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

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 #

What Do We Tell New Research Subjects? Medicare Advantage Plan Information Sheet (patient handout) http://www.ohsu.edu/xd/research/about/integrity/irb /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 #

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 #

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 #

Patient Information Sheet #

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 http://ozone.ohsu.edu/research/rates/index.shtml Device trial enrollment notification Notify CRBO when a patient signs consent for a device trial #

Questions? Call the CRBO with ANY questions about billing for clinical services on a study. Clinical Research Billing website http://www.ohsu.edu/xd/research/about/in tegrity/irb/clinical-research-billing.cfm Email CRBO@ohsu.edu 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 #