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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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As we posted last week, the Nevada draft regulations are up and starting to become a hot topic. The same day as our last post, Nevada updated the Frequently Asked Questions and the SB 539 Reporting requirements. Frequently Asked Questions... Continue reading
Posted 12 hours ago at Policy and Medicine
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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018. For life science compliance... Continue reading
Posted 12 hours ago at Policy and Medicine
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On January 9, 2018, the Senate Finance Committee held a nomination hearing for Alex Azar, President Trump’s pick to lead the Department of Health and Human Services (HHS). The Committee is expected to vote later this month on whether to... Continue reading
Posted yesterday at Policy and Medicine
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Maine has posted a revised version of their gifts to physicians law which bans cash payments from pharmaceutical manufacturers, wholesalers agents for research, consulting, promotional speaking related payments but exempts educational materials, modest meals, prescription drug samples, honorarium at educational... Continue reading
Posted 2 days ago at Policy and Medicine
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The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although... Continue reading
Posted 2 days ago at Policy and Medicine
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Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta. In October... Continue reading
Posted 5 days ago at Policy and Medicine
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We have written many times on the Nevada law passed in Summer 2017 that requires patient advocacy organizations to report all payments they receive from industry, regardless of the nature of the payment. The legislation was signed into law by... Continue reading
Posted 6 days ago at Policy and Medicine
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United States Senators Susan Collins and Claire McCaskill, the Chairwoman and Ranking Member of the Senate Aging Committee, released a report on drug pricing titled, “Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Harms Patients, Taxpayers,... Continue reading
Posted 7 days ago at Policy and Medicine
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A report recently released by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) found that manufacturers may have misclassified as many as 885 drugs in the Medicaid rebate program in 2016. In September 2016, Congress... Continue reading
Posted Jan 9, 2018 at Policy and Medicine
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In an unusual administrative move – without passing any new laws – on December 22, 2017, the Attorney General of New Jersey finalized new rules governing physician interactions with pharmaceutical companies. The rule is titled: LIMITATIONS ON AND OBLIGATIONS ASSOCIATED... Continue reading
Posted Jan 8, 2018 at Policy and Medicine
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Kmart Corp. has agreed to pay $42 million to the federal government and several states to settle a whistleblower lawsuit jointly litigated by Phillips & Cohen LLP and Korein Tillery that alleged Kmart overcharged government healthcare programs and private insurers... Continue reading
Posted Jan 5, 2018 at Policy and Medicine
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We have written many times about the way growth in drug spending has significantly been below the growth rate of overall national healthcare spending, despite the media spotlight on the issue. Total nominal United States health care spending increased at... Continue reading
Posted Jan 4, 2018 at Policy and Medicine
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On December 8, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint in the United States District Court for the Eastern District of California, challenging SB 17, a law they allege is unconstitutional. The law was approved... Continue reading
Posted Jan 3, 2018 at Policy and Medicine
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FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a... Continue reading
Posted Jan 2, 2018 at Policy and Medicine
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As we continue our coverage of the MACRA Quality Payment Program (QPP) rule, the following article provides a more in-depth look at the regulations promulgated by CMS. We drafted an initial summary when the rule was released in early November.... Continue reading
Posted Dec 28, 2017 at Policy and Medicine
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The Office of Prescription Drug Promotion (OPDP) is known for monitoring company communications about medical products and when it considers those communications to be outside of regulatory parameters, issuing a letter warning the company of such promotion. For relatively minor... Continue reading
Posted Dec 27, 2017 at Policy and Medicine
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A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices.... Continue reading
Posted Dec 22, 2017 at Policy and Medicine
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On December 11, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued statements of support for several policy proposals focused on resolving the opioid crisis. The proposals included: limits on prescribing, a ban on prescribing of Schedule II opioids... Continue reading
Posted Dec 21, 2017 at Policy and Medicine
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On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” The FDA hopes to receive stakeholder input on how the... Continue reading
Posted Dec 20, 2017 at Policy and Medicine
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On June 9, 2017, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) participated in the third annual Joint Accreditation Leadership Summit. During this Summit, interprofessional continuing... Continue reading
Posted Dec 19, 2017 at Policy and Medicine
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On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding prescription drug promotion from the FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP). Final Guidance on... Continue reading
Posted Dec 18, 2017 at Policy and Medicine
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In late November, the Pharmaceutical Research and Manufacturers Association (PhRMA) released a new report examining how money flows through the supply chain and how that impacts what patients pay at the pharmacy. According to the report, this system often creates... Continue reading
Posted Dec 15, 2017 at Policy and Medicine
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Eleven medical societies – including the American College of Rheumatology, American Academy of Ophthalmology, American Society of Clinical Oncology and American Urological Association – are urging congressional leaders to preserve patients’ access to critical Part B drug treatments by preventing... Continue reading
Posted Dec 14, 2017 at Policy and Medicine
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Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to support regulatory decision-making for medical devices. The final guidance follows a July 2016 draft guidance on the topic in... Continue reading
Posted Dec 13, 2017 at Policy and Medicine
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On December 5, 2017, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to discuss the opioid epidemic and the possible role that Congress could play in the prevention, treatment, and recovery.... Continue reading
Posted Dec 12, 2017 at Policy and Medicine