Health Insurance Coverage of Clinical Trials

Historically, many health plans would not pay for items/services associated with clinical trials. Therefore, individuals who wanted or needed to participate in a clinical trial were often unable to do so because of the financial burden it imposed on them and their family. The Patient Protection and Affordable Care Act (ACA) is the first federal law requiring that private insurers cover routine patient costs for individuals participating in clinical trials for the prevention, detection, and treatment of cancer or other life-threatening diseases or conditions.

The ACA prohibits health plans from denying a “qualified individual” participation in an “approved clinical trial.” The ACA also prohibits health plans from denying or limiting coverage of routine patient costs for items/services furnished in connection with participation in an approved clinical trial. In addition, the ACA prohibits health plans from discriminating against the qualified individual on the basis of their participation in such trial. Exempt from this ACA provision are “grandfathered” health plans or health insurance coverage that was in existence on March 23, 2010. Plans lose their grandfathered status by making changes to their benefits and coverage. Once a plan loses its grandfathered status, it must comply with this ACA provision.

A “qualified individual” is a participant or beneficiary in a health plan that meets the trial’s eligibility criteria and whose participation is appropriate as determined by the referring health care professional. An “approved trial” is a clinical trial (phase I, II, III or IV) for the prevention, detection, or treatment of cancer or other life-threatening disease or condition and which is either federally funded or under an Investigational New Drug (IND) application or exempt from needing an IND. The term ‘life threatening condition’ means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

“Routine patient costs” include items/services consistent with coverage provided in the health plan that is typically covered for a qualified individual who is not enrolled in a clinical trial. Routine patient costs do not include the investigational item itself, or services rendered solely in connection with collecting data about the investigational item or are inconsistent with established standards of care for the condition being studied. Payers may require a qualified individual to use an in-network provider for the approved clinical trial if that provider is a trial participant and will accept the patient. Payers are not required to provide out-of-network benefits unless such benefits are part of the patient’s coverage or the approved clinical trial is only offered outside the patient’s state of residence.

The ACA is now the minimum national standard for insurance coverage of clinical trials. Illinois does have a law mandating coverage for certain cancer trials, however the ACA is more comprehensive in both who it covers and types of clinical trials.

Last, the ACA does not apply to Medicaid or Medicare beneficiaries. Medicare already covers the routine costs associated with clinical trial participation on most types of clinical trials. IL Medicaid provides us with woeful little other than stating that it does not provide coverage for experimental procedures or research oriented procedures. And finally, the ACA does not address research-related injuries. Therefore, we should strive to require trial sponsors to pay for such costs.

ASCO has created an attestation form that can help demonstrate that the trial and patient’s circumstances meet the ACA’s coverage requirements:

Please contact me if you any questions or would like assistance with obtaining coverage for your trial.