Mandatory Site of Service Management Policy
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial site-of-service coverage criteria
Covered when ALL of the following are met
New utilizers on or after 2021-01-01 and current utilizers at prior authorization renewal on or after 2021-01-01 are subject
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 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
Examples provided in policy; documentation must be submitted
Documentation of the co-morbid condition, potential adverse reaction, and clinical rationale must be submitted
Documentation of the prior anaphylactic reaction must be submitted
Documentation required
Both factors must be documented
Submission of documentation required
Documentation of the procedure/treatment must be submitted
Documentation of access and travel distance must be submitted
Requires written documentation; next site of care would be provider office
Select infused specialty medications included in the Site of Service program are subject to change. The policy list may be updated to add currently available infused specialty medications; prescribers will be notified in advance per provider contract terms. Specific exclusions or drugs not listed are outside the scope of this policy unless formally added to the program.
Drugs and Codes in Scope
| 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 |
| 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 |
| 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 |
Provider Actions & Requirements
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.
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.
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.
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
Initial Therapy / Site-of-Service Requirements
Initial therapy/site-of-service requirement
Initial and new utilizers
Program effective date January 1, 2021; current users become subject upon prior authorization renewal on or after that date
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
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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