Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 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, 40 Discarded Drugs and BiologicalsArticle TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Rituximab and biosimilars (DL38920) which addresses off-label use of Rituximab. Labeled indications are not included in this policy. FDA labeled indications include: chronic lymphocytic leukemia, non-Hodgkin lymphomas, pemphigus vulgaris, rheumatoid arthritis, Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (which includes microscopic polyangiitis, granulomatosis with polyangiitis (GPA) (formally Wegener's Granulomatosis) and eosinophilic GPA (formally ChurgStrauss syndrome).General Guidelines for Claims submitted to Part A or Part B MACProcedure 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.Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines:An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.Effective from April 1, 2010, non-covered services should be billed with modifier GA, -GX, -GY, or GZ, as appropriate.The GA modifier (Waiver of Liability Statement Issued as Required by Payer Policy) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.Modifier GX (Notice of Liability Issued, Voluntary Under Payer Policy) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.The GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. If the service is statutorily non-covered, or without a benefit category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.Documentation RequirementsThe 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 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 applicableIf use is due to lack of efficacy of prior treatments must document prior treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s)If use is due to adverse reaction to first-line therapydocumentation 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.If use for refractory diseasemust document all first-line treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s)If use is due to relapse in disease coursemust document 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).If use is for re-treatmentthen documentation of positive response to prior treatment must be included.