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Asset Publisher
Xeomin® (incobotulinumtoxinA)
Policy Number: PH-0241
Intramuscular/Intradetrusor/Intradermal
Last Review Date: 05/04/2023
Date of Origin: 06/21/2011
Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 02/2013, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 08/2018, 10/2018, 04/2019, 09/2019, 01/2020, 05/2020, 09/2020, 01/2021, 05/2021, 05/2022, 05/2023
Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy. |
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization 20
- Coverage will be provided for 6 months and may be renewed.
- Preoperative use in Ventral Hernia may NOT be renewed.
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- Xeomin 50 unit single-dose vial for injection: 1 vial per 84 day supply
- Xeomin 100 unit single-dose vial for injection: 1 vial per 84 day supply (per 112 days for severe primary axillary hyperhidrosis)
- Xeomin 100 unit single-dose vial for injection: 5 vials once (for Ventral Hernia only)
- Xeomin 200 unit single-dose vial injection: 2 vials per 84 day supply
B. Max Units (per dose and over time) [HCPCS Unit]:
Indication |
Billable Units |
Per # days |
Cervical Dystonia |
200 |
84 |
Blepharospasms |
100 |
84 |
Upper Limb Spasticity |
400 |
84 |
Prophylaxis for Chronic Migraines |
200 |
84 |
Incontinence due to Neurogenic Detrusor Overactivity |
200 |
84 |
Overactive Bladder (OAB) |
100 |
84 |
Severe Primary Axillary Hyperhidrosis |
100 |
112 |
Sialorrhea |
100 |
112 |
Ventral Hernia |
500 |
N/A |
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age (unless otherwise specified); AND
Universal Criteria 1
- Patient evaluated for any disorders which may contribute to respiratory or swallowing difficulty; AND
- Patient does not have a hypersensitivity to any botulinum toxin product; AND
- Patient does not have an active infection at the proposed injection site; AND
- Patient is not on concurrent treatment with another botulinum toxin (i.e., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB, etc.); AND
Cervical Dystonia † 1,2
- Patient has a history of recurrent involuntary contraction of one or more muscles in the neck and upper shoulders; AND
- Patient has sustained head tilt; OR
- Patient has abnormal posturing with limited range of motion in the neck
Blepharospasms † 1
Spastic Conditions 1
- Patient has one of the following:
- Upper Limb spasticity in adults (i.e., used post-stroke for spasms) †
- Pediatric upper limb spasticity in patients aged 2 years to 17 years of age, excluding spasticity caused by cerebral palsy †
Prophylaxis for Chronic Migraines ‡ 3,8,10,23-25
- Patient is utilizing prophylactic intervention modalities (i.e., avoiding migraine triggers, pharmacotherapy, behavioral therapy, physical therapy, etc.); AND
- Patient has a diagnosis of chronic migraines defined as 15 or more headache (tension-type-like and/or migraine-like) days per month for > 3 months; AND
- Patient has had at least five attacks with features consistent with migraine (with and/or without aura)§; AND
- On at least 8 days per month for > 3 months:
- Headaches have characteristics and symptoms consistent with migraine§; OR
- Patient suspected migraines are relieved by a triptan or ergot derivative medication; AND
- Patient has failed at least an 8-week trial of any two oral medications for the prevention of migraines (see list of migraine-prophylactic medications below for examples ±) prior to initiation of incobotulinumtoxinA
Incontinence due to Neurogenic Detrusor Overactivity ‡ 7,9,19
- Patient has detrusor overactivity associated with a neurologic condition (i.e., spinal cord injury, multiple sclerosis, etc.) that is confirmed by urodynamic testing; AND
- Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (i.e., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium) or beta-adrenergic (i.e., mirabegron) classes
Overactive Bladder (OAB) ‡ 7,9,19
- Patient has symptoms of urge urinary incontinence, urgency, and frequency; AND
- Patient has failed a 1 month or longer trial of two medications from either the antimuscarinic (e.g., darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine or trospium, etc.) or beta-adrenergic (e.g., mirabegron, vibegron, etc.) classes
Severe Primary Axillary Hyperhidrosis ‡ 4-6,26
- Patient has tried and failed ≥ 1 month trial of a topical agent (e.g., 20% aluminum chloride, glycopyrronium, aluminum zirconium trichlorohydrate, etc.); AND
- Patient has a history of medical complications such as skin infections or significant functional impairments; OR
- Patient has had a significant burden of disease or impact to activities of daily living due to condition (e.g., impairment in work performance/productivity, frequent change of clothing, difficulty in relationships and/or social gatherings, etc.)
