INSIDE COMPLIANCE – Page 76 – Loyola University Chicago School of Law

Waters of the United States: Revisited

December 17, 2018Uncategorized

Under the Obama administration, the Environmental Protection Agency (“EPA”) and the Army Corps of Engineers promulgated the Waters of the United States rule, which defined “Waters of the United States” to include small bodies of water, such as rivers and wetlands. However, in early 2018, the Trump administration suspended the rule to re-assess the definition. By the end of 2018, the EPA and the United States Department of Army released a new definition of “Waters of the United States,” restricting the definition to traditional navigable waters and their tributaries, certain ditches, certain lakes and ponds, impoundments and wetlands that are adjacent to water specifically covered by the rule.

Army Corps of Engineersclean water actClean Water RuleEnvironmental Protection Agencyenvironmental regulationEPAExecutive Order 13778United States Department of the ArmyWaters of the United StatesWOTUS

We Need to Change the Way We Deal with Food Recalls

December 13, 2018Compliance Spotlight, The Art of Compliance, The Marketplace

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.

CDCcomplianceFDAfoodguidanceillnessRegulation

Goldman Sachs Under Intense Scrutiny for Role in Sovereign Wealth Fund Fraud

December 7, 2018Finance & Banking, Fraud & Abuse

On Christmas Day 2013, The Wolf of Wall Street debuted to rave reviews and quickly became director Martin Scorsese’s top-grossing film. Audiences loved Leonardo DiCaprio’s portrayal of Jordan Belfort, an aggressive stockbroker who rapidly rises to wealth through smooth talking and high-pressure sales tactics. The film is filled with outrageous partying, unethical Wall Street stockbrokers and bankers, and culminates in the arrest of Belfort and the downfall of his criminal enterprise. While certain scenes from the film were arguably embellished, the film is based on a true story. The more amazing true story, however, is that The Wolf of Wall Street was funded and produced through a massive fraud that makes Jordan Belfort’s escapades look miniscule. On November 1, 2018, Timothy Leissner, a Goldman Sachs partner, plead guilty to conspiring to launder money and violating foreign antibribery laws for his role in a massive scandal that involves the prime minister of Malaysia, Middle Eastern sovereign wealth funds, and even Paris Hilton.

1MDBGoldman SachsMalaysia

CMS New Regulations Focus on Nursing Facilities Improving Resident Care

December 7, 2018Uncategorized

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.

Civil Money Reinvestment ProgramCMRPCMScomplianceFinancial IncentivesJournal of Regulatory ComplianceMedicare RatingNurse Staffing LevelNursing FacilitiesNursing HomesNursing ShortageNursing WorkforcePayroll DataQuality of CareReadmission RatesRegulationResident Care

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

December 6, 2018Uncategorized

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.

biotechnologycell-meatclean meatFDAJournal of Regulatory ComplianceRegulationUSDA

OIG Work Plan on Nursing Facility Staffing Levels

December 5, 2018Fraud & Abuse

In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).

ACACMScompliancecompliance programenforcementhealthcareHHSMedicaidmedicareMinimum Staffing RequirementsNursing HomesOIGOIG Work PlanPayroll-Based JournalQuality of CareRegulationSkilled Nursing Facilities

Election Compliance Across America Post Shelby County v. Holder

December 4, 2018Uncategorized

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.

electionJournal of Regulatory ComplianceVoting Rights

D.C. District Court Vacates CMS Overpayment Rule for Medicare Advantage Organizations

December 4, 2018Fraud & Abuse

On September 7, 2018, the United States District Court in the District of Columbia (“D.C. District Court”) vacated Medicare’s overpayment “report and return” rule as applied to Medicare Advantage Organizations (“MAOs”). The Patient Protection and Affordable Care Act (PPACA) created the requirement to report and return overpayments. The Centers of Medicare and Medicaid (CMS) issued rules to provide definitions that the PPACA did not define, create a procedure, payment options and timeframes. MAOs may no longer need to comply with CMS’ overpayment rule, but the PPACA remains intact. Providers who service Medicare beneficiaries will need to conduct the same analysis in order to comply with the PPACA “report and return” requirement.

Centers for Medicare and Medicaid ServicesCMSMAOMedicaidmedicareMedicare AdvantageMedicare Advantage OrganizationsOverpaymentReport and ReturnReverse False Claims

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

November 30, 2018Uncategorized

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.

e-cigarette; Illinois; Tobacco 21Health InsuranceJournal of Regulatory ComplianceRegulation

Protections for Accused Students or Problems for Victims?

November 30, 2018Uncategorized

The Trump administration has proposed new rules for schools dealing with sexual assault and harassment allegations that narrow the definition of sexual harassment and offering greater protections for the accused. Under the new rules, the Education Department is altering the procedures colleges that receive federal funding use to adjudicate complaints of assault and harassment. The new proposed rules come during the #MeToo movement, which will likely prove to be very controversial to both those who support the changes and those who oppose the changes. The federal guidelines stem from Title IX, which bars sex discrimination at schools that receive federal funding.

#MeTooBetsy DeVosDepartment of EducationEducationRegulationsexual assaultsexual harassment