Lyrica (pregabalin) received FDA approval in 2004 and was then listed as a schedule V controlled substance, having a low potential for abuse. Approved indications for Lyrica include treatment of neuropathic pain associated with diabetic peripheral neuropathy, spinal cord injury and post-herpetic neuralgia; fibromyalgia; and as adjunctive therapy for partial onset seizures. However, it is common to see Lyrica prescribed for off-label usage, such as chronic pain and anxiety disorder. Use of Lyrica for off-label indications may not be covered by Medicare.
In the past, the Workers’ Compensation Review Contractor (WCRC) excluded Lyrica from Workers’ Compensation Medicare Set-Aside Arrangements (WCMSAs), when the medication was prescribed for pain or radiculopathy; however, recently the WCRC has started to include Lyrica in certain situations, citing the WCMSA Reference Guide, Section 188.8.131.52, which states, “FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.” Given that the FDA indications and non-FDA approved uses have not changed in the major drug compendia, it is presumed the WCRC is relying on the accepted standards of medical practice to include Lyrica in WCMSAs. Attorneys should be careful to ensure that their client’s Lyrica will be covered pursuant to any settlement regardless of the contractor’s changing decisions on whether or not to include Lyrica in the MSA.