Pharmacy Medical Policy Botulinum Toxin Injection for muscle and nerve conditions

Transcription

1 Pharmacy Medical Policy Botulinum Toxin Injection for muscle and nerve conditions Table of Contents Policy: Commercial Policy History Endnotes Policy: Medicare Information Pertaining to All Policies Forms Coding Information References Policy Number: 006 BCBSA Reference Number: Related Policies Other indications for botulinum toxin are discussed separately in medical policy, 405, Treatment of Hyperhidrosis. Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Note: All requests for outpatient retail pharmacy for indications listed and not listed on the medical policy guidelines may be submitted to BCBSMA Clinical Pharmacy Operations by completing the Prior Authorization Form on the last page of this document. Physicians may also call BCBSMA Pharmacy Operations department at (800) to request a prior authorization/formulary exception verbally. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider website or directly on the web at Patients must have pharmacy benefits under their subscriber certificates. Please refer to the chart below for the formulary status of the medications affected by this policy. FORMULARY INFORMATION Drug Standard Formulary Status Botox Dysport Myobloc Xeomin PA Required PA Required PA Required PA Required 1

2 We cover onabotulinumtoxina (Botox ) and rimabotulinumtoxinb (MyoblocTM) injections for any of the following conditions: [For diagnoses that are considered medically necessary, see Coding section.]. Eye: Confirmed diagnosis of strabismus or blepharospasm (including benign essential blepharospasm) associated with dystonia or neuromyelitis optica Face: Cranial nerve VII disorders 1 such as hemifacial spasm, jaw-closing oromandibular dystonia, masseter spasticity, orofacial dyskinesia, and other conditions demonstrating increased muscle activity that impairs bodily functions, in patients 12 years and older Neck: Spasmodic torticollis or cervical dystonia in adults Throat: Spasmodic dysphonia or laryngeal dysphonia (laryngeal spasm); laryngeal dystonia (i.e., adductor spasmodic dysphonia) Esophagus: Achalasia patients who have not responded to dilatation therapy, or who are poor candidates for surgery Anal spasm and anal fissure Arms or Legs: for the following conditions: o Segmental spasticity in adults or children, such as adductor muscle spasms preventing adequate hygiene o Multiple sclerosis o Segmental peripheral dystonias, or focal limb dystonias such as organic writer s cramp, or other hand or foot dystonias o Cerebral palsy: Treatment of dynamic muscle contracture in pediatric cerebral palsy patients o Severe uncontrolled limb spasticity, such as stiff limb syndrome, idiopathic torsion dystonia, symptomatic torsion dystonia, spastic hemiplegia, spasticity related to stroke, hereditary spastic paraplegia, Schilder s disease, or other otherwise untreatable generalized spasms. Skin: Severe symptomatic hyperhidrosis (Botox only) (see Medical Policy #405 for further coverage details) Incontinence due to detrusor overreactivity (urge incontinence), either idiopathic or due to neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is inadequately controlled with anticholinergic therapy. Migraine headache when ALL of the following criteria are met: o Age 18 years or over o Prescribed by a neurologist, ophthalmologist or board certified headache medicine specialist. o Episodes of migraine for 15 days/month with duration 4 hours/day o Previous treatment for at least three months each or contraindication to all of the following therapeutic categories/medications: Beta blockers (e.g. propranolol, timolol) Topiramate Divalproex sodium Non-steroidal anti-inflammatory medications (e.g. ibuprofen, naproxen, diclofenac) Serotonin receptor agonists (e.g. sumatriptan, naratriptan). We cover onabotulinumtoxina abobotulinumtoxina (Dysport ) for the following condition: Neck: Cervical dystonia in both toxin-naïve and previously treated patients. For covered diagnoses, see Coding section. We cover incobotulinumtoxina (Xeomin ) for the following condition: Neck: Cervical dystonia in both toxin-naïve and previously treated patients. Eye: Confirmed diagnosis of blepharospasm and previous treatment failure with onabotulinumtoxin A (Botox ). We do not cover onabotulinumtoxina (Botox ), onabotulinumtoxina (Dysport ) rimabotulinumtoxinb (MyoblocTM) or incobotulinumtoxina (Xeomin ) injections for conditions, including but not limited to: Eye conditions not listed above, including: o Chronic paralytic strabismus (except to reduce antagonist contracture in conjuncture with surgical repair) 2

