L29088-LCD

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Local Coverage Determination (LCD) for Botulinum Toxins (L29088)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window Back to Top

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29088

LCD Title Botulinum Toxins

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

Contractor's Determination Number BOTULINUMTOXINS

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 03/29/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Transmittal 2147, Change Request 7299, dated February 4, 2011

CMS Transmittal 2150, Change Request 7319, dated February 4, 2011

CMS Transmittal 2185, Change Request 7343, dated March 25, 2011

CMS Transmittal 2278, Change Request 7540, dated August 19, 2011

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity

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):

• Onabotulinumtoxina (Botox®)

• Abobotulinumtoxina (Dysport™)

• Incobotulinumtoxina (Xeomin®)

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

Before consideration of coverage may be made, it should be established that the patient 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 in most cases.

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. 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 &reg,Dysport™, Xeomin® and Myobloc &reg medically reasonable and necessary when administered for treatment of the following FDA- labeled indications and other indications as specified below:

FDA Indications for Botox &reg:

• 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. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) toavoid 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 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 anticholinergic medication.

Off-label Indications for Botox &reg:

Botox &reg is used for a wide range of off-label uses. The use of Botox 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:

• dynamic muscle contracture in pediatric or adult cerebral palsy patients

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

• idiopathic torsion dystonia

• symptomatic torsion dystonia

• oromandibular dystonia

• spasmodic dysphonia

• orofacial dyskinesia

• focal hand dystonia (e.g., writer’s cramp)

• hereditary spastic paraplegia

• neuromyelitis optica

• Schilder’s disease

• spastic hemiplegia

• spasticity related to stroke

Coverage of Botox &reg for certain lower limb spasticity 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-CM section of this LCD. 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 &reg may be considered medically necessary in patients with laryngeal spasm and torticollis (whether congenital, due to child birth injury, or traumatic).

The use of Botox &reg may be considered medically necessary in patients with achalasia who have not responded to dilation therapy or who are considered poor surgical candidates.

The use of Botox&reg may be considered medically necessary as treatment of chronic anal fissure.

Treatment of gustatory hyperhidrosis (secondary) with Botox&reg may be considered medically necessary in patients with medical complications; such as skin maceration with secondary infections, or 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. 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®:

• 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)

FDA Indications for Myobloc &reg:

• 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 abstact and/or poster forms”. Therefore, effective 11/01/2006, FCSO Medicare will no longer allow this indication.

Coding Information

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

CPT/HCPCS Codes

J0585 INJECTION, ONABOTULINUMTOXINA, 1 UNIT J0586 INJECTION, ABOBOTULINUMTOXINA, 5 UNITS J0587 INJECTION, RIMABOTULINUMTOXINB, 100 UNITS J0588 INJECTION, INCOBOTULINUMTOXIN A, 1 UNIT

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 - 341.9 opens in new window NEUROMYELITIS OPTICA - DEMYELINATING DISEASE OF CENTRAL NERVOUS SYSTEM UNSPECIFIED

342.11 - 342.12 opens in new window SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING DOMINANT SIDE - 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

344.1 - 344.09* opens in new window QUADRIPLEGIA UNSPECIFIED - OTHER QUADRIPLEGIA

344.2 * PARAPLEGIA

344.3 * DIPLEGIA OF UPPER LIMBS

344.30 - 344.32* opens in new window MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

344.40 - 344.42* opens in new window MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE - 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 - 378.9 opens in new window ESOTROPIA UNSPECIFIED - 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

* These ICD-9-CM codes are to be used only when there is spasticity of central nervous system origin. 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 - 342.12 opens in new window SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE

344.1 - 344.09 opens in new window QUADRIPLEGIA UNSPECIFIED - OTHER QUADRIPLEGIA

344.2 PARAPLEGIA

344.3 DIPLEGIA OF UPPER LIMBS

344.30 - 344.32 opens in new window MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE

344.40 - 344.42 opens in new window MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SDE

344.5 UNSPECIFIED MONOPLEGIA

438.20 - 438.22 opens in new window HEMIPLEGIA AFFECTING UNSPECIFIED SIDE - HEMIPLEGIA AFFECTING NONDOMINANT SIDE

438.30 - 438.32 opens in new window MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SIDE

438.40 - 438.42 opens in new window MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE - 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

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations 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. 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.

• a statement that traditional methods of treatment 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.

• when Botox® (onabotulinumtoxina) is used for the FDA approved indication of prophylaxis of headaches in adult patients with chronic migraine (> 15 days per month with headache lasting 4 hours a day or longer), the documentation must support these specific symptom parameters.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

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.

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.

Advisory Committee Meeting Notes

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 05/01/2011

Revision History Number 8

Revision History Explanation Revision Number:8 Start Date of Comment Period: N/A

Start Date of Notice Period:05/01/2012 Revised Effective Date: 03/29/2012

LCR B2012-042

April 2012 Connection

Explanation of Revision: The ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD has been revised to remove the off-label indication for Botox® to treat neurogenic urinary incontinence and add this indication under the ‘FDA Indications for Botox®’ section which states: Treatment of 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 anticholinergic medication. In addition the “Sources of Information and Basis for Decision” section has been updated. This revision is effective for claims processed on or after 03/29/2012, for dates of service on or after 08/01/2011.

