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Asset Publisher
Infliximab: Remicade®; Inflectra™; Renflexis™; Avsola™; Infliximab*
Policy Number: PH-0104
Intravenous
Last Review Date: 10/03/2023
Date of Origin: 07/20/2010
Dates Reviewed: 09/2010, 12/2012, 2/2011, 03/2011, 06/2011, 09/2011, 10/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 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, 10/2018, 04/2019, 07/2019, 07/2020, 08/2021, 02/2022, 10/2022, 10/2023
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.
- Therapy for the Management of Immune-Checkpoint Inhibitor Related Toxicity and GVHD may not be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
Loading Dose:
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Maintenance Dose:
|
- Max Units (per dose and over time) [HCPCS Unit]:
- Rheumatoid Arthritis: 40 billing units at weeks 0, 2, 6, then 120 billing units every 28 days
- Ankylosing Spondylitis: 60 billing units at weeks 0, 2, 6, then 60 billing units every 42 days
- Crohn’s Disease & Ulcerative Colitis: 60 billing units at weeks 0, 2, 6 then 120 billing units every 56 days
- Psoriatic Arthritis, Plaque Psoriasis, Behcet’s Uveitis: 60 billing units at weeks 0, 2, 6 then 60 billing units every 56 days
- Management of Immune Checkpoint Inhibitor Related Toxicity: 60 billing units at weeks 0 & 2; no maintenance dosing
- Acute GVHD: 120 billing units at weeks 0, 1, 2, 3; no maintenance dosing
- Initial Approval Criteria 1-4
Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information. |
Coverage is provided in the following conditions:
For PEEHIP Members Only |
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For Commercial Members Only |
|
*unbranded biologic |
- Patient has been evaluated and screened for the presence of hepatitis B (HBV) infection (i.e., HBsAg and anti-HBc) prior to initiating treatment; AND
- Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND
- Patient is at least 18 years of age (unless otherwise specified); AND
Universal Criteria 1-4
- Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
- Patient does not have an active infection, including clinically important localized infections; AND
- Must not be administered concurrently with live vaccines or therapeutic infectious agents (i.e., BCG bladder instillation for bladder cancer, etc.); AND
- Patient is not on concurrent treatment with another TNF-inhibitor, IL-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitnib, etc.); AND
- Will not be used in patients with moderate or severe heart failure (i.e., New York Heart Association [NYHA] Functional Class III/IV) [Note: Only applies when doses >5mg/kg are used]; AND
Crohn’s Disease † Ф 1-4,11,13,23,38,75-78
Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:
|
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented moderate to severe disease; AND
- Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)
Pediatric Crohn’s Disease † Ф 1-4,80
Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:
|
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient is at least 6 years of age; AND
- Documented moderate to severe active disease; AND
- Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, etc.)
Ulcerative Colitis † 1-4,20,81-83, 91,93
Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:
|
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented moderate to severe active disease; AND
- Documented failure or ineffective response to a minimum (3) month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)] at maximum tolerated doses, unless there is a contraindication or intolerance to use
Pediatric Ulcerative Colitis † Ф 1-4,84
Requirement for a 3 month trial of traditional therapies is waived if ONE of the following applies:
|
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient is at least 6 years of age; AND
- Documented moderate to severe active disease; AND
- Documented failure or ineffective response to a minimum (3) month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)] at maximum tolerated doses, unless there is a contraindication or intolerance to use
Fistulizing Crohn’s Disease † 38,76
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient has at least one draining fistula (i.e., enterovesical, enterocutaneous, enteroenteric, or enterovaginal fistulas) for at least 3 months
Rheumatoid Arthritis (RA) † 1-4,74,85, 91
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented moderate to severe active disease; AND
- Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; AND
- Used in combination with methotrexate (MTX) unless contraindicated
Psoriatic Arthritis (PsA) † 1-4,39,41,71
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented moderate to severe active disease; AND
- For patients with predominantly axial disease, a trial and failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated; OR
- For patients with peripheral arthritis, dactylitis OR active enthesitis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.
