This is a CCW-derived field that indicates whether the prescription was subject to a step therapy protocol, according to the benefit structure and formulary for the beneficiary’s plan. If a product is part of two different step therapy protocols, this field is populated with the maximum step value for the product. If the value is greater than 1, then the beneficiary’s plan imposed some type of step therapy requirement, and the value indicates the number of steps or therapy trials needed before becoming eligible for the current drug.
Starting in 2010, this variable is included in the Formulary file (rather than the PDE file).
Part D plan sponsors submit the pricing, tiers, and formularies for their plan benefit packages to CMS via the Health Plan Management System (HPMS).
This includes information on which drugs are subject to step therapy, which requires a beneficiary to first try one or more other medications in the same therapeutic class. The CCW creates this variable based on the beneficiary’s plan of record, which is identified using the Part D contract and plan benefit package of record (the PLAN_CNTRCT_REC_ID and PLAN_PBP_REC_NUM variables). For a small number of beneficiaries, particularly those who changed plans around the time of the fill, the variable may not be an accurate reflection of whether the PDE was part of a step therapy protocol.
Source: PDE and Plan Characteristics (derived)
1-4 = The maximum step on the plan's formulary associated with the drug on the PDE.