The Affordable Care Act (ACA) presents many new compliance challenges that range from ensuring plan designs incorporate the required benefits to notifying employee’s about the public Exchange.

Clinical Trials

HCR Home » Compliance » Clinical Trials

For plan years beginning on or after January 1, 2014, fully-insured and self-insured non-grandfathered group health plans may not:

  • Deny any qualified individual the right to participate in an approved clinical trial
  • Deny or limit the coverage of routine patient costs for items and services furnished in connection with participation in an approved clinical trial
  • Discriminate against any qualified individual who participates in an approved clinical trial

Grandfathered group health plans are exempt from this requirement.

A plan participant or beneficiary is a qualified individual if he or she is eligible to participate in the trial based on its protocol and if one of the following requirements is met:  (1) a participating provider referred the individual and concluded that participation in the clinical trial would be appropriate, or (2) the individual provides medical and scientific information establishing that participation in the clinical trial would be appropriate.

An approved clinical trial is a Phase I, II, III or IV clinical trial for the prevention, detection or treatment of cancer, or other life-threatening condition or disease.

Routine patient costs include all medically necessary services provided as part of the clinical trial that would otherwise be covered under the plan if the individual were not participating in a trial.  The following are not considered routine patient costs:  (1) the device, equipment or drug being investigated, (2) items and services used for data collection and analysis but not used in direct clinical management of the participant, and (3) a service that is clearly inconsistent with widely accepted and established standards of care for the particular disease or condition.