07/12/2024

OOS Comments Submitted for Proposed LCD — Botulinum Toxin Injections

OOS President, Aleksandra Rachitskaya, MD submitted the following letter of comments on CGS’ draft local coverage determination (LCD) DL 39857 — Botulinum Toxin Injections.

July 2, 2024

Dear Colleagues,

The Ohio Ophthalmological Society (OOS), which represents 400 ophthalmologists in Ohio appreciates the opportunity to submit comments on CGS’ draft local coverage determination (LCD) DL 39857 — Botulinum Toxin Injections. We write to share our concerns that the proposed LCD will restrict patient access to proven, medically necessary care by arbitrarily restricting the dosage amounts, number of injections, and injection sites to be less than the longstanding standard of care for treatment of blepharospasm.

The coverage criteria proposed in DL 39857 reference the OnabotulinumtoxinA (Botox®) package insert, which was published in 1989 by the Food and Drug Administration and does not reflect current standards of clinical practice.

Blepharospasm is a progressive and lifelong condition which inhibits patients’ ability to independently function and go about their activities of daily living. Ophthalmologists must continuously monitor clinical reaction to injections and potentially adjust the dosage, injection site, and the type of botulinum toxin utilized in subsequent treatments.

Depending on manifestation of the disease, patients with blepharospasm may require 6 or more injections per eye across the orbicularis, procerus, corrugator, and frontalis muscles, totaling as much as 60 or more units of botulinum toxins for bilateral disease. Effective coverage policy should not limit treatment to less than this standard of care.

The OOS strongly supports policy revisions to finalize Medicare coverage which allows flexibility to deliver effective, medically necessary treatment for blepharospasm. Thank you for your consideration of these comments and recommendations. We look forward to continuing our dialogue. Please contact us with any further questions or to request a meeting.

Sincerely,

Aleksandra Rachitskaya, MD
OOS President