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Nov 15, 2024 | 
jamanetwork.com | Osman Moneer |James Johnston |Vinay K. Rathi |Joseph Ross
Key PointsQuestion What evidence do the Centers for Medicare & Medicaid Services (CMS) consider when approving or denying transitional pass-through payments (TPTPs) for new outpatient medical devices? Findings This cross-sectional study of 43 TPTP applications from 2017 to 2023 found that CMS approved 17 (40%), including all 8 (100%) applications for US Food and Drug Administration (FDA)-designated breakthrough devices.
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Nov 5, 2024 | 
ajmc.com | Daphne T. Hao |Vinay K. Rathi |Joseph Ross |Roy Xiao
PublicationArticleNovember 5, 2024The American Journal of Managed CareNovember 2024Author(s):,Private negotiated facility fees at hospitals are on average double the ambulatory surgery center facility fees for common outpatient procedures. Am J Manag Care. 2024;30(11):In Press_____Takeaway PointsOn average, hospital facility fees are more than double the ambulatory surgery center (ASC) facility fees for common outpatient procedures.
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May 8, 2024 | 
onlinelibrary.wiley.com | Peter Cooke |Michael Wu |Vinay K. Rathi |Sida Chen
• , , , , , . Prognoses and improvement for head and neck cancers diagnosed in Europe in early 2000s: the EUROCARE-5 population-based study . Eur J Cancer. ; ( ): - . • , , . Significance of induction chemotherapy in the treatment of locally advanced laryngeal cancer and hypopharyngeal cancer . Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. ; ( ): - . • , , , . The natural history of patients with squamous cell carcinoma of the hypopharynx . Laryngoscope. ; ( ): - . • , , , et al.
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Feb 15, 2024 | 
healthaffairs.org | Kushal Kadakia |Vinay K. Rathi |Sanket S Dhruva |Maryam Mooghali |Claudia See |Joseph Ross | +1 more
The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a request from Congress, initiated by Senators Durbin (D-IL) and Blumenthal (D-CT), to review FDA’s oversight of device recalls in the wake of the far-reaching and ongoing recall initiated by Philips Respironics, which affected 15 million devices.
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Feb 6, 2024 | 
statnews.com | Kushal Kadakia |Joseph Ross |Vinay K. Rathi
Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure machines, known as CPAP or BiPAP depending on their design, are sophisticated medical devices that have been used for decades by patients with sleep disorders like obstructive sleep apnea.
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Oct 25, 2023 | 
jamanetwork.com | Osman Moneer |Vinay K. Rathi |James Johnston
Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program Abstract Importance The US Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have different statutory authorities; FDA evaluates safety and effectiveness for market authorization of medical devices while CMS determines whether coverage is “reasonable and necessary” for its beneficiaries.
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Aug 21, 2023 | 
jamanetwork.com | Vinay K. Rathi |Joseph S. Ross |Rita F. Redberg
Unique Device Identifiers—Missing in Action Unique Device Identifiers for Medical Devices at 10 Years Sanket S. Dhruva, MD, MHS; Joseph S. Ross, MD, MHS; Natalia A. Wilson, MD, MPH Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices Xuan Wang, PhD; Vidul Ayakulangara Panickan, MS; Tianrun Cai, MD; Xin Xiong, MS; Kelly Cho, PhD, MPH; Tianxi Cai, ScD; Florence T.
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Jun 20, 2023 | 
onlinelibrary.wiley.com | Lucy Xu |Vinay K. Rathi |Michael Johns |Aalok Agarwala
Supporting Information Filename Description lary31623-sup-0001-Supplemental_Figure.pdfPDF document, 88 KB Supplemental Figure 1. Comparison of USNWR-eligible and USNWR-ineligible admission MS-DRGs between 2019 and 2021. USNWR—U.S. News & World Report, MS-DRG—Medical Severity-Diagnosis Related Group, CC—comorbidities or complications, MCC—major comorbidities or complications. BIBLIOGRAPHY 1, , , et al.
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Jun 2, 2023 | 
onlinelibrary.wiley.com | Margaret Mitchell |Alan D. Workman |Vinay K. Rathi |Neil Bhattacharyya
Original Report This manuscript has not been previously presented or published. Editor's Note: This Manuscript was accepted for publication on May 12, 2023. The authors have no funding, financial relationships, or conflicts of interest to disclose. Abstract Objective The aim of this study was to quantify the impact of COVID-19 on olfactory and gustatory function in US adults.
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May 9, 2023 | 
jamanetwork.com | Vinay K. Rathi |Alexander O. Everhart |Soumya Sen
To the Editor A recent study1 reported that 11% of the medical devices cleared via the 510(k) regulatory submission pathway experienced a class I or class II recall. Even though I share the concerns of Dr Everhart and colleagues1 about unsafe devices, I believe they may have underestimated the recall rate for devices cleared via the 510(k) process. Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
