Does J1577 require prior authorization?

No, J1577 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for J1577?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1577`, Injection, immune globulin (qivigy), 100 mg

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Initial therapy requires (a) diagnosis and (b) medical records documenting severity and diagnostic evidence, and (c) prescriber attests dosing per FDA labeling (or alternative evidence for dosing).
For varicella prophylaxis, progress notes must document one of: personal history of leukemia/lymphoma, HIV infection, current immunosuppressive therapy, or a newborn exposure with documentation why newborn is at increased risk (e.g., maternal exposure within 5 days of delivery).

For tetanus immune serum, progress notes must identify that the wound is other than a clean minor wound and the date of injury, and must document that active tetanus immunization is unknown/uncertain, or <2 prior tetanus doses, or a ≥24-hour delay between injury and initiation of prophylaxis.

HIV-related IVIG coverage requires documentation of age <13, evidence of qualitative or quantitative humoral immunologic defects, and current bacterial infections despite appropriate antimicrobial prophylaxis.

Autoimmune mucocutaneous blistering disease claims should reference the Medicare NCD (Pub 100-3: Chapter 1, Part 4, Section 250.3) to support coverage.

For desensitization prior to kidney transplant, documentation must include PRA level to demonstrate PRA ≤80% for covered use.

Key Coverage Criteria

Coverage for the following preferred immune globulin products Bivigam® (IV), Cutaquig® (SC), Cuvitru® (SC), Flebogamma® DIF (IV), Gammagard® Liquid (IV, SC), Gammagard® S/D (IV), Gammaked™ (IV, SC), Gammaplex® (IV), Gamunex®-C (IV, SC), Hizentra® (SC), HyQvia® (SC), Octagam® (IV), Privigen® (IV), and Xembify® (SC) is contingent on criteria in the General Requirements and Diagnosis-Specific Requirements sections.
Treatment with a non-preferred immune globulin is medically necessary for the indications specified in this policy when one of the following criteria is met: Both of the following: Documentation of a trial of all of the preferred immune globulin products resulting in minimal clinical response to therapy and residual disease activity; and Physician attests that in their clinical opinion, the clinical response would be expected to be superior with the requested non-preferred product, than experien [...]
Non-preferred immune globulin product may be approved if: (a) documentation of trial of all preferred products with minimal response and physician attestation that non-preferred would be superior; or (b) documentation of intolerance or contraindication to all preferred products and physician attestation that same intolerance would not occur with the non-preferred product.
IVIG may be indicated for pure red cell aplasia–related anemia.
Intramuscular immune globulin (gamma globulin) is indicated for post-exposure prophylaxis to hepatitis A.
IG is indicated for measles (rubeola) post-exposure prophylaxis in susceptible patients exposed less than 3 days prior to treatment.

12 Active Policies

WPS-J5-L34771, Immune Globulins

NGS-J6-L39314, Off-Label Use of Intravenous Immune Globulin (IVIG)

WPS-J8-L34771, Immune Globulins

FIRST_COAST-L34007, Immune Globulin

NORIDIAN-JE-L34314, Immune Globulin Intravenous (IVIg)

NORIDIAN-JF-L34314, Immune Globulin Intravenous (IVIg)

NOVITAS-JH-L35093, Immune Globulin

NGS-JK-L39314, Off-Label Use of Intravenous Immune Globulin (IVIG)

NOVITAS-JL-L35093, Immune Globulin

SUREST-POL-SUREST-immune-globulin-ivig-scig, Immune Globulin (IVIG and SCIG)

UMR-POL-UMR-immune-globulin-ivig-scig, Immune Globulin (IVIG and SCIG)

UHC-POL-immune-globulin-ivig-scig, Immune Globulin (IVIG and SCIG)

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J1577, Injection, immune globulin (qivigy), 100 mg