Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Site of Care or Site of Service Review

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.

Policy/
Coverage:

Effective February 15, 2026

The site of care or site of service policy only applies to Plans who have a Medical Pharmacy Mandatory Site of Care requirement.

This policy is for determination of whether the non-preferred site of care (e.g., site of service) meets Primary Coverage as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without Primary Coverage Criteria for the infusion and/or injection of the planned pharmacologic/biologic agent.

An infused and/or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the pharmacologic/biologic agent. Physician’s office, standalone infusion center, or home infusion are the least intensive, most cost-effective settings and are the preferred sites of service for the pharmacologic/biologic agents subject to this policy.

A hospital-based outpatient infusion department or hospital-based outpatient clinical level of care is non-preferred for the pharmacologic/biologic agents subject to this policy. Administration of pharmacologic/biologic agents subject to this policy at a hospital-based outpatient infusion department or hospital-based outpatient clinical level of care meets Primary Coverage Criteria when one of the following are met:

1. Individual is within first 90 days of therapy for the following:

a. The initial course of infusion or injection of a medication

b. Re-initiation of a medication after 6 months or longer following discontinuation of therapy; OR

2. Individual’s primary residence is not within 30 miles of an in-network stand-alone infusion center and there is no in-network home infusion provider available to the individual; OR

3. Individual’s clinical condition increases risk of complications for infusion or injections, including any of the following:

a. History of a prior serious adverse event with the administered pharmacologic/biologic agent or similar agent; OR

b. Deemed medically unstable as demonstrated in clinical records (e.g., subject to volume overload in the situation of large infusions); OR

c. Continuing serious adverse events not mitigated by other interventions (e.g., premedication, altered infusion rate, etc.); OR

d. Problems with vascular access requiring a more intensive level of care (e.g. children less than 13 years old).

For medications subject to this policy, see policy guidelines.

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 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

POLICY GUIDELINES

MEDICATIONS SUBJECT TO THIS POLICY:

The following is a list of pharmacologic and biologic agents that are subject to this policy. Please also refer to any specific Coverage Policy for additional specific coverage criteria for each pharmacologic and biologic agent.

