Oncotype DX Test for Breast Cancer Tissue Samples

Genomic Health, Inc. (www.genomichealth.com) has developed a laboratory test which can be performed on paraffin-embedded breast cancer tissue (“Oncotype DX”TM). The test is proposed to forecast prognostic factors and help guide therapeutic interventions more effectively than traditional breast cancer diagnostics.

At this time, NHIC California does not provide coverage for the Oncotype DX test, because Oncotype DX has not been determined to be reasonable and necessary for care.

NHIC notes that the test is not FDA-approved; and that as of late 2004, published noncoverage/experimental decisions were also found at private, Blue Cross, and governmental healthcare websites.

Billing Guidelines – Claims which fall under the jurisdiction of NHIC Part B as described above, may be submitted to NHIC for denial purposes for secondary insurers in conjunction with an Advance Beneficiary Notice (ABN) or to initiate appeal rights. An ABN is appropriate when there is a benefit category (laboratory tests; cancer care) but a particular service is not reasonable and necessary. The test should be submitted as CPT code 84999 (unlisted chemistry procedure) because the most closely relevant codes are those for DNA analysis such as polymerase chain reaction (PCR). Indicate in the comment field that the test is “Oncotype DX”. CPT code 84999 should be submitted as a global fee only (do NOT submit with the -26 and -TC modifiers). CPT code 89240 (unlisted miscellaneous pathology test) should not be used since it refers to anatomic pathology tests.