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MIR-2006-9A, September 2006
LCD and Article Revisions for September 2006
Rituximab (Rituxan) - L2175
LCD Revisions:
Under the “Indications and Limitations” section, changed heading to show “Indications” only. Also, under this section, updated letters B. and E. from:
- Based on the current medical literature, initial therapy for intermediate grade non-Hodgkin’s CD20 positive lymphoma includes 8 doses in combination with CHOP:
- An off-label use of a FDA-approved drug is covered when there is no specific contraindication and one of the following criteria is met:
To show the following:
- Based on the current medical literature, initial therapy for intermediate grade non-Hodgkin’s CD20 positive lymphoma includes 8 doses in combination with CHOP (cyclophosphamide, hydroxydoxorubicin, oncovin [vincristine] and prednisone):
- An off-label use of a FDA approved drug is supported when there is no specific contraindication and one of the criteria listed below is met. The literature will be reviewed by the Contractor Medical Director to determine approval of the off-label use of the drug:
Created the “Limitations” section, and added number 1:
Limitations:
- Rituximab is not covered for conditions where the effectiveness has not been demonstrated.
Under the “Documentation Requirements” section, moved number 3 (now number 1 in “Limitations” section):
- Rituximab is not covered for conditions where the effectiveness has not been demonstrated. Therefore, when using this agent for an indication not listed as covered on this policy, submit documentation with the claim to substantiate its use (ex. peer-reviewed articles, compendia listing).
Renumbered 4 and 5 to show as 3 and 4. Also under this section, updated number the new 4 from:
- To justify off-label uses, the documentation submitted must include three Phase III studies from the literature specified under “Indications and Limitations.”
To show the following:
- To justify off-label uses, the documentation submitted must include two Phase II studies from the literature specified under “Indications and Limitations.”
Under the “Utilization Guidelines” section, added number 1:
- Claims submitted for an unusual frequency of any of these services or services ordered for a diagnosis not listed as covered in this policy will be denied as not medically necessary in the absence of supportive documentation in the patient’s record.
Article Revisions:
Under the “Reasons for Denial” section, moved number 2 to the “Utilization Guidelines” of the LCD (see above).
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