ClearNote Health's Ovarian Cancer Test Gains Important CPT Code
ClearNote Health Gains CPT Code for Ovarian Cancer Test
ClearNote Health, a pioneering company in early cancer detection, has exciting news to share. The American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for the Avantect Ovarian Cancer Test. This new CPT code, 0507U, is set to take effect on October 1, 2024, and marks a significant advancement in the reimbursement pathways designed to enhance patient access and promote broader adoption of this vital ovarian cancer screening tool.
Enhanced Patient Access and Broader Adoption
The Avantect test serves an essential purpose by targeting those at high risk for ovarian cancer, including individuals with genetic predispositions like BRCA1 and BRCA2 mutations, as well as those with a family history of the disease or a personal background of breast cancer before age 40. By establishing a clearer reimbursement pathway, ClearNote Health aims to encourage more women to utilize this critical test, ultimately improving health outcomes.
CMS Proposals on Reimbursement Rates
The Centers for Medicare and Medicaid Services (CMS) have proposed preliminary reimbursement rates for the new CPT codes introduced by the AMA, including the 0507U for the Avantect Ovarian Cancer Detection Test. ClearNote Health is aligned with CMS’s recommendation of a reimbursement rate of $1,160.00 for this test. It's important to note that this rate mirrors a previous figure established for their Avantect Pancreatic Cancer Test, which has been successfully integrated into the existing Clinical Laboratory Fee Schedule.
Future Expectations
With the final determination from CMS expected later this year, it will be interesting to see how these rates will affect the commercialization of the Avantect test. The established rates will officially come into effect on January 1, 2025. ClearNote Health’s proactive approach in securing these reimbursements demonstrates its commitment to improving access to early cancer detection.
ClearNote Health’s Vision
Dave Mullarkey, CEO of ClearNote Health, expressed his excitement about this new development. He reiterated that achieving a CPT code and preliminary rate recommendation marks a pivotal commercial milestone for the organization, particularly in just a year’s time. This advancement reflects ClearNote Health's dedication to expanding patient access to early detection tools like the Avantect Ovarian Cancer Test. With ovarian cancer being the deadliest among gynecological cancers, early detection is crucial to improving survival rates, with stage 1 detection offering five-year survival rates of over 90%.
Proprietary Detection Methods
ClearNote Health's strategy involves utilizing proprietary epigenomic and genomic methods to facilitate early detection of cancers. Through standard blood draws, the company can identify cancer signals at early stages, analyzing levels of 5-hydroxymethylcytosine (5hmC), copy number variants, and fragment sizes in cell-free DNA. This groundbreaking approach positions ClearNote Health on the forefront of cancer diagnostics.
About ClearNote Health
ClearNote Health stands out as a transformative player in the cancer detection landscape, concentrating on technologies that empower individuals at risk for high-mortality cancers to lead healthier lives. The company leverages its proprietary epigenomic platform, merging innovative biology techniques with artificial intelligence, to detect DNA alterations as cancer progresses. Though headquartered in San Diego, ClearNote Health’s influence extends beyond state lines, reaching the San Francisco Bay Area and having an international presence.
Frequently Asked Questions
What is the significance of the new CPT code 0507U?
The CPT code 0507U enables easier reimbursement for the Avantect Ovarian Cancer Test, enhancing patient access and encouraging broader use of the test.
Who is the target population for the Avantect Ovarian Cancer Test?
This test is aimed at individuals at high risk for ovarian cancer, especially those with genetic predispositions or relevant personal or family medical histories.
How does ClearNote Health's testing method work?
ClearNote Health uses standard blood draws to analyze DNA signals associated with early-stage ovarian cancer, making detection possible at critical early points.
What recognition has ClearNote Health achieved recently?
ClearNote Health has secured a CPT code and preliminary reimbursement rate for its Avantect Ovarian Cancer Test, marking significant progress in cancer diagnostics.
When will the new reimbursement rates take effect?
The final reimbursement rates are expected to be established by CMS later this year, with effectiveness starting on January 1, 2025.
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