Botulinum Toxin Type A & Type B (L28555)
Contractor Information
|
Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - MAC |
LCD Information
Document Information
L28555 LCD Title Botulinum Toxin Type A & Type B Contractor's Determination Number INJ-018 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. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date For services performed on or after 05/16/2009 Original Determination Ending Date Revision Effective Date For services performed on or after 05/01/2012 Revision Ending Date |
CMS National Coverage Policy
Title
XVIII of the Social Security Act section 1862 (a)(1)(A). This section
allows coverage and payment of those services that are considered to be
medically reasonable and necessary.
Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services.
Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Transmittal: 2147 Pub. 100-04 February 4, 2011 Change Request: 7299
Change Request 7319 February 25, 2011
Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services.
Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Transmittal: 2147 Pub. 100-04 February 4, 2011 Change Request: 7299
Change Request 7319 February 25, 2011
Indications and Limitations of Coverage and/or Medical Necessity
Botulinum
toxins are potent neuromuscular blocking agents that are useful in
treating various focal muscle spastic disorders and excessive muscle
contractions, such as dystonia, spasms, and twitches. They produce a
presynaptic neuromuscular blockade by preventing the release of
acetylcholine from the nerve endings. Since the resulting chemical
denervation of muscle produces local paresis or paralysis, selected
muscles can be treated. The clinical indications for botulinum toxins
have increased exponentially since first used two decades ago. They are
used in the treatment of overactive skeletal muscles (e.g. Hemifacial
spasm, dystonia, spasticity), smooth muscles (e.g. Detrusor overactivity
and achalasia), glands (e.g. Sialorrhoea and hyperhidrosis) and
additional conditions that are being investigated.
There are currently four botulinum toxin products commercially available in the United States: onabotulinumtoxinA, rimabotulinumtoxinB, abobotulinumtoxinA, and incobotulinumtoxinA. Each preparation has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are also specific to the preparation of neurotoxin and are very different between different serotypes. Failure to recognize the unique characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes. It is expected that physicians will be familiar with and experienced in the use of these agents, and utilize evidence-based medicine to select the appropriate drug and dose regimen for each patient condition. Physicians may decide which agent to use in beneficiary care except as noted below. Although botulinum toxins have only been FDA-approved for limited uses, they are frequently used off-label as well. A patient who is not responsive or who ceases to respond to one serotype may respond to the other.
Limitations
It is generally not considered medically necessary to give botulinum toxin injections for spastic or excess muscular contraction conditions more frequently than every 90 days.
Voluntary muscular contraction depends upon the release of acetylcholine from vesicles within a nerve ending following stimulation of the nerve. The acetylcholine is released into the neuromuscular junction, binding to specific proteins called receptors in the membrane of the muscle fiber. The effect of the acetylcholine at these receptors is to cause the muscle to contract. When a sufficient amount of acetylcholine has been released with subsequent binding to the muscle fiber proteins, muscle contraction occurs. Botulinum toxin type A and botulinum toxin type B create a chemical blockade by inhibiting the release of acetylcholine from the nerve ending vesicles thereby preventing the acetylcholine from binding to the proteins in the receptor site on the muscle. Localized weakness or paralysis occurs in the muscle injected with botulinum toxin.
Approved indications for botulinum toxin type A and toxin type B differ. WPS Medicare has determined that the separate accepted indications for the botulinum toxin products will be combined into a single list of covered indications in this Local Coverage Determination (LCD) policy. It is the responsibility of providers, however, to use each drug in accordance with approved indications unless there are valid and documented reasons stating why the unapproved or unaccepted form is used. While this policy contains a single list of covered indications, this is not meant to imply that the two botulinum toxin products are interchangeable".
In clinical conditions, such as cervical dystonia, excessive and abnormal regional muscle contraction causes torsion, spasticity and pain. Botulinum toxin, injected in a local fashion, can produce neuromuscular blockade and/or paralysis; symptoms abate, although repeat injections may be required. Eventual loss of response to repeated injections may occur in some patients who have received botulinum toxin treatment. Immunoresistance may be one of the reasons for this development. As experience accumulates, with other toxin types also similar resistance could be observed.