3 o Patients with corneal exposure, persistent epithelial defect, or corneal ulceration Headaches including migraine unless criteria met above Tourette s syndrome Chronic Motor Tic disorder Patients with myasthenia gravis Wrinkles, glabellar lines or other cosmetic indications Myofascial pain syndrome Chronic low back pain Tremors such as benign essential tremor Sialorrhea (drooling) Lateral epicondylitis Benign prostatic hyperplasia Detrusor over reactivity not due to spinal cord injury Detrusor sphincteric dyssynergia Prevention of pain associated with breast reconstruction after mastectomy Hirschsprung s disease Gastroparesis. We do not cover abobotulinumtoxina (Dysport ) for any condition other than cervical dystonia in both toxin-naïve and previously treated patients. For patient safety, we do not cover any type of botulinum (Botox ) injections for: Patients who are pregnant or intend to become pregnant Patients who are on aminoglycoside therapy, as it may increase the risk of problems between the muscles and the nerves Patients with retrobulbar hemorrhages sufficient to compromise retinal circulation Patients with severe laryngeal or respiratory weakness Patients with sensitivity or allergy to Botox, or known high antibody titers to Botox. Individual Consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual s unique clinical circumstances may be considered in light of current scientific literature. Physicians may send relevant clinical information for individual patients for consideration to: Blue Cross Blue Shield of Massachusetts Clinical Pharmacy Department One Enterprise Drive Quincy, MA Tel: Fax: Managed Care Authorization Instructions Prior authorization is required for all out patient sites of service For retail pharmacy requests, physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients. Pharmacy Operations: (800) For all outpatient sites of service, physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients. For all outpatient sites of service, physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider website or directly on the web at 3

4 PPO and Indemnity Authorization Instructions Prior authorization is required when these medications are processed under the retail pharmacy benefit and home infusion therapy benefit. Prior authorization is not required when these drugs are purchased by the physician and administered in the office in accordance with this medical policy. For retail pharmacy requests, physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients. Pharmacy Operations: (800) Physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider website or directly on the web at CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT codes: Code Description Laryngoscopy, indirect; with vocal cord injection Laryngoscopy, direct, with injection into vocal cord(s), therapeutic Laryngoscopy, direct, with injection into vocal cord(s), therapeutic; with operating microscope or telescope Chemodenervation of internal anal sphincter Chemodenervation of parotid and submandibular salivary glands, bilateral Chemodenervation of muscle(s); muscle(s) innervated by facial nerve (eg, for blepharospasm, hemifacial spasm) Chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia) Chemodenervation of muscle(s); extremity(s) and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis) Chemodenervation of eccrine glands; both axillae Chemodenervation of eccrine glands; other area(s) (eg, scalp, face, neck), per day Chemodenervation of extraocular muscle Electrical stimulation for guidance in conjunction with chemodenervation Needle electromyography for guidance in conjunction with chemodenervation HCPCS Codes HCPCS codes: J0585 J0586 J0587 J0588 Code Description Injection, onabotulinumtoxina, 1 unit (Botox) Injection, abobotulinumtoxina, 5 units (Dysport) Injection, rimabotulinumtoxinb, 100 units (Myobloc) Injection, incobotulinumtoxina, 1 unit (Xeomin) 4

5 Diagnosis coding ICD-9-CM diagnosis codes: Code Description Genetic torsion dystonia Acute dystonia due to drugs Other acquired torsion dystonia Blepharospasm Orofacial dyskinesia Spasmodic torticollis (Includes Dysport) Organic writers' cramp Other fragments of torsion dystonia Stiff-man syndrome Hereditary spastic paraplegia 340 Multiple sclerosis Neuromyelitis optica Schilder's disease Other demyelinating diseases of central nervous system Demyelinating disease of central nervous system, unspecified Spastic hemiplegia and hemiparesis affecting unspecified side Spastic hemiplegia and hemiparesis affecting dominant side Spastic hemiplegia and hemiparesis affecting nondominant side Congenital diplegia Congenital hemiplegia Congenital quadriplegia Congenital monoplegia Infantile hemiplegia Other specified infantile cerebral palsy Infantile cerebral palsy, unspecified Migraine with aura, without mention of intractable migraine without mention of status Migraine with aura, with intractable migraine, so stated, without mention of status Migraine with aura, without mention of intractable migraine with status Migraine with aura, with intractable migraine, so stated, with status Migraine without aura, without mention of intractable migraine without mention of status Migraine without aura, with intractable migraine, so stated, without mention of status Migraine without aura, without mention of intractable migraine with status Migraine without aura, with intractable migraine, so stated, with status Variants of migraine, not elsewhere classified, without mention of intractable migraine without mention of status Variants of migraine, not elsewhere classified, with intractable migraine, so stated, without mention of status Variants of migraine, not elsewhere classified, without mention of intractable migraine with status Variants of migraine, not elsewhere classified, with intractable migraine, so stated, with status Hemiplegic migraine, without mention of intractable migraine without mention of status Hemiplegic migraine, with intractable migraine, so stated, without mention of status 5

