Procedure code and Description – J code list

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)

64615 Chronic Migraine Paradigm


64640 DESTRUCTION BY NEUROLYTIC AGENT; OTHER PERIPHERAL NERVE OR BRANCH

64999 UNLISTED PROCEDURE, NERVOUS SYSTEM

Coverage Indications, Limitations, and/or Medical Necessity

Botulinum toxin injections are used to treat various focal muscle spastic disorders and excessive muscle contractions such as dystonias, spasms and twitches. 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 Hall strain 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, though Noridian recognizes that Botulinum A and B are chemically and pharmacologically distinct and each has different clinical characteristics, potency, duration and safety profiles. Providers should keep in mind that there is now another approved Botulinum toxin A (INCOBOTULINUMTOXINA), but its labeled indications are currently limited to two: cervical dystonia and blepharospasm. Therefore, any and all off-label uses of the drug are subject to the same limitations noted in the following paragraphs as is true for any subsequently approved Botulinum toxins, either A or B.

Botulinum Toxin Type A and Botulinum Toxin Type B have many similarities, however, and as experience has been gained, medical consensus has gradually developed that the two toxin types have similar, but as noted above, not identical, properties. As a result, FDA-approved indications for the two toxins and additional members of each type may differ. Noridian has determined that the separate accepted indications for the toxins will be combined into a single list of covered indications in this Local Coverage Determination (LCD) policy. However, it is the responsibility of the provider to use each drug in accordance with approved indications unless there are valid and documented reasons stating why the unapproved form is used. While this policy contains a single list of covered indications, this is not meant to imply that the two toxins are completely interchangeable.

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. There is no universally recognized and applicable safe dose conversion ratio.

1. 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 or 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, upper limb spasticity or other conditions of central focal spasticity botulinum toxin is the preferred mode of therapy. In these circumstances it is not necessary to show that other methods of treatment have been tried and proven unsuccessful.

2. 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 Covered ICD-10-CM section of this policy. This group of codes shall be used only when appropriately accompanied by codes for spasticity of central nervous system origin. Recently, abotulinumtoxinA (Dysport) has been approved by the FDA for upper limb spasticity. 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, noncovered 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 policy, and any other spastic conditions not listed in the ICD-10 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.

3. Botulinum toxin can be used to reduce spasticity or excessive muscular contractions to relieve pain, to assist with improving and stabilizing posture and walking, to allow better range of motion, to permit better response to physical therapy and to reduce severe spasm in order to provide adequate perineal and palmar hygiene.

4. Due to the rarity of severe organic writer’s cramp, Medicare would not expect to see the treatment of this condition billed frequently. Frequent billing of such will invite post pay review scrutiny.

5. There may be patients who require electromyography in order to determine the proper injection site(s). The electromyography procedure codes specified in the HCPCS section of this policy 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 may produce both or either visible and audible components of electrical signals recorded from the muscle(s) studied by the needle electrode. Prior to the publication of 2009 CPT, its description of the required elements to support coding for such procedures required that the electromyography equipment had to 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. Though use of both is not required by Noridian for justifying coverage of EMG or electrical stimulation guidance to localize the site of injection for chemodenervation procedures with botulinum toxin (as noted in Clinical Vignettes published by the American Medical Association for CPT codes 95873 and 95874 as used to report guidance for chemodenervation), we are revising this policy to conform to the 2009 CPT description of this service and will no longer require that the equipment used as coded by 95873 or 95874 produce both visible and auditory signals.

6. For the appropriate initial and total doses of Botulinum toxins please consult the manufacturers’ FDA Package Insert recommendations or any CMS – approved drug compendium.

7. 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 a trial of an alternative Botulinum toxin to an appropriate or maximum dose of that alternative toxin in order to determine if a more satisfactory response can be obtained. Providers must also document the results of and response to these injections.

8. Requests may be considered for redetermination (formerly appeal) for continued treatment during a treatment period or for resumption at a later date if satisfactory results have not been obtained and compelling clinical evidence of medical necessity for continued treatment is presented.

