Proposal Would Limit Use of Botulinum Toxin on Patients with Hemifacial Spasm and Facial Dystonia

Clinical Question

How might a recent Medicare policy proposal concerning off-label use of botulinum toxin injections affect patients with hemifacial spasm and facial dystonia?

Bottom Line

The failure of a proposed Medicare policy regarding off-label use of botulinum toxin injections to account for variability in the needs of patients with hemifacial spasm and facial dystonia could result in compromised quality of care for this vulnerable population.

Background: Hemifacial spasm and facial dystonia cause significant physical

functional impairment and greatly impact patients’ psychological and social well-being. For many of these individuals, botulinum toxin provides substantial relief and improves quality of life; however, a new proposal seeks to limit the off-label uses of botulinum toxins in the Medicare population.

Study design: Commentary

Setting: Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tenn.

Synopsis: Authors describe the potential challenges of a policy proposal from the Centers for Medicare and Medicaid Services’ Medicare Administrative Contractor (MAC) CGS Administrators LLC. The Proposed Local Coverage Determination, Botulinum Toxin Injections (DL 39857) limits the off-label use of botulinum toxins in the Medicare population. In lowering the dosage amounts and injections covered, the proposal would impede physicians’ ability to adequately treat patients affected by hemifacial spasm and facial dystonia. For a patient with hemifacial spasm, for instance, the dosage limit of 25-30 BU on the affected side of the face may be insufficient to achieve the desired effects. The authors note the impact of this dosage limitation on patients with nonflaccid facial paralysis, as research shows that 2–106 BU of neurotoxin has been needed to achieve symptomatic control in these patients. Overall, the potential impact of these limitations on patient care is suboptimal treatment outcomes and a poorer quality of life for patients. Moreover, authors point out, inadequate symptom control may lead to more frequent visits to receive lower doses of neurotoxin, offsetting the cost savings the proposal is designed to achieve.

Citation: Barna AJ, et al. Impact of proposed Medicare policy changes for botulinum toxin coverage on hemifacial spasm and facial dystonia [published online ahead of print January 31, 2025]. Facial Plast Surg Aesthet Med. doi:10.1089/fpsam.2024.0281.

Comment: The Barna paper discusses the potential impacts of proposed Medicare policy changes for coverage of botulinum toxin for patients with hemifacial spasm and facial dystonia. These changes would impact how tens of thousands of patients with hemifacial spasm and facial paralysis receive standard-of-care treatment for their facial tightness, spasms, synkinesis, and asymmetry. Matthew Miller, MD