Osman Moneer
@osmanmoneer
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@StanfordMed Internal Medicine Resident. Formerly @YaleMed and @Columbia. he/him/his.
Joined February 2020
We’re moving to California! So excited to match at @StanfordDeptMed for Internal Medicine residency!!
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Latest in @JAMANetworkOpen: @MedicareGov's Coverage with Evidence Development (CED) program has commissioned 116 clinical studies on medical devices and therapies, nearly half (49.1%) of which have results, producing 556 unique research publications. https://t.co/e2gnvSiTr0
jamanetwork.com
This cross-sectional study assesses published research articles about medical items and services approved by the Coverage With Evidence Development program to characterize their scientific impact.
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It isn’t always clear whether a new drug or device is effective. When in doubt, @CMSGov can insure a product for further study, called Coverage with Evidence Development (CED). In @HealthAffairs, we examine the evidence CMS uses for final CED decisions:
healthaffairs.org
The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program provides coverage for items and services not meeting Medicare’s “reasonable and necessary”...
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In @Health_Affairs, we analyzed the availability and quality of recent @MedicareGov Local Coverage Determination decisions. The program has increasingly reported decision summaries. But the quality of evidence they cite within the summaries is lackluster. https://t.co/bXX7DCjwaB
healthaffairs.org
Under the 21st Century Cures Act of 2016, a summary of the evidence used to support local coverage determinations, which represent the vast majority of Medicare's coverage decisions for new technol...
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CMS should consider strengthening premarket evidence requirements to ensure that supplemental payments are reserved for technologies that meaningfully enhance the care of Medicare beneficiaries.
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We found that devices approved for supplemental payments more commonly received FDA authorization based on premarket clinical studies. However, these studies often lacked generalizability to Medicare beneficiaries, used surrogate measures, or didn't meet all primary endpoints.
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To facilitate adoption of new medical devices, CMS can award💰 extra payments 💰 on top of standard reimbursement. In JAMA Health Forum, we characterized the evidence considered by CMS when approving or denying applications for outpatient Medicare supplemental payments.
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Centers for Medicare & Medicaid Services (CMS) should consider strengthening premarket evidence requirements for breakthrough medical devices to improve patient care and inform treatment decisions. https://t.co/AsRRgpQLQa
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I am so thrilled to be joining the @StanfordCTSurg family with @osmanmoneer by my side!!! Many thanks to all the mentors, family and friends who helped us get here ❤️ See you soon, California!
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The Breakthrough Devices Program may qualify new, costly devices for supplemental Medicare payment despite the evidence supporting FDA authorization not being representative of CMS beneficiaries and persistent uncertainty of product benefit and risk.
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Fortunate to have worked with such an amazing team of co-authors!! Kudos to Vinay Rathi (@MassEyeAndEar), @JLJohnstonMD (@BrighamMedRes), @jsross119 (@Yale_CRRIT), and Sanket Dhruva (@UCSFCardiology)
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Along with an editor's note from @JAMACardio's @NMHheartdoc, Patrick O'Gara, and Robert Bonow contextualizing our work: https://t.co/whlxJ9YVwG
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With an excellent accompanying editorial from former Chief Medical Officer and Director of the Center for Clinical Standards and Quality at CMS @LeeAFleisher: https://t.co/dFoHwTj8ZH
jamanetwork.com
The pace of innovation in medicine has been accelerating with an increasing number of devices being approved by the US Food and Drug Administration (FDA). The 21st Century Cures Act created a...
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How can FDA & CMS align policies to ensure that medical device innovation is based on strong and representative evidence? In a new @JAMACardio Special Communication, we explore market authorization and coverage for Breakthrough cardiovascular🫀 devices. https://t.co/2dot88CyPW
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Many thanks to this great group & @Arnold_Ventures for a terrific past 2 days of engaging dialogue on all aspects of FDA advisory committees. Very much looking forward to continuing the discussion toward identifying opportunities for reform and crafting concrete recommendations.
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Check out our opinion piece in @bmj_latest! We discuss the challenges of evidence generation for Covid-19 drugs and suggest a role for observational studies in pandemic decision-making. @JoshuaDWallach @jsross119
https://t.co/TGoPRCzH9v
bmj.com
The urgency of the covid-19 pandemic highlighted the need to leverage any and all available data that may potentially inform clinical, public health, and regulatory decision making.1 Although...
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In this @bmj_latest linked Opinion, we discuss our recent manuscript, some challenges, and when observational studies can complement evidence generated from RCTs ... https://t.co/0eJWNPXi2Z
bmj.com
Objective To systematically identify, match, and compare treatment effects and study demographics from individual or meta-analysed observational studies and randomized controlled trials (RCTs)...
The urgency of the covid-19 pandemic highlighted the need to leverage any and all available data that may potentially inform decision making. Can observational research be a reliable proxy for RCTs? @JoshuaDWallach @osmanmoneer @jsross119
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The urgency of the covid-19 pandemic highlighted the need to leverage any and all available data that may potentially inform decision making. Can observational research be a reliable proxy for RCTs? @JoshuaDWallach @osmanmoneer @jsross119
bmj.com
The urgency of the covid-19 pandemic highlighted the need to leverage any and all available data that may potentially inform clinical, public health, and regulatory decision making.1 Although...
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Thrilled to represent @YaleCardiacSurg at #AATS2022 with our presentation on TAVR explantation! Grateful for the support of my mentors Dr. Williams and @ArnarGeirssonMD and looking forward to hearing more excellent discussion @AATSHQ
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