From Practice to Policy: Clinicians Back Safe Step Act Protections

In a recent Dermatology Times interview, Mark Lebwohl, MD, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, and chairman emeritus of its Dermatology Department, addressed the pervasive impact of insurer-mandated step therapy (or “fail-first”) requirements in dermatologic practice, the burden these place on patient care, and ongoing legislative efforts to rein in restrictive policies.

“These requirements are encountered with virtually every single patient that we take care of,” Lebwohl observed, underscoring how step therapy has become a near-universal obstacle in prescribing optimal therapies. Under step therapy protocols, patients must fail insurer-preferred agents before gaining access to physician-recommended or newer therapies. Such mandates affect a wide spectrum of chronic skin disease management, including psoriasis, atopic dermatitis, hidradenitis suppurativa, and more, where individualized treatment and timely escalation may be critical.

Legislative Context: The Safe Step Act (S. 652)

One of the most notable legislative responses to step therapy practices is the Safe Step Act (S. 652) introduced in the 118th Congress. This bill aims to impose guardrails on step therapy protocols by:

• Requiring health plans to establish an override, exception, and appeal process that is “transparent, timely, and convenient”
• Mandating that these processes permit physician attestation of medical necessity as sufficient grounds to bypass step therapy
• Requiring health plans to publish step therapy protocols, criteria, and rationale, and to report on rates of step therapy denials
• Prohibiting “fail-first” requirements for treatments that are FDA-labeled or guideline-endorsed for the patient’s indication
• Establishing penalties or sanctions if insurers fail to honor the override or exception determinations

If enacted, the Safe Step Act would represent a meaningful shift in regulatory oversight of insurer practices, bolstering clinician authority and potentially reducing delays in access to advanced or individualized therapies. The bill remains under consideration in committee at present.

Professional organizations such as the American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF) continue to drive awareness, education, and legislative advocacy around reform of step therapy policies. In the interview, Lebwohl credited both for their leadership, saying they “have played a pivotal role in getting step therapy legislation approved across the country.”

The AAD additionally offers a Prior Authorization and Appeal Letter Tool to help dermatologists streamline documentation and more effectively challenge step therapy denials. In daily practice, navigating these insurer frameworks, while striving to deliver evidence-based, patient-centric care, remains a critical operational challenge. Lebwohl’s commentary underscores the complex interplay between administrative constraints and physician clinical judgment in modern dermatologic management.