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

This 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 Churg-
Strauss syndrome).

  
**General Guidelines for Claims submitted to Part A or Part B MAC**  
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.  
  
 **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 Requirements**

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 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 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.  
 _If use for refractory disease_ must 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 course_ must 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-treatment_ then documentation of positive response to
prior treatment must be included.