Ankylosing Spondylitis (AS) † 1-4,19,73
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented active disease; AND
- Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs) over 4 weeks (in total), unless use is contraindicated
Plaque Psoriasis (PsO) † 1-4,67-69,79,88,89
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Documented moderate to severe chronic disease for at least 6 months with at least one of the following:
- Involvement of at least 3% of body surface area (BSA); OR
- Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
- Incapacitation or serious emotional consequences due to plaque location (i.e., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND
- Patient did not respond adequately (or is not a candidate) to a 4 week minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics,, tapinarof, roflumilast, retinoic acid derivatives, and/or vitamin D analogues); AND
- Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least one non-biologic systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
- Patient did not respond adequately (or is not a candidate**) to a 3 month minimum trial of phototherapy (i.e., psoralens with UVA light [PUVA] or UVB with coal tar or dithranol)
Uveitis Associated with Behçet’s Syndrome ‡ 8-10,21,22,34,35, 93
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient’s disease is refractory to immunosuppressive therapy (e.g., corticosteroids, cyclosporine, azathioprine, etc.); AND
- Patient had an inadequate response to a self-administered biologic therapy (e.g., adalimumab)
Graft Versus Host Disease (GVHD) ‡ 43,65,66
- Patient has received a hematopoietic stem cell transplant; AND
- Used for steroid-refractory acute GVHD; AND
- Used in combination with systemic corticosteroids as additional therapy following no response to first-line therapies
Management of Immune Checkpoint Inhibitor Related Toxicity ‡ 36,37,43,86
- Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, dostarlimab, tremelimumab, retifanlimab, etc.); AND
- Patient has one of the following toxicities related to their immunotherapy:
-
-
-
-
-
-
- Myocarditis if no improvement within 24-48 hours of starting high-dose methylprednisolone; OR
- Mild (G1) diarrhea or colitis if persistent or progressive symptoms and positive lactoferrin/calprotectin; OR
- Moderate (G2) to severe (G3-4) diarrhea or colitis; OR
- Moderate (G 2) pneumonitis if no improvement after 48-72 hours of corticosteroids; OR
- Severe (G3-4) pneumonitis if no improvement after 48 hours of methylprednisolone; OR
- Stage 3 acute kidney injury/elevated serum creatinine if toxicity remains >grade 2 after 4-6 weeks of corticosteroids or if creatinine increases during or after steroid taper; OR
- Uveitis (G1-4) that is refractory to high-dose systemic corticosteroids; OR
- Moderate to severe inflammatory arthritis; AND
-
-
-
-
- Used as additional disease-modifying antirheumatic drug (DMARD) therapy; AND
- Patient’s symptoms have not improved after holding immunotherapy AND one of the following:
-
- Patient has not responded to oral corticosteroids; OR
- Patient is unable to taper corticosteroids; OR
- Patient has not had response to conventional synthetic (cs) DMARDs (i.e., methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine)
-
-
-
**Examples of contraindications to phototherapy (PUVA or UVB) include the following: 67,68 |
|
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-4
Coverage can be renewed based upon the following criteria:
For PEEHIP Members Only |
|
For Commercial Members Only |
|
*unbranded biologic |
- Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, malignancy (e.g., lymphoma including hepatosplenic T-cell lymphoma, skin cancers, cervical cancer, etc.), significant hematologic abnormalities (e.g., leukopenia, neutropenia, thrombocytopenia, pancytopenia), serious infections (e.g., TB, serious fungal infections, HBV reactivation, etc.), cardiovascular and cerebrovascular accidents, heart failure, neurotoxicity/ demyelinating disorders, hepatotoxicity, lupus-like syndrome, etc.; AND
Crohn’s Disease 23
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].
Pediatric Crohn’s Disease 23
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Crohn’s Disease Activity Index (PCDAI) score or the Harvey-Bradshaw Index score].
Ulcerative Colitis 24-27
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].
Pediatric Ulcerative Colitis 24-26
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Ulcerative Colitis Activity Index (PUCAI) score or the Mayo Score].
Fistulizing Crohn’s Disease 23
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as a reduction in number of enterocutaneous fistulas draining upon gentle compression, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].
Psoriatic Arthritis 28,72
- 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. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].
Rheumatoid Arthritis 29-31, 91
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria].
Ankylosing Spondylitis 19,87
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)].
Plaque Psoriasis (PsO) 33,69,79,88,90
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started].
Uveitis Associated with Behçet’s Syndrome 34-35
- Disease response as indicated by an improvement in signs and symptoms compared to baseline [e.g. reduction in inflammation and/or lesions, dose reduction of oral glucocorticoids and/or immunosuppressive agents, improvement in vitreous haze, improvement in best corrected visual acuity (BCVA), disease stability and/or reduced rate of decline].
Acute GVHD ‡ 65,66
- May not be renewed (Note: Requests for continued therapy beyond four doses will be reviewed on a case-by-case basis.)
Management of Immune Checkpoint Inhibitor related Toxicity ‡ 86
- May not be renewed.