Before consideration of coverage may be made:
There are currently four botulinum toxin products commercially available in the United States: onabotulinumtoxinA, rimabotulinumtoxinB, abobotulinumtoxinA, and incobotulinumtoxinA. Each preparation has distinct pharmacological and clinical profiles specified on the product insert. Dosing patterns are also specific to the preparation of neurotoxin and are very different between different serotypes. Failure to recognize the unique characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes. It is expected that physicians will be familiar with and experienced in the use of these agents, and utilize evidence-based medicine to select the appropriate drug and dose regimen for each patient condition. Physicians may decide which agent to use in beneficiary care except as noted below. Although botulinum toxins have only been FDA-approved for limited uses, they are frequently used off-label as well. A patient who is not responsive or who ceases to respond to one serotype may respond to the other.
Limitations
It is generally not considered medically necessary to give botulinum toxin injections for spastic or excess muscular contraction conditions more frequently than every 90 days.
Voluntary muscular contraction depends upon the release of acetylcholine from vesicles within a nerve ending following stimulation of the nerve. The acetylcholine is released into the neuromuscular junction, binding to specific proteins called receptors in the membrane of the muscle fiber. The effect of the acetylcholine at these receptors is to cause the muscle to contract. When a sufficient amount of acetylcholine has been released with subsequent binding to the muscle fiber proteins, muscle contraction occurs. Botulinum toxin type A and botulinum toxin type B create a chemical blockade by inhibiting the release of acetylcholine from the nerve ending vesicles thereby preventing the acetylcholine from binding to the proteins in the receptor site on the muscle. Localized weakness or paralysis occurs in the muscle injected with botulinum toxin.
Approved indications for botulinum toxin type A and toxin type B differ. WPS Medicare has determined that the separate accepted indications for the botulinum toxin products will be combined into a single list of covered indications in this Local Coverage Determination (LCD) policy. It is the responsibility of providers, however, to use each drug in accordance with approved indications unless there are valid and documented reasons stating why the unapproved or unaccepted form is used. While this policy contains a single list of covered indications, this is not meant to imply that the two botulinum toxin products are interchangeable".
In clinical conditions, such as cervical dystonia, excessive and abnormal regional muscle contraction causes torsion, spasticity and pain. Botulinum toxin, injected in a local fashion, can produce neuromuscular blockade and/or paralysis; symptoms abate, although repeat injections may be required. Eventual loss of response to repeated injections may occur in some patients who have received botulinum toxin treatment. Immunoresistance may be one of the reasons for this development. As experience accumulates, with other toxin types also similar resistance could be observed.
Before consideration of coverage may be made:
- In most cases it should be established that the patient has been unresponsive to conventional methods of treatments such as medication, physical therapy and other methods used to control and/or treat spastic condition.
- Coverage of botulinum toxin for certain spastic conditions (e.g., cerebral palsy, stroke, head trauma, spinal cord injuries, and multiple sclerosis) will be limited to those conditions listed in the ICD-9 Codes that Support Medical Necessity section of this policy. All other uses in the treatment of other types of spasm will be considered as investigational and therefore, noncovered by Medicare.
- Since organic writer's cramp is uncommon, Medicare would not expect to see the treatment of this condition to be billed frequently.
- The patient who has a spastic or excessive muscular contraction condition is usually started with a low dose of botulinum toxin. Other spastic or muscular contraction conditions, such as eye muscle disorders, (e.g., blepharospasm) may require lesser amounts of botulinum toxin. For larger muscle groups, it is generally agreed that once a maximum dose per site has been reached and there is no response, the treatment is discontinued. The treatments may be resumed at a later date. With response, the effect of the injections generally lasts for three months at which time the patient may require repeat injections to control the spastic or excessive muscular condition.
- It is usually considered not medically necessary to give botulinum toxin injections for spastic conditions more frequently than every 90 days.
- Coverage of treatments provided may be continued unless any two treatments in a row, utilizing an appropriate or maximum dose of botulinum toxin failed to produce satisfactory clinical response.
