GLIMPSES OF NEW DRUG CODES (J CODES)

This article emphasizes about the new drug codes effective with the date of service 07/01/2020:

J0223: Injection, givosiran, 0.5 mg

A new level II HCPCS code J0223 is established to specifically report GIVLAARI (givosiran).

Indication:

GIVLAARI (givosiran) is the first aminolevulinic acid synthase1 (ALAS1)-targeting RNAi drug used for the treatment of acute hepatic porphyria (AHP) in adults.

Drug composition and dose:

The recommended dose of GIVLAARI is 1 mg/kg administered via subcutaneous injection once monthly. It is packaged as a sterile, preservative free, 1 mL colorless to yellow solution for subcutaneous injection containing 189 mg givosiran in a single dose, 2 mL Type 1 glass vial.

It is appropriate to use the existing modifier “JB” administered subcutaneously to specify route of administration.

J0591: Injection, deoxycholic acid, 1 mg

A new level II HCPCS code J0591 is established to identify KYBELLA (Deoxycholic acid injection, for subcutaneous use.

Indication:

The active ingredient in KYBELLA is deoxycholic acid. It is a cytolytic drug that functions by destroying the fat cells where it is injected into the body. It is used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called as “double chin”.

Drug composition and dose:

KYBELLA, 10 mg/mL injection is a clear, colorless, sterile solution supplied in 2 mL, single patient use vials in a four vial dispensing pack.

J0691: Injection, lefamulin, 1 mg

A new level II HCPCS code J0691 is established to identify XENLETA (lefamulin) injection.

Indication:

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms:

  • Streptococcus pneumoniae,
  • Staphylococcus aureus (methicillin-susceptible isolates),
  • Haemophilus influenzae,
  • Legionella pneumophila,
  • Mycoplasma pneumoniae, and
  • Chlamydophila pneumoniae.

Drug composition and dose:

XENLETA is a clear, colorless, sterile, non-pyrogenic solution for intravenous administration containing 150 mg of lefamulin in 15 mL 0.9% sodium chloride that is supplied in a single dose vial intended for dilution in 250 mL of 10 mM citrate buffered (pH 5) 0.9% sodium chloride.

J0742: Injection, imipenem 4 mg, cilastatin 4 mg and relebactam 2 mg

A new code J0742 is established to identify Imipenem, cilastatin and relebactam, Trade name: RECARBRIO.

Indication:

Recarbrio is a three drug combination of imipenem, cilastatin and relebactam. It is used for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged 18 years or older.

Drug composition and dose:

Recarbrio is supplied as a sterile powder for constitution in a single dose vial containing the following active ingredients:

Imipenem 500mg (anhydrate equivalent)

Cilastatin 500mg (free acid equivalent)

Relebactam 250mg (anhydrate equivalent)

The recommended dose for RECARBRIO ranges from 0.5 grams to 1.25 grams and is administered by IV infusion over 30 minutes every 6 hours.

J0791: Injection, crizanlizumab-tmca, 5 mg

New code J0791 is established to identify crizanlizumab-tmca. Trade name: ADAKVEO

Indication:

ADAKVEO, the first FDA approved selectin blocker, is indicated to reduce the frequency of vaso-occlusive crisis (VOCs) in adults and pediatric patients, aged 16 years and older with sickle cell disease.

Drug composition and dose:

ADAKVEO is supplied in a 10 ml (100mg/10ml) single-dose vial, as a sterile, preservative free, colorless to slightly brownish yellow solution for intravenous infusion. The recommended dose is 5mg/kg of actual body weight administered by intravenous infusion over a period of 30 minutes at week0, week 2 and every 4 weeks thereafter.

J0896: Injection, luspatercept-aamt, 0.25 mg

A new Level II HCPCS code J0896 is established to identify luspatercept-aamt. Trade name: REBLOZYL.

Indication:

REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require red blood cell (RBC) transfusions.

Drug composition and dose:

REBLOZYL for injection is an off-white lyophilized powder supplied in a single dose vial (25mg/vial and 75 mg/vial). Each carton has one vial. The recommended dose is a physician administered 1mg/kg once every three weeks by subcutaneous injection.

J1201: Injection, cetirizine hydrochloride, 0.5 mg

A new Level II HCPCS code J1201 is established to identify cetirizine hydrochloride injection for intravenous use. Trade name: QUZYTTIR

Indication:

QUZYTTIR for intravenous use is a histamine1 (H1) receptor antagonist and is indicated for the treatment of acute urticarial in adults and children 6 months of age and older.

Drug composition and dose:

It is a sterile, clear, colorless, non-pyrogenic, isotonic solution of cetrizine hydrochloride for intravenous injection. It is supplied in 2 mL size amber glass vials for single use. The recommended dosage is 10 mg (1mL) for a patient 12 years of age or older; 5 mg or 10 mg for children 6 to 11 years of age; and 2.5 mg for children 6 months to 5 years of age. QUZYTTIR is administered as an intravenous push over a period of 1 to 2 minutes.

J1429: Injection, golodirsen, 10 mg

A new Level II HCPCS code J1429 is established for VYONDYS 53 (golodirsen) for injection.