9. Providers are reminded that Medically Unlikely Edit (MUE) provisions and Bilateral procedure rules may apply to these claims situations and will be enforced by Noridian. See Coding Guidelines for this LCD for further information.

10. For 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.

11. Treatment of skin wrinkles ICD-10 CM code L11.8, L57.2, L57.4, L66.4, L87.1, L90.3, L90.4, L92.2, L94.8, L98.5, using Botulinum toxin is cosmetic and is not covered by Medicare (reference: Medicare Benefit Policy Manual Chapter 16, Section 120).

12. Acceptance of Botulinum Toxin Type A has not been clearly established for the following conditions:
? Purely restrictive strabismus (restrictive strabismus not associated with muscle contracture)
? Secondary strabismus caused by prior surgical over-recession of the antagonist muscle, except when used in an attempt to avoid further surgery.
? Chronic paralytic strabismus except to reduce antagonist contracture in conjunction with surgical repair
? Duane’s syndrome with lateral rectus muscle weakness (though expected to occur very rarely, Duane’s syndrome involving medial rectus muscle weakness only may be covered as appropriate)
? Recurrent temporomandibular joint (TMJ) disorder

These coverage restrictions apply also to Botulinum Toxin Type B.

13. Anal spasm, irritable colon, biliary dyskinesia, or any treatment of spastic conditions not listed as covered in this policy are considered to be cosmetic, investigational, or not safe and effective.

14. The use of Botulinum toxin to treat muscle tension or migraine headaches is considered not proven effective, thus not covered by Medicare.

15. Due to the short life of Botulinum toxin, Medicare will reimburse the unused portion of single-dose vials. Documentation must show in the patient’s medical record the exact dosage of the drug given and the exact amount of the discarded portion of the drug.

16. Scheduling of more than one patient is encouraged to prevent wastage of multi-dose vials of Botulinum toxins. If a multi-dose vial is split between two patients, the billing in these instances must be for the exact amount of Botulinum toxin used on each individual patient. Medicare would not expect to see billing for the full fee amount for Botulinum toxin on each beneficiary when the multi-dose vial is split between two or more patients. If an unused portion of a multi-dose vial remains as wastage, it should be noted as such on the last patient treated with the contents of that particular vial. Medicare does not pay for discarded portions of multi-dose packaging.

17. Effective for dates of service on or after October 15, 2010, the following indication has been added for BOTOX® (onabotulinumtoxinA): the prophylaxis of headaches in adult patients with Chronic Migraine (= 15 days per month with headache lasting 4 hours a day or longer. Note that medical record documentation must support these specific symptom parameters in order for payment to be appropriate by Medicare.

18. Effective for dates of service on or after January 18, 2013, the following indication has been added for Botulinum Toxin (onabotulinumtoxinA): for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.

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.
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


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 and spasticity), smooth muscles (e.g. Detrusor over activity 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. 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.


Chronic migraine:

On October 15, 2010, the FDA approved Botox injection for prevention of chronic migraine. Chronic migraine is defined as episodes that otherwise meet criteria for migraine (e.g., at least 4 hours in duration) that occur on at least 15 days per month for more than 3 months, in the absence of medication overuse.   Headache Classification (ICD-2) (ihs-classification.org/en/), diagnostic criteria for migraine without aura are:

A. At least 5 attacks fulfilling criteria B-D
B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) 
C. Headache has at least two of the following characteristics:
1. unilateral location
2. pulsating quality
3. moderate or severe pain intensity
4. aggravation by or causing avoidance of routine activity (e.g., walking or
climbing stairs)
D. During at least one of the following:
1. nausea and/or vomiting
2. photophobia and phonophobia
E. Not attributed to another disorder 

Medical Criteria:

Hyperhidrosis: J0585 Injection, Onabolulinumtoxina1 unit  (A), J0587 Injection,  rimabotulinumtoxinB100 units (B).