6 Hemiplegic migraine, without mention of intractable migraine with status Hemiplegic migraine, with intractable migraine, so stated, with status Menstrual migraine, without mention of intractable migraine without mention of status Menstrual migraine, with intractable migraine, so stated, without mention of status Menstrual migraine, without mention of intractable migraine with status Menstrual migraine, with intractable migraine, so stated, with status Persistent migraine aura without cerebral infarction, without mention of intractable migraine without mention of status Persistent migraine aura without cerebral infarction, with intractable migraine, so stated, without mention of status Persistent migraine aura without cerebral infarction, without mention of intractable migraine with status Persistent migraine aura without cerebral infarction, with intractable migraine, so stated, with status Persistent migraine aura with cerebral infarction, without mention of intractable migraine without mention of status Persistent migraine aura with cerebral infarction, with intractable migraine, so stated, without mention of status Persistent migraine aura with cerebral infarction, without mention of intractable migraine with status Persistent migraine aura with cerebral infarction, with intractable migraine, so stated, with status Chronic migraine without aura, without mention of intractable migraine without mention of status Chronic migraine without aura, with intractable migraine, so stated, without mention of status Chronic migraine without aura, without mention of intractable migraine with status Chronic migraine without aura, with intractable migraine, so stated, with status Other forms of migraine, without mention of intractable migraine without mention of status Other forms of migraine, with intractable migraine, so stated, without mention of status Other forms of migraine, without mention of intractable migraine with status Other forms of migraine, with intractable migraine, so stated, with status Migraine, unspecified, without mention of intractable migraine without mention of status Migraine, unspecified, with intractable migraine, so stated, without mention of status Migraine, unspecified, without mention of intractable migraine with status Migraine, unspecified, with intractable migraine, so stated, with status Bell's palsy Geniculate ganglionitis Other facial nerve disorders Facial nerve disorder, unspecified Esotropia, unspecified Monocular esotropia Monocular esotropia with A pattern Monocular esotropia with V pattern Monocular esotropia with other noncomitancies 6

7 Alternating esotropia Alternating esotropia with A pattern Alternating esotropia with V pattern Alternating esotropia with other noncomitancies Exotropia, unspecified Monocular exotropia Monocular exotropia with A pattern Monocular exotropia with V pattern Monocular exotropia with other noncomitancies Alternating exotropia Alternating exotropia with A pattern Alternating exotropia with V pattern Alternating exotropia with other noncomitancies Intermittent heterotropia, unspecified Intermittent esotropia, monocular Intermittent esotropia, alternating Intermittent exotropia, monocular Intermittent exotropia, monocular Intermittent exotropia, alternating Heterotropia, unspecified Hypertropia Hypotropia Cyclotropia Monofixation syndrome Accommodative component in esotropia Heterophoria, unspecified Esophoria Exophoria Vertical heterophoria Cyclophoria Alternating hyperphoria Paralytic strabismus, unspecified Third or oculomotor nerve palsy, partial Third or oculomotor nerve palsy, total Fourth or trochlear nerve palsy Sixth or abducens nerve palsy External ophthalmoplegia Total ophthalmoplegia Mechanical strabismus, unspecified Brown's (tendon) sheath syndrome Mechanical strabismus from other musculofascial disorders Limited duction associated with other conditions Duane's syndrome Progressive external ophthalmoplegia Strabismus in other neuromuscular disorders Palsy of conjugate gaze Spasm of conjugate gaze Convergence insufficiency or palsy Convergence excess or spasm Anomalies of divergence Internuclear ophthalmoplegia Other dissociated deviation of eye movements Unspecified disorder of eye movements 7

8 Laryngeal spasm Other diseases of larynx, not elsewhere classified Achalasia and cardiospasm Anal spasm Anal fissure Hypertonicity of bladder Other functional disorder of bladder Primary focal hyperhidrosis Secondary focal hyperhidrosis Torticollis, unspecified (Includes Dysport) Spasm of muscle Other musculoskeletal symptoms referable to limbs Congenital musculoskeletal deformities of sternocleidomastoid muscle (Includes Dysport) Generalized hyperhidrosis (see Medical Policy #405 for additional coverage information) Headache Other voice and resonance disorders Urinary incontinence, unspecified Urge incontinence Stress incontinence, male Mixed incontinence (male) (female) Incontinence without sensory awareness Post-void dribbling Nocturnal enuresis Continuous leakage Overflow incontinence Other urinary incontinence Sprain of neck (Includes Dysport) Facility coding ICD-9-CM procedure codes: Code Description Administration of botulism antitoxin ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description G11.4 Hereditary spastic paraplegia G24.02 Drug induced acute dystonia 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 G25.82 Stiff-man syndrome G25.89 Other specified extrapyramidal and movement disorders 8

