Not too long ago, Medicare began covering certain of the costs of those clinical trials which meet very specific approval requirements. Prior to that time, clinical trials were considered to be “experimental,” and nothing was covered under Medicare. The information on this is in section 2.13 of Managing Your Medicare, on page 57.
This section of the book also mentions that even beneficiaries in Medicare Advantage must have these costs covered, and that this is true even if they use out-of-network services, which is normally the case with clinical trials. For 2011, the Center for Medicare & Medicaid Services has given Medicare Advantage Plans additional direction on this issue, specifically:
1. Plans will be required to reimburse enrollees for the difference between fee-for-service cost sharing incurred for covered clinical trial items and services and the Medicare Advantage Plan’s in-network cost sharing for the same category of service. What this means is that if you get a clinical trial service that is Medicare covered, let’s say a specialist’s consultation, and that Original Medicare would approve $100 for the consult, and pay $80, and you are billed for the 20 percent coinsurance, or $20, but for this same type of consult your Plan’s in-network rule is that you are responsible for a co-payment of $15, then you are responsible for only this $15, and your Plan is responsible for the remaining $5.
What is basically going on here is that the clinical trial people are charging you as if you were in fee-for-service Medicare, but you are responsible only for what you would pay under the terms of your Plan’s benefit structure. One of the issues here is that because the clinical trial people have no contractual relationship with your Plan, they may bill you the standard Medicare coinsurance. If this happens, you may submit the bill to your Plan, and it must pay the provider any difference between what you owe under their rules and the Medicare fee-for-service amount.
(And it’s quite possible that the clinical trial people may send you a bill for the whole service because they don’t understand that you are in a Plan. If this happens, send the whole bill to your Plan, and make sure, when they process it, that they pay everything except what you would owe for an in-network service.)
So you get the nice benefit of getting a covered clinical trial service out-of-network, but you pay only what you pay if you had gone in-network. Not bad. But it gets better!
2. Starting in 2011, your Medicare Advantage Plan, in adding up all the medical costs which count toward your annual out-of-pocket maximum amount, must include in these medical costs not only what you pay out-of-pocket, but also what it must pay under the new rule just discussed. So in the example given, your Plan has to count toward your yearly maximum not only the $15 you were responsible for, but also the $5 it had to pay. That is, $20 will go to count for your annual out-of-pocket maximum, not just $15.
And be aware that you do not have to get any pre-authorization or permission from your Plan to join a clinical trial, or even advise them that you are in such a trial. However, best advice seems to be that, if you are in a coordinated care Plan of any type, letting your Plan’s health care providers know what is going on with all of your health care is very important. And, as it has no other way of knowing, your Plan may ask you for information it needs to properly process claims relating to the clinical trial.
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