Coverage Policy Manual
Policy #: 2020005
Category: Pharmacy
Initiated: March 2020
Last Review: March 2022
  Self-Administered Medication

Description:
Self-administered medications are medications a patient typically takes orally, by intramuscular or subcutaneous injection, by nebulizer, by insertion, or by topical application and do not require healthcare provider supervision.

Policy/
Coverage:
Effective September 1, 2022
 
Self-administered medications do not meet primary coverage criteria to be covered under the medical benefit. These medications are covered under the pharmacy benefit unless excluded from formulary and may be subject to Standard Guideline Management.
 
Medications are determined as self-administered primarily when the medication does not require administration or direct supervision by a qualified healthcare provider and the medication does not require continuous or periodic monitoring immediately before, during, or after administration by a qualified healthcare provider.
 
Other factors evaluated when considering self-administration include:
      • Medication route of administration is oral, inhaled, intranasal, rectal, subcutaneous injection, intramuscular injection, or topical application
      • Medication dosage form is a tablet, capsule, oral solution, prefilled syringe, auto-injector, suppository, nasal spray, metered dose inhaler, nebulized solution, or cream/ointment
      • Comorbid condition that interferes with medication delivery
      • Frequency of administration
      • Medication is not allowed by policy under the medical benefit
 
MEDICATIONS SUBJECT TO THIS POLICY:
Any medication that is FDA approved for self-administration is subject to this policy. Any new injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Any applicable clinician administered dosage form (e.g. intravenous infusion) of a drug that can also be self-administered may be covered under the medical benefit.
 
Below are a list of medications that are considered self-administered by FDA labeling and benefits should be checked under the pharmacy benefit. They are not covered under the medical benefit. This list may be updated periodically.
 
Effective April 01, 2021, the following list of medications will be excluded from the medical benefit and be directed toward the member’s pharmacy benefit.
 
Generic Name (brand name) HCPCS Code
 
Adalimumab (e.g., Humira) J0135
Alirocumab (e.g., Praluent) J3490
Anakinra (e.g., Kineret) J3590
Asfotase alfa (e.g., Strensiq) J3490
Benralizumab (e.g., Fasenra) J0517
Brodalumab (e.g., Siliq) J3590
C-1 esterase inhibitor (e.g., Haegarda) J0599
Dupilumab (e.g., Dupixent) J3590
Erenumab (e.g., Aimovig) J3590
Etanercept (e.g., Enbrel) J1438
Evolucumab (e.g., Repatha) J3490
Fremanezumab-vfrm (e.g., Ajovy) J3031
Galcanezumab-gnlm (e.g., Emgality) J3590
Glatiramer acetate (e.g., Copaxone) J1595
Glatiramer acetate (e.g., Glatopa) J1595
Guselkumab (e.g., Tremfya) J1628
Icatibant (e.g., Firazyr) J1744
Interferon beta-1a (e.g., Avonex) J1826
Interferon beta-1a (e.g., Rebif) Q3028
Interferon beta-1b (e.g., Betaseron) J1830
Interferon beta-1b (e.g., Extavia) J1830
Interferon gamma-1b (e.g., Actimmune) J9216
Ixekizumab (e.g., Taltz) J3590
Lanadelumab-flyo (e.g., Takhzyro) J0593
Mecasermin (e.g., Increlex) J2170
Mepolizumab (e.g., Nucala) J2182
Metreleptin (e.g., Myalept) J3950
Ofatumumab (e.g., Kesimpta) J3590
Omalizumab (e.g., Xolair) J2357
Pegcetacoplan (e.g., Empaveli) C9399
Peginterferon beta-1a (e.g., Plegridy) J3490
Ropeginterferon alfa-2b-nift (e.g., Besremi) C9399
Sarilumab (e.g., Kevzara) J3590
Satralizumab (e.g., Ensprying) J3490
Secukinumab (e.g., Cosentyx) J3590
Somapacitan-beco (e.g., Sogroya) J3590
Somatropin (e.g., Genotropin) J2941
Somatropin (e.g., Humatrope) J2941
Somatropin (e.g., Norditropin) J2941
Somatropin (e.g., Nutropin) J2941
Somatropin (e.g., Omnitrope) J2941
Somatropin (e.g., Saizen) J2941
Somatropin (e.g., Zomacton) J2941
Somatropin (e.g., Zorbtive) J2941
Tesamorelin acetate (e.g., Egrifta) J3490
Tralokinumab (e.g., Adbry) C9399
 
Effective January 1, 2022 to August 31, 2022
 
Self-administered medications do not meet primary coverage criteria to be covered under the medical benefit. These medications are covered under the pharmacy benefit unless excluded from formulary and may be subject to Standard Guideline Management.
 