Botulinum toxin is produced by the anaerobic clostridium botulinum. Only type A and type B preparations are available in this country. The 3 formulations of botulinum toxin type A are currently called onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), and incobotulinumtoxinA (Xeomin). The paralytic mechanism of action that makes botulinum toxin so dangerous also provides the foundation for it to be considered a therapeutic substance. When injected at therapeutic doses, it produces a localized chemical denervation muscle paralysis.  Botulinum toxin type A BOTOX® (onabotulinumtoxinA) is useful in reducing the excessive, abnormal contractions associated with blepharospasm. BOTOX® has been FDA- approved for strabismus, blepharospasm associated with dystonia, including benign essential blepharospasm, or nerve disorders in patients over 12 years of age and cervical dystonia inadults. 

DYSPORT® (abobotulinumtoxinA), XEOMIN® (incobotulinumtoxinA and MYOBLOC® (rimabotulinumtoxinB) have been FDA-approved for the treatment of adults with cervical dystonia.

On January 18, 2013 the US Food and Drug Administration (FDA) approved BOTOX® (onabotulinumtoxinA) for the treatment of overactive bladder with symptoms of urge incontinence.

The criteria for treatment of overactive bladder include:
o symptoms of urge urinary incontinence, and frequency
o adults who have an inadequate response to or are intolerant of an anticholinergic     medication.
o Urinary incontinence due to neurogenic detrusor overactivity (NDO) commonly occurs in patients with spinal cord injuries (SCI)
o neurological diseases such as multiple sclerosis (MS)

Other approved indications include: severe primary axillary hyperhidrosis, upper limb spasticity in adult patients, prophylaxis of headaches in adult patients with chronic  migraine urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS),and overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. 

Primary focal hyperhidrosis: Blue CHiP for Medicare

The definition of primary focal hyperhidrosis is severe sweating, beyond physiological needs; 
o focal, visible, severe sweating of at least six (6) months duration without apparent cause with at least (2) of the following characteristics: 
o bilateral and relatively symmetric
o significant impairment in daily activities
o age of onset less than 25 years
o positive family history
o cessation of focal sweating during sleep 

Primary focal hyperhidrosis: Commercial

The consequences of hyperhidrosis are primarily psychosocial in nature. Excessive perspiration may be socially embarrassing (e.g., limiting the ability to shake hands) or interfere with certain professions. For example, palmar hyperhidrosis may preclude artwork, working with electrical components, or playing certain musical instruments. In addition, hyperhidrosis may require several changes of clothing daily and may cause staining of clothing and/or shoes. Primary focal hyperhidrosis may be defined as excessive sweating, beyond a level required to maintain normal body temperature, in response to health exposure or exercise. It may be classified as either primary or secondary. Primary focal hyperhidrosis is a condition characterized by visible, excessive sweating of at least 6 months duration without apparent cause and with at least 2 of the following features

o Bilateral and relatively symmetric sweating;
o Impairment of daily activities;
o Frequency of at least once per week; 
o Age at onset younger than 25 years;
o Positive family history; and
o Cessation of focal sweating during sleep

Secondary hyperhidrosis: Secondary hyperhidrosis may result from a variety of drugs, such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), or underlying diseases/conditions, such as febrile diseases, diabetes mellitus, or menopause. Secondary hyperhidrosis is usually generalized or craniofacial sweating

Blue CHiP for Medicare Headache/Migraine Coverage is medically necessary for those patients with 

o chronic daily headaches including tension-type headache

1. headache disorders occurring greater than 15 days a month –in many cases daily with a duration of four or more hours – for a period of at least 3 months)

who have significant disability due to the headaches and have been refractory to standard and usual conventional therapy.

o   chronic migraine (CM). 

