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Coverage criteria policies

Botulinum toxins: abobotulinumtoxinA (Dysport®), incobotulinumtoxinA (Xeomin®), onabotulinumtoxinA (Botox®), & rimabotulinumtoxinB (Myobloc®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative Process

Use for migraines and off-label indications will not be covered without prior authorization from HealthPartners Pharmacy Administration.

Coverage

Coverage for botulinum toxin preparations is subject to the indications listed below, and per your plan documents.

Coverage for Medicare products will be provided according to the Local Coverage Determination for Botulinum Toxins. Please see the link in the Related content section to the right for a link to the Coverage Determination.

Botulinum toxin preparations are covered as follows based on indication:

Prevention of chronic migraine

Botox requires a prior authorization but will generally be approved when the following criteria are met:

  1. Chronic migraine (defined as ≥ 15 headache days/month lasting ≥4 hours a day) despite standard treatment including three or more preventive treatments (e.g., amitriptyline, topamax, verapamil and beta-blockers) or medical contraindications to one or more of these therapies.
  2. Prescribing by a headache specialist who has received training in the injection technique.
    The suggested maximum dose is 155 units.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Severe axillary hyperhidrosis

Botox does not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Cervical dystonia

All preparations are covered and do not require a prior authorization.

Upper limb spasticity in adults

Botox and Dysport do not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Lower limb spasticity in adults

Botox does not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Lower limb spasticity in pediatric patients

Dysport does not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Strabismus

Botox does not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Blepharospasm

Botox and Xeomin do not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Urinary incontinence and overactive bladder

Botox does not require a prior authorization for this use.

Coverage for all other preparations is off label, requires a prior authorization and will be reviewed on a case by case basis.

Indications that are not covered

  1. Cosmetic use (the treatment of glabellar lines or wrinkles) is not considered medically necessary.
  2. Other conditions not listed in this policy will be reviewed on a case by case basis for coverage.
Botox Quantity Limits

Claims for greater than 600 Units will not be covered without prior authorization. Claims for greater amounts will be reviewed for billing accuracy and an inadequate response to standard dosing.

A quantity limit for Botox used in the treatment of headaches will be applied to Botox claims submitted for this indication (including migraine-type headaches, tension-type headaches, and chronic daily headaches). Claims for greater than 300 Units will not be covered without prior authorization. Claims for greater amounts will be reviewed for billing accuracy and an inadequate response to standard dosing.

Definitions

Botulinum toxin is an acetylcholine release inhibitor and a neuromuscular blocking agent. It is a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. Each preparation has the following indications and dosing:

Botox (OnabotulinumtoxinA)

  • Treatment of 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.
  • Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
  • Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) – 155 units, as 5 unit injections per each site divided across 7 head/neck muscles
  • Treatment of spasticity in adult patients
  • Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain
  • Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients – 50 units per axilla
  • Treatment of blepharospasm associated with dystonia in patients ≥12 years of age – 1.25 units – 2.5 units into each of three sites per affected eye
  • Treatment of strabismus in patients ≥12 years of age – 1.25 units to 2.5 units initially in any one muscle
  • The temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity in adult patients ≤65 years of age – 20 units divided across five sites
  • Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients

Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month), treatment of upper or lower limb spasticity in pediatric patients or for treatment of hyperhidrosis in body areas other than axillary.

Do not exceed a total dose of 360 units administered every 12 to 16 weeks or at longer intervals.

Dysport (AbobotulinumtoxinA)

  • The treatment of adults with cervical dystonia patients – 500 units IM as a divided dose among the affected muscles and retreatment every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms with doses between 250 and 1000 units, not less than every 12 weeks and titration should occur in 250 unit increments
  • The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugators muscle activity in adult patients <65 years of age – 50 units divided in five equal aliquots of 10 units each, retreat no more frequently than every 3 months
  • The treatment of upper limb spasticity in adults
  • The treatment of lower limb spasticity in pediatric patients 2 years of age and older

Repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

MyoBloc (RimabotulinumtoxinB)

  • Treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia – initial doses of 2500 units to 5000 units divided among affected muscles with patients without a prior history of tolerating botulinum toxin injections receiving a lower initial dose

The duration of effect in patients responding to treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000-10,000 units.

Xeomin (IncobotulinumtoxinA)

  • Treatment of upper limb spasticity in adult patients
  • Treatment of adults with cervical dystonia – 120 units total dose initially with repeat dosing based on initial response
  • Treatment of blepharospasm in adults previously treated with onabotulinumtoxinA (Botox) – starting dose should be based on previous dosing of Botox. If the previous dose is unknown, the recommended starting dose is 1.25 – 2.5 units / injection site. In clinical trials the mean dose per injection site was 5.6 units, the mean number of injections per eye was 6, and the mean dose per eye was 33.5 units.
  • Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity in adult patients – 20 units per treatment session divided into five equal intramuscular injections of 4 units each.

