Author: Abhay Panchal

The new final rule, set to be enforced from January 1, 2026, aims to streamline and digitize the prior authorization process in healthcare. Key aspects of this rule include: Timelines for Authorization Decisions: The rule mandates that decisions on urgent prior authorization requests must be made within 72 hours, and within 7 days for standard requests. This is expected to expedite the process and reduce delays in patient care. Specific Reasons for Denials: Payers are required to provide specific reasons for denying authorization requests. Additionally, they must publicly report certain prior authorization metrics on their websites, enhancing transparency in the…

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From private equity’s growing presence in the specialty to changes in the use of anesthesia, here are three trends shaping the gastroenterology field in 2024. Changes in anesthesiaBeginning Jan. 1, Blue Cross Blue Shield Massachusetts stopped its coverage of monitored anesthesia for certain gastrointestinal patients undergoing endoscopic, bronchoscopic or interventional pain procedures. The insurer no longer considers monitored anesthesia “medically necessary” through this new policy except for cases wherein a patient receives documentation that specific risk factors or significant medical conditions are present from the operating physician or anesthesiologist/certified registered nurse anesthetist. Meanwhile, the shortage of anesthesiologists continues to affect…

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Geneoscopy said Friday that it has petitioned the US Patent and Trademark Office for inter partes review challenging the patentability of Exact Sciences’ patent No. 11,634,781, which is at the heart of a lawsuit filed by Exact against Geneoscopy last November. Geneoscopy said it moved to dismiss the suit in its entirety in December. The company’s new inter partes review petition argues that the claims of the ’781 patent, titled “Fecal Sample Processing and Analysis Comprising Detection of Blood,” are not inventive. Exact’s patent describes the preparation of stool samples for colorectal cancer testing, which includes removal of one portion…

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EndoClot Adhesive is an innovative hemostatic spray with a composition and mechanism of action that distinguish it from other available agents. The Adhesive Hemostatic Polymer technology underlying EndoClot Adhesive provides a unique mechanism to address limitations typically encountered with standard-of-care hemostatic options. EndoClot Adhesive is ideally suited to prevent bleeding after endoscopic mucosal resection and endoscopic submucosal dissection.

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Mainz Biomed N.V., a molecular genetics diagnostic company specializing in early cancer detection, provided a year-end summary of its corporate and product development progress for 2023. The company announced significant advancements in its clinical studies and commercial operations. Key highlights from the year-end review include: Overall, Mainz Biomed’s year-end review highlights significant progress in clinical studies, international commercial expansion, and preparations for pivotal FDA trials, positioning the company for continued growth and innovation in cancer diagnostics.

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Withings has introduced a new health tech device at CES this year, the BeamO, priced at $249.95. BeamO is a multiscope that combines several health monitoring functions into one device. It measures temperature, takes electrocardiograms (EKGs), reads blood oxygen levels, and functions as a stethoscope to monitor heart and lung health. Key features of the BeamO include: The BeamO represents Withings’ continued investment in developing an at-home health platform, aiming to simplify and enhance health monitoring for families. However, the actual availability of the device is subject to FDA approval, and Withings has a history of delays in getting clearance…

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In November, Blue Cross Blue Shield Massachusetts announced that beginning Jan. 1, it would no longer cover the use of monitored anesthesia for certain gastrointestinal patients undergoing endoscopic, bronchoscopic or interventional pain procedures. Now that the policy has officially gone into effect, monitored anesthesia is no longer considered “medically necessary” for these procedures by the insurer, unless a patient receives documentation by the operating physician or anesthesiologist/certified registered nurse anesthetist that specific risk factors or significant medical conditions are present. Patients with few or no comorbidities will no longer receive coverage. BCBS cited a study from the American Society for…

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The current approach to esophageal function testing is deemed insufficient for accurately characterizing esophageal motility disorders, particularly in patients with esophageal dysphagia. This inadequacy is highlighted in a report by Ravinder K. Mittal, MD, and Ali Zifan, PhD, from the University of California San Diego, published in Gastro Hep Advances. Key points from the report include:

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A phase 1 trial for a vaccine targeting micrometastatic disease markers in patients treated for pancreatic or colorectal cancer has shown promising results in preventing recurrence. The study, published in Nature Medicine, involved a vaccine that targets two different KRAS mutations (G12D and G12R) and is designed as an off-the-shelf vaccine. This vaccine binds to albumin in the body and targets the lymph nodes to increase the T-cell response, potentially fighting micrometastatic diseases. Key findings from the trial include: Dr. Shubham Pant, a professor in the department of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center,…

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