1 CM is characterized by headache on > 15 days per month, of which at least 8 headache days per month meet criteria for migraine without aura or respond to migraine-specific treatment.

o For continuing Botulism toxin therapy the patients must

1.    demonstrate a significant decrease in the number and frequency of headaches and 
2.   improvement in function upon receiving Botulinum toxin.     CommercialPrevention (treatment) of chronic migraine headache in the following situations: 
o Initial 6-month trial: Adult patients who:

1. meet International Headache Classification (ICHD-2) diagnostic criteria for chronic migraine headache (e.g. migraine headaches lasting at least 4 hours on at least 15 days per month; migraine headaches for at least 3 months in the absence of medication overuse); and

2.     have symptoms that persist despite adequate trials of at least 2 agents from different classes of medications used in   the treatment of chronic migraine headaches, e.g. antidepressants, antihypertensives and antiepileptics. Patients who have contraindications to preventive medications are not required to undergo a trial of these agents. 

Continuing treatment beyond 6-months:
1. Migraine headache frequency reduced by at least 7 days per month, or
2. Migraine headache duration reduced at least 100 hours per month.   Policy:

Preauthorization is required for BlueCHiP for Medicare members and recommended for all other BCBSRI products for the Botulinium Toxin A or B for the treatment of migraines or hyperhidrosis.

Botulinum toxin A and B is medically necessary when the criteria has been met for the treatment of migraines and hyperhidrosis

Coding: 

The following codes require preauthorization for hyperhidrosis and migraines, and are covered for other diagnosis as listed in the policy:
J0585 Injection, Onabolulinumtoxina, 1 unit  (A)
J0586 Injection, Abobotulinumtoxina, 5 units (A)
J0587 Injection, rimabotulinumtoxinB100 units (B)
J0588 Injection, Incobotulinumtoxin A, 1 unit


Covereage Limitations


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 GHA 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). 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 botulinum toxin products are interchangeable.


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 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. There may be slight variation based on FDA indications for a particular product.


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.


Medicare will allow payment for one injection per site regardless of the number of injections made into the site. The site description is included in the CPT code description. Payment will be based on the Medicare Physician Fee Schedule and National Correct Coding Initiative.


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:
The patient has failed conventional therapy;


The patient is at high risk of complications of pneumatic dilation or surgical myotomy;


The patient has failed a prior myotomy or dilation;


The patient has had a previous dilation-induced perforation;


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.


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, botulinum toxin is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botulinum toxin 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.


Botulinum toxin for chronic anal fissure may be considered for the patient who has not responded satisfactorily to conventional therapy.

When Botulinum Toxin Injection is covered

The use of botulinum toxin may be considered medically necessary for the following:

1. Cervical dystonia (spasmodic torticollis; applicable whether congenital, due to child birth injury, or traumatic injury). For this use, cervical dystonia must be associated with sustained head tilt or abnormal posturing with limited range of motion in the neck AND a history of recurrent involuntary contraction of one or more of the muscles of the neck, e.g., sternocleidomastoid, splenius, trapezius, or posterior cervical muscles*. (See additional details in Policy Guidelines section.)
2. Strabismus*
3. Blepharospasm or facial nerve (VII) disorders (including hemifacial spasm)*
4. Upper limb spasticity*
5. Prevention (treatment) of chronic migraine headache in the following situations*:
a. Initial 6-month trial: Adult patients who meet International Classification of Headache

Disorders (ICHD) diagnostic criteria for chronic migraine headache and have symptoms that persist despite adequate trials of at least 2 agents from different classes of medications used in the treatment of chronic migraine headaches (e.g., antidepressants, antihypertensives, antiepileptics). (Patients who have contraindications to preventive medications are not required to undergo a trial of these agents).

b. Continuation of treatment beyond 6 months:

• Migraine headache frequency reduced by at least 7 days per month compared to pretreatment level, or

• Migraine headache duration reduced at least 100 hours per month compared to pretreatment level.

