Latest news with #MolDX
Business Wire
6 days ago
- Health
- Business Wire
Cardio Diagnostics Receives Gapfill Payment Rates for AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS)
CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced that the Centers for Medicare and Medicaid Services (CMS), through the MolDX program, has issued preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™. A 'gapfill' payment rate means that pricing is determined by each Medicare contractor, including MolDX, based on cost data from Cardio Diagnostics. These preliminary payment rates, proposed as part of the calendar year 2025 gapfill pricing process, are expected to be finalized later this year and will be effective for claims with dates of service on or after January 1, 2025. The proposed rates represent a significant positive development in the Company's efforts to expand access to its advanced cardiovascular testing for Medicare beneficiaries. 'We view this as a critical step toward expanding timely access and improving care for Medicare patients' said Meesha Dogan, PhD., CEO and Co-Founder of Cardio Diagnostics. 'Many Medicare beneficiaries, who are at elevated risk for coronary heart disease, go undetected and undertreated, often resulting in avoidable heart attacks, hospitalizations, and poor outcomes.' Cardio Diagnostics clarified during a recent meeting with MolDX that initial public documentation had inadvertently transposed the pricing between the two tests, and MolDX confirmed the correct association of the proposed payment rates to their respective tests. Addressing the Leading Cause of Death Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older. In 2022 alone, over 700,000 Americans died from heart disease, with coronary heart disease (CHD) accounting for more than 370,000 deaths. PrecisionCHD™ is a groundbreaking AI-powered test designed to aid in the diagnosis of CHD by analyzing both genetic and epigenetic markers. Meanwhile, Epi+Gen CHD™ provides insight into a patient's three-year risk for a CHD event, such as a heart attack. Both tests are performed from a simple blood draw, enabling scalable, accessible, and non-invasive cardiovascular assessment. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, that were effective on April 1, 2024. About Cardio Diagnostics Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine ('Core Technology') for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit Forward-Looking Statements Certain statements and information included in this press release constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases 'will', 'will likely result,' 'expected to,' 'will continue,' 'anticipated,' 'estimate,' 'projected,' 'intend,' 'goal,' or similar expressions are intended to identify 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, and dependence on results as discussed in the Annual Report on Form 10-K for the period ended December 31, 2024, under the heading 'Risk Factors' in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release.
Scoop
29-04-2025
- Health
- Scoop
Triage Plus Price Set To Lift Pacific Edge's Economics
Pacific Edge notes today that the draft 'Gapfill' prices for Cxbladder Triage Plus2 have been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of US$1,018.44. When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test. In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026. Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline. Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication. Pacific Edge Chief Executive Dr Peter Meintjes said: 'We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk. 'The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.' Notes: 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+. 3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not. 4 Half year to 30 September 2024. 5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting. 6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126. 7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.
