CPT code 64612 - J0585, 64650 -Botulinum Toxin Types A and B


Procedure code and Description


J0585 : Injection, Onabotulinumtoxina, 1 Unit (for example (Botox ®) ) 



J0587 : Botulinum toxin type B, per 100 units

64612 CHEMODENERVATION OF MUSCLE(S); MUSCLE(S) INNERVATED BY FACIAL NERVE

64613 CHEMODENERVATION OF MUSCLE(S); NECK MUSCLE(S)


64614 CHEMODENERVATION OF MUSCLE(S); EXTREMITY(S) AND/OR TRUNK MUSCLE(S)

Coding Guidelines

Botulinum Toxin Types A and B - J3

1. Chemodenervation codes 64612, 64613, and 64614 are identified in the Medicare Physician Fee Schedule (MPFS) database as codes, which will allow 150% of the unilateral service fee schedule amount when performed bilaterally. Bilateral procedures are to be reported on a single line using modifier -50 and reporting 1 unit of service. The basis for this coding instruction is found in the Internet Only Manual (IOM)100-04, Chapter 12, Section 40.7 which states, "If a procedure is not identified by its terminology as a bilateral procedure (or “unilateral or bilateral”), physicians must report the procedure
with modifier “-50.” They report such procedure as a single line item. 

(NOTE: This Centers for Medicare and Medicaid Services (CMS) policy differs from the CPT coding guidelines which indicate that bilateral procedures should be billed as two line items.)"  (Emphasis added) To illustrate, bilateral neck injections, and bilateral upper extremity injections performed at one setting would be coded as 64613-50 and 64614-50 for one service each. In the case of spastic hemiplegia, where injections are given in the upper extremity and the lower extremity on the same side, code only 64614 for one service.

(Note that bilateral indicators have changed for the following CPT codes included in this LCD, as compared to the previous version of the policy: 64612, 64613, 64614, and 67345. Use bilateral modifier as appropriate and consistent with CPT code descriptions.) 

Please note that in a CPT Assistant newsletter in 2001, the American Medical Association's CPT Information Services indicated, "codes 64612–64614 should be reported only one time per procedure even if multiple injections are performed in sites along a single muscle or if several muscles are injected." (CPT Assistant. April 2001;11(4). The NAS policy is consistent with this directive. 


2. NAS understands that vocal cord injections for dysphonia may be performed either percutaneously or by direct injection via a laryngoscope. CPT 31513 describes indirect laryngoscopy with vocal cord injection and CPT 31570 describes direct laryngoscopy with injection into vocal cord(s). As noted in #1 above, these procedures should not be billed bilaterally.


When performing this procedure percutaneously, NAS requires the use of CPT code  31599, unlisted procedure, larynx. When using this code, it is necessary to place a description of the procedure in Item 19 on the CMS-1500 claim form or the electronic equivalent. However, the provider should not bill CPT 31599 with either of the laryngoscopy codes (CPT 31513, 31570) since they are mutually exclusive. These procedures, as well as 64613 chemodenervation of neck muscles, should not be billed bilaterally


