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Can a Health Plan Limit Coverage of Chemotherapy Provided in a Clinical Trial?



QUESTION: Our health plan generally covers chemotherapy to treat cancer. Can the plan limit coverage of chemotherapy if it is provided in connection with an approved clinical trial?

ANSWER: Coverage for chemotherapy in connection with an approved clinical trial generally may not be limited. Under the Affordable Care Act, a non-grandfathered health plan may not deny (or limit or impose additional conditions on) the coverage of “routine patient costs” for any items or services furnished in connection with participation in an approved clinical trial. But even if your plan typically covers chemotherapy for a qualified individual who is not enrolled in a clinical trial, it may be able to limit coverage of chemotherapy in clinical trials if the expenses are not “routine patient costs.”

Routine patient costs include all items and services consistent with the coverage provided in the plan that are typically covered for a qualified individual who is not enrolled in a clinical trial. However, routine patient costs do not include: (1) the investigational item, device, or service being studied in the approved clinical trial; (2) an item or service provided solely to satisfy the clinical trial’s data collection and analysis needs and that is not used in the direct clinical management of the patient; or (3) a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. Thus, your health plan generally must cover chemotherapy provided in connection with a clinical trial. For example, if your plan generally covers chemotherapy to treat cancer, it may not limit that coverage when the chemotherapy is provided in connection with an individual’s participation in an approved clinical trial for a new anti-nausea medication. However, your plan may be able to limit coverage if the chemotherapy is not a routine patient cost, for instance, because it is the investigational item being studied in the clinical trial.

Also note that health plans generally are not required to provide benefits for routine patient care services provided outside of the plan’s health care provider network unless out-of-network benefits are otherwise provided under the plan. The exceptions are narrow, so be careful. And keep in mind that other nondiscrimination laws, such as the Americans with Disabilities Act, may prohibit exclusions that might otherwise be permitted.

For more information, see EBIA’s Health Care Reform manual at Section XII.D (“Coverage for Individuals Participating in Approved Clinical Trials”) and EBIA’s Group Health Plan Mandates manual at Sections XIII.C (“Coverage for Individuals Participating in Clinical Trials”) and XX.D (“Analyzing Health Benefits Under the ADA”). See also EBIA’s Self-Insured Health Plans manual at Section XIII.C.7 (“Clinical Trials”).

Contributing Editors: EBIA Staff.

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