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Thomas Sullivan - Policy & Medicine Writing Staff
Columbia, Maryland
Former political consultant who founded Rockpointe, Inc. a bio-medical education company in 1995.
Interests: marketing, politics, baseball, cycling, medicine, university of florida sports, medical education, track and cross country, driving kids to various practices
Recent Activity
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Pharmaceutical companies have long been dealing with negative press about the supposed “rise of prescription drug costs.” Now, several organizations are adding themselves to the drama, developing different ways to assess the value of new medicines, based on attributes such... Continue reading
Posted yesterday at Policy and Medicine
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In the AseraCare case, the United States Department of Justice (DOJ) sought to show that AseraCare submitted false claims. Relying upon a single medical expert, the DOJ attempted to show patients’ medical records do not contain “clinical information and other... Continue reading
Posted yesterday at Policy and Medicine
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Two weeks ago, in the midst of the hubbub surrounding Mylan and its EpiPen, Jason Chaffetz and Elijah Cummings, Chairman and Ranking Member of the House Committee on Oversight and Government Reform, sent a letter to Mylan’s CEO, Heather Bresch.... Continue reading
Posted 2 days ago at Policy and Medicine
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Late last week, the Kaiser Family Foundation (KFF) released a new report, “Medicare Part D in 2016 and Trends over Time.” The report examined several different aspects of the Part D program, including enrollment and plan availability, premiums, benefit design... Continue reading
Posted 5 days ago at Policy and Medicine
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In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication on drugs approved on the basis of safety and effectiveness. This major revision of the Orange Book, known more formally... Continue reading
Posted 6 days ago at Policy and Medicine
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Recent plaintiff wins in lawsuits against life sciences companies seeking to recover lost shareholder value resulting from healthcare fraud investigations and enforcement actions seem to have emboldened more plaintiffs to aggressively pursue this remedy. An effective compliance program is intended... Continue reading
Posted 6 days ago at Policy and Medicine
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On July 15, 2016, the Food and Drug Administration (FDA) released a forty-six page document outlining how the FDA will use the user fees from industry, breaking down both the planned deadlines for new guidance documents and pilot projects, as... Continue reading
Posted 7 days ago at Policy and Medicine
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We have previously covered another of CMS’ transparency initiatives—its hospital star ratings—and some of the concerns industry has with the program. After a delay, CMS released the star ratings amid significant industry criticism. At the same time, a recent bipartisan... Continue reading
Posted Sep 20, 2016 at Policy and Medicine
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FDA’s requirements for clinical investigator d closure and the Open Payments requirements are at odds in many ways. This article explores those differences and what might be done to remedy the situation. As healthcare costs continue to rise and available... Continue reading
Posted Sep 20, 2016 at Policy and Medicine
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Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly engage human participants. Clinical trials have done a lot of good, providing advances in diagnosis, treatment, and prevention,... Continue reading
Posted Sep 19, 2016 at Policy and Medicine
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On Tuesday, September 20, 2016, at 11:00 am EDT, qordata is hosting a webinar on how to use analytics to reduce compliance risks. The webinar aims to cover a compliance officer’s perspective on how to use analytics to enhance existing... Continue reading
Posted Sep 19, 2016 at Policy and Medicine
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We’re only a few months removed from the constant news about Martin Shkreli and Valeant Pharmaceuticals and their price hikes on drugs. On Monday, August 22, 2016, a flurry of senatorial activity was taking place revolving around Mylan Labs and... Continue reading
Posted Sep 16, 2016 at Policy and Medicine
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In August 2016, new Health and Human Services (HHS) Office of Inspector General (OIG) guidance was issued on Independent Review Organization (IRO) independence and objectivity. This new guidance follows the original guidance offered in 2004, prompted by inquiries from individuals... Continue reading
Posted Sep 15, 2016 at Policy and Medicine
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Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at what has happened so far with transparency reporting in Europe and what the future may hold. In June 2013,... Continue reading
Posted Sep 15, 2016 at Policy and Medicine
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The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have expanded their collaboration in an effort to further expand the number and diversity of accredited CME activities that offer ABIM Maintenance of Certification... Continue reading
Posted Sep 14, 2016 at Policy and Medicine
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On September 12, 2016, the Government Accountability Office (GAO) released a report about generic drug prices in the Medicare Part D program. The report provides an overview of changes in Part D generic drug prices over time, the extent to... Continue reading
Posted Sep 13, 2016 at Policy and Medicine
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The pharmaceutical and medical technology industries appear to show marked transfer of value variations in this year’s Open Payments data. This study investigates further and asks, is it a case of two sectors using unique commercial models, or a simple... Continue reading
Posted Sep 13, 2016 at Policy and Medicine
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In a blog post, CMS announced changes to the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) that will allow physician practices to choose the level and pace at which they comply with the new payment reform model aimed... Continue reading
Posted Sep 12, 2016 at Policy and Medicine
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The National MACRA MIPS/APM Summit will be held November 30, 2016 through December 2, 2016, at the Hyatt Regency on Capitol Hill in Washington, D.C. The summit boasts a lengthy list of keynote speakers, including: Michael Leavitt, Founder and Chairman... Continue reading
Posted Sep 12, 2016 at Policy and Medicine
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Earlier this summer, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2017 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System policy changes, quality provisions, and payments rates proposed rule (CMS-1656-P).... Continue reading
Posted Sep 9, 2016 at Policy and Medicine
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The new Cardiovascular Systems, Inc. False Claims Act settlement has some in the industry wondering why CSI settled for such a small amount when we are used to pharmaceutical companies having to dive deep into their pockets to satisfy settlement... Continue reading
Posted Sep 9, 2016 at Policy and Medicine
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The United States Surgeon General, Vivek H. Murthy, M.D., M.B.A., penned a letter in August 2016 that he sent to doctors throughout the country. The letter starts out, “asking for your help to solve an urgent health crisis facing America:... Continue reading
Posted Sep 8, 2016 at Policy and Medicine
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The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress will be meeting October 19, 2016 through October 21, 2016, at the Mandarin Oriental in Washington, D.C. This year’s Pharma Congress boasts several keynote speakers, including Thomas W. Abrams, RPh, MBA,... Continue reading
Posted Sep 8, 2016 at Policy and Medicine
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In addition to the recent BMJ study about endocrinologists, cardiologists, and hematologists, another study was recently written about ophthalmologists and a purported association between reported industry payments and physician-prescribing habits. This study, published by JAMA Ophthalmology, compared the use of... Continue reading
Posted Sep 7, 2016 at Policy and Medicine
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Yet another study has been published by the BMJ, purporting to link payments by manufacturers of pharmaceuticals to physicians, asserting that such payments are “associated with greater regional prescribing of marketed drugs among Medicare Part D beneficiaries.” The study, led... Continue reading
Posted Sep 6, 2016 at Policy and Medicine