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Self-Administered Drugs and Biologics
08.00.78ay

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

For most of the Company's commercial products, self-administered drugs ​and biologics are not covered under the member's medical benefit and, therefore, a​re not eligible for reimbursement under the member's medical benefit. Coverage may be available under the pharmacy benefit or through a pharmacy vendor. Individual benefits must be verified.

The codes listed in Attachment A of this policy represent the products that the Company considers to meet the definition of self-administered drugs and biologics. These drugs are not eligible for reimbursement consideration under the member's medical benefit even if the drugs are provided or administered by a professional provider (for some products, there may be exceptions relating to coagulation factors for hemophilia and other bleeding conditions [please refer to the medical policy titled "Coagulation Factors", policy number 08.00.92]). Additionally, drugs may be considered self-administered by the Company even in circumstances where initial medical supervision and/or instruction is required prior to patient self-administration.

The self-administered designation does not apply to prescription drugs and biologics that are: (a) mandated to be covered by law under the medical benefit (e.g., insulin or any drug required for the treatment of diabetes); or (b) required for treatment of an emergency condition that requires the use of a Company-determined self-administered drug (e.g., epinephrine).

When the member or caregiver is unable to administer a self-administered drug, the drug can be administered by an eligible professional provider (e.g., a professional provider may administer the drug when a caregiver is unable to provide treatment due to a prolonged trip or absence). In this situation, the drug remains ineligible for coverage under the medical benefit; however, the administration fee for the professional provider is covered and eligible for reimbursement under the member's medical benefit.

Injection therapy services (represented by "S" codes listed in the coding table of this policy) must not be utilized by the eligible professional provider when reporting the administration of a self-administered drug because these services encompass more than the administration of the drug (e.g., pharmacy services, care coordination). Therefore, they are not covered and not eligible for reimbursement under the medical benefit of the Company. Coverage may be available under the pharmacy benefit or through a pharmacy vendor. For members enrolled in commercial plans in New Jersey, self-administered coagulation factors may be available under the applicable medical or pharmacy benefit. Individual benefits must be verified.

MAINTENANCE OF DRUG/BIOLOGICS LIST

The drugs and biologics listed in Attachment A of this policy are considered by the Company to be self-administered and are subject to change as new medications come to market or new determinations are made by the Company.

BILLING REQUIREMENTS

For drugs and biologics that have more than one method of administration, the appropriate modifier must be appended to indicate the route of administration.
  • To report the subcutaneous route of administration, append the following modifier: JB Administered Subcutaneously
Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, utilization management/referral requirements, provider contracts, and Company policies apply.​

Guidelines

BENEFIT APPLICATION

Self-administered drugs and biologics listed in Attachment A of this policy may be covered under the member's pharmacy benefit, if one exists. Therefore, individual benefits must be verified, as coverage may vary by product and/or group. Providers should work directly with the member's Pharmacy Benefit Administrator on options to obtain a self-administered drug through specialty pharmacy distribution under the member's pharmacy benefit.

MEMBERS ENROLLED IN NEW JERSEY PLANS

For members enrolled in New Jersey plans, self-administered coagulation factors may be available under the applicable medical or pharmacy benefit. Individual benefits must be verified.

Description

​The Company defines a self-administered prescription drug ("self-administered drug") as a drug that can be administered safely and effectively by the patient or caregiver without medical supervision, regardless of whether initial medical supervision and/or instruction is required.

PROCESS FOR DETERMINING SELF-ADMINISTERED DRUGS AND BIOLOGICS

The Company reviewed each drug listed in Attachment A to arrive at a determination of which drugs and biologics should be classified as self-administered. The review involved evaluation of each drug's route of administration (ROA), its use in the treatment of an acute or chronic condition, and the frequency of administration that will be required.

The ROA is defined as the path by which a drug enters the body. Some common examples of ROA are as follows:
  • Intramuscular (IM) drugs and biologics are injected directly into a muscle. Many vaccines and antibiotics are delivered through this ROA.
  • Subcutaneous (SC) drugs and biologics are injected under the skin. Insulin is commonly delivered through this ROA.
In general, drugs and biologics administered through the SC ROA are drugs and biologics that can be injected safely and effectively by the patient or caregiver without medical supervision and are considered by the Company to be self-administered drugs and biologics. Professional providers teach the patient or caregiver how to safely administer these products. There are other circumstances where drugs and biologics for less commonly used indications are considered by the Company to be self-administered (i.e., intramuscular injections for infertility) once the individual has been adequately trained.

The acuteness or chronicity of a condition and the frequency of drug administration typically required for treatment were also assessed to determine if a drug is considered self-administered. Drugs and biologics that are administered for a chronic condition (treatments generally lasting longer than 2 weeks) and/or are frequently administered (given one or more times per week) are generally considered self-administered. Conversely, drugs and biologics that are administered for an acute condition (treatments generally lasting less than 2 weeks) and/or are infrequently administered (less than once a week) are generally not considered self-administered.

In addition, some drugs and biologics​ can be used for more than one indication. The relative contribution for each indication to the total use of that drug (i.e., weighted average) was used to determine the overall designation of the ability to be self-administered. For example, a drug has three indications: the first indication comprises 95% of its use and is usually self-administered for this indication, and the second and third indications comprise 5% of its use and are usually not self-administered for these indications; thus the overall determination is that the drug is self-administered. Conversely, if the first indication comprises 5% of its use and the drug is usually self-administered, and the second and third indications comprise 95% of its use and the drug is not usually self-administered for these indications, the overall determination is that the drug is not self-administered.

