Botulinum Toxin Type

Date of Revision: 7/19/02 

DESCRIPTION: 

Botulinum Toxin Type A injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonias, spasms, twitches, etc. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. The resulting chemical-denervation of muscle produces local paresis or paralysis and allows individual muscles to be weakened selectively. It has the advantage of being a potent neuromuscular blocking agent with good selectivity, duration of action, with the smallest antigenicity, and fewest side effects. 

The following procedure codes are to be reported with the respective listed covered ICD-9-CM diagnosis code: (See Coding Guidelines for correct reporting of services) 

HCPCS CODES:

INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY: 

For dates of service prior to 03/15/1997, refer to Local Medical Review Policy titled "Botox".

Effective with date of service 03/15/1997, the following indications and limitations apply:

Before consideration of coverage may be made, it should be established that the patient(s) has been unresponsive to conventional methods of treatments such as medication, physical therapy and other appropriate methods used to control and/or treat spastic conditions.  

Coverage of Botulinum Toxin Type A for certain spastic conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries, and multiple sclerosis), will be limited to those conditions listed in the Covered ICD-9 section of this policy. All other uses in the treatment of other types of spasm, including smooth muscle types, will be considered as investigational and therefore, non-covered by the carriers.  

Botulinum Toxin Type A can be used to reduce spasticity or excessive muscular contractions to relieve pain; to assist in posturing and walking; to allow better range of motion; to permit better physical therapy; to reduce severe spasm in order to provide adequate perineal hygiene.  

Botox injections can be used to treat limb spasticity. Botox injections encompass different techniques, the number of injections made into each site or muscle, dosage, combinations of muscles injected, etc. Dosage appears to vary from 1-25 units per small muscle (e.g, eye) 50-200 units for medium to larger muscle groups (e.g., deltoid, biceps, quadriceps, hamstrings, etc.).  

Note that Americans use mouse units, Europeans use nannograms for a non-Botox medication (Disport), and they are not the same measurement. Dosage should be adjusted for youngsters. The degree of spasticity is also a deciding dose factor. Some recommend no more than 2-4 units/kgm body weight usually.  

Only 3-400 units are generally injected totally, up to 6-8 sites, into each limb. Some use even higher doses, up to 6-700 units for even more injections sites in select cases where toxicity is not a prime consideration. The failure of two injections in a row, using maximum dose for the size of the muscle, should preclude continued reimbursement. This could be altered initially, however, until a correct dose and site are found. Failure after two successful treatments in a row for initial therapy, using maximum amounts, could preclude additional coverage. If failure occurs, injections could be repeated in a year. It is felt that EMG guidance is generally not necessary, although this is also controversial. An exam which reveals site tenderness or pain is usually good enough to determine the injection site (except in the facial, hand, and neck areas). 

Botox can also be used in the treatment of achalasia (ICD-9 530.0). It appears to be safe and effective. Two-thirds respond within six months and effectiveness lasts on an average of a little over one year for an initial treatment, although shorter and longer durations have been reported.  

There is some question whether it is as good as or better than conventional therapy, pneumatic dilation or myotomy. Its use should not be endorsed for all patients but it can be considered individually in patients who:   

·        Have failed conventional therapy are at risk of complications of pneumatic dilatation or surgical myotomy

·        Have failed a prior myotomy or dilation

·        Have had a previous dilation induced perforation

·        Have an epiphrenic diverticulum or hiatal hernia both of which increase the risk of dilation -     induced perforation 

Some patients may fail a first injection and respond to a second. Further therapy should be questioned if two treatments in a row fail. Therapy can be repeated later in those who fail after an initial response. The usual dosage is about 20 units injected into each of four quadrants of the lower esophageal sphincter region for a total of 80 units. 

Due to the uncommonness of organic writer’s cramp, Medicare would not expect to see the treatment of this condition to be billed frequently.  

There may be patients who require electromyography in order to determine the proper injection site(s). The electromyography procedure codes specified in the HCPCS section of this policy may be covered if the physician has difficulty in determining the proper injection site.

Requests may be considered for continued treatment during a treatment period or for resumption at a later date if satisfactory results have not been obtained, if compelling clinical evidence of medical necessity is presented.  