6. Dystonia/spasticity resulting in functional impairment (interference with joint function, mobility, communication, nutritional intake) with or without pain. Examples include but are not limited to patients with any of the following:

a. Focal dystonias:
• Focal upper limb dystonia (e.g., organic writer’s cramp)
• Oromandibular dystonia (orofacial dyskinesia, Meige syndrome)
• Laryngeal dystonia (adductor spasmodic dysphonia)
• Idiopathic (primary or genetic) torsion dystonia
• Symptomatic (acquired) torsion dystonia
b. Spastic conditions
• Cerebral palsy
• Spasticity related to stroke
• Acquired spinal cord or brain injury
• Hereditary spastic paraparesis
• Spastic hemiplegia
• Neuromyelitis optica
• Multiple sclerosis or Schilder’s disease
7. Esophageal achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates
8. Sialorrhea (drooling) associated with Parkinson disease
9. Chronic anal fissure
10. Urinary incontinence due to detrusor overreactivity* associated with neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is inadequately controlled with anticholinergics
11. Overactive bladder* (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication

For continuation of therapy for any diagnosis, the following criteria must be met:
1. Documentation of positive clinical response to botulinum toxin therapy, and
2. Statement of expected frequency and duration of proposed botulinum toxin treatment, and
3. Botulinum toxin administration is no more frequent than every 12 weeks, regardless of diagnosis

When Botulinum Toxin Injection is not covered With the exception of cosmetic indications, the use of botulinum toxin is considered investigational for all other indications not specifically mentioned above, including, but not limited to:

• headaches, except as noted above for prevention (treatment) of chronic migraine headache
• chronic low back pain
• joint pain
• mechanical neck disorders
• neuropathic pain after neck dissection
• myofascial pain syndrome
• temperomandibular joint disorders
• trigeminal neuralgia
• pain after hemorrhoidectomy or lumpectomy
• tremors such as benign essential tremor (upper extremity)
• tinnitus
• sialorrhea (drooling) except that associated with Parkinson disease
• chronic motor tic disorder, and tics associated with Tourette syndrome (motor tics)
• lateral epicondylitis
• benign prostatic hyperplasia
• interstitial cystitis
• detrusor sphincteric dyssynergia (after spinal cord injury)
• piriformis
• prevention of pain associated with breast reconstruction after mastectomy
• Hirschsprung’s disease
• gastroparesis
• facial wound healing
• internal anal sphincter (IAS) achalasia
• depression

The use of botulinum toxin is not medically necessary as a treatment of wrinkles or other cosmetic indications.

The use of assays to detect antibodies to botulinum toxin is considered investigational.

This drug may require prior review. In cases for which botulinum toxin has been approved in the past, medical records may be required yearly to document ongoing effectiveness. For the indication of prevention of chronic migraine headaches, medical records may be required to document effectiveness after the initial 6-month trial and yearly thereafter. International Classification of Headache Disorders (ICHD-3) diagnostic criteria for chronic migraine headache include the following:

Headaches at least 15 days per month for more than 3 months; have features of migraine headache on at least 8 days.

Features of migraine headache:
• Lasts 4 to 72 hours;
• Has at least 2 of the following 4 characteristics:
o Unilateral
o Pulsating
o Moderate or severe pain intensity
o Aggravates or causes avoidance of routine physical activity
• Associated with:
o Nausea and/or vomiting
o Photophobia and phonophonia

(In ICHD-2, absence of medication overuse was one of the diagnostic criteria for chronic migraine. In the ICHD-3, this criterion was removed from the chronic migraine diagnosis and “medication overuse headache” is now a separate diagnostic category.) Continuing treatment with botulinum toxin beyond 6 months for chronic migraine includes the following:

