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LCD Reference Article Billing and Coding Article

Billing and Coding: Infliximab and biosimilars

A52423

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Source Article ID
N/A
Article ID
A52423
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Infliximab and biosimilars
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
10/01/2024
Revision Ending Date
N/A
Retirement Date
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Article Text

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Abstract:

Infliximab is a chimeric monoclonal antibody that binds to tumor necrosis factor alpha (TNFa), which is believed to be critical to the human body’s reaction to inflammation. TNFa is a cytokine that is a key biologic response mediator found to be increased in such chronic and inflammatory disorders as Crohn’s disease and rheumatoid arthritis, among others.

Infliximab-dyyb is the second biosimilar of reference biologic Remicade™ (infliximab) 

Infliximab-abda and infliximab axxq are other biosimilars of reference biologic Remicade™ (infliximab)

Documentation Requirements:

Medical records should include:
1) The basis for each diagnosis and that the diagnosis was made in accordance with recognized standards such as guidelines published by the American College of Rheumatology (ACR).
2) Weight when needed to determine appropriate dosing.
3) Evaluation for latent tuberculosis infection through medical evaluation and TB test. Treatment of latent tuberculosis infection should be initiated prior to therapy with infliximab.
4) Documentation of the disease specific relevant symptoms and signs which are both being treated and being followed to assess for response to treatment.
5) Documentation of Inadequate Response (includes lack of efficacy, adverse effects prohibiting further use of the drug or medical contraindications) to a 3 month trial of appropriately dosed and disease specific conventional (non-biologic) therapy).

Crohn’s disease: Relevant information includes the presence and severity of abdominal pain, diarrhea, extra-intestinal manifestations, enterocutaneous and/or rectovaginal fistulae. Retreatment of patients with Crohn’s disease will be covered when the medical record substantiates that the patient had a reduction in the clinical signs and symptoms of the disease after the initial treatment.

Plaque Psoriasis: For the treatment of plaque psoriasis, documentation to support that the conditions is chronic, severe, extensive or disabling could include percent body surface area (BSA) affected; Psoriasis Area Severity Index (PASI) score; Psoriasis Disability Index (PDI) score; and/or results from other psoriasis assessment tool(s). Infliximab given to treat plaque psoriasis should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Psoriasis patients should be monitored for nonmelanoma skin cancers, particularly those patients who have had prior prolonged phototherapy treatment.

Rheumatoid Arthritis: To support the continued use of infliximab beyond 30 weeks for the treatment of rheumatoid arthritis, the medical record must include evidence of at least 20% improvement in tender joint count and at least 20% improvement in swollen joint count. The patient’s medical record must document that the patient is also receiving methotrexate or clearly indicates the reason that the patient cannot take methotrexate. 

Utilization:

Dose and frequency for infliximab and biosimilars, should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Services performed for excessive frequency are subject to denial as not medically necessary. Frequency is considered excessive when services are performed more frequently than recommended in the FDA-approved package insert. 

Coding Information:

Claims submitted for treatment of pyoderma gangrenosum with coexisting inflammatory bowel disease must be submitted with a primary and a secondary ICD-10-CM code. If both the primary and secondary ICD-10-CM codes are not indicated on the claim, the service will be denied.

For claims submitted to the Part B MAC:

  1. Infliximab and biosimilars are available in 100-mg vials. The dosage associated with the HCPCS code is 10 mg. The number of units (rounded up to a whole unit) used, should be entered in Item 24G of the CMS 1500 claim form or the electronic equivalent.

  2. The following is an example of the correct reporting methodology for infliximab and biosimilars: If the dosage administered is 375 mg, 4 vials (or a total of 400 mg) will be used. Report this with a "40" in the units field. Since this will result in product wastage, the JW modifier should be applied to the amount of the drug or biological that is discarded and should be billed as a separate line item.  Effective July 1, 2023, the JZ modifier should be reported on all claims that bill for infliximab and biosimilars when there are no discarded amounts from single-dose containers or single-use packages.

FDA and Compendia Review:

  1. American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.
  2. Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 09/05/2022.
  3. FDA label for infliximab-dyyb (Inflectra™). FDA Web site: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed on 06/08/2016
  4. FDA label for infliximab-abda (Renflexis). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/index. Accessed on 08/21/2017.
  5. FDA label for inflizimab-axxq (Avsola™). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed on 07/14/2020.
  6. Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/05/2022.
  7. Micromedex DrugDex®. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 09/05/2022.
  8. National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 09/05/2022.
  9. U.S. Food and Drug Administration label approved 08/24/1998 accessed on line at
    http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 02/01/2008.
  10. United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.