Carriers will allow payment for one injection per site regardless of the number of injections made into the site. A site is defined as including muscles of a single contiguous body part, such as, a single limb, eyelid, face, neck etc.  

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY: 

For dates of service prior to 03/15/1997, refer to Local Medical Review Policy titled "Botox" for covered ICD-9 codes. 

Effective with date of service 03/15/1997, the following diagnosis restrictions apply: 

REASONS FOR DENIAL: 

Anal spasm, irritable colon, biliary dyskinesia or any treatment of other spastic conditions not listed as covered in this policy are considered to be cosmetic, investigational, (including the treatment of smooth muscle spasm), not safe and effective, and are not accepted as the standard of practice within the medical community. 

NONCOVERED ICD-9 CODE(s): 

Any ICD-9 code not listed in the Coding Guidelines section of this policy. 

CODING GUIDELINES: 

For dates of service prior to 03/15/1997, refer to the  Medical Review Policy titled "Botox". 

Effective with date of service 03/15/1997, the following coding guidelines must be followed:

When billing for injections of Botulinum Toxin Type A for covered conditions/diagnosis, the following guidelines should be used. Failure to report this procedure according to these guidelines may result in denial of claim.  

Will be allowed for idiopathic torsion dystonia (333.6), symptomatic torsion dystonia (333.7), multiple sclerosis (340), infantile cerebral palsy (343.0-343.4), and other specified infantile cerebral palsy (343.8)
67345 - Destroy nerve of eye muscle- allowed for strabismus (378.)
64640* - Injection treatment of nerve- allowed for writer’s cramp (333.84), other torsion dystonia (333.89), hereditary spastic paraplegia (334.1), other demyelinating diseases of central nervous system (341._), spastic hemiplegia (342.11, 342.12), spastic palsy (343.9), and spasm of muscle (728.85). 

For dates of service 03/15/1997-12/31/2000, 64640 could also be allowed for idiopathic torsion dystonia (333.6), symptomatic torsion dystonia (333.7), multiple sclerosis (340), infantile cerebral palsy (343.0-343.4), other specified infantile cerebral palsy (343.8). 

Report Botulinum Toxin A injections with the following HCPCS codes: 

J0585 Botulinum Toxin Type A per unit 

To bill medically necessary electromyography guidance, report the appropriate following procedure code(s): Only one EMG per injection site may be reported. Procedure 95869 should be used for diagnostic application for specific muscle groups whenever possible. It is suggested that procedure code 92265 be considered in place of 95860 or 95861. 

Botulinum Toxin A is supplied in vials, each vial contains 100 units.
Instead of the number of vials utilized (previous instructions), providers are to bill the number of units utilized. (12/08/1997)

For EMC billing, document the units injected in the units of service field, FAO.18. In each case, Botulinum Toxin A is coded as J0585.  

Due to the short life of the botulinum toxin, Medicare will reimburse the unused portion of this drug, only when the vial is not split between patients. Proper documentation must exist in the patient’s chart as to the true number of units administered and the number of units discarded. If only one patient receives 30 units out of a vial and the remaining 70 units are discarded, then the provider bills 100 units for that individual patient.  

Scheduling of more than one patient is encouraged to prevent wastage of Botulinum Toxin Type A. If three patients are scheduled and each receive 30 units out of one vial, the 10 units wasted are billed to the last patient. (12/08/1997) 

DOCUMENTATION REQUIREMENTS: 

• Support for the medical necessity of the Botulinum Toxin Type A injection,
• A covered diagnosis.
• A statement that traditional methods of treatments have been tried and proven unsuccessful.
• Dosage and frequency of the injections
• Support for the medical necessity of electromyography procedures
• Support of the clinical effectiveness of the injections
• Specify the site(s) injected

OTHER COMMENTS: 

NOTE: The CMD Drug Evaluation Clinical Workgroup was asked to consider expanding coverage of Botulinum Toxin Type A to incorporate the treatment of achalasia or cardiospasm. 

It is the recommendation of the CMD Drug Evaluation Clinical Workgroup that Botox should not be allowed for the initial treatment of achalasia. After consideration, the workgroup felt that treatment should be considered on a case by case basis for those individuals that have failed conventional therapy or who have had or have the potential for a serious complication (see #5 under INDICATIONS.