Tag:

Regulation

On this Day: the Federal Register (April)

Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law   The number of annually published pages of the Federal Register doesn’t tell us much about the growth of regulations in the United States. After all, even repeals of regulations take up page counts.  But the size of the Federal …
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The New Medicaid Managed Care Rule and Its Effects on Compliance Programs

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   The Centers for Medicare and Medicaid Services (CMS) recently published a new rule for state contracts with Medicaid Managed Care Organizations (MCO). Medicaid MCOs provide comprehensive services to beneficiaries for capitated payments. The effective date of the rule was July 5, 2016. …
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New Overtime Rules Have Employers Working Overtime

Ryan Whitney Managing Editor Loyola University Chicago School of Law, JD 2017   Beginning in December of this year, the Department of Labor will implement their final update to the rules governing overtime pay. The new income threshold will nearly double, thus encompassing 4 million workers nationwide. This update will have a large impact on …
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Dealing with 71 Medical Licensure Boards: American Doctors Trip Over State Lines

In April 2013, members of the Federation of State Medical Boards (FSMB) and the Council of State Governments (CSG) embarked on a venture to create the Interstate Medical Licensure Compact (the Compact or IMLC), a voluntary, expedited pathway to licensure for qualified physicians who wish to practice medicine in multiple states. On April 20, 2017, the Interstate Medical Licensure Compact Commission, (IMLCC) issued its first Interstate Medical License to a Wisconsin physician who applied to practice in Colorado, setting a groundbreaking precedent in medical licensure portability. While the IMLC is a great first step toward increasing access to healthcare by expanding licensure portability, this initiative faces multiple regulatory hurdles.

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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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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