References

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered Medical and Other Health Services. Section 50.2 Determining Self-Administration of Drug or Biological​ [CMS Website]. (Effective 07-02-12). Available at: 100-02 | CMS​. Accessed March 13, 2026.

Company Benefit Contracts.​​​​​​​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)

PLEASE SEE ATTACHMENT A FOR A LIST OF SELF-ADMINISTERED DRUGS AND BIOLOGICS.

THE INJECTION THERAPY SERVICES REPRESENTED BY THE FOLLOWING CODES ARE NOT COVERED WHEN USED TO BILL A SELF-ADMINISTERED DRUG OR BIOLOGIC:

S9370 Home therapy, intermittent antiemetic injection therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9372 Home therapy; intermittent anticoagulant injection therapy (e.g., Heparin); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code for flushing of infusion devices with Heparin to maintain patency)

S9537 Home therapy; hematopoietic hormone injection therapy (e.g., erythropoietin, G-CSF, GM-CSF); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9542 Home injectable therapy, not otherwise classified, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9558 Home injectable therapy; growth hormone, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9559 Home injectable therapy, interferon, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9560 Home injectable therapy; hormonal therapy (e.g., leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem​

Revenue Code Number(s)
N/A

Modifiers

JB Administered subcutaneously​

Coding and Billing Requirements

BILLING REQUIREMENTS

If there is no specific HCPCS code available for the drug administered, then the drug must be reported with the most appropriate unlisted code along with the corresponding National Drug Code (NDC).​

For drugs and biologics that have more than one method of administration, the appropriate modifier must be appended to indicate the route of administration.
  • To report the subcutaneous route of administration, append the following modifier: JB Administered Subcutaneously
Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, utilization management/referral requirements, provider contracts, and Company policies apply.​

Policy History

Revisions From 08.00.78ay:
10/01/2026
This version of the policy will become effective 10/01/2026.

​The following HCPCS codes have been removed from this policy:​
J1941 Injection, furosemide (furoscix), 20 mg​
J1938, J3490​ Lasix Onyu (for subcutaneous use) 

Revisions From 08.00.78ax:
07/01/2026
This version of the policy will become effective 07/01/2026​.​

This policy's Attachment A has been updated in consideration of the following products:​​

The following products, approved by the US Food and Drug Administration (FDA), were added to this policy:
  • Fesilty. Fibrinogen concentrate (human-chmt)​. ​Clotting Factor. HCPCS J7176. Date Drug Deemed Self-Administered:​ ​12/16/2025.
  • ​Immgolis (for subcutaneous use) Note: For Intravenous use of golimumab covered under the medical benefit, please refer to policy 08.01.15 Golimumab (Simponi Aria) Intravenous [IV] Injection). Golimumab-sldi. ​​Antiarthritic, Syst.Bio. Response Modifier. HCPCS J3590; Date Drug Deemed Self-Administered: ​05/15/20​26. ​
  • Saphnelo (for subcutaneous use). Anifrolumab-fnia. Biological Response Modifier. HCPCS J3590; Date Drug Deemed Self-Administered: ​04/24/20​26. Note: For Intravenous use of Saphnelo covered under the medical benefit, please refer to policy 08.01.82 Anifrolumab-fnia (Saphnelo®)​.​​​

The following pipeline product was already listed in the policy, and recently received FDA approval.  The suffix and FDA approval date were added to the entry: 

  • Hepcludex. (bulevirtide-gmod). ​Viral hepatitis products. HCPCS J3490; Date Drug Deemed Self-Administered: 05/22/2026. 

The following product is pending FDA approval and has been added to this policy:

  • ​Atacicept. Biological response modifier​. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA approval.​​


The following products were listed with the generic name/Company only, since they were not FDA approved. The drugs have since obtained FDA approval and this update will include the following brand names:

  • The brand name, Lerochol (lerodalcibep-liga), was added to the existing entry for the generic lerodalcibep, represented by J3590. FDA approval on 12/12/2025.
  • The brand name, Voyxact (sibeprenlimab-szsi), was added to the existing entry for the generic sibeprenlimab, represented by J3590. FDA approval on 11/25/2025.
  • The brand name, Yuviwel (navepegritide), was added to the existing entry for the generic navepegritide, represented by J3490. FDA approval on 02/27/2026.​
  • The brand name, Zycubo (copper histidinate), was added to the existing entry for the generic copper histidinate, represented by J3490. FDA approval on 01/12/2026.

The following NOC codes have been removed from this policy and are replaced by the following HCPCS codes, for the following products:

Vyvgart Hytrulo (prefilled syringe for self-administered administration). efgartigimod alfa and hyaluronidase-qvfc:

  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J9334 Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
​---------------------------------------------------------------------------------------------------
On 07/23/2026, the following coding change was made:

The following NOC code has been removed from this policy and is replaced by the following HCPCS code for ustekinumab-hmny (Starjemza*):
  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: Q5164 Injection, ustekinumab-hmny (starjemza), biosimilar, 1 mg

Additionally, an asterisk (*) was added to represent drug codes that must use modifier JB when the subcutaneous form of the drug is administered​



Revisions From 08.00.78aw:
01/01/2026
This version of the policy will become effective 01/01/2026.