- Requests may be considered for continued treatment during a treatment period or for resumption at a later date if satisfactory results have not been obtained, if compelling clinical evidence of medical necessity is presented.
- 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 all muscles of a single contiguous body part such as, a single limb, eyelid, face, neck, back, or chest.
- Botulinum
toxin may be covered in the treatment of achalasia. This use appears to
be safe and effective. Two-thirds of patients respond within six
months of treatment and effectiveness lasts an average of more than one
year for the initial treatment, although shorter and longer durations
have been reported.
The use of botulinum toxin should not be endorsed for all patients but it can be considered individually if:
a. The patient has failed conventional therapy;
b. The patient is at high risk of complications of pneumatic dilation or surgical myotomy;
c. The patient has failed a prior myotomy or dilation;
d. The patient has had a previous dilation-induced perforation;
e. The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilation-induced perforation.
Some patients may fail a first injection and respond to a second. Further therapy should be questioned if two treatments in a row fail. Therapy can be repeated later in those who fail after an initial response
This service should be reported using CPT codes 43201 or 43236 and an ICD-9-CM code 530.0 - achalasia and cardiospasm. - Treatment of cervical dystonia, strabismus, and blephorospasm
Botulinum toxin type A (onabotulinumtoxinA) is FDA-approved for the treatment of cervical dystonia (2000), strabismus (1989), blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above (1989), and severe primary axillary hyperhidrosis that is inadequately managed with topical agents (2004), and primary axillary hyperhidrosis ICD-9 705.21.
Botulinum toxin type A (incobotulinumtoxinA) received FDA-approved for the treatment of dystonia (ICD-9 code 333.83 spasmodic tortoicollis) and for blepharospasm (ICD-9 code 333.81), ONLY if there is a history of the beneficiary having previous history of receiving J0585 Injection, onabotulinumtoxinA, 1 Unit.
Botulinum toxin type 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 type B has not received FDA
approval for other indications. - The U.S. Food and Drug Administration approved onabotulinumtoxinA injection to prevent headaches in adult patients with chronic migraine Oct. 15, 2010. Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine. To treat chronic migraines, onabotulinumtoxinA is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. OnabotulinumtoxinA has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache.
- PLEASE NOTE: OnabotulinumtoxinA for the treatment of Migraines must be billed as one service/day (injection) and may be billed with either CPT code 64612 or 64613 but not both on the same date of service. If both CPT code 64612 and 64613 are billed in the same day one will be denied and the provider will not be able to bill the patient for additional "services".
- You must look at the billing and coding guidelines
NOTE:
WPS Medicare has confirmed with National Correct Coding Initiative (CCI), Centers for Medicare and Medicaid Services (CMS) and the AMA, if the description of the code is plural, regardless of the number of services performed, only one injection may be billed.
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.
Revenue Codes:
CPT/HCPCS 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.
| 31513 | LARYNGOSCOPY, INDIRECT; WITH VOCAL CORD INJECTION |
| 31570 | LARYNGOSCOPY, DIRECT, WITH INJECTION INTO VOCAL CORD(S), THERAPEUTIC; |
| 31571 | LARYNGOSCOPY, DIRECT, WITH INJECTION INTO VOCAL CORD(S), THERAPEUTIC; WITH OPERATING MICROSCOPE OR TELESCOPE |
| 43201 | ESOPHAGOSCOPY, RIGID OR FLEXIBLE; WITH DIRECTED SUBMUCOSAL INJECTION(S), ANY SUBSTANCE |
| 43236 | UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH DIRECTED SUBMUCOSAL INJECTION(S), ANY SUBSTANCE |
| 46505 | CHEMODENERVATION OF INTERNAL ANAL SPHINCTER |
| 53899 | UNLISTED PROCEDURE, URINARY SYSTEM |
| 64611 | CHEMODENERVATION OF PAROTID AND SUBMANDIBULAR SALIVARY GLANDS, BILATERAL |
| 64612 | CHEMODENERVATION OF MUSCLE(S); MUSCLE(S) INNERVATED BY FACIAL NERVE (EG, FOR BLEPHAROSPASM, HEMIFACIAL SPASM) |
| 64613 | CHEMODENERVATION OF MUSCLE(S); NECK MUSCLE(S) (EG, FOR SPASMODIC TORTICOLLIS, SPASMODIC DYSPHONIA) |
| 64614 | CHEMODENERVATION OF MUSCLE(S); EXTREMITY(S) AND/OR TRUNK MUSCLE(S) (EG, FOR DYSTONIA, CEREBRAL PALSY, MULTIPLE SCLEROSIS) |
| 64650 | CHEMODENERVATION OF ECCRINE GLANDS; BOTH AXILLAE |
| 64653 | CHEMODENERVATION OF ECCRINE GLANDS; OTHER AREA(S) (EG, SCALP, FACE, NECK), PER DAY |
| 67345 | CHEMODENERVATION OF EXTRAOCULAR MUSCLE |
| 92265 | NEEDLE OCULOELECTROMYOGRAPHY, 1 OR MORE EXTRAOCULAR MUSCLES, 1 OR BOTH EYES, WITH INTERPRETATION AND REPORT |
| 95860 | NEEDLE ELECTROMYOGRAPHY; 1 EXTREMITY WITH OR WITHOUT RELATED PARASPINAL AREAS |
| 95861 | NEEDLE ELECTROMYOGRAPHY; 2 EXTREMITIES WITH OR WITHOUT RELATED PARASPINAL AREAS |
| 95863 | NEEDLE ELECTROMYOGRAPHY; 3 EXTREMITIES WITH OR WITHOUT RELATED PARASPINAL AREAS |
| 95865 | NEEDLE ELECTROMYOGRAPHY; LARYNX |
| 95866 | NEEDLE ELECTROMYOGRAPHY; HEMIDIAPHRAGM |
| 95867 | NEEDLE ELECTROMYOGRAPHY; CRANIAL NERVE SUPPLIED MUSCLE(S), UNILATERAL |
| 95868 | NEEDLE ELECTROMYOGRAPHY; CRANIAL NERVE SUPPLIED MUSCLES, BILATERAL |
| 95869 | NEEDLE ELECTROMYOGRAPHY; THORACIC PARASPINAL MUSCLES (EXCLUDING T1 OR T12) |
| 95870 | NEEDLE ELECTROMYOGRAPHY; LIMITED STUDY OF MUSCLES IN 1 EXTREMITY OR NON-LIMB (AXIAL) MUSCLES (UNILATERAL OR BILATERAL), OTHER THAN THORACIC PARASPINAL, CRANIAL NERVE SUPPLIED MUSCLES, OR SPHINCTERS |
| 95873 | ELECTRICAL STIMULATION FOR GUIDANCE IN CONJUNCTION WITH CHEMODENERVATION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 95874 | NEEDLE ELECTROMYOGRAPHY FOR GUIDANCE IN CONJUNCTION WITH CHEMODENERVATION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 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
For ONLY HCPCS Code J0585 - Injection, onabotulinumtoxinA, 1 Unit Botulinum toxin type A:
| 346.70 | CHRONIC MIGRAINE WITHOUT AURA, WITHOUT MENTION OF INTRACTABLE MIGRAINE WITHOUT MENTION OF STATUS MIGRAINOSUS |
| 346.71 | CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS |
| 346.72 | CHRONIC MIGRAINE WITHOUT AURA, WITHOUT MENTION OF INTRACTABLE MIGRAINE WITH STATUS MIGRAINOSUS |
| 346.73 | CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS |
| 705.21 | PRIMARY FOCAL HYPERHIDROSIS |
| 333.81 | BLEPHAROSPASM |
| 333.83 | SPASMODIC TORTICOLLIS |
HCPCS Code J0585 - onabotulinumtoxinA, and
HCPCS Code J0586 abobotulinumtoxinA, and
HCPCS Code J0587 rimabotulinumtoxinB
Note that there are no published data on the use of botulinum toxin type B for the following medically accepted indications of botulinum toxin type A: strabismus, achalasia, organic writer's cramp, and multiple sclerosis.