Botulinum toxin injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonias, spasms, twitches, etc. These drugs 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. Botulinum toxins have the advantage of being potent neuromuscular blocking agents with good selectivity and duration of action.
Botulinum Toxin Type A has been used for more than two decades and is derived from a culture of the Hall strain of Clostridium botulinum. Botulinum Toxin Type B was approved by the FDA in December 2000 and is derived from the Bean strain of Clostridium botulinum. Type B has the same action on neuromuscular conduction (blockade) as Type A.
Botulinum Toxin Type A and Botulinum Toxin Type B have many similarities and as experience has been gained, medical consensus has gradually developed that the two toxins have similar, but not identical, properties. As a result, approved indications for the two toxins differ. The separate accepted indications for the two toxins will be combined into a single list of covered indications in this LCD. However, it is the responsibility of providers to use each drug in accordance with approved indications unless there are valid and documented reasons stating why the unapproved form is used.
At this time, there are four products on the market containing a botulinal toxin: abobotulinumtoxinA (Dysport, coded with J3490 through DOS 12/31/2009; coded with J0586 for DOS on or after 01/01/2010); rimabotulinumtoxinB (Myobloc®, coded with J0587); onabotulinumtoxinA (Botox®, coded with J0585); and incobotulinumtoxinA (Xeomin®, coded with Q2040). Please refer to the package insert for each product regarding the use of that product. Do not use J0585 for abobotulinumtoxinA (Dysport).
Please note that the unit dose of one form must not be equated with the unit dose of the other, i.e., one unit of the Type A toxin does not equal one unit of the Type B toxin.
  • 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. An exception to this general rule is that for certain treatments including focal dystonia, hemifacial spasm, orofacial dyskinesia, blepharospasm, severe writer’s cramp, laryngeal spasm or dysphonia, Botulinum toxin is the preferred mode of therapy and in these circumstances it is not necessary to show that other methods of treatment have been tried and proven unsuccessful.
  • 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-CM Codes that Support Medical Necessity” section of this LCD. This group of codes shall be used only when accompanied by spasticity of central nervous system origin. All other uses in the treatment of other types of spasm, including smooth muscle types, will be considered as investigational (not proven effective) and, therefore, non-covered by Medicare. Claims submitted for migraine headaches, tension headaches, myofascial pain, irritable colon, biliary dyskinesia, other forms of smooth muscle spasm not specifically addressed in the LCD, and any other spastic conditions not listed in the “ICD-9-CM Codes that Support Medical Necessity” section will be considered investigational, not safe and effective, or not accepted as the standard of practice within the medical community and, therefore, not medically reasonable and necessary.
  • Botulinum toxin can be used to reduce spasticity or excessive muscular contractions to relieve pain, to assist in posturing and walking, to allow better range of motion, to permit better physical therapy, and to reduce severe spasm in order to provide adequate perineal and palmar hygiene.
  • Due to the rarity of severe organic writer’s cramp, Medicare would not expect to see the treatment of this condition billed frequently.
  • There may be patients who require electromyography in order to determine the proper injection site(s). The electromyography procedure codes specified in the “CPT/HCPCS Codes” section of this LCD may be covered if the physician has difficulty in determining the proper injection site(s). It should be noted that needle electromyographic procedures include the interpretation of electrical waveforms measured by equipment that produces both visible and audible components of electrical signals recorded from the muscle(s) studied by the needle electrode. Electromyography equipment must be capable of showing both visual and auditory components of the electrical activity produced by and recorded from within muscle tissue by the needle electrode.
  • For the appropriate initial and total doses of Botulinum toxins, consult the manufacturers’ recommendations or the USP DI® or American Hospital Formulary Service Drug Information (AHFS DI).
  • Coverage of treatments provided may be continued unless any two treatments in a row, utilizing an appropriate or maximum dose of a Botulinum toxin, fail to produce a satisfactory clinical response. In such situations it may be appropriate to use an alternative Botulinum toxin once in order to determine if a more satisfactory response can be obtained. Providers must also document the results of and response to these injections.
Limitations
  • Treatment of achalasia and cardiospasm, Botulinum toxin should be used only after one or more of these conditions have been met and documented:
    • The patient has failed conventional therapy.
    • The patient is at high risk of complications from pneumatic dilation or surgical myotomy.
    • A prior myotomy or dilatation has failed.
    • A prior dilatation caused an esophageal perforation.
    • The patient has an epiphrenic diverticulum or hiatal hernia, both of which increase the risk of dilatation-induced perforation.
  • Treatment of skin wrinkles (ICD-9-CM code 701.8) is cosmetic and is not covered by Medicare (reference: Medicare Benefit Policy Manual Chapter 16 Section 120).
  • Acceptance of Botulinum Toxin Type A has not been established for the following conditions (USP DI 2006) (These same coverage restrictions apply to Botulinum Toxin Type B.):
    • Deviations over 50 prism diopters.
    • Restrictive strabismus.
    • Secondary strabismus caused by prior surgical over-recession of the antagonist muscle.
    • Chronic paralytic strabismus except to reduce antagonist contracture in conjunction with surgical repair.
    • Duane’s syndrome with lateral rectus muscle weakness.
    • Recurrent temporomandibular joint (TMJ) disorder.
  • Anal spasm, irritable colon, biliary dyskinesia, or any treatment of spastic conditions not listed as covered in this LCD are considered to be cosmetic, investigational or not safe and effective.
  • Treatment of muscle tension or migraine headaches is considered not proven effective.
  • Due to the short life of Botulinum toxin, Medicare will reimburse the unused portion of these drugs only when vials are not split between patients. However, documentation must show in the patient’s medical record the exact dosage of the drug given, exact amount and reason for unavoidable wastage, and the exact amount of the discarded portion of the drug.

Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient's medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient's medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in the attached article. Reference to national policy:Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.
Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.
Note: Bill Type and Revenue Codes DO NOT apply to Part B.
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.
12X, 13X, 18X, 21X, 22X, 23X, 71X, 73X, 77X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.

CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of shortCPT descriptors in policies published on the Web.
J0585*
Injection, onabotulinumtoxina, 1 unit
Note: Use J0585 to bill Botox®.
J0586*
Injection, abobotulinumtoxina, 5 units
Note: Use J0586 to bill Dysportfor DOS on or after 01/01/2010; Use J3490 to bill Dysportfor DOS on or before 12/31/2009.
J0587*
Injection, rimabotulinumtoxinb, 100 units
Note: Use J0587 to bill Myobloc®.
Q2040
Injection, incobotulinumtoxinbA, 1 unit (Xeomin®)
64612©
Destroy nerve, face muscle
64613©
Destroy nerve, neck muscle
64614©
Destroy nerve, extrem musc
64650©
Chemodenerv eccrine glands
64653©
Chemodenerv eccrine glands
67345©
Destroy nerve of eye muscle

ICD-10 Codes that Support Medical Necessity
  
    Procedure Code J0585- Injection, onabotulinumtoxina, 1 unit
   
    G04.1 Tropical spastic paraplegia
    G11.4 Hereditary spastic paraplegia
    G24.09 Other drug induced dystonia
    G24.1 Genetic torsion dystonia
    G24.2 Idiopathic nonfamilial dystonia
    G24.3 Spasmodic torticollis
    G24.4 Idiopathic orofacial dystonia
    G24.5 Blepharospasm
    G24.8 Other dystonia
    G24.9 Dystonia, unspecified
    G25.89 Other specified extrapyramidal and movement disorders
    G35* Multiple sclerosis
    G36.0 Neuromyelitis optica [Devic]
    G36.1 Acute and subacute hemorrhagic leukoencephalitis [Hurst]
    G36.8 Other specified acute disseminated demyelination
    G36.9 Acute disseminated demyelination, unspecified
    G37.0 Diffuse sclerosis of central nervous system
    G37.1 Central demyelination of corpus callosum
    G37.2 Central pontine myelinolysis
    G37.3 Acute transverse myelitis in demyelinating disease of central nervous system
    G37.4 Subacute necrotizing myelitis of central nervous system
    G37.5 Concentric sclerosis [Balo] of central nervous system
    G37.8 Other specified demyelinating diseases of central nervous system
    G37.9 Demyelinating disease of central nervous system, unspecified
    G43.711 Chronic migraine without aura, intractable, with status migrainosus
    G43.719 Chronic migraine without aura, intractable, without status migrainosus
    G51.2 Melkersson's syndrome
    G51.3 Clonic hemifacial spasm
    G51.4 Facial myokymia
    G51.8 Other disorders of facial nerve
    G80.0 Spastic quadriplegic cerebral palsy
    G80.1 Spastic diplegic cerebral palsy
    G80.2 Spastic hemiplegic cerebral palsy
    G80.3 Athetoid cerebral palsy
    G80.4 Ataxic cerebral palsy
    G80.8 Other cerebral palsy
    G80.9 Cerebral palsy, unspecified
    G81.11 Spastic hemiplegia affecting right dominant side
    G81.12 Spastic hemiplegia affecting left dominant side
    G81.13 Spastic hemiplegia affecting right nondominant side
    G81.14 Spastic hemiplegia affecting left nondominant side
    G82.20* Paraplegia, unspecified
    G82.21* Paraplegia, complete
    G82.22* Paraplegia, incomplete
    G82.50 Quadriplegia, unspecified
    G82.51 Quadriplegia, C1-C4 complete
    G82.52 Quadriplegia, C1-C4 incomplete
    G82.53 Quadriplegia, C5-C7 complete
    G82.54 Quadriplegia, C5-C7 incomplete
    G83.0* Diplegia of upper limbs
    G83.10* Monoplegia of lower limb affecting unspecified side
    G83.11* Monoplegia of lower limb affecting right dominant side
    G83.12* Monoplegia of lower limb affecting left dominant side
    G83.13* Monoplegia of lower limb affecting right nondominant side
    G83.14* Monoplegia of lower limb affecting left nondominant side
