 |
Showing 10 of 1,446. The full list, non-covered diagnoses and CSV export are in Caduvo.
What changed for J1561
- 2008-01-01: J1561 added to HCPCS Level II
- Next scheduled CMS quarterly update (HCPCS and DMEPOS fee schedule): 2027-01-01
Frequently asked questions
What is HCPCS code J1561?
J1561 is the HCPCS Level II code for injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg. Short descriptor: "Gamunex-c/gammaked".
How much does Medicare pay for J1561?
In 2024, the average Medicare payment was $38.11 per service (average allowed $47.87).
Does Medicare cover J1561?
Coverage code D — Special coverage instructions apply. Medicare covers it when its national or local coverage criteria are met.
Which diagnoses support coverage for J1561?
Medicare policy articles that cite J1561 list 1,446 covered ICD-10-CM diagnosis codes across 8 articles. The most cited include D69.3 (Immune thrombocytopenic purpura), C90.00 (Multiple myeloma not having achieved remission), C91.10 (Chronic lymphocytic leukemia of B-cell type not having achieved remission). A listed diagnosis is necessary but not sufficient; the policy's other criteria still apply.
How many units of J1561 can be billed per day?
360 on DME suppliers; 360 on outpatient hospital claims; 360 on practitioner claims (NCCI medically unlikely edits).
Related J15 codes
- J1551 — Injection, immune globulin (cutaquig), 100 mg
- J1552 — Injection, immune globulin (alyglo), 500 mg
- J1554 — Injection, immune globulin (asceniv), 500 mg
- J1555 — Injection, immune globulin (cuvitru), 100 mg
- J1556 — Injection, immune globulin (bivigam), 500 mg
- J1557 — Injection, immune globulin, (gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg
- J1558 — Injection, immune globulin (xembify), 100 mg
- J1559 — Injection, immune globulin (hizentra), 100 mg
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc
- J1562 — Injection, immune globulin (vivaglobin), 100 mg
- J1566 — Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg
- J1568 — Injection, immune globulin, (octagam), intravenous, non-lyophilized (e.g., liquid), 500 mg
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Next steps
- Run a reimbursement report for a device billed under J1561
- Watch J1561 for fee, coverage and descriptor changes
- Build a full Medicare revenue model for J1561
Sources: CMS HCPCS Level II release October 2025; CMS DMEPOS fee schedule; CMS NCCI MUE tables; CMS Medicare utilization (physician and DME supplier files); CMS Medicare Coverage Database articles. Fees are Medicare allowables, not commercial rates. Not billing or legal advice.