1. Medicare Advantage & Clinical Trials
Melanie Hawkins, BSN, RN, CCRC
Director, Clinical Research Billing Compliance

2. Changes Effective January 1, 2011
Medicare Advantage Plan will be required to “reimburse” patient for additional out-of-pocket expense associated with billing Medicare – eliminates disincentive to enroll in study
OHSU will bill Medicare Advantage Plan on patient’s behalf after Medicare has paid
Patient responsible for Medicare Advantage Plan co-pay
OHSU will bill patient for co-pay
No difference for in-network vs. out-of-network #

3. What Do We Tell New Research Subjects?
Medicare Advantage Plan Information Sheet (patient handout)
/clinical-research-billing.cfm
No signature required – No IRB approval necessary – No scanning into Epic
Patient will be billed for Medicare Advantage co-pay even if not notified at time of study enrollment
Same out-of-pocket cost per service #

4. What About Those Already Enrolled?
Patients who have been on trials and were grandfathered in due to lack of notification
No change - no out-of-pocket
Notification of billing change (form) is recommended to avoid confusion
Patients who were notified about Medicare billing at time of study enrollment and who are currently paying Medicare coinsurance
Less out-of-pocket
Notification of billing change recommended #

5. Will This Change Go Smoothly??
PBS/UMG has made already made change in registration and billing process
Some Medicare Advantage Plans are unaware of new requirement so we will be “educating” them
Some Medicare Advantage Plans will push back
Medicare has made it very clear that Medicare Advantage Plans must pay and that there is no distinction between in- network and out-of-network providers in this circumstance.
Plans may require that patient pay and be reimbursed – not allowed per Medicare #

6. Patient Information Sheet#

7. Other Research Billing Tidbits…
Updated Research Rates Forms
Old form has been revised and new form is available – use of either is acceptable
PBS only needs final Clinical Research Billing Schedule – do not send lay summary or Medicare checklist
Research Industrial Account Request Form still required to create research account
Forms can (soon) be found at
Device trial enrollment notification
Notify CRBO when a patient signs consent for a device trial #

8. Questions?
Call the CRBO with ANY questions about billing for clinical services on a study.
Clinical Research Billing website tegrity/irb/clinical-research-billing.cfm
Contacts:
Kristin Couture, Clinical Research Coverage Analyst, x4-4790
Dena Clawson, Clinical Research Billing Specialist, x4-3515
Melanie Hawkins, Director, Clinical Research Billing Compliance, x4-8586 #