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Asset Publisher
Ilaris® (canakinumab)
Policy Number: PH-0177
Subcutaneous
Last Review Date: 08/01/2024
Date of Origin: 11/07/2013
Dates Reviewed: 08/2014, 07/2015, 07/2016, 10/2016, 10/2017, 08/2018, 08/2019, 08/2020, 08/2021, 08/2022, 08/2023, 10/2023, 08/2024
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
Coverage will be provided for 12 months and may be renewed, unless otherwise specified.
- Gout Flare: Coverage will be provided for 1 dose (12 weeks). Additional doses for retreatment of a new flare will be covered, provided that the criteria for re-treatment is met. (Refer to Section III for specific re-treatment criteria)
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- Ilaris 150 mg single-dose vial: 2 vials every 28 days
B. Max Units (per dose and over time) [HCPCS Unit]:
Cryopyrin-Associated Periodic Syndromes:
- 150 billable units every 8 weeks (56 days)
Gout Flare:
- 150 billable units every 12 weeks (84 days)
All Other Indications:
- 300 billable units every 4 weeks (28 days)
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND
Universal Criteria 1
- Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment; AND
- Patient does not have an active infection, including clinically important localized infections; AND
- Will not be administered concurrently with live vaccines; AND
- Patient is not on concurrent therapy with other IL-1 blocking agents (e.g., anakinra, rilonacept, etc.): AND
- Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic immunomodulating agent (e.g., abrocitinib, apremilast, tofacitinib, baricitinib, upadacitinib, deucravacitinib, etc.); AND
Cryopyrin-Associated Periodic Syndromes (CAPS) † Ф 1,2,6,8,9
- Patient is at least 4 years of age; AND
- Used as a single agent; AND
- Patient has documented baseline serum levels of inflammatory proteins (C-Reactive Protein [CRP] and/or Serum Amyloid A [SAA]; AND
- Patient has documented laboratory evidence of a genetic mutation in the Cold-Induced Auto-inflammatory Syndrome 1 (CIAS1), also known as NLRP3; AND
- Diagnosis of Familial Cold Autoinflammatory Syndrome (FCAS); OR
- Diagnosis of Muckle-Wells Syndrome (MWS); AND
- Patient has two or more of any of the CAPS-typical symptoms:
- urticaria-like rash
- cold-triggered episodes
- sensorineural hearing loss
- musculoskeletal symptoms
- chronic aseptic meningitis
- skeletal abnormalities
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) † Ф 1,10
- Patient is at least 2 years of age; AND
- Used as a single agent; AND
- Patient has the presence of a pathogenic mutation in the tumor necrosis factor receptor-1 (TNFR1) gene (TNFRSF1A); AND
- Patient has chronic or recurrent disease (defined as > 6 flares per year); AND
- Patient has documented baseline serum levels of C-Reactive Protein (CRP)
Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) † Ф 1,10, 12
- Patient is at least 2 years of age; AND
- Used as a single agent; AND
- Patient has a confirmed diagnosis of HIDS/MKD by one of the following:
- Patient has a pathogenic mutation in the MVK gene; OR
- Patient has significantly elevated serum IgD levels; AND
- Patient has a documented history of at least three (3) febrile episodes within a 6 month period; AND
- Patient has documented baseline serum levels of C-Reactive Protein (CRP)
Familial Mediterranean Fever (FMF) † Ф 1,10
- Patient is at least 2 years of age; AND
- Used as a single agent; AND
- Patient has a confirmed diagnosis based on at least one known MEFV exon 10 mutation; AND
- Patient has failed on colchicine therapy or has a documented allergy or intolerance; AND
- Patient has active disease defined as at least one febrile episode per month; AND
- Patient has documented baseline serum levels of C-Reactive Protein (CRP)
Still’s Disease (Adult-Onset Still’s Disease [AOSD] and Systemic Juvenile Idiopathic Arthritis [SJIA]) † Ф 1,3,5,11
