LUGPA Policy Brief: Support for Step Therapy Reform – Safe Step Ad Hoc Coalition Comments to CMS

July 2026

At-a-Glance

What's Changing

CMS is considering reforms to step therapy protocols following a Request for Information (RFI) seeking stakeholder input on prior authorization, interoperability, and utilization management practices.

Why It Matters

Step therapy requirements can delay access to physician-recommended treatments, increase administrative burden, and negatively affect outcomes for patients with chronic and serious urologic conditions.

LUGPA Action

LUGPA joined the Safe Step Ad Hoc Coalition in urging CMS to establish stronger patient protections and standardized exceptions processes for step therapy protocols.

Background

LUGPA joined the Safe Step Ad Hoc Coalition in submitting comments to CMS Administrator Dr. Mehmet Oz in response to the agency's Request for Information regarding step therapy, also known as "fail-first" protocols. The coalition urged CMS to adopt regulatory safeguards that protect patients from inappropriate treatment delays and ensure timely access to medically necessary therapies.

Step therapy policies require patients to try and fail on insurer- or pharmacy benefit manager (PBM)-preferred medications before receiving the treatment prescribed by their physician. While intended to control costs, these requirements can lead to treatment delays, reduced medication adherence, disease progression, increased healthcare utilization, and, in some cases, irreversible patient harm.

Coalition Recommendations

The Safe Step Ad Hoc Coalition recommended that CMS:

• Require a clear and expedited exceptions process, including decisions within 24 hours for urgent requests and 72 hours for standard requests.
• Grant exceptions when:
• The required drug has previously failed or is likely to be ineffective;
• The required drug is contraindicated or likely to cause harm;
• Delays could result in irreversible disease progression or serious complications; or
• The patient is stable on an existing therapy.
• Require health plans to recognize prior payer determinations and step therapy approvals to preserve continuity of care during insurance transitions.
• Establish a standardized exceptions process across payers, including common forms, transparent clinical rationales, and consistent review criteria.
• Utilize technology and interoperability tools to streamline processes while avoiding additional administrative burdens.

The coalition also highlighted the Safe Step Act (S. 2903/H.R. 5509) as a model framework for protecting patients and preserving physician-directed treatment decisions.

Relevance to Independent Urology Practices

Step therapy requirements frequently affect medications used to treat:

• Advanced prostate cancer
• Overactive bladder (OAB)
• Benign prostatic hyperplasia (BPH)
• Erectile dysfunction
• Interstitial cystitis and other chronic urologic conditions

Delays in accessing the most appropriate therapy can lead to worsening symptoms, increased complications, avoidable procedures, disease progression, and diminished quality of life. For patients with urologic cancers, treatment delays may have particularly serious consequences.

Independent urology practices are disproportionately affected by the administrative burden associated with step therapy and utilization management requirements. These policies consume physician and staff resources, increase overhead costs, disrupt continuity of care, and can place smaller practices at a disadvantage compared to larger integrated health systems.

LUGPA's participation in the coalition reflects its commitment to protecting physician autonomy and ensuring timely access to evidence-based therapies for urologic patients.

LUGPA Position

LUGPA supports meaningful reforms to step therapy policies that prioritize patient safety, clinical appropriateness, and continuity of care.

While responsible cost management remains important, utilization management tools should not interfere with evidence-based treatment decisions or create barriers that ultimately increase downstream healthcare costs.

LUGPA commends CMS for seeking stakeholder input and emphasizes that technology solutions alone are insufficient. Regulatory safeguards are necessary to prevent the inappropriate use of step-therapy requirements, particularly for specialty medications commonly prescribed in urology.

LUGPA Urges CMS to:

• Require Medicare Advantage and other regulated health plans to implement a robust and expedited exceptions process consistent with the Safe Step Coalition's recommendations.
• Mandate recognition of prior payer step therapy approvals to ensure seamless transitions and continuity of care.
• Standardize forms, documentation requirements, and review criteria across payers to reduce administrative burden on physicians and practices.
• Align future policy development with the principles of the Safe Step Act to promote transparency, consistency, and clinically appropriate care.

By advancing these reforms, CMS can improve patient outcomes, reduce unnecessary treatment delays, and support the sustainability of independent physician practices while preserving the physician-patient relationship at the center of healthcare decision-making.

LUGPA will continue to work alongside the Safe Step Ad Hoc Coalition and other stakeholders to advocate for policies that place patients and physicians—not insurers or PBMs—at the center of treatment decisions.