For plan years beginning on or after January 1, 2014, with respect to individuals who participate in clinical trials, non-grandfathered health plans may not deny participation in a clinical trial, limit coverage for routine items and services typically covered for individuals who are not enrolled in clinical trials, or discriminate against individuals based on their participation in clinical trials. Plans do not have to pay for the investigational item, device, or service. The Agencies stated that this provision is self-implementing, and they will not issue guidance in the near future.
Note: The nondiscrimination rules applicable to clinical trial participants only apply to certain types of health plans, such as major medical insurance. They do not apply to HIPAA excepted benefits, such as disability, cancer, hospital indemnity, or accident insurance. Click here for more information about the types of benefits that are exempt from the ACA plan design mandates.