Contractor Information
Contractor Name:
Highmark Medicare Services
Contractor Number:
12102, 12202, 12302
Contractor Type:
MAC Part A & B
LCD Information
LCD Database ID Number
L27476
LCD Title
Botulinum Toxin Type A and B
Contractor’s Determination Number
L27476
AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.
CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
Primary Geographic Jurisdiction
Maryland, District of Columbia, Delaware
Oversight Region
Central Office
Original Determination Effective Date
For services performed on or after 07/11/2008
Original Determination Ending Date
N/A
Revision Effective Date
For services performed on or after N/A
Revision Ending Date
N/A
Indications and Limitations of Coverage and/or Medical Necessity
Compliance with the provisions in this policy may be monitored and addressed through data analysis and medical review audits.
Botulinum toxin type A and type B are purified neurotoxins that block neuromuscular conduction by inhibiting the release of acetylcholine and producing a localized chemical denervation muscle paralysis. The resulting decrease of contractility, strength and tension of certain muscle groups may improve clinical outcomes in patients with inappropriate or exaggerated muscle contraction.
This policy addresses coverage. Payment for the services discussed will be based on Medicare payment policy. This policy will NOT equate payment using the least costly alternative.
Covered Indications
This policy is specific to the coverage of botulinum toxin type A and type B. Although the FDA approvals and compendia indications for these drugs are different, the current medical literature and the accepted community standard of practice supports that the toxins are similar. Therefore, the following indications are considered medically reasonable and necessary for treatment with botulinum toxin type A and type B:
1. Blepharospasm and strabismus
2. Focal dystonias to relieve pain, to assist posturing and walking, to increase range of motion, to assist in the outcome of physical therapy, and/or to reduce spasm thus allowing adequate perineal hygiene. The patient must have attempted conventional spastic condition treatment methods without satisfactory improvement, or have a contraindication to such treatment.
3. Spasmodic dysphonia
4. Achalasia and cardiospasm when at least one of the following conditions is met:
- Patient has failed conventional therapy or has a contraindication to such therapy
- Patient is at high risk of complications from pneumatic dilation or surgical myotomy
- Prior myotomy or dilation has failed
- Prior dilation-induced esophageal perforation
- Patient has an epiphrenic diverticulum or hiatal hernia
5. Severe primary focal hyperhidrosis in patients who are not adequately managed with topical agents or ionotophoresis (or have a contraindication to such treatment), and who manifest all of the following indications:
- Severe sweating beyond physiological needs
- Focal, visible, severe sweating of at least 6 months duration without apparent cause with at least 2 of the following characteristics:
-Bilateral and relatively symmetric-Significant impairment in daily activities
-Age of onset less than 25 years
-Positive family history
-Cessation of focal sweating during sleep
6. Disability from sialorrhea due to conditions such as motor neuron disease or Parkinson's disease in those patients who have failed to respond to a reasonable trial of traditional therapies (i.e., anticholinergics, speech therapy, surgical therapy), or who have a contraindication to traditional therapy.7. Botulinum Toxin Type A can be used to treat urinary incontinence due to neurogenic bladder. This treatment will be reimbursed if used only after documented failure of medical therapy.
The determination regarding whether botulinum toxin type A or type B is the most appropriate course of treatment should be based on the physician’s judgment, clinical experience, and the patient’s individual history.
Electromyography procedure(s) may be medically necessary when the proper injection site(s) is difficult to determine.
Coverage Limitations
- Services performed for cosmetic reasons, i.e., those services directed at improving appearance and not to improve or restore bodily function, are excluded from Medicare coverage.
- All other types of spastic conditions not included in the covered ICD-9 section below are non-covered.
