Billing and Coding: Botulinum Toxins

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38809, Botulinum Toxins. Please refer to the LCD
for reasonable and necessary requirements.

According to the FDA Label indications, botulinum toxin treatment for
blepharospasm and chronic migraine headaches is limited to specific muscles.
The muscles that are currently FDA approved are listed below. Please refer to
the LCD for complete coverage guidelines.

Currently the following muscles are FDA approved for Onabotulinumtoxin A
(BOTOX) injections for chronic migraine headache treatment:

  * Corrugator
  * Procerus
  * Frontalis
  * Temporalis
  * Occipitalis
  * Cervical paraspinals
  * Trapezius

Currently the following muscles are FDA approved for Onabotulinumtoxin A
(BOTOX) injections for blepharospasm treatment:

  * Medial and lateral pre-tarsal orbicularis oculi muscle of the upper lid
  * Lateral pre-tarsal orbicularis oculi muscle of the lower lid

Currently the following muscles are FDA approved for Incobotulinumtoxin A
(Xeomin) injections for blepharospasm treatment:

  * Lateral and medial superior pre-tarsal part of the orbicularis oculi muscle
  * Lateral canthus of the orbicularis oculi muscle
  * Inferolateral portion of the orbicularis oculi muscle
  * Corrugator muscle 

**Coding Guidance**

**Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by the entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.

The administration/injection code should be reported on the same claim with
the botulinum toxin medication. When the botulinum toxin medication is denied,
the related injection code(s) will also be subject to denial.

**JW and JZ Modifiers**

When billing for Part B drugs and biologicals (except those provided under a
competitive acquisition program [CAP]), the use of the JW modifier to identify
unused drugs or biologicals from single-dose containers or single-use packages
that are appropriately discarded is required. The discarded amount shall be
billed on a separate claim line using the JW modifier. Providers are required
to document the discarded drug or biological in the patient's medical record.

Any amount wasted must be clearly documented in the medical record and should
include the date and time, amount of medication wasted, and the reason for the
wastage.

The use of the JZ modifier (attesting that there were no discarded amounts) is
required on claims to report there are no discarded amounts of unused drugs or
biologicals from single-dose containers or single-use packages.

Claims for drugs separately payable under Medicare Part B from single-dose
containers are required to report either the JW or JZ modifier to identify any
discarded amounts or to attest that there are no discarded amounts
respectively.

  * The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.
  * The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator "N1" (ASC).

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. Medical record documentation maintained by the ordering/referring provider must support the medical necessity of the services as stated in the LCD and should include the following elements in the event of a post payment review:

  *     * Documentation of unsuccessful, inadequate response, or not a candidate for conventional methods of treatment, and/or other appropriate methods used to control condition as applicable (a statement outlining relevant medical history is acceptable).
    * Results of pertinent tests/procedures.
    * Name of botulinum toxin, total dosage, each injection site with the dosage, and frequency of injections. 
    * Support of the clinical effectiveness of the injections. 
      * Documentation of the patient's response or lack of response to injections.
    * Support for the medical necessity of localization procedures if performed.
    * Documentation supporting the management of a chronic migraine diagnosis along with a history that supports migraines occur greater than or equal to 15 days per month.