The policy includes the requirement that migraine headache frequency be reduced by at least 7 days per month compared with pretreatment level, or that migraine headache duration be reduced by at least 100 hours per month compared with pretreatment level in order to continue treatment beyond 6 months. The 7 days per month represents a 50% reduction in migraine days for patients who have the lowest possible number of migraine days (15) that would allow them to meet the ICHD-3 diagnostic criteria fewest chronic migraine. A 50% reduction in frequency is a common outcome measure for assessing the efficacy of headache treatments and was one of the end points of the PREEMPT study. For complete classification of primary migraine and non-migraine headaches, please see the International Headache Classification (ICHD-3) at http://www.ihsclassification.org/_downloads/mixed/International-Headache-Classification-III-ICHD-III-2013-Beta.pdf
.
Cervical dystonia is a movement disorder (nervous system disease) characterized by sustained muscle contractions. This results in involuntary, abnormal, squeezing and twisting muscle contractions in the head and neck region. These muscle contractions result in sustained abnormal positions or posturing. Sideways or lateral rotation of the head and twisting of the neck are the most common findings in cervical dystonia. Muscle hypertrophy occurs in most patients. When using botulinum toxin to treat cervical dystonia, the postural disturbance and pain must be of a severity to interfere with activities of daily living; and the symptoms must have been unresponsive to a trial of standard conservative therapy. In addition, before using botulinum toxin, alternative causes of symptoms such as cervicogenic headaches must have been considered and excluded. Clinical improvement generally begins within the first two weeks after injection with maximum clinical benefit at approximately six weeks post-injection. Most patients have returned to pre-treatment status by 3 months post-treatment.



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

Group 1 Codes:

ICD-10 CODE DESCRIPTION
G11.4 Hereditary spastic paraplegia
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
G25.3 Myoclonus
G25.89 Other specified extrapyramidal and movement disorders
G36.1 Acute and subacute hemorrhagic leukoencephalitis [Hurst]
G36.8 Other specified acute disseminated demyelination
G37.0 Diffuse sclerosis of central nervous system
G37.1 Central demyelination of corpus callosum
G37.2 Central pontine myelinolysis
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
G43.011 Migraine without aura, intractable, with status migrainosus
G43.019 Migraine without aura, intractable, without status migrainosus
G43.109* Migraine with aura, not intractable, without status migrainosus
G43.111 Migraine with aura, intractable, with status migrainosus
G43.119 Migraine with aura, intractable, without status migrainosus
G43.701 Chronic migraine without aura, not intractable, with status migrainosus
G43.709 Chronic migraine without aura, not intractable, without status migrainosus
G43.711 Chronic migraine without aura, intractable, with status migrainosus
G43.719 Chronic migraine without aura, intractable, without status migrainosus
G50.8 Other disorders of trigeminal nerve
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
G80.4 Ataxic cerebral palsy
G80.8 Other cerebral palsy
G82.53 Quadriplegia, C5-C7 complete
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
G83.4 Cauda equina syndrome
H02.041 Spastic entropion of right upper eyelid
H04.213 Epiphora due to excess lacrimation, bilateral lacrimal glands
H49.01 Third [oculomotor] nerve palsy, right eye
H49.02 Third [oculomotor] nerve palsy, left eye
H49.03 Third [oculomotor] nerve palsy, bilateral
H49.11 Fourth [trochlear] nerve palsy, right eye
H49.12 Fourth [trochlear] nerve palsy, left eye
H49.13 Fourth [trochlear] nerve palsy, bilateral
H49.21 Sixth [abducent] nerve palsy, right eye
H49.22 Sixth [abducent] nerve palsy, left eye
H49.23 Sixth [abducent] nerve palsy, bilateral
H49.31 Total (external) ophthalmoplegia, right eye
H49.32 Total (external) ophthalmoplegia, left eye
H49.33 Total (external) ophthalmoplegia, bilateral
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
H49.9 Unspecified paralytic strabismus
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
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: G24.3* and G24.5* Labeled indications for Xeomin,Incobotulinumtoxin A, 1 unit
G25.3* Use for palatal Myoclonus
G43.109* Chart must document that patient has chronic migrane
H04.211*, H04.212*, H04.213*, Use for “crocodile tearing”
H50.811*, H50.812,* Use for medial rectus weakness only

Group 2 Paragraph: The following ICD-10-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis. (Two diagnoses are required for payment).

