Subject:
Site of Service for Administration for Infusion and Injectable Prescription Medications
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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This policy provides information about infusion and injectable therapy in the hospital outpatient setting.
This medical policy will apply to the following drugs:
- Infliximab (Remicade), Infliximab-dyyb (Inflectra), Infliximab-abda (Renflexis), Infliximab-qbtx (Ixifi)
- Tocillizumab (Actemra)
- Certolizumab pegol (Cimzia)
- Abatacept (Orencia)
- Vedolizumab (Entyvio)
- Golimumab (Simponi Aria)
- Ustekinumab (Stelara)
- Belimumab (Benlysta)
- Eculizumab (Soliris)
- Human C1 Inhibitor (Cinryze)
- Laronidase (Aldurazyme)
- Galsulfase (Naglazyme)
- Idursulfase (Elaprase)
- imiglucerase (Cerezyme)
- taliglucerase alfa (Elelyso)
- velaglucerase alfa (Vpriv)
- Agalsidase beta(Fabrazyme)
- Alglucosidase alfa(Lumizyme)
- Intravenous immune globulin (Bivigam, Carimune NF, Flebogamma, Gammagard S/D, Gammaplex, Gamunex, Octagam, Privigen)
- Subcutaneous immune globulin (Cuvitru, Gammagard liquid, Hizentra, Hyqvia)
- Ravulizumab-cwvz (Ultomiris)
- Octreotide acetate (Sandostatin LAR)
- Lanreotide acetate (Somatuline)
- Patisiran (Onpattro)
- Omalizumab (Xolair)
- Mepolizumab (Nucala)
- Reslizumab (Cinqair)
- Benralizumab (Fasenra)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
The requirements of the Horizon BCBSNJ Site of Service for Administration for Infusion and Injectable Prescription Medications Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
[INFORMATIONAL NOTE: Please refer to separate policy on Tocilizumab (Actemra) (Policy #076), Certolizumab Pegol (Cimzia) (Policy #059), Vedolizumab (Entyvio) (Policy #121), Infliximab (Remicade), Infliximab-dyyb (Inflectra), Infliximab-abda (Renflexis), and Infliximab-qbtx (Ixifi) (Policy #017), Abatacept (Orencia) (Policy #042), Golimumab (Simponi Aria) (Policy #068), Ustekinumab (Stelara) (Policy #071), Belimumab (Benlysta) (Policy #088), Ocrelizumab (Ocrevus) (Policy #150), Lemtrada (Alemtuzumab) (Policy #127), Natalizumab (Tysabri) (Policy #050), Eculizumab (Soliris) (Policy #061), Drug Therapy for Hereditary Angioedema [Cinryze, Berinert, Haegarda (Human C1 Inhibitor), Kalbitor (Ecallantide), Firazyr (Icatibant), Ruconest (C1 Esterase Inhibitor [Recombinant])] (Policy #063), Laronidase (Aldurazyme), Galsulfase (Naglazyme), and Idursulfase (Elaprase), elosulfase alfa (Vimizim), and vestronidase alfa (Mepsevii)
(Policy #027), Gaucher Disease Therapy (Policy #006), Agalsidase Beta (Fabrazyme) (Policy #028), Pompe Disease Treatment with Myozyme (Alglucosidase alfa) and Lumizyme (Alglucosidase alfa) (Policy #044), Intravenous Immunoglobulin (IVIG) Therapy (Policy #016), Immune Globulin Subcutaneous (Vivaglobin, Hizentra, Gammagard Liquid, Gamunex-C/Gammaked, HyQvia, and Cuvitru for Subcutaneous Administration) (Policy #045), Denosumab (Prolia, Xgeva) (Policy #079), Edaravone (Radicava) (Policy #156), Eculizumab (Soliris) and Ravulizumab-cwvz (Ultomiris) (Policy #061), Octreotide (Sandostatin, Sandostatin LAR depot), lanreotide (Somatuline Depo), pasireotide (Signifor LAR) (Policy #118), Patisiran (Onpattro), (Policy #182), Omalizumab (Xolair) (Policy #025), Monoclonal Interleukin-5 Antagonists [mepolizumab (Nucala), reslizumab (Cinqair), and benralizumab (Fasenra)] (Policy #133) under the Drug Section.]
I. The administration of the infusion and injectable therapy referenced in this policy in a hospital outpatient setting is not considered medically necessary unless the below criteria are met:
A. Hospital outpatient administration of infusion or injectable therapy is considered medically necessary for up to 60-day period for members beginning a new treatment OR for members who are re-initiating a treatment after six months of no treatment, unless the member meets policy statement B below.
