Botulinum Toxins

Date of Revision: 6/29/02

Description: 

Botulinum toxin (BT) is produced by the bacterium Clostridium Botulinum. Of the variety of toxins (types A to G), the type A (BTA) toxin was Food and Drug Administration (FDA) approved in 1989 for clinical use. Type B toxin (BTB) received FDA approval in December 2000. Botulinum toxin blocks neuromuscular transmission by inhibiting the release of presynaptic acetylcholine at peripheral neuromuscular junctions.

This action is probably mediated by cleaving the presynaptic vesicle membrane proteins. Thus, Botulinum toxin produces a chemical denervation. This is the basis for paralysis, which is a cardinal manifestation of botulism. 

Indications and Limitations of Coverage and/or Medical Necessity: 

Indications

In carefully selected patients, the following conditions may be alleviated by Botulinum toxin A: 

• Facial spasm;
• Blepharospasm;
• Hemifacial spasm;
• Cervical dystonia (Torticollis);
• Spasmodic dysphonia;
• Strabismus;
• Focal hand dystonia (Writers' Cramp);
• Chronic anal fissure refractory to conservative treatment;
• Esophageal achalasia patients in whom surgical treatment is not indicated;
• Frey’s syndrome;
• Hyperhidrosis;
• Spasticity (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 hygiene);
• Spasticity in Cerebral Palsy.

In clinical conditions, such as cervical dystonia, excessive and abnormal regional muscle contraction causes torsion, spasticity and pain. Botulinum toxin, injected in a focal fashion, produces neuromuscular blockade and paralysis. Symptoms abate, although repeat injections may be required. Eventual loss of response to repeated injections occurs in some patients who have received Botulinum toxin A treatment. Immunoresistance may be one of the reasons for this development. As experience accumulates, with other toxin types also, similar resistance could be observable. 

Injected locally, botulinum toxin is an alternative to surgery for treating extraocular muscle disorders.

In carefully selected patients, the following conditions may be alleviated by

Botulinum toxin B: 

• Cervical dystonia (torticollis)

Botulinum toxin B received FDA approval in December 2000 for, "...the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia." Botulinum toxin B has not received approval for other indications. The choice of selecting Botulinum toxin B or Botulinum toxin A as the preferred initial agent for cervical dystonia treatment, rests in the hands of the managing physician. 

Limitations 

• Treatment of headaches and craniofacial wrinkles will not be covered.
• Botulinum toxin treatment is not indicated for patients:
• receiving aminoglycosides, which may interfere with neuromuscular transmission; or
• with chronic paralytic strabismus, except to reduce antagonist contractor in conjunction with surgical repair.
• Botulinum toxin is not recommended for patients with:
• strabismus, when angles are over 50 prism diopters;
• estrictive strabismus;
• Duane's syndrome with lateral rectus weakness; or
• secondary strabismus caused by prior surgical over-recession of the antagonist.

CPT/HCPCS Code(s): 

ICD-9-CM Codes that Support Necessity: 

Diagnosis for Botulinum Toxin Type A (J0585) 

Diagnoses for Botulinum Toxin Type B (J0587) 

Note: Diagnostic codes are to be used at their highest level of specificity. Fourth and fifth digits should be utilized when they are available. 

Reason(s) for Denial: 

Claims not meeting the coverage criteria as stated in the indications section of this policy will be denied.

Cosmetic services will always be denied. 

Non-Covered ICD-9-CM Code(s): 

Any code not listed in the “ICD-9 Codes That Support Medical Necessity” section of this policy. 

Coding Guidelines: 

An appropriate injection/destruction CPT codes (64612-64614, 67345) for botulinum toxins (A or B) may be submitted in conjunction with the appropriate HCPCS drug code. CPT codes 64620-64640 are not appropriate codes to bill in conjunction with botulinum toxin injections. Reimbursement for the injection code will be per operative session, regardless of the number of injections performed.  

Electromyographic guidance may be used to ensure the proper needle location within the muscle. Medicare would not expect to see a complete diagnostic electromyography billed for electromyographic guidance.

If the upper and lower lid of the same eye and/or adjacent facial muscles or brow are injected at the same surgery, the procedure is considered to be unilateral.  

Please indicate the left (LT) or right (RT) modifier. Bilateral procedures will only be considered when both eyes or both sides of the face are injected. In this case, submit the procedure with a -50 modifier and the procedures will be reimbursed on a full and one-half basis. 

The cost of special syringes and needles is not separately payable. They are considered as part of the surgical procedure. 

Effective January 1, 2002, the description for HCPCS code J0587 reads “per 100 units.” Therefore, 100 units of J0587 will equal one billing unit. 

Effective 01/01/1997, the description of HCPCS code J0585 reads “per unit.” This requires the units of service on the claim to reflect the number of units used. 

Currently, botulinum toxin type A (BOTOX®) is available only in a 100 unit size. Once BOTOX® is reconstituted in the physician's office, it has a shelf life of only 4 hours. Often a patient receives less than a 100 unit dose. Because of the expense of the drug, we encourage physicians to schedule patients in such a way that they can use BOTOX® most efficiently. However, if a physician must discard the remainder of a vial after administering it to a Medicare patient, the program will cover the amount of the drug discarded along with the amount administered. 

Documentation Requirements: 

Documentation in the patient's medical record must show the exact dosage of the drug given and the exact amount of the discarded portion of the drug.

Documentation supporting the medical necessity of this item, such as ICD-9-CM codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

All coverage criteria must be documented in the patient’s medical record and made available to Medicare upon request. This information should be generally submitted on reconsideration only (or with the claim if the services are unusual or if denial is anticipated). 

Reconsiderations and Appeals - Claims resubmitted with a different diagnosis code must include medical record documentation to justify the diagnosis code change. Submission with diagnoses other than those listed in the “ICD-9 Codes That Support Medical Necessity” section of this policy will be individually reviewed by this carrier for medical necessity. 

Utilization Guidelines: 

If no benefit is demonstrable by two sets of injections, further injections will not be considered for coverage. Exceptions may be possible by special review by the carrier. 

Other Comments: 

Botulinum toxin is not the first or only treatment for covered conditions. Patient selection should be based on refractions to symptomatic treatment or oral medications. 

Because Botulinum toxin is harmful in certain conditions, the establishment of an appropriate diagnosis is necessary before initiating treatment.