Currentblue cross blue shield - alabamaPolicy PH-90001

Mandatory Site of Service Management Policy

Governs site-of-care requirements and prior authorization for select provider-administered infused specialty medications for Blue Cross Blue Shield - Alabama members participating in the Provider‑Administered Drug Program; affects providers ordering/administrating the listed infused specialty drugs.

Policy Summary

Payerblue cross blue shield - alabama

PolicyMandatory Site of Service Management Policy

Policy CodePolicy PH-90001

Change TypeNo material change

Effective DateJan 1, 2021

Next Review Date

Key ActionObtain prior authorization and document intended place of treatment for all drugs in the Mandatory Site of Service program.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2021-01-01program effective date

08/13/2024last review

multiplelisted infused specialty drug codes

Coverage Criteria

Initial site-of-service coverage criteria

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Program applicability: Member is in a group or individual plan participating in the Provider-Administered Drug Program with Mandatory Site of Service and has home healthcare benefits

New utilizers on or after 2021-01-01 and current utilizers at prior authorization renewal on or after 2021-01-01 are subject

Prior authorization is obtained for the requested drug and the intended place of treatment is documented

All drugs in the Mandatory Site of Service Management require prior authorization; additional criteria may be reviewed based on administration site; members identified as receiving listed drugs in a hospital outpatient setting will be referred to Prime Therapeutics' Infusion Referral Center (IRC)

IRC assessment and transition: If member is receiving a listed specialty drug in a hospital outpatient setting, IRC referral occurs to determine whether transition to an alternate site of care (home infusion or infusion suite) is appropriate

IRC will confirm criteria for transition and home infusion providers will obtain necessary nursing precertifications when required

Exceptions (hospital outpatient medically necessary)

Administration in a hospital outpatient setting may be considered medically necessary if ANY of the following exception conditions are met and documented

Immediate need for hospital-level services: Potential changes in clinical condition require immediate access to hospital services (emergency resuscitation equipment and personnel, inpatient admission or intensive care) due to risk of sudden life‑threatening changes

Examples provided in policy; documentation must be submitted

Higher risk for adverse reaction from co-morbid conditions: Member has co-morbid conditions (e.g., renal dysfunction, cardiopulmonary disease, physical/cognitive impairment) that increase risk of adverse reaction

Documentation of the co-morbid condition, potential adverse reaction, and clinical rationale must be submitted

History of anaphylaxis to related infusion therapy: Prior anaphylaxis to infusion therapy with a related pharmacologic or biologic agent despite standard premedication

Documentation of the prior anaphylactic reaction must be submitted

Intolerable fluid overload or unstable renal function: Member has intolerable fluid overload, including impaired or unstable renal function

Documentation required

No home caregiver with acute impairment: Acute mental status or cognitive changes or physical impairment AND no home caregiver available

Both factors must be documented

Unstable vascular access: Vascular access is not stable with significant documented venous access issues

Submission of documentation required

Recent bone marrow transplant: Member received a bone marrow transplant within the prior 6 months and requires enhanced monitoring at a specialized facility

Documentation of the procedure/treatment must be submitted

Lack of access to home or in-network infusion: No access to home infusion or in-network Ambulatory Infusion Suite AND nearest office-based provider exceeds travel distance to the current hospital outpatient center

Documentation of access and travel distance must be submitted

Unsafe home environment: Home is deemed unsafe for infusion (e.g., excessive pets, aggressive animals)

Requires written documentation; next site of care would be provider office

Drugs and Codes in Scope

Drugs in scope (group 1)HCPCSCovered

J3262	ACTEMRA / tocilizumab
J0791	ADAKVEO / crizanlizumab-tmca
J1931	ALDURAZYME / laronidase
J1554	ASCENIV / intravenous immune globulin
Q5121	AVSOLA / infliximab-axxq
J0490	BENLYSTA / belimumab
J0597	BERINERT / C1 esterase inhibitor
J1556	BIVIGAM / intravenous immune globulin
J1786	CEREZYME / imiglucerase
J0717	CIMZIA / certolizumab pegol

1–10 of 20

1/2

Drugs in scope (group 2)HCPCSCovered

J1569	GAMMAGARD LIQUID / intravenous immune globulin
J1566	GAMMAGARD S/D, CARIMUNE NF / intravenous immune globulin
J1561	GAMMAKED / intravenous immune globulin
J1557	GAMMAPLEX / intravenous immune globulin
J1561	GAMUNEX / intravenous immune globulin
J1599	IMMUNE GLOBULIN / intravenous immune globulin
Q5103	INFLECTRA / infliximab-dyyb
J2840	KANUMA / sebelipase alfa
J0221	LUMIZYME / alglucosidase alfa
J1458	NAGLAZYME / galsulfase

1–10 of 20

1/2

Drugs in scope (group 3)HCPCSCovered

Q5104	RENFLEXIS / infliximab-abda
J9312	RITUXAN (non-oncology diagnosis only) / rituximab
Q5119	RUXIENCE (non-oncology diagnosis only) / rituximab-pvvr
J1299	SOLIRIS / eculizumab
J3241	STELARA = TEPEZZA / teprotumumab-trbw
J2356	STELARA = TEZSPIRE / tezepelumab-ekko
J1746	STELARA = TROGARZO / ibalizumab-uiyk
Q5115	STELARA = TRUXIMA (non-oncology diagnosis only) / rituximab-abbs
J2323	STELARA = TYSABRI / natalizumab
J1303	STELARA = ULTOMIRIS / ravulizumab-cwvz

1–10 of 13

1/2

Program effective / new utilizer date

Program effective dateProgram effective January 1, 2021; applies to members initiating listed medications on or after 2021-01-01.