- Dosage/Administration 1-4,36,37,42,66,86
Indication |
Loading Doses |
Maintenance Dosing |
Maximum Dose & Frequency |
Rheumatoid Arthritis |
3 mg/kg at weeks 0, 2, & 6 |
3 mg/kg every 8 weeks thereafter |
Up to 10 mg/kg every 4 weeks |
Ankylosing Spondylitis |
5 mg/kg at weeks 0, 2, & 6 |
5 mg/kg every 6 weeks thereafter |
5 mg/kg every 6 weeks |
Crohn’s Disease & Ulcerative Colitis |
5 mg/kg at weeks 0, 2, & 6 |
5 mg/kg every 8 weeks thereafter |
Up to 10 mg/kg every 8 weeks |
Psoriatic Arthritis, Plaque Psoriasis, Behçet’s Uveitis |
5 mg/kg at weeks 0, 2, & 6 |
5 mg/kg every 8 weeks thereafter |
5 mg/kg every 8 weeks |
Management of Immune Checkpoint Inhibitor Related Toxicity |
5 mg/kg at weeks 0,2 |
N/A |
N/A |
Acute GVHD |
10 mg/kg at week 0,1,2 & 3 |
N/A |
N/A |
Note:
|
- Billing Code/Availability Information
HCPCS Code:
- J1745 – Injection, infliximab, excludes biosimilar, 10 mg; 1 billable unit = 10 mg (Includes unbranded biologic)
- Q5103 – Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg: 1 billable unit = 10 mg
- Q5104 – Injection, infliximab-abda, biosimilar, (renflexis), 10 mg; 1 billable unit = 10 mg
- Q5121 – Injection, infliximab-axxq, biosimilar, (avsola), 10 mg: 1 billable unit=10 mg
NDC:
- Remicade 100 mg single-dose vial for injection: 57894-0030-xx
- Infliximab 100 mg single-dose vial for injection: 57894-0160-xx (Unbranded biologic*)
- Inflectra 100 mg single-dose vial: 00069-0809-xx
- Renflexis 100 mg single-dose vial: 78206-0162-xx
- Avsola 100 mg single-dose vial for injection: 55513-0670-xx
*An unbranded biologic is the same as the brand biologic, Remicade, using the same cell-line as the brand-name reference biologic.
- References
- Remicade/Infliximab [package insert]. Horsham, PA; Janssen Biotech, Inc; October 2021. Accessed September 2023.
- Inflectra [package insert]. Yeonsu-gu, Incheon, Republic of Korea; CELLTRION, Inc; April 2023. Accessed September 2023.
- Renflexis [package insert]. Yeonsu-gu, Incheon, Republic of Korea; Samsung Bioepis Co., Ltd; January 2022. Accessed September 2023.
- Avsola [package insert]. Thousand Oaks, CA; Amgen, Inc; September 2021. Accessed September 2023.
- Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
- Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. doi: 10.1002/art.39298.
- Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007;56:31e1-15.
- Niccoli L, Nannini C, Benucci M, et al. Long-term efficacy of infliximab in refractory posterior uveitis of Behcet’s disease: a 24-month follow-up study. Rheumatology (Oxford). 2007 Jul;46(7):1161-4. Epub 2007 May 3.
- Giardina A, Ferrante A, Ciccia F, et al. One year study of efficacy and safety of infliximab in the treatment of patients with ocular and neurological Behcet’s disease refractory to standard immunosuppressive drugs. Rheumatol Int 2011;31:33–37.
- Okada A, Goto H, Ohno S, et al. Multicenter study of infliximab for refractory uveoretinitis in Behcet disease. Arch Ophthalmol 2012;130(5):592-598.
- Lichtenstein GR, Loftus EV, Isaacs KL, et al. American College of Gastroenterology. Clinical Guideline: Management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481-517.
- Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
- Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
- Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
- Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
- National Institute for Health and Clinical Excellence (NICE). Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Aug. 73 p. (Technology appraisal guidance; no. 195)
- Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
- Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
- Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770.
- Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
- Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
- Levy-Clarke G, Jabs DA, Read RW, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3. doi: 10.1016/j.ophtha.2013.09.048.
- National Institute for Health and Care Excellence. NICE 2019. Crohn’s disease: management. Published 03 May 2019. NICE guideline [NG129]. https://www.nice.org.uk/guidance/ng129. Accessed September 2023.
- Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi: 10.1002/ibd.20520
- Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
- Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology 13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
- Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
- National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed September 2023.
- National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
- National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 10 October 2012. Clinical Guideline [TA195]. https://www.nice.org.uk/guidance/ta195/resources/adalimumab-etanercept-infliximab-rituximab-and-abatacept-for-the-treatment-of-rheumatoid-arthritis-after-the-failure-of-a-tnf-inhibitor-pdf-82598558287813.
- Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi: 10.1002/art.38705
- National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
- Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
- Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
- Levy-Clarke G, Jabs DA, Read RW, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3. doi: 10.1016/j.ophtha.2013.09.048.
