See Policy CPT/HCPCS CODE section below for any prior authorization requirements

Transcription

1 Effective Date: 4/1/2017 Section: MED Policy No.: 209 Medical Officer 4/1/2018 Date Technology Assessment Committee Approved Date: 4/09;6/10, 01/11; 5/13; 2/15 Medical Policy Committee Approved Date: 11/09; 4/11; 9/11; 12/11; 1/12; 7/12; 1/13; 2/14; 2/16; 6/16; 3/17; 3/18 APPLIES TO: See Policy CPT/HCPCS CODE section below for any prior authorization requirements All lines of business BENEFIT APPLICATION Medicaid Members Oregon: Services requested for Oregon Health Plan (OHP) members follow the OHP Prioritized List and Oregon Administrative Rules (OARs) for coverage determinations. For other lines of business, refer to the Policy Criteria section below: CRITERIA I. Botox, Myobloc, Dysport and Xeomin may be considered medically necessary and covered for FDA approved indications and selected unlabeled uses as indicated below for up to 12 months, but no more than 1 injection every 3 months. Reassessment must be done and preauthorization obtained for each 12 month period. Note: Up to 4 injections over a 1-year period may be approved if medical necessity criteria are met. A. FDA approved indications for rimabotulinumtoxinb (Myobloc): 1. Cervical dystonia B. FDA approved indications for onabotulinumtoxina (Botox): 1. Blepharospasm 2. Cervical dystonia 3. Hemifacial spasm 4. Migraine headache prophylaxis may be approved for treatment by a neurologist with documentation of the all of the following: a. Diagnosis of migraine headache b. Documentation of more than 15 headache days per month and four distinct headache episodes lasting > = 4 hours in that month Page 1 of 6

2 c. Trial and failure of oral formulary medications for both migraine treatment and migraine prophylaxis 5. Overactive bladder with incontinence for those who cannot use or do not adequately respond to two of the following anticholinergic medications: Ditropan XL (oxybutynin), Detrol LA (tolterodine), Enablex (darifenacin), Myrbetriq (mirabegron), Toviaz (fesoterodine) or Vesicare (solifenacin). 6. Strabismus 7. Upper limb spasticity in adults 8. Urinary incontinence due to detrusor overactivity associated with neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate: a. Response to or are intolerant of an anticholinergic medication. b. Dysfunction of the urinary bladder due to disease of the central or peripheral c. Nervous system pathways involved in micturition. d. Detrusor instability in patients with spinal cord injury or multiple sclerosis e. Resistant to antimuscarinics. C. FDA approved indications for abobotulinumtoxina (Dysport Brand of Botulinum Toxin Type A): 1. Cervical dystonia D. FDA approved indications for incobotulinumtoxina (Xeomin Brand of Botulinum Toxin Type A): 1. Cervical dystonia 2. Blepharospasm E. Unlabeled Indications: 1. Achalasia 2. Adductor spasmodic dysphonia 3. Anal fissure and anismus 4. Detrusor instability in patients with spinal cord injury or multiple sclerosis resistant to Antimuscarinics 5. Focal dystonia - The fifth digit will depend on the location. a. Drug induced subacute dyskinesia b. Spasmodic torticollis c. Idiopathic orofacial dystonia d. Blepharospasm e. Dystonia, unspecified f. Other specified extrapyramidal and movement disorders) 6. Hyperhidrosis 7. Laryngeal dystonia 8. Oromandibular dystonia 9. Salivation: For control of excessive salivation in neurologic disorders with severe disability 10. Spasmotic dysphonia 11. Spasmotic torticollis 12. Spastic hemiplegia - The fifth digit will depend on which side 13. Sphincter of Oddi dysfunction Page 2 of 6

3 14. Tardive dystonia 15. Writer s cramp II. When the above criteria I. above are not met, Botox, Myobloc, Dysport and Xeomin is considered investigational and not covered as a treatment for all other conditions, including but not limited to: A. Any voiding dysfunction with urethral injections B. Depression C. Diabetic gastroparesis D. Chronic pain, including low back pain, mastectomy reconstruction pain, myofacial pain, etc. E. Headache (tension-type headache, chronic daily headache) F. Rhinitis G. TMJ treatment except as procedure of last resort when all conservative measures have been exhausted: 1. Pharmacological management 2. Physical therapy 3. Relaxation therapy and cognitive behavioral therapy 4. Reversible intraoral appliances III. Botox, Myobloc, Dysport and Xeomin is considered cosmetic and is not covered for the treatment of glabellar lines and/or fine wrinkles on the face. CPT/HCPCS CODES All Lines of Business Prior Authorization Required Laryngoscopy, indirect; with vocal cord injection Laryngoscopy, direct, with injection into vocal cord(s), therapeutic Unlisted procedure, larynx Unlisted procedure, esophagus Chemodenervation of internal anal sphincter Cystourethroscopy, with injection(s) for chemodenervation of the bladder Chemodenervation of parotid and submandibular salivary glands, bilateral Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm) Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine) Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis) Page 3 of 6

