Category:Compliance Spotlight
Trump Administration’s Proposal to Update Anti-Kickback Safe Harbors Gives Patients Drug Price Relief at the Pharmacy Counter
On January 31, 2019, the Trump administration proposed yet another regulation in efforts to control rising prescription costs for Americans. If the regulation becomes final, drug manufacturers and Pharmacy Benefit Managers (“PBM”) will no longer be able to harbor from Anti-Kickback violations when negotiating discounts with Medicare and Medicaid managed care programs. The Administrations, continuing the tone of transparency, will instead provide Medicare Part D beneficiaries with the ability to receive discounted prices at the pharmacy counter. The administration hopes this will allow patients to not endure high out-of-pocket costs by purchasing medications at a more affordable price necessary to sustain their health.
We Need to Change the Way We Deal with Food Recalls
In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.
Compliance Spotlight: Cheryl Miller, JD, CHC
Cheryl Miller is the Director of Risk, Compliance and Legal – and Chief Compliance Officer for Presbyterian Homes, a Life Plan Community (formerly branded as a Continuing Care Retirement Community (CCRC)) in Skokie, Illinois. Ms. Miller worked as a corporate paralegal for several years before and during law school, first at a large law firm and then at Brookdale Senior Living. She moved into healthcare regulatory work, and from there learned about the Health Care Compliance Institute and went to the annual meeting. “The preciseness of Stark and Anti-Kickback and the other multitude of regulations enthralled me. I was on-site at a client (Presbyterian Homes) two days per week providing risk management services. I asked about their compliance program and gave (what I thought was) constructive criticism. A year or so later, Presbyterian Homes hired me away from the firm.” Ms. Miller was recently invited by Professor Larry Singer to speak to his Health Care Business and Finance class about the Long-Term Care industry. Her discussion enlightened many of the students and inspired enrollment in Loyola’s Long-Term Care course. The following is an interview that highlights her insight and experiences about her work in an often-overlooked area of healthcare.
Compliance Spotlight: Joseph Adamczyk, OCC
Joseph Adamczyk, ’01 is the Senior Vice President and Chief Compliance Officer at OCC (Options Clearing Corporation). OCC is the world’s largest equity derivatives clearing organization, and works to promote stability and financial integrity in the marketplace. Mr. Adamczyk holds a J.D. from Loyola University Chicago School of Law, an MBA from the University of Chicago, and a B.S. in Business Administration from DePaul University.
The Path to Compliance: a Spotlight on Ted Banks
Ted Banks is a partner at the firm Scharf Banks Marmor and is also an adjunct professor at Loyola University Chicago School of Law, where he teaches a course on corporate compliance. At Scharf Banks Marmor, Mr. Banks concentrates his practice on compliance, antitrust, food law, and other corporate issues. He entered compliance by accident many years ago, and has been an innovator in the field ever since. Mr. Banks has been recognized as an Illinois “Super Lawyer” in the areas of corporate governance and compliance, and he has also been named a Risk & Compliance Trailblazer and Pioneer by the National Law Journal. Here, he has shared his story, tells us the real deal about compliance, and gives advice to students who wish to make compliance their career.
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.
Compliance Spotlight: Ali Gross, UC Los Angeles Health
Alanna J. Kroeker Executive Editor Loyola University Chicago School of Law, JD 2017 Ali Gross is currently a Senior Privacy Analyst at University of California Los Angeles Health (UCLA). Ms. Gross is a 2015 Loyola University Chicago School of Law Graduate where she also completed a health law certificate. Ms. Gross knew she wanted …
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Compliance Spotlight: Adam Solander, Epstein Becker Green
ADAM C. SOLANDER is a Member of Epstein Becker Green’s Health Care and Life Sciences practice, in the firm’s D.C. office. Mr. Solander advises clients on data breach/cybersecurity issues across industry lines, including compliance with HITECH, HIPAA, PCI, JCAHO, CMS, ISO, NIST, and various other federal, state, and business requirements.
The following is an interview with him discussing the unique cybersecurity challenges facing the healthcare sector, and how the industry can move past HIPAA compliance to a more robust definition of privacy and security.
Compliance Spotlight: Valerie Dixon, UC Irvine Health
Alanna J. Kroeker Executive Editor Loyola University Chicago School of Law, JD 2017 Valerie Dixon currently serves as the University of California Irvine Health (UCI) Deputy Compliance Officer. Ms. Dixon brings 17 years of compliance experience with her to UCI, as she started her compliance career in 1999 at UC San Diego. Prior to …
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