- Patient has active disease; AND
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR a systemic glucocorticoid (prednisone, methylprednisolone, etc.); AND
- Patient is at least 18 years of age and has active Adult-Onset Still’s Disease; OR
- Patient is at least 2 years of age and has active Systemic Juvenile Idiopathic Arthritis
Gout Flare † 1,13
- Patient is at least 18 years of age; AND
- Patient has NOT received previous treatment with canakinumab for gout flare(s); AND
- Patient has had ≥ 3 gout flares within the previous 12 months; AND
- Patient has failed on non-steroidal anti-inflammatory drugs (NSAIDs) therapy, unless contraindicated or intolerant; AND
- Patient has failed on colchicine therapy, unless contraindicated or intolerant; AND
- Patient is not a candidate for repeated courses of corticosteroids; OR
- Patient has received previous treatment with canakinumab for gout flare(s) resulting in a decrease or resolution of joint pain in the affected joints; AND
- Patient requires re-treatment for a new gout flare; AND
- Patient has not received treatment with canakinumab in the previous 12 weeks
- Patient has NOT received previous treatment with canakinumab for gout flare(s); AND
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1,3,8-11
Coverage can be renewed based upon the following criteria:
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in Section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, serious infections (including but not limited to tuberculosis), and macrophage activation syndrome (MAS); AND
Cryopyrin-Associated Periodic Syndromes
- Disease response as indicated by improvement in patient’s symptoms from baseline AND improvement in serum levels of inflammatory proteins (e.g. CRP and/or SAA, etc.) from baseline
Adult-Onset Still’s Disease/Systemic Juvenile Idiopathic Arthritis
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables]
Tumor Necrosis Factor Receptor Associated Periodic Syndrome; Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency; Familial Mediterranean Fever
- Disease response as indicated by improvement in patient’s symptoms from baseline AND improvement of serum levels of CRP
Gout Flare † 1,13
- Refer to Section III for re-treatment criteria
- Dosage/Administration 1
Indication |
Dose |
CAPS |
Weight: > 40 kg
Weight: 15 to 40 kg
|
AOSD and SJIA |
Weight: ≥ 7.5 kg
|
TRAPS, HIDS/MKD, and FMF |
Weight: > 40 kg
Weight: ≤ 40 kg
|
Gout Flare |
Administer 150 mg subcutaneously x 1 dose
|
Administration is by healthcare provider |
- Billing Code/Availability Information
HCPCS Code:
- J0638 – Injection, canakinumab, 1 mg: 1 billable unit = 1 mg
NDC:
- Ilaris 150 mg single-dose solution vial: 00078-0734-xx
- References
- Ilaris [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; August 2023. Accessed July 2024.
- Lachmann, HJ, Kone-Paut, I, Kuemmerle-Deschner, JB, et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med. 2009 Jun 4; 360(23):2416-25.
- Ruperto N, Brunner H, Quartier P, et al. Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis. N Engl J Med 2012; 367:2396-2406.
- Ringold, S., Weiss, P. F., Beukelman, T., DeWitt, E. M., Ilowite, N. T., Kimura, Y., Laxer, R. M., Lovell, D. J., Nigrovic, P. A., Robinson, A. B. and Vehe, R. K. (2013), 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Recommendations for the Medical Therapy of Children With Systemic Juvenile Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism, 65: 2499–2512. Doi: 10.1002/art.38092
- DeWitt EM, Kimura Y, Beukelman T, et al. Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2012 Jul;64(7):1001-10.
- Kuemmerle-Deschner JB, Ozen S, Tyrrell PN, et al. Diagnostic criteria for cryopyrin-associated periodic syndrome (CAPS). Ann Rheum Dis. 2017 Jun;76(6):942-947. Doi: 10.1136/annrheumdis-2016-209686.
