Prior Authorization for Infusion Drugs Based on Site of Service

March 1, 2018

Beginning June 1, 2018, you’ll need to request prior authorization for certain infusion medications. The prior authorization will be for medical necessity to ensure use is for FDA-approved indications as well as for site of service administration.

Why are we making this change?

Our goal is to cover infusion in the most appropriate, safe, and cost effective locale for each patient. Unless medically necessary in a hospital outpatient setting, the preferred infusion sites are an infusion suite, a physician's office, or in the patient's home by a home infusion agency.

What can you expect?

These drugs require prior authorization review for medical necessity and will also require site of service review. We’ll complete the site of service prior authorization when you submit your prior authorization request for medical necessity.

The following drugs will require prior authorization for site of service:

• As noted above, these drugs will have clinical prior authorization added to ensure use is for FDA-approved indications. Exondys 51 already has this prior authorization requirement.
• The clinical prior authorization criteria apply to all patients, according to medical policy criteria. The infusion site-of-service criteria applies to patients 13 years of age and older.

When is infusion in a hospital-based outpatient setting considered medically necessary?

Infusion in a hospital-based outpatient setting may be considered medically necessary only when:

• The patient has a clinical condition that puts him or her at increased risk of complications for infusions, including any of the following:
  • Known cardiac or pulmonary conditions that increase the risk of an adverse reaction
  • Unstable renal function which decreases the ability to respond to fluids
  • Difficult or unstable vascular access
  • Acute mental status changes or cognitive conditions that impact the safety of infusion therapy
• For the first 90 days to cover:
  • The initial course of infusion of a pharmacologic or biologic agent
  • Re-initiation of an agent after 6 months or longer of non-use
• The patient has a known history of severe adverse drug reactions and/or anaphylaxis to prior treatment with a related or similar drug
• Access to care

There’s no outpatient infusion center within 50 miles of the patient’s home and there’s no contracted home infusion agency that will travel to the home, or a hospital is the only place that offers infusions of the drug.

See our Medical Policy and Coding Updates page, Pharmacy policies section for additional information.

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