Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?

Posted on January 29, 2022Categories Drugs & Devices

As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.
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The Not-So-Sustainable Side of Electric Vehicles

Posted on January 28, 2022Categories Uncategorized

Set against the backdrop of climate change and a growing global push for sustainability, more people than ever before are turning toward Electric Vehicles (EVs) as a simple swap to reduce their carbon footprint – but are EVs really more sustainable? Although they might seem more sustainable, the long-term impacts of EVs on the environment are still not entirely known. While EVs reduce fossil fuel consumption now, what happens to the battery in an EV when it dies? Can it be recycled? How are the batteries produced? All these factors contribute to an uncertainty around EVs that has governments and scientists thinking of ways to improve the sustainability of the EV industry.
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Regulating Crypto Markets through the Build Back Better Act: Crypto Investors’ Future Compliance with Wash Sale Rules

Posted on January 27, 2022Categories The Marketplace, Finance & Banking

The Build Back Better Act, which passed through the House of Representatives in November 2021, has been stalled in the Senate for several months. Senate Majority Leader Chuck Schumer has insisted that Democrats will work until the bill is passed. Within the Build Back Better Act, cryptocurrencies are shifted from being treated like property to being treated more like traditional securities, subjecting all digital currencies to wash rules under Section 1091. With cryptocurrencies collectively evaluated at upwards of $3 Trillion in 2021, crypto investors under the Build Back Better Act would be subject to the regulatory anti-abuse rules that currently apply to both stocks and bonds. This move by Democrats is for taxing purposes, but ultimately will call into question the IRS’ ability to regulate certain crypto transactions and asset disclosures. Additionally, questions have been raised as to the future regulation of cryptocurrencies and what that will mean for one of the most volatile trading markets.

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Investor Choice Act Approved by House Committee

Posted on January 26, 2022Categories Finance & Banking

For several years, broker-dealers and investment advisory firms have typically required harmed investors to dispute matters through arbitration rather than the court system. However, the House of Representatives’ Financial Services Committee has approved a bill aimed at prohibiting mandatory arbitration commonly imposed by broker-dealers and investment advisory firms. H.R. 2620, known as The Investor Choice Act, restricts investment advisors and broker-dealers from including pre-dispute binding arbitration clauses in their client agreements. The Investor Choice Act addresses “long-standing and deeply unfair practices of forcing customers to resolve their claims through arbitration instead of as part of a class action,” according to Maxine Waters, Chairwoman of the Financial Services Committee.
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Expanding Mental Health Services Through Community-Based Care: Crisis Stabilization Centers

Posted on January 25, 2022Categories Uncategorized

Many believe that a hospital emergency department is potentially the worst place for an individual experiencing a mental health crisis. Emergency departments are often loud, bright, and bustling with hospital employees, emergency responders, patients, and visitors. These conditions are stressful and can further trigger additional symptoms for individuals facing a psychiatric crisis. Moreover, many individuals experiencing a mental health crisis do not require inpatient care at a psychiatric hospital. Rather, there is a growing trend to promote community-based care through Crisis Stabilization Center Models. Crisis stabilization centers or units provide an alternative to traditional emergency department and psychiatric hospitalization care by providing continuous care for a short period of time in a safe environment for those with an acute psychiatric crisis.
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America’s Fight Against Robocalls

Posted on January 24, 2022Categories Fraud & Abuse

Robocalls are an increasing threat to Americans across the country. In 2020, American consumers received nearly 4 billion robocalls per month. This number quickly increased in March 2021 when Americans received 4.9 billion robocalls. Although not all robocalls are illegal, illegal robocalls hurt Americans by spamming them to market a product. Americans have a choice to give their written consent, but the issue stems from robocalls marketing products without written consent. About 60 million Americans say they have been a victim to phone scams in the last year and have lost nearly $30 billion as a result. Unfortunately, despite the FCC and FTC increasingly targeting spammers and illegal robocalls, it is difficult to say when this problem will end.

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Stadiums, Casinos, and Riverboats: Illinois and Chicago Hedging Their Bets on the Future of Gambling Regulations

Posted on December 11, 2021Categories The Marketplace

Illinois has historically been at the forefront of gambling regulations in the United States.  Chicago, on the other hand, has resisted sanctioning formalized gambling locations until recently.  Following the passage of the 2019 Gaming Expansion Law, Illinois expanded gambling across the state and Chicago is planning to open its first casino by 2025.  Chicago is also concurrently debating an ordinance that would allow sports gambling within the city’s stadiums and arenas.
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Failure To Regulate NFTs and Crypto Currencies Will Lead to Catastrophic Environmental Implications

Posted on February 7, 2022Categories Uncategorized

Non-fungible tokens (NFTs) are emerging digital assets with numerous rights and obligations. However, regulations and laws in the United States are only barely beginning to catch up, and NFTs consume nearly as much energy as a small country. Without NFT regulation, climate change catastrophes are likely to be evident sooner than expected. 
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In Theory and In Practice: The Teaching Equitable Asian American Community History Act

Posted on February 7, 2022Categories Uncategorized

As we ring in the new year, there is a lot to celebrate in Illinois education law, including the Teaching Equitable Asian American Community History Act (TEAACH). TEAACH, which was signed into law by Illinois Governor J.B. Pritzker in July 2021, officially makes Illinois the first state to require public schools to teach a unit of Asian American History. With the law taking effect during the 2022-2023 school year, most Illinois schools must change their current elementary and high school curriculum starting this year.
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Sustainability en vogue — More Than Just a Fleeting Fashion Trend

Posted on February 25, 2022Categories Uncategorized

“Sustainable,” “eco-friendly,” “ethical,” “recycled” — all buzzwords you might see the next time you’re shopping for a new outfit, designed to make you as a consumer feel like you’re making better choices to help reduce your carbon footprint. But what do those buzzwords really mean — is there any traceable impact the company has made to reduce its carbon footprint? In many cases, unfortunately not. The fashion industry has a major impact on climate change. It is estimated to contribute between 4 and 8.6 percent of the world’s greenhouse gases, and for the most part is largely unregulated. Any efforts to increase sustainability, such as by reducing pollution or eliminating labor abuses, are predominately voluntary commitments with little to no repercussions for failing to uphold those commitments.
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