Primary diagnosis:




Group 2 Codes:

ICD-10 CODE DESCRIPTION
M62.411* Contracture of muscle, right shoulder
M62.412* Contracture of muscle, left shoulder
M62.421* Contracture of muscle, right upper arm
M62.422* Contracture of muscle, left upper arm
M62.431* Contracture of muscle, right forearm
M62.432* Contracture of muscle, left forearm
M62.441* Contracture of muscle, right hand
M62.442* Contracture of muscle, left hand
M62.451* Contracture of muscle, right thigh
M62.452* Contracture of muscle, left thigh
M62.461* Contracture of muscle, right lower leg
M62.462* Contracture of muscle, left lower leg
M62.471* Contracture of muscle, right ankle and foot
M62.472* Contracture of muscle, left ankle and foot
M62.48* Contracture of muscle, other site
M62.49* Contracture of muscle, multiple sites
M62.831* Muscle spasm of calf
M62.838* Other muscle spasm
Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: * The diagnosis codes above require a second code from Group 3 in order to be payable.
Showing 1 to 18 of 18 entries in Group 2
FirstPrevCurrently Selected1NextLast

Group 3 Paragraph: Secondary diagnoses:

Group 3 Codes:

ICD-10 CODE DESCRIPTION
G04.1* Tropical spastic paraplegia
G35* Multiple sclerosis
G80.4 Ataxic cerebral palsy
G80.8 Other cerebral palsy
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
G82.54 Quadriplegia, C5-C7 incomplete
G83.0* Diplegia of upper limbs
G83.11 Monoplegia of lower limb affecting right dominant side
G83.4* Cauda equina syndrome
G95.89* Other specified diseases of spinal cord
G97.2* Intracranial hypotension following ventricular shunting
G97.31* Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a nervous system procedure
G97.32* Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating other procedure
G97.81* Other intraoperative complications of nervous system
G97.82* Other postprocedural complications and disorders of nervous system
I60.01* Nontraumatic subarachnoid hemorrhage from right carotid siphon and bifurcation
I60.02* Nontraumatic subarachnoid hemorrhage from left carotid siphon and bifurcation
I60.11* Nontraumatic subarachnoid hemorrhage from right middle cerebral artery
I60.12* Nontraumatic subarachnoid hemorrhage from left middle cerebral artery
I60.2* Nontraumatic subarachnoid hemorrhage from anterior communicating artery
I60.31* Nontraumatic subarachnoid hemorrhage from right posterior communicating artery
I60.32* Nontraumatic subarachnoid hemorrhage from left posterior communicating artery
I60.4* Nontraumatic subarachnoid hemorrhage from basilar artery
I60.51* Nontraumatic subarachnoid hemorrhage from right vertebral artery
I60.52* Nontraumatic subarachnoid hemorrhage from left vertebral artery
I60.6* Nontraumatic subarachnoid hemorrhage from other intracranial arteries
I60.8* Other nontraumatic subarachnoid hemorrhage
I61.0* Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
I61.1* Nontraumatic intracerebral hemorrhage in hemisphere, cortical
I61.3* Nontraumatic intracerebral hemorrhage in brain stem
I61.4* Nontraumatic intracerebral hemorrhage in cerebellum
I61.5* Nontraumatic intracerebral hemorrhage, intraventricular
I61.6* Nontraumatic intracerebral hemorrhage, multiple localized
I61.8* Other nontraumatic intracerebral hemorrhage
I62.00 Nontraumatic subdural hemorrhage, unspecified
I62.01* Nontraumatic acute subdural hemorrhage
I62.02* Nontraumatic subacute subdural hemorrhage
I62.03* Nontraumatic chronic subdural hemorrhage
I62.1* Nontraumatic extradural hemorrhage
I63.011* Cerebral infarction due to thrombosis of right vertebral artery
I63.012* Cerebral infarction due to thrombosis of left vertebral artery
I63.013* Cerebral infarction due to thrombosis of bilateral vertebral arteries
I63.02* Cerebral infarction due to thrombosis of basilar artery
I63.031* Cerebral infarction due to thrombosis of right carotid artery
I63.032* Cerebral infarction due to thrombosis of left carotid artery
