HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-151-004
Topic:
Site of Care
Section:
Injections
Effective Date:
May 1, 2020
Issued Date:
May 1, 2020
Last Revision Date:
January 2020
Annual Review:
January 2020
 
 

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

J0180

J0221

J0222

J0256

J0257

J0490

J0596

J0597

J0598

J1300

J1301

J1303

J1322

J1458

J1459

J1556

J1557

J1561

J1566

J1568

J1569

J1572

J1599

J1602

J1743

J1745

J1786

J1931

J2350

J2840

J3060

J3262

J3380

J3385

Q5103

Q5104

 

 

 

 

 




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

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

J1599

Panzyga®, and intravenous immune globulin, non-lyophilized, not otherwise specified

I-14 Immune Globulin Therapy

J1745

Remicade®

I-28 Infliximab

Q5103

Inflectra®

I-28 Infliximab

Q5104

Renflexis®

I-28 Infliximab

J3262

Actemra®

I-31 Tocilizumab (Actemra)

J0490

Benlysta®

I-33 Belimumab (Benlysta)

J1602

Simponi®

I-35 Golimumab (Simponi, Simponi Aria)

J1931

Aldurazyme®

I-54 Laronidase (Aldurazyme)

J0180

Fabrazyme®

I-55 Agalsidase beta (Fabrazyme)

J0221

Lumizyme®

I-58 Alglucosidase alfa (Lumizyme)

J0129

Orencia®

I-90 Abatacept (Orencia) IV and SC

J1743

Elaprase®

I-93 Idursulfase (Elaprase)

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 Eculizumab (Soliris) and Ravulizumab (Ultomiris)

J1303

Ultomiris™

I-130 Eculizumab (Soliris) and Ravulizumab (Ultomiris)

J1322

Vimizim™

I-138 Elosulfase alfa (Vimizim)

J1458

Naglazyme®

I-140 Galsulfase (Naglazyme)

J2350

Ocrevus®

I-171 Ocrelizumab (Ocrevus)

J1301

Radicava®

I-173 Edaravone (Radicava)

J2840

Kanuma®

I-178 Sebelipase Alfa (Kanuma)

J0222

Onpattro®

I-201 Treatment of Hereditary Amyloidosis


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



Links






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, and subject to the applicable laws of your state.


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. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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.