Brand Name Generic Name HCPCS

Actemra IV Tocilizumab IV J3262

Adakveo Crizanlizumab-tcma J0791

Aldurazyme Laronidase J1931

Amvuttra Vutrisiran J0225

Aralast NP Alpha-1 proteinase inhibitor (human) J0256

Arcalyst Rilonacept J2793

Avsola Infliximab-axxq Q5121

Avtozma Tocilzumab-anoh Q5156

Benlysta IV Belimumab IV J0490

Berinert C1 Esterase, Inhib, Human J0597

Bkemv Eculizumab-aeeb Q5152

Briumvi Ublituximab-siiy J2329

Cimzia Certolizumab pego J0717

Cinqair Reslizumab J2786

Cinryze C1 Esterase, Inhib, Human J0598

Cosentyx IV Secukinumab IV J3247

Crysvita Burosumab - twza J0584

Duopa Levodopa-carpidopa intestinal gel J7340

Elaprase Idursulfase J1743

Elelyso Taliglucerase alfa J3060

Elfabrio Pegunigalsidase alfa-iwxj J2508

Enjaymo Sutimlimab-jome J1302

Entyvio Vedolizumab IV J3380

Epysqli Eculizumab-aagh Q5151

Erzofri Paliperidone palmitate J2428

Evenity Romosozumab-aqqg J3111

Evkeeza Evinacumab-dgnb J1305

Fabrazyme Agalsidase beta J0180

Flolan Epoprostenol J1325

Gamifant Emapalumab-Izsg J9210

Givlaari Givosiran J0223

Glassia Alpha-1 proteinase inhibitors J0257

Ilaris Canakinumab J0638

Ilumya Tildrakizumab-asmn J3245

Imuldosa Ustekinumab-srlf Q5098

Inflectra Infliximab-dyyb Q5103

Invega Sustenna Paliperidone palmitate J2426

Invega Trinza Paliperidone palmitate J2427

Ixifi Infliximab-qbtx Q5109

Kanuma Sebelipase alfa J2840

Kisunla Donanemab-azbt J0175

Krystexxa Pegloticase J2507

Lamzede Velmanase alfa-tycv J0217

Lanreotide Cipla J1932

Leqvio Inclisiran J1306

Lumizyme Alglucosidase alfa J0221

Mepsevii Vestronidase-alfa J3397

Naglazyme Galsulfase J1458

Nexviazyme Avalglucosidase alfa-ngpt J0219

Ocrevus Ocrelizumab J2350

Ocrevus Zunovo Ocrelizumab and hyaluronidase-ocsq J2351

Onpattro Patisiran J0222

Orencia Abatacept J0129

Otulfi IV and SC Ustekinumab-aauz Q9999

Oxlumo Lumasirian J0224

Pombiliti Cipaglucosidase alfa-atga J1203

Prolastin Alpha-1 proteinase inhibitor human J0256

Pyzchiva IV Ustekinumab-ttwe Q9997

Pyzchiva IV Ustekinumab-ttwe Q9996

Radicava Edaravone IV J1301

Reblozyl Luspatercept-aamt J0896

Relizorb Digestive enzyme cartridge B4105

Remicade and Unbranded Infliximab Infliximab J1745

Remodulin Treprostinil IV J3285

Renflexis Infliximab-abda Q5104

Revatio Sildenafil (IV) J3490

Rivfloza Nedosiran J3490

Rystiggo Rozanolixizumab-nol J9333

Saphnelo Anifrolumab-fnia J0491

Selarsdi Ustekinumab-aekn Q9998

Simponi Aria Golimumab J1602

Skyrizi IV Risankizumab-rzaa IV J2327

Vyjuvek Beremagene geperpavec-svdt J3401

Soliris Eculizumab J1299

Somatuline depot Lanreotide J1930

Stelara IV Ustekinumab J3358

Stelara SC Ustekinumab J3357

Steqeyma IV and SC Ustekinumab-stba Q5099

Tepezza Teprotumumab J3241

Tofidence Tocilizumab-bavi Q5133

Tremfya IV Guselkumab IV J1628

Tyenne IV Tocilizumab- aaqg IV Q5135

Ultomiris Ravulizumab-cwyz J1303

Uplizna Inebilizumab-cdon J1823

Uptravi IV Selexipag IV J3490

Veletri Epoprostenol J1325

Veopoz Pozelimab-bbfg J9376

Viltepso Vitolarsen J1427

Vimizim Elosulfase alfa J1322

Vyepti Eptinezmab-jjmr J3032

Vyvgart Efgartigimod alfa-fcab J9332

Vyvgart Hytrulo Efgartigimod alfa and hyaluronidase-qvfc J9334

Wezlana IV Ustekinumab-auub Q5138

Wezlana SC Ustekinumab-auub Q5137

Xenpozyme Olipudase alfa-rpcp J0218

Ycanth Cantharidin J7354

Yesintek IV and SC Ustekinumab-kfce Q5100

Zemaira Alpha-1 proteinase inhibitor (human) J0256

Effective December 2022 to February 14, 2025

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:

The administered pharmacologic/biologic agent must meet primary coverage criteria as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without primary coverage criteria AND must meet any applicable Arkansas Blue Cross Blue Shield coverage policy AND must not be an exclusion in the member benefit certificate of coverage; AND
The administered pharmacologic/biologic agent must NOT have a site-of-service restriction per FDA labeling; AND
The member receiving the administered pharmacologic/biologic agent must NOT have any of the following:

a. History of a prior serious adverse event with the agent necessitating a more intensive level of care during or after the infusion/injection of the agent; OR

b. Deemed medically unstable as demonstrated in clinical records (e.g., subject to volume overload in the situation of large infusions); OR

c. Continuing serious adverse events not mitigated by other interventions (e.g., premedication, altered infusion rate, etc.), OR

d. Problems with vascular access requiring a more intensive level of care (e.g. children < 13 years old); OR

e. Absence of caretaker or absence of alternative levels of service.

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.

Due to the detail of the policy statement, the document containing the coverage statements for dates prior to December 2022 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com

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