Category:

Journal of Regulatory Compliance

CMS New Regulations Focus on Nursing Facilities Improving Resident Care

The Centers for Medicare and Medicaid Services (CMS) efforts to strengthen the nation’s health care through its oversight of health care programs, including Medicare, has continuously made strides to ensure its beneficiaries receive the quality and affordable health care needed. The U.S. has struggled with the quality of care provided in nursing homes to the most vulnerable citizens for years. Nursing homes have continued to remain highly regulated, but the U.S. government has failed to hold the nursing homes industry accountable for the poor quality of care provided. America’s shortage of nurses has contributed to the poor quality of care that leads to life threatening problems of Medicare beneficiaries living in nursing homes. Furthermore, despite the nursing home industry’s large profitability, and the level of hands on care that the nurses provide, the pay for staff nurses in nursing homes is less than other major employers. Thus, CMS has implemented regulations to guarantee nursing homes are properly staffed in order to improve resident care and safety by monitoring payroll-based data and holding nursing homes accountable for poor care by minimizing reimbursement for conditions that could be averted with better oversight.

Joint Agency Decision Serves Up A New Regulatory Framework For Cell-Based Meat

Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat.  The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.

Election Compliance Across America Post Shelby County v. Holder

Five years after the Supreme Court decision in Shelby County v. Holder, the effects of dismantling Section 5 of the Voting Rights Act are manifesting themselves across the United States. Since 2013, several states have passed laws that have the ability to suppress voters. Voters in Georgia and South Dakota have recently filed suits claiming the state’s laws and practices in the 2018 election amounted to voter suppression.  

Illinois Law Makers Seeking to Curb E-Cigarette Use Among Teens and Children

In the wake of rising e-cigarette use among teens and children, Illinois lawmakers seek a legal solution to protect Illinois youths from smoking-related illnesses and pre-mature death. Illinois’s Congress introduced Tobacco 21, a bill designed to raise the legal age to purchase tobacco products like e-cigarettes to 21 years of age. Despite a lack of support from Governor Bruce Rauner, Illinois politicians continue to fight to save the bill, and with good reason. The United States Food and Drug Administration (FDA) recently announced its Youth Tobacco Prevention Plan, which addresses the rising e-cigarette use among adolescents. The FDA’s plan is two-fold: (1) crack down on the sale and marketing of e-cigarettes and (2) educate teens and children about the dangers of using e-cigarettes. Tobacco 21 provides support for the FDA’s Plan.

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.

New York Federal Court Rules in Favor of CFTC in its First Ever Anti-Fraud Enforcement Action Involving Bitcoin

Judge P. Kevin Castel of the U.S. District Court for the Southern District of New York entered an Order for Final Judgment and Consent Order for Final Judgment (“the Orders”) early this month, resolving charges of a Commodity Futures Trading Commission (the “CFTC”) Complaint against a New York Corporation, Gelfman Blueprint Inc. (“GBI”) and its Chief Executive Officer, Nicholas Gelfman. The CFTC’s complaint, filed in January of 2017, marked the first anti-fraud enforcement action involving Bitcoin filed by the Commodity Futures Trading Commission. The Orders found that from approximately January of 2014-January 2016 Defendants Gelfman and GBI, through its officers and agents and employees, operated a Bitcoin Ponzi scheme in which they fraudulently solicited more than $600,000 from at least 80 customers.

Climate Change: A Compliance Crisis

In October 2018, the Intergovernmental Panel on Climate Change of the United Nations issued a special report on the impact of global warming. The report shared extensive research about our changing atmosphere and issued a grave warning: we must act immediately. The harrowing news came just over one year after President Trump ordered the United States’ withdrawal from the Paris Climate Agreement in June 2017. This begs the question:  how will changes be made when the world’s most powerful and impactful hegemon refuses to cooperate?

SCOTUS Overturns Stay, “Dark Money” Donors Will Be Partially Disclosed

On September 18, 2018, the United States Supreme Court overturned a stay blocking a District Court ruling requiring non-profits to disclose identity of all contributors who give more than $200 a year. Prior to the ruling, IRS designated 501(c)(4) social welfare organizations and 501(c)(6) organizations such as business leagues and boards of trade, who do not register as political committees with the Federal Election Commission (FEC), were required to disclose donors only when they contributed for specific political advertisements. While the ruling requires the FEC to give guidance, newly issued FEC rules limit the scope of the court’s intention. It is likely that the new ruling will allow some donors to remain undisclosed while requiring partial disclosure of donors who contribute towards certain, but not all, expenditures.

Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments

The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules.  The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework.  The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).

International Business Travel Comes with Potential Data Risks

The economic rebound seen in the last decade has resulted in a substantial increase in business travel, both foreign and domestic. Increasingly complex global supply chains are necessitating that business leaders travel the world in order to expand their businesses and forge valuable new partnerships. Unfortunately, this increase in travel also presents an increased risk for the theft of proprietary or confidential information.