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Since the Centers for Medicare & Medicaid Services (CMS) codified the use of step therapy (ST) for Medicare Part B drugs in 2019, this and other forms of utilization management have been increasingly used by health plans, including Medicare Advantage (MA) plans. The stated intent of ST is to guide prescribing decisions toward cost-effective, evidence-based therapies. Avalere Health recently surveyed 300 healthcare providers to better understand their real-world experiences with ST protocols, particularly as they apply to physician-administered therapies.

We found that ST is widely used by MA plans, although many providers reported administrative demands and challenges in aligning utilization management decisions with clinical judgment. Respondents identified delays in patient access and adjustments to practice operations as recurring issues. These findings indicate an opportunity for further refinement of ST policy implementation to balance cost containment, clinical efficacy, and patient-centered care.

Key Findings

Trends in Part B Step Therapy Utilization: Among providers that had experience managing Part B ST protocols, the vast majority indicated that they felt use of ST is increasing: 84% reported that Part B ST use has risen over the past five years. Nearly 40% said that more than half of their MA patients are subject to ST for one or more Part B therapy.

Clinical Considerations and Alignment: A recurring theme in survey responses was the degree to which Part B ST protocols align—or misalign— with clinical practice:

• 94% of respondents said that ST limits access to their preferred Part B treatments.
• 53% reported this interference occurred frequently (“often” or “always”).
• 74% believed that ST protocols for Part B products were not consistently based on established clinical guidelines.

Patient Experience and Treatment Access: Providers shared that ST requirements can have direct impacts on patient care:

• Over 60% of providers described the burden on their patients of ST for Part B drugs as “high” or “extremely high.”
• 60% said that patients often wait weeks to receive their original prescribed therapy.

Providers noted that while many patients ultimately gain access through exceptions or appeals, delays may contribute to anxiety or exacerbation of symptoms. These impacts are particularly concerning for patients with conditions that require early or aggressive intervention.

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 Funding for this research was provided by ASP Coalition. Avalere Health retained full editorial control.