Indication:

VYONDYS 53 is an FDA approved exon-skipping therapy. It is used to treat Duchenne muscular dystrophy (DMD) which is a rare disease affecting primarily the boys. It is usually caused by the low levels of a muscle protein called dystropin. The lack of dystrophin causes progressive muscle weakness and premature death.

Drug composition and dose:

It is a clear to slightly opalescent, colorless liquid solution supplied in single dose vials. The recommended dose of golodirsen is 30mg/kg administered once weekly as a 35-60 minute IV infusion.

J1558: Injection, immune globulin (Xembify), 100 mg

A new Level II HCPCS code J1558 is established for XEMBIFY, a new biological product.

Indication:

XEMBIFY (immune globulin subcutaneous human–klhw) is a 20% immune globulin (IG) protein for subcutaneous administration. It is an antibody replacement therapy used to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older.

Drug composition and dose:

XEMBIFY is packaged as a single use vials containing 1, 2, 4 and 10 grams of protein in 5, 10, 20 and 50 mL, respectively (200 mg protein/mL). The dosage is individualized amount based on patient’s serum IgG trough level and pharmacokinetic and clinical response, administered 1-7 times/week as a subcutaneous infusion.

J3399: Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5×10^15 vector genomes

A new Level II HCPCS code J3399 is established to identify ZOLGENSMA (onasemnogene abeparvovec-xioi), a suspension for intravenous infusion.

Indication:

ZOLGENSMA is a gene therapy approved by the US Food and Drug Administration (FDA) for children less than 2 years old with spinal muscular Atrophy (SMA).

Drug composition and dose:

ZOLGENSMA is a suspension for intravenous infusion, supplied as single-use vials. It is administered as an intravenous infusion over 60 minutes. It is provided in a kit containing 2 to 9 vials, as a combination of 2 vial fill volumes (either 5.5 mL or 8.3 mL). All vials have a nominal concentration of 2.0 x 10^13 vector genomes (vg) per mL. Each vial of ZOLGENSMA contains an extractable volume of not less than either 5.5 mL or 8.3 mL.

J7169: Injection, coagulation factor xa (recombinant), inactivated-zhzo (andexxa), 10 mg

A new Level II HCPCS code is established to identify ANDEXXA, a coagulation factor Xa protein.

Indication:

ANDEXXA is a recombinant modified human factor Xa (FXa) protein. It is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Drug composition and dose:

ANDEXXA is intravenously administered, with a target rate of 30 mg/min, followed by continuous infusion for up to 120 minutes. It is available in 4 single- use vials, with a blue flip off cap, each containing 100 mg of factor Xa (recombinant), inactivated-zhzo as a white to off-white lyophilized cake or powder as well as in cartons of 4 single use vials, with red flip-off cap, each containing 200 mg of factor Xa (recombinant), inactivated-zhzo as a white to off white lyophilized cake or powder.

J7204: Injection, factor viii, antihemophilic factor (recombinant), (esperoct), glycopegylated-exei, per iu

A new Level II HCPCS code is established to identify ESPEROCT (antihemophilic factor (recombinant), glycopegylated-exei).

Indication:

ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a coagulation factor VIII concentrate indicated for use in adults and children with haemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Drug composition and dose:

ESPEROCT is available as white to off white lyophilized powder in single use vials containing 500, 1000, 1500, 2000 or 3000 IU of Factor VIII activity. It is reconstituted with 4 mL of 0.9% saline diluent provided in a prefilled glass syringe in the package.

J7333: Hyaluronan or derivative, visco-3, for intra-articular injection, per dose

Read more about this drug!

J9177: Injection, enfortumab vedotin-ejfv, 0.25 mg

A new Level II HCPCS code is established to identify PADCEV (enfortumab vendotin-ejfv)

Indication:

PADCEV (enfortumab vedotin-ejfv) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Drug composition and dose:

PADCEV is supplied as a sterile, preservative-free, and white to off white lyophilized powder in single dose vials for reconstitution containing 20 mg or 30 mg per vial. The recommend dose of PADCEV is 1.25 mg/kg (up to a maximum of 125 mg for patients >100 kg) administered as intravenous infusion over 30 minutes on Day 1, 8, and 15 of a 28 -day cycle until disease progression or unacceptable toxicity.

J9198: Injection, gemcitabine hydrochloride, (infugem), 100 mg

A new code is established to report gemcitabine injection, 100mg. This code allows the discontinuation of the existing code J9199 which reads gemcitabine injection for 200mg.

J9246: Injection, melphalan (evomela), 1 mg

A new Level II HCPCS code is established to identify melphalan injection, powder, lyophilized, for solution. Trade name: EVOMELA

Indication:

EVOMELA (melphalan injection, powder, lyophilized, for solution) is a single-source drug product indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma and also for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Drug composition and dose:

EVOMELA is supplied in a single carton containing 1 vial. Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.

J9358: Injection, fam-trastuzumab deruxtecan-nxki, 1 mg

A new Level II HCPCS code is established to identify ENHERTU (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use.

Indication:

ENHERTU is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments.

Drug composition and dose: It is packaged one vial per carton and supplied as a single dose vial containing 100 mg lyophilized powder. The recommended dose of ENHERTU is 5.4 mg/kg given as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. The first infusion should be administered over 90 minutes. Subsequent infusions should be administered over 30 minutes if prior infusions were well tolerated.

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