LCD/NCD Portal

L28788

 

BOTULINUM TOXINS

 

10/18/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

• Before consideration of coverage may be made, it should be established that the patient has been unresponsive to conventional methods of treatments such as:

o Medication.

o Physical therapy.

o Other appropriate methods used to control and/or treat spastic conditions when applicable.

• It is expected that a patient will not receive continued injections of botulinum toxin if treatment failure occurs after 2 consecutive injections, using maximum dose for the size of the muscle.

• First Coast Service Options, Inc. (FCSO) Medicare will allow payment for one injection per site regardless of the number of injections made into the site.

o A site is defined as including muscles of a single contiguous body part, such as, a single limb, eyelid, face, neck, etc.

• FCSO Medicare will consider botulinum toxins (Botox ®, Dysport™, Xeomin® and Myobloc ® medically reasonable and necessary when administered for treatment of the following FDA-labeled indications and other indications as specified below:

 

• FDA Indications for Botox ®:

• Strabismus and blepharospasm associated with dystonia.

• Benign essential blepharospasm.

• Facial nerve (cranial nerve VII) disorders in patients 12 years of age and older.

• Cervical dystonia to reduce the severity of abnormal head position and neck pain (i.e., spasmodic torticollis).

• Severe primary axillary hyperhidrosis inadequately managed with topical agents.

o Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

• upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).

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

• Treatment of urinary incontinence due to detrusor over activity 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 anticholinergic medication.

 

• Off-label Indications for Botox ®: (Botox ® is used for a wide range of off-label uses.)

• The use of Botox<SUP®< sup> may be considered a medically necessary off-label indication for the treatment of dystonia or lower limb spasticity resulting in functional impairment (interference with joint function, mobility) and/or pain in patients with any of the following hereditary, acquired, degenerative, or demyelinating diseases of the central nervous system:

o Dynamic muscle contracture in pediatric or adult cerebral palsy patients.

o Synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration (e.g., hemi facial spasm).

o Idiopathic torsion dystonia.

o Symptomatic torsion dystonia.

o Oromandibular dystonia.

o Spasmodic dysphonia.

o Orofacial dyskinesia.

o Focal hand dystonia (e.g., writer’s cramp).

o Hereditary spastic paraplegia.

o Neuromyelitis optica.

o Schilder’s disease.

o Spastic hemiplegia.

o Spasticity related to stroke.

• Coverage of Botox ® for certain lower limb spasticity conditions will be limited to those conditions listed in the Covered ICD-9-CM section of this LCD.

o Cerebral palsy.

o Stroke.

o Head trauma.

o Spinal cord injuries.

o Multiple sclerosis.

o All other uses in the treatment of other types of spasm, including smooth muscle types, will be considered as investigational and therefore, noncovered by FCSO Medicare.

• The use of Botox ® may be considered medically necessary:

o In patients with laryngeal spasm and torticollis whether:

 Congenital.

 Due to child birth injury.

 Traumatic.

o Patients with achalasia who have not responded to dilation therapy.

Or

o Patients with achalasia who are considered poor surgical candidates.

Or

o Treatment of chronic anal fissure.

Or

o Treatment of gustatory hyperhidrosis (secondary).

Or

o With Botox® may be considered medically necessary.

 Patients with medical complications; such as skin maceration with secondary infections.

Or

 Patients with significant functional impairments.

 

• FDA Indication for Dysport ™:

• The 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.

 

• Off-label Indications for Dysport ™:

• Benign essential blepharospasm.

• Hemifacial spasm in adults (ICD-9-CM code 333.82).

• Spasticity of the arm in patients following a stroke.

• Severe primary axillary hyperhidrosis inadequately managed with topical agents.

o Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

 

• FDA Indications for Xeomin®:

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

o Blepharospasm in adults previously treated with onabotulinumtoxina (Botox).

 

• FDA Indications for Myobloc ®:

o Cervical dystonia to reduce the severity of abnormal head position and neck pain (i.e., spasmodic torticollis).

 

A USPDI revision dated December 5, 2005, reversed their decision to allow treatment of spasticity caused by stroke or brain injury listing under “Acceptance not established”.