    G83.20* Monoplegia of upper limb affecting unspecified side
    G83.21* Monoplegia of upper limb affecting right dominant side
    G83.22* Monoplegia of upper limb affecting left dominant side
    G83.23* Monoplegia of upper limb affecting right nondominant side
    G83.24* Monoplegia of upper limb affecting left nondominant side
    G83.30 Monoplegia, unspecified affecting unspecified side
    G83.31 Monoplegia, unspecified affecting right dominant side
    G83.32 Monoplegia, unspecified affecting left dominant side
    G83.33 Monoplegia, unspecified affecting right nondominant side
    G83.34 Monoplegia, unspecified affecting left nondominant side
    H49.00 Third [oculomotor] nerve palsy, unspecified eye
    H49.01 Third [oculomotor] nerve palsy, right eye
    H49.02 Third [oculomotor] nerve palsy, left eye
    H49.03 Third [oculomotor] nerve palsy, bilateral
    H49.10 Fourth [trochlear] nerve palsy, unspecified eye
    H49.11 Fourth [trochlear] nerve palsy, right eye
    H49.12 Fourth [trochlear] nerve palsy, left eye
    H49.13 Fourth [trochlear] nerve palsy, bilateral
    H49.20 Sixth [abducent] nerve palsy, unspecified eye
    H49.21 Sixth [abducent] nerve palsy, right eye
    H49.22 Sixth [abducent] nerve palsy, left eye
    H49.23 Sixth [abducent] nerve palsy, bilateral
    H49.30 Total (external) ophthalmoplegia, unspecified eye
    H49.31 Total (external) ophthalmoplegia, right eye
    H49.32 Total (external) ophthalmoplegia, left eye
    H49.33 Total (external) ophthalmoplegia, bilateral
    H49.40 Progressive external ophthalmoplegia, unspecified eye
    H49.41 Progressive external ophthalmoplegia, right eye
    H49.42 Progressive external ophthalmoplegia, left eye
    H49.43 Progressive external ophthalmoplegia, bilateral
    H49.881 Other paralytic strabismus, right eye
    H49.882 Other paralytic strabismus, left eye
    H49.883 Other paralytic strabismus, bilateral
    H49.889 Other paralytic strabismus, unspecified eye
    H50.00 Unspecified esotropia
    H50.011 Monocular esotropia, right eye
    H50.012 Monocular esotropia, left eye
    H50.021 Monocular esotropia with A pattern, right eye
    H50.022 Monocular esotropia with A pattern, left eye
    H50.031 Monocular esotropia with V pattern, right eye
    H50.032 Monocular esotropia with V pattern, left eye
    H50.041 Monocular esotropia with other noncomitancies, right eye
    H50.042 Monocular esotropia with other noncomitancies, left eye
    H50.05 Alternating esotropia
    H50.06 Alternating esotropia with A pattern
    H50.07 Alternating esotropia with V pattern
    H50.08 Alternating esotropia with other noncomitancies
    H50.10 Unspecified exotropia
    H50.111 Monocular exotropia, right eye
    H50.112 Monocular exotropia, left eye
    H50.121 Monocular exotropia with A pattern, right eye
    H50.122 Monocular exotropia with A pattern, left eye
    H50.131 Monocular exotropia with V pattern, right eye
    H50.132 Monocular exotropia with V pattern, left eye
    H50.141 Monocular exotropia with other noncomitancies, right eye
    H50.142 Monocular exotropia with other noncomitancies, left eye
    H50.15 Alternating exotropia
    H50.16 Alternating exotropia with A pattern
    H50.17 Alternating exotropia with V pattern
    H50.18 Alternating exotropia with other noncomitancies
    H50.21 Vertical strabismus, right eye
    H50.22 Vertical strabismus, left eye
    H50.30 Unspecified intermittent heterotropia
    H50.311 Intermittent monocular esotropia, right eye
    H50.312 Intermittent monocular esotropia, left eye
    H50.32 Intermittent alternating esotropia
    H50.331 Intermittent monocular exotropia, right eye
    H50.332 Intermittent monocular exotropia, left eye
    H50.34 Intermittent alternating exotropia
    H50.40 Unspecified heterotropia
    H50.411 Cyclotropia, right eye
    H50.412 Cyclotropia, left eye
    H50.42 Monofixation syndrome
    H50.43 Accommodative component in esotropia




ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes J0585, J0586/J3490*, J0587,Q2040, 64612, 64613, 64614, 64650, 64653 and 67345:
*Note: Use J0586 to bill Dysportfor DOS on or after 01/01/2010; use J3490 to bill Dysportfor DOS on or before 12/31/2009.
Note: The following ICD-9-CM codes may be used alone.
Covered for:
333.6
Genetic torsion dystonia
333.71
Athetoid cerebral palsy
333.79
Other acquired torsion dytonia
333.81–333.84*
Fragments of torsion dystonia
Note: 333.84* (organic writer’s cramp) Due to infrequent occurrence, Medicare would not expect to see the treatment of this condition billed frequently.
333.89
Other fragments of torsion dystonia
334.1
Hereditary spastic paraplegia
341.0–341.1
Other demyelinating diseases of central nervous system
341.22
Idiopathic transverse myelitis
341.8–341.9
Other, unspecified demyelinating diseases of central nervous system
343.0–343.4
Infantile cerebral palsy
343.8–343.9
Infantile cerebral palsy, other, unspecified
344.31–344.32
Monoplegia of lower limb
344.41–344.42
Monoplegia of upper limb
346.01
Migraine with aura, stated as intractable, without mention of status migrainosus.
346.11
Migraine without aura, stated as intractable, without mention of status migrainosus.
346.71–346.73
Chronic migraine without aura
350.8
Other specified trigeminal nerve disorders
351.8
Other facial nerve disorder; facial spasm
378.00–378.08
Esotropia
378.10–378.18
Exotropia
378.20–378.24
Intermittent heterotropia
378.30–378.35
Other and unspecified heterotropia
378.40–378.45
Heterophoria
378.50–378.56
Paralytic strabismus
378.60–378.63
Mechanical strabismus
378.71–378.73
Other specified strabismus
378.81–378.87
Other disorders of binocular eye movements
378.9
Unspecified disorder of eye movement
478.29
Other diseases of pharynx or nasopharynx
478.75
Laryngeal spasm
478.79
Other disease of the larynx (dysphonia spastica)
527.7
Disturbance of salivary secretion
530.0
Achalasia and cardiospasm
565.0
Anal fissure
596.54–596.55
Other functional disorders of bladder
705.21–705.22
Focal hyperhidrosis
723.5
Torticollis, unspecified
729.82
Other musculoskeletal symptoms referable to limbs, cramp
754.1
Congenital deformity of sternocleidomastoid muscle
784.49
Other voice and resonance disorders
Medicare is establishing the following dual-diagnosis limited coverage for CPT/HCPCS codes J0585,J0586/J3490*, J0587, Q2040, 64612, 64613, 64614, 64650, 64653 and 67345.
*Note: Use J0586 to bill Dysportfor DOS on or after 01/01/2010; use J3490 to bill Dysportfor DOS on or before 12/31/2009.
The primary ICD-9-CM code must be:
728.85
Spasm of muscle
The secondary ICD-9-CM diagnosis code must be one from the list below:
340
Multiple sclerosis
342.11–342.12
Spastic hemiplegia affecting dominant site, non-dominant site
344.00–344.04
Quadriplegia and quadriparesis
344.1–344.2
Quadriplegia and quadriparesis
344.5
Unspecified monoplegia
430
Subarachnoid hemorrhage
431
Intracerebral hemorrhage
432.0–432.1
Other and unspecified intracranial hemorrhage
