Komen Foundation White Paper Cites Lack of Uniform Standards and Reimbursement Issues Contributing to Errors in Diagnosis for More Than 90,000 Breast Cancer Patients

White Paper Cites Errors in Diagnosis Affecting More Than 90,000 Breast Cancer Patients

DALLAS - October 2, 2006 - The Susan G. Komen Breast Cancer Foundation, recognized as the global leader in the fight against breast cancer, today issued a white paper calling for the review of gaps in current breast cancer pathology guidelines and procedures.

The white paper, Why Current Breast Pathology Practices Must Be Evaluated, developed by the Komen Foundation with a panel of leading experts in oncology, breast pathology, surgery and radiology, identifies a lack of uniform national standards in pathology practices, tissue handling, preservation and access, and current reimbursement policies as key issues that need to be addressed.

Potential for inaccurate diagnosis
While it is difficult to determine the incidence of errors in breast cancer diagnosis, the white paper estimates that the error rate could be as high as two to four percent. Based on this estimate, approximately 5,000 to 10,000 women diagnosed each year (invasive and in-situ disease) may have an inaccurate diagnosis, and more than 90,000 women currently living with breast cancer may also have diagnoses that are not entirely accurate. This could include mistaking benign and malignant disease, non-invasive and invasive disease, as well as estrogen receptor (ER) and HER2 status - two important predictive and prognostic markers that require specific treatment.

"Pathology is the foundation on which all treatment decisions are made, and the key to future developments in breast cancer research, treatment and care," said Dr. Rebecca Garcia, vice-president of health sciences at the Susan G. Komen Breast Cancer Foundation. "Getting the most accurate diagnosis possible is a major concern for breast cancer patients, given that successful treatment of this complex disease is so dependent on distinguishing the type of tumor and identifying bio-markers such as HER2 and ER status."

The mandate for quality standards in breast pathology
A number of factors impede the ability to obtain a completely accurate breast cancer diagnosis. To address these issues, the white paper outlines the following possible solutions:

• Improving standards for training in breast cancer pathology and specialization, and mandating compliance
• Encouraging or mandating second pathology opinions for appropriate cases
• Integrating pathology into the clinical care team for greater consensus diagnosis, especially between pathologists and radiologists

Overcoming reimbursement challenges
Compounding these issues are reimbursement policies that often dictate which pathology services will be used or deny payment for second opinions. More pressing, however, is the concern that reimbursement rates are not in line with the workload required to accurately diagnosis specific types of breast cancer, creating a disincentive for more thorough review when clinically appropriate.

In addition to inaccurate breast pathology diagnostics and issues with health insurance and reimbursement practices, the white paper also discusses the related issue of tissue handling - the impact on research of falling participation in tissue banking and the appropriate roles for organizations, medical societies and government in promoting standards for tissue handling, preservation and access for the patient as well as for research.

"The recommendations made in the white paper begin with the way we think about breast cancer: it is not one disease but many, some of which are more difficult to accurately diagnose," added Dr. Cheryl Perkins, senior clinical advisor for the Susan G. Komen Breast Cancer Foundation. "Improving pathology standards is critical, not only to getting the right treatment, but also to advancing our understanding of breast cancer biology and allowing us to translate that knowledge into more personalized care. At the end of the day, it will take the collaboration of the patient's entire healthcare team to assure that standards exist across the pathology and tissue spectrum."

Foundation's goal in creating the white paper
The Foundation's goal in creating the white paper was to raise awareness of these critical issues, stimulate dialogue and challenge professional societies, government and the healthcare system to take action to develop new standards, improve quality control, and examine needed changes to reimbursement and insurance policies.

The white paper is the first in a series of year-long initiatives the Foundation is implementing to identify and detail emergent issues essential to ensuring quality breast cancer care and survivorship. In early 2007, the Foundation will issue a second white paper on tissue access and ownership, and continue to facilitate a quality of care dialogue with all stakeholders in breast cancer, including patients, practitioners, advocates, government and public health officials.

Read full text of the white paper, including proposed solutions. (PDF)