• The USPDI revision further states, “The data describing the treatment of Botulinum toxin type B for upper limb spasticity are limited and inconclusive.

• In a single, randomized, placebo-controlled trail, BTX-B did not demonstrate a benefit in reducing muscle tone in the elbow, wrist or finger flexors in post-stroke patients.

• However, improvements in upper limb spasticity were reported in a few small open-labeled trials presented in abstract and/or poster forms”.

• Therefore, effective 11/01/2006, FCSO Medicare will NO longer allow this indication.

 

ICD-9 Codes that Support Medical Necessity

 

 

Procedure Code J0585

333.6 GENETIC TORSION DYSTONIA

333.71 ATHETOID CEREBRAL PALSY

333.79 OTHER ACQUIRED TORSION DYSTONIA

333.81 BLEPHAROSPASM

333.82 OROFACIAL DYSKINESIA

333.83 SPASMODIC TORTICOLLIS

333.84 ORGANIC WRITERS' CRAMP

333.89 OTHER FRAGMENTS OF TORSION DYSTONIA

334.1 HEREDITARY SPASTIC PARAPLEGIA

340* MULTIPLE SCLEROSIS

341.0 NEUROMYELITIS OPTICA

341.1 SCHILDER'S DISEASE

341.20 ACUTE (TRANSVERSE) MYELITIS NOS

341.21 ACUTE (TRANSVERSE) MYELITIS IN CONDITIONS CLASSIFIED ELSEWHERE

341.22 IDIOPATHIC TRANSVERSE MYELITIS

341.8 OTHER DEMYELINATING DISEASES OF CENTRAL NERVOUS SYSTEM

341.9 DEMYELINATING DISEASE OF CENTRAL NERVOUS SYSTEM UNSPECIFIED

342.11 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING DOMINANT SIDE

342.12 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE

343.1 CONGENITAL HEMIPLEGIA

343.2 CONGENITAL QUADRIPLEGIA

343.3 CONGENITAL MONOPLEGIA

343.4 INFANTILE HEMIPLEGIA

343.8 OTHER SPECIFIED INFANTILE CEREBRAL PALSY

343.9 INFANTILE CEREBRAL PALSY UNSPECIFIED

344.00 QUADRIPLEGIA UNSPECIFIED

344.01 QUADRIPLEGIA C1-C4 COMPLETE

344.02 QUADRIPLEGIA C1-C4 INCOMPLETE

344.03 QUADRIPLEGIA C5-C7 COMPLETE

344.04 QUADRIPLEGIA C5-C7 INCOMPLETE

344.09* OTHER QUADRIPLEGIA

344.1* PARAPLEGIA

344.2* DIPLEGIA OF UPPER LIMBS

344.30 MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE

344.31 MONOPLEGIA OF LOWER LIMB AFFECTING DOMINANT SIDE

344.32* MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

344.40 MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE

344.41 MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE

344.42* MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SDE

344.5 UNSPECIFIED MONOPLEGIA

346.71 CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS

346.73 CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS

351.8 OTHER FACIAL NERVE DISORDERS

378.00 ESOTROPIA UNSPECIFIED

378.01 MONOCULAR ESOTROPIA

378.02 MONOCULAR ESOTROPIA WITH A PATTERN

378.03 MONOCULAR ESOTROPIA WITH V PATTERN

378.04 MONOCULAR ESOTROPIA WITH OTHER NONCOMITANCIES

378.05 ALTERNATING ESOTROPIA

378.06 ALTERNATING ESOTROPIA WITH A PATTERN

378.07 ALTERNATING ESOTROPIA WITH V PATTERN

378.08 ALTERNATING ESOTROPIA WITH OTHER NONCOMITANCIES

