This is Thomas Sullivan - Policy & Medicine Writing Staff's Typepad Profile.
Join Typepad and start following Thomas Sullivan - Policy & Medicine Writing Staff's activity
Join Now!
Already a member? Sign In
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
Image
On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating that a biosimilar is interchangeable with a reference product. This guidance specifically focuses on therapeutic protein products and gives an... Continue reading
Posted 3 hours ago at Policy and Medicine
Image
United States Senators Susan Collins (R-ME) and Claire McCaskill (D-MO), the Chairwoman and Ranking Member of the Senate Aging Committee, respectively, released a report on drug pricing titled, “Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that... Continue reading
Posted yesterday at Policy and Medicine
Image
DOJ may have a new focus for Anti-Kickback Statute violations: care facilities and their owners. This year alone, at least two high-profile cases have emerged where a care facility wound up in high-profile enforcement actions involving antikickback violations. This article... Continue reading
Posted yesterday at Policy and Medicine
Image
We recently had the pleasure of speaking with Michaeline Daboul, President and CEO of MediSpend, about the upcoming administration and what she portends for the future of compliance and enforcement. Ms. Daboul introduced the first open source SaaS compliance solution... Continue reading
Posted 4 days ago at Policy and Medicine
Image
Health insurance providers and out-of-network providers, have found themselves in murky water by providing waivers of co-payments, coinsurance, and deductibles to patients treated by out-of-network laboratories and other providers, where commercial insurers continue to seek legal reimbursement actively, recovery and... Continue reading
Posted 4 days ago at Policy and Medicine
Image
Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end ahead of the January 20th inauguration of Donald Trump as president. Deputy commissioner Dr. Stephen Ostroff is expected... Continue reading
Posted 5 days ago at Policy and Medicine
Image
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product manufacturers, packers, and distributors, on how FDA evaluates firms’ medical product communications – including promotional materials – that present information not... Continue reading
Posted 6 days ago at Policy and Medicine
Image
Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new and revised audits and evaluations, as well as some older audits and evaluations that OIG continues to focus on.... Continue reading
Posted 6 days ago at Policy and Medicine
Image
United States Senators Sherrod Brown (D-OH) and Al Franken (D-MN) led the charge to send a letter to President-Elect Donald Trump, outlining specific action items they would like to see his Administration taken to help Congress bring down the cost... Continue reading
Posted 7 days ago at Policy and Medicine
Image
The House Ways & Means Health Subcommittee recently released updated draft legislation that would establish value-based incentive payments for Medicare post-acute care (PAC) providers such as skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), home health agencies (HHAs), and long-term... Continue reading
Posted Jan 16, 2017 at Policy and Medicine
Image
Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy Shield from organizations looking to transfer personal data collected within the European Union to the United States. This article provides an overview of... Continue reading
Posted Jan 16, 2017 at Policy and Medicine
Image
With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did not include language that would allow generic pharmaceutical companies to obtain samples of products under the Risk Evaluation... Continue reading
Posted Jan 13, 2017 at Policy and Medicine
Image
Although compliance professionals tend to view Corporate Integrity Agreements (“CIAs”) as setting the basic compliance standards, in the area of medical inquiry monitoring, they appear to buck the trend by relying on data analytics. This article explores what these professionals... Continue reading
Posted Jan 13, 2017 at Policy and Medicine
Image
On Wednesday, January 11, 2017, President-Elect Donald Trump held a news conference in New York; a conference that was held out for weeks to be the time when the country could expect learn what he would be doing with his... Continue reading
Posted Jan 12, 2017 at Policy and Medicine
Image
Despite Republicans’ call for a suspension on new rules, the Department of Health and Human Services (HHS) pushed regulations regarding Medicare and Medicaid alternative pay models and insurance exchange stability out the door in the final weeks of the Obama... Continue reading
Posted Jan 11, 2017 at Policy and Medicine
Image
The Health and Human Services Office of Inspector General has released new guidance on an important topic, Independent Review Organizations within Corporate Integrity Agreements. This article goes through the recent guidance and explains the requirements of objectivity and independence. The... Continue reading
Posted Jan 11, 2017 at Policy and Medicine
Image
On January 4, 2017, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, requesting comments on research, “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” While empirical research has... Continue reading
Posted Jan 10, 2017 at Policy and Medicine
Image
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) today released a report examining federal spending on drugs in the catastrophic portion of the Medicare Part D prescription drug benefit. Although the optional benefit is provided... Continue reading
Posted Jan 9, 2017 at Policy and Medicine
Image
Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the importance of developing and implementing needs assessments related to engaging healthcare professionals to provide services to pharmaceutical or medical device companies. It describes a... Continue reading
Posted Jan 9, 2017 at Policy and Medicine
Image
As we reported, in July CMS released its first-ever hospital quality star ratings on its Hospital Compare website. The overall star ratings are based on 64 quality measures grouped under three process categories—effectiveness of care, efficient use of medical imaging,... Continue reading
Posted Jan 6, 2017 at Policy and Medicine
Image
The Partnership for Health Analytics Research (PHAR, LLC), a leading health services research consultancy, recently conducted a study analyzing predictions of health care costs, compared to actual costs. This study, once again disproves the misleading claims that pharmacy benefit managers... Continue reading
Posted Jan 6, 2017 at Policy and Medicine
Image
The Affordable Care Act and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare and Medicaid Services (CMS) with tremendous authority, by creating the Center for Medicare and Medicaid Innovation (CMMI). With the recent election leaving the... Continue reading
Posted Jan 5, 2017 at Policy and Medicine
Image
In fall 2016, the Department of Justice (DOJ) reached a settlement agreement with Ralph J. Cox, III, the former CEO for Tuomey Health System, Inc (Tuomey). The settlement resolved allegations that Cox was personally involved in the notable Tuomey Stark... Continue reading
Posted Jan 4, 2017 at Policy and Medicine
Image
As we previously announced, President Elect Donald Trump plans to nominate Seema Verma, a private health policy consultant, to head the Centers for Medicare and Medicaid Services (CMS). While Ms. Verma likely has a few ideas of her own that... Continue reading
Posted Jan 3, 2017 at Policy and Medicine
Image
The Department of Health and Human Services (HHS) issued its Semiannual Report to Congress, covering April 1, 2016 to September 30, 2016, on November 30, 2016. The Report summarizes the activities of the HHS Office of Inspector General (OIG) for... Continue reading
Posted Dec 30, 2016 at Policy and Medicine