- Minor DR, Chin K, Sashani-Sabet M, et al. Infliximab in the treatment of anti-CTLA4 antibody (Ipilimumab) induced immune-related colitis. Cancer Biotherapy & Radiopharmaceuticals. 2009 June; 24 (3). https://doi.org/10.1089/cbr.2008.0607
- Villadolid J, Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Translational Lung Cancer Research. 2015;4(5):560-575. doi:10.3978/j.issn.2218-6751.2015.06.06.Appendix 1 – Covered Diagnosis Codes
- Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology. Vol. 0, No. 0, Month 2018, pp 1–28 DOI 10.1002/art.40726
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019 Feb 13. pii: S0190-9622(18)33001-9. https://doi.org/10.1016/j.jaad.2018.11.057.
- American Academy of Dermatology Work Group, Menter A, Korman NJ, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.
- Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
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- Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017 Feb;76(2):355-363.
- Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017 Feb;76(2):346-354.
- Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019 Jun;285(6):653-669.
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Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
D89.810 |
Acute graft-versus host disease |
D89.812 |
Acute on chronic graft-versus-host-disease |
D89.813 |
Graft-versus-host disease unspecified |
H30.891 |
Other chorioretinal inflammations, right eye |
H30.892 |
Other chorioretinal inflammations, left eye |
H30.893 |
Other chorioretinal inflammations, bilateral |
H30.899 |
Other chorioretinal inflammations, unspecified eye |
H30.90 |
Unspecified chorioretinal inflammation, unspecified eye |
H30.91 |
Unspecified chorioretinal inflammation, right eye |
H30.92 |
Unspecified chorioretinal inflammation, left eye |
H30.93 |
Unspecified chorioretinal inflammation, bilateral |
H44.111 |
Panuveitis, right eye |
H44.112 |
Panuveitis, left eye |
H44.113 |
Panuveitis, bilateral |
H44.119 |
Panuveitis, unspecified eye |
I30.8 |
Other forms of acute pericarditis |
I30.9 |
Acute pericarditis, unspecified |
I40.8 |
Other acute myocarditis |
I40.9 |
Acute myocarditis, unspecified |
J70.2 |
Acute drug-induced interstitial lung disorders |
J70.4 |
Drug-induced interstitial lung disorders, unspecified |
K50.00 |
Crohn’s disease of small intestine without complications |
K50.011 |
Crohn’s disease of small intestine with rectal bleeding |
K50.012 |
Crohn’s disease of small intestine with intestinal obstruction |
K50.013 |
Crohn’s disease of small intestine with fistula |
K50.014 |
Crohn’s disease of small intestine with abscess |
K50.018 |
Crohn’s disease of small intestine with other complication |
K50.019 |
Crohn’s disease of small intestine with unspecified complications |
K50.10 |
Crohn’s disease of large intestine without complications |
K50.111 |
Crohn’s disease of large intestine with rectal bleeding |
K50.112 |
Crohn’s disease of large intestine with intestinal obstruction |
K50.113 |
Crohn’s disease of large intestine with fistula |
K50.114 |
Crohn’s disease of large intestine with abscess |
K50.118 |
Crohn’s disease of large intestine with other complication |
K50.119 |
Crohn’s disease of large intestine with unspecified complications |
K50.80 |
Crohn’s disease of both small and large intestine without complications |
K50.811 |
Crohn’s disease of both small and large intestine with rectal bleeding |
K50.812 |
Crohn’s disease of both small and large intestine with intestinal obstruction |
K50.813 |
Crohn’s disease of both small and large intestine with fistula |
K50.814 |
Crohn’s disease of both small and large intestine with abscess |
K50.818 |
Crohn’s disease of both small and large intestine with other complication |
K50.819 |
Crohn’s disease of both small and large intestine with unspecified complications |
K50.90 |
Crohn’s disease, unspecified, without complications |
K50.911 |
Crohn’s disease, unspecified, with rectal bleeding |
K50.912 |
Crohn’s disease, unspecified, with intestinal obstruction |
K50.913 |
Crohn’s disease, unspecified, with fistula |
K50.914 |
Crohn’s disease, unspecified, with abscess |
K50.918 |
Crohn’s disease, unspecified, with other complication |
K50.919 |
Crohn’s disease, unspecified, with unspecified complications |
K51.00 |
Ulcerative (chronic) pancolitis without complications |
K51.011 |
Ulcerative (chronic) pancolitis with rectal bleeding |
K51.012 |
Ulcerative (chronic) pancolitis with intestinal obstruction |
K51.013 |
Ulcerative (chronic) pancolitis with fistula |
K51.014 |
Ulcerative (chronic) pancolitis with abscess |
K51.018 |
Ulcerative (chronic) pancolitis with other complication |
K51.019 |
Ulcerative (chronic) pancolitis with unspecified complications |
K51.20 |
Ulcerative (chronic) proctitis without complications |
K51.211 |
Ulcerative (chronic) proctitis with rectal bleeding |
K51.212 |
Ulcerative (chronic) proctitis with intestinal obstruction |
K51.213 |
Ulcerative (chronic) proctitis with fistula |
K51.214 |
Ulcerative (chronic) proctitis with abscess |
K51.218 |
Ulcerative (chronic) proctitis with other complication |
