FORT MYERS, Fla., Oct. 20, 2026 /PRNewswire/ -- Insurer-driven step-editing practices in oncology continue to increase the risk of serious harm to cancer patients and providers, according to an extensive review conducted by physician and executive leaders of Florida Cancer Specialists & Research Institute. The findings, detailed in an article published in The Oncologist, indicate that insurer management policies are becoming increasingly common in cancer care and may create barriers that delay timely access to clinically recommended, potentially life-saving treatments. The authors note that these delays can compromise patient outcomes, limit physician autonomy, and raise legal and ethical concerns.

"In cancer care, timing matters," said FCS President & Managing Physician Lucio N. Gordan, MD, a coauthor of the article. "The effectiveness of a treatment depends not only on selecting the right therapy, but also on starting it at the right time. When patients are required to cycle through insurer-preferred options before receiving their physician's recommended therapy, even short delays can have significant consequences."

Step therapy, sometimes called "fail first," requires patients to undergo certain treatments before coverage is approved for another medication recommended by their physician. While requirements vary by health plan and treatment, step therapy, prior authorization and other coverage restrictions for oncology drugs have become increasingly common in recent years.

To examine the clinical, economic and equity implications of these policies, the authors reviewed peer-reviewed literature from 2010 to 2025 and relevant U.S. regulatory and policy documents.  

"Cancer treatment should be guided by clinical evidence and the unique biology of a patient's disease, not insurance-driven treatment algorithms," said David Wenk, MD, FCS assistant managing physician and article coauthor. "Our research confirms that payer-preferred regiments, while intended to manage healthcare spending, can have outsized clinical consequences for patients that lead to delays, added risks and interruptions in care."

The authors identified four recurring ways step therapy may harm patients with cancer: delaying access to the most appropriate treatment, requiring therapies that may not align with a patient's specific cancer or biomarker profile, exposing patients to unnecessary side effects from less suitable treatments and disrupting care when insurance coverage changes.

"Our extensive review found that utilization management policies can place significant burdens on patients already navigating the challenges of cancer treatment," said Kiana Mehring, coauthor and FCS senior vice president payer strategy, revenue cycle operations and value-based care. "In one survey, 69% of patients who experienced prior authorization reported delays in care, nearly three-quarters of those delays lasted at least two weeks, and 22% said they did not receive recommended treatment because of authorization-related delays or denials. The evidence also suggests these barriers may disproportionately affect patients with fewer resources and support systems, raising concerns about equity and access to timely care."

Beyond their impact on patients, insurer-mandated treatment requirements can increase administrative burden, delay care, strain healthcare teams and create inefficiencies across the healthcare system. The authors noted that these challenges can be particularly significant in community oncology practices, where most Americans receive cancer care.

"The urgency of cancer care demands a different approach," said FCS CEO and article coauthor Ryan Ciarrocchi. "Policies should include rapid exceptions and appeals, continuity-of-care protections, transparent standards, and reduced administrative requirements for practices that consistently follow evidence-based guidelines."

The authors concluded that these safeguards are essential to reducing treatment delays and preserving patient access to evidence-based, physician-directed cancer care. "Without these safeguards, step therapy risks shifting the focus away from patients and the treatment plan best suited to their cancer, replacing clinical judgment with administrative requirements and creating barriers to the timely, personalized care that is the foundation of community oncology," Ciarrocchi added.

Dr. Wenk noted that one of the most important findings was how little research has specifically examined step therapy in oncology. "The limited evidence available should not be interpreted to mean these policies have little effect," he said. "More research is needed to better understand how they affect patients and cancer care delivery."

FCS co-authors also include Matthew Fink, MD, medical oncologist and hematologist, Paul Chadwick, chief procurement officer, Josh Eaves, chief development and strategy officer, and Austin Cox, PharmD, vice president, pharmacy services. Michael Reff, NCODA, also contributed to the abstract.

To view the article: The Perils and Consequences of Payer Step Editing ("Step Therapy") in U.S. Medical Oncology: Evidence, Case Examples, and Policy Remedies, The Oncologist, 2026;, oyag398

About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program.

FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval.

Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes.

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SOURCE Florida Cancer Specialists & Research Institute