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Coding Information

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1

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 Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

(77 Codes)
Group 1 Paragraph

The following ICD-10-CM codes should be reported for Crohn’s disease with or without fistulizing complications; and for ulcerative colitis.

 Group 1 Codes
Code Description
K50.00 - K50.919 Crohn's disease of small intestine without complications - Crohn's disease, unspecified, with unspecified complications
K51.00 - K51.919 Ulcerative (chronic) pancolitis without complications - Ulcerative colitis, unspecified with unspecified complications

Group 2

(453 Codes)
Group 2 Paragraph

The following ICD-10-CM codes should be reported for reductions of signs and symptoms of rheumatoid arthritis in patients who have had inadequate response to methotrexate.

 Group 2 Codes
Code Description
L40.0 - L40.9 Psoriasis vulgaris - Psoriasis, unspecified
M05.00 - M05.9 Felty's syndrome, unspecified site - Rheumatoid arthritis with rheumatoid factor, unspecified
M06.00 - M06.39 Rheumatoid arthritis without rheumatoid factor, unspecified site - Rheumatoid nodule, multiple sites
M06.80 - M06.9 Other specified rheumatoid arthritis, unspecified site - Rheumatoid arthritis, unspecified
M08.00 - M08.29 Unspecified juvenile rheumatoid arthritis of unspecified site - Juvenile rheumatoid arthritis with systemic onset, multiple sites
M08.2A Juvenile rheumatoid arthritis with systemic onset, other specified site
M08.3 Juvenile rheumatoid polyarthritis (seronegative)
M08.80 - M08.99 Other juvenile arthritis, unspecified site - Juvenile arthritis, unspecified, multiple sites
M08.9A Juvenile arthritis, unspecified, other specified site
M45.0 - M45.9 Ankylosing spondylitis of multiple sites in spine - Ankylosing spondylitis of unspecified sites in spine
M48.8X1 - M48.9 Other specified spondylopathies, occipito-atlanto-axial region - Spondylopathy, unspecified
M65.911 Unspecified synovitis and tenosynovitis, right shoulder
M65.912 Unspecified synovitis and tenosynovitis, left shoulder
M65.919 Unspecified synovitis and tenosynovitis, unspecified shoulder
M65.921 Unspecified synovitis and tenosynovitis, right upper arm
M65.922 Unspecified synovitis and tenosynovitis, left upper arm
M65.929 Unspecified synovitis and tenosynovitis, unspecified upper arm
M65.931 Unspecified synovitis and tenosynovitis, right forearm
M65.932 Unspecified synovitis and tenosynovitis, left forearm
M65.939 Unspecified synovitis and tenosynovitis, unspecified forearm

Group 3

(88 Codes)
Group 3 Paragraph

The following ICD-10-CM codes should be reported for other conditions for which patients have failed to respond to standard pharmacologic therapy.

Group 3 Codes
Code Description
A18.54 Tuberculous iridocyclitis
D86.0 - D86.9 Sarcoidosis of lung - Sarcoidosis, unspecified
D89.810 Acute graft-versus-host disease
D89.812 Acute on chronic graft-versus-host disease
H20.00 - H20.9 Unspecified acute and subacute iridocyclitis - Unspecified iridocyclitis
H44.111 - H44.119 Panuveitis, right eye - Panuveitis, unspecified eye
H44.131 - H44.139 Sympathetic uveitis, right eye - Sympathetic uveitis, unspecified eye
I44.0 Atrioventricular block, first degree
I44.1 Atrioventricular block, second degree
I44.2 Atrioventricular block, complete
I44.39 Other atrioventricular block
I45.0 Right fascicular block
I45.19 Other right bundle-branch block
I45.2 Bifascicular block
I45.3 Trifascicular block
I45.4 Nonspecific intraventricular block
I45.5 Other specified heart block
I45.6 Pre-excitation syndrome
I45.81 Long QT syndrome
I45.89 Other specified conduction disorders
I47.21 Torsades de pointes
I47.29 Other ventricular tachycardia
K52.1 Toxic gastroenteritis and colitis
K52.89* Other specified noninfective gastroenteritis and colitis
L73.2 Hidradenitis suppurativa
M30.1 Polyarteritis with lung involvement [Churg-Strauss]
M31.30 Wegener's granulomatosis without renal involvement
M31.31 Wegener's granulomatosis with renal involvement
M31.4 Aortic arch syndrome [Takayasu]
M35.2 Behcet's disease
M35.81* Multisystem inflammatory syndrome
T86.09 Other complications of bone marrow transplant
Z94.81 Bone marrow transplant status
Group 3 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*K52.89 should be reported to indicate microscopic colitis.

