Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A59101)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimCMS Manual System, Pub 100-04,Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, 2018CMS Internet-Only Manual, Pub 100-04,Medicare Claims Processing Manual, Chapter 17, Section 40 Discarded Drugs and BiologicalsArticle TextThis 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.However, for the convenience of providers, we have added a list of labeled and compendia approved diagnoses in the Group 2 section for ICD-10-CM Codes that Support Medical Necessity below.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 patients 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 visitRelevant medical historyResults of pertinent tests/proceduresSigned 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 responseDuration of disease course and response to previous treatment if applicableIf 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.