RETIRED - Oral Anticancer Drugs - Covered Diagnoses


Content Provided on this page contains outdated information and instruction and should not be considered current. Noridian is providing this archived information for research purposes only. This archived article contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

Article retired due to content incorporation into the applicable Local Coverage Determination or related Policy Article.

Original Effective Date: 08/12/2010
Revision Effective Date: 11/01/2013

In March 2010, a revised medical policy on Oral Anticancer Drugs was published with an effective date of June 1, 2010. That policy revision defined the ICD-9 diagnosis codes for which each drug would be covered. The policy was revised to be consistent with Medicare's national coverage policy for Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. That policy is found in the Medicare Benefit Policy Manual, Publication # 100-02, Chapter 15, Section 50.4.5:

That policy states that off-label indications are covered in two general situations:

  • The use is (a) supported in any of the following four compendia:
    • National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium - Categories 1 or 2A
    • American Hospital Formulary Service - Drug Information
    • Thomson Micromedex DrugDex - Class I, IIa or IIb
    • Clinical Pharmacology and (b) not listed as unsupported/not medically accepted in any of the compendia (e.g., Category 3 in NCCN or Class III in DrugDex).
  • The Medicare contractor makes a determination based on its analysis of the published literature from one or more of the 26 journals listed in that section.

A further revision of the Oral Anticancer Drugs Policy Article is being released with the addition of a number of ICD-9 codes. The effective date of this expanded list of diagnosis codes is retroactive to June 1.

If suppliers or physicians think that there are additional diagnoses that meet the criteria defined in the Medicare Benefit Policy Manual, they may send documentation to:

Richard W. Whitten, MD, FACP
Medical Director, DME MAC Jurisdiction D
Noridian Administrative Services
PO Box 6727
Fargo, ND 58108-6727

The documentation should be copies of either the pertinent sections of one of the four compendia or full text versions of published articles from the specified journals. The preference is that these be electronic documents submitted on a disc; however, hard copy printouts are also acceptable.

Suppliers should refer to the Oral Anticancer Drugs Local Coverage Determination and Policy Article for complete information concerning coverage criteria, coding guidelines, and documentation requirements.


Last Updated Dec 11 , 2023