| Coverage Policy Manual | |
| Policy #: | 2018030 |
| Category: | Pharmacy |
| Initiated: | December 2018 |
| Last Review: | December 2023 |
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| Site of Care or Site of Service Review | |
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| Description: |
Many pharmacologic and biologic agents infused historically in a facility (hospital, outpatient hospital, or associated infusion center) setting have been evaluated and determined to be safe for use in a non-hospital infusion center and through home infusion services. These alternative settings offer quality services that are often more convenient and less costly to the member and payer as compared to hospital-based services without impeding efficacy or safety.
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Policy/ Coverage: |
EFFECTIVE December 2022
This policy is for determination of whether the site of care (e.g., site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL the following:
Sites of care (sites of service) include the following: in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices, and home-based setting (including approved nursing home).
Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. A frequently updated list will be maintained on the Plan’s website.
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
EFFECTIVE November 2021 November 2022
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
Sites of care (sites of service) include the following: in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices, and home-based setting (including approved nursing home).
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. A frequently updated list will be maintained on the Plan’s website.
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
MEDICATIONS SUBJECT TO THIS POLICY:
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
EFFECTIVE December 2020 to October 2021
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
Sites of care (sites of service) include the following: in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices, and home-based setting (including approved nursing home).
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. A frequently updated list will be maintained on the Plan’s website.
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
MEDICATIONS SUBJECT TO THIS POLICY:
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
EFFECTIVE JANUARY 1, 2019 to November 2020
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
Sites of care (sites of service) include the following: in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices, and home-based setting (including approved nursing home).
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. A frequently updated list will be maintained on the Plan’s website.
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
MEDICATIONS SUBJECT TO THIS POLICY:
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
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| Rationale: |
Evidence for effectiveness and safety includes a review by Polinski et al., which included 13 relevant studies identified through MEDLINE, EMBASE and Science Citation index search, concluded that patients receiving home infusions were no more likely to experience adverse drug events or side effects (all p >0.05). Patients overwhelmingly preferred receiving infusion at home rather than in a health care facility. The review also showed that home infusion is well suited to medication delivery in clinical areas such as neurology, oncology, hematology, rheumatology and gastroenterology.
In a trial evaluating patients with paroxysmal nocturnal hemoglobinuria, after initial 2-5 doses of eculizumab (Soliris), 79 patients received continued infusion with every 14 days in the home setting for the duration of the study – 1-98 months, mean duration of 39 months. The survival of patients treated with eculizumab was not different from age- and sex-matched normal controls (P = .46) but was significantly better than 30 similar patients managed before eculizumab (P = .030). Three patients on eculizumab, all over 50 years old, died of causes unrelated to PNH. Twenty-one patients (27%) had a thrombosis before starting eculizumab (5.6 events per 100 patient-years) compared with 2 thromboses on eculizumab (0.8 events per 100 patient-years; P < .001). Twenty-one patients with no previous thrombosis discontinued warfarin on eculizumab with no thrombotic sequelae. Forty of 61 (66%) patients on eculizumab for more than 12 months achieved transfusion independence. The 12-month mean transfusion requirement reduced from 19.3 units before eculizumab to 5.0 units in the most recent 12 months on eculizumab (P < .001). Eculizumab dramatically alters the natural course of PNH, reducing symptoms and disease complications as well as improving survival to a similar level to that of the general population.
2019 Update
Annual policy review completed.
2020 Update
Annual policy review completed.
2021 Update
Annual policy review completed.
2022 Update
Annual policy review completed.
2023 Update
Annual policy review completed.
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| CPT/HCPCS: | |
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| References: |
1) Polinski JM, Kowal MK, Gagnon M, et al.(2016) Home infusion: safe clinically effective, patient preferred, and cost saving. Healthcare. 2016. 2) Kelly RJ, Hill A, Arnold LM, et al.(2011) Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood. 2011;117(25):6786-92. American Academy of Allergy Asthma and Immunology.(2011) Guidelines for the site of care for administration of IGIV therapy. December 2011. Available at:http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/Guidelines-for-thesite-of-care-for-administration-of-IGIV-therapy.pdf. Basch E, Hesketh PJ, Kris MG, et al.(2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Onc. 2011; 29(31):4189-4198. Chataway J, Porter B, Riazi A, et al.(2006) Home versus outpatient administration of intravenous steroids for multiplesclerosis relapses: a randomized controlled trial. Lancet Neurol. 2006; 5(7):565-571. Gutierrez-Aguirre CH, Ruiz-Arguelles G, Cantu-Rodriguez OG, et al.(2010) Outpatient reduced-intensity allogeneic stem cell transplantation for patients with refractory or relapsed lymphomas compared with autologous stem cell transplantation using a simplified method. Annals of Hematology 2010; 89(10):1045-1052. Mank A, van der Lelie J, de Vos R, Kersten MJ.(2011) Safe early discharge for patients undergoing high dose chemotherapy with or without stem cell transplantation: a prospective analysis of clinical variables predictive for complications after treatment. Journal of Clinical Nursing 2011; 20(3-4):388-395. Milligan A, Hughes D, Goodwin S, et al.(2006) Intravenous enzyme replacement therapy: better in home or hospital? Br J Nurs. 2006; 15(6):330-333. NCCN Clinical Practice Guidelines in Oncology®.(2017) © 2018 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Antiemesis (V.2.2018). Revised April 30, 2018. Prevention and Treatment of Cancer-Related Infections. (V.1.2018) Revised December 1, 2017. Riazi A, Porter B, Chataway J, et al.(2011) A tool to measure the attributes of receiving IV therapy in a home versus hospital setting: the Multiple Sclerosis Relapse management Scale (MSRMS). Health Qual Life Outcomes. 2011;9:80. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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