Among the many catchphrases of the Affordable Care Act — individual mandates, pre-existing conditions — “clinical trials” is one that has flown under the radar. But in terms of immediate impact, it is one that plan sponsors, benefit brokers and third-party administrators should get to know.

In the past, coverage for clinical trials has not been uniformly provided under employer-sponsored plans. Today, the ACA has opened the door for more plan participants to take part in a wider array of clinical trials. Under current ACA requirements, non-grandfathered health insurance plans taking effect on or after Jan. 1, 2014:

  • May not deny qualified individuals the participation in approved clinical trials with respect to the treatment of cancer or other life-threatening conditions;
  • May not deny (or limit or impose additional conditions on) 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.

While the intent of the regulation is clear, the ACA provides few specifics about the implementation of these requirements, leaving room for interpretation and uncertainty. Understanding clinical trials now may prevent you from being caught off-guard by future claims.
Understanding ACA clinical trials

Eligible clinical trials under the ACA requirements are conducted to assist in the prevention, detection or treatment of cancer or other life-threatening diseases or conditions — those from which death is likely if the course of the disease is not interrupted. To be considered “qualified” for plan coverage under the ACA, clinical trials must be approved or sponsored by one or more federal agencies, including the National Institutes of Health, the Centers for Medicare & Medicaid Services and the Food and Drug Administration. Among other purposes, the U.S. National Institutes of Health says qualified clinical trials may be conducted as a means of:

  • Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition.
  • Finding ways to prevent the initial development or recurrence of a disease or condition, including medicines, vaccines, or lifestyle changes.
  • Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition.
  • Examining methods for identifying a condition or risk factors for that condition.

What is covered?

The ACA mandates coverage of “routine patient costs” associated with the individual’s participation in any of the four “phases” of approved clinical trials. Each of the four phases of a clinical trial is designed to address a specific research concern, according to the U.S. National Library of Medicine:

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

“Routine patient costs” are generally understood to include all medically necessary health care provided to the individual for purposes of the trial, consistent with a plan’s medical coverage, as well as regular services that would be covered for those not enrolled in clinical trials.
Note that the ACA has grandfathered self-funded plans that were in effect prior to March 23, 2010 (the date the ACA was enacted). These plans are exempt from the clinical trials coverage provision, provided the plan’s benefits are not later reduced and costs are not increased (at which point, grandfathered status is revoked).

Planning for coverage

While the ACA’s objectives surrounding clinical trials are well understood — ensuring participants have access to potentially life-saving treatments — the guidelines for implementation thus far have been vague. The U.S. Department of Health and Human Services instructs group health plans and health insurance issuers to implement the requirements “using a good-faith, reasonable interpretation of the law.” This has left the regulations open to interpretation and has permitted a degree of flexibility for plan administrators.

Here are some key issues to consider when developing or amending plans to include coverage for routine patient costs of clinical trials:

  • Be prepared for higher costs.The clinical trials provision of the ACA may encourage more participation in clinical trials. In addition to higher participant numbers, clinical trials can present a greater risk for complications and associated treatment expenses. Plan sponsors and stop-loss carriers should be prepared to accept additional risk and cost when clinical trials are appropriate for participants.
  • Watch for gaps in coverage.Plan Sponsors should ensure that clinical trial expenses are covered by their stop loss policy. Gaps in coverage may leave them at risk of unforeseen costs if participants are approved for clinical trials that the plan sponsor’s stop loss policy does not cover. It is imperative that clinical trial coverage in the stop loss policy matches that of the plan document.
  • Know the regulations.In many cases, state-driven regulations regarding clinical trial coverage may already be in place. But, whether coverage already exists or must now be implemented, plan sponsors, brokers, TPAs and stop-loss carriers must work closely to ensure that coverage remains in compliance in the new health care marketplace.


Clinical trials are an important component of our modern health care system. When appropriate, clinical trials may provide valuable treatment for participants and can help advance treatment for others in the future. However, as with many ACA regulations, compliance and cost containment will require a team effort between brokers, TPAs, carriers and plan sponsors. Understanding the laws now — and adjusting coverage accordingly — will help ensure that plan sponsors aren’t caught by surprise when clinical trial claims appear.

Diaz is vice president of stop-loss claims in the Benefits Division of Symetra Life Insurance Company. In her role, Marien is responsible for providing direction to a team of claims and registered nurse professionals who are experts in the management of catastrophic claims and cost-containment. She has 30 years of experience working in self-funded markets in different roles at third-party administrators and various insurance companies.

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