Last Review Date: 08/13/2024

Date of Origin: 07/10/2020

1. Background

The Provider-Administered Drug Program includes a Mandatory Site of Service program, effective January 1, 2021, which requires members to use the most cost- effective, clinically- appropriate location to receive their infusion(s) of select specialty medications as listed in this policy.

2. Scope

1. 1. Applicable to all groups and individual health plans that participate in the Provider- Administered Drug Program, have home healthcare benefits, and the Mandatory Site of Service benefit.

1. 1. 1. New utilizers of these medications on or after January 1, 2021 will be subject to the program requirements.
      2. Members currently using these medications will be subject to the program requirements upon prior authorization renewal on or after January 1, 2021.

3. Program Requirements

1. 1. Impacted members will be identified through the existing Provider Administered Drug prior authorization program and/or through paid claims reporting for identification of current utilizers.

1. 2. All drugs in the Mandatory Site of Service Management require prior authorization for the drug requested to ensure medical necessity criteria is met. As part of this review, information concerning the intended place of treatment is obtained and additional criteria may be reviewed based on where the drug is to be administered.

1. 3. Members with approved drug prior authorizations and identified as receiving the select specialty drugs as listed in section IV in a hospital outpatient setting will be referred to Magellan Rx’s Infusion Referral Center (IRC) as a next internal step in the Site of Service process.

1. 4. The IRC will confirm that the following criteria are met in order for the member to be transitioned to an alternate place of treatment, such as a home infusion provider or infusion suite.

1. 5. When required, the home infusion provider will obtain all necessary nursing precertification as specified by the member’s benefits.

4. Exceptions

If it is determined that the administration of the injectable therapy in an outpatient setting is medically necessary, an exception to this site of service program can be made. Reviews to determine the medical necessity for the outpatient facility place of treatment can be performed during the prior authorization process or at any point during the assessment of the case. Documentation must be submitted to support any exceptions to the Mandatory Site of Service Policy.

1. 1. The administration of the infusion and injectable therapy referenced in this policy in a hospital outpatient setting may be considered medically necessary if the following criteria are met:

1. 1. 1. The administration of the infusion and injectable therapy referenced in this policy in a hospital outpatient setting may be considered medically necessary if the following criteria are met:
      2. An outpatient infusion or injectable therapy service in a hospital outpatient setting is considered medically necessary for the applicable validity period when any of the following are present:

1. 1. 1. 1. Potential changes in the member's clinical condition are such that immediate access to specific services of a hospital setting, having emergency resuscitation equipment and personnel, and inpatient admission or intensive care is necessary. For example, the member is at significant risk of sudden life-threatening changes in medical status based on clinical conditions including but not limited to:

1. 1. 1. 1. 1. The member has a higher risk of an adverse reaction due to a co-morbid condition (e.g., renal dysfunction, cardiopulmonary disease, physical/cognitive impairment) – documentation of co-morbid condition, potential adverse reaction, and clinical rationale all must be submitted; or
            2. The member has a history of anaphylaxis to prior infusion therapy with a prior infusion therapy with a related pharmacologic or biologic agent despite standard premedication – documentation of previous anaphylaxis reaction noted must be submitted; or
            3. The member has intolerable fluid overload, including impaired or unstable renal function; or

ci. The member has acute mental status/cognitive changes or physical impairment AND no home caregiver available; documentation of both factors required or cii. The member’s vascular access is not stable and member has significant, documented venous access issues; submission of documentation required or

cii. The member has documented clinical history of cardiopulmonary conditions that may cause an increased risk of severe adverse reactions (including but not limited to thromboembolism, hypotension, seizures, aseptic meningitis syndrome, anaphylaxis, acute respiratory distress, pulmonary edema, apnea and transfusion associated with lung disease) – documentation must be submitted; or

g. The member has received a bone marrow transplant (BMT) in the prior 6 months and requires enhanced medical supervision/monitoring at a specialized facility – documentation of the procedure/treatment must be submitted; or

h. The member does not have access to home infusion or in-network Ambulatory Infusion Suite AND the nearest office based provider who can provide the service