This policy's Attachment A has been updated in consideration of the following products:​


The following products, approved by the US Food and Drug Administration (FDA), were added to this policy:

  • Forzinity (elamipretide)​. Musculoskeletal Products, Other​​. Healthcare Common Procedure Code System (HCPCS)​ HCPCS J3490. Date Drug Deemed Self-Administered: 09/19/2025.
  • Lasix Onyu (for subcutaneous use), furosemide. Diuretics, Loop. HCPCS J1938 or J3490. Date Drug Deemed Self-Administered: 10/07/2025.​
  • Redemplo (plozasiran). Antihyperlipidemic Agents. Familial chylomicronemia syndrome (FCS). HCPCS J3490; Date Drug Deemed Self-Administered: 11/18/2025.​
  • Sandostatin*​ (for subcutaneous use). octreotide acetate. Somatostatin Analogue​.     HCPCS J2354​. Date Drug Deemed Self-Administered: 01/01/2026.
  • Ustekinumab (for subcutaneous use)*. Brand names included, with HCPCS codes: Yesintek* (Q5100​), Stelara (J3357), Otulfi* (Q9999), Selarsdi (Q9998), Wezlana (Q5137​), Starjemza (J3590), Imuldosa* (Q5098), Steqeyma* (Q5099), Pyzchiva (Q9996). Monoclonal Antibodies​.  Date Drug Deemed Self-Administered: 01/01/2026.​​​
  • Vyvgart Hytrulo (prefilled syringe for self-administered administration). efgartigimod alfa and hyaluronidase-qvfc.  NERVOUS SYSTEM DISORDERS, OTHER. HCPCS J3590; Date Drug Deemed Self-Administered: 01/01/2026.​​


The following products are pending FDA approval and have been added to this policy:

  • Copper histidinate. Nervous System Disorders, Other​​. Menkes disease. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA approval.
  • ​Lerodalcibep. Antihyperlipidemic Agents​. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.​
  • Navepegritide. Growth Agents. Achondroplasia​. HCPCS J3490​; Date Drug Deemed Self-Administered: Upon FDA approval.
  • ​Sibeprenlimab. Nephropathy Agents. Treatment of IgA  nephropathy. HCPCS J3590​; Date Drug Deemed Self-Administered: Upon FDA approval.​
​
The following products were listed with the generic name/Company only, since they were not FDA approved. The drugs have since obtained FDA approval and this update will include the following brand names:
  • The brand name, Dawnzera (donidalorsen), was added to the existing entry for the generic donidalorsen​​, represented by J3590.​ FDA approval on 08/21/2025.
  • The brand name, Andembry (garadacimab-gxii), was added to the existing entry for the generic garadacimab, represented by J3590.  FDA approval on 06/16/2025. 


The following products and HCPCS codes have been removed from this policy:

  • Leqembi SQ*​ (lecanemab-irmb). Alzheimer-type Dementia.​ HCPCS J0174.​
  • J1655 Injection, tinzaparin sodium, 1000 iu   
  • J2940 Injection, somatrem, 1 mg
  • J3355 Injection, urofollitropin, 75 iu
  • J9212 Injection, interferon alfacon-1, recombinant, 1 microgram

​
Revisions From 08.00.78av:
10/01/2025
This version of the policy will become effective 10/01/2025.

The following NOC codes have been removed from this policy and are replaced by the following HCPCS code, for the following products:

fosdenopterin (Nulibry) 
  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J1809 Injection, fosdenopterin, 0.1 mg
​concizumab-mtci (Alhemo)
  • Suffix "--mtci​" was added to the entry
  • Coding Change: 
    • REMOVED: J3590 Unclassified biologics
    • REPLACED WITH: J7173 Injection, concizumab-mtci, 0.5 mg
fitusiran (Qfitlia)
  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J7174 Injection, fitusiran, 0.04 mg​

Revisions From 08.00.78au:
07/01/2025
This version of the policy will become effective 07/01/2025​.


This policy's Attachment A has been updated in consideration of the following products:​


The following products, approved by the US FDA, were added to this policy:

  • Tryngolza (olezarsen). ​Antihyperlipidemic Agents​. Healthcare Common Procedure Code System (HCPCS)​ HCPCS J3490. Date Drug Deemed Self-Administered: 12/19/2024.
  • Qfitlia (fitusiran). Coagulants, Other. Healthcare Common Procedure Code System (HCPCS)​ HCPCS J3590. Date Drug Deemed Self-Administered: 03/28/2025

The following products are pending FDA approval and have been added to this policy:

  • Donidalorsen. Biologicals, Other. Treatment for hereditary angioedema (HAE). HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.​
  • Leqembi SQ*​ (lecanemab-irmb). Alzheimer-type Dementia.​ HCPCS J0147; Date Drug Deemed Self-Administered: Upon FDA approval. (Note: Drug/Biologic codes that must use modifier JB when the subcutaneous form of the drug/biologic is administered are listed with an asterisk * in this Coding Table.​)
​The following products were listed with the generic name/Company only, since they were not FDA approved. The drugs have since obtained FDA approval and this update will include the following brand names:
  • The brand name, Alhemo (concizumab), was added to the existing entry for the generic concizumab​​, represented by J3590.​ FDA approval on 12/20/2024. 
  • The brand name, Brekiya​ was added to the existing entry for the generic dihydroergotamine mesylate, represented by J3490. FDA approval on 05/15/2025. 

