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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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PhRMA President and CEO Steve Ubl recently joined the Medium blogging website and penned his first post, "Health Care Veteran Gaines New Perspective." The post goes through the struggles his family experienced with chronic disease, and how they have shaped... Continue reading
Posted 2 days ago at Policy and Medicine
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When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement, however, provides us a rare glimpse into the nature of the Compliance Officer himself and how that can affect matters. In March,... Continue reading
Posted 2 days ago at Policy and Medicine
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In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality... Continue reading
Posted 3 days ago at Policy and Medicine
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Thanks to an increase in experienced compliance officers, settlements and court judgments between pharmaceutical manufacturers and the federal and state governments are shrinking. While there are many possible theories for the reduction, we would like to think it’s thanks to... Continue reading
Posted 3 days ago at Policy and Medicine
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The former Chief Executive Officer and Vice President of Sales of Acclarent, Inc., a medical device company and division of Johnson & Johnson, were recently convicted of ten misdemeanor counts of fraud. However, the two execs each were acquitted on... Continue reading
Posted 4 days ago at Policy and Medicine
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Corporate Integrity Agreement (CIAs) are a tool commonly employed by the HHS OIG to resolve healthcare fraud issues. This article explores the issue of whether CIAs really strengthen company compliance programs. This author is not so sure Corporate Integrity Agreements... Continue reading
Posted 4 days ago at Policy and Medicine
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FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members appear to lack impartiality. This applies even to those who do not have financial interests and relationships that are conflicts of interests.... Continue reading
Posted 5 days ago at Policy and Medicine
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On August 2, 2016, at 1:30 pm EST, the Centers for Medicare & Medicaid Services (CMS) Open Payments Program will host a "Special Open Door Forum" to receive live feedback from stakeholders on the solicitation to inform future rulemaking in... Continue reading
Posted 5 days ago at Policy and Medicine
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On July 20, 2016, CMS released a report that showed investments that are made in program integrity activities – such as stamping out fraud and reducing and deterring other improper payments – pay off for taxpayers and beneficiaries alike. For... Continue reading
Posted 6 days ago at Policy and Medicine
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In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO Pharmaceuticals for failing to disclose publicly as part of its quarterly financial filings that the FDA had recommended a second round of... Continue reading
Posted 6 days ago at Policy and Medicine
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Earlier this year, the Centers for Medicare and Medicaid Services (CMS) through its Innovation Center (CMMI) released a request for information (RFI) (see here) on the use of global budgets, a payment scheme that "prospectively establishes an annual budget for... Continue reading
Posted Jul 22, 2016 at Policy and Medicine
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The agreement in principle reached between Pfizer, Inc. and the Department of Justice has been finalized. The deal includes $784.6 million in fines, but no provisions for Corporate Integrity Agreement updates. This article goes through the case, the settlement, and... Continue reading
Posted Jul 22, 2016 at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) postponed publication of its hospital ratings after numerous members of Congress objected to the rating system's possible unfairness. The publication may now be published this month, but could see delay if there... Continue reading
Posted Jul 21, 2016 at Policy and Medicine
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Recently the U.S. District Court for the Eastern District of Pennsylvania dismissed Plaintiffs’ qui tam False Claim Act (FCA) claims, finding that the plaintiffs had failed to produce any evidence that Defendants “influenced” any health care provider to submit a... Continue reading
Posted Jul 21, 2016 at Policy and Medicine
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The Accreditation Council for Continuing Medical Education (ACCME) released their 2015 Annual Report, which includes data from a community of nearly 1900 accredited continuing medical education (CME) providers from around the country that offer physicians and healthcare teams a wide... Continue reading
Posted Jul 20, 2016 at Policy and Medicine
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This year’s Medical Affairs Strategic Summit (MASS) West will be held September 14 – 2016, 2016 at the Hard Rock Hotel San Diego. MASS West combines three conferences into one all-access summit: the 11th Annual Medical Affairs Executive Forum, the... Continue reading
Posted Jul 20, 2016 at Policy and Medicine
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We have previously written about the change in the Washington, D.C. pharmaceutical detailer license requirements. The change made it so that if you were engaged in detailing for less than thirty consecutive calendar days per year, you no longer needed... Continue reading
Posted Jul 19, 2016 at Policy and Medicine
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Salix, a subsidiary of Valeant Pharmaceuticals International, Inc., recently settled claims involving Anti-Kickback and False Claims Act violations. Interestingly, while many of these agreements we have seen lately do not include any admission of guilt, Salix accepted responsibility for many... Continue reading
Posted Jul 19, 2016 at Policy and Medicine
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Three members of Congress, a bipartisan trio that spans both the House and the Senate, have introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act in the House of Representatives and the Senate on Friday, June 24.... Continue reading
Posted Jul 18, 2016 at Policy and Medicine
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The Tenth Annual Forum on Transparency and Aggregate Spend will be held August 15 – 17, 2016, at the Ritz-Carlton in Washington, D.C. Day One: Monday, August 15, 2016 Day One is a pre-conference day, offering attendees two pre-conference workshops:... Continue reading
Posted Jul 18, 2016 at Policy and Medicine
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The Independent Payment Advisory Board (IPAB) is one of the "cost control mechanisms" that can be found within the Affordable Care Act (ACA) and is designed to bring per-capita Medicare spending back in line with statutory benchmarks, if those benchmarks... Continue reading
Posted Jul 15, 2016 at Policy and Medicine
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A long list of over one hundred specialty groups and state medical societies penned a joint letter to Senator John Barrasso expressing their “strong support” for S. 2978, the Senate bill that would exempt certain continuing medical education (CME) from... Continue reading
Posted Jul 14, 2016 at Policy and Medicine
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With the nearly 4,000 comments now in for the proposed MACRA rule, we are taking a look at what organizations had to say about including Continuing Medical Education (CME) as a Clinical Practice Improvement Activity (CPIA) under the new Merit-based... Continue reading
Posted Jul 13, 2016 at Policy and Medicine
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With the acquittal of Carl Reichel, the Government's track record on securing convictions against individuals continues to be very mixed. This article explores possible reasons why and how the government may respond. In what came as a surprise to many... Continue reading
Posted Jul 13, 2016 at Policy and Medicine
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Europe has recently pulled the trigger on their version of our Sunshine Act. While it is true that, with the exception of Denmark, France, and Portugal, the requirement to disclose does not have the force of law, information on money... Continue reading
Posted Jul 12, 2016 at Policy and Medicine