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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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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 yesterday 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 2 days ago 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 2 days ago 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 3 days ago at Policy and Medicine
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In August, House Ways and Means Subcommittee on Health Chairman, Kevin Brady (R-TX), released the Protecting Integrity in Medicare Act of 2014 (PIMA), a discussion draft aimed at combating fraud, waste, and abuse in Medicare . The Act put forth... Continue reading
Posted 5 days ago at Policy and Medicine
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A recent editorial published in the Wall Street Journal entitled "Doctoring in the Age of ObamaCare" provides a glimpse at a day in the life of an endocrinologist working in solo private practice. Dr. Mark Sklar has experienced the changing... Continue reading
Posted 6 days ago at Policy and Medicine
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An interesting False Claims Act issue cropped up in a recent $8 million settlement involving U.K.-based medical device manufacturer Smith & Nephew. The company allegedly violated the U.S. Federal Trade Agreement Act by selling orthopedic devices to the Department of... Continue reading
Posted 7 days ago at Policy and Medicine
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The Food and Drug Administration has released a guidance document that offers insight into their decision-making when reviewing 510(k) premarket notification applications. Medical device sponsors submit a 510(k) to FDA in order for the agency to clear their device for... Continue reading
Posted 7 days ago at Policy and Medicine
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Pharmaceutical manufacturers routinely offer copayment coupons to reduce or eliminate the cost of patients' out-of-pocket payment for specific brand name drugs. On Friday, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) released a report that such... Continue reading
Posted Sep 23, 2014 at Policy and Medicine
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Life science trade associations PhRMA, Advamed, and BIO have sent a letter to the Centers for Medicare and Medicaid Services (CMS) voicing concerns about the Sunshine Act public database, set to go live on September 30. The associations request CMS... Continue reading
Posted Sep 22, 2014 at Policy and Medicine
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Two bipartisan efforts in Congress underscore the importance of up-to-date medical education. On Thursday, Reps. Michael Burgess (R-TX) and Frank Pallone (D-NJ) sent a letter to the Centers for Medicare and Medicaid Services (CMS), to voice concern about the agency's... Continue reading
Posted Sep 22, 2014 at Policy and Medicine
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In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX), Vice Chairman and Frank Pallone (D-NJ), Ranking Minority Member of the Health subcommittee of the House Energy and Commerce Committee, came together to encourage the Centers for Medicare and Medicaid... Continue reading
Posted Sep 22, 2014 at Policy and Medicine
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In July of last year, Chinese authorities accused GlaxoSmithKline (GSK) of using a network of travel agencies to channel around $489 million in bribes to health officials. The former head of GSK China, Mark Reilly, was also charged with corruption... Continue reading
Posted Sep 19, 2014 at Policy and Medicine
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AMP - Accelerating Medicines Partnership In February, we wrote about the National Institutes of Health (NIH) announcement of a partnership with ten drug makers, as well as eight non-profit organizations, to accelerate the discovery of new therapies for Alzheimer's disease,... Continue reading
Posted Sep 19, 2014 at Policy and Medicine
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A New York federal judge recently dismissed two separate cases brought by Fox Rx Inc.--one against Omnicare, the other against Walgreens. In both complaints, Fox asserted that the pharmacies (1) failed to substitute generic drugs for brand-name drugs in states... Continue reading
Posted Sep 18, 2014 at Policy and Medicine
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A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the Pharmaceutical Research and Manufacturers of America (PhRMA) and subsequently the Department of Justice, both of whom have filed amicus curiae briefs... Continue reading
Posted Sep 17, 2014 at Policy and Medicine
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The U.S. Court of Appeals for the Eighth Circuit rejected a whistleblower suit against Stryker Corp. and other pain pump manufacturers because the allegations were based on information that had already been made public. The Court upheld the District Court... Continue reading
Posted Sep 16, 2014 at Policy and Medicine
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In June, we noted that Accountable Care Organizations (ACOs) have proliferated throughout the United States in the past few years, but they are still a comparatively new model for delivering low-cost, high quality care. As of mid-2013, there were over... Continue reading
Posted Sep 16, 2014 at Policy and Medicine
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Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. The inherently... Continue reading
Posted Sep 15, 2014 at Policy and Medicine
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Sixty-four patient organizations including the ALS Association, American Diabetes Association, and American Heart Association have petitioned the Centers for Medicare and Medicaid Services (CMS) to make an Open Payments reporting exemption for indirect payments made to voluntary health agencies (VHAs).... Continue reading
Posted Sep 15, 2014 at Policy and Medicine
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The Journal of European Continuing Medical Education recently published a recap of this year’s “Union Européenne des Médecins Spécialistes” (UEMS) Conference on continuing medical education (CME) in Europe. We have provided highlights from the conference report, written by Julie Simper,... Continue reading
Posted Sep 12, 2014 at Policy and Medicine
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Last night, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored individuals and organizations for their work in the field of HIV/AIDS at the 2014 PhRMA Research and Hope Awards. The event served as both a celebration of groundbreaking achievements... Continue reading
Posted Sep 11, 2014 at Policy and Medicine
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We outlined a special fraud alert that targeted the relationship between blood-testing laboratories and physicians. In it, the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services made clear that they will be scrutinizing... Continue reading
Posted Sep 11, 2014 at Policy and Medicine
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The Pharmaceutical Research and Manufacturers of America (PhRMA) recently launched an impressive website—the “Innovation Hub”—which showcases the latest data and research on innovation in the biopharmaceutical industry. The website offers a central place for PhRMA’s resources related to the R&D... Continue reading
Posted Sep 10, 2014 at Policy and Medicine
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The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to reserve proprietary names as early as the end of Phase II trials. According to Regulatory Focus, FDA has posted the Pharmaceutical Research and... Continue reading
Posted Sep 10, 2014 at Policy and Medicine