Health Insurance Coverage for Clinical Trials

National Coalition for Cancer Research worked tirelessly to secure a provision in the Patient Protection and Affordable Care Act to require health plans to provide coverage of routine patient costs associated with clinical trial participation. We are working with our colleagues in the research community to ensure the implementing regulations provide the maximum health insurance coverage for clinical trial participants. These include:

  • Prevention of Delays and Administrative Barriers – We encourage the Secretary to establish explicit safeguards protecting individuals with cancer from delays and administrative barriers that undermine access to clinical trials.
  • Prevention, Detection, and Treatment of Complications – We encourage inclusion of explicit safeguards to ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered by group health plans and insurance issuers as routine patient costs under Section 2709 of the Public Health Service Act.
  • Geographic Safeguard to Preserve Local Access – Implementing regulations should prevent group health plans and insurance issuers from requiring patients to travel extensive distances to enroll in a clinical trial with an in-network provider.
  • Clear Coverage Information for Enrollees – There should be safeguards to ensure patients are informed in an unambiguous manner as to whether or not their group health plan or insurance issuer covers the routine costs associated with participation in clinical trials.
  • Referral to Specialists – Implementing rules should prevent financial incentives arising from Accountable Care Organizations or other new delivery models from inadvertently creating barriers for patients to participate in clinical trials.
  • Method for Consumer Reporting – There should be a clear and effective mechanism for reporting concerns relating to the coverage of clinical trials.