*M35.81 must be billed with ICD-10 code Z20.822 to report multisystem inflammatory syndrome in children post SARS-CoV-2 infection

 

Group 4

(1 Code)
Group 4 Paragraph

For the treatment of pyoderma gangrenosum with coexisting inflammatory bowel disease which may be described by regional enteritis, ulcerative colitis, or pseudopolyposis of the colon. A diagnosis from Group 4 and one from Group 5 must be reported.

Group 4 Codes
Code Description
L88 Pyoderma gangrenosum

Group 5

(77 Codes)
Group 5 Paragraph

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 Group 5 Codes
Code Description
K50.00 - K50.919 Crohn's disease of small intestine without complications - Crohn's disease, unspecified, with unspecified complications
K51.00 - K51.919 Ulcerative (chronic) pancolitis without complications - Ulcerative colitis, unspecified with unspecified complications
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Coding Table Information

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Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2024 R26

Due to the annual ICD-10-CM update, code M65.9 was deleted from Group 2 and replaced with codes M65.911, M65.912, M65.919, M65.921, M65.922, M65.929, M65.931, M65.932, M65.939 effective for services rendered on or after 10/01/2024.
08/01/2024 R25

This article has been revised to add *K52.89 to indicate microscopic colitis, Group 3 - "ICD-10 Codes that support medical necessity" section.
07/01/2023 R24

Based on Transmittal 12067 (CR 13056) - New Claims Modifier Requirement for Drugs and Biologicals from a Single-Dose Container or Single-Use Package, Modifier JZ has been added to Coding Information #2 in the "Article Text" section of the article.
10/01/2022 R23

Documentation requirement #2 – removed height and #3 has been updated to remove reference to skin test PPD.
10/01/2022 R22

Correction: ICD-10 code M06.1 is included in the Group 2 code range M06.00 - M06.39 so it has been removed from the Group 3 list.
10/01/2022 R21

Based on the annual ICD-10 code update, ICD-10 code I47.0 has been deleted and replaced with I47.21 and I47.29. Based on compendia review, ICD-10 code M06.1 has been added to the Group 3 list effective for dates of service on or after 10/01/2022.
07/01/2022 R20

Based on compendia review, ICD-10 code M35.81 has been added to the Group 3 list effective for dates of service on or after 07/01/2022. An asterisk has been added to indicate that ICD-10 code M35.81 must be billed with ICD-10 code Z20.822.
05/01/2021 R19

Based on compendia review, ICD-10 code I47.2 has been added to the Group 3 list effective for dates of service on or after 05/01/2021.
10/01/2020 R18

Based on the annual ICD-10 update, ICD-10 codes M05.7A and M05.8A have been added to ICD-10 code range M05.00-M05.9, ICD-10 code M06.0A has been added to ICD-10 code range M06.00-M06.39, ICD-10 code M06.8A has been added to ICD-10 code range M06.80-M06.9, ICD-10 code M08.0A has been added to ICD-10 code range M08.00-M08.29 and ICD-10 codes M08.2A and M08.9A have been added in Group 2.
08/01/2020 R17

Based on Transmittal 10120 (CR 11788 - Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2020 Update), HCPCS code Q5121 has been added to report infliximab-axxq effective for dates of service on or after 07/01/2020.Coding guidelines 1 and 2 have been revised to include “biosimilars”. Coding guideline 2 has been revised to add JW modifier language. Coding guidelines 3 and 4 have been deleted.
05/01/2020 R16

Based on compendia review, ICD-10-CM codes I44.0, I44.1, I44.2, I44.39, I45.0, I45.19, I45.2, I45.3, I45.4, I45.5, I45.6, I45.81 and I45.89 have been added to Group 3 effective for dates of service on or after 05/01/2020.
01/01/2020 R15

Based on compendia review, ICD-10 codes D89.810, D89.812, T86.09 and Z94.81 have been added to the Group 3 list effective for dates of service on or after 01/01/2020.

11/07/2019 R14

This article was converted to the new Billing and Coding Article format and the title has been changed to Infliximab and biosimilars. The Article Text section has been revised to remove the indications which can be found on the FDA Web site and in the approved compendia. The limitations have been moved to the “Documentation” and “Utilization” sections. The “Sources of Information” has been revised to “FDA and Compendia Review.” Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394. The Bill type codes have been removed from this article. Guidance on these codes is available in the Bill type code section.
04/01/2018 R13

Based on Transmittal 3966 - Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update, HCPCS code Q5102 has been deleted and replaced with HCPCS codes Q5103 and Q5104 and use of modifiers ZB and ZC have been discontinued effective for dates of service on or after 04/01/2018.
11/01/2017 R12

Based on a reconsideration request, the "Indications expanded per this article" section has been revised to add:

    Severe immune-related colitis that does not respond promptly (within 1 week) to therapy with high-dose steroids. A single dose of infliximab is sufficient to resolve immune-related colitis in most patients.