9 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 G37.4 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 G Migraine without aura, not intractable, with status G Migraine without aura, not intractable, without status G Migraine without aura, intractable, with status G Migraine without aura, intractable, without status G Migraine with aura, not intractable, with status G Migraine with aura, not intractable, without status G Migraine with aura, intractable, with status G Migraine with aura, intractable, without status G Hemiplegic migraine, not intractable, with status G Hemiplegic migraine, not intractable, without status G Hemiplegic migraine, intractable, with status G Hemiplegic migraine, intractable, without status G Persistent migraine aura without cerebral infarction, not intractable, with status G Persistent migraine aura without cerebral infarction, not intractable, without status G Persistent migraine aura without cerebral infarction, intractable, with status G Persistent migraine aura without cerebral infarction, intractable, without status G Persistent migraine aura with cerebral infarction, not intractable, with status G Persistent migraine aura with cerebral infarction, not intractable, without status G Persistent migraine aura with cerebral infarction, intractable, with status G Persistent migraine aura with cerebral infarction, intractable, without status G Chronic migraine without aura, not intractable, with status G Chronic migraine without aura, not intractable, without status G Chronic migraine without aura, intractable, with status G Chronic migraine without aura, intractable, without status G Other migraine, not intractable, with status G Other migraine, not intractable, without status G Other migraine, intractable, with status G Other migraine, intractable, without status G Menstrual migraine, not intractable, with status G Menstrual migraine, not intractable, without status G Menstrual migraine, intractable, with status G Menstrual migraine, intractable, without status G Migraine, unspecified, not intractable, with status G Migraine, unspecified, not intractable, without status 9

10 G Migraine, unspecified, intractable, with status G Migraine, unspecified, intractable, without status G43.A0 Cyclical vomiting, not intractable G43.A1 Cyclical vomiting, intractable G43.B0 Ophthalmoplegic migraine, not intractable G43.B1 Ophthalmoplegic migraine, intractable G43.C0 Periodic headache syndromes in child or adult, not intractable G43.C1 Periodic headache syndromes in child or adult, intractable G43.D0 Abdominal migraine, not intractable G43.D1 Abdominal migraine, intractable G44.1 Vascular headache, not elsewhere classified G51.0 Bell's palsy G51.1 Geniculate ganglionitis G51.2 Melkersson's syndrome G51.3 Clonic hemifacial spasm G51.4 Facial myokymia G51.8 Other disorders of facial nerve G51.9 Disorder of facial nerve, unspecified 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 G80.9 Cerebral palsy, unspecified G81.10 Spastic hemiplegia affecting unspecified side 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 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 H Other paralytic strabismus, right eye H Other paralytic strabismus, left eye 10

11 H Other paralytic strabismus, bilateral H Other paralytic strabismus, unspecified eye H49.9 Unspecified paralytic strabismus H50.00 Unspecified esotropia H Monocular esotropia, right eye H Monocular esotropia, left eye H Monocular esotropia with A pattern, right eye H Monocular esotropia with A pattern, left eye H Monocular esotropia with V pattern, right eye H Monocular esotropia with V pattern, left eye H Monocular esotropia with other noncomitancies, right eye H 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 H Monocular exotropia, right eye H Monocular exotropia, left eye H Monocular exotropia with A pattern, right eye H Monocular exotropia with A pattern, left eye H Monocular exotropia with V pattern, right eye H Monocular exotropia with V pattern, left eye H Monocular exotropia with other noncomitancies, right eye H 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 H Intermittent monocular esotropia, right eye H Intermittent monocular esotropia, left eye H50.32 Intermittent alternating esotropia H Intermittent monocular exotropia, right eye H Intermittent monocular exotropia, left eye H50.34 Intermittent alternating exotropia H50.40 Unspecified heterotropia H Cyclotropia, right eye H Cyclotropia, left eye H50.42 Monofixation syndrome H50.43 Accommodative component in esotropia H50.50 Unspecified heterophoria H50.51 Esophoria H50.52 Exophoria H50.53 Vertical heterophoria H50.54 Cyclophoria H50.55 Alternating heterophoria H50.60 Mechanical strabismus, unspecified H Brown's sheath syndrome, right eye 11

