Site of care refers to the location in which care is provided. It is synonymous with “Place of Service”. For the purposes of this policy, it will refer specifically to the site of injectable drug administration and drug infusion therapy.
Home infusion therapy is the administration of drugs through intravenous, intraspinal, epidural, or subcutaneous routes, under a physician prescribed treatment plan and in a member’s home or other appropriate location requested by the member.
The medications identified in this policy may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.
Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in settings other than an outpatient facility setting:
Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis.
The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.
J0129 |
J0172 |
J0174 |
J0175 |
J0180 |
J0218 |
J0219 |
J0221 |
J0222 |
J0256 |
J0257 |
J0490 |
J0491 |
J0596 |
J0597 |
J0598 |
J0791 |
J1203 |
J1300 |
J1301 |
J1302 |
J1303 |
J1305 |
J1322 |
J1458 |
J1459 |
J1554 |
J1556 |
J1557 |
J1561 |
J1566 |
J1568 |
J1569 |
J1572 |
J1576 |
J1602 |
J1743 |
J1745 |
J1747 |
J1786 |
J1823 |
J1931 |
J2350 |
J2840 |
J3032 |
J3060 |
J3241 |
J3262 |
J3380 |
J3385 |
J3397 |
J9332 |
Q5103 |
Q5104 |
Q5121 |
Q5133 |
Procedure Code |
Drug Name |
Policy |
J1786 |
Cerezyme® |
I-9 Treatment of Gaucher Disease |
J3060 |
Elelyso® |
I-9 Treatment of Gaucher Disease |
J3385 |
Vpriv® |
I-9 Treatment of Gaucher Disease |
J1569 |
Gammagard® |
I-14 Immune Globulin Therapy |
J1561 |
Gamunex®- C |
I-14 Immune Globulin Therapy |
J1459 |
Privigen® |
I-14 Immune Globulin Therapy |
J1568 |
Octagam ® |
I-14 Immune Globulin Therapy |
J1554 |
Asceniv™ |
I-14 Immune Globulin Therapy |
J1557 |
Gammaplex® |
I-14 Immune Globulin Therapy |
J1556 |
Bivigam® |
I-14 Immune Globulin Therapy |
J1572 |
Flebogamma® |
I-14 Immune Globulin Therapy |
J1566 |
Carimune® NF, Gammagard® S/D, and intravenous immune globulin, lyophilized, not otherwise specified |
I-14 Immune Globulin Therapy |
J1576 |
Panzyga® |
I-14 Immune Globulin Therapy |
J1745 |
Remicade® |
I-28 Infliximab |
Q5103 |
Inflectra® |
I-28 Infliximab |
Q5104 |
Renflexis® |
I-28 Infliximab |
Q5121 |
AvsolaTM |
I-28 Infliximab |
J3262 |
Actemra® |
I-31 Tocilizumab (Actemra) and Tocilizumab Biosimilars |
Q5133 |
Tofidence™ |
I-31 Tocilizumab (Actemra) and Tocilizumab Biosimilars |
J0490 |
Benlysta® |
I-33 Belimumab (Benlysta) |
J1602 |
Simponi® |
I-35 Golimumab (Simponi, Simponi Aria) |
J1931 |
Aldurazyme® |
I-58 Enzyme Replacement Therapies |
J0180 |
Fabrazyme® |
I-58 Enzyme Replacement Therapies |
J0218 |
XenpozymeTM |
I-58 Enzyme Replacement Therapies |
J0219 |
NexviazymeTM |
I-58 Enzyme Replacement Therapies |
J0221 |
Lumizyme® |
I-58 Enzyme Replacement Therapies |
J1743 |
Elaprase® |
I-58 Enzyme Replacement Therapies |
J1322 |
Vimizim™ |
I-58 Enzyme Replacement Therapies |
J1458 |
Naglazyme® |
I-58 Enzyme Replacement Therapies |
J2840 |
Kanuma® |
I-58 Enzyme Replacement Therapies |
J3397 |
MepseviiTM |
I-58 Enzyme Replacement Therapies |
J1203 |
Pombiliti™ |
I-58 Enzyme Replacement Therapies |
J0129 |
Orencia® |
I-90 Abatacept (Orencia) IV and SC |
J0597 |
Berinert® |
I-122 Treatment of Hereditary Angioedema (HAE) |
J0598 |
Cinryze® |
I-122 Treatment of Hereditary Angioedema (HAE)H |
J0596 |
Ruconest® |
I-122 Treatment of Hereditary Angioedema (HAE)H |
J0256 |
Aralast ™ ZemairaTM, Prolastin® |
I-126 Alpha1-Proteinase Inhibitor Infusions |
J0257 |
Glassia® |
I-126 Alpha1-Proteinase Inhibitor Infusions |
J3380 |
Entyvio® |
I-129 Vedolizumab (Entyvio) |
J1300 |
