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Journal of Regulatory Compliance

Pressing Pause: A Survey of Regulatory Recovery After the Government Shutdown

Although the nation’s longest-ever government shutdown has ended, agencies forced to furlough employees and shutter temporarily are still facing the effects of the funding gap. On January 25th, President Trump agreed to sign a continuing resolution that will reopen and fund the federal government through February 15th. The government reboot means that the roughly 800,000 federal employees furloughed or forced to work without pay should expect to receive their back pay soon, but the thirty-five-day suspension of government functions comes with significant aftershock. While various regulatory agencies scramble to address their backlog of work, life for Americans who interact with these agencies has been hindered indefinitely.

The Years Long Process to a Revised Common Rule and Implementation

The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.

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.

Accessible UI/UX Design: Making Websites ADA Compliant

The World Wide Web Consortium (“W3C”) is a collaborative community that develops standards for the Internet. One of W3C’s goals is to make the web accessible to everyone, regardless of an individual’s accessibility needs. Section 508 of the Rehabilitation Act requires that the electronic and information technology of federal agencies are accessible to people with disabilities, whether they are employees or members of the public. W3C publishes the Web Content Accessibility Guide (WCAG), which addresses how to create accessible websites. The WCAG was used by the U.S. Access Board to create standards for Section 508. Recent cases like Gorecki v. Hobby Lobby Stores, Inc. and Gil v. Winn-Dixie Stores, Inc. reveal the need to not only comply with these laws and regulations, but to adopt a culture that goes above and beyond the minimum.

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.

States Fail At Mental Health

The Mental Health Parity and Addiction Equity Act (“the Parity Act”) is a federal civil rights and consumer protection law. The Parity Act prohibits most public and private insurance plans from imposing more restrictive standards on mental health (“MH”) and substance use disorder (“SUD”) benefits than they impose on similar medical/surgical benefits. However, ten years since its passage, states have failed to appropriately enforce the Parity Act.