​For cross-reference to relevant policies, the following notes were added: 

  • Cosentyx (secukinumab) (for subcutaneous use) entry: Note: for Intravenous use of Cosentyx ​covered under the medical benefit, please refer to policy 08.02.28 Secukinumab (Cosentyx®) for Intravenous Use
  • Omvoh* (mirikizumab) (for subcutaneous use) entry: Note: for Intravenous use of Omvoh covered under the medical benefit, please refer to policy 08.02.19 Mirikizumab-mrkz (Omvoh™) for Intravenous Use​
    • An asterisk (*) was added to represent drug codes that must use modifier JB when the subcutaneous form of the drug is administered​​
  • Tremfya* (guselkumab) (for subcutaneous use) entry: Note: for Intravenous use of Tremfya covered under the medical benefit, please refer to policy 08.02.33 Guselkumab (Tremfya®) Injection for Intravenous Use
    • An asterisk (*) was added to repre​sent drug codes that must use modifier JB when the subcutaneous form of the drug is administered​​
  • Tyenne* (for subcutaneous use) (tocilizumab) entry: Note: for Intravenous use of Tyenne covered under the medical benefit, please refer to policy 08.00.85 Tocilizumab and Related Bi​​osimilars for Intravenous Infusion
    • An asterisk (*) was added to repre​sent drug​ codes that must use modifier JB when the subcutaneous form of the drug is administered​

The following NOC code has been removed from this policy for marstacimab-hncq (Hympavzi) and is replaced by the following HCPCS code: 

  • ​REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J7172 Injection, marstacimab-hncq, 0.5 mg

The following product was alre​ady listed in the policy, but the HCPCS code has changed: 

​Ravulizumab-cwvz (Ultomiris*​ for subcutaneous use). 

  • FROM: HCPCS J3590 Unclassified biologics​
  • TO: HCPCS J1303 ​Injection, ravulizumab-cwvz, 10 mg​

The following HCPCS codes have been added to this policy:

J2312 Injection, naloxone hydrochloride, not otherwise s​pecified, 0.01 mg
J2313 Injection, naloxone hydrochloride (zimhi), 0.01 mg

The following HCPCS codes have been removed from this policy:
J2310 Injection, naloxone hydrochloride, per 1 mg
J2311 Injection, naloxone hydrochloride (zimhi), 1 mg

An asterisk (*) was removed from the following drugs. They do not require the use of modifier JB, since they are represented by non-specific code J3590: Benlysta, Orencia, Skyrizi.
​
Revisions From 08.00.78at:
01/01/2025
This version of the policy will become effective 01/01/2025​​.


This policy's Attachment A has been updated in consideration of the following products:


The following products, approved by the US FDA, were added to this policy:

  • (Nemluvio)​ ​nemolizumab-ilto. Dermatologicals. Healthcare Common Procedure Code System (HCPCS)​ HCPCS J3590. Date Drug Deemed Self-Administered: 08/12/2024.   
  • (​​Zurnai) nalmefene injection​. Opioid antagonist​. HCPCS J3490​​. Date Drug Deemed Self-Administered:08/07/2024.

The brand name was changed for palopegteriparatide, due to FDA approval 08/09/2024:

  • FROM: TransCon PTH​
  • TO: Yorvipath
​The following products were listed with the generic name/Company only, since they were not FDA approved. The drugs have since obtained FDA approval and this update will include the following brand names:
  • The brand name, Hympavzi (marstacimab-hncq), was added to the existing entry for the generic marstacimab​, represented by J3590.​ FDA approval on 10/11/2024. ​​
  • The brand name, Ebglyss (lebrikizumab-lbkz) was added to the existing entry for the generic lebrikizumab​, represented by J3590. ​​FDA approval on 09/13/2024.
The following product was removed from this policy, since it is healthcare-provider administered. 
  • ​Crovalimab (for subcutaneous use). Paroxysmal Nocturnal Hemoglobinuria. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval

The following NOC code has been removed from this policy and is replaced by the following HCPCS code:

adalimumab-fkjp (Hulio)

REMOVED: J3590 Unclassified biologics

REPLACED WITH: Q5140 Injection, adalimumab-fkjp, biosimilar, 1 mg


adalimumab-aaty (Yuflyma)

REMOVED: J3590 Unclassified biologics

REPLACED WITH: Q5141   Injection, adalimumab-aaty, biosimilar, 1 mg


adalimumab-ryvk (Simlandi)

REMOVED: J3590 Unclassified biologics

REPLACED WITH: Q5142   Injection, adalimumab-ryvk biosimilar, 1 mg


adalimumab-adbm (Cyltezo)

REMOVED: J3590 Unclassified biologics

REPLACED WITH: Q5143 Injection, adalimumab-adbm, biosimilar, 1 mg


The following HCPCS codes have been added to this policy:

J0139    Injection, adalimumab, 1 mg

Q5144   Injection, adalimumab-aacf (idacio), biosimilar, 1 mg

Q5145   Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg

 

The following HCPCS codes have been removed from this policy:

J0135 Injection, adalimumab, 20 mg

Q5131 Injection, adalimumab-aacf (idacio), biosimilar, 20 mg

Q5132 Injection, adalimumab-afzb (abrilada), biosimilar, 10 mg​​


Revisions From 08.00.78as:
10/01/2024
This version of the policy will become effective 10/01/2024.​

The following NOC code has been removed from this policy for Tyenne (for subcutaneous use) and is replaced by the HCPCS code indicated below.

  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: Q5135 Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg

Revisions From 08.00.78ar:
07/01/2024
This version of the policy will become effective 07/01/2024​.


This policy's Attachment A has been updated in consideration of the following products:


The following products, approved by the US FDA, were added to this policy:

  • Tyenne (for subcutaneous use).Tocilizumab-aazg. Monoclonal Antibodies. Healthcare Common Procedure Code System (HCPCS) J3590. Date Drug Deemed Self-Administered: 03/05/2024   
  • ​​Winrevair. Sotatercept-csrk. Cardiac agents, others. HCPCS J3590. Date Drug Deemed Self-Administered: 03/26/2024.​

The following products are pending FDA approval and have been added to this policy:

  • Glepaglutide. Gastrointestinal, Other. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.