378.10 EXOTROPIA UNSPECIFIED

378.11 MONOCULAR EXOTROPIA

378.12 MONOCULAR EXOTROPIA WITH A PATTERN

378.13 MONOCULAR EXOTROPIA WITH V PATTERN

378.14 MONOCULAR EXOTROPIA WITH OTHER NONCOMITANCIES

378.15 ALTERNATING EXOTROPIA

378.16 ALTERNATING EXOTROPIA WITH A PATTERN

378.17 ALTERNATING EXOTROPIA WITH V PATTERN

378.18 ALTERNATING EXOTROPIA WITH OTHER NONCOMITANCIES

378.20 INTERMITTENT HETEROTROPIA UNSPECIFIED

378.21 INTERMITTENT ESOTROPIA MONOCULAR

378.22 INTERMITTENT ESOTROPIA ALTERNATING

378.23 INTERMITTENT EXOTROPIA MONOCULAR

378.24 INTERMITTENT EXOTROPIA ALTERNATING

378.30 HETEROTROPIA UNSPECIFIED

378.31 HYPERTROPIA

378.32 HYPOTROPIA

378.33 CYCLOTROPIA

378.34 MONOFIXATION SYNDROME

378.35 ACCOMMODATIVE COMPONENT IN ESOTROPIA

378.40 HETEROPHORIA UNSPECIFIED

378.41 ESOPHORIA

378.42 EXOPHORIA

378.43 VERTICAL HETEROPHORIA

378.44 CYCLOPHORIA

378.45 ALTERNATING HYPERPHORIA

378.50 PARALYTIC STRABISMUS UNSPECIFIED

378.51 THIRD OR OCULOMOTOR NERVE PALSY PARTIAL

378.52 THIRD OR OCULOMOTOR NERVE PALSY TOTAL

378.53 FOURTH OR TROCHLEAR NERVE PALSY

378.54 SIXTH OR ABDUCENS NERVE PALSY

378.55 EXTERNAL OPHTHALMOPLEGIA

378.56 TOTAL OPHTHALMOPLEGIA

378.60 MECHANICAL STRABISMUS UNSPECIFIED

378.61 BROWN'S (TENDON) SHEATH SYNDROME

378.62 MECHANICAL STRABISMUS FROM OTHER MUSCULOFASCIAL DISORDERS

378.63 LIMITED DUCTION ASSOCIATED WITH OTHER CONDITIONS

378.71 DUANE'S SYNDROME

378.72 PROGRESSIVE EXTERNAL OPHTHALMOPLEGIA

378.73 STRABISMUS IN OTHER NEUROMUSCULAR DISORDERS

378.81 PALSY OF CONJUGATE GAZE

378.82 SPASM OF CONJUGATE GAZE

378.83 CONVERGENCE INSUFFICIENCY OR PALSY

378.84 CONVERGENCE EXCESS OR SPASM

378.85 ANOMALIES OF DIVERGENCE

378.86 INTERNUCLEAR OPHTHALMOPLEGIA

378.87 OTHER DISSOCIATED DEVIATION OF EYE MOVEMENTS

378.9 UNSPECIFIED DISORDER OF EYE MOVEMENTS

438.21 HEMIPLEGIA AFFECTING DOMINANT SIDE

438.22 HEMIPLEGIA AFFECTING NONDOMINANT SIDE

438.31 MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE

438.32 MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SIDE

438.41 MONOPLEGIA OF LOWER LIMB AFFECTING DOMINANT SIDE

438.42 MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

478.75 LARYNGEAL SPASM

478.79 OTHER DISEASES OF LARYNX

530.0 ACHALASIA AND CARDIOSPASM

564.6 ANAL SPASM

565.0 ANAL FISSURE

596.54 NEUROGENIC BLADDER NOS

596.55 DETRUSOR SPHINCTER DYSSYNERGIA

596.59 OTHER FUNCTIONAL DISORDER OF BLADDER

705.21 PRIMARY FOCAL HYPERHIDROSIS

705.22 SECONDARY FOCAL HYPERHIDROSIS

723.5 TORTICOLLIS UNSPECIFIED

 

J0586

333.81 BLEPHAROSPASM

333.82 OROFACIAL DYSKINESIA

333.83 SPASMODIC TORTICOLLIS

342.11 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING DOMINANT SIDE

342.12 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE

705.21 PRIMARY FOCAL HYPERHIDROSIS

723.5 TORTICOLLIS UNSPECIFIED

 