Chronic Sialorrhea † 1,13,22
- Patient has a history of troublesome sialorrhea for at least a 3 month period; AND
- Patient has Parkinson’s disease, atypical Parkinsonism, stroke, or traumatic brain injury †; OR
- Patient has a severe developmental delay ‡; OR
- Patient has cerebral palsy, other genetic or congenital disorders, or traumatic brain injury †; AND
- Patient is at least 2 years of age
Ventral Hernia ‡ 20,21
- Patient has a large ventral hernia with loss of domain or contaminated ventral hernia; AND
- Used preoperatively in patients scheduled to receive abdominal wall reconstruction (AWR)
† FDA Approved Indication(s); ‡ Literature Supported Indication; Ф Orphan Drug
± Migraine-Prophylaxis Oral Medications (list not all-inclusive) 11,12,16 |
|
§ Migraine Features § 16,23,24 |
Migraine without aura
|
Migraine with aura
|
- Renewal Criteria 1
Coverage can be renewed based upon the following criteria:
- Patient continues to meet universal and indication-specific criteria as identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: symptoms of a toxin spread effect (e.g., asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties, etc.), serious hypersensitivity reactions (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea, etc.), corneal exposure/ulceration, ectropion in patients treated for blepharospasm, etc.; AND
- Disease response as evidenced by the following:
Blepharospasms 1
- Improvement of severity and/or frequency of eyelid spasms
Cervical Dystonia 1
- Improvement in the severity and frequency of pain; AND
- Improvement of abnormal head positioning
Upper Limb Spasticity 1
- Decrease in tone and/or resistance, of affected areas, based on a validated measuring tool (e.g., Ashworth Scale, Physician Global Assessment, Clinical Global Impression (CGI), etc.)
Severe Primary Axillary Hyperhidrosis 4-6
- Significant reduction in spontaneous axillary sweat production; AND
- Patient has a significant improvement in activities of daily living
Prophylaxis for Chronic Migraines 10,16,23
- Significant decrease in the number, frequency, and/or intensity of headaches; AND
- Improvement in function; AND
- Patient continues to utilize prophylactic intervention modalities (i.e., pharmacotherapy, behavioral therapy, physical therapy, etc.)
Incontinence due to Detrusor Overactivity 9
- Significant improvements in weekly frequency of incontinence episodes; AND
- Patient’s post-void residual (PVR) periodically assessed as medically appropriate
Overactive Bladder (OAB) 9
- Significant improvement in daily frequency of urinary incontinence or micturition episodes and/or volume voided per micturition; AND
- Patient’s post-void residual (PVR) periodically assessed as medically appropriate
Chronic Sialorrhea 1,13,22
- Significant decrease in saliva production
Ventral Hernias 20,21
- May not be renewed.
- Dosage/Administration 1-23
Indication |
Dose |
Cervical Dystonia
|
The recommended initial total dose for cervical dystonia is 120 units. Initial dose is divided among the affected muscles every 12 weeks or longer, as necessary. |
Blepharospasm |
The recommended initial dose for treatment naïve patients is 50 units (25 units per eye). Subsequent doses in patients previously treated with Xeomin should not exceed the maximum dose of 100 units per treatment session (50 units per eye), every 12 weeks or longer, as necessary. |
Upper Limb Spasticity |
The dosage, frequency, and number of injection sites should be tailored to the individual patient based on the size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness, patient’s response to previous treatment, and adverse event history with Xeomin. Localization of the involved muscles with electromyographic guidance, nerve stimulation, or ultrasound techniques is recommended. Adults Up to 400 units total, repeated no sooner than every 12 weeks Pediatrics 8 units/kg, divided among affected muscles, up to a maximum dose of 200 units per single upper limb. If both upper limbs are treated, total Xeomin dosage should not exceed 16 Units/kg, up to a maximum of 400 units, repeated no sooner than every 12 weeks |
Chronic Migraine |
Up to 200 units divided among the affected muscles every 12 weeks |
