Eliminating Misdiagnosis and Reducing Wasteful Medicare Spending
Every 20 minutes an American man dies from prostate cancer. The American Cancer Society estimates that 161,360 men were told they have prostate cancer in 2017. Early detection is critical because research shows the five-year survival rate for all men with prostate cancer is nearly 100%.
The current method to diagnose prostate cancer is via needle biopsy of the prostate. Over 800,000 prostate biopsies are performed every year. However, despite the most rigorous protocols for obtaining and handling specimens, about 2.5% are subject to misappropriation or contamination.
This clearly poses an immense issue for the American public. Not only do patients receiving false-negatives lose the opportunity to treat their cancer at its earliest possible stage, but patients receiving false-positives – an estimated 1.3%, according to peer-reviewed literature – are erroneously told they have prostate cancer when they do not. This results in extreme financial and emotional stress, as well as unnecessary, expensive and invasive procedures, including radical prostatectomy and radiation therapy.
Misdiagnosis and subsequent medical expenses can be eliminated through the use of DNA Specimen Provenance Assay, or “DSPA.” This method of testing has evolved over the last several years, and it is recognized as the highest standard of care among prostate biopsy procedures. DSPA matches each patient’s unique genetic profile to that of the diagnostic tissue read by a pathologist or genetic counselor, in order to rule out the presence of undetected provenance complications prior to treatment. This ensures the proper patient is matched to his specimen.
Despite widespread adoption of DSPA as standard of care, the Centers for Medicare & Medicaid Services (CMS) says that DSPA does not fall within a permitted benefit category, and is, therefore, not reimbursed by Medicare. This interpretation poses a tremendous threat to hundreds of thousands of Medicare beneficiaries. To deprive Medicare beneficiaries of access to an important test which eliminates medical errors is contrary to the best interests of patients.
Clinical urologists support efforts to make DSPA testing available to Medicare beneficiaries for prostate biopsies. We urge members of Congress to protect patients from the devastating impact of misdiagnosis by enacting legislation that provides Medicare reimbursement for the simple and cost-saving DNA test that can eradicate medical errors.
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