inject drug i-m

Injections: Drugs I-M Policy1

This section outlines policy related to billing for injection services, listed in alphabetical order by generic drug name or drug type. For general billing policy information regarding injections services, refer to the Injections: An Overview section in this manual. Additional policy information for injection services can be found in the following sections of this manual:

  • Injections: Drugs A–DPolicy
  • Injections: Drugs E–HPolicy
  • Injections: Drugs N–RPolicy
  • Injections: Drugs S–ZPolicy
  • Injections: Hydration
  • Immunizations

IbandronateIbandronate sodium, 1 mg, (HCPCS J1740) is reimbursablefor the treatment of women with post-menopausal osteoporosis.

DosageDosing frequency is 3 mg every three months administered intravenously over 15 – 30 seconds by a health care provider. Ibandronate is contraindicated in patients with hypocalcemia or those who have a known hypersensitivity to ibandronate sodium.

Required Diagnosis CodeRestricted to ICD-10-CM diagnosis code M81.0.

BillingProviders must submit the following documentation in the Remarks field (Box 80)/Additional Claim Information field (Box 19) on the claim or on an attachment:

  • A diagnostic T score of -2.5 or more in women who have documented difficulty with the oral bisphosphonates dosing requirement, which includes an inability to sit upright for 30 to 60 minutes and/or difficulty in swallowing a pill; or,
  • A diagnostic T score of -2.5 or more in women with documented esophagitis, gastritis, gastric or esophageal ulcers which prohibit the use of oral bisphosphonates.

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IbuprofenThe daily maximum dosage for HCPCS code J1741 (injection, ibuprofen, 100 mg) is 3,200 mg.

AuthorizationFor doses greater than 3,200 mg per day, an approved Treatment Authorization Request (TAR) is required for reimbursement.

IdursulfaseFor detailed billing policy information about idursulfase, refer to the “Enzyme Replacement Drugs” topic in the Injections: Drugs E-H Policy manual section.

ImigluceraseFor detailed billing policy information about imiglucerase, refer to the “Enzyme Replacement Drugs” topic in the Injections: Drugs E-H Policy manual section.

Immune GlobulinImmune globulin preparations contain highly purified (>90 percent) polyvalent IgG. Immune globulin preparations are made from pooled human plasma from several thousand screened volunteer donors. Cold alcohol fractionation is used to isolate the immunoglobulin-containing fraction. This is followed by further purification techniques including several specific treatments to inactivate or remove potentially present blood-borne pathogens. These include low pH treatment, solvent-detergent treatment, pasteurization and/or nanofiltration.

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IndicationsImmune globulin is indicated for any of the following:

  • Primary congenital hypogammaglobulinemia

-X-linked hypogammaglobulinemia

-Common variable immunodeficiency

-Severe combined immune deficiency

-Ataxia-telangiectasia

-Wiscott-Aldrich syndrome

  • Secondary acquired antibody deficiency

-Chronic lymphocytic leukemia (CLL)

-HIV infection in children

  • Autoimmune disorders

-Idiopathic thrombocytopenic purpura (ITP)

-Anti-factor VIII autoantibodies

-Kawasaki disease

-Polymyositis and dermatomyositis

-Guillain-Barre syndrome (GBS)

  • Other

-Chronic inflammatory demyelinating polyneuropathy

AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement. TARs may be approved for any of the indications above. In many instances immune globulin is not considered first line therapy and may be used as second line therapy or in special circumstances. The TAR must not only state the diagnoses but also must contain sufficient clinical information to establish medical necessity.

Routes ofImmune globulin may be administered intravenously, intramuscularly

Administrationor subcutaneously. In most cases, products are designed for a specific route of administration, although some preparations designed for intravenous administration can also be given subcutaneously. Subcutaneous and intramuscular products are generally more concentrated than intravenous preparations.