433.01
Occlusion and stenosis of basilar artery with cerebral infarction
433.11
Occlusion and stenosis of carotid artery with cerebral infarction
433.21
Occlusion and stenosis of vertebral artery with cerebral infarction
433.31
Occlusion and stenosis of multiple and bilateral precerebral arteries with cerebral infarction
433.81
Occlusion and stenosis of other specified precerebral artery with cerebral infarction
433.91
Occlusion and stenosis of unspecified precerebral artery with cerebral infarction
434.01
Cerebral thrombosis with cerebral infarction
434.11
Cerebral embolism with cerebral infarction
434.91
Cerebral artery occlusion unspecified with cerebral infarction
438.21–438.22
Hemiplegia/hemiparesis
438.31–438.32
Monoplegia of upper limb
438.41–438.42
Monoplegia of lower limb
438.51–438.53
Other paralytic syndrome
806.00–806.09
Fracture of vertebral column with spinal cord injury, cervical, closed
806.10–806.19
Fracture of vertebral column with spinal cord injury, cervical, open
806.20–806.29
Fracture of vertebral column with spinal cord injury, dorsal (thoracic), closed
806.30–806.39
Fracture of vertebral column with spinal cord injury, dorsal (thoracic), open
907.2
Late effect of spinal cord injury
952.00–952.09
Cervical (Spinal cord injury w/o evidence of spinal bone injury)
952.10–952.19
Dorsal (Spinal cord injury w/o evidence of spinal bone injury)
997.01–997.02
Nervous system complications
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
Documentation should include the following elements:
  • Support for the medical necessity of the Botulinum Toxin Type A or Type B injection.
  • Type of Botulinum toxin used (A or B).
  • Strength of toxin used for Type B (2500 units, 5000 units, or 10,000 units).
  • A covered diagnosis (However, when a form of Botulinum toxin is used for an indication that is not a listed indication in the USP DI or AHFS DI, a physician statement in the medical record indicating the reason(s) why the unapproved form was used is also required).
  • A statement that traditional methods of treatments have been tried and proven unsuccessful (except for focal dystonia, hemifacial spasm, orofacial dyskinesia, blepharospasm, severe writer’s cramp, laryngeal spasm or dysphonia).
  • Dosage used in the injections.
  • Support for the medical necessity of electromyography procedures if performed.
  • Support of the clinical effectiveness of the injections.
  • A complete description of the site(s) injected.
Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:
  • Date and time.
  • Amount of medication wasted.
  • Reason for the wastage.
Appendices
N/A
Utilization Guidelines
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, one side of the face, etc.
Notice: This LCD imposes utilization guideline limitations that support automated frequency denials. Despite Medicare's allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

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