- Terreri MT, Bernardo WM, Len CA, et al. Guidelines for the management and treatment of periodic fever syndromes: Cryopyrin-associated periodic syndromes (cryopyrinopathies – CAPS). Rev Bras Reumatol Engl Ed. 2016 Jan-Feb;56(1):44-51. Doi: 10.1016/j.rbre.2015.08.020.
- Koné-Paut I, Lachmann HJ, Kuemmerle-Deschner JB, et al. Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study. Arthritis Res Ther. 2011;13(6):R202. Doi:10.1186/ar3535.
- Kuemmerle-Deschner JB, Hachulla E, Cartwright R, et al. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011;70(12):2095-2102. Doi:10.1136/ard.2011.152728.
- De Benedetti F, Gattorno M, Anton J, et al. Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. N Engl J Med. 2018;378(20):1908-1919. Doi:10.1056/NEJMoa1706314.
- Nirmala N, Brachat A, Feist E, et al. Gene-expression analysis of adult-onset Still’s disease and systemic juvenile idiopathic arthritis is consistent with a continuum of a single disease entity. Pediatr Rheumatol Online J. 2015;13:50. Published 2015 Nov 20. Doi:10.1186/s12969-015-0047-3.
- Drenth JP, van der Meer JW. Hereditary periodic fever. N Engl J Med. 2001;345(24):1748.
- Schlesinger N, Alten RE, Bardin T, et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised, multicentre, active-controlled, double-blind trials and their initial extensions. Ann Rheum Dis. 2012 Nov;71(11):1839-48. doi: 10.1136/annrheumdis-2011-200908. Epub 2012 May 14.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
M04.1 |
Periodic fever syndromes |
M04.2 |
Cryopyrin-associated periodic syndromes |
M04.9 |
Autoinflammatory syndrome, unspecified |
M06.1 |
Adult-onset Still’s disease |
M08.0A |
Unspecified juvenile rheumatoid arthritis, other specified site |
M08.011 |
Unspecified juvenile rheumatoid arthritis, right shoulder |
M08.012 |
Unspecified juvenile rheumatoid arthritis, left shoulder |
M08.019 |
Unspecified juvenile rheumatoid arthritis, unspecified shoulder |
M08.021 |
Unspecified juvenile rheumatoid arthritis, right elbow |
M08.022 |
Unspecified juvenile rheumatoid arthritis, left elbow |
M08.029 |
Unspecified juvenile rheumatoid arthritis, unspecified elbow |
M08.031 |
Unspecified juvenile rheumatoid arthritis, right wrist |
M08.032 |
Unspecified juvenile rheumatoid arthritis, left wrist |
M08.039 |
Unspecified juvenile rheumatoid arthritis, unspecified wrist |
M08.041 |
Unspecified juvenile rheumatoid arthritis, right hand |
M08.042 |
Unspecified juvenile rheumatoid arthritis, left hand |
M08.049 |
Unspecified juvenile rheumatoid arthritis, unspecified hand |
M08.051 |
Unspecified juvenile rheumatoid arthritis, right hip |
M08.052 |
Unspecified juvenile rheumatoid arthritis, left hip |
M08.059 |
Unspecified juvenile rheumatoid arthritis, unspecified hip |
M08.061 |
Unspecified juvenile rheumatoid arthritis, right knee |
M08.062 |
Unspecified juvenile rheumatoid arthritis, left knee |
M08.069 |
Unspecified juvenile rheumatoid arthritis, unspecified knee |
M08.071 |
Unspecified juvenile rheumatoid arthritis, right ankle and foot |
M08.072 |
Unspecified juvenile rheumatoid arthritis, left ankle and foot |
M08.079 |
Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot |
M08.08 |
Unspecified juvenile rheumatoid arthritis, vertebrae |
M08.09 |
Unspecified juvenile rheumatoid arthritis, multiple sites |
M08.2A |
