Category:The Marketplace
Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?
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.
Regulating Crypto Markets through the Build Back Better Act: Crypto Investors’ Future Compliance with Wash Sale Rules
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.
Stadiums, Casinos, and Riverboats: Illinois and Chicago Hedging Their Bets on the Future of Gambling Regulations
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.
The DOJ Challenges Penguin Random House’s Acquisition of Simon & Schuster
In the United States, “The Big Five” denote the largest five publishing houses. These publishing empires print everything from medical textbooks to children’s books and together control over eighty percent of the publishing market. The Big Five includes Penguin Random House, HarperCollins, Simon & Schuster, Hachette, and Macmillan. In November of 2020, Viacom announced the sale of Simon & Schuster to Penguin Random House for $2.175 billion. A year later on November 2, 2021, the U.S. Department of Justice announced a lawsuit challenging the acquisition to ensure “fair competition in the U.S. publishing industry.”
Price Control Legislation for Generic Drugs – A Delaware Case Study
Price Control Legislation for Generic Drugs – A Delaware Case Study Andrew Thompson Associate Editor Loyola University Chicago School of Law, JD 2023 Earlier, I wrote here about how American drug prices are approximately 256 to 344 percent higher than prices in OCED member markets. Federal legislators confronting patent extensions, pay-for-delay agreements, and other tools …
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The Story That Sounded Too Good to Be True Was, Indeed, Too Good to Be True.
The process of the criminal trial of the youngest woman self-made billionaire, has recently started up again after being stalled due to Covid restrictions in the past year. Former CEO and founder of Theranos, Elizabeth Holmes, and her former president and one-time boyfriend, Ramesh Balwani, have been accused of misleading investors and raising hundreds of millions of dollars by making false or exaggerated claims in defiance of the anti-fraud provisions of federal securities laws. While she is currently facing a federal indictment on twelve different charges, including two counts of conspiracy to commit wire fraud and ten counts of wire fraud, Holmes has already settled her civil charges, which were brought forth by the Securities Exchange Commission (SEC). The civil charges brought forth by the SEC have now put Silicon Valley on alert by ensuring that technology companies who claim that they have a new groundbreaking technology that can change the world must be based on factual evidence, not purely myths.
A Case for Regulating Facebook
Recently, whistleblower Frances Haugen testified before a Senate subcommittee that Facebook has been deliberately putting its own profits before users’ safety. As Facebook’s former product manager for civic misinformation, Haugen calls for federal regulation of social media platforms and asserts that Facebook will not solve what she calls a “crisis” of deliberately ignoring users’ wellbeing for the sake of its own profits without Congress’s help. She points to tobacco, automobiles, and opioids, stating that when it became clear that those products were harming people, the government took action.
Talk Kickback to Me: Healthcare Provider Remuneration by Big Pharma
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
FDA-USPTO Collaboration and Bipartisan Efforts to Lower Drug Prices
The Food and Drug Administration (FDA) has partnered with the Patent and Trademark Office (USPTO) to address the high cost of prescription drugs. While the FDA possesses the authority to approve generic, lower cost drugs, the USPTO has an important and symbiotic role in bringing affordable drugs to market by blocking anti-competitive patent extensions. FDA-USPTO collaboration has gained congressional support and is the subject of key pieces of new legislation.
NCAA Name, Image and Likeness Legislation Raises Concerns
On June 29, 2021, Illinois Governor J.B. Pritzker signed a bill into law that allows collegiate student-athletes to hire agents and sign endorsement deals effective as of July 1, 2021. This bill puts Illinois among a number of states which have begun to pass legislation allowing student-athletes to receive payment for the use of their name, image, and likeness (“NIL”). While these laws open opportunities for student-athletes, they also present several potential challenges to the NCAA, the governing body for collegiate athletics in the United States, and its member institutions barring any Congressional assistance.