K51.219 |
Ulcerative (chronic) proctitis with unspecified complications |
K51.30 |
Ulcerative (chronic) rectosigmoiditis without complications |
K51.311 |
Ulcerative (chronic) rectosigmoiditis with rectal bleeding |
K51.312 |
Ulcerative (chronic) rectosigmoiditis with intestinal obstruction |
K51.313 |
Ulcerative (chronic) rectosigmoiditis with fistula |
K51.314 |
Ulcerative (chronic) rectosigmoiditis with abscess |
K51.318 |
Ulcerative (chronic) rectosigmoiditis with other complication |
K51.319 |
Ulcerative (chronic) rectosigmoiditis with unspecified complications |
K51.50 |
Left sided colitis without complications |
K51.511 |
Left sided colitis with rectal bleeding |
K51.512 |
Left sided colitis with intestinal obstruction |
K51.513 |
Left sided colitis with fistula |
K51.514 |
Left sided colitis with abscess |
K51.518 |
Left sided colitis with other complication |
K51.519 |
Left sided colitis with unspecified complications |
K51.80 |
Other ulcerative colitis without complications |
K51.811 |
Other ulcerative colitis with rectal bleeding |
K51.812 |
Other ulcerative colitis with intestinal obstruction |
K51.813 |
Other ulcerative colitis with fistula |
K51.814 |
Other ulcerative colitis with abscess |
K51.818 |
Other ulcerative colitis with other complication |
K51.819 |
Other ulcerative colitis with unspecified complications |
K51.90 |
Ulcerative colitis, unspecified, without complications |
K51.911 |
Ulcerative colitis, unspecified with rectal bleeding |
K51.912 |
Ulcerative colitis, unspecified with intestinal obstruction |
K51.913 |
Ulcerative colitis, unspecified with fistula |
K51.914 |
Ulcerative colitis, unspecified with abscess |
K51.918 |
Ulcerative colitis, unspecified with other complication |
K51.919 |
Ulcerative colitis, unspecified with unspecified complications |
K52.1 |
Toxic gastroenteritis and colitis |
L40.0 |
Psoriasis vulgaris |
L40.50 |
Arthropathic psoriasis, unspecified |
L40.51 |
Distal interphalangeal psoriatic arthropathy |
L40.52 |
Psoriatic arthritis mutilans |
L40.53 |
Psoriatic spondylitis |
L40.59 |
Other psoriatic arthropathy |
M05.10 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified site |
M05.111 |
Rheumatoid lung disease with rheumatoid arthritis of right shoulder |
M05.112 |
Rheumatoid lung disease with rheumatoid arthritis of left shoulder |
M05.119 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder |
M05.121 |
Rheumatoid lung disease with rheumatoid arthritis of right elbow |
M05.122 |
Rheumatoid lung disease with rheumatoid arthritis of left elbow |
M05.129 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow |
M05.131 |
Rheumatoid lung disease with rheumatoid arthritis of right wrist |
M05.132 |
Rheumatoid lung disease with rheumatoid arthritis of left wrist |
M05.139 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist |
M05.141 |
Rheumatoid lung disease with rheumatoid arthritis of right hand |
M05.142 |
Rheumatoid lung disease with rheumatoid arthritis of left hand |
M05.149 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified hand |
M05.151 |
Rheumatoid lung disease with rheumatoid arthritis of right hip |
M05.152 |
Rheumatoid lung disease with rheumatoid arthritis of left hip |
M05.159 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified hip |
M05.161 |
Rheumatoid lung disease with rheumatoid arthritis of right knee |
M05.162 |
Rheumatoid lung disease with rheumatoid arthritis of left knee |
M05.169 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified knee |
M05.171 |
Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot |
M05.172 |
Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot |
M05.179 |
Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot |
M05.19 |
Rheumatoid lung disease with rheumatoid arthritis of multiple sites |
M05.20 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified site |
M05.211 |
Rheumatoid vasculitis with rheumatoid arthritis of right shoulder |
M05.212 |
Rheumatoid vasculitis with rheumatoid arthritis of left shoulder |
M05.219 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder |
M05.221 |
Rheumatoid vasculitis with rheumatoid arthritis of right elbow |
M05.222 |
Rheumatoid vasculitis with rheumatoid arthritis of left elbow |
M05.229 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow |
M05.231 |
Rheumatoid vasculitis with rheumatoid arthritis of right wrist |
M05.232 |
Rheumatoid vasculitis with rheumatoid arthritis of left wrist |
M05.239 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist |
M05.241 |
Rheumatoid vasculitis with rheumatoid arthritis of right hand |
M05.242 |
Rheumatoid vasculitis with rheumatoid arthritis of left hand |
M05.249 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand |
M05.251 |
Rheumatoid vasculitis with rheumatoid arthritis of right hip |
M05.252 |
Rheumatoid vasculitis with rheumatoid arthritis of left hip |
M05.259 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip |
M05.261 |
Rheumatoid vasculitis with rheumatoid arthritis of right knee |
M05.262 |
Rheumatoid vasculitis with rheumatoid arthritis of left knee |
