Tag:Regulation
Government Scrutiny of Patient Assistance Programs
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.
Compliance Spotlight: Dominique Vittori, Abbott Laboratories
Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.
The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.
Call for Papers: Center for Compliance Studies 2018 Symposium “What is the Role of a Regulation if it is Not Enforced?”
The Center for Compliance Studies at Loyola University Chicago School of Law and The Loyola Journal of Regulatory Compliance invite original paper submissions for presentation at our Second Compliance Studies Symposium: “What is the Role of a Regulation if it is Not Enforced?” The Symposium will take place at Loyola University Chicago School of Law …
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Finalized Rule: Tough Love for Medicaid MCOs?
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 Last May, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for Medicaid managed care, which told states to stop making pass-through payments to healthcare providers. Pass-through payments have played a critical role in funding safety net hospitals which …
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Regulatory Freeze for Review of Pending Rules
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law As has been the case for every new Administration since 1981, the President has issued a freeze of final regulations that have not gone into effect. The instruction usually comes through the Chief of Staff and is referred to …
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The Opening of 2017 in Regulatory Compliance
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law In continuing to examine the regulatory Wunderkammer of the Federal Register, the first volume of the year holds some interesting items in its opening pages. Page 1 of the 81st volume starts out somberly with Executive Order 13757, “Taking …
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The Closing of 2016 in Regulatory Compliance
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law Early before dawn on the last day of the 2016 Federal Register, 19 pistachio handlers in the United States were greeted with an easier compliance burden for 2017. But we’ll return to that later. Why January 1 starts the new year is a bit …
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On this Day: Federal Register Update
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law As we approach the end of another calendar year, let’s see how the Federal Register page count is going. We have occasionally checked in on the status of the horse race of pages compared to previous years. Here is …
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Donald Trump and What It Means for Regulatory Compliance
Mac Matarieh Associate Editor Loyola University Chicago School of Law, JD 2018 Inside of President-Elect Donald Trump’s 100 Day Action Plan is a requirement that for every new federal regulation, two existing regulations would be eliminated. Mr. Trump has consistently pushed the narrative of an outright repeal of the Affordable Care Act. Further, Mr. …
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Detroit Receiving Hospital, an affiliation of Detroit Medical Center Allegedly Used Contaminated Surgical Equipment
Fannie Fang Executive Editor Loyola University Chicago School of Law, JD 2017 On September 15, 2016, Michigan state regulators cited the Detroit Medical Center (“DMC”) for violating the State’s Public Health Code for failing to properly sterilizing surgical instruments. Although DMC promised to address the issue with correction actions, the violation has left an …
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