| 332.0 | PARALYSIS AGITANS |
| 333.1 | ESSENTIAL AND OTHER SPECIFIED FORMS OF TREMOR |
| 333.3 | TICS OF ORGANIC ORIGIN |
| 333.6 | GENETIC TORSION DYSTONIA |
| 333.71 | ATHETOID CEREBRAL PALSY |
| 333.72 | ACUTE DYSTONIA DUE TO DRUGS |
| 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 |
| 341.8 | OTHER DEMYELINATING DISEASES OF CENTRAL NERVOUS SYSTEM |
| 341.9 | DEMYELINATING DISEASE OF CENTRAL NERVOUS SYSTEM UNSPECIFIED |
| 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 |
| 343.0 | CONGENITAL DIPLEGIA |
| 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 |
| 351.8 | OTHER FACIAL NERVE DISORDERS |
| 374.03 | SPASTIC ENTROPION |
| 374.13 | SPASTIC ECTROPION |
| 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 |
| 438.0 | COGNITIVE DEFICITS |
| 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 |
| 438.41 | MONOPLEGIA OF LOWER LIMB AFFECTING DOMINANT SIDE |
| 438.42 | MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE |
| 438.50 | OTHER PARALYTIC SYNDROME AFFECTING UNSPECIFIED SIDE |
| 438.51 | OTHER PARALYTIC SYNDROME AFFECTING DOMINANT SIDE |
| 438.52 | OTHER PARALYTIC SYNDROME AFFECTING NONDOMINANT SIDE |
| 438.53 | OTHER PARALYTIC SYNDROME BILATERAL |
| 478.30 | UNSPECIFIED PARALYSIS OF VOCAL CORDS |
| 478.31 | PARTIAL UNILATERAL PARALYSIS OF VOCAL CORDS |
| 478.32 | COMPLETE UNILATERAL PARALYSIS OF VOCAL CORDS |
| 478.33 | PARTIAL BILATERAL PARALYSIS OF VOCAL CORDS |
| 478.34 | COMPLETE BILATERAL PARALYSIS OF VOCAL CORDS |
| 478.75 | LARYNGEAL SPASM |
| 527.2 | SIALOADENITIS |
| 527.7 | DISTURBANCE OF SALIVARY SECRETION |
| 530.0 | ACHALASIA AND CARDIOSPASM |
| 596.54 | NEUROGENIC BLADDER NOS |
| 596.55 | DETRUSOR SPHINCTER DYSSYNERGIA |
| 596.59 | OTHER FUNCTIONAL DISORDER OF BLADDER |
| 723.5 | TORTICOLLIS UNSPECIFIED |
| 728.85 | SPASM OF MUSCLE |
| 729.89 | OTHER MUSCULOSKELETAL SYMPTOMS REFERABLE TO LIMBS |
| 754.1 | CONGENITAL MUSCULOSKELETAL DEFORMITIES OF STERNOCLEIDOMASTOID MUSCLE |
| 781.0 | ABNORMAL INVOLUNTARY MOVEMENTS |
| 784.40 - 784.49 | VOICE AND RESONANCE DISORDER, UNSPECIFIED - OTHER VOICE AND RESONANCE DISORDERS |
| 784.51 | DYSARTHRIA |
| 784.52 | FLUENCY DISORDER IN CONDITIONS CLASSIFIED ELSEWHERE |
| 784.59 | OTHER SPEECH DISTURBANCE |
| 788.31 | URGE INCONTINENCE |
| 788.41 | URINARY FREQUENCY |
Diagnoses that Support Medical Necessity
See ICD-9 Listed above
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 codes not listed in this policy
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Diagnoses not listed in this policy.
General Information
Documentation should include the following elements:
1. Support for the medical necessity of the botulinum toxin (type A or type B) injection
2. A covered diagnosis
3. Dosage and frequency of the injections
4. Support for the medical necessity of electromyography procedures performed in conjunction with botulinum toxin type A injections to determine the proper injection site(s)
5. Support of the clinical effectiveness of the injections
6. Specific site(s) injected
7. Medical Record must support the treatment of chronic migraine (ICD-9 code 346.73) with a history of migraine and experiencing headaches on most days of the month.