M05.269 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee |
M05.271 |
Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot |
M05.272 |
Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot |
M05.279 |
Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot |
M05.29 |
Rheumatoid vasculitis with rheumatoid arthritis of multiple sites |
M05.30 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified site |
M05.311 |
Rheumatoid heart disease with rheumatoid arthritis of right shoulder |
M05.312 |
Rheumatoid heart disease with rheumatoid arthritis of left shoulder |
M05.319 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder |
M05.321 |
Rheumatoid heart disease with rheumatoid arthritis of right elbow |
M05.322 |
Rheumatoid heart disease with rheumatoid arthritis of left elbow |
M05.329 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow |
M05.331 |
Rheumatoid heart disease with rheumatoid arthritis of right wrist |
M05.332 |
Rheumatoid heart disease with rheumatoid arthritis of left wrist |
M05.339 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist |
M05.341 |
Rheumatoid heart disease with rheumatoid arthritis of right hand |
M05.342 |
Rheumatoid heart disease with rheumatoid arthritis of left hand |
M05.349 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified hand |
M05.351 |
Rheumatoid heart disease with rheumatoid arthritis of right hip |
M05.352 |
Rheumatoid heart disease with rheumatoid arthritis of left hip |
M05.359 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified hip |
M05.361 |
Rheumatoid heart disease with rheumatoid arthritis of right knee |
M05.362 |
Rheumatoid heart disease with rheumatoid arthritis of left knee |
M05.369 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified knee |
M05.371 |
Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot |
M05.372 |
Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot |
M05.379 |
Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot |
M05.39 |
Rheumatoid heart disease with rheumatoid arthritis of multiple sites |
M05.40 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified site |
M05.411 |
Rheumatoid myopathy with rheumatoid arthritis of right shoulder |
M05.412 |
Rheumatoid myopathy with rheumatoid arthritis of left shoulder |
M05.419 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder |
M05.421 |
Rheumatoid myopathy with rheumatoid arthritis of right elbow |
M05.422 |
Rheumatoid myopathy with rheumatoid arthritis of left elbow |
M05.429 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow |
M05.431 |
Rheumatoid myopathy with rheumatoid arthritis of right wrist |
M05.432 |
Rheumatoid myopathy with rheumatoid arthritis of left wrist |
M05.439 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist |
M05.441 |
Rheumatoid myopathy with rheumatoid arthritis of right hand |
M05.442 |
Rheumatoid myopathy with rheumatoid arthritis of left hand |
M05.449 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified hand |
M05.451 |
Rheumatoid myopathy with rheumatoid arthritis of right hip |
M05.452 |
Rheumatoid myopathy with rheumatoid arthritis of left hip |
M05.459 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified hip |
M05.461 |
Rheumatoid myopathy with rheumatoid arthritis of right knee |
M05.462 |
Rheumatoid myopathy with rheumatoid arthritis of left knee |
M05.469 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified knee |
M05.471 |
Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot |
M05.472 |
Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot |
M05.479 |
Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot |
M05.49 |
Rheumatoid myopathy with rheumatoid arthritis of multiple sites |
M05.50 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site |
M05.511 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder |
M05.512 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder |
M05.519 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder |
M05.521 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow |
M05.522 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow |
M05.529 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow |
M05.531 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist |
M05.532 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist |
M05.539 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist |
M05.541 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right hand |
M05.542 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left hand |
M05.549 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand |
M05.551 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right hip |
M05.552 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left hip |
M05.559 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip |
M05.561 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right knee |
M05.562 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left knee |
M05.569 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee |
M05.571 |
Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot |
M05.572 |
Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot |
M05.579 |
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot |
M05.59 |
Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites |
M05.60 |
Rheumatoid arthritis of unspecified site with involvement of other organs and systems |
M05.611 |
Rheumatoid arthritis of right shoulder with involvement of other organs and systems |
M05.612 |
Rheumatoid arthritis of left shoulder with involvement of other organs and systems |
M05.619 |
Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems |
M05.621 |
Rheumatoid arthritis of right elbow with involvement of other organs and systems |
M05.622 |
Rheumatoid arthritis of left elbow with involvement of other organs and systems |
M05.629 |
Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems |
M05.631 |
Rheumatoid arthritis of right wrist with involvement of other organs and systems |
M05.632 |
Rheumatoid arthritis of left wrist with involvement of other organs and systems |
M05.639 |
Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems |
M05.641 |
Rheumatoid arthritis of right hand with involvement of other organs and systems |
M05.642 |
Rheumatoid arthritis of left hand with involvement of other organs and systems |
M05.649 |
Rheumatoid arthritis of unspecified hand with involvement of other organs and systems |
M05.651 |
Rheumatoid arthritis of right hip with involvement of other organs and systems |
M05.652 |
Rheumatoid arthritis of left hip with involvement of other organs and systems |
M05.659 |
Rheumatoid arthritis of unspecified hip with involvement of other organs and systems |
M05.661 |
Rheumatoid arthritis of right knee with involvement of other organs and systems |
M05.662 |
Rheumatoid arthritis of left knee with involvement of other organs and systems |
M05.669 |
Rheumatoid arthritis of unspecified knee with involvement of other organs and systems |
M05.671 |
Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems |
M05.672 |
Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems |
M05.679 |
Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems |
M05.69 |
Rheumatoid arthritis of multiple sites with involvement of other organs and systems |
M05.7A |
Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement |
M05.711 |
Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement |
M05.712 |
Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement |
M05.719 |
Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement |
M05.721 |
Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement |
M05.722 |
Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement |
M05.729 |
Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement |
M05.731 |
Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement |
M05.732 |
Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement |
M05.739 |
Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement |
M05.741 |
Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement |
M05.742 |
Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement |
M05.749 |
Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement |
M05.751 |
Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement |
M05.752 |
Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement |
M05.759 |
Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement |
M05.761 |
Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement |
M05.762 |
Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement |
M05.769 |
Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement |
M05.771 |
Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement |
M05.772 |
Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement |
M05.779 |
Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement |
M05.79 |
Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement |
M05.8A |
Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement |
M05.811 |
Other rheumatoid arthritis with rheumatoid factor of right shoulder |
M05.812 |
Other rheumatoid arthritis with rheumatoid factor of left shoulder |
M05.819 |
Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder |
M05.821 |
Other rheumatoid arthritis with rheumatoid factor of right elbow |
M05.822 |
Other rheumatoid arthritis with rheumatoid factor of left elbow |
M05.829 |
Other rheumatoid arthritis with rheumatoid factor of unspecified elbow |
M05.831 |
Other rheumatoid arthritis with rheumatoid factor of right wrist |
M05.832 |
Other rheumatoid arthritis with rheumatoid factor of left wrist |
M05.839 |
Other rheumatoid arthritis with rheumatoid factor of unspecified wrist |
M05.841 |
Other rheumatoid arthritis with rheumatoid factor of right hand |
M05.842 |
Other rheumatoid arthritis with rheumatoid factor of left hand |
M05.849 |
Other rheumatoid arthritis with rheumatoid factor of unspecified hand |
M05.851 |
Other rheumatoid arthritis with rheumatoid factor of right hip |
M05.852 |
Other rheumatoid arthritis with rheumatoid factor of left hip |
M05.859 |
Other rheumatoid arthritis with rheumatoid factor of unspecified hip |
M05.861 |
Other rheumatoid arthritis with rheumatoid factor of right knee |
M05.862 |
