INSIDE COMPLIANCE – Page 96 – Loyola University Chicago School of Law

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

December 7, 2018Fraud & Abuse, Finance & Banking

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.

1MDBMalaysiaGoldman Sachs

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 ProgramcomplianceCMSCMRPMedicare RatingJournal of Regulatory ComplianceNursing WorkforceNursing ShortageNursing HomesNursing FacilitiesNurse Staffing LevelFinancial IncentivesQuality of CareReadmission RatesPayroll DataResident CareRegulation

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.

clean meatcell-meatbiotechnologyJournal of Regulatory ComplianceFDAUSDARegulation

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”).

compliance programcomplianceCMSenforcementACAmedicareMedicaidOIG Work PlanOIGNursing HomesMinimum Staffing RequirementsHHShealthcareQuality of CarePayroll-Based JournalSkilled Nursing FacilitiesRegulation

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.

CMSCenters for Medicare and Medicaid ServicesMAOMedicare Advantage OrganizationsMedicare AdvantagemedicareMedicaidOverpaymentReverse False ClaimsReport and Return

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 21Journal of Regulatory ComplianceHealth InsuranceRegulation

“Dr. Death” Loses Appeal, Court Upholds Life Sentence

February 7, 2019The Art of Compliance

In December 2018, Dr. Christopher Duntsch lost his appeal and the court upheld his life sentence. The name may not sound familiar, but to the medical community in Dallas, Texas, Christopher Duntsch represents what happens when every part of the medical regulatory system fails to protect patients. Christopher Duntsch was given the nickname “Dr. Death” in November 2016 when the DMagazine ran a cover story on him and his victims. In 2018, Wondery produced a six-part podcast series named “Dr. Death” detailing Duntsch’s educational and medical history and the acts that led him to incarceration.

Christopher Duntschcompliance programcomplianceDr. Deathinvestigationhealthcare

Trump Administration’s Proposal to Update Anti-Kickback Safe Harbors Gives Patients Drug Price Relief at the Pharmacy Counter

February 7, 2019Fraud & Abuse, Compliance Spotlight

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.

compliance programcompetitiondrug pricing blueprintDrug ManufacturersDirect DiscountsAmerican Patients FirstAKSMedicare Part DincentivesHHStransparencyTrump AdministrationrebatesPBMPharmacy Benefit Managerpharmacysafe harbor

The Value of Privacy: How Facebook Paid for Access to the Personal Data of Teens and Adults

February 28, 2019Uncategorized

On January 29, 2019, TechCrunch released an investigation finding that Facebook had been paying users as young as 13 for unlimited access to their data. Facebook marketed the application, not available through the iOS app store, to users aged 13-to-35 by offering to pay $20 per month plus referral fees for downloading and using a “Facebook Research” app. The app, once downloaded, provided Facebook with unrestricted access to all private data on the users iPhone including messages, photos and videos, and website usage. This was not the first app launched by Facebook to track user’s data, Apple removed a similar app called Onavo from the app store in 2018. This app is a clear violation of the 2011 consent decree Facebook signed with the Federal Trade Commission.

data collectionFTCFacebookFederal Trade CommissionPrivacy & Security