HEMLIBRA Sample Coding
This coding information may assist you as you complete the payer forms for HEMLIBRA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding for single-use vials and wastage.
You can generate a PDF of these coding tables by selecting either the "Download All" or the "Download Section" button:
- "Download All" lets you download or print a coding table for all indications
- "Download Section" lets you download or print a coding table for a specific indication
Effective January 1, 2019, J-code J7170 replaces temporary Q-code Q9995.
|Diagnosis: ICD-10-CM||D66||Hereditary factor VIII deficiency: hemophilia A|
Effective January 1, 2019
|J7170 ||Injection, emicizumab-kxwh, 0.5 mg|
|Drug: NDC |
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
|50242-920-01 ||50242-0920-01 ||30
mg/1 mL (30 mg/mL) |
|50242-921-01||50242-0921-01 ||60 mg/0.4
mL (150 mg/mL) |
|50242-922-01 ||50242-0922-01 ||105
mg/0.7 mL (150 mg/mL) |
|50242-923-01 ||50242-0923-01 ||150
mg/1 mL (150 mg/mL) |
|Administration procedures: CPT ||96372||Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular|
|96401||Chemotherapy, administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic|
CPT=Current Procedural Terminology.
HCPCS=Healthcare Common Procedure Coding System.
ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code.
These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.
Many payers will not accept unspecified codes. If you use an
unspecified code, please check with your payer.
If your patient’s health insurance plan has issued a denial, your Field Reimbursement Manager (FRM) or HEMLIBRA Access Solutions Case Manager can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.
If a plan issues a denial:
- The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
- Your FRM or HEMLIBRA Access Solutions Case Manager has local payer coverage expertise and can help you determine specific requirements for your patient.
A sample appeal letter and additional considerations are available in Forms and Documents.
Appeals cannot be completed or submitted by HEMLIBRA Access
Solutions on your behalf.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.
Important Safety Information
Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.
Warnings and Precautions
- Laboratory coagulation test interference: HEMLIBRA interferes with activated clotting time (ACT); activated partial thromboplastin time (aPTT); and coagulation laboratory tests based on aPTT, including one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); and Bethesda assays (clotting-based) for factor VIII (FVIII) inhibitor titers. Intrinsic pathway clotting-based laboratory tests should not be used
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.