Site of Service program for infused specialty medications
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Defines Medica's Site of Service program directing members to the most cost-effective, clinically appropriate locations (e.g., home infusion or physician office) for select infused specialty medications and governs prior authorization and exceptions for applicable Commercial and Individual memberships.
No material clinical or coverage changes in this revision.
Site of Service Coverage Criteria
Site of Service coverage criteria
Covered with criteria and prior authorization; temporary medical necessity waivers available.
Temporary transition/waiver
- Site of Service program requirements will be waived for 60-90 days to allow members beginning a new treatment or initial continuation review to transition to an alternate infusion site; this temporary approval is granted via the prior authorization process.
Longer-term medical necessity exceptions (case-by-case)
- Hospital outpatient administration may be considered medically necessary when potential changes in the member's clinical condition require immediate access to hospital services (e.g., need for emergency resuscitation equipment/personnel, potential for inpatient admission or intensive care).
- History of anaphylaxis to prior infusion therapy with a related agent despite standard premedication.
- Unstable or not intact vascular access that prevents safe administration outside the hospital.
- Documented cardiopulmonary conditions or other clinical history that increase risk of severe adverse reactions (examples include thromboembolism, hypotension, seizures, aseptic meningitis syndrome, anaphylaxis, acute respiratory distress, pulmonary edema, apnea, transfusion-associated lung injury).
- Lack of access to home infusion services and travel to the nearest office-based provider exceeds travel to the currently servicing hospital outpatient facility.
- Age-based considerations (member is younger than 18 or older than 64) or other member-specific reasons documented by the provider (e.g., caregiver availability, exposure concerns) that justify hospital outpatient administration.
Infused Specialty Medication Codes in Scope
Provider Requirements and Exceptions
Prior Authorization Required
Prior authorization is required for all drugs in the Site of Service program. Submit prior authorization requests at gatewayPA.com — select Providers and use the Access Request - Provider workflow if this is your first time. To avoid delays in care, program requirements may be temporarily waived for a 60–90 day transition period following prior authorization approval to allow members to move to an alternate infusion site.
- All Site of Service drugs require prior authorization
- Submit requests at gatewayPA.com (Providers -> Access Request - Provider for first-time users)
- Temporary waiver of site requirements for 60–90 days after prior authorization approval to permit transition
Exceptions and Medical Necessity Review
Exceptions to the Site of Service program are reviewed via prior authorization and may be granted on a case-by-case medical necessity basis. Hospital outpatient administration of infusion or injectable therapy is generally not considered medically necessary unless one of the following applies: a medically necessary 60–90 day period for members beginning a new treatment or at initial review of continuation of therapy; or documented clinical indications that require hospital-level services, emergency resuscitation capability, or immediate inpatient admission/ICU availability.
- Exceptions reviewed through prior authorization on a case-by-case medical necessity basis
- Hospital outpatient administration may be authorized for up to 60–90 days for new treatment starts or initial continuation review
- Hospital outpatient administration may be authorized when there is risk of sudden life‑threatening change requiring hospital services (examples include: intolerable fluid overload or unstable renal function; acute mental status/cognitive changes or physical impairment with no home caregiver; history of anaphylaxis to prior infusion despite premedication; unstable vascular access; documented cardiopulmonary conditions that increase risk of severe adverse reactions)
- Authorization may be considered when the member lacks access to home infusion and the nearest office-based provider exceeds travel distance to the current hospital outpatient site
- Age-based considerations may apply (e.g., members <18 or >64) and other individual member circumstances may be considered during review
Key Definitions
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