QUESTION: Our company’s self-insured health plan contains an exclusion for items and services that are experimental or investigational in nature. We have heard that health care reform includes a clinical trials mandate. Does this mean we will need to amend our plan to start covering clinical trials?
ANSWER: Health care reform does not require coverage of clinical trials. The provision you are referring to prohibits non-grandfathered group health plans from denying qualified individuals the right to participate in an approved clinical trial, and from denying, limiting, or imposing additional conditions on the plan’s coverage of “routine patient costs” for items and services furnished in connection with participation in an approved clinical trial. This provision is effective for plan years beginning on or after January 1, 2014.
“Routine patient costs” are items and services typically covered under the plan for a participant not enrolled in a clinical trial. They do not include—(1) the investigational item, device, or service itself; (2) items and services not included in the direct clinical management of the patient, but instead provided in connection with data collection and analysis; or (3) a service clearly not consistent with widely accepted and established standards of care for the particular diagnosis. Thus, the health care reform requirement does not prevent a plan from excluding certain courses of treatment, devices, or services as experimental and investigational. But you should review the wording of the exclusion in your plan document and summary plan description to confirm that it does not exclude related services that are required to be covered as routine patient costs. You may find that you need to make some changes to the wording of your exclusion provision (or in the “definitions” section of your plan) in order to comply. If so, you should work with the plan’s TPA to ensure that the revised exclusion provision will be administered correctly, so that items and services that ordinarily would be covered by the plan are not excluded solely because the individual is participating in a clinical trial. And, if the company maintains stop-loss insurance in connection with the plan, you should be aware that stop-loss insurance is not required to comply with any health care reform mandates (because it is not health insurance). Thus, if the stop-loss policy’s exclusion is broader than the plan’s exclusion, the company will ultimately be responsible for any exposure.
Also, aside from the health care reform provision, keep in mind that plan exclusions for experimental or investigational treatments are often challenged by participants. These exclusions should be drafted with as much specificity as possible, to avoid having a court define an ambiguous term. For example, consider listing specific procedures in the plan document as excluded, along with a general reservation of authority to exclude other procedures determined to be experimental or investigational under stated (and preferably objective) criteria. And, as with all plan terms, the plan document should clearly state that the plan administrator (or its delegate) retains discretion to interpret the exclusion.
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