Medicare Advantage & Clinical Trials

MEDICARE ADVANTAGE & CLINICAL TRIALS

CHANGES EFFECTIVE 1/1/11

(Revised 01/06/11)

Effective 1/1/11, Medicare Advantage Plans (Med Adv) are required to pay the difference between Medicare coinsurance and Med Adv co-pays for research subjects with Med Adv. Medicare will still be billed for all qualifying clinical trial services, but Med Adv will be billed as secondary and the patient will only be responsible for Med Adv co-pay amounts.

Medicare Advantage Research Subject Study Status / Previous OHSU Procedure / New OHSU Procedure Effective 1/1/11 / Change for Research Subject Costs? / Research Subject Out-of-Pocket Costs? / Notification to Research Subject of Change?
Enrolled on qualifying clinical trial prior to 1/1/11 and NOT notified of additional out-of-pocket expense associated with billing Medicare (did not sign Med Adv Information Form) / All clinical trial services billed to Medicare. Research subjects NOT required to pay any Medicare coinsurance for past or future services on qualifying clinical trial due to lack of notification at time of study enrollment and no Med Adv co-pays collected. / All clinical trial services billed to Medicare. Med Adv Plan billed as secondary. Research subjects NOT required to pay any Medicare coinsurance for past or future services on qualifying clinical trial due to lack of notification at time of study enrollment and no Med Adv co-pays collected / None / None / Yes*
Enrolled on qualifying clinical trial prior to 1/1/11 and notified of additional out-of-pocket expense associated with billing Medicare (signed Med Adv Information Form) / All clinical trial services billed to Medicare. Research subjects responsible for Medicare coinsurance. / All clinical trial services billed to Medicare. Med Adv Plan billed as secondary. Research subjects responsible for Med Adv co-pay / Yes. Medicare coinsurance now paid by Med Adv Plan. / Med Adv co-pay / Yes**
Medicare Advantage Research Subject Study Status / Previous OHSU Procedure / New OHSU Procedure Effective 1/1/11 / Change for Research Subject Costs? / Research Subject Out-of-Pocket Costs? / Notification to Research Subject of Change?
Enrolled on qualifying clinical trial after 1/1/11 / Not applicable / All clinical trial services billed to Medicare. Med Adv Plan billed as secondary. Research subjects responsible for Med Adv co-pay / Not applicable / Med Adv co-pay / Yes**

*Research subjects who have not been previously responsible for any out-of-pocket costs due to lack of notification at time of consent will continue to have no out-of-pocket costs. However, they should be notified that the Med Adv plan is now being billed for Medicare coinsurance.

**Lack of notification to the research subject does NOT prevent OHSU from billing the research subject for Med Adv co-pay amount. This is due to the fact that research subjects would be responsible for Med Adv co-pay amounts regardless of clinical trial participation.

NOTE: Pre-authorization requirements associated with billing Med Adv plans may still apply even when billing as secondary insurance. When in doubt, confirm with plan.

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