Denial of Off-Label Medicines in Medicare Part D

I have been helping the Medicare Rights Center (MRC) with some appeals of Medicare Part D plans denying coverage for off-label uses of FDA approved medicines. These denials are based on a very detailed provision in the 2003 Medicare Modernization Act that the Centers for Medicare and Medicaid Services (CMS) interprets to mean that Part D can only cover FDA approved medicines for off-labeled uses that are listed in at least one of three specific compendia.

I became involved with the MRC’s work on this issue because as a Congressional staff person I had helped write a 1993 law that expanded coverage for cancer treatments under Medicare Part B (that’s “B” as in ball) to specifically include off-label uses listed in the compendia OR supported by articles published in peer reviewed literature. (The Department of Health and Human Services developed a list of acceptable peer reviewed journals.) This process has worked well, but what it means now is that off-label uses of medicines to treat cancer supported by peer reviewed literature are covered under Medicare Part B, but NOT under Part D (that’s “D” as in drag).

For those interested in more details: The general difference between prescription drug coverage under Medicare Parts B and D is that Part B pays for medicines that patients cannot give to themselves, (so-called not “self-administerable” forms of medicines), while Part D pays for pills (and other forms of medicines that are self-administerable). However, the 1993 law required Part B to cover pills-type medicines to treat cancer if they are the same chemical medicine that Part B would otherwise pay for in an infusion form. Therefore, almost all oral medicines are covered under Part D.

Without getting into too many details of federal law, the issue for the MRC’s appeals comes down to how the Medicare Part D law references Medicaid’s definition of “medically approved indication” in directing what medicines are covered in what situations. The problem arises because Medicaid’s “medically approved indication” definition does not include coverage based upon peer reviewed literature – even though State Medicaid plans can include that coverage – and over 40 states do!

While this is a narrow situation, its impact on an individual can be huge – potentially representing of thousands of dollars per year per person. Medicare Part D says these costs are not their responsibility. State Medicaid programs (many of which would pay for these medicines for patients if Medicaid was their primary insurer) say these costs are not their responsibility since Medicare should be paying for them. So individuals are left to pay for these medicines themselves. And since Medicare doesn’t even “count” this spending towards the patient’s “drug spending,” it doesn’t move them through the Medicare Part D donut hole into the catastrophic coverage zone, where Medicare Part D would at least pay most of the costs of all their other medicines.

The Medicare Rights Center is handling a number of appeals on this issue, and is also involved with other groups trying to clarify the underlying law. If you have any other situations like this, I’d like to hear about it. You can also contact the MRC, although I understand that because of resource limitations, they are not taking any more specific Part D off-label appeal cases. However, they do have an appeals handbook and other Part D resources for physicians and patients [See halfway down the page under “Using Your Drug Plan.”]

What do you think about all this?

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