Botulinum Toxin Injections
“Chemodenervation” refers to the use of chemical agents to produce neuromuscular blockade for the purpose of selective weakening of specific muscles or muscle groups. Neurotoxins, as well as other chemical agents, are used for this purpose.
Botulinum toxin, a neurotoxin produced by clostridium botulinum, produces a clinical effect by blocking the release of neurotransmitters, principally acetylcholine, from nerve endings. There are currently four botulinum neurotoxins available in the US with different FDA-approved indication(s): three distinct serotype A botulinum toxin therapeutic products, onabotulinumtoxinA (BOTOX®), abobotulinumtoxinA (DYSPORT®) and incobotulinumtoxinA (XEOMIN®), and the serotype B botulinum toxin product, rimabotulinumtoxinB (MYOBLOC®). These products are not interchangeable, and it is the physician's responsibility to select the appropriate product and dose in accordance with FDA-approval indications for use, compendia-supported uses, and supported by peer reviewed specific scientific literature.
Medicare allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member. Botulinum toxin injections are not covered for cosmetic purposes. Palmetto GBA Local Coverage Determination L33458 outlines twelve conditions where chemodenervation techniques may be covered/indicated. The coverage indications are specific and include limitations. Details of coverage indications are available in the L33458 local coverage determination in the reference section included with this article.
Dosage and Frequency
In addition to coverage limitations, there are also dosage and frequency limitations. Chemodenervation treatment has a variable lasting beneficial effect from twelve to sixteen weeks, following which the procedure may need to be repeated. It is appropriate to inject the lowest clinically effective dose at the greatest feasible interval that results in the desired clinical result. Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.
Legible documentation to support medical necessity must be present for each date of service billed on the claim and should include the following elements:
- Specific botulinum toxin used
- Dosage of toxin used (including dosage in units per site)
- A complete description of the site(s) injected
- A covered diagnosis (however, when a form of botulinum toxin is used for an indication that is not supported by FDA-approval and/or compendia support, a physician statement in the medical record stating the reason or reasons why the unsupported form was used is also required)
- Support of the clinical effectiveness of the injections, noting date of last injection, if applicable
- Support for the medical necessity of electromyography or stimulation guidance procedures if performed
- Local Coverage Determination: L33458
- Title XVIII of the Social Security Act, §1862 (a)(1)(A)
- CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15 (PDF, 1.58 MB), §50.4.1
|Botulinum Toxin Injections Documentation Checklist||Yes||No||N/A|
|Does the patient have a covered diagnosis?|
|Is there a documented history of symptoms supporting the covered diagnosis?|
|Does the documentation detail the frequency, duration and severity of symptoms?|
|If applicable, is there documentation that supports that alternative causes of the symptoms have been considered and ruled out?|
|Does the documentation support the medical necessity of the botulinum toxin (type A or type B) injection?|
|When applicable, does the documentation include a statement that traditional/conventional methods of treatments such as medication, physical therapy, and other appropriate methods have been tried and proven unsuccessful? (History of failure, contraindication, or intolerance to more conventional therapies.)|
|If treated with botulinum for migraine in the past, is there documentation detailing response to the treatment?|
|For support of management of a chronic migraine diagnosis, does the medical record include a history of migraine with patient experiencing headaches on most days of the month?|
|Does the documentation support the medical necessity of electromyography procedures performed in conjunction with botulinum toxin type A Injections to determine the proper injection site(s), when applicable?|
|Does documentation detail the specific botulinum toxin used?|
|Is the product and dose in accordance with FDA-approved indications for use, compendia-supported uses, and supported by peer reviewed specific scientific literature?|
|Is the dosage (including dosage in unis per site) and frequency included in the documentation?|
|Does the documentation include the specific site of the injection(s) and a complete description of the injection site(s)?|
|Is there documentation of the amount of drug discarded?|
|Does the documentation support of the clinical effectiveness of the injections (for continuous treatment)?|