- At this time, the clinical efficacy of botulinum toxin in the treatment of the following conditions is not proven in the published medical literature and, therefore, is considered not medically reasonable and necessary:
- Chronic migraine and intractable headache (e.g., tension)
- Myofascial pain
- Temporomandibular disorder
- Biliary dyskinesia
- Irritable colon
- The safety and efficacy of botulinum toxin type B has not been established in the pediatric population. Therefore, coverage of pediatric indications is limited, at this time, to botulinum toxin type A.
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Coverage Topic
Outpatient Hospital Services
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.
11x | Hospital-inpatient (including Part A) |
12x | Hospital-inpatient or home health visits (Part B only) |
13x | Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00) |
85x | Special facility or ASC surgery-rural primary care hospital (eff 10/94) |
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.
0636 | Drugs requiring specific identification-detailed coding (eff 3/92) |
CPT/HCPCS Codes
Italicized and/or quoted material is excerpted from the American Medical Association, Current Precedural Terminology (CPT) codes.
J0585 | BOTULINUM TOXIN TYPE A, PER UNIT |
J0587 | BOTULINUM TOXIN TYPE B, PER 100 UNITS |
ICD-9 Codes that Support Medical Necessity
It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.
For code J0585 and J0587:
It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.
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For Code J0585 Only
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Diagnoses that Support Medical Necessity
N/A
ICD-9 Codes that DO NOT Support Medical Necessity
All those not listed under the "ICD-9 Codes that Support Medical Necessity" section of this policy.
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.
General Information
Documentation Requirements
- All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
- The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
The medical record documentation must support the medical necessity and frequency of this treatment. The documentation must include all of the following:
- A history and physical pertinent to the indications of this policy
- The conventional methods of treatment attempted and patient response or contraindication to such treatment as appropriate
- Site, dosage and frequency of administration
- Patient response to treatment with botulinum toxin
- Medical necessity of electromyography procedure(s) if performed
When a portion of the drug is discarded, the medical record must clearly document the amount administered and the amount wasted.
The medical record must be available to the carrier upon request.
Utilization Guidelines
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.
The unit doses of type A and type B toxins may not be equated. Appropriate dosing for effectiveness and safety must be determined independently for each neurotoxin.
Appropriate dosing is to be determined by the physician and each unique, clinical, patient situation taking into account the size of the muscle group injected, the degree of spasticity and potential for toxicity.
Treatment of spasticity or excessive muscular contractions is typically initiated with a low dose of botulinum toxin and increased as needed based on individual patient response.
In the treatment of larger muscle groups, it is considered not reasonable and necessary to continue treatment if no response is elicited with a maximum dose per site. Treatment may be resumed at a later date if deemed clinically appropriate.
The generally accepted frequency for treatment of spasticity or excessive muscular contractions is repeat injections once every three months.
Treatment will no longer be considered reasonable and necessary if any two treatments in a row of the appropriate or maximum dosage failed to produce a satisfactory clinical response.
Sources of Information and Basis for Decision
Abram SE. Does botulinum toxin have a role in the management of myofascial pain? Anesthesiology. 2005; 103: 223-224.
Acquadro MA, Borodic GE. Botulinum toxin efficacy for the treatment of pain. Journal of Clinical Anesthesia. 2005 Aug; 17(5).
Adler CH, Bansberg SF, Krein-Jones K, Hentz JG. Safety and efficacy of botulinum toxin type B (Myobloc) in adductor spasmodic dysphonia. Movement Disorders. 2004; 19(9): 1075-1079.
Allergan (manufacturer) product information.
Argoff CE. Successful treatment of chronic daily headache with botulinum toxin type B (Myobloc®). Archives of Pharmacology. 2002 June; 365(2).
Antonella Giannantoni, et al, Intravesical resiniferatoxin versus Botulinum – A Toxin Injections for Neurogenic Detrusor Overactivity: A Prospective Randomized Study. The JNL of Urology, 172:240-243, 2004.
Baumann LS, Halem ML. Botulinum toxin-B and the management of hyperhidrosis. Clinics in Dermatology. 2004; 22: 60-65.