12 H Brown's sheath syndrome, left eye H50.69 Other mechanical strabismus H Duane's syndrome, right eye H Duane's syndrome, left eye H50.89 Other specified strabismus H50.9 Unspecified strabismus H51.0 Palsy (spasm) of conjugate gaze H51.11 Convergence insufficiency H51.12 Convergence excess H51.20 Internuclear ophthalmoplegia, unspecified eye H51.21 Internuclear ophthalmoplegia, right eye H51.22 Internuclear ophthalmoplegia, left eye H51.23 Internuclear ophthalmoplegia, bilateral H51.8 Other specified disorders of binocular movement H51.9 Unspecified disorder of binocular movement J38.5 Laryngeal spasm J38.7 Other diseases of larynx K22.0 Achalasia of cardia K59.4 Anal spasm K60.0 Acute anal fissure K60.1 Chronic anal fissure K60.2 Anal fissure, unspecified L Primary focal hyperhidrosis, axilla L Primary focal hyperhidrosis, face L Primary focal hyperhidrosis, palms L Primary focal hyperhidrosis, soles L Primary focal hyperhidrosis, unspecified L74.52 Secondary focal hyperhidrosis M43.6 Torticollis M62.40 Contracture of muscle, unspecified site M Contracture of muscle, right shoulder M Contracture of muscle, left shoulder M Contracture of muscle, unspecified shoulder M Contracture of muscle, right upper arm M Contracture of muscle, left upper arm M Contracture of muscle, unspecified upper arm M Contracture of muscle, right forearm M Contracture of muscle, left forearm M Contracture of muscle, unspecified forearm M Contracture of muscle, right hand M Contracture of muscle, left hand M Contracture of muscle, unspecified hand M Contracture of muscle, right thigh M Contracture of muscle, left thigh M Contracture of muscle, unspecified thigh M Contracture of muscle, right lower leg M Contracture of muscle, left lower leg M Contracture of muscle, unspecified lower leg M Contracture of muscle, right ankle and foot M Contracture of muscle, left ankle and foot M Contracture of muscle, unspecified ankle and foot 12

13 M62.48 Contracture of muscle, other site M62.49 Contracture of muscle, multiple sites M Muscle spasm of calf M Other muscle spasm N31.9 Neuromuscular dysfunction of bladder, unspecified N32.81 Overactive bladder N39.3 Stress incontinence (female) (male) N39.41 Urge incontinence N39.42 Incontinence without sensory awareness N39.43 Post-void dribbling N39.44 Nocturnal enuresis N39.45 Continuous leakage N39.46 Mixed incontinence N Overflow incontinence N Other specified urinary incontinence Q68.0 Congenital deformity of sternocleidomastoid muscle R Other symptoms and signs involving the musculoskeletal system R32 Unspecified urinary incontinence R49.8 Other voice and resonance disorders R51 Headache R61 Generalized hyperhidrosis S13.4xxA Sprain of ligaments of cervical spine, initial encounter S13.4xxD Sprain of ligaments of cervical spine, subsequent encounter S13.4xxS Sprain of ligaments of cervical spine, sequela S13.8xxA Sprain of joints and ligaments of other parts of neck, initial encounter S13.8xxD Sprain of joints and ligaments of other parts of neck, subsequent encounter S13.8xxS Sprain of joints and ligaments of other parts of neck, sequela S16.1xxA Strain of muscle, fascia and tendon at neck level, initial encounter S16.1xxD Strain of muscle, fascia and tendon at neck level, subsequent encounter S16.1xxS Strain of muscle, fascia and tendon at neck level, sequela ICD-10 Procedure Codes ICD-10-PCS procedure codes: 3E0234Z 3E0134Z 3E013TZ 3E023TZ 3E030TZ 3E033TZ 3E040TZ 3E043TZ 3E050TZ 3E053TZ 3E060TZ 3E063TZ 3E093TZ 3E097TZ 3E09XTZ Code Description Introduction of Serum, Toxoid and Vaccine into Muscle, Percutaneous Approach Introduction of Serum, Toxoid and Vaccine into Subcutaneous Tissue, Percutaneous Approach Introduction of Destructive Agent into Subcutaneous Tissue, Percutaneous Approach Introduction of Destructive Agent into Muscle, Percutaneous Approach Introduction of Destructive Agent into Peripheral Vein, Open Approach Introduction of Destructive Agent into Peripheral Vein, Percutaneous Approach Introduction of Destructive Agent into Central Vein, Open Approach Introduction of Destructive Agent into Central Vein, Percutaneous Approach Introduction of Destructive Agent into Peripheral Artery, Open Approach Introduction of Destructive Agent into Peripheral Artery, Percutaneous Approach Introduction of Destructive Agent into Central Artery, Open Approach Introduction of Destructive Agent into Central Artery, Percutaneous Approach Introduction of Destructive Agent into Nose, Percutaneous Approach Introduction of Destructive Agent into Nose, Via Natural or Artificial Opening Introduction of Destructive Agent into Nose, External Approach 13