Severe Primary Axillary Hyperhidrosis |
50 units intradermally per axilla every 16 weeks |
Neurogenic Bladder/ Detrusor Overactivity |
Up to 200 units per treatment divided among the affected muscles every 12 weeks. |
Overactive Bladder (OAB) |
Up to 100 units per treatment divided among the affected muscles every 12 weeks |
Sialorrhea |
Adults: 30 units per parotid gland and 20 units per submandibular gland (50 units per each side of the face for a total recommended dose of 100 units per treatment session), repeated no sooner than every 16 weeks Pediatrics: Dosing is based on body weight as noted below and is repeated no sooner than every 16 weeks
|
Ventral Hernia |
500 units divided among abdominal muscles, injected 2-4 weeks prior to AWR surgery. May not be renewed. |
Note: - The recommended maximum cumulative dose for any indication should not exceed 400 Units in a treatment session (unless used for Ventral Hernia). - Units of Xeomin are specific to the preparation and assay method utilized and are not interchangeable with other preparations of botulinum toxin products and cannot be compared to or converted into units of any other botulinum toxin products |
- Billing Code/Availability Information
HCPCS Code:
- J0588 – Injection, incobotulinumtoxinA, 1 unit; 1 billable unit = 1 unit
NDC(s):
- Xeomin 50 unit powder for injection; single-dose vial: 00259-1605-xx
- Xeomin 100 unit powder for injection; single-dose vial: 00259-1610-xx
- Xeomin 200 unit powder for injection; single-dose vial :00259-1620-xx
- References
- Xeomin [package insert]. Dessau-Rosslau, Germany; Merz Group Services GmbH; August 2021. Accessed April 2023.
- Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016: 86:1-9
- Grogan P, Robinson A, Chao W, Ford A. Incobotulinumtoxin A for the Preventive Treatment of Chronic Migraine Headaches. Neurology April 8, 2014 vol. 82 no. 10 Supplement P7.188
- Lakraj AA1, Moghimi N, Jabbari B. Hyperhidrosis: anatomy, pathophysiology and treatment with emphasis on the role of botulinum toxins. Toxins (Basel). 2013 Apr 23; 5(4):821-40. doi: 10.3390/toxins5040821.
- Pastorelli F, Michelucci R, Plasmati R. A Randomized Controlled Trial Comparing Botulinum Toxin Type A Xeomin ® and Dysport ® for Treatment Of Primary Axillary Hyperhidrosis (P3.021). Neurology April 8, 2014 vol. 82 no. 10 Supplement P3.021
- Dressler D. Routine use of Xeomin in patients previously treated with Botox: long term results. Eur J Neurol. 2009 Dec; 16 Suppl 2:2-5. doi: 10.1111/j.1468-1331.2009.02877.x.
- Hampel C, D’Andrea D, Gillitzer R, et al. Comparison of two different Botulinumtoxin A products (Xeomin, Botox) used for detrusor injection in patients with bladder overactivity (BO) – a prospective randomized double-blind study. Paper presented at: the 27th Annual European Association of Urology (EAU) Congress - February 24 - 28, 2012 - Le Palais des Congrès de Paris, Paris, France
- The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2013 Jul;33(9):629-808.
- Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309.
- Schwedt TJ. Chronic Migraine. BMJ. 2014;348:g1416.
- Modi S, Lowder DM. Medications for migraine prophylaxis. Am Fam Physician. 2006 Jan 1; 73(1):72-8.
- Pringheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can Jneurol Sci. 2012 Mar; 39(2 Suppl 2):S1-S9.
- Blitzer A, Friedman A, Michel O, et al. SIAXI: IncobotulinumtoxinA for Sialorrhea in Parkinson’s Disease, Stroke, and Other Etiologies-Phase III results. Archives of Physical Medicine and Rehabilitation, 2017 Dec. Volume 98, Issue 12, e161.
- Jost W, Friedman A, Michel O, et al. SIAXI: Efficacy and safety of Xeomin (incobotulinumtoxinA) for the treatment of sialorrhea in Parkinson’s disease (PD) and other neurological conditions: Results of a Phase III, placebo-controlled, randomized, double-blind study (S2.007). Neurology Apr 2018, 90 (15 Supplement) S2.007;
- Glaser DA, Hebert AA, Nast A, et al. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2019;80(1):128. Epub 2018 Jul 10
- American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019 Jan;59(1):1-18. doi: 10.1111/head.13456. Epub 2018 Dec 10.
- Haider A, Solish N. Focal hyperhidrosis: diagnosis and management. CMAJ. 2005;172(1):69-75.
