CMS, Medicare Set-Aside Blog, WCRC on October 14, 2020
Posted by Noel D. Sturtz, Client Program Manager

An Amended Review success for our client: Their initial CMS-approved MSA included lumbar surgery and a spinal cord stimulator, both of which we had allocated based on the records reviewed. Per the additional records for the Amended Review, the claimant subsequently underwent lumbar fusion, with significant improvement such that the treating physician ultimately concluded that a spinal cord stimulator was not required. In our Amended Review, CMS agreed with our removal of the spinal cord stimulator. This resulted in a net 88% decrease from the original CMS approval amount.

It is noteworthy that in the above case the additional records did not contain discussions or recommendations for a spinal cord stimulator. As the original CMS approval included the stimulator, such “negative evidence” in the additional records would unlikely be sufficient in itself for successful removal from the allocation – especially with our noting where CMS has been aggressively including stimulators. The pivotal factor in this case, which we were able to find in the additional records, was the treating physician’s explicit recommendation against the need for the spinal cord stimulator.

Your takeaway: An original CMS-approved MSA is not necessarily a one-off. Interim changes in a claimant’s treatment and/or medication regimen may indeed warrant resubmitting to CMS.

The CMS Amended Review process is a one-time request to resubmit, provided that all of the following criteria are met:

  • CMS has issued a conditional approval/approved amount at least 12 months’ but no more than 72 months’ prior;
  • The case has not yet settled as of the date of the request for re-review;
  • No prior Amended Review has been submitted to CMS for consideration;
  • The new proposed amount results in at least a potential 10% or $10,000 change (whichever is greater) from CMS’s previously approved amount as a result of a change in medical treatment and/or medication regimen.

There is a caveat to the above: Changing from brand-name to generic drug types cannot be the sole reason for the Amended Review request. For example, a previously approved MSA included Lyrica 75mg, at #90 capsules per month. On July 22, 2019 generic Lyrica (pregabalin) was approved by the Food and Drug Administration. CMS will deny the request for re-review if it is solely to reflect the pricing difference between brand-name and generic Lyrica. However, should there be additional changes, such as a change in dosage and/or frequency, this would qualify for a re-review request (providing that the above-mentioned criteria are also met).

We are here to answer your questions about a potential Amended Review. Please feel to contact us at [email protected]

You may also wish to view the section on Amended Reviews in the updated WCMSA Reference Guide (version 3.2), which can be found here.