DRAFT LCD Reference Article Billing and Coding Article

Billing and Coding: Infliximab and biosimilars

DA52423

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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
A52423
Draft Article ID
DA52423
Original ICD-9 Article ID
Not Applicable
Draft Article Title
Billing and Coding: Infliximab and biosimilars
Article Type
Billing and Coding
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Retirement Date
ANTICIPATED 04/30/2025

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Article Guidance

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.

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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

(445 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
M65.9 Synovitis and tenosynovitis, unspecified

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

N/A

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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Other Coding Information

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Coding Table Information

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Revision History Information

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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