14 3E0B3TZ 3E0B7TZ 3E0BXTZ 3E0C3TZ 3E0C7TZ 3E0CXTZ 3E0D3TZ 3E0E3TZ 3E0F3TZ 3E0G3TZ 3E0G7TZ 3E0G8TZ 3E0H3TZ 3E0H7TZ 3E0H8TZ 3E0J3TZ 3E0K3TZ 3E0L3TZ 3E0M3TZ 3E0N3TZ 3E0P3TZ 3E0Q3TZ 3E0R3TZ 3E0S3TZ 3E0T3TZ 3E0U3TZ 3E0V3TZ 3E0W3TZ 3E0X3TZ 3E0Y3TZ Introduction of Destructive Agent into Ear, Percutaneous Approach Introduction of Destructive Agent into Ear, Via Natural or Artificial Opening Introduction of Destructive Agent into Ear, External Approach Introduction of Destructive Agent into Eye, Percutaneous Approach Introduction of Destructive Agent into Eye, Via Natural or Artificial Opening Introduction of Destructive Agent into Eye, External Approach Introduction of Destructive Agent into Mouth and Pharynx, Percutaneous Approach Introduction of Destructive Agent into Products of Conception, Percutaneous Approach Introduction of Destructive Agent into Respiratory Tract, Percutaneous Approach Introduction of Destructive Agent into Upper GI, Percutaneous Approach Introduction of Destructive Agent into Upper GI, Via Natural or Artificial Opening Introduction of Destructive Agent into Upper GI, Via Natural or Artificial Opening Endoscopic Introduction of Destructive Agent into Lower GI, Percutaneous Approach Introduction of Destructive Agent into Lower GI, Via Natural or Artificial Opening Introduction of Destructive Agent into Lower GI, Via Natural or Artificial Opening Endoscopic Introduction of Destructive Agent into Biliary and Pancreatic Tract, Percutaneous Approach Introduction of Destructive Agent into Genitourinary Tract, Percutaneous Approach Introduction of Destructive Agent into Pleural Cavity, Percutaneous Approach Introduction of Destructive Agent into Peritoneal Cavity, Percutaneous Approach Introduction of Destructive Agent into Male Reproductive, Percutaneous Approach Introduction of Destructive Agent into Female Reproductive, Percutaneous Approach Introduction of Destructive Agent into Cranial Cavity and Brain, Percutaneous Approach Introduction of Destructive Agent into Spinal Canal, Percutaneous Approach Introduction of Destructive Agent into Epidural Space, Percutaneous Approach Introduction of Destructive Agent into Peripheral Nerves and Plexi, Percutaneous Approach Introduction of Destructive Agent into Joints, Percutaneous Approach Introduction of Destructive Agent into Bones, Percutaneous Approach Introduction of Destructive Agent into Lymphatics, Percutaneous Approach Introduction of Destructive Agent into Cranial Nerves, Percutaneous Approach Introduction of Destructive Agent into Pericardial Cavity, Percutaneous Approach Policy History Date Action 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/ /2014 Updated to include adding the sub specialty of board certified headache medicine 1/2014 Updated to remove Blue Value. 12/2012 Updated to add new CPT code effective 1/1/ /2012 Updated to reclassify as a pharmacy medical policy. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. 7/2012 Updated to clarify coverage criteria and coding for Dysport (abobotulinumtoxina), add diagnosis codes for cervical dystonia, clarify the patient safety section, and add ophthalmologist under migraine criteria. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2011 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. 14

15 5/2011 Updated to include coverage criteria for new FDA approved indication of migraine for Botox 2/2011 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 12/2010 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. 12/2010 Updated to include coverage criteria for new FDA-approved product Xeomin (incobotulinumtoxina). 6/2010 Updated to include coverage criteria for new FDA-approved product Dysport (abobotulinumtoxina). 6/2010 BCBSA National medical policy review. Changes to policy statements. 2/2010 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 1/2010 Updated to include 10/1 UM requirements. 12/2009 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. 12/2009 Updated to remove coverage of Botulinum Type B, Myobloc for all types of hyperhidrosis. 2/2009 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. 1/2009 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 12/2008 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. 1/2008 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 12/2007 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. 1/2007 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 1/2007 BCBSA National medical policy review. Changes to policy statements. 1/1/2001 New policy, effective 1/1/2001, describing covered and non-covered indications. References TEC Assessment; Tab Vaezi MF, Richter JM, Wilcox CM et al. Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomized trial. Gut 1999;44(2): Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal myofascial pain syndrome. Spine 1998; 23(15): Kirazli Y, On AY, Kismali B et al. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil 1998;77(6): Smith SJ, Ellis E, White S et al. A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000;14(1): Maria G, Cassetta E, Gui D et al. A comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N Engl J Med 1998;338(4):