  • ​(Oclaiz) octreotide. Somatostatin analogue. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA approval. ​

  • ​Garadacimab. Clotting Factor inhibitor. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.
  • Crovalimab (for subcutaneous use). Paroxysmal Nocturnal Hemoglobinuria. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.​
  • Marstacimab. Clotting Factor; Monoclonal Antibodies​. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA approval.​

The following products were listed with the generic name/Company only, since they were not FDA approved. The drugs have since obtained FDA approval and this update will include the following brand names:  

  • The brand name, Simlandi (adalimumab-ryvk), was added to the existing entry for the generic adalimumab by the pharmaceutical company Alvotech, represented by J3590.​ FDA approval on 02/23/2024.​​
  • The brand name, Wainua, was added to the existing entry for the generic eplontersen, represented by J3490. ​​FDA approval on 12/21/2023.
The following NOC code has been removed from this policy for infliximab-dyyb (Zymfentra) and has been replaced by the  HCPCS code indicated below. (The asterisk [*] represents drug codes that must use modifier JB when the subcutaneous form of the drug is administered​:
  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J1748  Injection, infliximab-dyyb (Zymfentra), 10 mg

The following NOC code has been removed from this policy for Omvoh (for subcutaneous use) and is replaced by the HCPCS code indicated below.

  • REMOVED: J3590 Unclassified biologics
  • REPLACED WITH: J2267 Injection, mirikizumab-mrkz, 1 mg

Clarified Cosentyx (secukinumab) entry by adding the formulation/route: (for subcutaneous use)​


Revisions From 08.00.78aq:
04/01/2024
This version of the policy will become effective 04/01/2024.

The following HCPCS code has been deleted from this policy:

J3380-JB Injection, vedolizumab, 1 mg​ that represents for vedolizumab (Entyvio) for subcutaneous use

Revisions From 08.00.78ap:
01/01/2024This version of the policy will become effective 01/01/2024.

This policy's Attachment A has been updated in consideration of the following products:

Added the Statement at the beginning of the document to state what occurs with biosimilars: Any US Food and Drug Administration (FDA)-approved biosimilar products will be managed the same way as their reference product, already listed in this Table.​

The following FDA-approved products were added to this policy:
  • Furoscix (for subcutaneous use)​, furosemide. Diuretics, Loop. HCPCS J1941. ​Date Drug Deemed Self-Administered: ​10/07/2022.
  • Omvoh (for subcutaneous use) . mirikizumab-mrkz. Monoclonal Antibodies. HCPCS J3590. ​Date Drug Deemed Self-Administered: ​10/26/2023 ​
  • Rivfloza. nedosiran. Genitourinary Tract, Other. HCPCS J3590​. ​Date Drug Deemed Self-Administered: ​09/29/2023.
  • Tezspire (for subcutaneous use)​. tezepelumab-ekko. Respiratory Other. HCPCS J2356​. ​Date Drug Deemed Self-Administered: 01/01/2024
  • Yuflyma. adalimumab-aaty. Antiarthritic, Syst. Bio. Response Modifier. HCPCS J3590. ​Date Drug Deemed Self-Administered: ​05/24/2023.  
  • Zepbound. tirzepatide. Human GLP-1 Analogs. HCPCS J3490; Date Drug Deemed Self-Administered: 11/08/2023.
  • Zymfentra. infliximab-dyyb. Monoclonal Antibodies. HCPCS J3590; Date Drug Deemed Self-Administered: ​​10/23/2023. Note: For Intravenous use of Infliximab covered under the medical benefit, please refer to policy 08.00.34 Intravenous Infliximab and Related Biosimilars.​

The following products are pending FDA-approval and have been added to this policy:

  • eplontersen. Neuropathic Pain, Other.  HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA-approval​.
  • lebrikizumab. Monoclonal Antibodies. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval​.
The following NOC code has been removed from this policy for Abrilada and is replaced by the following HCPCS code:
REMOVED: J3590 Unclassified Biologics
REPLACED WITH: Q5132 Injection, adalimumab-afzb (abrilada), biosimilar, 10 mg

The following products were listed with generic names only, since at the time they were added, they were not FDA approved. They have since obtained FDA approval and this update will include their brand Names:  
  • The Brand name Bimzelx was added to the existing entry for the generic bimekizumab-bkzx, represented by J3590. 
  • The Brand name Ngenla was added to the existing entry for the generic somatrogon-ghla​​. HCPCS code was changed from J3490 to J2941. 
  • The Brand name Zilbrysc was added to the existing entry for the generic zilucoplan, represented by J3490. 
  • Vedolizumab entry (represented by J3590) was revised:
    • Nomenclature: 
      • FROM: Entyvio SC ​
      • TO: Entyvio (for subcutaneous use) Note: For Intravenous use of Entyvio covered under the medical benefit, please refer to policy 08.01.18 Vedolizumab (Entyvio®)
    • ICD-10 was updated:
      • ​FROM: J3590 
      • TO: J3590 or J3380-JB​​

Revisions From 08.00.78ao:
10/01/2023This version of the policy will become effective 10/01/2023.

The following HCPCS code has been removed* from this policy for Altuviiio and is replaced by the following HCPCS code:
REMOVED: J7192 Factor VIII (antihemophilic factor, recombinant) per IU, not otherwise specified
REPLACED WITH: J7214 Injection, factor viii/von willebrand factor complex, recombinant (altuviiio), per factor viii i.u.

*Note: J7192 will remain in the policy to represent other agents. 

Revisions From 08.00.78an:
07/01/2023This version of the policy will become effective 07/01/2023.

This policy's Attachment A has been updated in consideration of the following products:

The following code has been replaced by the following HCPCS code for Ixinity:
Removed: J7195 Injection, factor IX (antihemophilic factor, recombinant) per IU, not otherwise specified
Replaced With: J7213 Injection, coagulation factor ix (recombinant), ixinity, 1 i.u.