Procedure Code J0587

333.83 SPASMODIC TORTICOLLIS

723.5 TORTICOLLIS UNSPECIFIED

 

Procedure Code J0587 – Effective 05/08/2006 through 11/30/2006

 

 

342.10 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE

342.11 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING DOMINANT SIDE

342.12 SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE

344.00 QUADRIPLEGIA UNSPECIFIED

344.01 QUADRIPLEGIA C1-C4 COMPLETE

344.02 QUADRIPLEGIA C1-C4 INCOMPLETE

344.03 QUADRIPLEGIA C5-C7 COMPLETE

344.04 QUADRIPLEGIA C5-C7 INCOMPLETE

344.09 OTHER QUADRIPLEGIA

344.1 PARAPLEGIA

344.2 DIPLEGIA OF UPPER LIMBS

344.30 MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE

344.31 MONOPLEGIA OF LOWER LIMB AFFECTING DOMINANT SIDE

344.32 MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

344.40 MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE

344.41 MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE

344.42 MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SDE

344.5 UNSPECIFIED MONOPLEGIA

438.20 HEMIPLEGIA AFFECTING UNSPECIFIED SIDE

438.21 HEMIPLEGIA AFFECTING DOMINANT SIDE

438.22 HEMIPLEGIA AFFECTING NONDOMINANT SIDE

438.30 MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE

438.31 MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE

438.32 MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SIDE

438.40 MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE

438.41 MONOPLEGIA OF LOWER LIMB AFFECTING DOMINANT SIDE

438.42 MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

754.1 CONGENITAL MUSCULOSKELETAL DEFORMITIES OF STERNOCLEIDOMASTOID MUSCLE

 

Procedure code J0588 - Injection, incobotulinumtoxin a, 1 unit – Effective 01/01/2012

333.81 BLEPHAROSPASM

333.83 SPASMODIC TORTICOLLIS

723.5 TORTICOLLIS UNSPECIFIED

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of botulinum toxin by clearly indicating the condition for which this drug is being used.

o This documentation is usually found in the history and physical or in the office/progress notes and should include the following elements in the event of a post payment review:

 Support for the medical necessity of the botulinum toxin injection.

 A covered diagnosis.

 Documentation of unsuccessful conventional methods of treatment such as the timing and duration of medication, and/or physical therapy, and/or other appropriate methods used to control and/or treat spastic conditions. (statement outlining specific past history is acceptable).

 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.

• When Botox® (onabotulinumtoxina) is used for the FDA approved indication of prophylaxis of headaches in adult patients with chronic migraine; the documentation must support these specific symptom parameters.

o >15 Days per month.

And

o Headache lasting 4 hours a day or longer.

 

Treatment Logic:

• Clostridium botulinum toxin describes a family of neurotoxins produced by the anaerobic bacteria of the species C. botulinum.

• There are seven distinct serotypes of botulinum toxin: A, B, C, D, E, F and G.

• All botulinum neurotoxin serotypes are understood to produce their clinical effect by blocking the release of the neurotransmitters, principally acetylcholine, from nerve endings.

• There are three distinct serotype A botulinum toxin therapeutic products and one serotype B botulinum toxin product that have been approved by the U.S. Food and Drug Administration (FDA):

o Onabotulinumtoxina (Botox®).

o Abobotulinumtoxina (Dysport™).

o Incobotulinumtoxina (Xeomin®).

o Rimabotulinumtoxinb (Myobloc®).

• Whether a botulinum toxin is produced from the same or a different serotype producing strain, they undergo different manufacturing processes which yield differences in the size and weight of the molecules.

o Because of this, Botox ®, Dysport ™, Xeomin® and Myobloc®, as well as other type A products available internationally, are not interchangeable.

o They are chemically, pharmacologically and clinically distinct.

• Please note the FDA labeling in each product’s package insert states: “Units of biological activity cannot be converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method”.

• Botulinum toxin injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonias, spasms, twitches, etc.

o They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings.

o The resulting chemical-denervation of muscle produces local paresis or paralysis and allows individual muscles to be weakened selectively.

