CPT j0585, j0588 – biologicals botulinum toxins

Coverage Indications, Limitations, and/or Medical Necessity

Indications

Because Botulinum Toxins (BT) are invasive, their use should be reserved for patients in whom a diagnosis has been established with reasonable certainty.

For most patients with these conditions BT promises significant but variable relief of symptoms that last for varying periods of time. Often times repeated injections are required for sustained relief of symptoms. Long-term effects of chronic BT therapy are unknown. Loss of response to repeated injections is seen and immunoresistance is thought to be one mechanism.

OnabotulinumtoxinA (Botulinum Toxin A) (Botox ®) (J0585):

FDA: Treatment of:

Upper limb spasticity in adult patients;

Cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain;

Severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients;

Blepharospasm associated with dystonia in patients =12 years of age;

Strabismus in patients =12 years of age;

Prophylaxis of headaches in adult patients with chronic migraine (= 15 days per month with headache lasting 4 hours a day or longer);

Urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication

Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Off Label Use:

Facial Spasm; 

Hemifacial Spasm; 

Spasmodic Dysphonia; 

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; 

Spasticity resulting from brain, spinal cord and other neurological diseases (e.g. Cerebral Palsy, CVA, traumatic brain injury, anoxic brain injury, Multiple Sclerosis, etc.) that results in pain and/or impaired activities of daily living (ADLs);

Headache – Coverage for carefully-selected patients with intractable headache due to tension who have been refractory to standard and usual conventional therapy will be allowed. The medical literature now has more negative than positive studies for the use of botulinum toxin in the treatment of tension headache, however, research is ongoing. Reports in the literature, and from experienced clinicians, note response to therapy in some patients refractory to other standard therapy. For continuing botulinum toxin therapy, the patient must demonstrate a significant decrease in the number and frequency of headaches and an improvement in function upon receiving botulinum toxin. Note: This indication is to be coded with ICD-10 code Z01.89.

Sialorrhea

AbobotulinumtoxinA (Botulinum Toxin A) (Dysport ®) (J0586):

FDA: 

Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients;

Upper limb spasticity in adult patients.

Off Label Use:

Severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients;

Blepharospasm associated with dystonia in patients =12 years of age;

Strabismus in patients =12 years of age.

Prophylaxis of headaches in adult patients with chronic migraine (= 15 days per month with headache lasting 4 hours a day or longer).

Facial Spasm; 

Hemifacial Spasm; 

Spasmodic Dysphonia; 

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; 

Spasticity resulting from brain, spinal cord and other neurological diseases (e.g. Cerebral Palsy, CVA, traumatic brain injury, anoxic brain injury, Multiple Sclerosis, etc.) that results in pain and/or impaired activities of daily living (ADLs);

Headache – Coverage for carefully-selected patients with intractable headache due to tension who have been refractory to standard and usual conventional therapy will be allowed. The medical literature now has more negative than positive studies for the use of botulinum toxin in the treatment of tension headache, however, research is ongoing. Reports in the literature, and from experienced clinicians, note response to therapy in some patients refractory to other standard therapy. For continuing botulinum toxin therapy, the patient must demonstrate a significant decrease in the number and frequency of headaches and an improvement in function upon receiving botulinum toxin. Note: This indication is to be coded with ICD-10 code Z01.89.

Sialorrhea

IncobotulinumtoxinA (Botulinum Toxin A) (Xeomin ®) (J0588)

FDA: Treatment of

Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients;

Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox ®).

Off Label Use:

Upper limb spasticity in adult patients.

Severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients.

Spasticity resulting from brain, spinal cord and other neurological diseases (e.g. Cerebral Palsy, CVA, traumatic brain injury, anoxic brain injury, Multiple Sclerosis, etc.) that results in pain and/or impaired activities of daily living (ADLs);

Sialorrhea.

RimabotulinumtoxinB (Botulinum Toxin B) (Myobloc ®) (J0587):

FDA: 

Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Off Label Use:

Sialorrhea

Myobloc ® will be covered for the same indications (other than cervical dystonia and sialorrhea) as Botox ®/Dysport ® when 

documentation supports the patient is unresponsive to Botox ®/Dysport ®.

Limitations

Treatment for cosmetic reasons such as craniofacial wrinkles will not be covered.

Medicare will allow payment for one injection per each functional muscle group/anatomical site regardless of the number of injections made into each group/site or the number of muscles that comprise the functional group.

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; 

restrictive strabismus; 

Duane’s syndrome with lateral rectus weakness; or 

secondary strabismus caused by prior surgical over-recession of the antagonist.

OnabotulinumtoxinA (Botulinum Toxin A) (Botox ®) and AbobotulinumtoxinA (Botulinum Toxin A) (Dysport ®) are not indicated for patients with new onset headache. Please refer to FDA Indications and Off Label Use for these products.

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable