Safe Step Act Supports Timely Access to Essential Therapy

"In the states where there is no step therapy legislation, this is life-changing,” said Mark Lebwohl, MD, dean for clinical therapeutics at Mount Sinai and chairman emeritus of its Department of Dermatology, in a recent interview with Dermatology Times. This statement highlights a persistent challenge in clinical practice: navigating insurance-mandated “fail-first” protocols, commonly known as step therapy, which require patients to try insurer-preferred medications before receiving the treatment their clinician prescribes.

The introduction of the Safe Step Act, a bipartisan federal bill establishing guardrails for step therapy, represents a potential turning point for clinicians and patients alike. By codifying timely exception processes, promoting transparency, and emphasizing patient safety, this legislation could meaningfully influence how clinicians prescribe and manage therapy for chronic immune-mediated diseases.¹

The bill, introduced into the 118th Congress and carried forward into the 119th, seeks to impose guardrails on step therapy protocols for group health plans governed by the Employee Retirement Income Security Act. A recent news release from the National Psoriasis Foundation (NPF) emphasized the bill’s relevance to approximately 160 million Americans living with chronic conditions covered under employer plans.²

Lebwohl noted that clinicians often default to triamcinolone ointment for patients requiring topical therapy because it is reliably covered and generally bypasses additional administrative steps.

But although inexpensive, these less-effective agents may substitute for superior options, delaying optimal care and, in some cases, placing patients at risk of worsening disease. For clinicians, requesting and managing appeals adds a considerable administrative burden, with one study finding that 59% of physicians reported long processing times.¹

According to a 2020 NPF survey, 70% of people with psoriatic disease taking a biologic have experienced step therapy. Patients on step therapy-restricted plans were 19% to 27% less likely to achieve effective outcomes, and adherence to prescribed therapy was 19% to 29% lower compared with patients without access restrictions.

From a clinician’s perspective, a 2024 survey found that 77% of dermatologists reported that insurance formularies “moderately or majorly” impact their biologic use, and only 14% noted alignment with their first-line choice at least 75% of the time. In a 2022 AMA prior authorization (PA) physician survey, 33% of clinicians reported that PA resulted in “serious adverse events,” and 25% even stated it led to “patient hospitalization.”³

Key Provisions of the Safe Step Act

The Safe Step Act would require a compliant group health plan to do:

• Implement a clear, transparent exception process for step therapy protocols (allowing a treating clinician to request bypass of the protocol).
• Recognize 5 specific circumstances under which exceptions must be granted:
  1. The patient previously tried and failed the required drug.
  2. A delay in treatment would lead to irreversible harm or severe outcomes.
  3. The required step therapy drug is contraindicated or likely to cause harm.
  4. The required drug would prevent the patient from performing activities of daily living or working.
  5. The patient is stable on a drug previously approved and covered by the plan.
• Require plans to respond to an exemption request within 72 hours, or 24 hours in life-threatening circumstances.
• Avoid eliminating step therapy entirely, but ensure a “clear, timely, and convenient” override, exception, and appeal process.
• Increase transparency, as plans must publish step therapy protocols, criteria, and rationale, and report denial rates.⁴

What This Means for Dermatologists

1. Physician decision-making and patient safety

As Lebwohl noted, in states without step therapy legislation, the impact on treatment access can be substantial. “If a physician knows that a particular treatment is better for their patient, they can prescribe that treatment immediately.”

When a clinician identifies that a patient with severe plaque psoriasis or generalized pustular psoriasis requires a biologic or advanced therapy, the Safe Step Act strengthens the clinician’s ability to advocate for the appropriate initial therapy rather than defaulting to insurer-preferred agents. Lebwohl describes a patient with life-threatening generalized pustular psoriasis who needed a biologic:

“Whenever this patient’s not getting the drug, she relapses, and is literally debilitated, for she cannot do anything.”

He also highlighted the challenge of navigating insurance approvals, even in this case, when the patient works for the insurer. “She works for the company that covers her. They first refused to pay for spesolimab. They then, even though we cleared her pustular psoriasis and we’re now able to keep it away with subcutaneous spesolimab, they won’t pay for the drug she needs to treat her plaque psoriasis,” Lebwohl explained. “For the last 2 years, she has been on disability from her job because they will not let us treat her appropriately.”

