Blue Cross Blue Shield of Minnesota Medical Policy


Medical Policy:
Site of Service for Selected Specialty Medical Drugs
Effective Date:
October 5, 2020
Issued Date:
June 28, 2021
Last Revision Date:
May 2020
Annual Review:
June 2021

This policy version was replaced on August 2, 2021. To find the newest version, go to, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

This policy is used for determining the medical necessity of hospital outpatient facility level of care for selected specialty medical drugs. The policy addresses patient and/or procedural factors that may increase a patient’s risk of requiring urgent access to a higher level of care available in a hospital outpatient facility.


Medical drugs: Drugs and biologics administered by a healthcare professional that process under the medical benefit. These drugs are generally delivered by infusion or injection through intravenous, intramuscular, or other less common routes of administration (e.g., intrathecal, intraocular). Medical drugs do not include drugs that process under the pharmacy benefit, such as self-administered drugs and oral agents. 

Site of service: The location where the infusion or injection is performed, including the following:

  • Office (Code 11): Location, other than a hospital, skilled nursing facility (SNF), military treatment facility, community health center, state or local public health clinic, or intermediate care facility (ICF) where the health professional routinely provides health examinations, diagnosis, and treatment of illness or injury on an ambulatory basis.
  • Home (Code 12): Location, other than a hospital or other facility, where the patient receives care in a private residence.
  • Off Campus-Outpatient Hospital (Code 19): A portion of an off-campus hospital provider-based department which provides diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services to sick or injured persons who do not require hospitalization or institutionalization.
  • On Campus-Outpatient Hospital (Code 22): A portion of a hospital’s main campus which provides diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services to sick or injured persons who do not require hospitalization or institutionalization.
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 circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.


  • This policy applies to commercial health plan members only.
  • See table below for medical drugs included in the site of service program.
  • Medical necessity of the drug may be separately reviewed against the appropriate criteria.
  • When policy criteria for use of a hospital outpatient facility are not met, a non-hospital outpatient setting (e.g., freestanding infusion center or home infusion) should be used.

I.     Use of a hospital outpatient facility for infusion or injection of a medical drug may be considered MEDICALLY NECESSARY AND APPROPRIATE when ANY of the following criteria are met:

  • Age <18 years; OR
  • Nearest in-network non-hospital outpatient facility with supervised infusion or injection capabilities is >25 miles from patient’s home AND patient is not eligible for home infusion; OR
  • First dose or <60 days from the first dose; OR
  • Reinitiating therapy after not being on therapy for ≥6 months (Note: this does not include maintenance therapy); OR
  • History of a severe adverse event with prior infusion or injection therapy (e.g. anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure); OR
  • History of adverse events with prior infusion or injection therapy (e.g. hypersensitivity or allergic reactions), which have not been successfully managed through standard premedications or infusion rate adjustments; OR
  • Comorbidity or medical condition that increases the risk of an adverse event, including but not limited to the following:
    • Cardiopulmonary conditions; or
    • Inability to safely tolerate intravenous volume loads, including unstable renal function; or
    • Difficult or unstable vascular access;
  • OR
  • Physical or cognitive impairment such that infusion or injection in a non-hospital outpatient setting would present an unnecessary health risk; OR
  • Concurrent treatment with medications that require a higher level of monitoring (e.g. intravenous cytotoxic chemotherapy, blood products).

II.   Use of a hospital outpatient facility for infusion or injection of a medical drug when the criteria in section I are not met is considered NOT MEDICALLY NECESSARY.


Table 1. Specialty Medical Drugs Included in the Site of Service Program


Policy #

Abatacept (Orencia®)


Agalsidase Beta (Fabrazyme®)


Alglucosidase Alfa (Lumizyme®)


Alpha-1 Proteinase Inhibitors

·         Alpha-1 Antitrypsin (Aralast NP™)

·         Alpha-1 Antitrypsin (Glassia®)

·         Alpha-1 Antitrypsin (Prolastin-C®)

·         Alpha-1 Antitrypsin (Zemaira®)


Belimumab (Benlysta®)


Benralizumab (Fasenra®)


Burosumab (Crysvita®)


Certolizumab Pegol (Cimzia®)


Eculizumab (Soliris®)


Edaravone (Radicava®)


Elosulfase alfa (Vimizim®)


Galsufase (Naglazyme®)


Golimumab (Simponi Aria®)


Idursulfase (Elaprase®)


Immunoglobulin Therapy (e.g., Hizentra®, Gamunex®-C, Gammaked™, Gammagard Liquid®, Cuvitru™, HyQvia)


Infliximab (Remicade® )


Intravenous Enzyme Replacement Therapy for Gaucher Disease

·         Imiglucerase (Cerezyme®)

·         Taliglucerase Alfa (Elelvso®)

·         Velaglucerase Alfa (Vpriv®)


Laronidase (Aldurazyme®)


Mepolizumab (Nucala®)


Natalizumab (Tysabri®)


Ocrelizumab (Ocrevus®)


Omalizumab (Xolair®)


Patisiran (Onpattro™)


Pegloticase (Krystexxa®)


Pharmacologic Therapies for Hereditary Angioedema

·         C1 Esterase Inhibitor (Berinert®)

·         C1 Esterase Inhibitor (Cinryze®)

·         Ecallantide (Kalbitor®)

·         C1 Esterase Inhibitor (Ruconest®)


Reslizumab (Cinqair®)


Rituximab (Rituxan®)


Romiplostim (Nplate®)


Sebelipase Alfa (Kanuma®)


Tildrakizumab (Ilumya™)


Tocilizumab (Actemra™)


Ustekinumab (Stelara®)


Vedolizumab (Entyvio®)


Vestronidase Alfa (Mepsevii™)



Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.


CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.