Juvenile rheumatoid arthritis with systemic onset, other specified site |
M08.211 |
Juvenile rheumatoid arthritis with systemic onset, right shoulder |
M08.212 |
Juvenile rheumatoid arthritis with systemic onset, left shoulder |
M08.219 |
Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder |
M08.221 |
Juvenile rheumatoid arthritis with systemic onset, right elbow |
M08.222 |
Juvenile rheumatoid arthritis with systemic onset, left elbow |
M08.229 |
Juvenile rheumatoid arthritis with systemic onset, unspecified elbow |
M08.231 |
Juvenile rheumatoid arthritis with systemic onset, right wrist |
M08.232 |
Juvenile rheumatoid arthritis with systemic onset, left wrist |
M08.239 |
Juvenile rheumatoid arthritis with systemic onset, unspecified wrist |
M08.241 |
Juvenile rheumatoid arthritis with systemic onset, right hand |
M08.242 |
Juvenile rheumatoid arthritis with systemic onset, left hand |
M08.249 |
Juvenile rheumatoid arthritis with systemic onset, unspecified hand |
M08.251 |
Juvenile rheumatoid arthritis with systemic onset, right hip |
M08.252 |
Juvenile rheumatoid arthritis with systemic onset, left hip |
M08.259 |
Juvenile rheumatoid arthritis with systemic onset, unspecified hip |
M08.261 |
Juvenile rheumatoid arthritis with systemic onset, right knee |
M08.262 |
Juvenile rheumatoid arthritis with systemic onset, left knee |
M08.269 |
Juvenile rheumatoid arthritis with systemic onset, unspecified knee |
M08.271 |
Juvenile rheumatoid arthritis with systemic onset, right ankle and foot |
M08.272 |
Juvenile rheumatoid arthritis with systemic onset, left ankle and foot |
M08.279 |
Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot |
M08.28 |
Juvenile rheumatoid arthritis with systemic onset, vertebrae |
M08.29 |
Juvenile rheumatoid arthritis with systemic onset, multiple sites |
M08.3 |
Juvenile rheumatoid polyarthritis (seronegative) |
M08.4A |
Pauciarticular juvenile rheumatoid arthritis, other specified site |
M08.411 |
Pauciarticular juvenile rheumatoid arthritis, right shoulder |
M08.412 |
Pauciarticular juvenile rheumatoid arthritis, left shoulder |
M08.419 |
Pauciarticular juvenile rheumatoid arthritis, unspecified shoulder |
M08.421 |
Pauciarticular juvenile rheumatoid arthritis, right elbow |
M08.422 |
Pauciarticular juvenile rheumatoid arthritis, left elbow |
M08.429 |
Pauciarticular juvenile rheumatoid arthritis, unspecified elbow |
M08.431 |
Pauciarticular juvenile rheumatoid arthritis, right wrist |
M08.432 |
Pauciarticular juvenile rheumatoid arthritis, left wrist |
M08.439 |
Pauciarticular juvenile rheumatoid arthritis, unspecified wrist |
M08.441 |
Pauciarticular juvenile rheumatoid arthritis, right hand |
M08.442 |
Pauciarticular juvenile rheumatoid arthritis, left hand |
M08.449 |
Pauciarticular juvenile rheumatoid arthritis, unspecified hand |
M08.451 |
Pauciarticular juvenile rheumatoid arthritis, right hip |
M08.452 |
Pauciarticular juvenile rheumatoid arthritis, left hip |
M08.459 |
Pauciarticular juvenile rheumatoid arthritis, unspecified hip |
M08.461 |
Pauciarticular juvenile rheumatoid arthritis, right knee |
M08.462 |
Pauciarticular juvenile rheumatoid arthritis, left knee |
M08.469 |
Pauciarticular juvenile rheumatoid arthritis, unspecified knee |
M08.471 |
Pauciarticular juvenile rheumatoid arthritis, right ankle and foot |
M08.472 |
