National Legislation

Coverage for individuals participating in approved clinical trials (August 2013)

Effective on January 1, 2014, a new statute (42 U.S.C.A § 300gg-8) under the Patient Protection and Affordable Care Act (PPACA Section 2709), mandates that group health plans [including self-funded arrangements, plans under the Employee Retirement Income Security Act (ERISA), and Federal Employees Health Benefits Program (FEHBP)] provide coverage of routine patient costs associated with participation in an approved clinical trial to a qualified individual. Medicare already provides coverage of standard of care costs for many clinical trials and their policies are not impacted by this new statute. This federal law establishes a national minimum coverage determination. Individual state laws may still require additional coverage.

Routine patient costs are defined to include all items and services consistent with the coverage provided in the plan (or coverage) 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, device, or service, itself;
  • Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or,
  • Services clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

In general, an approved clinical trial is considered a phase I, phase II, phase II, or phase IV clinical trial conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition; and has federal funding or approval. A life-threatening condition is considered any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

Clinical trials approved or funded by one or more of the following entities are generally considered approved:

  • The National Institutes of Health (NIH)
  • The Centers for Disease Control and Prevention (CDC)
  • The Agency for Health Care Research and Quality (AHRQ)
  • The Center for Medicare & Medicaid Services (CMS)
  • Cooperative group or center of the NIH, CDC, AHRQ, CMS, Department of Defense (DOD), or Department of Veterans Affairs (VA)
  • A qualified non-governmental research entity identified in the guidelines by the NIH for center support grants
  • The VA, DOD, or Department of Energy (if that Department's Secretary determines that the study is comparable to the system of peer review of studies and investigations used by the NIH, and assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review).

If the study is conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration (FDA) or a drug trial exempt from IND application requirements, it is also generally considered approved.

A qualified individual is defined as a person insured by a group health plan or health insurer who offers group or individual health insurance coverage and:

  1. the individual is eligible to participate in an approved clinical trial according to the trial protocol; and,
  2. the referring health care professional is a participating health care provider and has concluded that the individual's participation is appropriate, or the participant/beneficiary provides medical and scientific information establishing that the individual's participation in the trial would be appropriate.

Under the ACA clinical trials statute, if an insurer provides coverage to an qualified individual, then they may not deny the individual participation in approved clinical trials for which they qualify; may not put limitation or impose additional conditions in the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and, may not discriminate against the individual on the basis of the individual's participation in the trial.

Insurers may require that the qualified individual participate in the trial through an in-network provider if there is a participating provider participating in the trial, and if that provider will accept the individual as a participant.

Although insurers may require use of in-network providers, if the qualified individual has out-of-network benefits and the approved clinical trial is only being conducted outside the state in which the qualified individual resides, the insurer is required to cover routine patient costs delivered by out-of-network providers. Insurers are not required to provide out-of-network benefits if that benefit is not normally part of the patients' insurance plan outside of the study.

There are certain insurance plans considered 'grandfathered' and exempt from certain provisions of the ACA's clinical trials policy. These grandfathered plans existed on March 23, 2010 (the day PPACA was signed) and have not reduced benefits or increased costs to enrollees since that date. If a grandfathered plan makes significant changes in its benefits or costs, it loses its grandfathered status and must comply with clinical trial provisions under ACA.