16 7. Jost WH. One hundred cases of anal fissure treated with botulinum toxin: early and long-term results. Dis Colon Rectum 1997;40(9): Brisinda G, Maria G, Bentivoglio AR et al. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med 1999;341(2): Pahwa R, Busenbark K, Swanson-Hyland EF et al. Botulinum toxin treatment of essential head tremor. Neurology 1995;45(4): Silberstein S, Mathew N, Saper J et al. Botulinum toxin type A as a migraine preventive treatment. Headache 2000;40(6): Rollnik JD, Tanneberger O, Schubert M et al. Treatment of tension-type headache with botulinum toxin type A: a double-blind placebo-controlled study. Headache 2000;40(4): Smuts JA, Baker MK, Smuts HM et al. Prophylactic treatment of chronic tension-type headache using botulinum toxin type A. Eur J Neurol 1999;6(suppl 4):S99-S Freund BJ, Schwartz M. Treatment of chronic cervical-associated headache with botulinum toxin A: a pilot study. Headache 2000;40(3); Pal PK, Calne DB, Calne S et al. Botulinum toxin A as treatment for drooling saliva in PD. Neurology 2000;54(1): Bhatia KP, Munchau A, Brown P. Botulinum toxin is a useful treatment in excessive drooling of saliva. J Neurol Neurosurg Psychiatr 1999,67(5): Wheeler AH. Botulinum toxin A, adjunctive therapy for refractory headaches associated with pericranial muscle tension. Headache 1998;38(6): TEC Assessment. Botulinum toxin for the treatment of primary chronic headache disorders. 18. Schmitt WJ, Slowey E, Fravi N et al. Effect of botulinum toxin A injections in the treatment of chronic tension-type headache: a double-blind, placebo-controlled trial. Headache 2001; 41(7): Foster L, Clapp L, Erickson M et al. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology 2001; 56(10): Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson s disease. Neurology 2004; 62(1): Mancini F, Zangaglia R, Cristina S et al. Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in Parkinsonism. Mov Disord 2003; 18(6): Lipp A, Trottenberg T, Schink T et al. A randomized trial of botulinum toxin A for treatment of drooling. Neurology 2003; 61(9): Mathew NT, Frishberg BM, Gawel M et al. Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Headache 2005; 45(4): Silberstein SD, Stark SR, Lucas SM et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc 2005; 80(9): Wong SM, Hui ACF, Poon DWF et al. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 2005; 143(11): Hayton MJ, Santini AJ, Hughes PJ et al. Botulinum toxin injection in the treatment of tennis elbow. A double-blind, randomized, controlled, pilot study. J Bone Joint Surg Am 2005; 87(3): Laskawi R, Drobik C, Schonebeck C. Up-to-date report of botulinum toxin type A treatment in patients with gustatory sweating (Frey s syndrome). Laryngoscope 1998; 108(3): Schnider P, Binder M, Auff E et al. Double-blind trial of botulinum A toxin for the treatment of focal hyperhidrosis of the palms. Br J Dermatol 1997; 136(4): Shelley WB, Talanin NY, Shelley ED. Botulinum toxin therapy for palmar hyperhidrosis. J Am Acad Dermatol 1998; 38(2 pt 1): Naumann M, Hofmann U, Bergmann I et al. Focal hyperhidrosis: effective treatment with intracutaneous botulinum toxin. Arch Dermatol 1998; 134(3): Naumann MK, Hamm H, Lowe NJ. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. Br J Dermatol 2002; 147(6): Nauman M, Lowe NJ, Kumar CR et al. Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch Dermatol 2003; 139(6):

