HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-151-016
Topic:
Site of Care
Section:
Injections
Effective Date:
September 1, 2024
Issued Date:
September 1, 2024
Last Revision Date:
August 2024
Annual Review:
August 2024
 
 

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. 

Policy Position

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:

  • Member’s home is considered unsuitable for care by the home infusion provider; or
  • Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
  • Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
  • Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
  • Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
  • Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
  • Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

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

I-245 Anifrolumab-fnia (Saphnelo)

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)

 


Related Policies

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.


Place of Service: Outpatient-Infusion

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.



The policy position applies to all commercial lines of business



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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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

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.