Health insurers would review step-therapy exceptions for medical need

Health insurers and review organizations would provide a process for enrollees and prescribers to request an exception to a step-therapy drug requirement. The process would cover prescription drugs restricted by a step-therapy protocol under a pharmacy or medical benefit, including drugs given by patients or clinicians. The insurer or review organization would have to quickly approve an exception when the required drug could cause harm, would likely not work, previously failed or caused a reaction, is not medically appropriate, the enrollee is stable on another drug, or the selected drug treats serious mental illness. An approved exception would require coverage of the prescriber's selected drug. Insurers could still require a generic drug or interchangeable biological product before covering an equivalent brand-name drug. The process would apply 90 days after the act's passage. Urgent requests would require a decision within 72 hours, non-urgent electronic requests within 7 calendar days, and other non-urgent requests within 14 days after all needed information is received; emergent requests would require a decision within 24 hours.

Insurers and review organizations would keep covering the prescribed drug while they decide an exception request or appeal, and would treat a missed deadline as approval. The rule would apply to step-therapy exception requests and appeals made by covered people or their health care providers. The enrollee could appeal an exception decision. The insurer or review organization would have to notify the covered person and provider of the decision. The bill would not stop a provider from prescribing a drug that the provider considers medically necessary. Coverage during the request or appeal, and the missed-deadline approval rule, would begin 90 days after passage and would apply for the period before a final decision.

Insurers and review organizations would be prohibited from using step therapy for certain drugs used to treat advanced, metastatic cancer or related conditions. The prohibition would cover drugs for advanced, metastatic cancer and associated conditions when the drugs meet the bill's treatment, evidence, and federal approval requirements. The drugs would have to follow best practices for treating the cancer or related condition. The drugs would have to be supported by peer-reviewed, evidence-based literature and approved by the federal Food and Drug Administration. The prohibition would apply 90 days after the act's passage.