AngelMed Announces CMS Approval of Transitional Pass-Through (TPT) Payment Category For The Guardian™ Effective January 1, 2022
EATONTOWN, N.J., Nov. 11, 2021 /PRNewswire/ -- Angel Medical Systems, Inc., (dba AngelMed) a company focused on improving long-term management of high-risk coronary disease in patients who have survived one or more heart attacks, announced today the Center for Medicare & Medicaid Services (CMS) has granted The Guardian™ implantable acute coronary syndrome (ACS) event detector a transitional pass-through (TPT) payment category and a new HCPCS C code (C1833) effective January 1, 2022 and will remain in effect for the following two to three years. The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which The Guardian is used.
"This is a seminal moment for AngelMed with the assignment of a dedicated C-code that supports our value proposition and facilitates offering The Guardian at Hospitals and ASCs," said Brad Snow, Chief Executive Officer (CEO) of AngelMed. "The infrastructure investment will propel the company's technology as a valuable clinical option for high-risk ACS patients who have already survived a prior heart attack."
"The new technology payment team provided a thorough assessment of our clinical results and the submitted public comments. The TPT approval by CMS supports the ability for the combination of technology and patient behavior to provide a substantial clinical improvement for management of recurrent ACS events in high-risk patients when compared to current standard of care," said Sasha John, Chief Scientific Officer (CSO) of AngelMed.
TPT payment applies to patients with traditional Medicare. Applicability of separate additional payment is based on the hospital's contract with the patient's health plan.
About The Guardian System
The Guardian device is implanted subcutaneously by a cardiologist during a low-risk, outpatient surgical procedure. The Guardian's proprietary algorithm uses machine learning to establish a patients baseline then continuously records the heart's electrical activity, 24/7, detecting and alerting for heart attacks. The Guardian device provides a more effective diagnosis of a life-threatening event when compared to patient symptoms alone.1
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc., is a cutting edge medical device company offering the world's first and only FDA approved Class III implantable to detect silent and atypical symptomatic heart attacks in real time. Angel Medical Systems maintains a robust portfolio of U.S. patents pertaining to Acute Coronary Syndrome (ACS) events.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.
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Mike Gillem
Chief Commercial Officer
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phone # 623-760-7300
1. Food and Drug Administration Website. Summary of Safety and Effectiveness Data. https://www.fda.gov/media/96475/download. Accessed October 26, 2021
SOURCE Angel Medical Systems
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