Revision Number:7

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012

LCR B2012-017

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. HCPCS code Q2040 was deleted and replaced with HCPCS code J0588. The effective date of this revision is based on date of service. Revision Number:6

Start Date of Comment Period:N/A Start Date of Notice Period:05/01/2011 Revised Effective Date: 04/01/2011

LCR B2011-058

April 2011 Update

Explanation of Revision: LCD revised in accordance with CMS Change Requests 7299, dated 02/04/2011, CMS Change Request 7319, dated 02/04/ 2011 and CMS Change Request 7343, dated 03/25/2011. In this regard, the ‘CPT/HCPCS Codes’ and ‘ICD-9 Codes that Support Medical Necessity’ sections of the LCD have been revised to delete HCPCS codes J3590/C9278 and add HCPCS code Q2040 incobotulinumtoxina (Xeomin®). This revision is effective for claims processed on or after 04/04/2011, for dates of service on or after 04/01/2011.

Revision Number:5

Start Date of Comment Period:N/A Start Date of Notice Period:04/01/2011 Revised Effective Date: 03/03/2011

LCR B2011-039

March 2011 Update

Explanation of Revision: The ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD has been revised in the ‘FDA Indications for Botox’ section to add: prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer). The ‘ICD-9 Codes that Support Medical Necessity’ section of the LCD, under section ‘Procedure J0585’ has been revised to add ICD-9-CM codes 346.71 and 346.73 in this regard, and the ‘Documentation Requirements’ section has also been revised in relation to this new FDA approved indication. This revision is effective for claims processed on or after 03/03/2011, for services rendered on or after 10/15/2010.

The LCD has also been revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to add language regarding incobotulinumtoxina (Xeomin®). A new section was added, ‘FDA Indications for Xeomin’. The ‘CPT/HCPCS Codes’ section of the LCD has been revised to add HCPCS code J3590 – Unclassified biologics and HCPCS code C9278 - Injection, incobotulinumtoxin a, 1 unit (for ASCs only). The ‘ICD-9 Codes that Support Medical Necessity’ section of the LCD has been revised to add a new section, ‘Procedure code J3590 - incobotulinumtoxina (Xeomin) and Procedure code C9278 - Injection, incobotulinumtoxin a, 1 unit (ASCs only). In addition, the ‘Sources of Information and Basis for Decision’ has been updated. These revisions to the LCD are effective for claims processed on or after 03/03/2011, for services rendered on or after July 30, 2010, for HCPCS code J3590 and claims processed on or after 03/03/2011, for services rendered on or after January 1, 2011, for HCPCS code C9278.

Revision Number:4

Start Date of Comment Period:N/A Start Date of Notice Period:08/01/2010 Revised Effective Date: 09/13/2010

LCR B2010-059

July 2010 Update

Explanation of Revision: LCD revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to update language and add language regarding the differences in preparation for botulinum toxins. A bullet was also added under the ‘FDA Indications for Botox’ section for “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)”. The ‘ICD-9 CM Codes that Support Medical Necessity’ section has been revised for ‘Procedure Code J0585’ to add ICD-9-CM code 705.22 and to delete ICD-9-CM codes 343.0, 728.85 and 780.8. The ‘ICD-9 CM Codes that Support Medical Necessity’ section has also been revised for ‘Procedure Code J0586’ to add ICD-9-CM codes 333.81, 333.82, 342.11, 342.12 and 705.21. The effective date of this revision is based on date of service.

Revision Number:3

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR B2010-016

December 2009 Update

Explanation of Revision: Annual 2010 HCPCS Update. Descriptors revised for HCPCS codes J0585 and J0587. HCPCS code J3590 was deleted and replaced with HCPCS code J0586. The effective date of this revision is based on date of service.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 07/31/2009

LCR B2009-109

December 2009 Update

Explanation of Revision: The ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD revised, in accordance with the FDA, to update the established drug name for ‘botulinum toxin type A’ to ‘onabotulinumtoxinA’ and to update the established drug name for ‘botulinum toxin type B’ to ‘rimabotulinumtoxinB’. The LCD revision for the established drug names is effective for services rendered on or after the FDA approval date of 07/31/2009.

The ‘Indications and Limitations of Coverage and/or Medical Necessity’ section has also been revised to add language regarding an additional botulinum toxin approved by the FDA on 04/29/09: abobotulinumtoxinA (Dysport™) and a new section has been added under the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section: ‘FDA indication for Dysport™’. The ‘CPT/HCPCS Codes’ section has been revised to include HCPCS Code J3590 (unclassified biologics) and the ‘ICD-9 CM Codes that Support Medical Necessity’ section has been revised to add HCPCS Code J3590 (abobotulinumtoxinA (Dysport™) and ICD-9-CM codes 333.83 and 723.5. The ‘Sources of Information and Basis for Decision’ section has also been updated. The LCD revision for the addition of abobotulinumtoxinA (Dysport™) is effective for services rendered on or after the FDA approval date of 04/29/2009.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:04/01/2009 Revised Effective Date: 04/06/2009

LCR B2009-054

April 2009 Update

Explanation of Revision: ‘Indications and Limitations of Coverage and/or Medical Necessity’section of LCD revised under ‘Off-label indications for Botox’ to add language regarding coverage for neurogenic urinary incontinence and neurogenic detrusor overactivity. ‘ICD-9-CM Codes that Support Medical Necessity’ section of LCD also revised to add ICD-9-CM codes 596.54, 596.55 and

596.59. And ‘Sources of Information and Basis for Decision’ section updated. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-044FL LCR B2009-045PR/VI

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO). For Florida (00590) this LCD (L29088) replaces LCD L5840 as the policy in notice. This document (L29088) is effective on 02/02/2009.

11/15/2009 - The description for CPT/HCPCS code J0585 was changed in group 1 11/15/2009 - The description for CPT/HCPCS code J0587 was changed in group 1

04/09/2011 - The following CPT/HCPCS codes were deleted: C9278 was deleted from Group 1

11/21/2011 - The following CPT/HCPCS codes were deleted: Q2040 was deleted from Group 1

Reason for Change Coverage Change (actual change in medical parameters)