8. Botulinum toxin type A incobotulinumtoxinA for blepharospasm (ICD-9 code 333.81), ONLY if there is a history of the beneficiary having previous history of receiving J0585 onabotulinumtoxinA.
1. Support for the medical necessity of the botulinum toxin (type A or type B) injection
2. A covered diagnosis
3. Dosage and frequency of the injections
4. Support for the medical necessity of electromyography procedures performed in conjunction with botulinum toxin type A injections to determine the proper injection site(s)
5. Support of the clinical effectiveness of the injections
6. Specific site(s) injected
7. Medical Record must support the treatment of chronic migraine (ICD-9 code 346.73) with a history of migraine and experiencing headaches on most days of the month.
8. Botulinum toxin type A incobotulinumtoxinA for blepharospasm (ICD-9 code 333.81), ONLY if there is a history of the beneficiary having previous history of receiving J0585 onabotulinumtoxinA.
Appendices
Utilization Guidelines
NA
* - An asterisk indicates a revision to that section of the policy.
Sources of Information and Basis for Decision
* - An asterisk indicates a revision to that section of the policy.
Annals Otorhinolaryngology, 103(1):31-35, Jan. >94, (Cricopharyngeal)
Brashear, MD et al. (1999) Safety and Efficacy of Neurobloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology; 53:1439-1446
Brin, M.F. et al. (1999) Safety and efficacy of neurobloc (botulinum toxin type B) in type A- resistant cervical dystonia. Neurology; 53:1431-1438
Kyrmizakis, D.E., Pangalos, A., Papadakis, C.E. et al. (2004, July) The use of botulinum toxin type A in the treatment of Frey and crocodile tears syndromes. J Oral Maxillofac Surg, 62(7):840-4
Naumann, M., So, Y., Argoff, C.E. et al. (2008, May 6) Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review). Report from the American Academy of Neurology Therapeutics and Technology Assessment subcommittee. Neurology,70(19):1707-14
Pasricha, Pankaj et al. (1996). Botulinum toxin for achalasia; long-term outcome and predictors of response, Gastroenterology; 1410-1415
Restivo, D.A., Lanza, S., Patti, F. et al (2002, December 24) Improvement of diabetic autonomic gustatory sweating by botulinum toxin type A. Neurology, 59(12):1971-3
Saadia, D., Voustianiouk, A., Wang, A.K. et al. (2001, December 11) Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology, 11; 57(11):2095-9
Brashear, MD et al. (1999) Safety and Efficacy of Neurobloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology; 53:1439-1446
Brin, M.F. et al. (1999) Safety and efficacy of neurobloc (botulinum toxin type B) in type A- resistant cervical dystonia. Neurology; 53:1431-1438
Kyrmizakis, D.E., Pangalos, A., Papadakis, C.E. et al. (2004, July) The use of botulinum toxin type A in the treatment of Frey and crocodile tears syndromes. J Oral Maxillofac Surg, 62(7):840-4
Naumann, M., So, Y., Argoff, C.E. et al. (2008, May 6) Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review). Report from the American Academy of Neurology Therapeutics and Technology Assessment subcommittee. Neurology,70(19):1707-14
Pasricha, Pankaj et al. (1996). Botulinum toxin for achalasia; long-term outcome and predictors of response, Gastroenterology; 1410-1415
Restivo, D.A., Lanza, S., Patti, F. et al (2002, December 24) Improvement of diabetic autonomic gustatory sweating by botulinum toxin type A. Neurology, 59(12):1971-3
Saadia, D., Voustianiouk, A., Wang, A.K. et al. (2001, December 11) Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology, 11; 57(11):2095-9
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 09/26/2008
Illinois 09/17/2008
Michigan 09/24/2008
Minnesota 09/11/2008
Iowa 10/16/2008
Kansas 10/16/2008
Missouri 10/17/2008
Nebraska 10/16/2008
Open Meeting Date
August 13, 2008
This policy replaces all previous WPS and other contractors for these states LCDs on this subject. This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from all states.
