INSIDE COMPLIANCE

Injunctions Halt Trump Administration’s Attempt to Expand Religious Exemption for Obamacare Contraceptive Mandate

February 4, 2019Seth JohnsonDrugs & Devices

A pair of injunctions in the Northern District of California on January 13, and the Eastern District of Pennsylvania on January 14, halted the implementation of amendments to a religious exemption to the so-called contraception “mandate” of the Affordable Care Act, also known as Obamacare. The “mandate” requires most employers to include contraception coverage in the insurance plans they offer to employees. While Obama administrative agencies contemplated religious exemptions early on, contentious litigation and political transition expanded the scope of the exemption until these latest developments.

Administrative Procedure ActAffordable Care ActContraception MandateDepartment of LaborDepartment of the TreasuryHealth InsurancehealthcareHHSHRSAreligion

The Coming Sea Change for Consumer Goods Companies

February 4, 2019Nicole ShamoonUncategorized

“I sometimes wonder if we’re in the branded litter business, branded trash.” That was a presumably half-joking statement made at the World Economic Forum in Davos by Alan Jope, CEO of Unilever, one of the world’s largest consumer goods companies. What certainly was not a joke was the pressure and criticism major consumer goods companies faced in Davos from activists and groups that believe not enough is being done to cut use of plastic packaging in goods. Companies like Coca-Cola and Procter & Gamble (P&G) have emerged as new targets of environmental groups, who see these companies as major contributors to polluted oceans and endangered marine life. The impact of plastic waste on the environment has also drawn the ire of millennials, to the extent that one industry analyst claims the war on plastics is part of consumer goods companies’ marketing plans. While companies may be tailoring marketing plans and making pledges to reduce the amount of plastic in their products, the 8 million tons of plastic that end up in the world’s oceans each year means these companies will continue to feel the heat from activists, millennials, and regulators.

Davosenvironmentenvironmental regulationGreenpeacePlasticsWorld Economic Forum

A New Era of Ethics

January 31, 2019Abigail MarshallUncategorized

Corporate success was once measured by the numbers on a balance sheet. Today, however, corporations have entered a new era where morals and ethics are increasingly important. Whether this change is a product of outside influence or internal conflict, there is a new trend in corporate culture. Given the business expertise and media-friendly personalities of many CEOs, they may be the leaders chosen to lead the change.

Employment

On Proposed Title IX changes: Advocates See Needed Protections for the Accused, Critics See Increased Vulnerability for Victims

December 28, 2018Seth JohnsonUncategorized

On November 16, 2018, the Department of Education through its Office for Civil Rights, opened a series of proposed regulations for public comment. Interested parties anticipated the release of the regulations for some time, following the Department of Education’s 2017 rescission of the Obama administration’s 2011 “Dear Colleague”. The 2011 letter required educational institutions receiving federal funds to use a preponderance of the evidence standard in adjudicating institutional sexual assault proceedings, among other things. The recent proposal makes that standard permissive, rather than mandatory, while stressing that institutional proceedings must preserve a presumption of innocence on the part of the accused. Though many groups applaud the new proposals, others raise concerns that the proposals stand to harm victims of sexual assault.

Department of EducationEducationTitle IX

Waters of the United States: Revisited

December 17, 2018Jacqueline MietusUncategorized

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, 2018Manisha ReddyCompliance 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, 2018Nicole ShamoonFinance & 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, 2018Mya StraussUncategorized

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, 2018Diana AkmakjianUncategorized

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, 2018Sarah B. GaleliFraud & 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