2. Administrative implications and workflow integration

While the Safe Step Act promises faster decision-making, practices must maintain workflows for generating exception requests, clinically justifying why step therapy is inappropriate, and tracking appeals.

Lebwohl emphasized how his practice handles this: “There is a tool called the prior authorization letter writing tool on the American Academy of Dermatology [AAD] website. It literally takes my secretary less than a minute to generate one of those letters.”

The AAD’s Prior Authorization Appeal Letter Tool supports over 70 drugs and allows member dermatologists to generate customizable letters. If the Safe Step Act becomes law, practices can integrate these resources and streamline exception requests from day 1.⁵

However, recent analysis notes that although the act may reduce delays, it does not fully relieve the administrative burden on practices. As Shan et al noted, “While the act could expedite access to necessary medications...it falls short in relieving the administrative burdens on dermatology clinics.”

Clinicians should anticipate some ongoing documentation work, albeit within tighter timelines and clearer rules.¹

3. Strategic practice advice for dermatologists

Review your clinic’s workflow for step therapy and prior authorization; assign responsibilities for initiating exception requests and tracking response timelines.

Familiarize your team with AAD’s letters and advocate tools.

Document clinical rationale early—especially when a patient’s history, comorbidities, or disease severity justify bypassing lower-tier therapy.

Educate patients about the exception process, as many are unaware that they may challenge insurer step protocols.

Lebwohl emphasized the judicious use of clinical judgment. “A patient might have a history of squamous cell carcinoma of the skin, and the insurance company tells you to put the patient on a [tumor necrosis factor] blocker, which usually is their drug of choice,” he said. “That predisposes you to more squamous cell carcinomas of the skin. So why would you do that?”

Limitations and Considerations

The Safe Step Act does not eliminate step therapy; instead, it preserves the practice while strengthening oversight and creating clearer exception pathways.1 However, administrative burdens, such as documentation requirements and workflow coordination, still persist. Insurers may continue to exert formulary leverage, and cost-containment pressures remain a significant factor. State-level variability continues to influence how these policies are applied in clinical practice.⁵

Although the legislation is promising, clinical practices must treat the Safe Step Act as an enabling tool rather than a panacea.

Conclusion

For clinicians treating chronic immune-mediated diseases, such as psoriasis, hidradenitis suppurativa, and atopic dermatitis, the Safe Step Act provides a framework to advocate for timely, clinically appropriate therapy. “Step therapy legislation will help us treat our patients, more efficiently, more effectively,” said Lebwohl.

By integrating AAD tools, refining clinic workflows, and educating both staff and patients, practices can be prepared to utilize the exception pathways effectively. While step therapy will remain part of the insurance landscape, the Safe Step Act offers structured guidance to better align insurer protocols with clinical judgment, potentially improving patient access to optimal treatments.

References

1. Shan DM, Greenzaid JD, Greene E, Feldman SR. Analyzing the benefits and costs of the Safe Step Act on patients, physicians, and insurers. J Psoriasis Psoriatic Arthritis. 2024;9(3):115-120. doi:10.1177/24755303241253203
2. National Psoriasis Foundation applauds congressional leaders for introducing the “Safe Step Act” and calls for swift passage to protect millions of patients. News release. National Psoriasis Foundation. September 19, 2025. Accessed November 7, 2025. https://www.psoriasis.org/safe-step-act-press-release/
3. American Medical Association. AMA prior authorization (PA) physician survey. 2022. Accessed November 7, 2025. https://www.ama-assn.org/system/files/prior-authorization-survey.pdf
4. Safe Step Act, HR 5509, 119th Cong (2025). Accessed November 7, 2025. https://www.congress.gov/bill/119th-congress/house-bill/5509/text
5. Prior authorization appeal letter tool. American Academy of Dermatology. Accessed November 7, 2025. https://www.aad.org/member/practice/drugs/prior-authorization