The following code has been replaced by the following HCPCS code for Idacio​:
Removed: J3590 Unclassified biologics
Replaced With: Q5131 Injection, adalimumab-aacf (idacio), biosimilar, 20 mg​​

The following product was removed from this policy, since it will not be a self-administered drug: 
efgartigimod (for subcutaneous use). (Vyvgart Hytrulo). ​Nervous System Disorders, Other. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval.​​​

Revisions From​ 08.00.78am:
06/05/2023This version of the policy will become effective 06/05/2023​.

This policy's Attachment A has been updated in consideration of the following products:

The following FDA-approved products were added to this policy:
  • Altuviiio. Clotting Factor (Factor VIII concentrate). antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl. HCPCS J7192. ​Date Drug Deemed Self-Administered: 02/22/2023​. 
  • Idacio. adalimumab-aacf. Antiarthritic, Syst. Bio. Response Modifier. HCPCS J3590. ​Date Drug Deemed Self-Administered: 12/13/2022​

The following FDA-approved product was removed from this policy, since the product was discontinued: Evzio (naloxone HCl) Opioid antagonist. J2310.

The following products are pending FDA-approval and have been added to this policy:

  • concizumab. Coagulants, Other. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval​
  • ​efgartigimod (for subcutaneous use). Nervous System Disorders, Other. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval​
  • TransCon™ PTH. palopegteriparatide. Parathyroid agent. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA-approval​
  • zilucoplan. Nervous System Disorders, Other. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA-approval​​

Revisions From 08.00.78al:
01/01/2023This version of the policy will become effective 01/01/2023.

The following HCPCS code has been added to this policy:
J2311 Injection, naloxone hydrochloride (zimhi), 1 mg

(Note: The HCPCS code "J2310 for Injection, naloxone hydrochloride, per 1 mg" represents ​Evzio or generic naloxone hydrochloride​ products). 

Revisions From​ 08.00.78ak:
10/24/2022This version of the policy will become effective 10/24/2022​​.

This policy's Attachment A has been updated in consideration of the following products:

Clarification that this policy addresses Skyrizi subcutaneous formulation; not the intravenous formulation, which is addressed in Policy: Risankizumab-rzaa (Skyrizi®) for Intravenous Use 08.01.95.

The following FDA-approved products were added to this policy:
  • ​Tyvaso DPI (inhalation powder, for oral inhalation use), treprostinil. Prostacyclin Mimetic​. HCPCS J3490. Date Drug Deemed Self-Administered: ​05/23/2022.
  • Ravulizumab-cwvz (Ultomiris for subcutaneous use). Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.  HCPCS J3590; Date Drug Deemed Self-Administered: 07/22/2022. ​​Note: for Intravenous use of Ultomiris covered under the medical benefit, please refer to policy 08.00.84h Eculizumab (Soliris®) and Related Biosimilars, Ravulizumab-cwvz (Ultomiris®) 

The following products are pending FDA-approval and have been added to this policy:

  • dihydroergotamine (DHE) (prefilled autoinjector ​for self-administered administration). Anti-Migraine, Other. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA-approval​
  • bulevirtide (Hepcludex). ​Viral hepatitis products. HCPCS J3490; Date Drug Deemed Self-Administered: Upon FDA-approval​

Revisions From​ 08.00.78aj:
04/11/2022This version of the policy will become effective 04/11/2022​.

This policy has been updated in consideration of the following products:


The following FDA-approved products were added to this policy:

  • (Xolair) omalizumab (prefilled syringe​ for self-administered administration) Note: For administration by a professional provider, covered under the medical benefit, please refer to policy 08.00.55 Omalizumab (Xolair®). ​Respiratory, Other​. HCPCS J3590. FDA-approved 04/09/2021​.    
  • ​(Yusimry) ​adalimumab-aqvh. Antiarthritic, Syst. Bio. Response Modifier.  HCPCS J3590. ​FDA-approved 12/17/2021​.

The following FDA-approved product was removed from this policy, since the FDA approved this drug with the criteria of administration by a professional provider. This product will be eligible under the Medical Benefit:

  • ​Tezepelumab. Respiratory, Other. J3590​


The Brand name Adbry was added to the existing entry for the generic tralokinumab-ldrm​, represented by J3590.​

The Brand name Besremi was added to the existing entry for the generic ropeginterferon alfa-2b-njft, represented by J3490.​

The Brand name Voxzogo was added to the existing entry for the generic vosoritide, represented by J3490.​​


Revisions From​ 08.00.78ai:
10/25/2021This version of the policy will become effective 10/25/2021​​​.

This policy has been updated in consideration of the following products:


The following FDA-approved products were added to this policy:

  • (Wegovy) ​semaglutide ​- Anti-Obesity​. ​HCPCS J3490; FDA-approved 06/04/2021.
  • (Profilnine) coagulation Factor IX complex (human). Clotting Factor, HCPCS J7194.​

The following FDA-approved product was removed from this policy, since it was discontinued by the manufacturer:

  • (Profilnine SD) coagulation Factor IX complex (human). Clotting Factor, HCPCS J7194.​


​The following products are pending FDA-approval and have been added to this policy:

  • adalimumab biosimilars by Pharmaceutical companies: Alvotech, Coherus. Antiarthritic, Syst. Bio. Response Modifier. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval​
  • tezepelumab. Respiratory, Other. HCPCS J3590; Date Drug Deemed Self-Administered: Upon FDA-approval
​

The Brand name Empaveli was added to the existing entry for the generic pegcetacoplan, represented by J3490.​


The Brand name Skytrofa was added to the existing entry for the generic lonapegsomatropin-tcgd​, represented by J3490.​


The Pharmaceutical companies, Pfizer Inc. and OPKO Health Inc., were added for  the existing entry for the somatropin product which is in the pipeline and not FDA-approved yet.


