INSIDE COMPLIANCE – Page 81 – Loyola University Chicago School of Law

The Show Must Go On: Clinical Trials for Other Conditions Continue During COVID-19 Pandemic

September 16, 2020Uncategorized

In early April of 2020, a high-tech, temperature-controlled cooler traveled halfway across the country on an airplane with a man whose sole job was to get the contents of that cooler –– a promising trial drug to treat a specific form of muscular dystrophy –– from a Baltimore-based research hospital to a family member of mine living in a west Chicago neighborhood. Ordinarily, this family member would make a monthly visit to Baltimore and take the trial drug under the supervision of researchers, but with a pandemic raging on, researchers made do. COVID-19 has undoubtedly changed the way people around the world are going about their lives and everyone is doing their best to be flexible. Clinical drug trials are no different.

Regulation

DHS’s Partnership with Private Industries Leads to a Crackdown of Fraudulent Behavior During the Pandemic

September 15, 2020Fraud & Abuse

After the COVID-19 pandemic spread to the U.S. in February of 2020, there was a surge in fraudulent behavior as criminals took advantage of the fear revolving around the pandemic to profit from selling defective goods and scamming the public. This has resulted in the loss of millions of dollars by the public. Scammers will continue to benefit and take advantage of the public until the government steps in and takes preventative measures to stop this criminal behavior during the pandemic.

cyber fraudCOVID-19complianceDHSJournal of Regulatory Compliancefraud and abuseRegulation

CMS Issues New Rigid COVID-19 Requirements for Skilled Nursing Facilities

September 15, 2020Uncategorized

The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.

COVID-19complianceCMSData ReportingCDCmedicareHHSHealth InsurancehealthcareTrump Administrationpublic healthRegulationrulemaking

Workplaces and Regulations During a Public Health Crisis

September 23, 2020Uncategorized

The U.S. Department of Labor’s Wage and Hour Division (“WHD”) recently announced alterations to its previous regulations which expanded family and medical leave provisions and paid sick leave of April’s Families First Coronavirus Response Act (“FFCRA”). These revisions serve to clarify the responsibilities of employers and the rights of workers as they relate to the paid leave of FFCRA. These revisions come after a decision from the U.S. District Court for the Southern District of New York which invalidated portions of the initial regulations. The WHD’s revisions are an example of the lack of clarity and adequate response from regulations designed to protect workers during the current pandemic.

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CRISPR Technology. A Chicken-And-the-Egg Problem of Scientific Advancement and Regulatory Oversight.

September 24, 2020Uncategorized

It’s been nearly two years since Chinese researcher He Jiankui shocked the scientific community and the world when he claimed to have genetically modified the genome of two human babies for resistance to HIV using CRISPR technology. Jiankui operated under the guise of reducing the HIV/AIDS disease burden in Africa, a seemingly admirable pursuit. But geneticists and ethicists considered the experiment , and done in pursuit of personal gain.

Journal of Regulatory ComplianceRegulation

DOL Proposes Rule That Could Recategorize Many Employees into Independent Contractors

October 14, 2020Uncategorized

The U.S. Department of Labor (“DOL”) has recently proposed a rule change that would revise its interpretation of “independent contractor” under the Fair Labor Standard Act (“FLSA”). According to DOL, which has the power to investigate worker complaints about misclassifications, this change is needed to promote certainty for stakeholders, reduce litigation, and encourage innovation in the economy. However, this proposed rule could also diminish employee rights because independent contractors have fewer protections under FLSA. This rule widens the scope of who can be considered an independent contractor. Thus, many workers classified as employees could be reclassified as independent contractors and lose protections under FLSA.

EmploymentDepartment of LaborLabor and EmploymentJournal of Regulatory ComplianceIndependent ContractorsWorkers' RightsRegulation

Rural Hospitals in Crisis Receive a Boost to Value-Based Care Model from New CMS CHART Model

October 14, 2020Uncategorized

The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.

CMSCHART ModelmedicareMedicaidJournal of Regulatory Compliancefundsfederal grantsHHSHealth InsurancehealthcareTrump AdministrationRegulationrural healthcareruralrulemaking

The Constitutionality of the ACA: California v. Texas

October 13, 2020Uncategorized

Signed by President Obama on March 23, 2010, The Affordable Care Act (“ACA”) provided a monumental change to healthcare. The ACA created access, added provisions to improve quality, and created cost containment measures. However, the ACA created a quintessential question of Federalism. As it exists today, the Supreme Court will listen to oral arguments in November on the constitutionality of the ACA, in California v. Texas. If the Court decides that the ACA is unconstitutional, millions of Americans who are insured under the Act will lose coverage. Additionally, aside from access, the ACA includes regulatory laws such as Section 1557’s nondiscriminatory provisions, and amendments to the False Claims Act & HIPAA.

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The New SEC Whistleblower Rules and their Impact on Whistleblower Litigation

October 13, 2020Finance & Banking

Whistleblowers are crucial to the Securities and Exchange Commission’s (SEC) ability to enforce regulatory standards. Because of their knowledge, they can help the SEC protect investors and capital markets, as well as hold those performing unlawful conduct accountable. Through Section 21F of the Exchange Act the SEC has power to award whistleblowers for the information they provide. Last month, an amendment was added to this section altering the rules of whistleblower award allocations.

whistleblowerSecurities and Exchange CommissionSEC

Open Meetings and Government Transparency in the Wake of COVID-19

October 2, 2020Compliance Spotlight

On March 16, 2020, Governor JB Pritzker issued Executive Order 2020-07 which, among other things, suspended certain provisions of the Illinois Open Meetings Act (“OMA”), an act which ensures transparency regarding meetings, discussions, and actions taken by public actors concerning public business. The executive order was a response to the practical challenges to compliance with the OMA’s in-person and physical quorum requirements facing local governments as they grapple with restrictions on public gatherings due to the public health threat of COVID-19, declared an emergency in Illinois by Pritzker’s Gubernatorial Disaster Declaration on March 12, 2020. Since March, Pritzker has continued to re-issue and extend COVID-19-related executive orders and the disaster declarations, including the executive actions identified above and their restrictions and suspensions applicable to the OMA, most recently through Executive Order 2020-55 on September 18, 2020. While the suspensions through executive order have provided a temporary solution allowing local governments to comply with the OMA in such an emergency situation, the Illinois legislature took it upon itself to address the issue permanently by amending the OMA statute.

COVID-19local governmentsJournal of Regulatory ComplianceOMAopen meetingsmunicipal lawGovernment TransparencyGovernment Oversighttransparency