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
|Diagnosis: ICD-10-CM||D66||Hereditary factor VIII deficiency: hemophilia A|
|Drug: HCPCS||J3590||Unclassified biologics|
|J9999||Not otherwise classified, antineoplastic drugs|
|J7199 ||Hemophilia clotting factor,
not otherwise classified |
|Hospital outpatient HCPCS||C9399||Unclassified drugs or biologicals|
|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, checklist and additional tips 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 with hemophilia A (congenital factor VIII deficiency) with 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
Thrombotic Microangiopathy (TMA) Associated with HEMLIBRA and aPCC
Cases of thrombotic microangiopathy (TMA) were reported from clinical trials 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. In clinical trials, thrombotic microangiopathy was reported in 1.6% of patients (3/189) and in 8.3% of patients (3/36) who received at least one dose of aPCC. Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
Evidence of improvement was seen within one week following discontinuation of aPCC. One patient resumed HEMLIBRA following resolution of TMA.
Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Monitor for the development of TMA when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms and/or laboratory findings consistent with TMA occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA on a case-by-case basis.
Thromboembolism Associated with HEMLIBRA and aPCC
Thrombotic events were reported from clinical trials when on average a cumulative amount of >100 U/kg/24 hours of aPCC was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. In clinical trials, thrombotic events were reported in 1.1% of patients (2/189) and in 5.6% of patients (2/36) who received at least one dose of aPCC.
No thrombotic event required anticoagulation therapy. Evidence of improvement or resolution was seen within one month following discontinuation of aPCC. One patient resumed HEMLIBRA following resolution of thrombotic event.
Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Monitor for the development of thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with thromboembolism occur, and manage as clinically indicated.Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of thrombotic events on a case-by-case basis.
Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT), activated partial thromboplastin time (aPTT), and all assays based on aPTT, such as one-stage factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based laboratory test results in patients treated with HEMLIBRA should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.
Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based, single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.
Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrobin time (PT)-based, single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (e.g., Factor V Leiden, Prothrombin 20210).
Most Common Adverse Reactions
The most frequently reported adverse reactions observed in ≥ 10% of subjects treated with at least one dose of HEMLIBRA were injection site reactions, headache, and arthralgia.
Characterization of aPCC Treatment in Pooled Clinical Trials
There were 125 instances of aPCC treatment in 36 patients, of which 13 instances (10.4%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; two of the 13 were associated with thrombotic events and three of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.
Injection Site Reactions
In total, 35 patients (19%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 88% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (7.4%), injection site pruritus (5.3%), and injection site pain (5.3%).
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC. There is a possibility for hypercoagulability with activated recombinant factor VII (rFVIIa) or FVIII with HEMLIBRA based on preclinical experiments.
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.