B. An outpatient infusion or injectable therapy service in a hospital outpatient setting is considered medically necessary for 6 months when all of the following are present:
1. Inherent complexity of the infusion such that it can be performed safely and effectively only by or under the supervision of physician; AND
2. Potential changes in the member's clinical condition are such that immediate access to specific services of a hospital setting, having emergency resuscitation equipment and personnel, and inpatient admission or intensive care is necessary. For example, the member is at significant risk of sudden life-threatening changes in medical status based on clinical conditions including but not limited to:
a. Intolerable fluid overload, including impaired or unstable renal function, or
b. History of anaphylaxis to prior infusion therapy with a related pharmacologic or biologic agent despite standard premedication, or
- Documentation (e.g. infusion records, medical records) of a severe or potentially life-threatening adverse event (e.g. anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following a previous infusion of the prescribed drug, and documentation showing the adverse event cannot be managed despite pre‐medication (e.g. acetaminophen, steroids, diphenhydramine, fluids) or infusion rate reductions in the home or office setting is provided
c. Acute mental status/cognitive changes or physical impairment AND no home caregiver available; or
d. Vascular access not stable/member has significant documented venous access issues; or
e. Documented clinical history of cardiopulmonary conditions that may cause an increased risk of severe adverse reactions (including but not limited to thromboembolism, hypotension, seizures, aseptic meningitis syndrome, anaphylaxis, acute respiratory distress, pulmonary edema, apnea and transfusion associated lung disease); or
f. The member does not have access to home infusion AND the hospital-outpatient center is 45 miles closer (no more than 60 minutes away) than the nearest office based provider who can provide that service.
OR
3. The prescribed medication has a site of administration restriction based on the FDA approved label.
II. All other reasons for administering the infusion and injectable therapy services referenced in this policy in a hospital outpatient setting are not considered medically necessary.
Under relevant New Jersey law, “Medical necessity” or “medically necessary” “means or describes a health care service that a health care provider, exercising his prudent clinical judgment, would provide to a covered person for the purpose of evaluating, diagnosing or treating an illness, injury, disease or its symptoms and that is in accordance with the “generally accepted standards of medical practice”; clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the covered person's illness, injury or disease; not primarily for the convenience of the covered person or the health care provider; and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that covered person's illness, injury or disease.” N.J. Stat. § 17B:30-50 [Emphasis added]. Section II is based in part on the assumption that receiving the infusion therapies covered by this Medical Policy in the hospital outpatient setting in the absence of the circumstances set forth in Sections IA and IB above will typically be more costly than if those services were received in the home or in a physician’s offices. As such, in the event that a given patient’s medical circumstances are found by Horizon BCBSNJ to not meet the criteria set forth in Sections IA or IB, but the cost for being provided those services in a particular hospital outpatient setting are found to be equal to or less than the costs for receiving those services at the patient’s home or in a physician’s office in the patient’s local, geographic area, Horizon BCBSNJ reserves the right to approve a request for coverage for the patient to receive those services in the particular hospital outpatient setting on a case by case basis.
In addition, Horizon BCBSNJ may use reasonable discretion in applying this policy to services provided outside the State of New Jersey.
Medicare Coverage
**Note this policy does not apply to Medicare Advantage Products.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies covered under the Medicare portion of the member’s benefit package, the above Medicaid; and (2) to the extent the service is not Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Site of Service for Administration for Infusion and Injectable Prescription Medications
Site of Administration for Infusion and Injectable Prescription Medications
Site of Care for Administration for Infusion and Injectable Prescription Medications
Infusion Prescription Medications, Site of Administration for
Injectable Prescription Medications, Site of Administration for
Prescription Medications, Site of Administration for Infusion and Injectable
References:
1. American Academy of Allergy, Asthma and Immunology. Guidelines for the site of care for administration of IVIG policy. Available at: http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/Guidelines-for-the-site-of-care-for-administration-of-IGIV-therapy.pdf. Accessed on July 21, 2016. Accessed on. July 27, 2016
2. MCGTMCare Guidelines, 18th edition, 2015. Home infusion therapy, CMT: CMT-009(SR). Accessed on. July 27, 2016
3. Rigas M, Tandan R, Sterling R. Safety of Liquid Intravenous Immunoglobulin for Neuroimmunologic Disorders in the Home Setting: A Retrospective Analysis of 1085 Infusions. J Clin Neuromusc Dis 2008; 10:52-55. Accessed on. July 27, 2016
4. National Home Infusion Association. About infusion therapy. Available at: http://www.nhia.org/about-home-infusion.cfm. Accessed on. July 27, 2016
5. Teuffel O, Ethier MC, Alibhai SM, et al. Outpatient management of cancer patients with febrile neutropenia: a systematic review and meta-analysis. Annals of Oncology. 2011; 22(11):2358-2365.
6. Centers for Medicare & Medicaid Services: Place of Service Code Set. http://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.html. Accessed June 20, 2017.
7. MCGTMCare Guidelines, 21st edition, 2017. Home infusion therapy, CMT: CMT-009(SR). Accessed on. January 23, 2018.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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