Clarification of the Title of the Last Column: 
FROM: Date Drug Added
TO: Date Drug Classified as Self-Administered


Revisions From​ 08.00.78ah:
06/21/2021This version of the policy will become effective 06/21/2021​.

This policy has been updated in consideration of the following products:


The following FDA-approved product was added to this policy:

  • (Zegalogue) dasiglucagon ​- severe hypoglycemia in diabetes. ​HCPCS J3490

​The following products are pending FDA-approval and have been added to this policy:

  • bimekizumab. Monoclonal Antibodies.  HCPCS J3590
  • lonapegsomatropin. Anabolic Hormones. HCPCS J3490
  • pegcetacoplan - Hemolysis reduction. HCPCS J3490
  • ropeginterferon alfa-2b - Interferons. HCPCS J3490
  • somatropin. Anabolic Hormones. HCPCS J3490
  • tralokinumab - Monoclonal Antibodies.  HCPCS J3590
  • vosoritide. Bone growth disorder. HCPCS J3490
The following HCPCS codes were added to this policy:
  • Added J3031 for (Ajovy) fremanezumab-vfrm
  • Added J3490 for: (Betaseron, Extavia) interferon beta–1b, (Caverject, Edex) alprostadil, (Imitrex, Sumavel DosePro) sumatriptan
  • Added J3590 for: (Cimzia) certolizumab pegol, (Enbrel) etanercept, (Takhzyro) lanadelumab-flyo
The Brand name Nulibry was added to the existing entry for the generic Fosdenopterin, represented by J3590.

Revisions From 08.00.78ag:
01/01/2021This policy has been updated in consideration of the following products:


The following products were added to this policy:

  • (Fasenra) benralizumab - Monoclonal Antibodies - HCPCS J0517 (product was removed from policy 08.01.23 for Interleukin-5 (IL-5) Receptor Antagonist)
  • (Imcivree) setmelanotide​ - Anti-obesity in rare disease – HCPCS J3490​
  • (Nucala) mepolizumab - Monoclonal Antibodies - HCPCS J2182 (product was removed from policy 08.01.23 for Interleukin-5 (IL-5) Antagonist)
  • (Sogroya) somapacitan-beco - Analog; growth hormone – HCPCS J3590​

The following product was removed from this policy since it is not being studied for this indication anymore: 

“canakinumab to reduce risk of recurrent CV events in stable post-MI with elevated hsCRP. Note: This self-administered product is not Ilaris, which is covered under the medical benefit. Please refer to policy 08.01.51 Canakinumab (Ilaris®). Represented by J3590, added 01/01/2019". 


​The following products are pending FDA-approval and have been added to this policy:

  • Fosdenopterin – Molybdenum cofactor deficiency (MoCD) Type A treatment. Nervous system disorders, Other – HCPCS J3590

The following product, Egrifta, was removed from the market and replaced with Egrifta SV as of 11/2019. The name was revised in this updated. 


The following HCPCS code has been removed for Sevenfact and is replaced by the following HCPCS code:

REMOVED: J7189 Factor VIIa (antihemophilic factor, recombinant), per 1 mcg

REPLACED WITH:  J7212 Factor viia (antihemophilic factor, recombinant)-jncw (sevenfact), 1 microgram​


Revisions From 08.00.78af:
10/05/2020This policy has been updated in consideration of the following new FDA-approved products:
  • (Bonsity) teriparatide - Bone Formation Agents - HCPCS J3590
  • (Enspryng) satralizumab - Monoclonal Antibodies - HCPCS J3590​
  • (Kesimpta) ofatumumab - Monoclonal Antibodies - HCPCS J3590​
  • (RediTrex) methotrexate - folic acid antagonist - HCPCS J3490
  • (Sevenfact) coagulation factor VIIa (recombinant)-jncw - clotting factor - HCPCS J7189
  • (Hulio) adalimumab-fkip - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
The following product was already listed in the policy, but the generic and trade names have been updated due to its FDA approval:
  • (Abrilada) adalimumab-afzb - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
The following products are pending FDA-approval and have been added to this policy:
  • (Entyvio SQ) vedolizumab - Monoclonal Antibodies - HCPCS J3590
  • (Zimhi) naloxone HCl - Opioid antagonist - HCPCS J2310
A Billing Requirement was added to this policy regarding the Coding Modifier, JB Administered Subcutaneously, for Actemra SC, Benlysta SC, and Orencia SC.

The following HCPCS code has been removed (J3490) for Evzio, since a more specific code exists (J2310).

The following coagulation products have been removed from this policy since they have been removed from the market.
  • Helixate® FS, represented by HCPCS J7192
  • Monoclate-P, represented by HCPCS J7190
  • NovoSeven (not to be confused with NovoSeven RT), represented by HCPCS J7189
  • ReFacto®, represented by HCPCS J7192

Revisions From 08.00.78ae:
07/01/2020This policy has been identified for the HCPCS code update, effective 07/01/2020.

