Lyrica has been the subject of recent discussions within the Medicare Set-Aside professional community. Submitters have been surprised to find CMS including Lyrica in WCMSA determinations in situations where it had previously been excluded. Since the Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide (Version 2.7, March 19, 2018) purports to explain the process used by CMS in approving proposed WCMSA amounts, an analysis of the Reference Guide drug projection provisions is warranted.
It is well settled that a WCMSA should only include injury related Medicare covered treatment and drug projections. Section 9.4.4 Step 9 of the Reference Guide notes that when reviewing prescription medications, reviewers will include medications that are “Food and Drug Administration (FDA) approved or supported for inclusion in the approved compendia.” Section 220.127.116.11 identifies the approved compendia as Micromedex’s DrugDex database and the American Hospital Formulary Service Drug Information database. If one or both of the compendia confirm a medically accepted off-label, or non FDA approved usage of the drug, the drug is covered by Medicare.
The Reference Guide further elaborates on off-label usage by referring to Medicare’s Internet Only Manual (“IOM”) 100-02, Chapter 15 Section 50.4.2 that discusses “unlabeled use of drug.” The IOM section discusses that the Medicare Part D carrier may determine that an unlabeled use of drug is covered by Medicare if the use is medically accepted. This decision would take into account “the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.”
In determining whether Lyrica is Medicare covered and thus belongs in the WCMSA, it is important to determine the FDA approved indications for the drug. Lyrica has been FDA approved as treatment for different conditions over the years. In 2004, Lyrica was FDA approved for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and as an adjunctive therapy for the treatment of partial seizures in adults. In 2007, Lyrica was FDA approved to treat fibromyalgia. In 2012, Lyrica was FDA approved for the management of neuropathic pain associated with spinal cord injury. Spinal cord injury may result from a fracture or dislocation of vertebrae, or it may be due to congenital abnormalities or infections. Lyrica CR extended-release was FDA approved in 2017 for management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Off-label compendia approved purposes for Lyrica also include the management of a generalized anxiety disorder and restless leg syndrome.
Lyrica is often prescribed in workers’ compensation cases for diagnoses outside of the FDA-approved indications, such as for neuropathic pain associated with lumbar radiculopathy. The lumbar radiculopathy is usually associated with a herniated or bulging disc. In applying the CMS test to determine the Medicare covered status of a drug, Lyrica would appear to be FDA approved if the herniated or bulging disc that causes the neuropathic pain is viewed as a “spinal cord injury.” Medical literature however suggests that an injury to a disc is different than an injury to the spinal cord. This interpretation is also consistent with CMS’ historical exclusion of Lyrica from CMS determinations involving neuropathic pain associated with a lumbar radiculopathy from a herniated disc. These determinations however were made by the prior Workers’ Compensation Review Contractor, Provider Resources Inc.
Given the recent CMS determinations that include Lyrica as a Medicare covered drug for neuropathic pain associated with a lumbar radiculopathy from a herniated disc, it is possible that the new WCRC has surreptitiously modified their interpretation of a “spinal cord injury.” On the other hand, the WCRC may also be viewing the workers’ compensation carrier’s payment of Lyrica in the underlying workers’ compensation claim as evidence that Lyrica is Medicare covered for the purpose for which it is prescribed. In either scenario, the WCRC’s actions in including Lyrica for a non-compendia approved non-FDA approved purpose conflict with the guidance outlined in the relevant WCMSA Reference Guide provisions. In addition, a carrier’s payment for a service or drug does not make it a Medicare-covered service.
Any change in a CMS Workers’ Compensation Review Contractor will always result in a bit of inconsistency when compared with the actions of the prior Workers’ Compensation Review Contractor. The inconsistency however should not and does not impact the determination of whether a drug is Medicare-covered for a specific diagnosis. This issue, unlike others, is straightforward. Attempts to thwart the established analysis of Medicare coverage of drugs should be challenged.
We will keep you advised of further developments.