 

Sources of Information and Basis for Decision

 

Allergan Pharmaceutical Manufacturers Package Insert

 

American Medical Association. (1998). Coding consultation. CPTTM Allergan Pharmaceutical Manufacturers Package Insert

 

American Medical Association. (1998). Coding consultation. CPTTM Assistant, 8(10), 10. This article further clarified the use of procedure codes 64612-64614.

 

American Medical Association. (2001). Chemodenervation. CPTTM Assistant, 11(4), 1-2. The article further defined the use of procedure codes 64612-64614.

 

Aoki, K. (2001). A comparison of the safety margins of botulinum neurotoxin serotypes A, B, and F in mice. Elsevier Science, 39(12), 1815-1820.

 

Brashear, A. (2003). Dosing of Botox and Myobloc: Consensus and Controversies. Practical Neurology, September, 45-49.

 

Brashear, A., Watts, M. Marchetti, A., Magar, R., Lau, H., Wang, L (2000). Duration of effect of botulinum type A in adult patients with cervical dystonia: A retrospective chart review. Clinical Therapeutics, 22(12), 1516-1524.

 

Brubaker, L., Richter, H., Visco, A., Mahajan, S., Nygaard, I., Braun, T., Barber, M., Menefee, S., Schaffer, J., Weber, A., & Wei, J. (2008). Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol, 180, 217-222.

 

Callaway, J., Arezzo, J., Grethlein, A. (2002). Botulinum toxin type B: An overview of its biochemistry and preclinical pharmacology. Disease-A-Month, 48(5). Retrieved October 6, 2003 from mdconsult database (12511392).

 

Dysport™ (abobotulinumtoxina) prescribing information. Ipsen Biopharm Ltd.

 

FCSO LCD 29088, Botulinum Toxins, 10/18/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Lowe, N., Yamauchi, P., Lask, G., Patnaik, R., Iyer, S. (2003). Efficacy and safety of botulinum toxin type A in the treatment of palmar hyperhidrosis: A double-blind, randomized, placebo-controlled study. American Society for Dermatologic Surgery, 28(9), 822-827.

 

Mosby’s Drug Consult. (2003). Botulinum Toxin. Retrieved October 2, 2003, from mdconsult database (214903164/1/514).

 

Myobloc® (rimabotulinumtoxinb) prescribing information. Solstice Neurosciences, Inc.

 

Naumann, M., Lowe, N., Kumar, C., Hamm, H., (2003). Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months. Arch Dermatol, 139, 731-736.

 

Naumann, M., Lowe, N., (2001). Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomized, parallel group, double blind, placebo controlled trial. British Medical Journal, 323, 596-599.

 

O’Brien, C. (2002). Treatment of spasticity with botulinum toxin. The Clinical Journal of Pain. 18, 182-190.

 

U.S. Food and Drug Adminstration (FDA). (2011). Department of Health and Human Services. CDER web sites updates. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf.

 

U.S. Food and Drug Administration (FDA) Drug Alert. (08/2009). Information for Healthcare Professionals: onabotulinumtoxinA (marketed as Botox/Botox Cosmetic), abobotulinumtoxinA (marked as Dysport) and rimabotulinumtoxinB (marketed as Myobloc). Retrieved on September 2, 2009 from www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHealthcareProfessionals/ucm174949.htm.

 

USPDI Compendia Update. 2004 Thomson MICROMEDEX. December 5, 2005.

 

Verheyden, J., Blitzer, A. (2002). Other noncosmetic uses of botox. Disease-A-Month, 48(5). Retrieved October 6, 2003 from mdconsult database (12511391).

 

Ward, A., Aguilar, M., DeBey, Z., Gedin, S., Kanovsky, P., Molteni, F., Wissel, J., Yakovieff, A. (2003). Use of botulinum toxin type A in management of adult spasticity – A European consensus statement. J Rehabil Med, 35(2), 98-99.

 

Xeomin® (incobotulinumtoxina) prescribing information. Merz Group Services GmbH.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

© Automated Clinical Guidelines, LLC 2012-2014

 

LCD Local Coverage Determination (LCD) for Botulinum Toxins (L28788)