Answers by Amy

4.24.2019 Blog

A few months ago, we submitted an MSA in a case where Lyrica was being prescribed “off-label” for a diagnosis of lumbar radiculopathy.  CMS included it in the MSA.  The inclusion of Lyrica inflated the MSA astronomically, and nearly prevented the case from settling.  I received this question:  “How can the rules just change like this?  Isn’t there some sort of advance notice required for changes like this?  This just isn’t right!”

The Medicare Secondary Payer (MSP) industry started seeing the inclusion of Lyrica in cases with diagnoses of lumbar radiculopathy in late-2018, months prior to the publication of the updated Reference Guide in January of 2019.  Prior to that publication, the Executive Board of the National Alliance of Medicare Set-Aside Professionals (NAMSAP), including myself, discussed the Lyrica problem with the Division of MSP Program Operations at Medicare (CMS).  Mr. Steve Forry and his team essentially explained that their team (now) sees radicular pain as neuropathic pain stemming from spinal cord injury.  With that noted, local coverage determinations do not always support the coverage of Lyrica for lumbar radiculopathy.  So how can a change like this, which was tremendously expensive, have happened without any notice?  My cynical answer – Because every dollar in a CMS-approved MSA is accounted for as “savings” by Medicare, and the industry hasn’t fought back on unannounced, big changes like this enough in the past.

The Lyrica question has now been answered in the Reference Guide as mentioned above, but this is not the only time CMS has made changes within their approval process without advanced notice to the Medicare Secondary Payer community.  We have recently seen inclusion of quarterly urinary drug screens (UDS) in cases with opioid projections, over life, even when the treating physician has never prescribed a UDS.  The Centers for Disease Control and Prevention do not recommend quarterly drug screens, and in fact notes that for UDS to be effective it should not be done on a schedule but instead randomly.

Another example is blood work.  There are plenty of medications which do not require routine blood work, but any time any medication is included in an MSA, we see at least annual blood work included in the WCMSA approval.  Why is this, and isn’t this excessive?

The purpose of the MSP Program Operations division is to protect the integrity of the Medicare Trust Fund and ensure monies are not spent from that trust fund when a primary payer should be paying.  The MSA program is a legal fiction, a voluntary process devised by Medicare in an attempt to avoid making post-settlement medical payments.  It is in Medicare’s best interest to over-include medications and services rather than under-include.

The MSA program does not adapt well for variations in state law; MSA pricing policies are applied across-the-board, regardless of whether there would be coverage under the state law.  The workers’ compensation industry has perceived such a benefit to closing all aspects of a file, and payers voice great concern about being made “the example” if they do not use the “voluntary” WC MSA submission. As I see it, both of these have led to complacency in fighting back against inappropriate and constantly changing CMS MSA policies.  Unfortunately, too many insurers and self-insurers have resigned to over funding MSAs.

In answer to our questioner’s inquiry, CMS’ voluntary process is tweaked internally all the time without notice to the payers or submitters.  In a system that oft surrenders to over-funding of MSAs, and constantly expresses concern of being “made an example of,” CMS’ behavior is not surprising.  For this reason, NBKL and NAMSAP are leading the charge for notice, fairness and equity on this playing field.

I will be attending a meeting with Mr. Forry and his group on April 30, 2019 to address issues like this, including the inclusion of urinary drug screen and blood work, and will push for advanced notice of these types of changes and publication in the Reference Guide moving forward.  We plan to underscore that when the rules constantly change in the middle of the game, people pick up their balls and go home.  If CMS really wants to continue with this “voluntary” review process, the rules will have to be laid out in advance or CMS will be facing a reality of more “non-submit” programs.  Currently, non-submit MSAs are not included in CMS’ reported “savings,” which means that over time, bullying MSA submitters will backfire.

As a workers’ compensation defense attorney, a Medicare Secondary Payer professional who submits MSAs, and as the current President of NAMSAP, I will continue to push for fairness and transparency in the MSA process.  Hopefully, with persistence and these demands for accountability, we will not see a repeat of the Lyrica debacle that cost payers hundreds of thousands of dollars without advance notice and due process.

Are you interested in being part of the fight?  Consider joining NAMSAP:


The NBKL blog is provided for informational purposes; we are not giving legal advice or creating an attorney/client relationship by providing this information.  Before relying on any legal information of a general nature, you may consider consulting legal counsel as to your particular facts and applications of the law.