The following code has been removed from this policy for Esperoct and is replaced by the following HCPCS code:
REMOVED: J7192 Factor viii (antihemophilic factor, recombinant) per i.u., not otherwise specified
REPLACED WITH: J7204 Injection, factor viii, antihemophilic factor (recombinant), (esperoct), glycopegylated-exei, per iu

Revisions From 08.00.78ad:
10/21/2019This policy has been updated in consideration of the following new FDA-approved products:
  • (Cablivi) caplacizumab-yhdp (for subcutaneous use)- Platelet Inhibitors, Other - HCPCS J3590
  • (Esperoct) antihemophilic factor (recombinant), glycopegylated-exei - Clotting Factor VIII - HCPCS J7192
  • (Eticovo) etanercept-ykro - (Biosimilar for Enbrel) - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
  • (Hadlima) adalimumab-bwwd - (Biosimilar for Humira) - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
  • (Hyrimoz) adalimumab-adaz - (Biosimilar for Humira) - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
  • (Skyrizi) risankizumab-rzaa - Monoclonal Antibodies - plaque psoriasis - HCPCS J3590
  • (Vyleesi) bremelanotide - Sexual Function Disorders - HCPCS J3490
The following product pending FDA-approval has been added to this policy:
  • adalimumab (PF-06410293) by Pfizer - (Biosimilar for Humira) - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
The following drug was already listed in this policy, but further clarification was required:
  • FROM: canakinumab (for subcutaneous use)
  • TO: canakinumab to reduce risk of recurrent CV events in stable post-MI with elevated hsCRP. Note: This self-administered product is not Ilaris, which is covered under the medical benefit. Please refer to policy 08.01.51 Canakinumab (Ilaris®)
The following NOC HCPCS code has been updated with the following specific code:
  • Tremfya
    • FROM: J3590
    • TO: J1628 Injection, guselkumab, 1 mg
The following drug name has been removed from this Policy since it has been withdrawn from the market. The code J7194 represents other drugs, therefore the code remains active in the policy:
  • Bebulin (coagulation factor IX complex [human]) - Clotting Factor - J7194
The following drugs have been removed from this Policy since they have been withdrawn from the market. They were all represented by HCPCS J3490.
  • (Kynamro) mipomersen
  • (Luveris) lutropin alfa
  • (Mulsevo) semuloparin

Revisions From 08.00.78ac:
10/01/2019This policy has been identified for the HCPCS code update, effective 10/01/2019.

The following NOC code has been removed from this policy and is replaced by the following HCPCS code:

REMOVED: J3590: Unclassified biologics
REPLACED WITH: J0593 Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered)

Revisions From 08.00.78ab:
07/01/2019This policy has been identified for the HCPCS code update, effective 07/01/2019.

The following HCPCS code has been added to this policy as Medically Necessary: J7208 Injection, factor viii, (antihemophilic factor, recombinant), pegylated-aucl, (jivi), 1 i.u.
  • Note: This code no longer represents Jivi: J7207 Injection, factor VIII, (antihemophilic factor, recombinant), PEGylated, 1 IU

Revisions From 08.00.78aa:
01/01/2019This version of the policy will become effective 01/01/2019.

The following drug has been removed from this policy:
  • daclizumab (high-yield process) (Zinbryta) - withdrawn from the market (HCPCS J3590)
This policy has been updated in consideration of the following new products:
  • (Ajovy) fremanezumab-vfrm - Monoclonal Antibodies - HCPCS J3590
  • (Arcalyst) rilonacept - Immunomodulators - HCPCS J2793
  • (Jivi) antihemophilic Factor VIII - Clotting Factor - HCPCS J7207
  • (Takhzyro) lanadelumab-flyo - Monoclonal Antibodies - treatment of HAE - HCPCS J3590
  • canakinumab (for subcutaneous use) - Monoclonal Antibodies - reduce the risk of recurrent cardiovascular (CV) events - HCPCS J3590
  • (Tegsedi) inotersen - Neuropathic Pain, Other - hereditary ATTR amyloidosis (hATTR) - HCPCS J3490
  • volanesorsen sodium - Antihyperlipidemia Agents - HCPCS J3490
The following drugs were already listed in this policy, but their name has been revised:
  • FROM: galcanezumab - HCPCS J3590
  • TO: galcanezumab-gnlm (Emgality) - HCPCS J3590
  • FROM: Fibryna
  • TO: Fibryga
The following coding changes were made:
  • Fibryga HCPCS coding change - FROM: J7178 TO: J7177
  • Rebinyn HCPCS coding change - FROM: J7195 TO: J7203
  • Hemlibra HCPCS coding change - FROM: Q9995 TO: J7170
  • Haegarda HCPCS coding change - FROM: J3590 TO: J0599

Revisions From 08.00.78z:
07/01/2018This policy has been identified for the HCPCS code update, effective 04/01/2018.

The following HCPCS code has been added and the corresponding non-specific code removed from this policy:
ADDED: Q9995 Injection, emicizumab-kxwh, 0.5 mg
REMOVED: J7199 Hemophilia clotting factor, not otherwise classified

Revisions From 08.00.78y:
05/28/2018This version of the policy will become effective 05/28/2018.

This policy has been updated in consideration of the following new products:
  • (Cyltezo) adalimumab-adbm - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
  • (Xyosted) testosterone enanthate - Sex Hormones, Other - HCPCS J3121
  • (Hemlibra) emicizumab-kxwh - Clotting Factor; Monoclonal Antibodies - HCPCS J7199
  • eptacog beta, activated - recombinant activated human Coagulation Factor VIIa - Clotting Factor - HCPCS J7189
  • erenumab-aooe (Aimovig) - Monoclonal Antibodies - HCPCS J3590
  • galcanezumab - Monoclonal Antibodies - HCPCS J3590
  • pegvaliase-pqpz (Palynziq) - Enzymes, Systemic - HCPCS J3590

Effective 10/05/2017 this policy has been updated to the new policy template format.
10/1/2026
10/1/2026
08.00.78
Claim Payment Policy Bulletin
Commercial
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