Health Insurance - Step Therapy or Fail-First Protocols - Drugs to Treat Associated Conditions of Advanced Metastatic Cancer
Summary
SB 921 amends Maryland insurance law to limit the use of step therapy, also known as fail-first protocols, for certain prescription drugs related to advanced metastatic cancer. Under the bill, insurers, nonprofit health service plans, and health maintenance organizations may not require patients to try one or more alternative drugs before covering a drug prescribed by a treating physician when the drug is used to treat stage four advanced metastatic cancer and meets specified evidence-based criteria.
The bill also extends this protection to drugs prescribed to treat symptoms of advanced metastatic cancer or side effects from its treatment, so long as the treating provider determines the symptom or side effect would negatively affect the patient’s health if left untreated. In those cases, the drug must be consistent with best practices, supported by peer-reviewed medical literature, and covered under the patient’s policy or contract. The act applies to policies, contracts, and health benefit plans issued, delivered, or renewed on or after January 1, 2026.
Impact
The bill amends Insurance Article § 15-142 by adding a new exception to the general authority of insurers and health plans to use step therapy or fail-first protocols. It narrows utilization management for a subset of cancer-related prescriptions, requiring coverage without prior-step requirements when the statutory conditions are met. The change affects insurers, nonprofit health service plans, health maintenance organizations, and pharmacy benefit arrangements in Maryland, and it will apply to new, delivered, or renewed coverage beginning January 1, 2026.
Sentiment
The bill appears to have broad bipartisan support and little visible opposition. It passed the Senate unanimously and the House by an overwhelming margin, with only one dissenting vote on final passage. The vote pattern suggests general agreement with easing access to medically necessary cancer-related drugs and reducing administrative barriers for patients with advanced metastatic cancer.
Contention
The main policy issue is the balance between insurer cost-control tools and patient access to prescribed cancer treatments. Supporters of the bill likely view step therapy as an inappropriate barrier for patients with advanced metastatic cancer, especially when treating symptoms or side effects that can quickly worsen health if untreated. Any opposition would likely center on preserving insurer flexibility to manage drug utilization and costs, but the recorded votes indicate that such concerns did not generate significant legislative resistance. The bill’s evidentiary requirements and coverage limitation to drugs already covered under the policy also suggest an effort to narrow the exception and address insurer concerns.