News, CDC

UnitedHealthcare has removed the requirement to submit a pathology report to obtain coverage for trastuzumab. This change is effective for claims submitted after January 1, 2009. Herceptin claims that were submitted in 2008 that are pending payment will require the submission of the pathology report showing over expression of the HER2 gene. The pathology reports should be faxed to (915) 231-1970 and you should use the dedicated fax cover sheet.

Herceptin claims submitted after January 1, 2009, will continue to be subjected to two reimbursement policies that may impact the reimbursement: the National Comprehensive Cancer Network (NCCN) policy and the Maximum Dosage Edit policy. Both of these policies address Herceptin claims and are posted on the unitedhealthcareonline web site.

UnitedHealthcare launched the Herceptin policy requiring submission of pathology reports in early 2006 based on an audit showing that 12 percent of the patients being treated with trastuzumab did not have over-expression of the HER2 gene. Our last audit in September 2008, demonstrated that less than 1 percent of the submissions failed to show over- expression.

Our medical policy hasn\’t changed – treatment of patients with under-expression is still inappropriate. We believe the recent audit demonstrates that this quality parameter is being followed and no longer requires the quality check.

There are other critical issues with HER2 gene expression testing. Studies show that concordance between local laboratories and a central laboratory with quality controls can be poor.*

The College of American Pathology has established accreditation for HER2 gene testing, but participation in the accreditation process is voluntary.

UnitedHealthcare contracts with two national laboratories that meet the ASCO / CAP guideline recommendations and proficiency testing for HER2, Genezyme and Laboratory Corporation of America (LabCorp). We encourage the use of laboratories that meet these standards. If you don\’t know the accreditation status of your current lab for HER2, we would encourage retesting, or a second opinion, from either of these laboratories for your patients who are UnitedHealthcare enrollees.
*Reddy et al, Clin Breast Ca, 2006: 153-157