ALL of the following

• The drug is a prescription medication FDA-approved as evidenced by an NDA, ANDA, or BLA (or coverage is otherwise required by law or the member’s specific benefit contract).
• The prescribing provider has submitted any required documentation (e.g., diagnosis, prior treatments, supporting medical records) when the drug is subject to Utilization Management (UM) requirements such as Prior Authorization, Step Therapy, or Quantity Limits.

  Operational: documentation must support medical necessity for PA determinations.

• If the drug is a specialty medication, it is dispensed through the plan’s specialty pharmacy (Accredo) when required by the plan, and limited distribution requirements are followed.
• For drugs with available generic equivalents, coverage and member cost-sharing follow the plan’s generic substitution policy (mandatory, restricted, or voluntary) as applicable to the member’s benefit.
• Maintenance drug supply limits (30-day standard; up to 90-day for select maintenance drugs per plan design) and specialty drug 30-day limits apply.

• AND (specialty dispensing)

  • Specialty drugs are processed through the plan-designated specialty pharmacy (Accredo) when required.
  • Limited distribution specialty products must be obtained from approved dispensing pharmacies per manufacturer/plan restrictions.

Utilization Management applicability

• Prior Authorization (PA) may be required for specific drugs or indications; if required, the provider must obtain approval before the drug will be covered.

  PA requirements are indicated in the formulary where commonly applied.

• Step Therapy (ST) may apply — trial of specified preferred agents required before coverage of non-preferred products.

  Failure to document trials may result in denial without PA override.

• Quantity Limits (QL) may restrict the covered amount or dosing interval for certain agents (e.g., specialty drugs limited to 30-day supply).
• Nonformulary exception process is available when a provider deems a non-formulary FDA-approved drug medically necessary prior to P&T review; submit nonformulary exception/PA requests with supporting information.