Key Takeaways
- The Avantect Ovarian Cancer Test now has a dedicated CPT code (0507U) and a preliminary reimbursement rate from CMS, making it more accessible to patients at high risk for ovarian cancer.
- Early detection of ovarian cancer through Avantect’s blood-based diagnostic tool can significantly improve survival rates, with detection in stage 1 potentially raising the five-year survival rate to over 90%.
- ClearNote Health’s partnership with CMS represents a critical milestone in expanding access to early cancer detection technologies, addressing a significant unmet need in high-risk patient populations.
ClearNote Health, a leading company in early cancer detection, has reached a significant milestone with the announcement of a new Current Procedural Terminology (CPT) code for its Avantect Ovarian Cancer Test. The American Medical Association (AMA) has assigned the new CPT Proprietary Laboratory Analyses (PLA) code 0507U, which will become effective on October 1, 2024.
This new code will establish a reimbursement pathway, making it easier for patients to access the test and increasing its adoption among healthcare providers. The Avantect Ovarian Cancer Test is specifically designed for patients at high risk of developing ovarian cancer, such as those with genetic predispositions like BRCA1 and BRCA2 mutations, a family history of ovarian cancer, or a personal history of breast cancer diagnosed before the age of 40.
Ovarian cancer is the most lethal gynecological cancer and the fifth leading cause of cancer-related deaths among women. Early detection is critical because four out of five women are diagnosed when the disease has already reached an advanced stage, which severely limits treatment options and worsens outcomes. Dave Mullarkey, CEO of ClearNote Health, emphasized the importance of early detection: “Ovarian cancer is the deadliest gynecological cancer and the fifth leading cause of cancer-related deaths among women. Four out of five women are diagnosed with advanced disease, which is unacceptable when detection in stage 1 could increase five-year survival to over 90 percent or more.”
CMS Proposes Reimbursement Rate for Avantect Ovarian Cancer Test Following CPT Code Approval
In addition to the issuance of the CPT code, the Centers for Medicare and Medicaid Services (CMS) has proposed a preliminary reimbursement rate for the Avantect Ovarian Cancer Test. The proposed rate of $1,160.00 aligns with the rate set for the Avantect Pancreatic Cancer Test, which is currently reimbursed under CPT code 0410U. The final determination on the reimbursement rate for 0507U will be issued later this year, with the new rates becoming effective on January 1, 2025, under the Clinical Laboratory Fee Schedule.
The Avantect Ovarian Cancer Test offers a non-invasive, blood-based approach to early cancer detection. By analyzing biological markers such as 5-hydroxymethylcytosine (5hmC), copy number variants, and DNA fragment sizes in cell-free DNA, the test provides critical information to help identify the presence of ovarian cancer in its earliest stages. This innovative diagnostic tool supports healthcare providers in making more informed decisions about whether to proceed with further diagnostic procedures, such as a biopsy, following abnormal test results like high prostate-specific antigen (PSA) levels, or digital rectal examinations (DRE).
ClearNote Health Expands Access to Life-Saving Early Cancer Detection with CPT Code and Reimbursement for Avantect Ovarian Cancer Test
ClearNote Health’s ongoing efforts to provide life-saving diagnostic tools are helping to address the unmet need for early detection in high-risk patients. This achievement follows the company’s earlier success with the Avantect Pancreatic Cancer Test and underscores its commitment to expanding access to cutting-edge cancer detection technologies. The newly issued CPT code and proposed reimbursement rate will play a key role in ensuring that more patients can benefit from the test’s early detection capabilities.
As ClearNote Health continues to advance the field of precision diagnostics, the Avantect Ovarian Cancer Test represents a breakthrough in the early detection of highly lethal cancer. With the support of CMS and the new reimbursement pathways, ClearNote Health is poised to significantly impact patient outcomes and improve survival rates for those at risk of ovarian cancer.
Resource: ClearNote Health, September 26, 2024
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