Medicare DISadvantage in clinical trials

Kelly M. Willenberg (Kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg, LLC in Chesnee, SC.

A Medicare Advantage Plan (MAP) is a type of a Medicare health plan offered by a private company that contracts with Medicare to provide Part A and Part B benefits for beneficiaries. If a patient chooses to join a Medicare Advantage Plan, some clinical trial costs may be covered by the plan. What exactly does that mean for the patient?

According to the Medicare Claims Processing Manual, Chapter 68.4, clinical trials involving an investigational device are billable to Medicare as long as the services are a routine cost. The Category B device is also allowed to be billed as long as the trial is approved by Medicare. The Medicare Managed Care Manual then goes on to explain (in Chapter 10.7.2 — Payment for Investigational Device Exemption (IDE) Studies) that the MAP is responsible for payment of claims related to enrollees’ participation in both Category A and B IDE studies that are covered by the Medicare Contractor that has jurisdiction over the MAP’s service area. So, the MAP is supposed to cover routine costs in IDE studies but not drug studies. Why is there a difference? Can we make this process any more confusing?

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