New Year, New Changes to the Workers’ Compensation Medicare Set-Aside Reference Guide

Today CMS issued an announcement that they have released Version 2.9 of the Workers’ Compensation Medicare Set-Aside Arrangement Reference Guide (Reference Guide), which can be found here. Per the new version, the changes included in this version of the guide are as follows:

• To eliminate issues around Development Letter and Alert templates auto populating with individual Regional Office (RO) reviewer names and direct phone numbers, these will now display the generic “Workers’ Compensation Review Contractor (WCRC)” and the WCRC customer service number “(833) 295-3773” (Appendix 5).
• Per CMS’ request, certain references to memoranda on cms.gov have been removed.
• The CDC Life Table has been updated for 2015 (Section 10.3).
• Updates have been provided for spinal cord stimulators and Lyrica (Sections 9.4.5 and 9.4.6.2)

The most noteworthy changes are those in regards to the spinal cord stimulators and Lyrica. In regards to the spinal cord stimulators, CMS specifically included in this version that “Routine replacement of the neurostimulator pulse generator includes the lead implantation up to the number of leads related to the associated code. Revision surgeries should only be used where a historical pattern of a need to relocate leads exist” …and “Surgery pricing may include physician, facility, and anesthesia fees. SCS pricing is based on identification of: 1.) Rechargeable vs. Non-rechargeable and 2.) Single vs. Multiple Arrays (leads). If unknown, CMS will default to non-rechargeable single array.” These pricing clarifications appear to be in line with the approved MSAs that CMS has approved over the last few months.

Lyrica has been a hotly discussed topic over the last few months. Those who are active in the industry have noted that Lyrica has been included more and more in many MSAs for conditions that are not related to a spinal cord injury, when this has been historically argued as an off-label usage. However, CMS seems to have quashed this debate with the release of the updated language regarding this prescription. Per the new update, “Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. Lyrica is considered acceptable for pricing as a treatment for WCMSAs that include diagnoses related to radiculopathy because radiculopathy is a type of neuropathy related to peripheral nerve impingement caused by injury to the supporting structures of the spinal cord.” In other words, a diagnosis of radicular/neuropathic pain would now support the inclusion of Lyrica in a MSA. Again, this has been in line with the recent approvals issued by CMS wherein this prescription medication has been included for radicular pain, such as radicular pain noted into the upper and/or lower extremity pain. However, in its attempts to clarify Lyrica’s accepted usage CMS has muddied the waters in the language when indicating “injury to the supporting structures of the spinal cord”. This could open the door to inclusion for conditions that are arguably unrelated to the spine simply because other areas of the body touch the spine. I.e. If prescribed for pain that originates not at the spine (ex. radicular pain from a shoulder injury).

The Gordon and Rees Medicare group will continue to follow this issue closely and will update you as soon as additional information is available.