The frequency of repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS Codes

Codes

Description

J0585

Injection, onabotulinumtoxinA, 1 unit (Botox)

J0586

Injection, abobotulinumtoxinA, 5 units (Dysport)

J0587

Injection, rimabotulinumtoxinB, 100 units (Myobloc)

J0588

Injection, incobotulinumtoxinA, 1 unit (Xeomin)

NDC Codes

Codes

Description

00023114501

100 unit single-use vial (Botox)

00023392102

200 unit single-use vial (Botox)

00023923201

100 unit single-use vial (Botox Cosmetic)

00023391950

50 unit single-use vial (Botox Cosmetic)

15054053006

300 unit single-use vial (Dysport)

15054050001

500 unit single-use vial (Dysport)

15054005001

500 unit single-use vial (Dysport)

10454071210

10,000 unit/2 mL single-use vial (Myobloc)

10454071010

2,500 unit/0.5 mL single-use vial (Myobloc)

10454071110

5,000 unit/mL single-use vial (Myobloc)

00259161001

100 unit single-use vial (Xeomin)

00259162001

200 units single-use vial (Xeomin)

00259160501

50 unit single-use vial (Xeomin)

ICD-10-CM Codes
For all agents, the following codes do not require prior authorization.

Codes

Description

F45.8

Other somatoform disorders [bruxism] [painful]

G11.4

Hereditary spastic paraplegia [limb spasticity due to]

G24.01-G24.9

Dystonia

G25.89

Other specified extrapyramidal and movement disorders

G51.0-G51.9

Facial nerve disorders

G80.0-G80.9

Cerebral palsy

G81.10-G81.14

Spastic hemiplegia

G82.20–G83.34

Paraplegia and quadriplegia and other paralytic syndromes

G83.4

Cauda equina syndrome

H49.00-H51.9

Strabismus and other disorders of binocular eye movements

I69.051-I69.959

Sequelae of cerebrovascular disease [hemiplegia/hemiparesis]

J38.5

Laryngeal spasm

K11.7

Disturbances of salivary secretion

K22.0

Achalasia of cardia

K59.4

Anal spasm

K60.1

Chronic anal fissure

K60.2

Anal fissure, unspecified

L74.510-L74.519

Primary focal hyperhidrosis

L74.52

Secondary focal hyperhidrosis

R25.0-R25.9

Abnormal involuntary movements

R29.891

Ocular torticollis

R49.0

Dysphonia

R49.9

Unspecified voice and resonance disorder

S04.50XA

Injury of facial nerve, unspecified side, initial encounter

S04.51XA

Injury of facial nerve, right side, initial encounter

S04.52XA

Injury of facial nerve, left side, initial encounter

For all agents, the following codes DO require prior authorization.

Codes

Description

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

For Botox only, the following codes do not require prior authorization.

Codes

Description

N31.0

Uninhibited neuropathic bladder, not elsewhere classified

N31.1

Reflex neuropathic bladder, not elsewhere classified

N31.9

Neuromuscular dysfunction of bladder, unspecified

N32.81

Overactive bladder

N36.44

Muscular disorders of urethra

N39.41

Urge incontinence

N39.46

Mixed incontinence

All other codes require prior authorization.

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Botox and Botox Cosmetic prescribing information. Allergan, Inc. 2/2016.
  2. MyoBloc prescribing information. Solstice Neurosciences, Inc. 5/2010.
  3. Dysport prescribing information. Ipsen Biopharm Ltd. 7/2016.
  4. Xeomin prescribing information. Merz Pharmaceuticals, LLC. 12/2015.
  5. Elkind AH, O'Carroll P, Blumenfeld A, DeGryse R, Dimitrova R; BoNTA-024-026-036 Study Group. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006 Oct;7(10):688-96.
  6. Silberstein SD, Stark SR, Lucas SM, Christie SN, Degryse RE, Turkel CC; BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo- controlled trial. Mayo Clin Proc. 2005 Sep;80(9):1126-37.
  7. Evers S, Vollmer-Haase J, Schwaag S, Rahmann A, Husstedt IW, Frese A. Botulinum toxin A in the prophylactic treatment of migraine--a randomized, double-blind, placebo-controlled study. Cephalalgia. 2004 Oct;24(10):838- 43.
  8. Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group. Headache. 2000 Jun;40(6):445-50.
  9. Naumann M, So Y, Argoff CE, Childers MK, Dykstra DD, Gronseth GS, Jabbari B, Kaufmann HC, Schurch B, Silberstein SD, Simpson DM; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008 May 6;70(19):1707-14.
  10. ICSI, Headache, Jan 2011. http://www.icsi.org/guidelines_and_more/gl_os_prot/
    other_health_care_conditions/headache/headache diagnosis_and_treatment_of__guideline_.html.

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Policy activity

  • 10/01/1996 - Date of origin
  • 10/01/1996 - Effective date
Review date
  • 05/2016
Revision date
  • 11/07/2016

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