Medications are determined as self-administered primarily when the medication does not require administration or direct supervision by a qualified healthcare provider and the medication does not require continuous or periodic monitoring immediately before, during, or after administration by a qualified healthcare provider.
 
Other factors evaluated when considering self-administration include:
      • Medication route of administration is oral, inhaled, intranasal, rectal, subcutaneous injection, intramuscular injection, or topical application
      • Medication dosage form is a tablet, capsule, oral solution, prefilled syringe, auto-injector, suppository, nasal spray, metered dose inhaler, nebulized solution, or cream/ointment
      • Comorbid condition that interferes with medication delivery
      • Frequency of administration
      • Medication is not allowed by policy under the medical benefit
 
MEDICATIONS SUBJECT TO THIS POLICY:
Any medication that is FDA approved for self-administration is subject to this policy. Any new injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Any applicable clinician administered dosage form (e.g. intravenous infusion) of a drug that can also be self-administered may be covered under the medical benefit.
 
Below are a list of medications that are considered self-administered by FDA labeling and benefits should be checked under the pharmacy benefit. They are not covered under the medical benefit. This list may be updated periodically.
 
Effective April 01, 2021, the following list of medications will be excluded from the medical benefit and be directed toward the member’s pharmacy benefit.
 
Generic Name (brand name) HCPCS Code
 
Adalimumab (Humira) J0135
Alirocumab (Praluent) J3490
Anakinra (Kineret) J3590
Asfotase alfa (Strensiq) J3490
Benralizumab (Fasenra) J0517
Brodalumab (Siliq) J3590
C-1 esterase inhibitor (Haegarda) J0599
Dupilumab (Dupixent) J3590
Erenumab (Aimovig) J3590
Etanercept (Enbrel) J1438
Evolucumab (Repatha) J3490
Fremanezumab-vfrm (Ajovy) J3031
Galcanezumab-gnlm (Emgality) J3590
Glatiramer acetate (Copaxone) J1595
Glatiramer acetate (Glatopa) J1595
Guselkumab (Tremfya) J1628
Icatibant (Firazyr) J1744
Interferon beta-1a (Avonex) J1826
Interferon beta-1a (Rebif) Q3028
Interferon beta-1b (Betaseron) J1830
Interferon beta-1b (Extavia) J1830
Interferon gamma-1b (Actimmune) J9216
Ixekizumab (Taltz) J3590
Lanadelumab-flyo (Takhzyro) J0593
Mecasermin (Increlex) J2170
Mepolizumab (Nucala) J2182
Metreleptin (Myalept) J3950
Ofatumumab (Kesimpta) J3590
Omalizumab (Xolair) J2357
Peginterferon beta-1a (Plegridy) J3490
Risankizumab-rzaa (Skyrizi) J3590
Sarilumab (Kevzara) J3590
Satralizumab (Ensprying) J3490
Secukinumab (Cosentyx) J3590
Somapacitan-beco (Sogroya) J3590
Somatropin (Genotropin) J2941
Somatropin (Humatrope) J2941
Somatropin (Norditropin) J2941
Somatropin (Nutropin) J2941
Somatropin (Omnitrope) J2941
Somatropin (Saizen) J2941
Somatropin (Zomacton) J2941
Somatropin (Zorbtive) J2941
Tesamorelin acetate (Egrifta) J3490
  
 
Effective April 2021 to December 2021
 
Self-administered medications do not meet primary coverage criteria to be covered under the medical benefit. These medications are covered under the pharmacy benefit unless excluded from formulary and may be subject to Standard Guideline Management.
 
Medications are determined as self-administered primarily when the medication does not require administration or direct supervision by a qualified healthcare provider and the medication does not require continuous or periodic monitoring immediately before, during, or after administration by a qualified healthcare provider.
 
Other factors evaluated when considering self-administration include:
    • Medication route of administration is oral, inhaled, intranasal, rectal, subcutaneous injection, intramuscular injection, or topical application
    • Medication dosage form is a tablet, capsule, oral solution, prefilled syringe, auto-injector, suppository, nasal spray, metered dose inhaler, nebulized solution, or cream/ointment
    • Comorbid condition that interferes with medication delivery
    • Frequency of administration
    • Medication is not allowed by policy under the medical benefit
 
MEDICATIONS SUBJECT TO THIS POLICY:
 
Any medication that is FDA approved for self-administration is subject to this policy. Any new injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Any applicable clinician administered dosage form (e.g. intravenous infusion) of a drug that can also be self-administered may be covered under the medical benefit.
 
Below are a list of medications that are considered self-administered by FDA labeling and benefits should be checked under the pharmacy benefit. They are not covered under the medical benefit. This list may be updated periodically.  
 
Effective April 01, 2021, the following list of medications will be excluded from the medical benefit and be directed toward the member’s pharmacy benefit.
 
