Currently, one of the most talked about MSA topics is off-label drug costs.  The CMS May 14, 2010 policy memo (which can be read at our website) allows off-label drug costs to be excluded from MSA's.  However, claims handlers, attorneys, and MSA providers have been dismayed by the inconsistencies in CMS application of this policy memo. 

 

When a drug is prescribed for a use that has not been approved by the FDA, it is considered "off-label."  CMS interprets accepted drug compendia to determine whether or not a drug is prescribed for an off-label use. 

 

We recently requested a CMS "re-review" for the purpose of removing the cost of Cymbalta from an MSA.  We prevailed in our argument that Cymbalta was being prescribed for an off-label use, and CMS removed over $46,000.00 from the MSA.  Our request cited a doctor's note, which clearly stated Cymbalta was being prescribed specifically for neuropathic pain in the lumbar area.  Per the CMS accepted compendia, treatment of neuropathic lumbar pain is not an approved use of this drug. 

 

Recently, a client asked us how to reduce MSA costs for a case she was trying to settle. We let her know that $70,000.00 had been included in the MSA for the cost of the drug, Omeprazole.  We explained that if she could obtain medical documentation of the specific reason the doctor was prescribing Omeprazole, we could evaluate whether it was being prescribed for off-label use.  Our client obtained the doctor's signed statement indicating he was prescribing it for gastrointestinal problems caused by other medications.  Omeprazole has not been approved by the FDA for this problem.  So, we were able to remove the $70,000.00 cost from the MSA.  When CMS reviewed the proposed MSA, exclusion of this substantial cost was allowed. 

 

CMS interpretation of the drug compendia is not always clear.  For example, CMS has included MSA costs for drugs that are approved for the treatment of Major Depression, even when that diagnosis has not been documented in the medical records.  If symptoms of any form of depression are documented in the medical records. CMS tends to include the drug cost, even in the absence of the Major Depression diagnosis. 

 

Remember that your Medicare Set Aside (MSA) is only as definitive as the medical records that support it.  If it is unclear why a particular medication is being prescribed, it will be difficult to argue that medication is being prescribed for off-label use.

 

Our firm will continue to diligently seek ways to mitigate the high cost of medications by making medically indicated drug reductions based on contra-indications, duplication of drugs, over-utilization and lifetime medical impact on the claimant. We continue to observe and challenge the manner in which CMS applies the May 14, 2010 policy memo. As always, should you have questions about MSA drug costs or any other MSA issues, we are here to help.