New utilizer applicabilityNew utilizers of listed medications on or after 2021-01-01 are subject to the Mandatory Site of Service program.

Current utilizer applicabilityMembers currently using listed medications become subject to the program upon prior authorization renewal on or after 2021-01-01.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

All drugs in the Mandatory Site of Service Management require prior authorization. As part of the prior authorization review, information about the intended place of treatment will be obtained and additional criteria may be reviewed based on where the drug will be administered. Failure to obtain required prior authorization or failure to provide necessary documentation may result in denial of coverage.

Prior authorization required for all drugs in the Mandatory Site of Service program.
Intended place of treatment will be collected during prior authorization review.
Additional criteria may be applied depending on the planned site of administration.

Note

Site-of-Service Referral Process

Members identified as receiving listed specialty drugs in a hospital outpatient setting will be referred to Prime Therapeutics' Infusion Referral Center (IRC). The IRC will review the case and confirm whether the member can be transitioned to an alternate place of treatment (e.g., home infusion provider or infusion suite). When transition is required, the selected home infusion provider must obtain any necessary nursing precertifications as specified by the member's benefits.

Referral to Prime Therapeutics' Infusion Referral Center for members receiving select specialty drugs in a hospital outpatient setting.
IRC confirms eligibility for transition to home infusion or infusion suite.
Home infusion provider responsible for nursing precertifications when required.

Documentation Required

Exception Documentation Requirements

Documentation supporting medical necessity is required to support exceptions to the Mandatory Site of Service Policy when outpatient/hospital administration is requested. Submit clear clinical rationale and relevant supporting evidence at the time of prior authorization or during case assessment. Missing or insufficient documentation may lead to denial of the exception request.

Clinical rationale explaining why outpatient/hospital administration is medically necessary.
Documentation of co-morbid conditions and how they increase risk of adverse reaction (e.g., renal dysfunction, cardiopulmonary disease).
Records documenting prior anaphylaxis or severe reaction to related infusion therapy, if applicable.
Evidence of intolerable fluid overload or unstable renal function, if applicable.
Documentation of acute mental status/cognitive changes or physical impairment and lack of home caregiver, when claimed.
Evidence of unstable vascular access or significant venous access issues.
Clinical history of cardiopulmonary conditions that increase risk of severe adverse reactions.
Documentation of bone marrow transplant within prior 6 months, when applicable.
Proof that member lacks access to home infusion or in-network ambulatory infusion suite and that travel to the nearest office-based provider exceeds travel to the hospital outpatient center.
Documentation that the home environment is unsafe for infusion (e.g., excessive pets, unsafe conditions) with justification for office-based administration.

Denial Risk

Prior Authorization Requirement and Potential Denial

Prior authorization is required for all drugs in the Mandatory Site of Service program. If prior authorization is not obtained or required exception documentation is not submitted, the authorization request or claim may be denied.

All drugs in the Mandatory Site of Service program require prior authorization — denials possible if not obtained.
Exception reviews may occur during prior authorization or at any point during case assessment; timely submission of documentation is required.

Background

The purpose of the Mandatory Site of Service program is to ensure infusions of select specialty medications occur in the most cost‑effective, clinically appropriate location. The program directs members receiving listed provider‑administered infused specialty drugs toward alternative sites of care (for example, home infusion or infusion centers) when appropriate, while allowing hospital outpatient administration only when medically necessary and documented. Changes to the list of drugs included in the program may occur; prescribers will receive advance notification as specified in provider contracts.

Definitions

Mandatory Site of Service program — definition

Program definitionA component of the Provider‑Administered Drug Program that directs members to use the most cost‑effective, clinically appropriate infusion setting for select specialty medications and requires prior authorization for listed drugs.

Primary goalEnsure infusion occurs in the most cost‑effective, clinically appropriate location (e.g., home or infusion center vs hospital outpatient) when clinically appropriate.

Prior authorization requirementPrior authorization is required for drugs in the Mandatory Site of Service program and will document intended place of treatment; referrals may be made during PA processing.

Referral processMembers receiving listed specialty drugs in a hospital outpatient setting will be referred to an Infusion Referral Center to assess transition to home infusion or an infusion suite when appropriate.

Step Therapy

Step	Requirement	Provider action
1	Members identified as receiving listed specialty drugs in a hospital outpatient setting will be referred to Prime Therapeutics' Infusion Referral Center (IRC)	Document intended place of treatment during prior authorization; cooperate with IRC referral and provide clinical information as requested to support transition to an alternate site (home infusion or infusion suite).
2	IRC will assess whether criteria are met to transition the member to an alternate place of treatment (e.g., home infusion provider or infusion suite)	Provide timely clinical documentation and any required nursing precertifications to the designated home infusion provider when transition is approved.

Site of Care Rules

Note

Use the most cost‑effective, clinically appropriate infusion site

Members must receive infusion therapy at the most cost‑effective, clinically appropriate location; hospital outpatient administrations will be referred to the IRC for evaluation of transition to home infusion or an infusion suite when appropriate.

Program effective date: members initiating medications on or after 2021-01-01 are subject to the requirement; current users are subject at PA renewal on/after that date.

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