Pauciarticular juvenile rheumatoid arthritis, left ankle and foot |
M08.479 |
Pauciarticular juvenile rheumatoid arthritis, unspecified ankle and foot |
M08.48 |
Pauciarticular juvenile rheumatoid arthritis, vertebrae |
M08.80 |
Other juvenile arthritis, unspecified site |
M08.811 |
Other juvenile arthritis, right shoulder |
M08.812 |
Other juvenile arthritis, left shoulder |
M08.819 |
Other juvenile arthritis, unspecified shoulder |
M08.821 |
Other juvenile arthritis, right elbow |
M08.822 |
Other juvenile arthritis, left elbow |
M08.829 |
Other juvenile arthritis, unspecified elbow |
M08.831 |
Other juvenile arthritis, right wrist |
M08.832 |
Other juvenile arthritis, left wrist |
M08.839 |
Other juvenile arthritis, unspecified wrist |
M08.841 |
Other juvenile arthritis, right hand |
M08.842 |
Other juvenile arthritis, left hand |
M08.849 |
Other juvenile arthritis, unspecified hand |
M08.851 |
Other juvenile arthritis, right hip |
M08.852 |
Other juvenile arthritis, left hip |
M08.859 |
Other juvenile arthritis, unspecified hip |
M08.861 |
Other juvenile arthritis, right knee |
M08.862 |
Other juvenile arthritis, left knee |
M08.869 |
Other juvenile arthritis, unspecified knee |
M08.871 |
Other juvenile arthritis, right ankle and foot |
M08.872 |
Other juvenile arthritis, left ankle and foot |
M08.879 |
Other juvenile arthritis, unspecified ankle and foot |
M08.88 |
Other juvenile arthritis, other specified site |
M08.89 |
Other juvenile arthritis, multiple sites |
M08.9A |
Juvenile arthritis, unspecified, other specified site |
M08.911 |
Juvenile arthritis, unspecified, right shoulder |
M08.912 |
Juvenile arthritis, unspecified, left shoulder |
M08.919 |
Juvenile arthritis, unspecified, unspecified shoulder |
M08.921 |
Juvenile arthritis, unspecified, right elbow |
M08.922 |
Juvenile arthritis, unspecified, left elbow |
M08.929 |
Juvenile arthritis, unspecified, unspecified elbow |
M08.931 |
Juvenile arthritis, unspecified, right wrist |
M08.932 |
Juvenile arthritis, unspecified, left wrist |
M08.939 |
Juvenile arthritis, unspecified, unspecified wrist |
M08.941 |
Juvenile arthritis, unspecified, right hand |
M08.942 |
Juvenile arthritis, unspecified, left hand |
M08.949 |
Juvenile arthritis, unspecified, unspecified hand |
M08.951 |
Juvenile arthritis, unspecified, right hip |
M08.952 |
Juvenile arthritis, unspecified, left hip |
M08.959 |
Juvenile arthritis, unspecified, unspecified hip |
M08.961 |
Juvenile arthritis, unspecified, right knee |
M08.962 |
Juvenile arthritis, unspecified, left knee |
M08.969 |
Juvenile arthritis, unspecified, unspecified knee |
M08.971 |
Juvenile arthritis, unspecified, right ankle and foot |
M08.972 |
Juvenile arthritis, unspecified, left ankle and foot |
M08.979 |
Juvenile arthritis, unspecified, unspecified ankle and foot |
M08.98 |
Juvenile arthritis, unspecified, vertebrae |
M08.99 |
Juvenile arthritis, unspecified, multiple sites |
M10.00 |
Idiopathic gout, unspecified site |
M10.011 |
Idiopathic gout, right shoulder |
M10.012 |
Idiopathic gout, left shoulder |
M10.019 |
Idiopathic gout, unspecified shoulder |
M10.021 |
Idiopathic gout, right elbow |
M10.022 |
Idiopathic gout, left elbow |
M10.029 |
Idiopathic gout, unspecified elbow |
M10.031 |
Idiopathic gout, right wrist |
M10.032 |
Idiopathic gout, left wrist |
M10.039 |
Idiopathic gout, unspecified wrist |