I63.033* Cerebral infarction due to thrombosis of bilateral carotid arteries
I63.09* Cerebral infarction due to thrombosis of other precerebral artery
I63.111* Cerebral infarction due to embolism of right vertebral artery
I63.112* Cerebral infarction due to embolism of left vertebral artery
I63.113* Cerebral infarction due to embolism of bilateral vertebral arteries
I63.12* Cerebral infarction due to embolism of basilar artery
I63.133* Cerebral infarction due to embolism of bilateral carotid arteries
I63.19* Cerebral infarction due to embolism of other precerebral artery
I63.211 Cerebral infarction due to unspecified occlusion or stenosis of right vertebral arteries
I63.212 Cerebral infarction due to unspecified occlusion or stenosis of left vertebral arteries
I63.213 Cerebral infarction due to unspecified occlusion or stenosis of bilateral vertebral arteries
I63.22 Cerebral infarction due to unspecified occlusion or stenosis of basilar arteries
I63.231 Cerebral infarction due to unspecified occlusion or stenosis of right carotid arteries
I63.232 Cerebral infarction due to unspecified occlusion or stenosis of left carotid arteries
I63.233 Cerebral infarction due to unspecified occlusion or stenosis of bilateral carotid arteries
I63.29 Cerebral infarction due to unspecified occlusion or stenosis of other precerebral arteries
I63.311* Cerebral infarction due to thrombosis of right middle cerebral artery
I63.312* Cerebral infarction due to thrombosis of left middle cerebral artery
I63.313* Cerebral infarction due to thrombosis of bilateral middle cerebral arteries
I63.321* Cerebral infarction due to thrombosis of right anterior cerebral artery
I63.322* Cerebral infarction due to thrombosis of left anterior cerebral artery
I63.331* Cerebral infarction due to thrombosis of right posterior cerebral artery
I63.332* Cerebral infarction due to thrombosis of left posterior cerebral artery
I63.341* Cerebral infarction due to thrombosis of right cerebellar artery
I63.342* Cerebral infarction due to thrombosis of left cerebellar artery
I63.39* Cerebral infarction due to thrombosis of other cerebral artery
I63.411* Cerebral infarction due to embolism of right middle cerebral artery
I63.412* Cerebral infarction due to embolism of left middle cerebral artery
I63.421* Cerebral infarction due to embolism of right anterior cerebral artery
I63.422* Cerebral infarction due to embolism of left anterior cerebral artery
I63.431* Cerebral infarction due to embolism of right posterior cerebral artery
I63.432* Cerebral infarction due to embolism of left posterior cerebral artery
I63.441* Cerebral infarction due to embolism of right cerebellar artery
I63.442* Cerebral infarction due to embolism of left cerebellar artery
I63.49* Cerebral infarction due to embolism of other cerebral artery
I63.511 Cerebral infarction due to unspecified occlusion or stenosis of right middle cerebral artery
I63.512 Cerebral infarction due to unspecified occlusion or stenosis of left middle cerebral artery
I63.522 Cerebral infarction due to unspecified occlusion or stenosis of left anterior cerebral artery
I63.531 Cerebral infarction due to unspecified occlusion or stenosis of right posterior cerebral artery
I63.532 Cerebral infarction due to unspecified occlusion or stenosis of left posterior cerebral artery
I63.541 Cerebral infarction due to unspecified occlusion or stenosis of right cerebellar artery
I63.542 Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery
I63.59 Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery
I63.6* Cerebral infarction due to cerebral venous thrombosis, nonpyogenic
I63.8* Other cerebral infarction
I69.031* Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right dominant side
I69.032* Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting left dominant side
I69.033* Monoplegia of upper limb following nontraumatic subarachnoid hemorrhage affecting right non-dominant side





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.