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BillingIntravenous immune globulin injections:

HCPCS CodeDescription

J1459Injection, immune globulin, (Privigen),
non-lyophilized (e.g. liquid), 500 mg

J1556Injection, immune globulin, (Bivigam), 500 mg

J1557Injection, immune globulin, (Gammaplex),
non-lyophilized (e.g. liquid), 500 mg

J1561Injection, immune globulin, (Gamunex/
Gamunex-C/Gammaked), non-lyophilized (e.g. liquid), 500 mg

J1566Injection, immune globulin, lyophilized (e.g. powder), not otherwise specified, 500 mg

J1568Injection, immune globulin, (Octagam),
non-lyophilized (e.g. liquid), 500 mg

J1569Injection, immune globulin, (Gammagard Liquid),
non-lyophilized (e.g. liquid), 500 mg

J1572Injection, immune globulin, (flebogamma/flebogamma DIF), non-lyophilized (e.g. liquid), 500 mg

J1599Injection, immune globulin, non-lyophilized (e.g. liquid), not otherwise specified, 500 mg

Intramuscular or subcutaneous immune injections:

HCPCS CodeDescription

J1460Injection, gamma globulin, intramuscular 1 cc

J1555Injection, immune globulin (Cuvitru), 100 mg

J1559Injection, immune globulin, (Hizentra), 100 mg

J1560Injection, gamma globulin, intramuscular over

10 cc

J1562Injection, immune globulin, (Vivaglobin), 100 mg

J1575Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immunoglobulin

Providers must use the correct code when submitting claims or the claim will be denied. Claims submitted with codes J1460, J1560, J1566 or J1599 must include an invoice or the claim will be denied.

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Immune GlobulinImmune globulin subcutaneous (human), 20% solution (Cuvitru™)

Subcutaneous (Human)supplies a broad spectrum of opsonizing and neutralizing IgG

20% solutionantibodies against a wide variety of bacterial and viral agents. Cuvitru also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes.

IndicationsImmune globulin subcutaneous 20% solution is indicated for the treatment of patients two years of age and older, with immune globulin subcutaneous (human), 20% solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.

DosageIndividualize dose based on the patient’s pharmacokinetic and clinical response.

Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed.

Switching from immune globulin intravenous (human) treatment (IGIV) or adult patients switching from immune globulin infusion 10% (human) with recombinant human hyaluronidase (HyQvia):

  • Begin treatment one week after the patient’s last IGIV or HyQvia infusion
  • Establish initial weekly dose by converting the monthly IGIV or HyQvia dose into equivalent weekly dose and increasing it using a dose adjustment factor.

Initial weekly dose = [Previous IGIV or HyQvia dose (in grams)/Number of weeks between IGIV of HyQvia doses] x 1.30.

  • Frequent dosing (two to seven times per week): divide the calculated weekly dose by the desired number of times per week
  • Biweekly dosing: multiply the calculated weekly dose by 2.

Switching from immune globulin subcutaneous (human) treatment (IGSC)

  • Weekly dose (in grams) should be the same as the weekly dose of prior IGSC treatment (in grams)
  • Frequent dosing (two to seven times per week): divide the calculated weekly dose by 2.

Infusion sites: up to four infusion sites simultaneously, with at least four inches between sites avoiding bony prominences. Rotate sites with each administration.

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AuthorizationA Treatment Authorization Request (TAR) is required for reimbursement.

BillingHCPCS code J1555 (immune globulin (Cuvitru), 100 mg)

IncobotulinumtoxinAFor more detailed billing policy information about incobotulinumtoxinA,refer to the “Botulinum Toxins A and B” topic in the Injections: Drugs A-D Policy manual section.

InfliximabInfliximab may be reimbursed when used for:

  • Crohn’s disease:

For reduction in the signs and symptoms of Crohn’s disease

in patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

For reduction in the number of draining enterocutaneous fistulae in patients with fistulizing Crohn’s disease.

  • Rheumatoid arthritis:

When used in combination with methotrexate, for the reduction in signs and symptoms of rheumatoid arthritisin patients who have had an inadequate responseto methotrexate, or who are refractory to otherdisease-modifying anti-rheumatic drugs. If the patientis intolerant to methotrexate, infliximab must be used in conjunction with another disease-modifying agent.

  • Refractory ankylosing spondylitis.
  • Destructive psoriatic arthropathy.
  • Active ulcerative colitis that has had an inadequate response to conventional therapy.
  • Plaque psoriasis that covers 10 percent or more of the patient’s body surface area.

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DosageFor treatment of moderate to severe Crohn’s disease, the recommended dose of infliximab is an initial 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg doses given at two and six weeks, then every eight weeks thereafter. The dosage may be increased to 10 mg/kg for patients who have an incomplete response to the 5 mg/kg dose. If patients do not respond to the increased dosage after 14 weeks, providers should consider discontinuing treatment with infliximab.

