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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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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 8 hours ago 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 yesterday 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 yesterday 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 2 days ago 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 2 days ago 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 5 days ago 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 6 days ago 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 6 days ago 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 7 days ago 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 7 days ago at Policy and Medicine
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On Friday, August 22, the U. S. Drug Enforcement Administration (DEA) published their Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more restrictive Schedule II. The change will take effect 45-days from the Final Rule, so... Continue reading
Posted Sep 9, 2014 at Policy and Medicine
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September 2nd marked the last day for comments on CMS’ proposed rule to eliminate the accredited continuing medical education (CME) exemption from Sunshine Act reporting. In an overwhelming display of support for the exemption, over 800 comments were submitted encouraging... Continue reading
Posted Sep 8, 2014 at Policy and Medicine
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On Tuesday, we walked through the problematic Open Payments roll-out from a manufacturer perspective. Today, we will outline the arduous path that physicians and teaching hospitals have had to tread in order to simply review their payment data—only to find... Continue reading
Posted Sep 4, 2014 at Policy and Medicine
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This summer, in a letter to counsel, the Food and Drug Administration (FDA) granted citizen petitions that asked the agency to clarify its regulations and policies regarding truthful, non-misleading scientific communications and activities related to investigational new drugs and devices,... Continue reading
Posted Sep 4, 2014 at Policy and Medicine
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The Fifteenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, www.PharmaCongress.com, will take place from November 3 - 5, 2014 at the Hyatt Regency on Capitol Hill in Washington, DC. Registrants may attend the event in person or... Continue reading
Posted Sep 3, 2014 at Policy and Medicine
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The CME Coalition has submitted their comment voicing serious concerns over CMS’s proposal to eliminate the CME exemption from Sunshine Act reporting. The Coalition notes that, as written, the proposed changes will have a detrimental effect on the professional training... Continue reading
Posted Sep 3, 2014 at Policy and Medicine
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Pharmaceutical and device manufacturers spent several years and millions of dollars developing systems and processes to properly track the reams of data required to comply with the Physician Payments Sunshine Act. Two weeks ago, many manufacturers had to read ProPublica... Continue reading
Posted Sep 2, 2014 at Policy and Medicine
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Many physicians and other healthcare providers refer a high volume of patient specimens to third party clinical laboratories every day. The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services recently issued a Special... Continue reading
Posted Aug 29, 2014 at Policy and Medicine
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CMS still aiming to publish its data by September 30th. The Centers for Medicare and Medicaid Services (CMS) just emailed out new updates for physicians looking to access their payment data on Open Payments: Access to the Open Payments system... Continue reading
Posted Aug 28, 2014 at Policy and Medicine
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Physicians in all specialties have steadily adopted electronic health records (EHRs). However, as doctors have embraced technology for streamlining patient records, we have seen a marked uptick in data breaches by hackers who want access to the reams of information... Continue reading
Posted Aug 28, 2014 at Policy and Medicine
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On Tuesday, Pharmaceutical Research and Manufacturers of America (PhRMA) Assistant General Counsel, John Murphy, issued a statement regarding the announcement by the Centers for Medicare and Medicaid Services (CMS) to delay publication of a significant portion of data in the... Continue reading
Posted Aug 28, 2014 at Policy and Medicine
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Starting in 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies will make public the details of payments and transfers of value made to healthcare professionals and healthcare organizations. EFPIA sets out the requirements for tracking and reporting... Continue reading
Posted Aug 27, 2014 at Policy and Medicine
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The EFPIA Disclosure Code requires all member companies of EFPIA, the European Federation of Pharmaceutical Industries and Associations, to disclose payments and other transfers of value made to healthcare practitioners and organizations. Like the Physician Payments Sunshine Act, the 33... Continue reading
Posted Aug 26, 2014 at Policy and Medicine
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After a 12-day delay in the Dispute Resolution process, it seems like some doctors were anxious to get into Open Payments and review their data: The American Medical Association (AMA) has been urging CMS to extend the dispute window and... Continue reading
Posted Aug 26, 2014 at Policy and Medicine
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The Accreditation Council for Continuing Medical Education (ACCME) has sent a letter to CMS urging them to reconsider their proposal to remove Section 403.904(g)(1), the CME exemption, from the Sunshine Act. The ACCME joins a long list of commenters who... Continue reading
Posted Aug 25, 2014 at Policy and Medicine