Soliris® |
I-130 Complement Inhibitors |
J1303 |
Ultomiris™ |
I-130 Complement Inhibitors |
J2350 |
Ocrevus® |
I-171 Ocrelizumab (Ocrevus) |
J1301 |
Radicava® |
I-173 Edaravone (Radicava) |
J0222 |
Onpattro® |
I-201 Treatment of Hereditary Amyloidosis |
J0791 |
Adakveo® |
I-218 Crizanlizumab-tmca (Adakveo) |
J3241 |
Tepezza® |
I-220 Teprotumumab-trbw (Tepezza) |
J3032 |
VyeptiTM |
I-222 Eptinezumab-jjmr (Vyepti) |
J1823 |
UpliznaTM |
I-227 Inebilizumab-cdon (Uplizna) |
J1305 |
Evkeeza™ |
I-238 Evinacumab-dgnb (Evkeeza) |
J0172 |
Aduhelm® |
I-244 Aducanumab-avwa (Aduhelm) |
J0491 |
SaphneloTM |
|
J9332 |
Vyvgart™ |
I-247 Efgartigmod alfa-fcab (Vyvgart) |
J1302 |
Enjaymo™ |
I-251 Sutimlimab-jome (Enjaymo) |
J1747 |
Spevigo® |
I-254 Spesolimab (Spevigo) |
J0174 |
Leqembi™ |
I-266 Lecanemab-irmb (Leqembi) |
J0175 |
Kisunla |
I-291 Donanemab (Kisunla) |
Refer to Medical Policy I-9 Treatment of Gaucher Disease for additional information.
Refer to Medical Policy I-14 Immune Globulin Therapy for additional information.
Refer to Medical Policy I-28 Infliximab for additional information.
Refer to Medical Policy I-31 Tocilizumab (Actemra) and Tocilizumab Biosimilars for additional information.
Refer to Medical Policy I-33 Belimumab (Benlysta) for additional information.
Refer to Medical Policy I-35 Golimumab (Simponi, Simponi Aria) for additional information.
Refer to Medical Policy I-58 Enzyme Replacement Therapies for additional information.
Refer to Medical Policy I-90 Abatacept (Orencia) for additional information.
Refer to Medical Policy I-122 Treatment of Hereditary Angioedema (HAE) for additional information.
Refer to Medical Policy I-126 Alpha1-Proteinase Inhibitor Infusions for additional information.
Refer to Medical Policy I-129 Vedolizumab (Entyvio) for additional information.
Refer to Medical Policy I-130 Complement Inhibitors for additional information.
Refer to Medical Policy I-171 Ocrelizumab (Ocrevus) for additional information.
Refer to Medical Policy I-173 Edaravone (Radicava) for additional information.
Refer to Medical Policy I-201 Treatment of Hereditary Amyloidosis for additional information.
Refer to Medical Policy I-218 Crizanlizumab-tmca (Adakveo) for additional information.
Refer to Medical Policy I-220 Teprotumumab-trbw (Tepezza) for additional information.
Refer to Medical Policy I-222 Eptinezumab-jjmr (Vyepti) for additional information.
Refer to Medical Policy I-227 Inebilizumab-cdon (Uplizna) for additional information.
Refer to Medical Policy I-238 Evinacumab-dgnb (Evkeeza) for additional information.
Refer to Medical Policy I-244 Aducanumab-avwa (Aduhelm) for additional information.
Refer to Medical Policy I-245 Anifrolumab-fnia (Saphnelo) for additional information.
Refer to Medical Policy I-247 Efgartigmod alfa-fcab (Vyvgart) for additional information.
Refer to Medical Policy I-251 Sutimlimab-jome (Enjaymo) for additional information.
Refer to Medical Policy I-254 Spesolimab (Spevigo) for additional information.
Refer to Medical Policy I-266 Lecanemab-irmb (Leqembi) for additional information.
Refer to Medical Policy I-291 Donanemab (Kisunla) for additional information.
Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home. Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475
, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697
(TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association. Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania. Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York]. All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.