Tag:

Regulation

Captive Insurance Compliance after Avrahami

Captive insurance companies, insurance companies owned by persons related to the insureds, have long served as an important risk management tool for businesses as varied as Sears and The New York Times. In recent years, there has been an explosion of “micro-captive” insurance companies, companies with premiums that do not exceed $1.2 million in a year. Until 2017, $1.2 million was the allowable maximum amount of premiums for an insurance company to elect favorable tax treatment under I.R.C. § 831(b), allowing the small insurance company to be taxed only on its investment income. The IRS believes that these “831(b)” micro-captives are often used as tax-shelters rather than for legitimate business purposes.

Averting Disaster: Building Regulations in the Wake of Hurricane Irma

After Hurricane Irma’s dissipation on September 15, 2017, the residents of Florida can now begin to assess the damage caused by the strongest hurricane making landfall since Katrina in 2005. According to early estimates, Irma has caused over 62 billion dollars in damage. However, amongst the destruction there is a silver lining; the damage caused was significantly limited by building regulations that went into effect in 2002. Homes and buildings that would have otherwise been destroyed by Hurricane Irma were able to survive, and suffered only minor damage.

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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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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