For treatment of fistulizing Crohn’s disease, the recommended dose of infliximab is an initial dose of 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg doses given at two and six weeks after the initial dose.

For treatment of rheumatoid arthritis, the recommended dose of infliximab is an initial 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg doses given at two and six weeks,then every eight weeks thereafter. The dosage may be adjusted to
10 mg/kg every eight weeks or 5 mg/kg every four weeks for patients who have an incomplete response to the 3 mg/kg dose. Infliximab should be given in combination with methotrexate or another
disease-modifying agent.

TAR RequiredInfliximab treatment requires a Treatment Authorization Request (TAR). The patient’s condition must be entered in the Medical Justification area of the TAR. When requesting authorization for plaque psoriasis, documentation stating that the plaque psoriasis covers 10 percent or more of the patient’s body surface area must be on or attached to the TAR.

BillingHCPCS code J1745 (injection, infliximab, excludes biosimilar, 10 mg)

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Infliximab-abdaInfliximab-abda injection is a tumor necrosis factor (TNF) blocker for intravenous (IV) use. Infliximab-abda is biosimilar to infliximab.

IndicationsInfliximab-abda injection is indicated for use in adults to treat the following conditions:

1)Crohn’s Disease

  • moderate-to-severely active disease refractory to conventional therapy.
  • enterocutaneous or rectovaginal fistulizing active disease.

2)Ulcerative Colitis

  • moderate-to-severely active disease refractory to conventional therapy.

3)Rheumatoid Arthritis

  • moderate-to-severely active disease, refractory to methotrexate alone and/or to other conventional therapy.

4)Ankylosing Spondylitis

  • active disease refractory to conventional therapy.

5)Psoriatic Arthritis

  • active disease refractory to conventional therapy.

6)Plaque Psoriasis

  • chronic severe (i.e. extensive and/or disabling) disease in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Infliximab-abda injection is indicated for use in children 6 years of age and older to treat the following condition:

7)Pediatric Crohn’s Disease

  • moderate-to-severely active disease that is refractory to conventional therapy.

Age6 years and older

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DosageThe dosage for infliximab-abda is as follows:

1)Crohn’sDisease

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.
  • the dose may be increased up to 10 mg/kg in patients who initially respond but then lose their response.
  • patients who do not respond by week 14 are unlikely to respond with continued dosing; consider discontinuing therapy.

2)Ulcerative Colitis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

3)Rheumatoid Arthritis

  • 3 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter, in conjunction with methotrexate.
  • the dose may be increased up to 10 mg/kg or given as often as every 4 weeks in patients who have an incomplete response.

4)Ankylosing Spondylitis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 6 weeks thereafter.

5)Psoriatic Arthritis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter, with or without methotrexate.

6)Plaque Psoriasis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

7)Pediatric Crohn’s Disease

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

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AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement. The TAR must include clinical documentation that demonstrates the following:

  • the service is medically necessary;
  • alternative, conventional therapy has been tried or considered, has failed, or is contra-indicated; and
  • a clinician’s written order, prescription, and/or treatment plan for the service requested.

BillingHCPCS code Q5104 (injection, infliximab-abda, biosimilar, [renflexis], 10 mg)

One (1) unit of Q5104 = 10 mg of infliximab-abda solution

Infliximab-dyybInfliximab-dyyb injection is a tumor necrosis factor (TNF) blocker for intravenous (IV) use. Infliximab-dyyb is biosimilar to infliximab.

IndicationsInfliximab-dyyb injection is indicated for use in adults to treat the following conditions:

1)Crohn’s Disease

  • moderate-to-severely active disease refractory to conventional therapy.
  • enterocutaneous or rectovaginal fistulizing active disease.

2)Ulcerative Colitis

  • moderate-to-severely active disease refractory to conventional therapy.

3)Rheumatoid Arthritis

  • moderate-to-severely active disease, when used in combination with methotrexate, refractory to methotrexate alone and/or to other conventional therapy.

4)Ankylosing Spondylitis

  • active disease refractory to conventional therapy.

5)Psoriatic Arthritis

  • active disease refractory to conventional therapy.

6)Plaque Psoriasis

  • chronic severe (i.e. extensive and/or disabling) disease in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

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Infliximab-dyyb injection is indicated for use in children 6 years of age and older to treat the following condition:

7)Pediatric Crohn’s Disease

  • moderate-to-severely active disease that is refractory to conventional therapy.