- Nawrocki S, Cha J. The Etiology, Diagnosis and Management of Hyperhidrosis: A Comprehensive Review. Part II. Therapeutic Options. J Am Acad Dermatol. 2019 Jan 30. pii: S0190-9622(19)30167-7.
- Kuo HC, Chen SL, Chou CL, et al. Taiwanese Continence Society clinical guidelines for diagnosis and management of neurogenic lower urinary tract dysfunction. Urological Science, Volume 25, Issue 2, 2014, pp. 35-41
- Motz BM, Schlosser KA, Heniford BT. Chemical Components Separation: Concepts, Evidence, and Outcomes. Plast Reconstr Surg. 2018 Sep;142(3 Suppl):58S-63S. doi: 10.1097/PRS.0000000000004856.
- Elstner KE, Read JW, Saunders J, et al. Selective muscle botulinum toxin A component paralysis in complex ventral hernia repair. Hernia. 2019 Apr 4. doi: 10.1007/s10029-019-01939-3.
- Merz Pharmaceuticals. Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability (SIPEXI). Available from: https://clinicaltrials.gov/ct2/show/NCT02270736?cond=incobotulinumtoxinA+for+sialorrhea&draw=2&rank=3. NLM identifier: NCT02270736. Accessed December 22, 2020
- The International Classification of Headache Disorders, 3rd edition (beta version).Headache Classification Committee of the International Headache Society (IHS) Cephalalgia. 2018 Jan;38(1):1-211.
- Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153.
- Garza I, Schwedt TJ. (2022) Chronic Migraine. In Swanson JW (Ed). UpToDate. Accessed on April 11, 2022). Available from https://www.uptodate.com/contents/chronic-migraine?search=chronic%20migraine&source=search_result&selectedTitle=1~68&usage_type=default&display_rank=1.
- Mcconaghy J, Fosselma D. Hyperhidrosis: Management Options. Am Fam Physician. 2018;97(11):729-734. https://www.aafp.org/pubs/afp/issues/2018/0601/p729.html#afp20180601p729-b4
- National Government Services, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A52848). Centers for Medicare & Medicaid Services, Inc. Updated on 12/29/2022 with effective date 01/05/2023. Accessed April 2023.
- Noridian Administrative Services, LLC Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B (A57186). Centers for Medicare & Medicaid Services, Inc. Updated on 01/16/2023 with effective date 01/01/2023. Accessed April 2023.
- Wisconsin Physicians Service Insurance Corporation. Local Coverage Article: Billing and Coding: Botulinum Toxin Type A & Type B (A57474). Centers for Medicare & Medicaid Services, Inc. Updated on 10/18/2022with effective date 10/27/2022. Accessed April 2023.
- CGS, Administrators, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxins (A56472). Centers for Medicare & Medicaid Services, Inc. Updated on 12/29/2022 with effective date 12/29/2022. Accessed April 2023.
- Noridian Healthcare Solutions, LLC. Local Coverage Article: Billing and Coding: Botulinum Toxin Types A and B Policy (A57185). Centers for Medicare & Medicaid Services, Inc. Updated on 01/16/2023 with effective date 01/01/2023. Accessed April 2023.
- Palmetto GBA. Local Coverage Article: Billing and Coding: Chemodenervation (A56646). Centers for Medicare & Medicaid Services, Inc. Updated on 01/17/2023 with effective date 01/01/2023. Accessed April 2023.
- First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A57715). Centers for Medicare & Medicaid Services, Inc. Updated on 02/04/2022 with effective date 02/10/2022. Accessed April 2023.
- Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Botulinum Toxins (A58423). Centers for Medicare & Medicaid Services, Inc. Updated on 02/04/2022 with effective date 02/10/2022. Accessed April 2023.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
||
G24.3 |
Spasmodic torticollis |
||
G24.5 |
Blepharospasm |
||
G25.89 |
Other specified extrapyramidal and movement disorders |
||
G35 |
Multiple sclerosis |
||
G37.0 |
Diffuse sclerosis of central nervous system |
||
G43.709 |
Chronic migraine without aura, not intractable, without status migrainosus |
||
G43.719 |
Chronic migraine without aura, intractable, without status migrainosus |
||
G43.701 |
Chronic migraine without aura, not intractable, with status migrainosus |
||
G43.711 |
Chronic migraine without aura, intractable, with status migrainosus |
||
G80.0 |
Spastic quadriplegic cerebral palsy |
||
G80.1 |
Spastic diplegic cerebral palsy |
||
G80.2 |
Spastic hemiplegic cerebral palsy |
||
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 |
||
G82.53 |
Quadriplegia, C5-C7, complete |
||
G82.54 |
Quadriplegia, C5-C7, incomplete |
||
G83.0 |
Diplegia of upper limbs, Diplegia (Upper), Paralysis of both upper limbs |
||
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 |
||
|
|
||
I69.032 |
|
||
I69.033 |
|
||
I69.034 |
|
||
|
|
||
I69.051 |
Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right dominant side |
||
I69.052 |
|
||
I69.053 |
Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting right non-dominant side |
||
I69.054 |
Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting left non-dominant side |
||
I69.059 |
Hemiplegia and hemiparesis following nontraumatic subarachnoid hemorrhage affecting unspecified side |
||
I69.131 |
|
||
I69.132 |
|
||
I69.133 |
|
||
I69.134 |
|
||
I69.139 |
|
||
I69.151 |
|
||
I69.152 |
|
||
I69.153 |
|
||
I69.154 |
|
||
I69.159 |
Hemiplegia and hemiparesis following nontraumatic intracerebral hemorrhage affecting unspecified side |
||
I69.231 |
|
||
I69.232 |
|
||
I69.233 |
|
||
I69.234 |
|
||
I69.239 |
|
||
I69.251 |
|
||
I69.252 |
|
||
I69.253 |
|
||
I69.254 |
|
||
I69.259 |
|
||
I69.331 |
|
||
I69.332 |
|
||
I69.333 |
|
||
I69.334 |
|
||
I69.339 |
|
||
I69.351 |
|
||
I69.352 |
|
||
I69.353 |
|
||
I69.354 |
|
||
I69.359 |
|
||
I69.831 |
|
||
I69.832 |
|
||
I69.833 |
|
||
I69.834 |
|
||
I69.839 |
|
||
I69.851 |
|
||
I69.852 |
|
||
I69.853 |
|
||
I69.854 |
|
||
I69.859 |
|
||
I69.931 |
Monoplegia of upper limb following unspecified cerebrovascular disease affecting right dominant side |
||
I69.932 |
Monoplegia of upper limb following unspecified cerebrovascular disease affecting left dominant side |
||
I69.933 |
Monoplegia of upper limb following unspecified cerebrovascular disease affecting right non-dominant side |
||
I69.934 |
Monoplegia of upper limb following unspecified cerebrovascular disease affecting left non-dominant side |
||
I69.939 |
Monoplegia of upper limb following unspecified cerebrovascular disease affecting unspecified side |
||
I69.951 |
Hemiplegia and hemiparesis following unspecified cerebrovascular disease affecting right dominant side |
||
I69.952 |
|
||
I69.953 |
|
||
I69.954 |
|
||
I69.959 |
|
||
K11.7 |
Disturbances of salivary secretion |
||
K43.6 |
Other and unspecified ventral hernia with obstruction, without gangrene |
||
K43.7 |
Other and unspecified ventral hernia with gangrene |
||
K43.9 |
Ventral hernia without obstruction or gangrene |
||
M43.6 |
Torticollis |
||
N31.0 |
Uninhibited neuropathic bladder, not elsewhere classified |
||
N31.1 |
Reflex neuropathic bladder, not elsewhere classified |
||
N31.8 |
Other neuromuscular dysfunction of bladder |
||
N31.9 |
Neuromuscular dysfunction of bladder, unspecified |
||
N32.81 |
Overactive bladder |
||
L74.510 |
Primary focal hyperhidrosis, axilla |
Dual coding requirements:
- Primary G and M codes require a secondary G or I code in order to be payable
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):
Jurisdiction(s): J & M |
NCD/LCD/LCA Document (s): A56646 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56646&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): 5 & 8 |
NCD/LCD/LCA Document (s): A57474 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57474&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): 6& K |
NCD/LCD/LCA Document (s): A52848 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52848&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): 15 |
NCD/LCD/LCA Document (s): A56472 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56472&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): F |
NCD/LCD/LCA Document (s): A57186 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57186&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): E |
NCD/LCD/LCA Document (s): A57185 |
https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57185&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP |
Jurisdiction(s): N |
NCD/LCD/LCA Document (s): A57715 |
Jurisdiction(s): H & L |
NCD/LCD/LCA Document (s): A58423 |
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
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Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |
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XEOMIN® (incobotulinumtoxinA) Prior Auth Criteria |
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