Tag:Regulation
Vertical Healthcare Companies Merging Compliance Programs
Vertical Healthcare Companies Merging Compliance Programs Perri Nena Smith Senior Editor Loyola University Chicago School of Law, JD 2021 In 2020, The Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) released guidelines for vertical mergers to give clarity to companies so they can avoid harmful mergers. Healthcare companies are an industry that has been …
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Final Rule and Updates to Non-discrimination Regulations of the ACA
The Department of Health and Human Services (“HHS”) finalized revised regulations that implemented Section 1557 of the Affordable Care Act (“ACA”) in June of 2020. This section prohibits discrimination within health programs and activities receiving federal financial assistance based on race, color, sex, age, disability, and national origin. In comparison to the Obama-era regulations issued in 2016, the new final rule does away with gender identity and sexual orientation nondiscrimination protections not only under Section 1557, but under ten other federal regulations as well. This also includes a roll back of certain health insurance coverage protections for transgender individuals.
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
The Clean Water Act: The Broadening of the National Pollutant Discharge Elimination System Permitting Program to Regulate Indirect Discharge Through Groundwater
On January 14, 2021, the United States Environmental Protection Agency (“EPA”) issued a Guidance Memorandum (hereinafter “Memo”) addressing the recent decision of the Supreme Court of the United States in the case County of Maui v. Hawai’i Wildlife Foundation, 140 S. Ct. 1462 (2020) regarding the regulation of water pollution under the Clean Water Act (CWA or “the Act”). The Memo outlined how the Court’s recent ruling in the County of Maui applies to the National Pollutant Discharge Elimination System (“NPDES”) permit program created under Section 402 of the Clean Water Act (hereinafter “Section 402”). The intent of the EPA in publishing the Memo is to help clarify the effect of the Court’s ruling in County of Maui for owners and operators of facilities subject to the regulation of the CWA, the primary regulatory framework for governing water pollution in the United States. The ruling in County of Maui expands the types of discharge that are subject to the CWA’s regulatory permit program and illuminates the steps required of facility owners and operators to comply with that framework.
Investing in Income Sharing: Why Regulators Should Pay Attention to the Innovative Set Up Now
As of November 8, 2020, the student debt crisis reached $1,769,280,155,524. There’s no easy way to address a $1.7 trillion problem and the increasing cost of higher education, coupled with the necessity of a four-year degree, will only exacerbate the issue. From 2000 to 2016, the average annual cost of college more than doubled, from around $15,000 a year to nearly $32,000. The New York Fed most recently identified a phenomenon acknowledging that when you flood the marketplace with subsidies, like grants, loans, etc., it enables higher education to continue to raise prices. For every dollar of new public subsidy, prices for college have risen between 60 and 70 cents. There are a number of proposals as to how to address this crisis – from federal statutes to private intervention – but income sharing agreements (ISAs) have largely been left out of the conversation. ISAs are not without criticism, particularly because of concerns about excessive interest. However, many of the criticisms could and should be addressed by comprehensive regulation, as any other type of lending has been. ISAs will likely be part of the future solutions of financing education and, as a result, regulators need to pay attention.
How Federal Data Privacy Regulation Could Help Curb the COVID-19 Pandemic
It cannot be denied that the COVID-19 pandemic has led to many novel legal and regulatory issues. One topic of major concern both domestically and abroad is how to manage the massive amounts of consumer data being collected in the attempt to quell the spread of the virus. This issue is especially complicated to address in the United States, where a convoluted patchwork of state and federal laws interact to create a relentlessly fragmented data regulation system. Now, as state and local governments, along with tech giants like Apple and Google, continue to roll out contact tracing applications, the need for comprehensive data privacy regulation is more pressing than ever.
Extracting the Middle Ground: Is it Time to Federally Regulate Fracking?
The use of fracking has made the United States the global leader in natural gas and crude oil production. However, the practice is not without controversy. Activist groups have called for a ban against fracking as scientists have warned of potential health and environmental impacts, while energy lobbyists have fought bitterly against any restrictions or regulations. As it stands, U.S. regulating of fracking has been mostly left ineffectively to the states, with exemptions to federal regulations on the books. As the societal costs of fracking become better understood, regulators and policy makers must make difficult decisions regarding the practice.
Running a Restaurant in the Covid Era; So Much Regulation, So Little Guidance.
Americans miss dining out. In fact, surveys indicate that sitting down in a restaurant is the most missed pastime of the Covid-19 pandemic. As the monotony of homebound living grows and already economically fragile restaurants operate at a diminished capacity, patrons and restaurants alike are flouting regulations to get back to normal. Between the pressure of dwindling stimulus loans and eager customers, regulation must be balanced with economic relief to encourage responsible and sustainable reopening.
Changes in Healthcare Information Regulation: Information Blocking
On November 3, 2020 new rules from the Health and Human Services Department concerning information blocking in healthcare will come into effect. The rules are an implementation of the 21st Century Cures Act (“Act”) which is the latest in the government’s effort to lower costs and allow for greater patient access to electronic health information (“EHI”). The Act aims to prevent covered healthcare providers from restricting the flow of EHI in inappropriate ways. Violations of the new Act may result in considerable civil fines.
2020 Title IX Regulations Update
The new Title IX regulations that were introduced by the Department of Education (the Department) in May are officially in effect and require school districts to implement multiple changes in their Title IX compliance practices. Title IX explains that educational programs and activities receiving federal funding from the Department must not act in a discriminatory manner on the basis of sex. These new regulations extend many new protections against sexual harassment, and aim to protect the rights of students, mainly their right to due process. However, in light of the COVID-19 pandemic, schools are challenged with implementing these new regulations while navigating the obstacles brought by the virus.