Wisconsin 09/26/2008
Illinois 09/17/2008
Michigan 09/24/2008
Minnesota 09/11/2008
Iowa 10/16/2008
Kansas 10/16/2008
Missouri 10/17/2008
Nebraska 10/16/2008
Open Meeting Date
August 13, 2008
This policy replaces all previous WPS and other contractors for these states LCDs on this subject. This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from all states.
Start Date of Comment Period
10/18/2008
End Date of Comment Period
12/03/2008
Start Date of Notice Period
05/01/2011
Revision History Number
16
Revision History Explanation
06/01/2012, sixteen,
corrected typos, spelling, and case, placed Sources of Information and
Basis for Decision In APA format;
05/01/2012, fifteen, added CPT code 64653 and ICD-9 codes: 438.20, 438.21, 438.22, 438.30, 438.50, 438.51-438.53
02/01/2012, fourteen, removed information regarding CPT codes 64612/64613 regarding bilateral indication in MFSDB;
01/01/2012, 2012, Thirteen, update, effective dated of service 01/01/2012, added J0588 Injection, incobotulinumtoxinA, 1 unit, removed HCPCS code Q2040;
01/06/2012 - Corrected typo in HTML coding to allow "hidden" text in paragraph for group #3 of ICD-9 Codes that Support Medical Necessity to corretly display line of text "HCPCS Code J0586 Abobotulinumtoxina, and". NO change to coverage. Text line was included in previous versions of policy but, was "hidden" due to typo in coding. NO changes to coverage.
11/21/2011 - The following CPT/HCPCS codes were deleted:
Q2040 was deleted from Group 1
10/01/2011, Twelve, Effective October 1, 2011, Botox for the treatment of Migraines may be billed with either CPT code 64612 or 64613 but not both on the same date of service, added CPT code 64611. Added ICD-9 codes 332.0 and 527.2;
05/01/2011; eleven, MPFSDB update changed information regarding bilateral billing,
03/01/2011, ten, per Transmittal: 2147 Pub. 100-04 February 4, 2011 Change Request: 7299 added HCPCS Code Q2040 Injection, incobotulinumtoxinA, 1 Unit effective 4/01/2011, removed HCPSC code J3490 unclassified drug effective 03/31/2011;
01/01/2011, nine, per FDA approval of J0585 for this service added ICD-9 code 346.70 – 346.73, not covered for J0585 346.01 or 346.91, corrected typo - Botulinum toxins type A HCPCS Code J0586 abobotulinumtoxinA;
12/01/2010, eight, added xcomin using HCPCS Code NOC code J3490 for ICD-9 333.81 & 333.83 for dates of service on and after 7/30/2010, added ICD-9 code 346.01, 346.71, 346.91for J0585 dates of service after 10/15/10;
11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
64612 descriptor was changed in Group 1
64613 descriptor was changed in Group 1
64614 descriptor was changed in Group 1
95860 descriptor was changed in Group 1
95861 descriptor was changed in Group 1
95863 descriptor was changed in Group 1
95865 descriptor was changed in Group 1
95866 descriptor was changed in Group 1
95869 descriptor was changed in Group 1
95870 descriptor was changed in Group 1
95873 descriptor was changed in Group 1
95874 descriptor was changed in Group 1
10/01/2010, seven, added ICD-9 784.52 2011 ICD-9 update;
09/01/2010, six, added ICD-9 codes 596.54, 596.55 when billed with CPT code 53899, 64614 or 64647 with an effective date of 05/16/2009;
02/01/2010, five, added CPT code 53899, added ICD-9 596.59 and 788.41 with an effective date of 05/16/2009;
01/01/2010, four, annual HCPCS update change in description of CPT code 95860, J0585, J0587, added J0586, removed reference to brand names in text of LCD;
11/15/2009 - The description for CPT/HCPCS code 95860 was changed in group 1
11/15/2009 - The description for CPT/HCPCS code 95870 was changed in group 1
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
10/01/2009, three, annual ICD-9, 2010 code update description change 784.40, 784.49 codes 784.42,784.43,784.44 added to range, added new codes 784.51,784.59 Deleted code 784.5 ;
07/01/2009, two, added ICD-9 code 374.03 and 333.1 to CPT codes 64614 and 64640;
04/01/2009, one, this is a merge of LCD L26654 (MAC B), L8178 (legacy B).