Age6 years of age and older

DosageThe dosage for infliximab-dyyb is as follows:

1)Crohn’sDisease

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.
  • the dose may be increased up to 10 mg/kg in patients who initially respond but then lose their response.
  • patients who do not respond by week 14 are unlikely to respond with continued dosing; consider discontinuing therapy.

2)Ulcerative Colitis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

3)Rheumatoid Arthritis

  • 3 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter, in conjunction with methotrexate.
  • the dose may be increased up to 10 mg/kg or given as often as every 4 weeks in patients who have an incomplete response.

4)Ankylosing Spondylitis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 6 weeks thereafter.

5)Psoriatic Arthritis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter, with or without methotrexate.

6)Plaque Psoriasis

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

7)Pediatric Crohn’s Disease

  • 5 mg/kg given IV at weeks 0, 2, 6, and every 8 weeks thereafter.

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AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.

The TAR must include clinical documentation that demonstrates all of the following:

  • the service is medically necessary;
  • alternative, conventional therapy has been tried or considered, has failed, or is contra-indicated; and
  • a clinician’s written order, prescription, and/or treatment plan for the service requested.

BillingHCPCS code Q5103 (injection, infliximab-dyyb, biosimilar, [inflectra], 10 mg)

One (1) unit of Q5103 = 10 mg of infliximab-dyyb solution

Iron SucroseIron sucrose injection is an aqueous complex of polynuclear
iron (III)-hydroxide in sucrose containing 20 mg elemental iron per ml. Iron is essential to the formation of hemoglobin. Untreated depletion of iron stores leads to iron-deficient erythropoiesis and, in turn, to iron deficiency anemia. Administration of iron sucrose replenishes tissue iron stores, reverses iron depletion and iron-deficient erythropoiesis, and corrects or prevents iron deficiency anemia. Following intravenous administration, iron sucrose is dissociated into iron and sucrose by the reticuloendothelial system and iron is transferred from the blood to a pool of iron in the liver and bone marrow. After a series of interactions with storage and transport proteins, iron becomes internalized and intracellular iron becomes hemoglobin in circulating red blood cells.

IndicationsIron sucrose is indicated in the treatment of iron deficiency anemia in the following patients:

  • Non-dialysis dependent-chronic kidney disease patients receiving an erythropoietin
  • Non-dialysis dependent-chronic kidney disease patients not receiving an erythropoietin
  • Hemodialysis dependent-chronic kidney disease patients receiving an erythropoietin
  • Peritoneal dialysis dependent-chronic kidney disease patients receiving an erythropoietin

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DosageIron sucrose must only be administered intravenously either by slow injection or infusion.

Hemodialysis Dependent Chronic Kidney Disease Patients:
Iron sucrose may be administered undiluted as a 100 mg slow intravenous injection over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of1,000 mg.

Non-Dialysis Dependent-Chronic Kidney Disease Patients:
Iron sucrose is administered as a total cumulative dose of 1,000 mg over a 14-day period as a 200 mg slow intravenous injection over a period of at least 15 minutes on five different occasions within the
14-day period.

Diagnosis RestrictionsTwo ICD-10-CM diagnosis codes are required for reimbursement. One code must be for chronic kidney disease (N18.1 – N18.6) and the other must be for iron deficiency anemia (D50.9).

BillingHCPCS code J1756 (injection, iron sucrose, 1 mg)

LacosamideLacosamide injection is indicated for intravenous use as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible. The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated.

DosageThe initial dose should be 100 mg intravenously in two divided doses and can be increased at weekly intervals by 100 mg per day in two divided doses up to the recommended maintenance dose of 200 to 400 mg per day.

The maximum daily dose is 400 mg.

BillingHCPCS code C9254 (injection, lacosamide, 1 mg)

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LanreotideLanreotide acetateis reimbursable for the treatment of acromegaly and gigantism, and patients with unresectable, well-differentiated or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

IndicationsLanreotide (somatuline) is indicated for:

  • The long-term treatment of patients with acromegaly and pituitary gigantism, who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy
  • The treatment of patients with unresectable, well-differentiated or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival

DosageFor patients with acromegaly, the dose range is 60 mg to 120 mg every four weeks. Recommended starting dose is 90 mg every four weeks for three months. Adjust thereafter based on growth hormone (GH) and/or insulin growth factor-1 (IGF-1) levels.