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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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We recently wrote about Shire’s $56.5 million settlement to resolve False Claims Act allegations involving the company’s ADHD drugs Adderall XR and Vyvanse. Shire agreed to a Corporate Integrity Agreement (CIA) with HHS-OIG in exchange for avoiding exclusion from participation... Continue reading
Posted 8 hours ago at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) made a number of announcements related to their Open Payments system this afternoon. The Open Payments website now has a search tool by physician name, teaching hospital, and company. CMS also announced... Continue reading
Posted 3 days ago at Policy and Medicine
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Silicon Valley has been interested in the healthcare industry for many years. Genetic testing startup 23andMe’s battle with the FDA highlights the continued tension between Silicon Valley’s desire to innovate and FDA’s interest in a rigorous—often slow—regulatory framework. A recent... Continue reading
Posted 3 days ago at Policy and Medicine
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Recently, the Combination Products Coalition ("CPC") wrote a letter to Leslie Kux, FDA's Assistant Commissioner for Policy, to reiterate a June 2014 comment regarding concerns with FDA's guidance development process. The CPC is a group of leading companies in the... Continue reading
Posted 3 days ago at Policy and Medicine
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The benefits of minimally invasive surgery (MIS), surgery done through one or more tiny incisions rather than one large opening, are well-documented at this point for a range of procedures. A recent study published in BMJ found that MIS is... Continue reading
Posted 4 days ago at Policy and Medicine
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In August, the Department of Health and Human Services (HHS) issued a final rule which delayed the transition to ICD-10 until October 1, 2015, one year away. Prior to the enactment of the Protecting Access to Medicare Act of 2014... Continue reading
Posted 5 days ago at Policy and Medicine
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Our continued coverage of the CMS Open Payments website includes transparency-related issues regarding the Physical Payment Sunshine Act and also a look at similar CMS projects. In particular, in August it was announced that CMS quietly stopped publicly reporting when... Continue reading
Posted 5 days ago at Policy and Medicine
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Pharmaceutical manufacturer co-payment coupons have come under a lot of scrutiny recently. HHS-OIG recently warned these coupons may violate the anti-kickback statute if they encourage the purchase of Medicare Part D drugs. Manufacturers seem to be safe, however, from co-pay... Continue reading
Posted 6 days ago at Policy and Medicine
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On October 2, 2014, the European Medicines Agency (EMA) unanimously voted to publish the clinical reports “that underpin the decision-making on medicines.” EMA will publish data submitted as part of marketing applications starting January 1, 2015. Beginning July 1, 2015,... Continue reading
Posted 7 days ago at Policy and Medicine
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The Secretary of the Department of Health and Human Services, Sylvia Burwell, yesterday held a press conference on health care policy. During the session, Burwell took time away from mostly Ebola-related questions for an Open Payments and transparency inquiry. In... Continue reading
Posted Oct 10, 2014 at Policy and Medicine
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This past July we wrote about the 21st Century Cures initiative and its efforts to bridge the gap between medical advances and the regulatory policies that govern them. The initiative, a bipartisan collaboration between Rep. Fred Upton (R–MI), chair of... Continue reading
Posted Oct 10, 2014 at Policy and Medicine
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Late last week, the Food and Drug Administration released its “cybersecurity” guidance, outlining recommendations that manufacturers “should consider” in order to protect patient information that may be stored on medical devices or transferred between wireless systems. The FDA recommends companies... Continue reading
Posted Oct 9, 2014 at Policy and Medicine
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Open Payments currently presents a vague portrait of how pharmaceutical and device manufacturers interact with physicians. The Centers for Medicare and Medicaid Services (CMS) noted on Monday that $3.3 billion out of $4.6 billion total payments from industry are either... Continue reading
Posted Oct 8, 2014 at Policy and Medicine
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Many payments in the Open Payments website wouldn't cover a doctor's popcorn and soda, let alone a movie ticket. Out of the 2.6 million lines of identifiable general payments that manufacturers collected and reported to CMS about their interactions with... Continue reading
Posted Oct 7, 2014 at Policy and Medicine
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The American Hospital Association’s Physician Leadership Forum examined the value of CME to hospitals as a "strategic resource for physician-hospital alignment." The report provides recommendations for how to improve the value of CME, including greater use of performance-based CME, more... Continue reading
Posted Oct 7, 2014 at Policy and Medicine
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FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to requests for additional time to allow interested parties to submit comments. As stated in the Federal Register, starting on September... Continue reading
Posted Oct 6, 2014 at Policy and Medicine
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Trends-in-Medicine is offering updates on Ebola, which recently has shown up inside the United States. We don’t normally cover this type of story on Policy and Medicine, but found Lynne Peterson’s articles to provide important information from the Centers for... Continue reading
Posted Oct 3, 2014 at Policy and Medicine
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CMS launched Open Payments on Tuesday. Instead of stories entitled “Find Out How Much Your Doctor Makes From Industry!” the media surrounding the release has for the most part focused on the deficiencies in the roll out of the system.... Continue reading
Posted Oct 3, 2014 at Policy and Medicine
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The Colombia Ministry of Health and Social Protection recently published a draft law which would require pharmaceutical and device manufacturers to disclose their payments and in-kind transfers to “those who participate in any manner in the provision, insurance, or education... Continue reading
Posted Oct 2, 2014 at Policy and Medicine
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CMS published the Open Payments database yesterday. Once we were able to download and analyze the full Excel spreadsheets (this took a while), we found that research payments from manufacturers to teaching hospitals and physicians equaled close to $1.5 billion.... Continue reading
Posted Oct 1, 2014 at Policy and Medicine
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Today, CMS launched its Open Payments System. The website went live at 2pm. Open Payments gives users the option of (1) downloading gigantic excel files of data or (2) using CMS’s “data explorer tool.” We took advantage of both options,... Continue reading
Posted Sep 30, 2014 at Policy and Medicine
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After over four years since the passage of the Affordable Care Act, September 30th marks the date for the release of the 2013 Sunshine Act data. Today, the Centers for Medicare and Medicaid Services (CMS) is set to publish a... Continue reading
Posted Sep 29, 2014 at Policy and Medicine
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On September 17, FDA hosted a public hearing on the Generic Drug User Fee Amendments of 2012 to solicit public comments on its guidances related to implementation of GDUFA. GDUFA requires industry to pay user fees to supplement the costs... Continue reading
Posted Sep 29, 2014 at Policy and Medicine
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The Justice Department announced last week that pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several products, including ADHD... Continue reading
Posted Sep 29, 2014 at Policy and Medicine
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FDA does not have “inherent reconsideration authority” to reclassify medical devices without notice and a comment period, states the Federal Circuit Court of Appeals for the District of Columbia. The Court ruled Friday that the FDA may not “short-circuit” the... Continue reading
Posted Sep 28, 2014 at Policy and Medicine