Baumann L, Slezinger A, Black L, et al. A double-blinded, randomized placebo-controlled pilot study of the safety and efficacy of MYOBLOC® (botulinum toxin type B) for the treatment of axillary hyperhidrosis. (Unpublished data).
Blumenfeld AM, Dodick DW, Silberstein SD. Botulinum toxin for the treatment of migraine and other primary headache disorders. Dermatologic Clinics. 2004 April; 22(2).
Botox® package insert.
Botulinum Toxin Type A. USP DI September 01, 2005.
Botulinum Toxin Type B. USP DI July 01, 2005.
Brashear A, McAfee AL, Kuhn ER, Ambrosius WT. Treatment with botulinum toxin type B for upper-limb spasticity. Arch Phys Medicine and Rehab. 2003 Jan; 84: 103-107.
Brigitte Schurch et al, Botulinum Toxin Type A is Safe and Effective Treatment ofr Neurogenic Urinary Incontinence: Results of a Single Treatment, Randomized, Placebo Controlled 6-Month Study. The JNL of Urology, 174:196-200, 2005.
Christopher P Smith and Michael B Chancellor, Emergining Role of Botulinum Toxin in the Management of Voiding Dysfunction. The JNL of Urology 171:2128-2137, 2004.
De Andres J, Cerda-Olmedo G, Valia JC, et al. Use of botulinum toxin in the treatment of chronic myofascial pain. Clin J Pain. 2003 July; 19(4): 269-275.
Difazio M, Jabbari B. A focused review of the use of botulinum toxins for low back pain. The Clinical Journal of Pain. 2002.
Dressler D, Adib SF, Benecke R. Botulinum toxin type B of a treatment of axillary hyperhidrosis. Neurol. 2002; 249: 1729-32.
Dressler D, Saberi FA, Benecke R. Botulinum toxin-B and the management of hyperhidrosis. J Neurology. 2002; 249: 1729-1732.
Dystonia Study Group, C.L. Comella. A direct comparison of botulinum toxin type A and type B in cervical dystonia: a multicenter, randomized, double blind, parallel study. United States; Chicago, Illinois, USA.
Ferrante FM, Barn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005; 103: 377-383.
Fried GW, Fried KM. Spinal cord injury and use of botulinum toxin in reducing spasticity. Phys Med Rehabil Clin N Am. 2003; 14: 901-910.
Gooch JL, Patton CP. Combining botulinum toxin and phenol to manage spasticity in children. Arch Phys Med Rehabil. 2004; 85: 1121-24.
Hecht M, Birklein F, Winterholler. Successful treatment of axillary hyperhidrosis with very low doses of botulinum toxin B: a pilot study. Arch Dermatol Res. 2004; 295: 318-319.
Hornberger J, Grimes K, Naumann M, et al. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004; 51: 274-286.
Lang AM. A preliminary comparison of the efficacy and tolerability of botulinum toxin serotypes A and B in the treatment of myofascial pain syndrome: a retrospective, open-label chart review. Clin Ther. 2003 Aug; 28(8): 2268-2278.
Leong M, et al. A randomized double-blind study to compare the effects of neurobloc (myobloc; botulinum toxin type B) with botox (botulinum toxin type A) in toxin-naïve subjects with cervical dystonia. Poster presentation at the International Conference 2005 Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins. Denver CO, June 23-25, 2005. (under the auspices of the Neurotoxicity Society).
Lipp A, Trottenberg T, Schink T, et al. A randomized trial of botulinum toxin A for treatment of drooling. Neurology. 2003 Nov; 61(9).
Lowe NJ, Yamauchi PS, Lask GP, et al. Efficacy and safety of botulinum toxin type A in the treatment of palmar hyperhidrosis: A double-blind, randomized, placebo-controlled study. Dermatol Surg. 2002; 28: 822-827.
Myobloc® package insert.