Brand Name (generic name) HCPCS Code
 
Actimmune (interferon gamma-1b) J9216
Aimovig (erenumab) J3590
Ajovy (fremanezumab-vfrm) J3031
Avonex (interferon beta-1a) J1826
Betaseron (interferon beta-1b) J1830
Copaxone (glatiramer acetate) J1595
Cosentyx (secukinumab) J3590
Dupixent (dupilumab) J3590
Egrifta (tesamorelin acetate) J3490
Emgality (galcanezumab-gnlm) J3590
Enbrel (etanercept) J1438
Ensprying (satralizumab) J3490
Extavia (interferon beta-1b) J1830
Firazyr (icatibant ) J1744
Genotropin (somatropin) J2941
Glatopa (glatiramer acetate) J1595
Haegarda (c-1 esterase inhibitor) J0599
Humatrope (somatropin) J2941
Humira (adalimumab) J0135
Increlex (mecasermin) J2170
Kesimpta (ofatumumab) J3590
Kevzara (sarilumab) J3590
Kineret (anakinra) J3590
Myalept (metreleptin) J3950
Norditropin (somatropin) J2941
Nutropin (somatropin) J2941
Omnitrope (somatropin) J2941
Plegridy (Peginterferon beta-1a) J3490
Praluent (alirocumab) J3490
Rebif (Interferon beta-1a) Q3028 & Q3026
Repatha (evolucumab) J3490
Saizen (somatropin) J2941
Siliq (brodalumab) J3590
Skyrizi (risankizumab-rzaa) J3590
Sogroya (somapacitan-beco) J3590
Strensiq (asfotase alfa) J3490
Takhzyro (lanadelumab-flyo) J0593
Taltz (ixekizumab) J3590
Tremfya (guselkumab) J1628
Zomacton (somatropin) J2941
Zorbtive (somatropin)  J2941
 
 
Effective 3/26/2020 through 3/31/ 2021
 
Self-administered medications do not meet primary coverage criteria to be covered under the medical benefit. These medications are covered under the pharmacy benefit unless excluded from formulary and may be subject to Standard Guideline Management.
 
Medications are determined as self-administered primarily when the medication does not require administration or direct supervision by a qualified healthcare provider and the medication does not require continuous or periodic monitoring immediately before, during, or after administration by a qualified healthcare provider.
 
Other factors evaluated when considering self-administration include:
    • Medication route of administration is oral, inhaled, intranasal, rectal, subcutaneous injection, intramuscular injection, or topical application
    • Medication dosage form is a tablet, capsule, oral solution, prefilled syringe, auto-injector, suppository, nasal spray, metered dose inhaler, nebulized solution, or cream/ointment
    • Comorbid condition that interferes with medication delivery
    • Frequency of administration
    • Medication is not allowed by policy under the medical benefit
 
MEDICATIONS SUBJECT TO THIS POLICY:
Any medication that is FDA approved for self-administration is subject to this policy. Any new injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Any applicable clinician administered dosage form (e.g. intravenous infusion) of a drug that can also be self-administered may be covered under the medical benefit.

CPT/HCPCS:
C9399Unclassified drugs or biologicals
J0135Injection, adalimumab, 20 mg
J0517Injection, benralizumab, 1 mg
J0593Injection, 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)
J0599Injection, c 1 esterase inhibitor (human), (haegarda), 10 units
J1438Injection, etanercept, 25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
J1595Injection, glatiramer acetate, 20 mg
J1628Injection, guselkumab, 1 mg
J1744Injection, icatibant, 1 mg
J1826Injection, interferon beta 1a, 30 mcg
J1830Injection, interferon beta 1b, 0.25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
J2170Injection, mecasermin, 1 mg
J2182Injection, mepolizumab, 1 mg
J2357Injection, omalizumab, 5 mg
J2941Injection, somatropin, 1 mg
J3031Injection, fremanezumab vfrm, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
J9216Injection, interferon, gamma 1 b, 3 million units
Q3028Injection, interferon beta 1a, 1 mcg for subcutaneous use

References: Clinical Pharmacology [database online]. URL: http://www.clinicalpharmacology.com

FDA Approved Medication Package Insert https://www.fda.gov/

Medicare Benefit Policy Manual. (2019, July 12) Retrieved March 13, 2020, from https://www.cms.gov/Regulations-and Guidance/Guidance/Manuals/downloads/bp102c15.PDF

Self-Administration Drug Exclusion Report List. (n.d.) Retrieved March 13, 2020, from https://www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?Cntrctr=All&AllHCPCS=yes&DateFrom=01/01/2019&DateTo=03/01/2020&bc=AIAAAEAAAAAA&#ResultsAnchor

Lexicomp Online(2020) Lexicomp Online Lexi-Drugs Online, Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.

The benefits and risks of self-medication. Retrieved March 13, 2020, from http://apps.who.int/medicinedocs/en/p/about/


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2022 American Medical Association.