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Thomas Sullivan
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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On Friday, the Centers for Medicare and Medicaid Services (CMS) added approximately 68,000 payment records—valued at more than $200 million—to the Open Payments dataset. “With this new data, Open Payments now reports information on $3.7 billion in payments and transfers... Continue reading
Posted 12 hours ago at Policy and Medicine
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GlaxoSmithKline’s 2012 Corporate Integrity Agreement made mandatory the company’s policy that it would not provide sales reps with incentive compensation based upon volume of sales. In December 2013, GSK announced that they would stop paying healthcare professionals to speak at... Continue reading
Posted 3 days ago at Policy and Medicine
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OIG Plans to Focus on How FDA Inspects Generic Manufacturers and Enforces Postmarketing and Clinical Trial Transparency Requirements; Will Also Look Into the Early Experiences With DSCSA The Department of Health and Human Services Office of Inspector General recently released... Continue reading
Posted 4 days ago at Policy and Medicine
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The focal point of the EFPIA HCP Code provisions on scientific or educational meetings and conferences is "appropriateness." This loose standard is fleshed out some in Section 10, outlined in detail below, as well as individual EFPIA member codes. EFPIA... Continue reading
Posted 5 days ago at Policy and Medicine
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Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued three FAQs and an example grid to supplement their recent revision to the Physician Payments Sunshine Act continuing medical education (CME) exemption. Instead of clarifying the new Rule, however, this... Continue reading
Posted 6 days ago at Policy and Medicine
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The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online database of country-specific clinical research regulatory information “designed to save time and effort in planning and implementing clinical research.” The website, ClinRegs,... Continue reading
Posted Dec 12, 2014 at Policy and Medicine
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The Department of Health and Human Services Office of Inspector General recently released its 2015 Work Plan. OIG’s annual Work Plan summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to HHS programs and operations... Continue reading
Posted Dec 11, 2014 at Policy and Medicine
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A paralegal recently fired by French drug manufacturer Sanofi has filed a whistleblower lawsuit, claiming she was discharged after protesting an alleged kickback scheme involving Sanofi’s diabetes products. Diane Dupont brought the case in a New Jersey state court last... Continue reading
Posted Dec 11, 2014 at Policy and Medicine
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A paralegal recently fired by French drug manufacturer Sanofi has filed a whistleblower lawsuit, claiming she was discharged after protesting an alleged kickback scheme involving Sanofi’s diabetes products. Diane Dupont brought the case in a New Jersey state court last... Continue reading
Posted Dec 10, 2014 at Policy and Medicine
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Bipartisan legislation drafted by Senators Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health records and clinical decision support software from FDA oversight. Introduced late last week, the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH)... Continue reading
Posted Dec 10, 2014 at Policy and Medicine
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Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications. Manufacturers of devices face less burdensome regulation and far cheaper application fees. A long-litigated case, Prevor v. FDA (Prevor II),... Continue reading
Posted Dec 9, 2014 at Policy and Medicine
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On Monday, the Measure Applications Partnership (MAP) began its annual review of performance measures that the Centers for Medicare and Medicaid Services (CMS) is considering for use in 20 federal health programs. The 202 measures considered by the group have... Continue reading
Posted Dec 5, 2014 at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) today made a number of announcements related to the Open Payments program. Updates to the physician and manufacturer search tool CMS previously announced the availability of the Open Payments data search tool... Continue reading
Posted Dec 4, 2014 at Policy and Medicine
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The Industry Alliance for Continuing Education's (IACE) Benchmark Work Group (BWG) have shared their 2014 study of the life science industry's best practices related to commercial support of independent medical education (IME). The BWG has surveyed industry for several years... Continue reading
Posted Dec 4, 2014 at Policy and Medicine
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Last month, the Department of Justice filed an indictment charging Vascular Solutions Inc. and its chief executive officer, Howard Root, with selling medical devices without FDA-approval and “conspiring to defraud the United States by concealing the illegal sales activity.” The... Continue reading
Posted Dec 3, 2014 at Policy and Medicine
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Developing a new prescription medicine that gains marketing approval is estimated to cost drugmakers $2.6 billion according to a recent study by Tufts Center for the Study of Drug Development. This is up from $802 million in 2003—equal to approximately... Continue reading
Posted Dec 2, 2014 at Policy and Medicine
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DaVita, a leading dialysis services provider, has agreed to one of the largest healthcare settlements of 2014. The Department of Justice announced that DaVita will pay $350 million to resolve allegations that the company violated the False Claims Act by... Continue reading
Posted Dec 1, 2014 at Policy and Medicine
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The Food and Drug Administration (FDA) recently finalized guidance which allows fixed-combination drugs consisting of at least one new drug product to be eligible for a five-year “New Chemical Entity” (NCE) exclusivity period. FDA’s policy, entitled New Chemical Entity Exclusivity... Continue reading
Posted Nov 26, 2014 at Policy and Medicine
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In recent months, we have written about the expansion of Accountable Care Organizations (ACOs) across the country. An estimate indicates there are nearly 289,000 total healthcare providers and business personnel aligned with this new model for delivering care. Other studies... Continue reading
Posted Nov 26, 2014 at Policy and Medicine
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At a recent meeting in Washington, D.C., Rep. Michael Burgess, M.D. (R-TX) spoke to the importance of H.R. 5539, bipartisan legislation he co-sponsored that would exempt peer-reviewed medical journal reprints and independent continuing medical education from Sunshine Act reporting. Burgess... Continue reading
Posted Nov 25, 2014 at Policy and Medicine
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On Thursday, December 11, the law firm Arnold and Porter will be hosting a webinar: “Drug Supply Chain Security Act (DSCSA): How To Get Ready (Fast) for Track & Trace.” The presentation is part of a three-part series entitled “Pharmaceutical... Continue reading
Posted Nov 24, 2014 at Policy and Medicine
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Insurer Medical Mutual of Ohio has sued Abbvie, Abbott Laboratories, Solvay, Eli Lilly, Auxilium, Actavis, and a host of subsidiaries over each company’s respective “low testosterone” disease awareness activities and promotion of testosterone replacement therapy (TRT) drugs. “These TRT drugs... Continue reading
Posted Nov 24, 2014 at Policy and Medicine
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During last week’s 2014 AMA Interim Meeting in Dallas, AMA House of Delegates voted to update the AMA’s policy on maintenance of certification (MOC). The adopted policy outlines principles that emphasize the need for an evidence-based process that is evaluated... Continue reading
Posted Nov 21, 2014 at Policy and Medicine
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The 4th Annual Health Law Regulatory & Compliance Competition will be held on Saturday, February 21, 2015, at the University of Maryland Francis King Carey School of Law. View the announcement and detailed competition information here. Download the Intent to... Continue reading
Posted Nov 20, 2014 at Policy and Medicine
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Yesterday, the Department of Health and Human Services and the National Institutes of Health (NIH) proposed to “increase the transparency of clinical trials via information submitted to ClinicalTrials.gov.” NIH notes that “[a] major proposed change from current requirements is the... Continue reading
Posted Nov 20, 2014 at Policy and Medicine