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Changes ahead for clinical trial coverage

A concern for many individuals enrolling in a clinical trial is whether their health insurance will cover the cost of treatment. The Affordable Care Act (ACA) intends to help ease these concerns by covering approved clinical trials involving cancer or life-threatening diseases/conditions.


The importance of clinical trials

Clinical trials are controlled studies in which people volunteer to participate in tests of new drugs or procedures. Doctors use the results of these trials to develop new treatments for serious diseases, such as cancer.


Who pays for the costs of a clinical trial?

Clinical trials typically have costs associated with the study itself in addition to routine patient costs. In many cases, the clinical trial's sponsor covers the cost of tests, procedures, drugs, extra doctor visits, and any research related to the study. The sponsor may be a government agency, a pharmaceutical company, or some other research organization.


Routine patient costs, such as doctor visits, hospital stays, lab tests, and imaging services, are the usual medical care patients would receive whether they're participating in a clinical trial or not. Many health plans define clinical trials as "experimental" or "investigational," and therefore may not cover these costs — requiring individuals to either pay out of pocket or not participate in the trial.


What is changing in 2014?

As part of the ACA, effective January 1, 2014, non-grandfathered individual and employer health insurance plans in all states will be required to cover costs for, and prohibit discrimination against, approved clinical trial participants. More specifically, plans may not:

  1. Deny qualifying individuals participation in certain clinical trials
  2. Deny the coverage of routine patient costs for items and services furnished in connection with the clinical trial
  3. Discriminate against individuals who participate in such trials

It should be noted that the state of Iowa already mandates coverage of approved clinical trials for cancer treatments. This federal law would expand upon the Iowa law to include approved clinical trials for life-threatening diseases/conditions.


What is an approved clinical trial?

The ACA defines an "approved clinical trial" as a phase I, II, III, or IV clinical trial that is conducted for the prevention, detection, or treatment of cancer or another life-threatening disease, and is one of the following:

  1. Federally funded; OR
  2. Conducted under an investigational new drug application reviewed by the Food and Drug Administration or a drug trial that is exempt from having an investigational new drug application. 

Can a plan require an enrollee to participate in a clinical trial through a participating provider?

If a provider participates in an approved clinical trial and will accept the individual as a trial participant, a plan can require the individual to participate in the trial through that provider. An employer health plan is not required to provide benefits for routine patient care services provided outside of the plan's provider network unless out-of-network benefits are otherwise provided under the plan.


Where can I get more information?

Wellmark is here to inform, lead, assist and support you through all the ACA changes. For more information call your Wellmark representative.

Related Information

Blue Cross and Blue Shield Association publications on health care reform issues:
»   12 Myths About Health Insurance pdf image
»   Health Care Spending by Major Payor pdf image
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