Local Coverage Article Billing and Coding

Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars


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Article Information

General Information

Article ID
Article Title
Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars
Article Type
Billing and Coding
Original Effective Date
Revision Effective Date
Revision Ending Date
Retirement Date
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CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim

CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, 2018

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40 Discarded Drugs and Biologicals

Article Guidance

Article Text

This article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Off-label Use of Rituximab and Rituximab Biosimilars which addresses off-label use of rituximab.

This article defines off-label, non-compendia approved, uses for Rituximab.

Coding Information:
Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.

The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.

Documentation Requirements:

If a patient is treated with rituximab, they are expected to be treated with the standard doses per medical literature for the condition. After the initial treatment, re-treatment requires a positive response to rituximab documented in the medical record.

The patient’s medical record should include but is not limited to:

  • The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit
  • Relevant medical history
  • Results of pertinent tests/procedures
  • Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed)
  • Previous treatments including dosing and frequency of treatments, duration of treatment and documentation of response
  • Duration of disease course and response to previous treatment if applicable

If use is due to:

  • Lack of efficacy of prior treatments, documentation of prior treatment(s) must include dosing, frequency of dosing, duration of treatment(S) and documentation of response(s).
  • Adverse reaction to first-line therapy, documentation must include the event which absolutely contraindicates further use of the medication, or side effects that are not likely to be transient and resolve with further treatment, or that impair functional capacity and/or activities of daily living.
  • Refractory disease, documentation must include all first-line treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s).
  • Relapse in disease course, documentation must include prior first-line treatment(s), dosing, frequency of dosing, duration of each treatment(s), and duration of improvement on prior treatment(s). Pertinent clinical history, exam findings and test results that support relapse in disease course should be documented. Documentation of response treatment(s) at time of relapse, including duration, dosing and response to subsequent treatment(s).
  • Re-treatment, then documentation of positive response to prior treatment must be included.

Coding Information


Group 1

(4 Codes)
Group 1 Paragraph


Group 1 Codes

CPT/HCPCS Modifiers


ICD-10-CM Codes that Support Medical Necessity

Group 1

(39 Codes)
Group 1 Paragraph


Group 1 Codes
D68.311 Acquired hemophilia
D69.3 Immune thrombocytopenic purpura
D89.89 Other specified disorders involving the immune mechanism, not elsewhere classified
G35 Multiple sclerosis
G61.81 Chronic inflammatory demyelinating polyneuritis
G72.41 Inclusion body myositis [IBM]
G72.49 Other inflammatory and immune myopathies, not elsewhere classified
M31.10 Thrombotic microangiopathy, unspecified
M31.11 Hematopoietic stem cell transplantation-associated thrombotic microangiopathy [HSCT-TMA]
M31.19 Other thrombotic microangiopathy
M33.12 Other dermatomyositis with myopathy
M33.22 Polymyositis with myopathy
M33.92 Dermatopolymyositis, unspecified with myopathy
M34.2 Systemic sclerosis induced by drug and chemical
M34.81 Systemic sclerosis with lung involvement
M34.82 Systemic sclerosis with myopathy
M34.83 Systemic sclerosis with polyneuropathy
M34.89 Other systemic sclerosis
M34.9 Systemic sclerosis, unspecified
M35.00 Sjogren syndrome, unspecified
M35.01 Sjogren syndrome with keratoconjunctivitis
M35.02 Sjogren syndrome with lung involvement
M35.03 Sjogren syndrome with myopathy
M35.04 Sjogren syndrome with tubulo-interstitial nephropathy
M35.09 Sjogren syndrome with other organ involvement
N05.0 Unspecified nephritic syndrome with minor glomerular abnormality
T86.01 - T86.03 Bone marrow transplant rejection - Bone marrow transplant infection
T86.11 - T86.13 Kidney transplant rejection - Kidney transplant infection
T86.21 - T86.23 Heart transplant rejection - Heart transplant infection
T86.31 - T86.33 Heart-lung transplant rejection - Heart-lung transplant infection
T86.810 Lung transplant rejection

ICD-10-CM Codes that DO NOT Support Medical Necessity


ICD-10-PCS Codes


Additional ICD-10 Information


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.

0x TBD

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.


Other Coding Information


Revision History Information


Associated Documents

Related National Coverage Documents
Statutory Requirements URLs
Rules and Regulations URLs
CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
09/09/2022 11/01/2022 - N/A Currently in Effect You are here