Billing and Coding: Botulinum Toxin Types A and B Policy

The following coding and billing guidance is to be used with its associated
Local coverage determination.

Documentation must support the medical necessity of this service as outlined
in the Indication and Limitations of Coverage and/or Medical Necessity section
of the LCD Botulinum Toxin Types A and B.  
 _Additional Documentation Requirement:_  
The patient's medical record should include the following elements to support
the medical necessity of the botulinum toxin injection:

  * Type of botulinum toxin used: Botox (onabotulinumtoxinA), Dysport (abotulinumtoxinA), Xeomin (incobotulinumtoxinA) or Myobloc (rimabotulinumtoxinB)
  * Strength of toxin used
  * A covered diagnosis (However, when a form of botulinum toxin is used for an indication that is not a listed indication in the AHFS, a physician statement in the medical record stating the reason(s) why the unapproved form was used is also required).
  * A statement that traditional methods of treatments have been tried and proven unsuccessful (except for focal dystonia, hemifacial spasm, orofacial dyskinesia, blepharospasm, severe writer's cramp, laryngeal spasm, or dysphonia).
  * Dosage used in the injections.
  * Support for the medical necessity of electromyography procedures if performed.
  * Support of the clinical effectiveness of the injections.
  * A complete anatomic description of the site(s) injected.

When the documentation does not meet the criteria for the service rendered or
the documentation does not establish the medical necessity for the services,
such services will be denied as not reasonable and necessary.

Due to the short life of botulinum toxin, Medicare will reimburse the unused
portion of these drugs. (R3538CP-1) Therefore, scheduling of more than one
patient, where possible, is allowed to prevent wastage of botulinum toxin.

In all cases, the documentation must show the exact dosage of the drug given
to the patient, the reason for unavoidable wastage, and the amount of the
discarded portion of the drug.

If a single dose vial is split between multiple patients, Medicare will allow
payment only for the portion used for the beneficiary plus a pro rata amount
for wastage. Note that if non-Medicare patients are treated with a portion of
the same vial, it would be expected that those non-Medicare patients be billed
for their pro rata share of wastage.

Bill Medicare patients for wastage using the -JW modifier on a separate line
and the appropriate number of units, rounded to the nearest unit such that the
total billed does not exceed the contents of the vial.

For split vials, for example, if patient 1 received 30 units and patient 2
received 60 units from a 100 unit vial, wastage billed with -JW would be:

  * patient 1: 3 units [(30 units used for the patient/90 total units used) * 10 units of wastage = 3.33 rounded to 3]
  * patient 2: 7 units [(60 units used for the patient/90 total units used) * 10 units of wastage = 6.66 rounded to 7]

If additional vials are needed to address the needs of a set of patients, pro
rata wastage should be calculated over the total vial volume for that session.
Furthermore it is expected that a provider will use the most economical
combination of vials that will meet the needs of a set of patients should
multiple sizes be available.

If the HCPCS code for the administered drug represents other than 1 unit of
drug (e.g., 100 units of the drug could be 1 HCPCS "unit") rounding should be
in relation to the nearest full HCPCS unit for the administered drug (rounded
down) and any reported wastage (rounded up, but not to exceed the total
contents of the vial)