Other rheumatoid arthritis with rheumatoid factor of left knee |
M05.869 |
Other rheumatoid arthritis with rheumatoid factor of unspecified knee |
M05.871 |
Other rheumatoid arthritis with rheumatoid factor of right ankle and foot |
M05.872 |
Other rheumatoid arthritis with rheumatoid factor of left ankle and foot |
M05.879 |
Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot |
M05.89 |
Other rheumatoid arthritis with rheumatoid factor of multiple sites |
M05.9 |
Rheumatoid arthritis with rheumatoid factor, unspecified |
M06.0A |
Rheumatoid arthritis without rheumatoid factor, other specified site |
M06.011 |
Rheumatoid arthritis without rheumatoid factor, right shoulder |
M06.012 |
Rheumatoid arthritis without rheumatoid factor, left shoulder |
M06.019 |
Rheumatoid arthritis without rheumatoid factor, unspecified shoulder |
M06.021 |
Rheumatoid arthritis without rheumatoid factor, right elbow |
M06.022 |
Rheumatoid arthritis without rheumatoid factor, left elbow |
M06.029 |
Rheumatoid arthritis without rheumatoid factor, unspecified elbow |
M06.031 |
Rheumatoid arthritis without rheumatoid factor, right wrist |
M06.032 |
Rheumatoid arthritis without rheumatoid factor, left wrist |
M06.039 |
Rheumatoid arthritis without rheumatoid factor, unspecified wrist |
M06.041 |
Rheumatoid arthritis without rheumatoid factor, right hand |
M06.042 |
Rheumatoid arthritis without rheumatoid factor, left hand |
M06.049 |
Rheumatoid arthritis without rheumatoid factor, unspecified hand |
M06.051 |
Rheumatoid arthritis without rheumatoid factor, right hip |
M06.052 |
Rheumatoid arthritis without rheumatoid factor, left hip |
M06.059 |
Rheumatoid arthritis without rheumatoid factor, unspecified hip |
M06.061 |
Rheumatoid arthritis without rheumatoid factor, right knee |
M06.062 |
Rheumatoid arthritis without rheumatoid factor, left knee |
M06.069 |
Rheumatoid arthritis without rheumatoid factor, unspecified knee |
M06.071 |
Rheumatoid arthritis without rheumatoid factor, right ankle and foot |
M06.072 |
Rheumatoid arthritis without rheumatoid factor, left ankle and foot |
M06.079 |
Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot |
M06.08 |
Rheumatoid arthritis without rheumatoid factor, vertebrae |
M06.09 |
Rheumatoid arthritis without rheumatoid factor, multiple sites |
M06.4 |
Inflammatory polyarthropathy |
M06.8A |
Other specified rheumatoid arthritis, other specified site |
M06.811 |
Other specified rheumatoid arthritis, right shoulder |
M06.812 |
Other specified rheumatoid arthritis, left shoulder |
M06.819 |
Other specified rheumatoid arthritis, unspecified shoulder |
M06.821 |
Other specified rheumatoid arthritis, right elbow |
M06.822 |
Other specified rheumatoid arthritis, left elbow |
M06.829 |
Other specified rheumatoid arthritis, unspecified elbow |
M06.831 |
Other specified rheumatoid arthritis, right wrist |
M06.832 |
Other specified rheumatoid arthritis, left wrist |
M06.839 |
Other specified rheumatoid arthritis, unspecified wrist |
M06.841 |
Other specified rheumatoid arthritis, right hand |
M06.842 |
Other specified rheumatoid arthritis, left hand |
M06.849 |
Other specified rheumatoid arthritis, unspecified hand |
M06.851 |
Other specified rheumatoid arthritis, right hip |
M06.852 |
Other specified rheumatoid arthritis, left hip |
M06.859 |
Other specified rheumatoid arthritis, unspecified hip |
M06.861 |
Other specified rheumatoid arthritis, right knee |
M06.862 |
Other specified rheumatoid arthritis, left knee |
M06.869 |
Other specified rheumatoid arthritis, unspecified knee |
M06.871 |
Other specified rheumatoid arthritis, right ankle and foot |
M06.872 |
Other specified rheumatoid arthritis, left ankle and foot |
M06.879 |
Other specified rheumatoid arthritis, unspecified ankle and foot |
M06.88 |
Other specified rheumatoid arthritis, vertebrae |
M06.89 |
Other specified rheumatoid arthritis, multiple sites |
M06.9 |
Rheumatoid arthritis, unspecified |
M35.2 |
Behçet’s disease |
M45.0 |
Ankylosing spondylitis of multiple sites in spine |
M45.1 |
Ankylosing spondylitis of occipito-atlanto-axial region |
M45.2 |
Ankylosing spondylitis of cervical region |
M45.3 |
Ankylosing spondylitis of cervicothoracic region |
M45.4 |
Ankylosing spondylitis of thoracic region |
M45.5 |
Ankylosing spondylitis of thoracolumbar region |
M45.6 |
Ankylosing spondylitis lumbar region |
M45.7 |
Ankylosing spondylitis of lumbosacral region |
M45.8 |
Ankylosing spondylitis sacral and sacrococcygeal region |
M45.9 |
Ankylosing spondylitis of unspecified sites in spine |
M79.10 |
Myalgia, unspecified |
M79.11 |
Myalgia of mastication muscle |
M79.12 |
Myalgia of auxiliary muscles, head and neck |
M79.18 |
Myalgia, other site |
N17.8 |
Other acute kidney failure |
N17.9 |
Acute kidney failure, unspecified |
R19.7 |
Diarrhea, unspecified |
T86.09 |
Other complications of bone marrow transplant |
Z94.81 |
Bone marrow transplant status |
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): A56432 |
Jurisdiction(s): 6,K |
NCD/LCD/LCA Document (s): A52423 |
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, 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 |