Naumann M, Lowe HJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomized, parallel group, double blind, placebo controlled trial. Brit Med J. 2001; 323: 1-4.
Naumann M, Lowe NJ, Kumar et al. Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months. Arch Dermatol. 2003; 139: 731-736.
Naumann MK, Hamm H, Lowe NJ. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. BJD. July 2002; 147(6): 1218-1226.
Naumann MK, Hamm H, Spalding JR, et al. Comparing the quality of life effect of primary focal hyperhidrosis to other dermatological conditions as assessed by the Dermatology Life Quality Index (DLQI). Presented at the International Society for Pharmacoeconomics and Outcomes Research 2003.
Nelson L, Bachoo P, Holmes J. Botulinum toxin type B: a new therapy for axillary hyperhidrosis. British Journal of Plastic Surgery. 2005; 58: 228-232.
Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in parkinson’s disease. Neurology. 2004; 62: 37-40.
Opida CL. Open-label study of Myoblocä (botulinum toxin type B) in the treatment of patients with transformed migraine headaches. Archives of Pharmacology. 2002 June; 365(2).
Prajapati DN, Hogan WJ. Sphincter of Oddi dysfunction and other functional biliary disorders: evaluation and treatment. Gastroenterol Clin N Am. 2003; 32: 601-618.
Racette BA, Good L, Sagitto S, Perlmutter JS. Botulinum toxin B reduces sialorrhea in parkinsonism. Movement Disorders. 2003; 18(9): 1059-1061.
Raj PP. Botulinum toxin therapy in pain management. Anesthesiology Clin N Am. 2003. 21: 715-731.
Sahai A, et al, Botulinim Toxin-A For Patients with Idiopathic Detrusor Overactivity: Early Results from a Randomized, Double-Blind, Placebo-Controlled Trial.
Sataloff RT, Heman-Ackah YD, Simpson LL, et al. Botulinum toxin type B for the treatment of spasmodic dysphonia. Journal of Voice. 2002 Sept; 16(3): 422-424.
Schwerin A, Berweck S, Fietzek UM et al. Botulinum toxin B treatment in children with spastic movement disorders: a pilot study. Pedi Neurol. 2004; 31(2): 109-113.
Smith HS, Audette J, Royal MA. Botulinum toxin in pain management of soft tissue syndromes. The Clinical Journal of Pain. 2002; 18(6): S147-S154.
Solstice (manufacturer) product information.
Strutton DR, Kowalski JW, Glaser DA, et al. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004; 51: 241-248.
Taqi D, Gunyea I, Bhakta B, et al. Botulinum toxin type B (Myobloc) in the treatment of refractory myofascial pain. Pain Medicine. 2002 June; 3(2): 25-27
Zalvan C, Bentsianov B, Blitzer A. Noncosmetic uses of botulinum toxin. Dermatologic Clinics. 2004 April; 22(2).
Other carrier’s policies: AdminaStar Federal, BCBC of Arkansas, CIGNA Government Services, Empire Medicare Services, Noridian Administrative Services, TrailBlazer Health Enterprises.
From the Department of Urology, Guy’s and St. Thomas’ NHS & GKT School of Medicine.
Other Contractor’s Policies
Highmark Medicare Services Contractor Medical Directors
Advisory Committee Meeting Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups that include representatives from the appropriate specialty (ies).
CAC/IAC Distribution: 04/01/2008
Start Date of Comment Period
End Date of Comment Period:
05/15/2008
Start Date of Notice Period
05/23/2008
Revision History
Revision History Number
L27476
Revision History Explanation
| Date | Policy # | Description |
|---|---|---|
05/23/2008 |
L27476 |
Original LCD posted for notice. LCD to become effective 07/11/2008 for Maryland Part B, DCMA Part B and Delaware Part B. |
04/01/2008 |
Draft J12-D4 |
Original LCD posted for comment. |
Last Reviewed On
05/22/2008
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