17 33. Campanati A, Penna L, Guzzo T et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther 2003; 25(1): Lowe NJ, Yamauchi PS, Lask GP et al. Efficacy and safety of botulinum toxin type A in the treatment of palmar hyperhidrosis: a double-blind, randomized, placebo-controlled study. Dermatol Surg 2002; 28(9): Saadia D, Voustianiouk A, Wang AK et al. Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology 2001; 57(11): Naumann M, Lowe NJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BMJ 2001; 323(7313): Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001; 344(7): Schurch B, de Seze M, Denys P et al. Botulinum toxin type A is a safe and effective treatment of neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6- month study. J Urol 2005; 174(1): Werner M, Schmid DM, Schussler B. Efficacy of botulinum-a in the treatment of detrusor overactivity incontinence: a prospective nonrandomized study. Am J Obstet Gynecol 2005; 192(5): de Seze M, Petit H, Gallien P et al. Botulinum a toxin and detrusor sphincter dyssynergia: a doubleblind lidocaine-controlled study in 13 patients with spinal cord disease. Eur Urol 2002; 42(1): Maria G, Brisinda G, Civello IM et al. Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study. Urology 2003; 62(2): Endnotes 1. FDA-approved indications 2. From National Blue Cross Blue Shield Association policy Local Medicare policy and CMS guidelines 4. Intrasphincteric botulinum toxin for the treatment of achalasia. NEJM 1995 March 23;322:744-8, by Paricha et al. 5. A comparison of Botulinum toxin an saline for the treatment of chronic anal fissure, NEJM 1998 Jan 22;338: by Maria et al. Based upon advice from representative physician experts of the Massachusetts Neurologic Association, Recommendations from Joel Stein, MD; Massachusetts General Hospital, EBR 1/ /00 FDA-approved indication 8. In accordance with local Medicare policy published in the September 2001 Medicare B Resource. See also: 9. Based upon the 2002 and 2004 Blue Cross Blue Shield Association national policy Pediatrics volume 108 number 5 November Botulinum toxin type A neuromuscular blockade in the treatment of Equinus deformity in cerebral palsy. Based upon the 2002 and 2004 Blue Cross Blue Shield Association National policy Foster L, Clapp L, Erickson M et al. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology 2001;56(10): Based upon the 2002 and 2004 Blue Cross Blue Shield Association National policy The National policy offered the following rationale: 12. Individual consideration guideline for cervicogenic migraine headache is based upon local expert opinion. 13. Based upon the 2004 Blue Cross Blue Shield Association National policy Botulinum toxin for Sialorrhea (drooling). Based upon the 2005 Blue Cross Blue Shield Association National policy issued 12/ Based upon the 2005 Blue Cross Blue Shield Association National policy Treatment of Hyperhidrosis issued 12/05 with a coding update only. Based upon Blue Cross Blue Shield National Policy Botulinum Toxin issued 4/ Dysport [package insert]. Brisbane, CA: Tercica, Inc., May Xeomin [package insert]. Greensboro, NC: Merz Pharmaceuticals, LLC.; August

18 17. "FDA Approves Botox to Treat Chronic Migraines." FDA.gov. Food and Drug Administration, 15 Oct Web. 23 Mar

19 Request for Outpatient Retail Pharmacy Prior Authorization Fax to: Clinical Pharmacy Program (800) Phone Authorization (800) or Web: We plan to respond to your request within two business days of our receipt. To ensure that we can confirm your request (required by NCQA), please be sure to include your fax number. We cannot process requests unless they contain all of the information requested below: Patient Information (REQUIRED) Name BCBSMA ID number Is the patient a BCBSMA employee? If yes, please fax request to: (617) Date of Birth Patient s Diagnosis ICD-9-CM code Physician Information (REQUIRED) Name Medical Specialty BCBSMA Provider number/npi number Telephone Number Fax Number Is this fax number secure for PHI receipt/transmission per HIPAA requirements? (circle one) Yes Contact Name (if different from physician) Please select one of the two following sections to complete, depending on the nature of your request for the above-named patient. Formulary Exception Request Name of non-covered drug you want to prescribe Reason for Individual Consideration Request (please check one): Treatment failure with the following covered drugs in class Documented adverse reaction to the following covered drugs in class Other clinical reason (please specify) Outpatient Retail Pharmacy Prior Authorization Request Drug name: Start/End date (must be one year or less): MD signature: Date: Yes No No 19

20 Outpatient Medical Prior Authorization Form Please complete and fax to: (888) Please contact Pharmacy Operations with questions at (800) If the patient is a BCBSMA employee, please fax the form to: (617) Servicing Provider Name: NPI Number: Requesting Provider Name: NPI Number: Phone# Fax# Contact person: Phone# Fax# Contact person: Patient Name: DOB / / Diagnosis: Patient BCBSMA ID# Is this fax number secure for PHI receipt/transmission per HIPAA requirements? (circle one) Yes No Drug/Therapy: Drug Name: Dates of Service: / / to / / Dose: Frequency: Route of Administration: Additional Clinical (including previous treatment failure): Physician signature: Date: 20