November 7, 2018 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Kelly Willenberg, Manager of Kelly Willenberg & Associates.

Kelly, what is the problem with Medicare Advantage plans and clinical trials?

Conventional Medicare Parts A and B cover routine costs in qualifying clinical trials, i.e., those costs that a study participant would incur in the absence of a clinical trial, plus provisions around the investigational drug and the prevention and monitoring of complications. When a site enrolls a Medicare Advantage (Part C) patient, it gets complicated, and it matters whether the participant is on a drug or device.

If you enroll a study participant who is in a Medicare Advantage plan, routine study costs are supposed to be covered by his or her Advantage plan in an IDE device study, but, if it is an NDA drug study, the participant must be converted over to traditional Medicare. If the conversion is not done correctly, the participant can be left holding the bag.

So, let me get this straight, if I pay extra money to get better healthcare through a Medicare Advantage plan, I lose coverage when I enroll in a clinical study?

Yes, sometimes that can happen, and the participant’s costs increase. It’s complicated, since it can depend on the type of study, the plan, and the claims processing rules.

Whose idea was that?

It might not have been anybody’s idea, just another example of clinical research falling in a crack when larger issues of healthcare are addressed. Medicare Advantage plans are

responsible for payment of claims related to enrollees’ participation in both

Category A and B IDE studies that are covered by the Medicare Administrative Contractor with jurisdiction over the Advantage plan’s service area. (Medicare Managed Care Manual Chapter 4 - Benefits and Beneficiary Protections 10.72)

If the participant is in a drug study, his or her payer changes. Also, some Medicare Advantage plans will not cover IDEs — it depends on the plan and the benefit coverage.

So, what can you do?

There are three options, none of them very pleasing. The first option is for a patient to drop his or her Medicare Advantage plan for the duration of the study and then restart it after the study, but Medicare enrollment is limited to annual enrollment periods. The second option is for the site to apply to Medicare for reimbursement of each instance of routine care in a drug trial, bill the Advantage plan for the gap so the patient is made whole, and consent the patient properly so he or she is aware of what will happen and what costs he or she will incur. This process is very time consuming for sites, assuming a site even understands the rules. The third option is to just throw up your hands and forget about participating in clinical trials, which some patients opt for when they are told how it works, which can lead to lower study accruals.

How much money do Medicare Advantage insurers save with this policy?

While they do save on routine costs during a drug trial, they can pay a lot more when a policy holder does not enroll in an IDE device trial and is thus not provided with the device at no cost. This tradeoff is one reason Medicare Parts A and B started to cover routine costs during all qualifying clinical trials, as per the expanded clinical trial benefits in NCD 310.1, in 2000. Remember, the commercial companies that operate Medicare Advantage plans have discretion over what those plans do or do not cover.

Am I the only one confused by all this?

Not hardly. Feel free to call the CMS Administrator and sort it out with her.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.