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from all relevant medical specialties.
05/01/2012, fifteen, added CPT code 64653 and ICD-9 codes: 438.20, 438.21, 438.22, 438.30, 438.50, 438.51-438.53
02/01/2012, fourteen, removed information regarding CPT codes 64612/64613 regarding bilateral indication in MFSDB;
01/01/2012, 2012, Thirteen, update, effective dated of service 01/01/2012, added J0588 Injection, incobotulinumtoxinA, 1 unit, removed HCPCS code Q2040;
01/06/2012 - Corrected typo in HTML coding to allow "hidden" text in paragraph for group #3 of ICD-9 Codes that Support Medical Necessity to corretly display line of text "HCPCS Code J0586 Abobotulinumtoxina, and". NO change to coverage. Text line was included in previous versions of policy but, was "hidden" due to typo in coding. NO changes to coverage.
11/21/2011 - The following CPT/HCPCS codes were deleted:
Q2040 was deleted from Group 1
10/01/2011, Twelve, Effective October 1, 2011, Botox for the treatment of Migraines may be billed with either CPT code 64612 or 64613 but not both on the same date of service, added CPT code 64611. Added ICD-9 codes 332.0 and 527.2;
05/01/2011; eleven, MPFSDB update changed information regarding bilateral billing,
03/01/2011, ten, per Transmittal: 2147 Pub. 100-04 February 4, 2011 Change Request: 7299 added HCPCS Code Q2040 Injection, incobotulinumtoxinA, 1 Unit effective 4/01/2011, removed HCPSC code J3490 unclassified drug effective 03/31/2011;
01/01/2011, nine, per FDA approval of J0585 for this service added ICD-9 code 346.70 – 346.73, not covered for J0585 346.01 or 346.91, corrected typo - Botulinum toxins type A HCPCS Code J0586 abobotulinumtoxinA;
12/01/2010, eight, added xcomin using HCPCS Code NOC code J3490 for ICD-9 333.81 & 333.83 for dates of service on and after 7/30/2010, added ICD-9 code 346.01, 346.71, 346.91for J0585 dates of service after 10/15/10;
11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
64612 descriptor was changed in Group 1
64613 descriptor was changed in Group 1
64614 descriptor was changed in Group 1
95860 descriptor was changed in Group 1
95861 descriptor was changed in Group 1
95863 descriptor was changed in Group 1
95865 descriptor was changed in Group 1
95866 descriptor was changed in Group 1
95869 descriptor was changed in Group 1
95870 descriptor was changed in Group 1
95873 descriptor was changed in Group 1
95874 descriptor was changed in Group 1
10/01/2010, seven, added ICD-9 784.52 2011 ICD-9 update;
09/01/2010, six, added ICD-9 codes 596.54, 596.55 when billed with CPT code 53899, 64614 or 64647 with an effective date of 05/16/2009;
02/01/2010, five, added CPT code 53899, added ICD-9 596.59 and 788.41 with an effective date of 05/16/2009;
01/01/2010, four, annual HCPCS update change in description of CPT code 95860, J0585, J0587, added J0586, removed reference to brand names in text of LCD;
11/15/2009 - The description for CPT/HCPCS code 95860 was changed in group 1
11/15/2009 - The description for CPT/HCPCS code 95870 was changed in group 1
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
10/01/2009, three, annual ICD-9, 2010 code update description change 784.40, 784.49 codes 784.42,784.43,784.44 added to range, added new codes 784.51,784.59 Deleted code 784.5 ;
07/01/2009, two, added ICD-9 code 374.03 and 333.1 to CPT codes 64614 and 64640;
04/01/2009, one, this is a merge of LCD L26654 (MAC B), L8178 (legacy B).
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from all relevant medical specialties.
Reason for Change
Typographical Correction
Related Documents
This LCD has no Related Documents.
LCD Attachments
Coding & Billing 060112 (PDF - 43 KB)
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Page Last Updated: Tuesday, 22-May-2012 12:28:11 CDT
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