The Plan members may be eligible for medication infusions or injections to treat acute and chronic conditions.

These infusions/injections can be delivered in several different settings, including inpatient hospitals, outpatient hospitals, infusion centers, and the home or office. The site of care for the medication delivery depends on a number of factors, such as the results of previous infusions, the medication(s) being used, and the member’s other medical conditions. This guideline provides guidance for selecting the appropriate site of care for infusion or injection, but it does not determine the clinical coverage of the selected medications.

NOTE: The Plan may require the use of preferred medications as a first-line treatment. For a comprehensive list of preferred and non-preferred drugs, please refer to the Plan Clinical Guideline - Commercial Preferred Physician-Administered Specialty Drugs (CG052).

Definitions

Inpatient hospital is a traditional hospital setting where patients with acute medication conditions are typically managed. An inpatient hospital may have several care settings within, including intensive care units.

Outpatient hospital facility is similar to an inpatient medical center and may be the same physical location, but the service is provided in an outpatient setting, meaning that the patient is not admitted to the hospital for care. In these cases, the patient will usually leave the same day as they arrive. This care setting may be used for certain procedures, same day surgeries, or infusions of certain medications or chemotherapy agents.

Non-hospital outpatient facility (e.g., infusion center) is an outpatient setting that is not hospital- based. Non-hospital based outpatient facilities can be freestanding infusion centers, dialysis locations, or even physician offices. Infusions or injections of medications, simple procedures, and standard office visits may be conducted in this care setting.

Home refers to using the non-healthcare location that the patient resides as the site of care. Medical support staff including physicians, nurses, and other skilled healthcare workers may visit the patient at their home to deliver infusions, injections, and other specialized care. Patients may also be instructed on how to perform their own injections/infusions in the home care setting.

State Law Conflicts

For any provision of this policy that directly conflicts with or is prohibited by state law, the provisions of the state law will apply instead of the provisions of this policy. This means that in instances where state regulations diverge from or directly oppose the Site-of-Service (Site-of-Care) (Infusion Therapy & Physician-Administered Drugs) (CG046) Medical Necessity Criteria for Authorization or requirements, the policy's criteria will not apply.

Clinical Indications

Medical Necessity Criteria for Authorization

The Plan considers the infusion or injection of medications in the outpatient hospital facility setting medically necessary for members meeting ANY one of the following criteria:

1. Member is receiving the first infusion/injection of the requested medication; or
2. Member is resuming therapy after a period of 6 months or longer since the previous infusion/injection since the previous infusion/injection; or
3. Member experienced a severe and/or life-threatening adverse event attributed to a previous infusion/injection that cannot be safely managed through pre-medication or other preventive care in an alternative setting (i.e., the home, office, or non-hospital outpatient setting); or
4. Member is considered a poor candidate for other care settings due to ANY of the following:
   • comorbid conditions that may create an unsafe setting for home or office infusion (e.g., dementia, active drug abuse); or
   • documented comorbidities that increase the risk of serious adverse events; or
   • poor or unreliable vascular access; or
   • medical instability; or
   • need for continued close observation or daily nursing care;

The member’s overall medical condition or the specific medication(s) being infused require specialized monitoring that may not be available or appropriate for alternative settings such as:

1. Pediatric members (up to 18 years of age) who may require special monitoring; or
2. Members actively receiving a chemotherapy regimen at the hospital which might be disrupted when moved to an alternative site.

If the above prior authorization criteria are met, administration of the requested product by infusion or injection in the outpatient hospital facility setting will be authorized for an initial period of up to 6-months.

When the above criteria for outpatient hospital facility infusion/injection are NOT met, the member should be directed to an alternative site of care within access standards for medication delivery, such as the home or a non-hospital outpatient facility. Coverage is not authorized for administration of medications in an outpatient hospital facility infusion center if the above medical necessity criteria are not met.

Please note the following:

• Infusions for medications in-scope for this policy will not be covered when administered in a hospital outpatient infusion center if the above criteria for outpatient hospital facility infusion/injection are not met.
• Home infusion services are separate from the Home Health Care coverage/benefit and do not have the same limitations or requirements.
  • Home infusions provided by preferred home infusion providers or in a professional office setting will not count toward the Plan’s limit for Home Health Care services.
  • Members receiving home infusion services are not required to meet the home-bound status criteria applicable to Home Health Care services (e.g., Home Care - Skilled Nursing Care (RN, LVN/LPN) (CG020)). Home Health Care coverage/benefit specifically covers part-time or intermittent care provided by a Home Health Agency, while home infusions can be delivered by medical support staff, including physicians, nurses, and other skilled healthcare workers.