4 64617 Chemodenervation of muscle(s); larynx, unilateral, percutaneous (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed Destruction by neurolytic agent; other peripheral nerve or branch Chemodenervation of one extremity; 1-4 muscle(s) Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) (List separately in addition to code for primary procedure) Chemodenervation of one extremity; 5 or more muscles Chemodenervation of one extremity; each additional extremity, 5 or more muscles (List separately in addition to code for primary procedure) Chemodenervation of trunk muscle(s); 1-5 muscle(s) Chemodenervation of trunk muscle(s); 6 or more muscles Chemodenervation of eccrine glands; both axillae Chemodenervation of eccrine glands; other area(s) (eg, scalp, face, neck), per day Unlisted procedure, nervous system Chemodenervation of extraocular muscle J0585 J0586 J0587 J0588 S2340 S2341 DESCRIPTION Needle oculoelectromyography, 1 or more extraocular muscles, 1 or both eyes, with interpretation and report Electrical stimulation for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure) Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure) Injection, onabotulinumtoxina, 1 unit Injection, abobotulinumtoxina, 5 units Injection, rimabotulinumtoxinb, 100 units Injection, incobotulinumtoxin a, 1 unit Chemodenervation of abductor muscle(s) of vocal cord Chemodenervation of adductor muscle(s) of vocal cord Botulinum toxins types A and B are neurotoxins produced by Clostridium Botulinum. The rationale for treatment is to create temporary paralysis of sufficient depth and duration that the injected muscles become slightly atrophied and stretched. The antagonist muscle shortens simultaneously taking up the slack created by agonist paralysis. After several weeks enervation to the injected muscle returns. The safety and efficacy of long term Botox, Myobloc, Dysport or Xeomin is unknown; however, there are recent concerns over adverse systemic side effects INSTRUCTIONS FOR USE Providence Health Plan (PHP) and Providence Health Assurance (PHA) Medical Policies serve as guidance for the administration of plan benefits. Medical policies do not constitute medical advice nor a guarantee of coverage. PHP and PHA Medical Policies are reviewed annually and are based upon published, peer-reviewed scientific evidence and evidence-based clinical practice guidelines that are Page 4 of 6

5 available as of the last policy update. PHP and PHA reserve the right to determine the application of Medical Policies and make revisions to its Medical Policies at any time. Providers will be given at least 60-days notice of policy changes that are restrictive in nature. The scope and availability of all plan benefits are determined in accordance with the applicable coverage agreement. Any conflict or variance between the terms of the coverage agreement and PHP and PHA Medical Policy will be resolved in favor of the coverage agreement. REGULATORY STATUS Mental Health Parity Statement Coverage decisions are made on the basis of individualized determinations of medical necessity and the experimental or investigational character of the treatment in the individual case. REFERENCES 1. Pediatr Neurol Jan;54:70-5. doi: /j.pediatrneurol Epub 2015 Sep 28.Ultrasound-Guided Botulinum Toxin Type A Salivary Gland Injection in Children for Refractory Sialorrhea: 10-Year Experience at a Large Tertiary Children's Hospital. Lungren MP1, Halula S2, Coyne S2, Sidell D3, Racadio JM4, Patel MN4. 2. Cranio Dec 29:1-8. [Epub ahead of print] Botulinum toxin for the treatment of bruxism. Tinastepe N1, Küçük BB, Oral K. Urology Nov 30. pii: S (15) doi: /j.urology [Epub ahead of print] Botulinum Toxin Type a Injections for the Treatment of Continent Catheterizable Ileal-Colic Urinary Diversion Muscularis Overactivity. Raup VT1, Eswara JR2, Marshall SD3, Brandes SB3. Joint Bone Spine Nov 29. pii: S X(15) doi: /j.jbspin [Epub ahead of print] 3. Usefulness of intra-articular botulinum toxin injections. A systematic review. Khenioui H1, Houvenagel E2, Catanzariti JF3, Guyot MA4, Agnani O4, Donze C4 4. Trials Dec 3;16(1):550. doi: /s z. Botulinum neurotoxin type A in the treatment of classical Trigeminal Neuralgia (BoTN): study protocol for a randomized controlled trial. Burmeister J1, Holle D2, Bock E3, Ose C4, Diener HC5, Obermann M6. 5. Can J Neurol Sci Nov 24:1-13. [Epub ahead of print] Adverse Clinical Effects of Botulinum Toxin Intramuscular Injections for Spasticity. Phadke CP1, Balasubramanian CK2, Holz A1, Davidson C1, Ismail F1, Boulias C1. 6. Highlights of Prescribing Information, BOTOX (onabotulinumtoxina) for injection, for intramuscular, intradetrusor, or intradermal use. Retrieved 5/16/2016; 7. Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry Aug;75(8): doi: /JCP.13m PubMed PMID: Page 5 of 6

6 8. Finzi E, Rosenthal NE. Treatment of depression with onabotulinumtoxina: a randomized, doubleblind, placebo controlled trial. J Psychiatr Res May;52:1-6. doi: /j.jpsychires Epub 2013 Dec 1. PubMed PMID: Page 6 of 6