Real answers to the questions patients actually ask about insurance and denials.
In March 2026, the FDA announced new steps to further streamline biosimilar development and make biologic medicines more affordable. This announcement continues a policy direction the agency has been pursuing for several years, and it has real implications for anyone who takes a specialty biologic.
Read full article→On March 30, 2026, the FDA approved Ponlimsi (denosumab-adet), the first biosimilar to Prolia, manufactured by Teva Pharmaceutical. The approval covers every indication that Prolia is already approved for.
Read full article→For three years during the COVID-19 pandemic, states were not allowed to disenroll anyone from Medicaid. It was called the continuous enrollment requirement, and it was a federal protection that kept millions of people covered even if their income or circumstances changed.
Read full article→On January 21, 2026, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to soficabtagene geleucel (WU-CART-007), an investigational allogeneic CAR-T cell therapy for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Read full article→A Komodo Health analysis published in July 2025, based on a review of more than 4 billion insurance claims, found that prescription denials by private insurers increased by approximately 25 percent between 2016 and 2023.
Read full article→The Inflation Reduction Act gave Medicare the power to negotiate drug prices directly with manufacturers for the first time in the program's history. The first ten negotiated prices took effect January 1, 2026. Now CMS has announced the second round: fifteen more drugs with negotiated Maximum Fair Prices taking effect January 1, 2027.
Read full article→If you receive health insurance through your employer, the denial you just received is governed by federal law, not state law. This matters more than you might think.
Read full article→Your prior authorization went through. Your insurance company said yes. But when you get to the pharmacy, your copay is $1,800. You cannot afford it, so you do not fill the prescription.
Read full article→The Mental Health Parity and Addiction Equity Act requires that insurance companies treat mental health and substance use disorder benefits equally to medical and surgical benefits. In practice, this law is violated constantly.
Read full article→The No Surprises Act, which took effect January 1, 2022, was supposed to largely eliminate surprise medical bills. More than two years later, patients are still receiving them.
Read full article→Federal lawsuits filed in 2023 and 2024 allege that major health insurers used artificial intelligence systems to deny claims at rates and speeds that could not reflect individualized medical review.
Read full article→When your child's medication is denied due to step therapy requirements, you may have stronger appeal rights than adult patients. Many states have enacted specific protections for pediatric step therapy.
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