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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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Calling into question whether value-based care will ever truly work, a recent report casts dark news for ACOs. As reported, nearly half of physicians participating in the Medicare Shared Savings Program (MSSP) ACO in 2015 did not know if they... Continue reading
Posted 2 days ago at Policy and Medicine
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It has been over one-year since the US Department of Justice has launched its pilot program aimed to incentivize companies to self-report potential Foreign Corrupt Practices Act violations. Since its launch on April 5, 2016, the Justice Department resolved nine... Continue reading
Posted 2 days ago at Policy and Medicine
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During September 7th’s Medicare Payment Advisory Commission (MedPAC) public meeting, its commissioners discussed issues related to pharmacy benefit managers (PBMs). The slides during the presentation can be found here and an issue brief here as well. The Commission discussed issues... Continue reading
Posted 3 days ago at Policy and Medicine
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Nevada passed legislation earlier this year, putting many new restrictions and regulations on the pharmaceutical industry there. Now, we see that the state is moving much quicker than we had anticipated on implementing those regulations. Timeline The legislation had many... Continue reading
Posted 4 days ago at Policy and Medicine
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Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in the eighth year of over $3 billion in FCA recoveries. Additionally, recent judicial decisions in FCA suits have further... Continue reading
Posted 4 days ago at Policy and Medicine
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Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers... Continue reading
Posted 5 days ago at Policy and Medicine
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On September 2, 2017, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed a lawsuit challenging the constitutionality of Nevada’s first-in-the-nation insulin transparency law. The two groups allege that implementing the law would violate patient... Continue reading
Posted 6 days ago at Policy and Medicine
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The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations,... Continue reading
Posted 6 days ago at Policy and Medicine
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The Senate Health, Education, Labor and Pensions (HELP) Committee recently held the first hearing of several about ways to stabilize premiums and help individuals in the individual insurance market. The Committee heard from five different state insurance commissioners regarding their... Continue reading
Posted Sep 15, 2017 at Policy and Medicine
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The Joint Commission recently released a report to help hospitals better understand and comply with new pain assessment and management standards that will be applicable to all Joint Commission-accredited hospitals, effective January 1, 2018. An independent, not-for-profit organization, The Joint... Continue reading
Posted Sep 14, 2017 at Policy and Medicine
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Novo Nordisk will pay roughly $58.7 million to resolve claims that the company’s sales force downplayed the importance of mandated United States Food and Drug Administration (FDA) warnings about the cancer risks of its diabetes prescription, Victoza. In a civil... Continue reading
Posted Sep 13, 2017 at Policy and Medicine
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Tomorrow, September 14, 2017, from 10:00 am EST – 11:00 am EST, qordata is hosting a webinar on the three years of Open Payments data that has been made public. The speaker is none other than our editor, Thomas Sullivan,... Continue reading
Posted Sep 13, 2017 at Policy and Medicine
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The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Cipher Pharmaceuticals over promotional materials for its combination immediate- and extended-release opioid tramadol hydrochloride, ConZip. The warning letter, addressed to Cipher... Continue reading
Posted Sep 11, 2017 at Policy and Medicine
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According to LexisNexis State Net, during 2017, about half of the states and Congress collectively introduced almost 90 measures intended to address soaring prescription drug prices. Most would either cap drug prices or force drug makers to be more transparent... Continue reading
Posted Sep 11, 2017 at Policy and Medicine
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Late July 2017, Celgene Corp., a manufacturer of pharmaceuticals, agreed to pay $280 million to settle fraud allegations related to the promotion of two cancer treatment drugs for uses not approved by the United States Food and Drug Administration (FDA).... Continue reading
Posted Sep 8, 2017 at Policy and Medicine
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In July 2017, The Network for Excellence in Health Innovation (NEHI) released a new report that outlines steps for greater transparency in health care. The report states that helping consumers make well-informed decisions can lead to higher quality of care,... Continue reading
Posted Sep 7, 2017 at Policy and Medicine
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In the last days of his administration, New Jersey Governor Chris Christie has introduced a regulation to cap the amount physicians can earn from drug companies – an already rule-laden area – to $10,000 per year. The Regulation In addition... Continue reading
Posted Sep 6, 2017 at Policy and Medicine
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In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol- Myers Squibb in a jurisdictional argument at the nation’s Highest Court. This article outlines the background, the case decision, and the... Continue reading
Posted Sep 6, 2017 at Policy and Medicine
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In late August 2017, the United States Department of Justice (DOJ) announced a $12 million settlement with Sightpath Medical and TLC Vision Corporation, as well as the former CEO of both entities, James Tiffany. The suit was brought by Kipp... Continue reading
Posted Sep 5, 2017 at Policy and Medicine
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Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance from the Justice Department and OIG-HHS about effective compliance programs does elaborate on what a strong policy management program should do. In... Continue reading
Posted Sep 5, 2017 at Policy and Medicine
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Chicago Alderman Edward M. Burke recently held a hearing on the proposed city ordinance, “Chicago Drug Pricing Transparency Ordinance.” The ordinance would mandate that pharmaceutical manufacturers whose drugs are sold in Chicago must disclose any rise in prices ninety days... Continue reading
Posted Sep 1, 2017 at Policy and Medicine
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As part of the process of entering into civil and criminal settlement negotiations with the government resulting from allegations of noncompliance, life science companies are increasingly seeking the retention of third-party regulatory compliance and auditing companies, designated collectively as independent... Continue reading
Posted Sep 1, 2017 at Policy and Medicine
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Last week, Mylan Inc. and Mylan Specialty L.P. (hereinafter “Mylan”) reached an agreement with the United States Department of Justice (“DOJ”) to pay $465 million to resolve claims that they violated the False Claims Act (“FCA”). Mylan knowingly misclassified EpiPen... Continue reading
Posted Aug 31, 2017 at Policy and Medicine
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On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made... Continue reading
Posted Aug 31, 2017 at Policy and Medicine
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Congress has recently taken a few months off from constantly barraging the pharmaceutical industry with daily probes and negative news. However, on Thursday, August 17, 2017, Representatives Elijah Cummings of Maryland and Peter Welch of Vermont announced a probe into... Continue reading
Posted Aug 30, 2017 at Policy and Medicine