M10.041 |
Idiopathic gout, right hand |
M10.042 |
Idiopathic gout, left hand |
M10.049 |
Idiopathic gout, unspecified hand |
M10.051 |
Idiopathic gout, right hip |
M10.052 |
Idiopathic gout, left hip |
M10.059 |
Idiopathic gout, unspecified hip |
M10.061 |
Idiopathic gout, right knee |
M10.062 |
Idiopathic gout, left knee |
M10.069 |
Idiopathic gout, unspecified knee |
M10.071 |
Idiopathic gout, right ankle and foot |
M10.072 |
Idiopathic gout, left ankle and foot |
M10.079 |
Idiopathic gout, unspecified ankle and foot |
M10.08 |
Idiopathic gout, vertebrae |
M10.09 |
Idiopathic gout, multiple sites |
M10.311 |
Gout due to renal impairment, right shoulder |
M10.312 |
Gout due to renal impairment, left shoulder |
M10.319 |
Gout due to renal impairment, unspecified shoulder |
M10.321 |
Gout due to renal impairment, right elbow |
M10.322 |
Gout due to renal impairment, left elbow |
M10.329 |
Gout due to renal impairment, unspecified elbow |
M10.331 |
Gout due to renal impairment, right wrist |
M10.332 |
Gout due to renal impairment, left wrist |
M10.339 |
Gout due to renal impairment, unspecified wrist |
M10.341 |
Gout due to renal impairment, right hand |
M10.342 |
Gout due to renal impairment, left hand |
M10.349 |
Gout due to renal impairment, unspecified hand |
M10.351 |
Gout due to renal impairment, right hip |
M10.352 |
Gout due to renal impairment, left hip |
M10.359 |
Gout due to renal impairment, unspecified hip |
M10.361 |
Gout due to renal impairment, right knee |
M10.362 |
Gout due to renal impairment, left knee |
M10.369 |
Gout due to renal impairment, unspecified knee |
M10.371 |
Gout due to renal impairment, right ankle and foot |
M10.372 |
Gout due to renal impairment, left ankle and foot |
M10.379 |
Gout due to renal impairment, unspecified ankle and foot |
M10.38 |
Gout due to renal impairment, vertebrae |
M10.39 |
Gout due to renal impairment, multiple sites |
M10.40 |
Other secondary gout, unspecified site |
M10.411 |
Other secondary gout, right shoulder |
M10.412 |
Other secondary gout, left shoulder |
M10.419 |
Other secondary gout, unspecified shoulder |
M10.421 |
Other secondary gout, right elbow |
M10.422 |
Other secondary gout, left elbow |
M10.429 |
Other secondary gout, unspecified elbow |
M10.431 |
Other secondary gout, right wrist |
M10.432 |
Other secondary gout, left wrist |
M10.439 |
Other secondary gout, unspecified wrist |
M10.441 |
Other secondary gout, right hand |
M10.442 |
Other secondary gout, left hand |
M10.449 |
Other secondary gout, unspecified hand |
M10.451 |
Other secondary gout, right hip |
M10.452 |
Other secondary gout, left hip |
M10.459 |
Other secondary gout, unspecified hip |
M10.461 |
Other secondary gout, right knee |
M10.462 |
Other secondary gout, left knee |
M10.469 |
Other secondary gout, unspecified knee |
M10.471 |
Other secondary gout, right ankle and foot |
M10.472 |
Other secondary gout, left ankle and foot |
M10.479 |
Other secondary gout, unspecified ankle and foot |
M10.48 |
Other secondary gout, vertebrae |
M10.49 |
Other secondary gout, multiple sites |
M10.9 |
Gout, unspecified |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
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 |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
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 |