ICD-10-CM code K52.1 has been added to Group 3 effective for dates of service on or after 11/01/2017.

References have been added to the "Sources of Information" section of the article. 

 
10/01/2017 R11

The article has been revised to add information for infliximab-abda (Renflexis) throughout the article. Based on Transmittal 3850, HCPCS code Q5102 must be billed with modifier ZC to identify the manufacturer for infliximab-abda, effective for dates of service on or after 07/24/2017.
01/01/2017 R10 Based on the annual CPT/HCPCS update the description for HCPCS code J1745 has changed.
07/01/2016 R9 The article has been revised to add information for infliximab-dyyb (Inflectra™) throughout the article. HCPCS code Q5102 has been added to the “CPT/HCPCS Codes” section of the article effective for dates of service on or after 04/05/2016. Based on Transmittal 1542, HCPCS code Q5102 must be billed with modifier ZB to identify the manufacturer for biosimilar drugs. Effective for dates of service on or after 04/05/2016, HCPCS code Q5102 submitted without modifier ZB will be returned to the provider.
05/01/2016 R8 Based on a reconsideration request, the first paragraph for ankylosing spondylitis has been revised to indicate treatment with TNF alpha inhibitors as “second line” after NSAIDS. The “Inadequate Response” information has been moved to the “Documentation Requirements:” section of the article. The “Sources of Information” section has been updated to add American College of Rheumatology guidelines. The changes are retroactive to 10/01/2015. Lexi-Drugs compendium has been added to the “Abstract” section of the article and Lexi-Drugs Web site has been added to the “Sources of Information” section.
02/04/2016 R7 Based on a reconsideration request for graft vs host disease (GVHD), sources have been added to the “Sources of Information” section of the article. No changes were made in coverage.
02/01/2016 R6 The following has been added to the “Indications expanded per this Article” section:
    Behçet’s Disease (BD), also known as Behçet’s Syndrome, in patients without an adequate response to initial therapy, for the treatment of clinical manifestations of BD such as severe ocular involvement, major organ involvement, severe gastrointestinal or neurological involvement and resistant cases of joint or mucocutaneous involvement (i.e., painful oral and genital ulcers).

ICD-10-CM code M35.2 has been added to the Group 3: Codes effective for dates of service on or after 01/01/2016. Sources have also been added to the “Sources of Information” section of the article.
10/01/2015 R5 The Indication for uveitis, refractory; adjunct has been revised to add the following language: (for example, but not limited to, uveitis associated with Behcet’s). ICD-10-CM codes H44.111-H44.119 and H44.131-H44.139 have been added effective 10/01/2015.
10/01/2015 R4 Based on a reconsideration request, the indication for psoriatic arthropathy has been revised. Other indications in the article have also been revised to include reference to Inadequate Response*. A description for inadequate response has been added to the "Indications" section of the article. The "Documentation Requirements" section has been revised and medical record guidelines have been added. The following bulleted item has been added to the "Utilization" section: Infliximab has been associated with adverse outcomes in patients with heart failure, and should not be administered at doses greater than 5 mg/kg in patients with moderate to severe heart failure.

10/01/2015 R3 The following ICD-10-CM codes have been added to Group 1: and Group 5: Codes: K50.019, K50.119, K50.819, K50.90, K50.911, K50.912, K50.913, K50.914, K50.918, K50.919, K51.019, K51.219, K51.319, K51.419, K51.519, K51.819, K51.90, K51.911, K51.912, K51.913, K51.914, K51.918 and K51.919. These ICD-10-CM codes have been put into ranges. ICD-10-CM codes L40.50, L40.9, M45.9, M48.8X9 and M48.9 have been added to the Group 2: Codes and these codes have been put into ranges. ICD-10-CM code D86.9, H20.00, H20.019, H20.029, H20.039, H20.049, H20.059, H20.10, H20.20, H20.819, H20.829 and H20.9 have been added to the Group 3: Codes and these codes have been put into ranges.
10/01/2015 R2 The following ICD-10-CM code ranges have been added to the Group 2: Codes: M05.00-M05.9, M06.00-M06.39, M06.80-M06.9, M08.00-M08.29 and M08.80-M08.99. The coding guidelines for the Part B MAC have been removed and the utilization guidelines have been revised to indicate the dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses).
10/01/2015 R1 Updated to include revisions made since April 2014.
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