Allocating for Botulinum Toxin Injections

Medicare Set-Aside Blog, Medicare Set-Asides on June 26, 2013
Posted by Marilyn Larrimer, JD, RN

Botulinum toxins are neuromuscular blocking agents that are prescribed and administered by physicians for a variety of spastic disorders and excessive muscle contractions. Botulinum toxins aid in the treatment of overactive skeletal muscles, smooth muscles and glands. Currently, in the United States, the available botulinum products are: Botox®, Myobloc®, Dysport® and Xeomin®. While similar in form, yet distinct chemically, these products have unique characteristics and dosing properties. Each product is FDA approved for specific conditions which vary from product to product.

Completing an MSA for a Claimant receiving injections of botulinum toxins requires a careful analysis of the diagnosis for which the injections were recommended. The specific drug used, dosage and method of administration and efficacy of the injections must be taken into consideration. Although Medicare will provide coverage for botulinum injections if certain criteria are met, there is no National Coverage Determination (NCD) as yet from Medicare to provide guidance. There are several Local Coverage Determinations (LCDs) that do provide guidance with the understanding that LCDs by definition have jurisdictional restrictions. 

Although an LCD may not be applicable in the jurisdiction for which the MSA is being written, the LCDs still provide some guidance as to possible Medicare coverage.

The first step in the analysis is to determine if the botulinum injections are prescribed for a condition for which Medicare provides coverage (Botox for cosmetic purposes is not a Medicare-covered expense). Cervical dystonia, spasmodic torticollis, spastic hemiplegia and chronic headaches are diagnoses frequently encountered during the completion of an MSA that require an analysis to determine if the condition is approved and if so, a reasonable allocation. The cost for  the injections is typically expensive (for example, the AWP unit price for 100 units of Botox, NDC 0023114501, is $630.00) and allocation over a long life expectancy for injections administered every three to six months can be significant.  Factors to be considered in the analysis include the diagnosis for which the injections are administered, the frequency of the injections, the dose used, and the documented efficacy of the treatment. Administration of botulinum toxin for treatment of headaches is an area that requires extra scrutiny to determine if the injections would likely be Medicare covered. Documentation as to the frequency and duration of headaches, failure of conventional treatments, and documentation of a decrease in the frequency of headaches are considerations articulated in the LCDs.

Medicare will approve payment for one injection site without consideration as to the number of muscles injected. Failure of two consecutive treatments involving a muscle or group of muscles may preclude coverage of additional injections with that particular medication for a period of one year, although treatment with another form of botulinum toxin is not precluded.

Although a NCD would greatly aid in the analysis and allocation of botulinum injections, in the end, the analysis which results in a reasonable allocation will always require an evaluation specific to the individual Claimant and his/her treatment plan as articulated by the physician.   



LCD for Botulinum Toxins (L26841)
LCD l32624-Botulinum Toxin Types A and B